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11,500 | 26,422,811 | Evidence from individual studies was largely of low quality ( study design limitations , imprecision ) , and suggested that pain and functional disability , but not sick leave , were significantly reduced following a multi-modal intervention ( manual therapy , exercise and education ) for low-back and pelvic pain .
Evidence from single studies suggests that acupuncture or craniosacral therapy improves pregnancy-related pelvic pain , and osteomanipulative therapy or a multi-modal intervention ( manual therapy , exercise and education ) may also be of benefit . | BACKGROUND More than two-thirds of pregnant women experience low-back pain and almost one-fifth experience pelvic pain .
The two conditions may occur separately or together ( low-back and pelvic pain ) and typically increase with advancing pregnancy , interfering with work , daily activities and sleep .
OBJECTIVES To up date the evidence assessing the effects of any intervention used to prevent and treat low-back pain , pelvic pain or both during pregnancy . | Background Trigger points have been shown to be active in many myofascial pain syndromes . Treatment of trigger point pain and dysfunction may be explained through the mechanisms of central and peripheral paradigms . This study aim ed to investigate whether the mind/body treatment of Neuro Emotional Technique ( NET ) could significantly relieve pain sensitivity of trigger points presenting in a cohort of chronic neck pain sufferers . Methods Sixty participants presenting to a private chiropractic clinic with chronic cervical pain as their primary complaint were sequentially allocated into treatment and control groups . Participants in the treatment group received a short course of Neuro Emotional Technique that consists of muscle testing , general semantics and Traditional Chinese Medicine . The control group received a sham NET protocol . Outcome measurements included pain assessment utilizing a visual analog scale and a pressure gauge algometer . Pain sensitivity was measured at four trigger point locations : suboccipital region ( S ) ; levator scapulae region ( LS ) ; sternocleidomastoid region ( SCM ) and temporom and ibular region ( TMJ ) . For each outcome measurement and each trigger point , we calculated the change in measurement between pre- and post- treatment . We then examined the relationships between these measurement changes and six independent variables ( i.e. treatment group and the above five additional participant variables ) using forward stepwise General Linear Model . Results The visual analog scale ( 0 to 10 ) had an improvement of 7.6 at S , 7.2 at LS , 7.5 at SCM and 7.1 at the TMJ in the treatment group compared with no improvement of at S , and an improvement of 0.04 at LS , 0.1 at SCM and 0.1 at the TMJ point in the control group , ( P < 0.001 ) . Conclusion After a short course of NET treatment , measurements of visual analog scale and pressure algometer recordings of four trigger point locations in a cohort of chronic neck pain sufferers were significantly improved when compared to a control group which received a sham protocol of NET . Chronic neck pain sufferers may benefit from NET treatment in the relief of trigger point sensitivity . Further research including long-term r and omised controlled trials for the effect of NET on chronic neck pain , and other chronic pain syndromes are recommended . Trial Registration This trial has been registered and allocated the Australian Clinical Trials Registry ( ACTR ) number ACTRN012607000358448 . The ACTR has met the requirements of the ICMJE 's trials registration policy and is an ICMJE acceptable registry Background This pilot r and omized controlled trial evaluated the feasibility of conducting a full scale study and compared the efficacy of exercise , spinal manipulation , and a mind-body therapy called Neuro Emotional Technique for the treatment of pregnancy-related low back pain , a common morbidity of pregnancy . Methods Healthy pregnant women with low back pain of insidious onset were eligible to enroll in the study at any point in their pregnancy . Once enrolled , they remained in the study until they had their babies . Women were r and omly allocated into one of three treatment groups using opaque envelopes . The treatment schedule paralleled the prenatal care schedule and women received individualized intervention . Our null hypothesis was that spinal manipulation and Neuro Emotional Technique would perform no better than exercise in enhancing function and decreasing pain . Our primary outcome measure was the Rol and Morris Disability Question naire and our secondary outcome measure was the Numeric Pain Rating Scale . Intention to treat analysis was conducted . For the primary analysis , regression was conducted to compare groups on the outcome measure scores . In a secondary responder analysis , difference in proportions of participants in attaining 30 % and 50 % improvement were calculated . Feasibility factors for conducting a future larger trial were also evaluated such as recruitment , compliance to study protocol s , cost , and adverse events . Results Fifty-seven participants were r and omized into the exercise ( n = 22 ) , spinal manipulation ( n = 15 ) , and Neuro Emotional Technique ( n = 20 ) treatment arms . At least 50 % of participants in each treatment group experienced clinical ly meaningful improvement in symptoms for the Rol and Morris Disability Question naire . At least 50 % of the exercise and spinal manipulation participants also experienced clinical ly meaningful improvement for the Numeric Pain Rating Scale . There were no clinical ly meaningful or statistically significant differences between groups in any analysis . Conclusions This pilot study demonstrated feasibility for recruitment , compliance , safety , and affordability for conducting a larger study in the future . Spinal manipulation and exercise generally performed slightly better than did Neuro Emotional Technique for improving function and decreasing pain , but the study was not powered to detect the between-group differences as statistically significant . Trial registration Clinical Trials.gov ( Identifier : NCT00937365 ) OBJECTIVE Pregnancy-related lumbopelvic pain is a major problem for the majority of pregnant women . Complementary medicine has been used to alleviate pain , and yoga is one of the most commonly chosen alternative methods . The objective of this study was to assess the effectiveness of Hatha yoga in the reduction of lumbopelvic pain in pregnancy . METHODS A r and omized controlled trial with 60 pregnant women ( age range , 14 - 40 years ) who reported lumbopelvic pain at 12 to 32 weeks of gestation was conducted from June 2009 to June 2011 . Pregnant women who had twin pregnancies , had medical restrictions for exercise , used analgesics , and participated in physical therapy were excluded from the study . Pregnant women were divided into two groups : the yoga group , practicing exercises guided by this method , and the postural orientation group , performing st and ardized posture orientation according to instructions provided in a pamphlet . Treatment in each group lasted 10 weeks . A visual analog scale ( VAS ) was used to measure pain intensity . Lumbar pain and posterior pelvic pain provocation tests were used to confirm the presence of pain . Statistical analysis included the Mann-Whitney test , the McNemar test , a paired Wilcoxon test , and analysis of covariance . RESULTS The median pain score was lower in the yoga group ( p<.0058 ) than the postural orientation group . Lumbar pain provocation tests showed a decreased response in relation to posterior pelvic pain provocation tests and a gradual reduction in pain intensity during 10 yoga sessions ( p<.024 ) . CONCLUSIONS The yoga method was more effective at reducing lumbopelvic pain intensity compared with postural orientation Background Both maternal pre-pregnancy obesity and excessive gestational weight gain are increasing in prevalence and associated with a number of adverse pregnancy outcomes for both mother and child . Observational studies regarding physical activity in pregnancy have found reduced weight gain in active mothers , as well as reduced risk of adverse pregnancy outcomes . There is however a lack of high quality , r and omized controlled trials on the effects of regular exercise training in pregnancy , especially those with a pre-pregnancy body mass index ( BMI ) at or above 30 kg/m2 . Methods We are conducting a r and omised , controlled trial in Norway with two parallel arms ; one intervention group and one control group . We will enroll 150 previously sedentary , pregnant women with a pre-pregnancy BMI at or above 30 kg/m2 . The intervention group will meet for organized exercise training three times per week , starting in gestation week 14 ( range 12 - 16 ) . The control group will get st and ard antenatal care . The main outcome measure will be weight gain from baseline to delivery . Among the secondary outcome measures are changes in exercise capacity , endothelial function , physical activity level , body composition , serum markers of cardiovascular risk , incontinence , lumbopelvic pain and cardiac function from baseline to gestation week 37 ( range 36 - 38 ) . Offspring outcome measures include anthropometric variables at birth , Apgar score , as well as serum markers of inflammation and metabolism in cord blood . Discussion The results of this trial will provide knowledge about effects of regular exercise training in previously sedentary , obese pregnant women . If the program proves effective in reducing gestational weight gain and adverse pregnancy outcomes , such programs should be considered as part of routine pregnancy care for obese women . Trial Registration Clinical Trials.gov : Background Previous publications indicate that acupuncture is efficient for the treatment of pelvic girdle pain , PGP , in pregnant women . However , the use of acupuncture for PGP is rare due to insufficient documentation of adverse effects of this treatment in this specific condition . The aim of the present work was to assess adverse effects of acupuncture on the pregnancy , mother , delivery and the fetus/neonate in comparison with women that received stabilising exercises as adjunct to st and ard treatment or st and ard treatment alone . Methods In all , 386 women with PGP entered this controlled , single-blind trial . They were r and omly assigned to st and ard treatment plus acupuncture ( n = 125 ) , st and ard treatment plus specific stabilising exercises ( n = 131 ) or to st and ard treatment alone ( n = 130 ) for 6 weeks . Acupuncture that may be considered strong was used and treatment was started as early as in the second trimester of pregnancy . Adverse effects were recorded during treatment and throughout the pregnancy . Influence on the fetus was measured with cardiotocography ( CTG ) before-during and after 43 acupuncture sessions in 43 women . A st and ardised computerized method to analyze the CTG reading numerically ( Oxford 8000 , Oxford , Engl and ) was used . After treatment , the women rated their overall experience of the treatment and listed adverse events if any in a question naire . Data of analgesia and oxytocin augmentation during labour , duration of labour , frequency of preterm birth , operative delivery , Apgar score , cord-blood gas/acid base balance and birth weight were also recorded . Results There were no serious adverse events after any of the treatments . Minor adverse events were common in the acupuncture group but women rated acupuncture favourably even despite this . The computerized or visually assessed CTG analyses of antenatal recordings in connection with acupuncture were all normal . Conclusion This study shows that acupuncture administered with a stimulation that may be considered strong led to minor adverse complaints from the mothers but had no observable severe adverse influences on the pregnancy , mother , delivery or the fetus/neonate Background : To compare the efficiency of transcutaneous electrical nerve stimulation ( TENS ) with those of exercise and acetaminophen for the treatment of pregnancy-related low back pain ( LBP ) during the third trimester of pregnancy . Methods : This prospect i ve study included 79 subjects ( ≥32 gestational weeks ) with visual analog scale ( VAS ) pain scores ≥5 . Participants were divided r and omly into a control group ( n = 21 ) and three treatment groups [ exercise ( n = 19 ) ; acetaminophen ( n = 19 ) ; TENS ( n = 20 ) ] . The VAS and the Rol and -Morris disability question naire ( RMDQ ) were completed before and 3 weeks after treatment to assess the impact of pain on daily activities . Results : During the study period , pain intensity increased in 57 % of participants in the control group , whereas pain decreased in 95 % of participants in the exercise group and in all participants in the acetaminophen and TENS groups . Post-treatment VAS and RMDQ values were significantly lower in the treatment groups ( p < 0.001 ) . VAS and RMDQ scores indicated a significantly greater degree of pain relief in the TENS group than in the exercise and acetaminophen groups ( p < 0.001 ) . No adverse effect of TENS application on pregnant women was observed during the study . Conclusion : TENS is an effective and safe treatment modality for LBP during pregnancy . TENS improved LBP more effectively than did exercise and acetaminophen Background . Low back and pelvic pain is common in pregnancy and postpartum , but there is no well documented effect of treatment in pregnancy . The aim of the study was to assess whether a group intervention program for pregnant women with pelvic girdle pain has any effect on pain and daily function postpartum . Methods . Pregnant women with pelvic pain between the 18th and 32nd week of gestation were invited to participate in a r and omized clinical study . Among 958 examined women , 569 ( 59 % ) fulfilled the inclusion criteria . Women r and omized to the intervention group ( n = 275 ) participated in an education program that consisted of information , ergonomics , exercises , pain management , advice for daily life movement , pelvic belt/crutches , and information about delivery . Women r and omized to the control group ( n = 285 ) were not offered any treatment , but were free to seek advice or other treatment . Clinical measures and self‐evaluated utility of the intervention were measured by a visual analogue scale 0–10 . Results . Mean debut of pelvic girdle pain in pregnancy was at week 15 . Altogether 42 % of the women reported problems with low back pain earlier , and 34 % reported a family history of pelvic girdle pain in pregnancy . Median visual analogue scale score for all activities at inclusion was 6 both in the control group and the intervention group . At 6 and 12 months postpartum the score was reduced to 1.7/1.6 and 1.1/0.9 . In the intervention group , 75 % marked a self‐evaluated utility visual analogue scale score > 7 . In the control group , 60 % had search ed for alternative treatment . Conclusions . Postpartum pelvic girdle pain improved with time both in the intervention group and the control group , but there were no statistically significant differences between the groups . Self‐evaluated utility of the intervention was , however , high in the intervention group OBJECTIVE To investigate the effect of an exercise program , including specific stabilizing exercises , on pain intensity and functional ability in women with pregnancy-related low back pain . METHODS Fifty women between 16 and 24 weeks of pregnancy were recruited at Tygerberg and Paarl Hospitals , Western Cape , South Africa . Twenty-six women were r and omized to a 10-week exercise program and 24 were r and omized as controls . RESULTS Overall , the most frequent type of back pain experienced was lumbar pain ( 36 [ 72.0 % ] ) . Pain intensity ( P=0.76 ) and functional ability ( P=0.29 ) were comparable between the groups on study entry . In the study group , there was a significant improvement in pain intensity ( P<0.01 ) and an improvement in functional ability ( P=0.06 ) at the end of the study . In the control group , there were no significant changes in pain intensity ( P=0.89 ) or functional ability ( P=0.70 ) at the end of the study . CONCLUSION A specific exercise program decreased back pain intensity and increased functional ability during pregnancy in South African women with lumbar and pelvic girdle pain This study was undertaken to investigate the effects of acupuncture in low back and pelvic pain during pregnancy under real life conditions , as compared with patients undergoing conventional treatment alone . A total of 61 conventionally treated pregnant women were allocated r and omly into two groups to be treated or not by acupuncture . Twenty-seven patients formed the study group and 34 the control group . They reported the severity of pain using a Numerical Rating Scale from 0 to 10 , and their capacity to perform general activities , to work , and to walk . We also assessed the use of analgesic drugs . Women were followed up for eight weeks and interviewed five times , at two-week intervals . All women completed the study . In the study group the average pain during the study period showed a larger reduction ( 4.8 points ) than the control group ( −0.3 points ) ( P<0.0001 ) . Average pain scores decreased by at least 50 % over time in 21 ( 78 % ) patients in the acupuncture group and in five ( 15 % ) patients in the control group ( P<0.0001 ) . Maximum pain and pain at the moment of interview were also less in the acupuncture group compared with the control group . The capacity to perform general activities , to work and to walk was improved significantly more in the study group than in the control group ( P<0.05 ) . The use of paracetamol was lower in the acupuncture group ( P<0.01 ) . These results indicate that acupuncture seems to alleviate low back and pelvic pain during pregnancy , as well as to increase the capacity for some physical activities and to diminish the need for drugs , which is a great advantage during this period Objective . To study lumbopelvic pain in women r and omized to a regular exercise program during pregnancy in comparison to women receiving st and ard antenatal care . Design . A two‐armed , two‐center , r and omized controlled trial . Setting . St Olavs Hospital , Trondheim University Hospital and Stavanger University Hospital . Population . A total of 855 pregnant women were r and omized to intervention or control groups . Methods . The intervention was a 12 week exercise program , including aerobic and strengthening exercises , conducted between 20 and 36 weeks of pregnancy . One weekly group session was led by physiotherapists , and home exercises were encouraged twice a week . The control group received st and ard antenatal care . Main outcome measures . Self‐reports of lumbopelvic pain and sick leave due to lumbopelvic pain . The data were analysed according to the “ intention‐to‐treat ” principle . Results . There were no significant differences between groups of women reporting lumbopelvic pain at 36 weeks ( 74 vs. 75 % , p=0.76 ) . The proportion of women on sick leave due to lumbopelvic pain was lower in the intervention group ( 22 % vs 31 % , p=0.01 ) . Conclusions . Exercise during pregnancy does not influence the prevalence of lumbopelvic pain , but women offered a regular exercise course seem to h and le the disorder better Background Antenatal preparation programmes are recommended worldwide to promote a healthy pregnancy and greater autonomy during labor and delivery , prevent physical discomfort and high levels of anxiety . The objective of this study was to evaluate effectiveness and safety of a birth preparation programme to minimize lumbopelvic pain , urinary incontinence , anxiety , and increase physical activity during pregnancy as well as to compare its effects on perinatal outcomes comparing two groups of nulliparous women . Methods A r and omized controlled trial was conducted with 197 low risk nulliparous women aged 16 to 40 years , with gestational age ≥ 18 weeks . Participants were r and omly allocated to participate in a birth preparation programme ( BPP ; n=97 ) or a control group ( CG ; n=100 ) . The intervention was performed on the days of prenatal visits , and consisted of physical exercises , educational activities and instructions on exercises to be performed at home . The control group followed a routine of prenatal care . Primary outcomes were urinary incontinence , lumbopelvic pain , physical activity , and anxiety . Secondary outcomes were perinatal variables . Results The risk of urinary incontinence in BPP participants was significantly lower at 30 weeks of pregnancy ( BPP 42.7 % , CG 62.2 % ; relative risk [ RR ] 0.69 ; 95 % confidence interval [ CI ] 0.51 - 0.93 ) and at 36 weeks of pregnancy ( BPP 41.2 % , CG 68.4 % ; RR 0.60 ; 95%CI 0.45 - 0.81 ) . Participation in the BPP encouraged women to exercise during pregnancy ( p=0.009 ) . No difference was found between the groups regarding to anxiety level , lumbopelvic pain , type or duration of delivery and weight or vitality of the newborn infant . Conclusions The BPP was effective in controlling urinary incontinence and to encourage the women to exercise during pregnancy with no adverse effects to pregnant women or the fetuses . Trial registration Clinical trials.gov , ( NCT01155804 Study Design . R and omized double blind controlled clinical trial . Objective . To evaluate the pain relief effect of locally injected corticosteroid treatment in women with long-lasting sacral low back pain with onset during pregnancy . Summary of Background Data . Pregnancy-related low back pain is a global problem . Almost 1 of 10 women still experienced disabling daily back pain 2 years after childbirth with high impact on the individual , family , and society . On spite of this , the sources of pain and effective treatment are uncertain . Methods . Thirty-six women were allocated to injection treatment , with slow-release triamcinolone and lidocaine or saline and lidocaine , given at the sacrospinous ligament insertion on the ischiadic spine bilaterally with 4 weeks follow-up time . Primary outcome measure was reported pain intensity on visual analogue scale and secondary outcome measures number of pain-drawing locations and pain-provoking test results . Results . The triamcinolone treatment group had significantly reduced pain intensity , number of pain locations , and pain-provoking test results between baseline and follow-up as compared with the saline treatment group . The absolute median change of visual analogue scale score in the triamcinolone treatment group was −24 mm and in the saline group + 4.5 mm ( P < 0.05 ) . A reduced number of pain drawing locations was reported by 16 of 18 women in the triamcinolone group as compared with 10 of 18 in the saline group ( P < 0.05 ) . In the triamcinolone treatment group , 17 of 18 women had an improved pain provocation test result as compared with 9 of 18 in the saline treatment group ( P < 0.01 ) . Conclusion . The anatomic region around the sacrospinous ligament insertion on the ischial spine is suggested to be one source of long-lasting sacral low back pain with onset during pregnancy . The pain was relieved by slow-release corticosteroid injection treatment to the ischial spine OBJECTIVE Women commonly experience low back pain during pregnancy . We examined whether a multimodal approach of musculoskeletal and obstetric management ( MOM ) was superior to st and ard obstetric care to reduce pain , impairment , and disability in the antepartum period . STUDY DESIGN A prospect i ve , r and omized trial of 169 women was conducted . Baseline evaluation occurred at 24 - 28 weeks ' gestation , with follow-up at 33 weeks ' gestation . Primary outcomes were the Numerical Rating Scale ( NRS ) for pain and the Quebec Disability Question naire ( QDQ ) . Both groups received routine obstetric care . Chiropractic specialists provided manual therapy , stabilization exercises , and patient education to MOM participants . RESULTS The MOM group demonstrated significant mean reductions in Numerical Rating Scale scores ( 5.8 ± 2.2 vs 2.9 ± 2.5 ; P < .001 ) and Quebec Disability Question naire scores ( 4.9 ± 2.2 vs 3.9 ± 2.4 ; P < .001 ) from baseline to follow-up evaluation . The group that received st and ard obstetric care demonstrated no significant improvements . CONCLUSION A multimodal approach to low back and pelvic pain in mid pregnancy benefits patients more than st and ard obstetric care OBJECTIVE To study osteopathic manipulative treatment of back pain and related symptoms during the third trimester of pregnancy . STUDY DESIGN A r and omized , placebo-controlled trial was conducted to compare usual obstetric care and osteopathic manipulative treatment , usual obstetric care and sham ultrasound treatment , and usual obstetric care only . Outcomes included average pain levels and the Rol and -Morris Disability Question naire to assess back-specific functioning . RESULTS Intention-to-treat analyses included 144 subjects . The Rol and -Morris Disability Question naire scores worsened during pregnancy ; however , back-specific functioning deteriorated significantly less in the usual obstetric care and osteopathic manipulative treatment group ( effect size , 0.72 ; 95 % confidence interval , 0.31 - 1.14 ; P = .001 vs usual obstetric care only ; and effect size , 0.35 ; 95 % confidence interval , -0.06 to 0.76 ; P = .09 vs usual obstetric care and sham ultrasound treatment ) . During pregnancy , back pain decreased in the usual obstetric care and osteopathic manipulative treatment group , remained unchanged in the usual obstetric care and sham ultrasound treatment group , and increased in the usual obstetric care only group , although no between-group difference achieved statistical significance . CONCLUSION Osteopathic manipulative treatment slows or halts the deterioration of back-specific functioning during the third trimester of pregnancy OBJECTIVE To investigate if water-gymnastics during pregnancy may reduce the intensity of back/low back pain and the number of days on sick-leave . METHODS A prospect i ve , r and omized study . One hundred and twenty-nine women were r and omized to participate in water-gymnastics once a week during the second half of pregnancy and 129 were r and omized to a control group . The women in both groups filled in question naires in gestational weeks 18 , 34 and within the first postpartum week . Every day from week 18 to labor they assessed the intensity of back/low back pain . RESULTS Back pain intensity increased during pregnancy . No excess risk for the pregnancy associated with water-gymnastics was observed . The women participating in water-gymnastics recorded a lower intensity of back/low back pain . The total number of days on sick-leave because of back/low back pain was 982 in the water-gymnastics group ( 124 women ) compared with 1484 in the control group ( 120 women ) . After weeks 32 33 , seven women in the water-gymnastics group compared with 17 in the control group were on sickleave because of back/ low back pain ( p=0.031 ) . CONCLUSIONS Intensity of back/low back pain increased with advancing pregnancy . There was no excess risk for urinary or vaginal infections associated with water-gymnastics . Water-gymnastics during the second half of pregnancy significantly reduced the intensity of back/ low back pain . Water-gymnastics decreased the number of women on sick-leave because of back/low back pain . Water-gymnastics during pregnancy can be recommended as a method to relieve back pain and may reduce the need for sick-leave Lower back pain and lordosis are among the most common complications during pregnancy ; their frequency in pregnant women is 4 times that in non-pregnant women [ 1 ] . The present study evaluated the effect of exercise on back pain during pregnancy . Inclusion criteria were maternal age of 20–30 years ; nulliparity ; gestational age of 16 weeks ( according to reliable last menstrual period and ultrasound confirmation in the first trimester ) ; and no regular exercise before entering the study . Exclusion criteria were any kind of systemic disorder or drug use ; any previous trauma , surgery , or damage to the spine or lower limbs ; any complications of pregnancy such as preterm labor , abortion , or pelvic pain ; and absence from the study exercise program on at least 3 occasions . All eligible women completed the Rol and –Morris question naire [ 2 ] , and lordosis was measured using a flexible ruler and the formula Θ=4 × [a rct an(2H/L ) ] ( Fig. 1 ) ; these measurements were repeated after 1 and 2 months . The participants were r and omly assigned to either the study group or the control group . In the study group ( n=15 ) , there was an initial 1-hour training session in which 7 main exercises — together with preparation and relaxation movements — were taught to the participants , who then performed 30 minutes of exercise 3 times per week Table 1 Prevalence of PAI-1 4G/5 G polymorphisms in the different groups of women studied Background About 45 % of all pregnant women suffer low back pain and /or pelvic girdle pain ( LBPGP ) . This study seeks to evaluate the effect of auricular acupuncture on LBPGP compared with placebo auricular acupuncture and with st and ard obstetric care in the field of primary health care . Methods and design This study will be a four-parallel-arm , multicentre , r and omised , placebo-controlled trial . A total of 212 pregnant women ( 24 to 36 weeks ’ gestation ) , aged at least 17 years , with LBPGP , will be r and omly assigned to the verum auricular acupuncture plus st and ard obstetric care group ( VAAc ) , to the non-specific auricular acupuncture plus st and ard obstetric care group ( NSAAc ) , to the non-specific placebo auricular acupuncture plus st and ard obstetric care group ( PAAc ) , or the st and ard obstetric care group ( SOC ) . The VAAc , NSAAc , and PAAc groups will receive treatment at three auricular acupuncture points ( specific points for the VAAc group or non-specific ones for the NSAAc and PAAc groups ) , once a week for 2 weeks ; the SOC group will receive only st and ard obstetric care during the same period . The primary outcome will be the reduction in pain intensity , according to the visual analogue scale ( iVAS ) , at 2 weeks after the start of treatment . The secondary outcomes will be functional status with respect to LBPGP ( according to the Rol and -Morris disability question naire ) , health-related quality of life ( SF12 ) at 2 weeks after the start of treatment , and iVAS at 12 and 48 weeks postpartum . Discussion This trial will implement a high- quality methodology and may provide evidence for the efficacy , safety , and specificity of auricular acupuncture as a treatment for pregnant women with LBPGP.Trial registration Current Controlled Trials IS RCT N41033073 ( date 20/03/2014 ) Abstract Objectives To compare the efficacy of st and ard treatment , st and ard treatment plus acupuncture , and st and ard treatment plus stabilising exercises for pelvic girdle pain during pregnancy . Design R and omised single blind controlled trial . Setting s East Hospital , Gothenburg , and 27 maternity care centres in Sweden . Participants 386 pregnant women with pelvic girdle pain . Interventions Treatment for six weeks with st and ard treatment ( n = 130 ) , st and ard treatment plus acupuncture ( n = 125 ) , or st and ard treatment plus stabilising exercises ( n = 131 ) . Main outcome measures Primary outcome measure was pain ( visual analogue scale ) ; secondary outcome measure was assessment of severity of pelvic girdle pain by an independent examiner before and after treatment . Results After treatment the stabilising exercise group had less pain than the st and ard group in the morning ( median difference = 9 , 95 % confidence interval 1.7 to 12.8 ; P = 0.0312 ) and in the evening ( 13 , 2.7 to 17.5 ; P = 0.0245 ) . The acupuncture group , in turn , had less pain in the evening than the stabilising exercise group ( −14 , −18.1 to −3.3 ; P = 0.0130 ) . Furthermore , the acupuncture group had less pain than the st and ard treatment group in the morning ( 12 , 5.9 to 17.3 ; P < 0.001 ) and in the evening ( 27 , 13.3 to 29.5 ; P < 0.001 ) . Attenuation of pelvic girdle pain as assessed by the independent examiner was greatest in the acupuncture group . Conclusion Acupuncture and stabilising exercises constitute efficient complements to st and ard treatment for the management of pelvic girdle pain during pregnancy . Acupuncture was superior to stabilising exercises in this study Background . The study was design ed to evaluate the analgesic effect and possible adverse effects of acupuncture for pelvic and low‐back pain during the last trimester of pregnancy Background Many women have low back pain ( LBP ) or pelvic girdle pain ( PGP ) during pregnancy , but there is limited evidence of effective primary and secondary preventive strategies . Objective The purpose of this study was to investigate whether a group-based exercise program can reduce the prevalence and severity of LBP and PGP in pregnant women . Design An observer-blinded r and omized controlled trial with equal assignments to a training group and a control group was conducted . Setting The study was conducted in primary care maternity units in 2 suburban municipalities in the southeastern part of Norway . Patients The participants were 257 pregnant women who were healthy and between 18 and 40 years of age before gestation week 20 . Intervention The training group received supervised exercises in groups once a week , and the control group received st and ard care . Measurements The main outcome measures were self-reported LBP and self-reported PGP . Secondary outcome measures were pain intensity in the morning and evening , disability , and 8-Item Short-Form Health Survey ( SF-8 ) Physical Component Summary ( PCS ) and Mental Component Summary ( MCS ) scores . Follow-up measurements were performed at gestation weeks 24 , 28 , 32 , and 36 . Results Overall , there was no effect of the program on the prevalence of PGP ( odds ratio=1.03 , 95 % confidence interval [CI]=0.66 to 1.59 ) or LBP ( odds ratio=0.77 , 95 % CI=0.50 to 1.19 ) . For the secondary outcomes , the estimated mean differences between the groups were −0.4 ( 95 % CI=−0.8 to 0.1 ) for pain intensity in the morning , −0.4 ( 95 % CI=−1.0 to 0.2 ) for pain intensity in the evening , −1.0 ( 95 % CI=−2.2 to 0.0 ) for disability , 1.8 ( 95 % CI=0.0 to 3.7 ) for the SF-8 PCS , and −0.6 ( 95 % CI=−2.2 to 1.4 ) for the SF-8 MCS . Limitations Due to low statistical power , the estimates for the primary outcomes are imprecise . Conclusions Supervised group exercise did not reduce the prevalence of LBP or PGP in pregnancy BACKGROUND AND PURPOSE Symphysis pubis pain is a significant problem for some pregnant women . The purpose of this study was to investigate the effects of exercise , advice , and pelvic support belts on the management of symphysis pubis dysfunction during pregnancy . SUBJECTS Ninety pregnant women with symphysis pubis dysfunction were r and omly assigned to 3 treatment groups . METHODS A r and omized masked prospect i ve experimental clinical trial was conducted . Specific muscle strengthening exercises and advice concerning appropriate methods for performing activities of daily living were given to the 3 groups , and 2 of the groups were given either a rigid pelvic support belt or a nonrigid pelvic support belt . The dependent variables , which were measured before and after the intervention , were a Rol and -Morris Question naire score , a Patient-Specific Functional Scale score , and a pain score ( 101-point numerical rating score ) . RESULTS After the intervention , there was a significant reduction in the Rol and -Morris Question naire score , the Patient-Specific Functional Scale score , and the average and worst pain scores in all groups . With the exception of average pain , there were no significant differences between groups for the other measures . DISCUSSION AND CONCLUSION The findings indicate that the use of either a rigid or a nonrigid pelvic support belt did not add to the effects provided by exercise and advice OBJECTIVE The primary aim of this study was to examine whether 1 week of continuous auricular acupuncture could reduce low back and posterior pelvic pain associated with pregnancy . STUDY DESIGN A r and omized controlled trial was conducted on pregnant women who have lower back and posterior pelvic pain . These women were r and omly assigned into an acupuncture group , a sham acupuncture group , or a waiting list control group . All participants were monitored for 2 weeks . RESULTS Baseline and day 7 showed significant group differences in pain ( F = 15 ; P < .0001 ) and in the disability rating index score ( F = 7 ; P < .0001 ) . The participants in the acupuncture group reported a significant reduction of pain and improvement of functional status as compared with those in the sham acupuncture and control groups . CONCLUSION One week of continuous auricular acupuncture decreases the pain and disability experienced by women with pregnancy-related low back and posterior pelvic pain OBJECTIVE Pelvic girdle pain is a common complaint of pregnant women . There are limited data on comparison between the effectiveness of stabilizing exercises and lumbopelvic belt on the treatment of these patients . The objective of this study was to compare the effect of lumbopelvic belt plus information , home based pelvic girdle stabilizing exercises plus information and information alone on pain intensity , functional status and quality of life of pregnant women with pelvic girdle pain . METHODS In this r and omized clinical trial pregnant women with pelvic girdle pain ( n=105 ) were r and omly allocated to three groups ; Control group ( n=35 ) that received general information , exercise group ( n=31 ) that in addition to general information were asked to perform specific pelvic stabilizing exercises at home and belt group ( n=31 ) that received non-rigid lumbopelvic belt and the information . The primary outcome variables were pain intensity and functional status of the participants which were measured using visual analogue scale and Oswestry Disability Index ( ODI ) respectively . Quality of life of participants was measured using WHOQOL-BREF question naire . All measurements were performed at baseline , 3 and 6 weeks after the study conduction . RESULTS The pain intensity of patients in belt group in comparison to other groups was decreased significantly at both 3 and 6 weeks follow-ups . The mean score of ODI of patients in belt group was also improved more than exercise and control groups significantly . CONCLUSIONS On base of our results , it can be found that in short term lumbopelvic belt and information in treatment of pregnant women with pelvic girdle pain is superior to exercise plus information or information alone Background . Prevention of lumbopelvic pain in pregnancy has been sparsely studied . One aim of this study was to assess if a 12‐week training program during pregnancy can prevent and /or treat lumbopelvic pain . A r and omized controlled trial was conducted at Trondheim University Hospital and three outpatient physiotherapy clinics . Three hundred and one healthy nulliparous women were included at 20 weeks of pregnancy and r and omly allocated to a training group ( 148 ) or a control group ( 153 ) . Methods . The outcome measures were self‐reported symptoms of lumbopelvic pain ( once per week or more ) , sick leave , and functional status . Pain drawing was used to document the painful area of the body . The intervention included daily pelvic floor muscle training at home , and weekly group training over 12 weeks including aerobic exercises , pelvic floor muscle and additional exercises , and information related to pregnancy . Results . At 36 weeks of gestation women in the training group were significantly less likely to report lumbopelvic pain : 65/148 ( 44 % ) versus 86/153 ( 56 % ) ( p = 0.03 ) . Three months after delivery the difference was 39/148 ( 26 % ) in the training group versus 56/153 ( 37 % ) in the control group ( p = 0.06 ) . There was no difference in sick leave during pregnancy , but women in the training group had significantly ( p = 0.01 ) higher scores on functional status . Conclusions . A 12‐week specially design ed training program during pregnancy was effective in preventing lumbopelvic pain in pregnancy OBJECTIVE The purpose of this study was to evaluate the efficacy of osteopathic manipulative treatment ( OMT ) to reduce low back pain and improve functioning during the third trimester in pregnancy and to improve selected outcomes of labor and delivery . STUDY DESIGN Pregnancy research on osteopathic manipulation optimizing treatment effects was a r and omized , placebo-controlled trial of 400 women in their third trimester . Women were assigned r and omly to usual care only ( UCO ) , usual care plus OMT ( OMT ) , or usual care plus placebo ultrasound treatment ( PUT ) . The study included 7 treatments over 9 weeks . The OMT protocol included specific techniques that were administered by board-certified OMT specialists . Outcomes were assessed with the use of self-report measures for pain and back-related functioning and medical records for delivery outcomes . RESULTS There were 136 women in the OMT group : 131 women in the PUT group and 133 women in the UCO group . Characteristics at baseline were similar across groups . Findings indicate significant treatment effects for pain and back-related functioning ( P < .001 for both groups ) , with outcomes for the OMT group similar to that of the PUT group ; however , both groups were significantly improved compared with the UCO group . For secondary outcome of meconium-stained amniotic fluid , there were no differences among the groups . CONCLUSION OMT was effective for mitigating pain and functional deterioration compared with UCO ; however , OMT did not differ significantly from PUT . This may be attributed to PUT being a more active treatment than intended . There was no higher likelihood of conversion to high-risk status based on treatment group . Therefore , OMT is a safe , effective adjunctive modality to improve pain and functioning during the third trimester INTRODUCTION Back pain is commonly experienced by pregnant women . Evidence suggests that progressive muscle relaxation ( PMR ) therapy , a complementary therapy widely used by pregnant women , may improve the physical and psychological outcomes of pregnancy . The aim of this study was to investigate the effects of PMR training accompanied by music on perceived pain and quality of life ( QOL ) in pregnant women with low back pain ( LBP ) . METHODS This was a prospect i ve r and omized controlled trial . The study was design ed to examine the effects of PMR accompanied by music on pregnant women with LBP . In total , 66 pregnant women were assigned r and omly to a PMR group or a control group ( 33 women in each ) . A personal information form was used as a data collection tool ; a visual analog scale was used for measuring pain ; and the Short Form-36 was used to evaluate QOL . RESULTS The control and intervention groups were comparable at baseline . Significant differences were observed between the 2 groups after 4 and 8 weeks of intervention . The intervention group showed significant improvement in all QOL subscales after the intervention . The intervention group , but not the control group , showed significant improvement in perceived pain after the intervention . The intervention group experienced a greater decrease in perceived pain and improved QOL than the control group . DISCUSSION Our findings show that PMR accompanied by music may be an effective therapy for improving pain and QOL in pregnant women with LBP . Large r and omized studies are recommended to confirm these results OBJECTIVES The physiological changes that occur during pregnancy , including increased blood volume and cardiac output , can affect hemodynamic control , most profoundly with positional changes that affect venous return to the heart . By using Osteopathic Manipulative Treatment ( OMT ) , a body-based modality theorized to affect somatic structures related to nervous and circulatory systems , we hypothesized that OMT acutely improves both autonomic and hemodynamic control during head-up tilt and heel raise in women at 30 weeks gestation . DESIGN One hundred subjects were recruited at 30 weeks gestation . SETTING The obstetric clinics of UNTHealth in Fort Worth , TX . INTERVENTION Subjects were r and omized into one of three treatment groups : OMT , placebo ultrasound , or time control . Ninety subjects had complete data ( N=25 , 31 and 34 in each group respectively ) . MAIN OUTCOME MEASURES Blood pressure and heart rate were recorded during 5 min of head-up tilt followed by 4 min of intermittent heel raising . RESULTS No significant differences in blood pressure , heart rate or heart rate variability were observed between groups with tilt before or after treatment ( p>0.36 ) , and heart rate variability was not different between treatment groups ( p>0.55 ) . However , blood pressure increased significantly ( p=0.02 ) and heart rate decreased ( p<0.01 ) during heel raise after OMT compared to placebo or time control . CONCLUSIONS These data suggest that OMT can acutely improve hemodynamic control during engagement of the skeletal muscle pump and this was most likely due to improvement of structural restrictions to venous return Study Design This study analyzed an education and training program concerning back and pelvic problems among pregnant women . Objective The program was aim ed at reducing tack and pelvic posterior pain during pregnancy . Summary of Background Data Low back and posterior pelvic pain accounts for the majority of sick leave among pregnant women . No previous study has suggested any type of solution to this problem . Methods Four hundred and seven consecutive pregnant women were included in the study and r and omly assigned into three groups . Group A served as controls while different degrees of interventions were made in groups B and C. Results Serious back or posterior pelvic pain developed in 47 % of all women . Pain-related problems were reduced in groups B and C ( P < 0.05 ) , and sick-leave frequency was reduced in group C ( P < 0.01 ) . For some of the women in this group pain intensity was also reduced 8 weeks post partum ( P < 0.005 ) . Weekly physical exercise before pregnancy reduced the risk for back pain problems in pregnancy ( P < 0.05 ) . A non-elastic sacro-illac belt offered some pain relief to 82 % of the women with posterior pelvic pain . Conclusions An individually design ed program reduced sick leave during pregnancy . Working with groups was less effective . Differentiation between low back and posterior pelvic pain was essential . Good physical fitness reduced the risk of back pain in a subsequent pregnency . Reduction of posterior pelvic pain by a non-elastic pelvic support was experienced by 82 % of the women with posterior pelvic pain Background . In this prospect i ve epidemiologic cohort study the aim was to identify possible risk factors for developing four different syndromes of pelvic girdle pain during pregnancy . Methods . Over a one‐year period a total of 2,269 consecutive pregnant women – at week 33 of gestation – responded to a structured question naire and underwent a thorough physical examination . Women who at baseline reported daily pain from pelvic joints and had corresponding objective findings were allocated , according to symptoms , into one of four classification groups , and followed up with question naires and physical examinations up to two years after delivery . Results . Multivariate analysis could distinguish the four pelvic pain sub groups from the “ Pelvic healthy ” group with respect to 13 of 24 variables . The pelvic girdle syndrome group revealed a history of previous low back pain , trauma of the back or pelvis , multiparae , had a relatively higher weight , a higher level of self reported stress and of job At a higher risk of developing symphysiolysis were women who were multiparae , had a relatively higher weight , and were smokers . If a woman had vocational training or a professional education , was stressed , had a poorer experience of previous delivery , had previous low back pain , trauma of back , or previous salpingitis , she had an increased risk of developing one‐sided sacroiliac syndrome . The risk factors for developing double‐sided sacroiliac syndrome were previous low back pain and trauma of the back or pelvis , multiparae , poorer relationship with spouse , and less job satisfaction . Conclusions . This study demonstrates no single dominant risk factor for developing pelvic girdle pain in pregnancy , but reveals a set of physical and psychosocial factors . The risk factors for developing pelvic girdle pain in general are : history of previous low back pain , trauma of the back or pelvis , multivariate , higher level of stress , and low job satisfaction OBJECTIVE To investigate the effect of exercise during pregnancy on the intensity of low back pain and kinematics of spine . METHOD A prospect i ve r and omized study was design ed . 107 women participated in an exercise program three times a week during second half of pregnancy for 12 weeks and 105 as control group . All filled a question naire between 17 - 22 weeks of gestation and 12 weeks later for assessment of their back pain intensity . Lordosis and flexibility of spine were measured by Flexible ruler and Side bending test , respectively , at the same times . Weight gain during pregnancy , Pregnancy length and neonatal weight were recorded . RESULT Low back pain intensity was increased in the control group . The exercise group showed significant reduction in the intensity of low back pain after exercise ( p<0.0001 ) . Flexibility of spine decreased more in the exercise group ( p<0.0001 ) . Weight gain during pregnancy , pregnancy length and neonatal weight were not different between the two groups . CONCLUSION Exercise during second half of the pregnancy significantly reduced the intensity of low back pain , had no detectable effect on lordosis and had significant effect on flexibility of spine Objective . An earlier publication showed that acupuncture and stabilising exercises as an adjunct to st and ard treatment was effective for pelvic girdle pain during pregnancy , but the post‐pregnancy effects of these treatment modalities are unknown . The aim of this follow‐up study was to describe regression of pelvic girdle pain after delivery in these women . Design . A r and omised , single blind , controlled trial . Setting . East Hospital and 27 maternity care centres in Göteborg , Sweden . Population . Some 386 pregnant women with pelvic girdle pain . Methods . Participants were r and omly assigned to st and ard treatment plus acupuncture ( n = 125 ) , st and ard treatment plus specific stabilising exercises ( n = 131 ) or to st and ard treatment alone ( n = 130 ) . Main outcome measures . Primary outcome measures : pain intensity ( Visual Analogue Scale ) . Secondary outcome measure : assessment of the severity of pelvic girdle pain by an independent examiner 12 weeks after delivery . Results . Approximately three‐quarters of all the women were free of pain 3 weeks after delivery . There were no differences in recovery between the 3 treatment groups . According to the detailed physical examination , pelvic girdle pain had resolved in 99 % of the women 12 weeks after delivery . Conclusions . This study shows that irrespective of treatment modality , regression of pelvic girdle pain occurs in the great majority of women within 12 weeks after delivery CONTEXT Back pain during pregnancy may be associated with deficits in physical functioning and disability . Research indicates that osteopathic manual treatment ( OMT ) slows the deterioration of back-specific functioning during pregnancy . OBJECTIVE To measure the treatment effects of OMT in preventing progressive back-specific dysfunction during the third trimester of pregnancy using criteria established by the Cochrane Back Review Group . DESIGN A r and omized sham-controlled trial including 3 parallel treatment arms : usual obstetric care and OMT ( UOBC+OMT ) , usual obstetric care and sham ultrasound therapy ( UOBC+SUT ) , and usual obstetric care ( UOBC ) . SETTING The Osteopathic Research Center within the University of North Texas Health Science Center in Fort Worth . PARTICIPANTS A total of 144 patients were r and omly assigned and included in intention-to-treat analyses . MAIN OUTCOME MEASURES Progressive back-specific dysfunction was defined as a 2-point or greater increase in the Rol and -Morris Disability Question naire ( RMDQ ) score during the third trimester of pregnancy . Risk ratios ( RRs ) and 95 % confidence intervals ( CIs ) were used to compare progressive back-specific dysfunction in patients assigned to UOBC+OMT relative to patients assigned to UOBC+SUT or UOBC . Numbers needed to treat ( NNTs ) and 95 % CIs were also used to assess UOBC+OMT vs each comparator . Subgroup analyses were performed using median splits of baseline scores on a numerical rating scale for back pain and the RMDQ . RESULTS Overall , 68 patients ( 47 % ) experienced progressive back-specific dysfunction during the third trimester of pregnancy . Patients who received UOBC+OMT were significantly less likely to experience progressive back-specific dysfunction ( RR , 0.6 ; 95 % CI , 0.3 - 1.0 ; P=.046 vs UOBC+SUT ; and RR , 0.4 ; 95 % CI , 0.2 - 0.7 ; P<.0001 vs UOBC ) . The effect sizes for UOBC+OMT vs UOBC+SUT and for UOBC+OMT vs UOBC were classified as medium and large , respectively . The corresponding NNTs for UOBC+OMT were 5.1 ( 95 % CI , 2.7 - 282.2 ) vs UOBC+SUT ; and 2.5 ( 95 % CI , 1.8 - 4.9 ) vs UOBC . There was no statistically significant interaction between subgroups in response to OMT . CONCLUSION Osteopathic manual treatment has medium to large treatment effects in preventing progressive back-specific dysfunction during the third trimester of pregnancy . The findings are potentially important with respect to direct health care expenditures and indirect costs of work disability during pregnancy The effect of Pycnogenol was studied in women in the third trimester of pregnancy , complaining of lower back pain , hip joint pain , pelvic pain ( pain in the inguinal region ) , pain due to varices or calf cramps . The women were supplemented with Pycnogenol at a dose of 30 mg/day without any other therapy . Alleviation of pain was evaluated by pain scores until delivery . A significant reduction of pain could be obtained compared with the control group , where no decrease in pain scores in any symptoms was reported . No unwanted effects were observed in the Pycnogenol group . These results indicate the potential of Pycnogenol to reduce pain associated with pregnancy OBJECTIVE To compare the effect of a l and -based , physical exercise program versus water aerobics on low back or pelvic pain and sick leave during pregnancy . DESIGN R and omized controlled clinical trial . SETTING Three antenatal care centers . PARTICIPANTS 390 healthy pregnant women . INTERVENTIONS A l and -based physical exercise program or water aerobic once a week during pregnancy . MAIN OUTCOME MEASURES Sick leave , pregnancy-related low back pain or pregnancy-related pelvic girdle pain , or both . RESULTS Water aerobics diminished pregnancy-related low back pain ( p=.04 ) and sick leave due to pregnancy-related low back pain ( p=.03 ) more than a l and -based physical exercise program . CONCLUSIONS Water aerobics can be recommended for the treatment of low back pain during pregnancy . The benefits of a l and -based physical exercise program are question able and further evaluation is needed Study Design . A r and omized assessor-blinded clinical trial was conducted . Objective . To compare 3 different physical therapy treatments with respect to pain and activity in women with pelvic girdle pain during pregnancy and 3 , 6 , and 12 months postpartum . Summary of Background Data . In spite of the high prevalence of back pain during pregnancy , documented treatment programs are limited . Methods . Based on a clinical examination , 118 women with pelvic girdle pain diagnosed during pregnancy were r and omized into 3 different treatment groups : Information Group , use of a nonelastic sacroiliac belt and oral/written information about pelvic girdle pain ( n = 40 ) ; Home Exercise Group , same as in the Information Group , with the addition of a home exercise program ( n = 41 ) ; and the In Clinic Exercise Group , same as in the Information Group , plus participation in a training program ( n = 37 ) . Pain intensity was rated on a visual analogue scale ( 0–100 mm ) and marked on a pain drawing concerning localization . The activity ability was scored using the Disability Rating Index , covering 12 daily activity items . Outcome measures were obtained at inclusion , on average in gestation week 38 , and 3 , 6 , and 12 months postpartum . Results . There was no significant difference among the 3 groups during pregnancy or at the follow-ups postpartum regarding pain and activity . In all groups , pain decreased and the activity ability increased between gestation week 38 and at 12 months postpartum . Conclusions . Women with pelvic girdle pain seemed to improve with time in all 3 treatment groups . Neitherhome nor in clinic exercises had any additional value above giving a nonelastic sacroiliac belt and information Study Design . A prospect i ve r and omized controlled 6‐year follow‐up study of women with back pain during pregnancy . Objectives . To describe the long‐term development of back pain in relation to pregnancy and to identify the effects of a physiotherapy and patient education program attended during pregnancy . Summary of Background Data . Pain incidence and intensity during pregnancy can be reduced by physiotherapy . No study has described the development of pain experienced for a period of years after delivery or the long‐term effect of physiotherapy . Methods . Pregnant women , registered consecutively , were r and omly assigned to one control group and to two intervention groups and were observed throughout pregnancy , with follow‐up after 3 months and 6 years . Results . The first phase of the study was completed by 362 women . After 3 months , 351 and after 6 years , 303 women had been observed . Back pain among 18 % of all women before pregnancy and among 71 % during pregnancy declined to 16 % after 6 years . Pain intensity was highest in Week 36 ( visual analog score , 5.4 ) and declined markedly 6 years later ( visual analog score , 2.5 ) . Slow regression of pain after partus correlated with having a back pain history before pregnancy , ( r = 0.30 ; P < 0.05 ) , with high pain intensity during pregnancy ( r = 0.45 ; P < 0.01 ) , and with much residual pain 3 months after pregnancy ( r = 0.41 ; P < 0.01 ) . These correlations were not found in the intervention groups . Furthermore , frequency of back pain attacks at 6 years correlated with frequency of attacks during pregnancy ( r = 0.41 ; P < 0.01 ) and with a vocational factor ( r = −0.25 ; P < 0.01 ) . Physiotherapy and patient education had no effects on back pain development among women without pain during pregnancy . Conclusions . Back pain during pregnancy regressed spontaneously soon after delivery and improved in few women later than 6 months post partum . Expected correlations between back pain in relation to pregnancy and back pain 6 years later were not present in the intervention groups who had attended a physiotherapy and education program during pregnancy . The program had no prophylactic effects on women without back or pelvic pain during pregnancy Eighty-four prenatally depressed women were r and omly assigned to yoga , massage therapy or st and ard prenatal care control groups to determine the relative effects of yoga and massage therapy on prenatal depression and neonatal outcomes . Following 12 weeks of twice weekly yoga or massage therapy sessions ( 20 min each ) both therapy groups versus the control group had a greater decrease on depression , anxiety and back and leg pain scales and a greater increase on a relationship scale . In addition , the yoga and massage therapy groups did not differ on neonatal outcomes including gestational age and birthweight , and those groups , in turn , had greater gestational age and birthweight than the control group Background . The aim of this study was to describe the effects of acupuncture in the treatment of low‐back and pelvic pain during pregnancy and compare it with physiotherapy Background . The efficacy of acupuncture on low‐back and /or pelvic pain in late pregnancy is review ed in few reports . Our aim was to evaluate the effects of two different acupuncture stimulation modes on pelvic pain intensity and some emotional symptoms due to the pain condition . Methods . In a prospect i ve r and omized controlled single‐blind study , pregnant women with pelvic pain , median gestational age 26 weeks ( range 18–35 ) , were given 10 acupuncture treatments . Needles were inserted subcutaneously over acupuncture points without further stimulation ( superficial , n=22 ) , or intramuscular and stimulated repeatedly until a perceived sensation of numbness , de qi , ( deep , n=25 ) . Self‐reported pain intensity at rest and during daily activities was assessed on a visual analog scale . The variables pain , emotional reactions , and loss of energy were assessed according to the Nottingham Health Profile question naire . Changes in assessed variables were analyzed with a nonparametric statistical method allowing for analysis of systematic group changes separated from additional individual changes . Results . After acupuncture stimulation , significant systematic group changes towards lower levels of pain intensity at rest and in daily activities as well as in rated emotional reaction and loss of energy were seen . The results also showed additional individual changes in most variables . In this study , no differences between the effects induced by the superficial and deep acupuncture stimulation modes were observed . Conclusion . Acupuncture stimulation that is individually design ed may be a valuable treatment to ameliorate suffering in the condition of pelvic pain in late pregnancy Twenty-six pregnant women were assigned to a massage therapy or a relaxation therapy group for 5 weeks . The therapies consisted of 20-min sessions twice a week . Both groups reported feeling less anxious after the first session and less leg pain after the first and last session . Only the massage therapy group , however , reported reduced anxiety , improved mood , better sleep and less back pain by the last day of the study . In addition , urinary stress hormone levels ( norepinephrine ) decreased for the massage therapy group and the women had fewer complications during labor and their infants had fewer postnatal complications ( e.g. , less prematurity ) The CONSORT statement is used worldwide to improve the reporting of r and omised controlled trials . Kenneth Schulz and colleagues describe the latest version , CONSORT 2010 , which up date s the reporting guideline based on new method ological evidence and accumulating experience . To encourage dissemination of the CONSORT 2010 Statement , this article is freely accessible on bmj.com and will also be published in the Lancet , Obstetrics and Gynecology , PLoS Medicine , Annals of Internal Medicine , Open Medicine , Journal of Clinical Epidemiology , BMC Medicine , and Trials |
11,501 | 32,168,393 | There is currently an absence of evidence to indicate the effectiveness of health education interventions involving healthcare providers or individuals or both to promote early presentation and referral for women with endometrial cancer symptoms . | BACKGROUND Diagnosis of endometrial ( womb ) cancer is normally made at an early stage , as most women with the disease experience abnormal vaginal bleeding , which prompts them to seek medical advice .
However , delays in presentation and referral can result in delay in diagnosis and management , which can lead to unfavourable treatment outcomes .
This is particularly a problem for pre- and peri-menopausal women .
Providing educational information to women and healthcare providers regarding symptoms relating to endometrial cancer may raise awareness of the disease and reduce delayed treatment .
OBJECTIVES To assess the effectiveness of health education interventions targeting healthcare providers , or individuals , or both , to promote early presentation and referral for women with endometrial cancer symptoms . | Background : Poor cancer survival rates in the United Kingdom are often blamed on delayed medical care . A local audit of endometrial cancer revealed a variety of preventable delays . We surveyed practice in the South West of Engl and to see if this was an isolated or widespread problem . Methods : All 15 hospitals in the South West of Engl and collected information prospect ively from all women with endometrial cancer over 3 months in the spring of 2009 . Results : There were delays in all stages of the uterine cancer pathway . Excluding extraneous cases , 52 % of women waited more than a month and 12 % waited more than 6 months to see their GP from the onset of symptoms . Almost half the cases said they were unaware that abnormal bleeding was a symptom of cancer . Only a quarter of women had treatment within 31 days from the outpatient visit to first definitive treatment and 18 % waited more than the target of 62 days for their treatment . Conclusions : Significant treatment delays occur because women do not report bleeding . If this is replicated throughout Britain , approximately 1000 women per year will delay presentation for at least 3 months and 600 will wait for more than 6 months OBJECTIVE To describe why , when and to whom general practitioners refer women with symptoms possibly attributable to cervical , endometrial or ovarian cancers , and to identify patient and GP factors that predict referral to either a gynaecologist or a gynaecological oncologist . DESIGN AND SETTING A national survey of GPs between 1 April and 31 August 2009 using a r and omised incomplete block design based on case vignettes , and using a self-completed postal or online question naire . PARTICIPANTS A sample of GPs , stratified by location and r and omly selected from a data base of GPs maintained by the Australasian Medical Publishing Company . MAIN OUTCOME MEASURES Proportion of vignettes that were deemed to reflect a high probability of cancer being referred ; and the patient and clinician factors that were the strongest predictors of referral . RESULTS Of the 3082 GPs who were selected for participation , 1402 responded , giving a response rate of 45.5 % . Overall , for vignettes identified as describing women with a high probability of cancer , 75 % were referred by metropolitan GPs and 73 % by rural practitioners . Metropolitan GPs were significantly more likely to refer women in scenarios indicative of endometrial cancer than rural GPs . For all three cancers , GPs were significantly more likely to refer a patient to a gynaecologist ( between 70.8 % and 95.4 % ) than a gynaecological oncologist . Metropolitan GPs had significantly greater access to both private and public gynaecological oncologists than their rural counterparts . Referral rates were higher for ovarian and cervical cancer ( 83 % and 80 % , respectively ) and lower for endometrial cancer ( 68 % ) . For all three cancers , patient factors were stronger predictors of referral than the demographic factors of participating GPs . CONCLUSION There appears to be significant variation in referral practice s among GPs and this variation is greater for endometrial cancer , for which there are currently no evidence -based clinical practice guidelines in Australia . There is a need for further research into underst and ing the basis of these differences , including a review of the existing guidelines for ovarian and cervical cancer and the development of guidelines for endometrial cancer Background Disadvantaged population s face many barriers to cancer care , including limited support in navigating through the complexities of the healthcare system . Family members play an integral role in caring for patients and provide valuable care coordination ; however , the effect of family navigators on adherence to cancer screening has not previously been evaluated . Training and evaluating trusted family members and other support persons may improve cancer outcomes for vulnerable patients . Methods Guided by principles of community based participatory research ( CBPR ) , “ Evaluating Coaches of Older Adults for Cancer Care and Healthy Behaviors ( COACH ) ” is a community-based r and omized controlled trial to assess the effectiveness of a trained participant- design ated coach ( support person or care giver ) in navigating cancer-screening for older African American adults , 50–74 years old . Participants are r and omly assigned as dyads ( participant + coach pair ) to receiving either printed educational material s only ( PEM — control group ) or educational material s plus coach training ( COACH — intervention group ) . We defined a coach as family member , friend , or other lay support person design ated by the older adult . The coach training is design ed as a one-time , 35- to 40-minute training consisting of : 1 ) a didactic session that covers the role of the coach , basic facts about colorectal , breast and cervical cancers ( including risk factors , signs and symptoms and screening modalities ) , engaging the healthcare provider in cancer screening , insurance coverage for screening , and related healthcare issues , 2 ) three video skits addressing misconceptions about and planning for cancer screening , and 3 ) an interactive role-play session with the trainer to reinforce and practice strategies for encouraging the participant to get screened . The primary study outcome is the difference in the proportion of participants completing at least one of the recommended screenings ( for breast , cervix or colorectal cancer ) between the control and intervention groups . Discussion Building on trusted patient contacts to encourage cancer screening , COACH is a highly sustainable intervention in a high-risk population . It has the potential to minimize the effect of mistrust of the medical establishment on screening behaviors by mobilizing participants ’ existing support networks . If effective , the intervention could have a high impact on health care disparities research across multiple diseases . Trial registration Clinical Trials.gov ( NCT01613430 ) . Registered June 5 , Non-r and omised studies of the effects of interventions are critical to many areas of healthcare evaluation , but their results may be biased . It is therefore important to underst and and appraise their strengths and weaknesses . We developed ROBINS-I ( “ Risk Of Bias In Non-r and omised Studies - of Interventions ” ) , a new tool for evaluating risk of bias in estimates of the comparative effectiveness ( harm or benefit ) of interventions from studies that did not use r and omisation to allocate units ( individuals or clusters of individuals ) to comparison groups . The tool will be particularly useful to those undertaking systematic review s that include non-r and omised studies Background The grading of recommendation , assessment , development and evaluation ( GRADE ) approach is widely implemented in health technology assessment and guideline development organisations throughout the world . GRADE provides a transparent approach to reaching judgements about the quality of evidence on the effects of a health care intervention , but is complex and therefore challenging to apply in a consistent manner . Methods We developed a checklist to guide the research er to extract the data required to make a GRADE assessment . We applied the checklist to 29 meta-analyses of r and omised controlled trials on the effectiveness of health care interventions . Two review ers used the checklist for each paper and used these data to rate the quality of evidence for a particular outcome . Results For most ( 70 % ) checklist items , there was good agreement between review ers . The main problems were for items relating to indirectness where considerable judgement is required . Conclusions There was consistent agreement between review ers on most items in the checklist . The use of this checklist may be an aid to improving the consistency and reproducibility of GRADE assessment s , particularly for inexperienced users or in rapid review s without the re sources to conduct assessment s by two research ers independently A postmenopausal bleeding ( PMB ) clinic was set up to provide quicker access for consultation , transvaginal ultrasound ( TVS ) and pipelle endometrial sampling in one visit . The aim of the study was to evaluate the impact of a one-stop PMB clinic on reaching a diagnosis and initiating treatment . One hundred and seven women have been referred to PMB clinic since the service started . We analysed the prospect i ve findings of 80 patients who met the criteria of direct GP referral to PMB clinic . The mean time from GP referral to consultation at PMB clinic was 14.8 days ( range : 2 - 24 days ) ; 97.5 % of women had TVS and abnormal findings were reported in 67.5 % . Pipelle endometrial sampling was performed in 31 patients and a sample obtained successfully in 21 women . Ten women were referred directly for diagnostic hysteroscopy and another 10 had hysteroscopy after a failed pipelle sampling . Twenty-four women ( 30 % ) were discharged back to their general practitioners ( GPs ) after reassurance by consultation and normal TVS . Seventy women ( 87.5 % ) considered a single PMB clinic visit was satisfactory . This study demonstrates the effective role of the one-stop PMB clinic to provide quick reassurance , arrive at a diagnosis and initiate plan of management during a single outpatient visit The value of any new therapeutic strategy or treatment is determined by the magnitude of its clinical benefit balanced against its cost . Evidence for clinical benefit from new treatment options is derived from clinical research , in particular phase III r and omised trials , which generate unbiased data regarding the efficacy , benefit and safety of new therapeutic approaches . To date , there is no st and ard tool for grading the magnitude of clinical benefit of cancer therapies , which may range from trivial ( median progression-free survival advantage of only a few weeks ) to substantial ( improved long-term survival ) . Indeed , in the absence of a st and ardised approach for grading the magnitude of clinical benefit , conclusions and recommendations derived from studies are often hotly disputed and very modest incremental advances have often been presented , discussed and promoted as major advances or ' breakthroughs ' . Recognising the importance of presenting clear and unbiased statements regarding the magnitude of the clinical benefit from new therapeutic approaches derived from high- quality clinical trials , the European Society for Medical Oncology ( ESMO ) has developed a vali date d and reproducible tool to assess the magnitude of clinical benefit for cancer medicines , the ESMO Magnitude of Clinical Benefit Scale ( ESMO-MCBS ) . This tool uses a rational , structured and consistent approach to derive a relative ranking of the magnitude of clinical ly meaningful benefit that can be expected from a new anti-cancer treatment . The ESMO-MCBS is an important first step to the critical public policy issue of value in cancer care , helping to frame the appropriate use of limited public and personal re sources to deliver cost-effective and affordable cancer care . The ESMO-MCBS will be a dynamic tool and its criteria will be revised on a regular basis The cluster r and omized trial with a concurrent economic evaluation is considered the gold st and ard evaluative design for the conduct of implementation research evaluating different strategies to promote the transfer of research findings into clinical practice . This has implication s for the planning of such studies , as information is needed on the effects of clustering on both effectiveness and efficiency outcomes . This paper describes the design considerations specific to implementation research studies , focusing particularly on the estimation of sample size requirements and on the need for reliable information on intracluster correlation coefficients for both effectiveness and efficiency outcomes OBJECTIVE To evaluate endometrial cancer ( EC ) risk assessment and early detection strategies in high-risk population s , we design ed a large , prospect i ve cohort study of women undergoing endometrial evaluation to assess risk factors and collect novel biospecimens for future testing of emerging EC biomarkers . Here we report on the baseline findings of this study . METHODS Women aged ≥45 years were enrolled at the Mayo Clinic from February 2013-June 2018 . Risk factors included age , body mass index ( BMI ) , smoking , oral contraceptive and hormone therapy use , and parity . We collected vaginal tampons , endometrial biopsies , and Tao brush sample s. We estimated mutually-adjusted odds ratios ( OR ) and 95 % confidence intervals ( CI ) using multinomial logistic regression ; outcomes included EC , atypical hyperplasia , hyperplasia without atypia , disordered proliferative endometrium , and polyps , versus normal endometrium . RESULTS Subjects included 1205 women with a mean age of 55 years ; 55 % were postmenopausal , and 90 % had abnormal uterine bleeding . The prevalence of EC was 4.1 % ( n = 49 ) , predominantly diagnosed in postmenopausal women ( 85.7 % ) . Tampons and Tao brushings were obtained from 99 % and 68 % of women , respectively . Age ( OR 1.14 , 95 % CI 1.1 - 1.2 ) and BMI ( OR 1.39 , 95 % CI 1.1 - 1.7 ) were positively associated with EC ; atypical hyperplasia ( OR 1.07 , 95 % CI 1.0 - 1.1 ; OR 2.00 , 95 % CI 1.5 - 2.6 , respectively ) , and polyps ( OR 1.06 , 95 % CI 1.0 - 1.1 ; OR 1.17 , 95 % CI 1.0 - 1.3 , respectively ) ; hormone therapy use and smoking were inversely associated with EC ( OR 0.42 , 95 % , 0.2 - 0.9 ; OR 0.43 , 95 % CI , 0.2 - 0.9 , respectively ) . Parity and past oral contraception use were not associated with EC . CONCLUSIONS Well-established EC risk factors may have less discriminatory accuracy in high-risk population s. Future analyses will integrate risk factor assessment with biomarker testing for EC detection |
11,502 | 32,345,274 | Studies of effect found that the format of feedback made little or no difference in parents attending further treatment , recognising their child as overweight or obese , reactions to the way the weight notification is given , motivation for lifestyle change , underst and ing how to reduce the risk of overweight , or taking any action .
However , parents receiving feedback with motivational interviewing have somewhat greater satisfaction with the way the healthcare provider supports them .
Qualitative studies found that parents had clear preferences for the format , timing , content and amount of information they wanted to receive in relation to both the weighing process and weight notification .
They also had clear preferences for how they wanted health care providers to interact and communicate with them and their children .
Both parents and children often felt that they were not receiving enough information and worried about how their results would be kept private .
Many parents experienced an emotional response when told about their child ’s weight ranging from positive , disbelief and negative feelings .
Those who reacted with disbelief or negatively were less likely to accept their child ’s weight status and /or act upon the notification letter . | Early intervention and conversation about a child ’s weight may offer an important chance of success in reducing weight and implementing a healthier lifestyle .
This review explores the most effective ways to notify parents and children about the child ’s weight as well as their preferences and experiences around weight notification . | This pilot aims to better underst and the market for childcare in Saudi Arabia – both the supply and dem and sides – and to design a r and omized controlled experiment to test whether access to affordable day care ( in the form of subsidies , for example ) would incentivize Saudi mothers to search actively for employment and to remain employed once they are hired . In addition , the study seeks to underst and the degree to which employment early on in one ’s life impacts employment in later stages . The pilot will provide information on the groups of women the experiment should target , appropriate levels for the childcare subsidy , and the quality and current geographic locations of daycare sites . Expected Impact Determine the effects of facilitating childcare access on Saudi women ’s employment . PRINCIPAL INVESTIGATORS Boston University Patricia Cortes Harvard University Claudia Goldin Swarthmore College Jennifer BACKGROUND School-based body mass index screenings ( S BMI S ) have been controversial . We aim ed to determine if parents would indicate improved utility with S BMI S when the report included parent education and whether parental intent to modify obesity risk factors would vary with report type or child weight . METHODS A cluster-controlled trial was conducted with 31 elementary schools r and omized to distribute a st and ard S BMI S report or the st and ard report plus education ( S BMI S+ ) . A r and om sub sample of parents completed a mailed survey ( 731 S BMI S , 738 S BMI S+ ) . Using a two-stage cluster sampling design , logistic regression models with school-level r and om effect were used to assess differences between conditions and by weight category . RESULTS Parents in the S BMI S+ condition vs. the st and ard condition were more likely to indicate that the report provided useful information ( not significant ) and an intent to help their child get enough sleep ( p < 0.001 ) . Parents of children who were overweight or obese were less likely than parents of children who were not to indicate that the report provided useful information about their child 's weight status ( p < 0.001 ) or access to re sources ( p < 0.05 ) . However , these parents were more likely to plan a visit to healthcare provider ( p < 0.001 ) and to intend to limit sugar-sweetened beverages ( p < 0.05 ) . CONCLUSIONS Parental education can enhance the utility of the S BMI S report and parental intention to modify at least one obesity risk factor . S BMI S reports prompted parents of children with overweight and obesity to seek clinical care and limit sugar-sweetened drinks Objectives As parents of young children are often unaware their child is overweight , screening provides the opportunity to inform parents and provide the impetus for behaviour change . We aim ed to determine if parents could recall and underst and the information they received about their overweight child after weight screening . Design R and omised controlled trial of different methods of feedback . Setting Participants were recruited through primary and secondary care but appointments took place at a University research clinic . Participants and intervention 1093 children aged 4–8 years were screened . Only overweight children ( n=271 , 24.7 % ) are included in this study . Parents of overweight children were r and omised to receive feedback regarding their child 's weight using best practice care ( BPC ) or motivational interviewing ( MI ) at face-to-face interviews typically lasting 20–40 min . 244 ( 90 % ) parents participated in a follow-up interview 2 weeks later to assess recall and underst and ing of information from the feedback session . Primary and secondary outcome measures Interviews were audio-taped and transcribed verbatim before coding for amount and accuracy of recall . Scores were calculated for total recall and sub-categories of interest . Results Overall , 39 % of the information was recalled ( mean score 6.3 from possible score of 16 ) . Parents given feedback via BPC recalled more than those in the MI group ( difference in total score 0.48 ; 95 % CI 0.05 to 0.92 ) . Although 94 % of parents were able to correctly recall their child 's weight status , fewer than 10 parents could accurately describe what the measurements meant . Maternal education ( 0.81 ; 0.25 to 1.37 ) and parental ratings of how useful they found the information ( 0.19 ; 0.04 to 0.35 ) were significant predictors of recall score in multivariate analyses . Conclusions While parents remember that their child 's body mass index is higher than recommended , they are unable to remember much of the information and advice provided about the result . Trial registration number Australian New Zeal and Clinical Trials Registry ACTRN12609000749202 Background Because parental recognition of overweight in young children is poor , we need to determine how best to inform parents that their child is overweight in a way that enhances their acceptance and supports motivation for positive change . This study will assess 1 ) whether weight feedback delivered using motivational interviewing increases parental acceptance of their child 's weight status and enhances motivation for behaviour change , and 2 ) whether a family-based individualised lifestyle intervention , delivered primarily by a MInT mentor with limited support from " expert " consultants in psychology , nutrition and physical activity , can improve weight outcomes after 12 and 24 months in young overweight children , compared with usual care . Methods / Design 1500 children aged 4 - 8 years will be screened for overweight ( height , weight , waist , blood pressure , body composition ) . Parents will complete question naires on feeding practice s , physical activity , diet , parenting , motivation for healthy lifestyles , and demographics . Parents of children classified as overweight ( BMI ≥ CDC 85th ) will receive feedback about the results using Motivational interviewing or Usual care . Parental responses to feedback will be assessed two weeks later and participants will be invited into the intervention . Additional baseline measurements ( accelerometry , diet , quality of life , child behaviour ) will be collected and families will be r and omised to Tailored package or Usual care . Parents in the Usual care condition will meet once with an advisor who will offer general advice regarding healthy eating and activity . Parents in the Tailored package condition will attend a single session with an " expert team " ( MInT mentor , dietitian , physical activity advisor , clinical psychologist ) to identify current challenges for the family , develop tailored goals for change , and plan behavioural strategies that best suit each family . The mentor will continue to provide support to the family via telephone and in-person consultations , decreasing in frequency over the two-year intervention . Outcome measures will be obtained at baseline , 12 and 24 months . Discussion This trial offers a unique opportunity to identify effective ways of providing feedback to parents about their child 's weight status and to assess the efficacy of a supportive , individualised early intervention to improve weight outcomes in young children . Trial registration Australian New Zeal and Clinical Trials Registry Background The National Child Measurement Programme was established to measure the height and weight of children at primary school in Engl and and provides parents with feedback about their child ’s weight status . In this study we will evaluate the impact of the National Child Measurement Programme feedback on parental risk perceptions of overweight , lifestyle behaviour and health service use . Methods The study will be a prospect i ve cohort study of parents of children enrolled in the National Child Measurement Programme and key service providers from 5 primary care trusts ( administrative bodies responsible for providing primary and secondary care services ) . We will conduct baseline question naires , followed by provision of weight feedback and 3 follow up question naires over the course of a year . Question naires will measure change in parental risk perception of overweight , health behaviours and health service use . Qualitative interviews will be used to identify barriers and facilitators to change . This study will produce preliminary data on National Health Service costs associated with weight feedback and determine which feedback approach ( letter and letter plus telephone ) is more effective . Discussion This study will provide the first large scale evaluation of the National Child Measurement Programme feedback . Findings from this evaluation will inform future planning of the National Child Measurement Programme AIM To determine whether a single session of motivational interviewing ( MI ) for feedback of a child 's overweight status promotes engagement in treatment following screening . METHODS One thous and ninety-three children aged 4 - 8 years were recruited through primary and secondary care to attend health screening , including assessment of parenting practice s and motivation ( question naire ) . Families with normal-weight children were informed about their child 's weight but had no further involvement . Parents of overweight ( body mass index ≥ 85th percentile ) children ( n = 271 ) were r and omised to receive weight feedback via MI or best practice care ( BPC ) using a traffic light concept to indicate degree of health risk . Follow-up interviews were held 2 weeks later to examine intervention uptake , changes to motivation and behaviour , and parental response to feedback . RESULTS Recruitment into the intervention was high ( 76 % ) and not altered by feedback condition ( percentage difference 6.6 ( 95 % confidence interval -2.9 , 16.0 ) . High scores on the Health Care Climate Question naire ( rating of the interviewer ) indicated satisfaction with how the information was provided to parents . No differences were observed in multiple indicators of harm . However , self-determined motivation for healthy life-styles was significantly higher in the MI condition at follow-up ( 0.18 : 0.00 , 0.35 ) , after only a single session of MI . CONCLUSIONS MI and BPC were both successful in encouraging parents to participate in a family-based intervention , with MI offering little significant benefit over BPC . A traffic light approach to weight feedback is a suitable way of providing sensitive information to parents not expecting such news School-based body mass index ( BMI ) screening and reporting could have a positive impact on student health , but best practice s for writing a report are unknown . Building on previous qualitative work , 8 focus groups were conducted with a diverse group of California parents ( n = 79 ) to elicit feedback on report content and design . Results indicate that parents want a visually appealing , picture-heavy report that clearly defines BMI , avoids stigmatizing language , and includes recommendations for appropriate actions whole families can take . Next steps involve using the final report in a statewide , r and omized trial to determine the effectiveness of school-based BMI screening and reporting in reducing childhood obesity |
11,503 | 11,134,916 | Results of these trials indicate that combination therapy produces larger sustained response rates than monotherapy .
Thus , ribavirin substantially increases drug costs compared with interferon monotherapy .
This shows it is worth treating all patients with combination therapy as first-line treatment for 6 months , but only worth treating those with one or two response factors for a further 6 months .
Those with three or four factors do well by 6 months , but gain very little from | BACKGROUND Hepatitis C is a viral disease of the liver , which frequently causes few or no symptoms at first infection but has a high probability of becoming an insidious chronic disease .
Treatment has traditionally been with interferon alfa but only a small proportion of patients have been cured by this method .
The recent introduction of ribavirin , given in combination , has led to a re- appraisal of the management of chronic hepatitis C. The current report considers the additional benefit of combination therapy ( interferon alfa and ribavirin ) compared with monotherapy ( interferon alfa alone ) for the treatment of patients with chronic hepatitis C. It supersedes two reports of combination therapy conducted by the Scottish Health Purchasing Information Centre and the Wessex Institute for Health Research and Development .
Two groups of chronic hepatitis C patients are expected to benefit from combination therapy : interferon-naive patients and relapse patients . | BACKGROUND AND AIM Interferon-alpha treatment of chronic hepatitis C is beneficial in only 20 - 30 % of patients . This study evaluates if combination therapy with Interferon-alfa plus ribavirin is effective in inducing a response in patients who did not respond to , or relapsed after , a st and ard Interferon-alfa treatment . PATIENTS AND METHODS A total of 88 patients , 49 non-responders and 39 relapsers to previous Interferon-alfa therapy , were r and omized to receive either natural Interferon-alfa ( 6 MU t.i.w . ) plus ribavirin ( 1000 mg/daily ) or natural Interferon-alfa alone ( 6 MU t.i.w . ) for 6 months . All were followed for 12 months after stopping therapy . Serum aminotransferase levels were assessed monthly and HCV RNA was evaluated by RT-PCR ( Amplicor , Roche ) at end of therapy and the end of follow-up . RESULTS After treatment , a higher response rate defined as return to normal of aminotransferases and absence of serum HCV RNA was observed among patients treated with Interferon-alfa-ribavirin : 4/28 ( 14 % ) vs 1/21 ( 5 % ) non-responder patients and 9/19 ( 47 % ) vs 5/20 ( 25 % ) in the relapsers group . At the end of follow-up , a sustained response was found only in the combination treatment group : 4 % and 32 % in non-responder and relapser patients , respectively . CONCLUSIONS Our results suggest that retreatment with natural Interferon-alfa plus ribavirin is more effective than Interferon-alfa alone in increasing the response rate in patients with chronic hepatitis C who relapse after a previous st and ard IFN treatment whereas it is less effective in non-responder patients A r and om-primed complementary DNA library was constructed from plasma containing the uncharacterized non-A , non-B hepatitis ( NANBH ) agent and screened with serum from a patient diagnosed with NANBH . A complementary DNA clone was isolated that was shown to encode an antigen associated specifically with NANBH infections . This clone is not derived from host DNA but from an RNA molecule present in NANBH infections that consists of at least 10,000 nucleotides and that is positive-str and ed with respect to the encoded NANBH antigen . These data indicate that this clone is derived from the genome of the NANBH agent and are consistent with the agent being similar to the togaviridae or flaviviridae . This molecular approach should be of great value in the isolation and characterization of other unidentified infectious agents The coadministration of ribavirin with recombinant interferon alfa-2b ( rIFN-alpha 2b ) compared with rIFN-alpha 2b alone markedly enhanced sustained virologic response rates in relapsed and treatment-naive chronic hepatitis C patients . The potential for ribavirin to likewise exacerbate the adverse events associated with the alpha interferons is review ed . The overall safety and tolerability of combination rIFN-alpha 2b/ribavirin therapy was evaluated in 2,089 patients treated in phase III clinical studies conducted in the United States and internationally . Serious adverse events were also evaluated on an interim basis in > 25,000 patients --a majority of whom were treated with combination therapy ( open label)--treated worldwide in investigator-initiated studies . Patients in the phase III studies received 3 million International Units rIFN-alpha 2b three times per week by subcutaneous injection plus either ribavirin or placebo orally in divided daily doses of 1,000 or 1,200 mg for patients weighing < or = 75 or > 75 kg , respectively . Adverse event frequency and severity and dose modifications were recorded throughout the 24-week ( relapse ) or 48-week ( naive ) treatment period and 24-week follow-up period . Clinical ly significant adverse events included anemia and depression . There was no evidence that the adverse effects of alpha interferon ( e.g. , fatigue , depression , neutropenia ) were exacerbated by ribavirin . Severe adverse events were limited due to strict adherence to dose-modification criteria ; approximately 6 % to 9 % of patients discontinued combination therapy because of an adverse event . Clinical ly serious adverse events , dose reductions and discontinuations , and potential mechanisms of toxicity associated with rIFN-alpha 2b and ribavirin are examined Chronic active hepatitis due to HCV represents a severe progressive disorder of the liver , At present , Interferon seems to be the most efficacious treatment available , however , only 20 - 25 % of the patients treated achieve complete remission . The efficacy has , therefore , been evaluated of Ribavirin , a nucleoside analogue active both on DNA and RNA viruses , in the treatment of non responders to a previous course of interferon . Twenty patients were r and omly assigned to two groups : A ) received the association R ( 800 mg/day for 2 months)+interferon ( 9 Mu/week for 6 months ) ; B ) received IFN ( 9 Mu/week for 6 months ) . All patients completed the study without important side effects . Four patients in group A presented reduced ALT and loss of viraemia during treatment with Ribavirin . Only one patient in group B had reduced indices of cell lysis and was negative for HCV-RNA during the course of the study . However , viremia and an increase of ALT values were observed in all of these subjects once treatment was interrupted . The results emerging from this study indicate that Ribavirin therapy , at the dose and duration of treatment employed , is not sufficient to change the natural course of events of chronic active hepatitis from HCV BACKGROUND More than 70 % of patients with chronic hepatitis C are resistant to interferon therapy . Ribavirin , in association with interferon , has been demonstrated as effective , at a dose of 800 - 1200 mg/day , but the efficacy of a lower dose has not been established . METHODS We assessed the effectiveness of the combination of 600 mg/day of ribavirin plus 3 MU of interferon over a period of 6 months , in a group of patients previously resistant to interferon . Sixty-two patients with chronic hepatitis C with serum and hepatic HCV RNA relapsers or non-responders to interferon , were r and omly divided into two groups : group A received 3 MU of interferon alpha-2b , three times a week for 6 months ; group B was given the same dose plus 600 mg per day of ribavirin for 6 months . Two patients from each group dropped from therapy . One patient from group A and two from group B withdrew from treatment because of adverse effects . RESULTS Mean alanine aminotransferase levels were similar in both groups throughout the study . A sustained response was observed in 7 % and 7.4 % of groups A and B with short-term response in 39 % and 59 % , and no response in 54 % and 34 % from both groups respectively ( non-significant ) . At 12 months , 4 and 7 patients from groups A and B respectively , cleared serum HCV RNA however , only one sustained responder from each group cleared HCV RNA from peripheral blood mononuclear cells . At 18 months , 3 patients remained serum HCV RNA negative . Adverse effects were similar . Only haemoglobin values were lower in group B in the first month of therapy ( p<0.05 ) . CONCLUSION In conclusion , the combination of 3 MU of interferon plus 600 mg of ribavirin is not effective in chronic hepatitis C resistant to interferon Although evidence of virologic elimination , normalization of serum alanine aminotransferase levels , and reduction in liver inflammation are the principal therapeutic outcome goals in chronic hepatitis C patients , improvement in health-related quality of life ( HQL ) is also an important aspect of therapeutic outcome . In a recent report of chronic hepatitis C patients treated for 24 weeks with interferon , sustained virologic response ( 24 weeks post-treatment ) was associated with improvement in HQL compared with nonresponse . We report on the relationship between sustained virologic response and Hepatitis Quality -of-Life Question naire ( HQLQ ) survey results of patients who relapsed after a previous course of interferon alfa who were subsequently treated with recombinant interferon alfa-2b ( rIFN-alpha 2b ) either alone or in combination with ribavirin . The HQLQ was administered at baseline , at treatment Weeks 12 and 24 , and at follow-up Weeks 12 and 24 . All patients received rIFN-alpha 2b 3 million International Units by subcutaneous injection three times weekly plus either oral ribavirin ( 1,000 or 1,200 mg ) or placebo daily for 24 weeks . At baseline , patients scored lower than adjusted population norms in HQL . Relative to patients treated with rIFN-alpha 2b monotherapy , patients receiving combination therapy showed better HQL in 6 of 13 domains . Furthermore , sustained virologic response in either treatment group was associated with improvement in the scores of both generic and hepatitis-specific HQL survey domains . These results indicate that successful therapeutic resolution of hepatitis C infection improves HQL as assessed by generic and hepatitis C-specific measures of functional health and well-being . Furthermore , improvements in HQL outcome measures may predict reduced dem and for health care re sources and greater productivity in the workplace BACKGROUND & AIMS Sustained response to interferon treatment for chronic hepatitis C is unsatisfactory . This study examined whether combining interferon alfa with ribavirin induces a better sustained efficacy than interferon alone in the treatment of chronic hepatitis C. METHODS Sixty noncirrhotic patients with chronic hepatitis C were r and omly assigned to three groups . Group 1 received 1200 mg oral ribavirin daily plus 3 million units of recombinant interferon alfa 2a thrice weekly for 24 weeks , group 2 received the same dose of interferon alfa 2a alone for 24 weeks , and group 3 received no treatment . The patients were then followed up for an additional 96 weeks . RESULTS At the end of treatment , a complete response ( normal serum alanine aminotransferase level and undetectable serum hepatitis C virus RNA ) was achieved in 16 of the 21 patients in group 1 ( 76 % ) , as compared with 6 of 19 in group 2 ( 32 % ) and none in group 3 . At 96 weeks after the end of treatment , patients in group 1 sustained a higher complete response rate than patients in group 2 ( 43 % vs. 6 % ) . CONCLUSIONS Combined treatment with ribavirin and interferon alfa 2a for 24 weeks is more effective than interferon alfa 2a alone for the treatment of chronic hepatitis C. The biochemical and virological responses were sustained in about one half of the treated patients for at least 2 years after cessation of the therapy We evaluated oral ribavirin as therapy for chronic hepatitis C infection in a pilot study including 10 patients . Patients ( 7 men , 3 women ; mean age 40 years , range 23 - 54 ) all had biopsy-proven chronic non-A , non-B hepatitis and were repeatedly positive for antibodies to hepatitis C virus . Treatment was with oral ribavirin 1000 - 1200 mg per day in two divided doses for 12 weeks . The median serum alanine aminotransferase concentration for all patients at enrollment was 3.15 mu kat/l ( range 1.22 - 7.79 ) and decreased significantly ( p less than 0.005 ) to 1.25 mu kat/l ( 0.78 - 2.04 ) after 12 weeks of treatment . Within 6 weeks of the end of treatment the median serum alanine aminotransferase concentration was not significantly different from that before treatment . Side-effects were mild and fully reversible after cessation of therapy . We conclude that ribavirin is the first drug to offer a potentially effective oral treatment for chronic hepatitis C. It should be further evaluated in controlled trials , possibly in combination with interferon alpha BACKGROUND / AIMS A sustained biochemical and virologic response to st and ard interferon therapy for chronic hepatitis C is seen in no more than 25 % of patients , and the efficacy of re-treatment or of higher doses in non-responders and relapsers has not been established . A more effective therapy for interferon alfa-resistant hepatitis C is needed . METHODS A study of ribavirin plus interferon alfa combination therapy was conducted in 30 patients with chronic hepatitis C resistant to a previous st and ard course of interferon alfa ( 14 interferon non-responders , 16 interferon relapsers ) . Patients were r and omly assigned to receive either ribavirin , 800 mg daily , and interferon alfa , 3 MU thrice weekly ( n = 15 ) , or interferon alfa alone , 3 MU thrice weekly ( n = 15 ) , for 6 months . RESULTS At the end of treatment , normal alanine aminotransferase levels were observed in eight patients in the combination therapy group : one ( 14 % ) interferon non-responder and seven ( 87 % ) interferon relapsers ( p = 0.01 ) . Six months post-therapy , sustained normalization of alanine aminotransferase was achieved in seven ( 87 % ) interferon alfa relapsers , but not in any of the interferon alfa non-responders ( p = 0.001 ) . In the group of patients treated with interferon alfa alone , sustained normalization of alanine aminotransferase was observed in one interferon relapser only . Serum HCV RNA became negative in eight patients receiving combination therapy -- two ( 28 % ) interferon non-responders and six ( 75 % ) interferon relapsers . Six months later , circulating HCV RNA remained negative in seven patients : one ( 14 % ) interferon non-responder and six ( 75 % ) interferon relapsers ( p = 0.04 ) . Sustained clearance of HCV RNA was not observed in patients re-treated with interferon alone . The sustained response to combination therapy was accompanied by reduced hepatic necroinflammatory activity on liver biopsy . Hepatitis C virus genotype was not significantly associated with response to combination therapy . Side effects were mild and well tolerated . CONCLUSIONS Our experience indicates that combination therapy of ribavirin plus interferon alfa induces sustained biochemical , virologic , and histologic responses in most patients who are interferon relapsers Thirty-nine of 61 prospect ively followed patients who had had acute non-A , non-B hepatitis in 1978 were clinical ly reexamined in 1991 and tested for antibodies to hepatitis C virus ( anti-HCV ) with a second generation ELISA and RIBA and for HCV RNA by PCR . Acute hepatitis C was diagnosed in stored sera from 1978 in 24 patients , who were found still to be anti-HCV positive in 1991 , and 16 of them were also HCV RNA positive . The majority of anti-HCV positive patients with or without HCV RNA had elevated serum ALT levels 13 years after onset of their acute hepatitis C. After 13 years follow-up , 1.6 % of the patients had died of end-stage liver disease , 8 % of anti-HCV positive patients had histologically confirmed liver cirrhosis , 79 % of anti-HCV positive patients were judged to have chronic infection , whereas 21 % seemed to have recovered . To conclude , we found that a majority of our patients with acute symptomatic hepatitis C continued to be viraemic 13 years after onset of hepatitis C , and that all continued to be anti-HCV positive by second-generation ELISA Interferon-alpha ( IFN-alpha ) induces sustained remission of chronic hepatitis C in approximately 25 % of patients . In patients who are non-responders to the first course of therapy , retreatment with IFN-alpha is of limited efficacy . Ribavirin has also been used to treat chronic hepatitis C , but it induces only a transient response . In this study , we evaluated the efficacy of ribavirin and IFN-alpha combination therapy for IFN-alpha resistant chronic hepatitis C. Twenty-four IFN-alpha non-responders and 24 relapsers were r and omized to receive either ribavirin ( 1000 mg per day ) together with IFN-alpha ( 3 - 6 million units ( MU ) thrice weekly ) or the same dose of IFN-alpha alone , for 6 months . Both at the end of treatment and 6 months later , normal transaminase levels were more common in the patients receiving combination therapy than in the group receiving IFN-alpha alone : 17 ( 70.8 % ) vs seven ( 29.2 % ) patients ( P = 0.009 ) and six ( 25 % ) vs one ( 4.2 % ) patient ( P = 0.034 ) , respectively . At the end of treatment and 6 months later , serum HCV RNA was no longer detectable in eight ( 33.3 % ) and five ( 20.8 % ) patients in the combination therapy group and in six ( 25 % ) and one ( 4.2 % ) patient in the IFN-alpha therapy group , respectively . Three patients ( 12.5 % ) were withdrawn prematurely from combination therapy because of side-effects ; ribavirin therapy was ceased or dosage reduced in six other patients ( 25 % ) , again because of side-effects . In conclusion , this combination treatment was more effective than retreatment with IFN-alpha , alone , in inducing sustained biochemical remission of chronic hepatitis C that was resistant to a previous course of IFN-alpha . The combination treatment , however , was frequently associated with significant side-effects |
11,504 | 29,344,366 | HCP-led interventions for ACS patients appear to have a small positive impact on medication adherence .
While we were able to identify BCTs among interventions , data were insufficient to determine the impact of particular BCTs on study effectiveness . | We conducted a systematic review and meta- analysis to determine the effectiveness of healthcare provider-led ( HCPs ) interventions to support medication adherence in patients with acute coronary syndrome ( ACS ) . | Background Adherence to evidence based medicines in patients who have experienced a myocardial infa rct ion remains low . Individual ’s beliefs towards their medicines are a strong predictor of adherence and may influence other factors that impact on adherence . Objective To investigate if community pharmacists discussing patients ’ beliefs about their medicines improved medication adherence at 12 months post myocardial infa rct ion . Setting This study included 200 patients discharged from a public teaching hospital in Queensl and , Australia , following a myocardial infa rct ion . Patients were r and omised into intervention ( n = 100 ) and control groups ( n = 100 ) and followed for 12 months . Method All patients were interviewed between 5 to 6 weeks , at 6 and 12 months post discharge by the research er using the repertory grid technique . This technique was used to elicit the patient ’s individualised beliefs about their medicines for their myocardial infa rct ion . In the intervention group , patients ’ beliefs about their medicines were communicated by the research er to their community pharmacist . The pharmacist used this information to tailor their discussion with the patient about their medication beliefs at design ated time points ( 3 and 6 months post discharge ) . The control group was provided with usual care . Main outcome measure The difference in non-adherence measured using a medication possession ratio between the intervention and control groups at 12 months post myocardial infa rct ion . Results There were 137 patients remaining in the study ( intervention group n = 72 , control group n = 65 ) at 12 months . In the intervention group 29 % ( n = 20 ) of patients were non-adherent compared to 25 % ( n = 16 ) of patients in control group . Conclusion Discussing patients ’ beliefs about their medicines for their myocardial infa rct ion did not improve medication adherence . Further research on patients beliefs should focus on targeting non-adherent patients whose reasons for their non-adherence is driven by their medication beliefs BACKGROUND Adherence to drugs and healthy lifestyles is low after acute coronary syndrome . We assessed whether trained community health workers could improve adherence to drugs , lifestyle changes , and clinical risk markers in patients with acute coronary syndrome in India . METHODS In this study done at 14 hospitals in India we r and omly assigned ( 1:1 ) patients with acute coronary syndrome 1 or 2 days before discharge from hospital to a community health worker-based intervention group or a st and ard care group . Patients were r and omly assigned with a telephone r and omisation service . In the intervention group , during four in-hospital and two home visits , community health workers used unstructured discussion s , visual methods , and patient diaries to educate patients on healthy lifestyle and drugs , and measures to enhance adherence . The primary outcome was adherence to proven secondary prevention drugs ( antiplatelet drugs , β blockers , angiotensin-converting enzyme inhibitors or angiotensin receptor blockers , and statins ) estimated using a Composite Medication Adherence Scale at 1 year . The secondary outcomes were difference in lifestyle factors ( diet , exercise , and tobacco and alcohol use ) , and clinical risk markers ( blood pressure , bodyweight , BMI , heart rate , and lipids ) . All analyses were by intention to treat . This trial is registered with the Clinical Trial Registry of India , number REF/2013/03/004737 , and Clinical Trials.gov , number NCT01207700 . RESULTS Between Aug 23 , 2011 , and June 25 , 2012 , 806 participants were r and omly assigned ( 405 to a community health worker-based intervention group and 401 to a st and ard care group ) . At 1 year , 40 patients had died and 15 had discontinued or been lost to follow-up , so 750 ( 93 % ) were included in the analyses ( 375 in each group ) . Secondary prevention drugs prescribed at discharge were 98 % ( 786/803 ) for any antiplatelet drug , 79 % ( 638/803 ) for dual antiplatelet drugs , 69 % ( 555/803 ) for β blockers , 69 % ( 552/803 ) for angiotensin-converting enzyme inhibitors and angiotensin receptor blockers , and 95 % ( 762/803 ) for statins . At one year , overall adherence ( ≥80 % ) to prescribed evidence -based drugs was higher in the intervention group than in the control group ( 97 % vs 92 % , odds ratio [ OR ] 2·62 , 95 % CI 1·32 - 5·19 ; p=0·006 ) . For individual drugs , we recorded significant differences for angiotensin-converting enzyme inhibitors and angiotensin receptor blockers ( 97 % [ 233/240 ] in the intervention group vs 93 % [ 223/240 ] in the control group ; p=0·036 ) and statins ( 97 % [ 346/356 ] vs 93 % [ 321/345 ] ; p=0·011 ) . The intervention group had significantly greater adherence to smoking cessation ( 85 % [ 110/129 ] vs 52 % [ 71/138 ] , OR 5·46 , 95 % CI 3·03 - 9·86 ; p<0·0001 ) , regular physical activity ( 89 % [ 333/375 ] vs 60 % [ 226/375 ] , OR 5·23 , 95 % CI 3·57 - 7·66 ; p<0·0001 ) , and healthy diet ( score 5·0 vs 3·0 , OR 2·47 , 95 % CI 1·88 - 3·25 ; p<0·0001 ) . More patients in the intervention group had stopped alcohol use at 1 year ( 87 % [ 64/74 ] vs 46 % [ 46/67 ] , OR 2·92 , 95 % CI 1·26 - 6·79 ; p = 0·010 ) . At 1 year , the mean systolic blood pressure ( 124·4 mm Hg [ SD 13·5 ] vs 128·0 mm Hg [ 15·9 ] ; p=0·002 ) , weight ( 65·0 kg [ 11·0 ] vs 66·5 kg [ 11·5 ] ; p<0·0001 ) , cholesterol ( 157·0 [ 40·2 ] vs 166·9 [ 48·4 ] ; p=0·184 ) , LDL ( 81·0 [ 20·6 ] vs 87·3 [ 29·9 ] ; p=0·191 ) , HDL ( 42·0 [ 11·4 ] vs 38·2 [ 6·5 ] ; p=0·042 ) , and BMI ( 24·4 kg/m(2 ) [ SD 3·7 ] vs 25·0 kg/m(2 ) [ 3·8 ] ; p<0·0001 ) were lower in the intervention group than in the control group . However , we noted no significant difference in diastolic blood pressure and heart rate . INTERPRETATION A community health worker-based personalised intervention strategy in patients with acute coronary syndrome improved adherence to evidence -based drugs and healthy lifestyles , and result ed in an improvement in clinical risk markers . Integration of trained community health workers can improve secondary prevention in coronary artery disease . FUNDING US National Heart , Lung , and Blood Institute ( NHLBI ) , National Institutes of Health , Department of Health and Human Services , and the UnitedHealth group , USA Background : Adherence to dietary and medication regimen plays an important role in successful treatment and reduces the negative complications and severity of the disease . Therefore , the present study aim ed to investigate the effect of nurse-led telephone follow-up on the level of adherence to dietary and medication regimen among patients after Myocardial Infa rct ion ( MI ) . Methods : This non-blinded r and omized controlled clinical trial was conducted on 100 elderly patients with MI who had referred to the cardiovascular clinics in Shiraz . Participants were selected and r and omly assigned to intervention and control groups using balanced block r and omization method . The intervention group received a nurse-led telephone follow-up . The data were collected using a demographic question naire , Morisky ’s 8-item medication adherence question naire , and dietary adherence question naire before and three months after the intervention . Data analysis was done by the SPSS statistical software ( version 21 ) , using paired t-test for intra-group and Chi-square and t-test for between groups comparisons . Significance level was set at<0.05 . Results : The results of Chi-square test showed no statistically significant difference between the intervention and control groups with respect to their adherence to dietary and medication regimen before the intervention ( P>0.05 ) . However , a statistically significant difference was found between the two groups in this regard after the intervention ( P<0.05 ) . The mean differences of dietary and medication adherence scores between pre- and post-tests were significantly different between the two groups . Independent t-test showed these differences ( P=0.001 ) . Conclusion : The results of the present study confirmed the positive effects of nurse-led telephone follow-up as a method of tele-nursing on improvement of adherence to dietary and medication regimen in the patients with MI . Trial Registration Number : I RCT 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 We investigated whether an intervention mainly consisting of a signed agreement between patient and physician on the objectives to be reached , improves reaching these secondary prevention objectives in modifiable cardiovascular risk factors six-months after discharge following an acute coronary syndrome . Background There is room to improve mid-term adherence to clinical guidelines ' recommendations in coronary heart disease secondary prevention , specially non-pharmacological ones , often neglected . Methods In CAM-2 , patients discharged after an acute coronary syndrome were r and omly assigned to the intervention or the usual care group . The primary outcome was reaching therapeutic objectives in various secondary prevention variables : smoking , obesity , blood lipids , blood pressure control , exercise and taking of medication . Results 1757 patients were recruited in 64 hospitals and 1510 ( 762 in the intervention and 748 in the control group ) attended the six-months follow-up visit . After adjustment for potentially important variables , there were , between the intervention and control group , differences in the mean reduction of body mass index ( 0.5 vs. 0.2 ; p < 0.001 ) and waist circumference ( 1.6 cm vs. 0.6 cm ; p = 0.05 ) , proportion of patients who exercise regularly and those with total cholesterol below 175 mg/dl ( 64.7 % vs. 56.5 % ; p = 0.001 ) . The reported intake of medications was high in both groups for all the drugs considered with no differences except for statins ( 98.1 % vs. 95.9 % ; p = 0.029 ) . Conclusions At least in the short term , lifestyle changes among coronary heart disease patients are achievable by intensifying the responsibility of the patient himself by means of a simple and feasible intervention AIM AND BACKGROUND Studies have reported that adherence to medications after hospital discharge for myocardial infa rct ion is poor with about 12 % to 20 % of patients discontinue their medications six months after discharge . This study aim ed to examine the effect of self-efficacy enhancement program on medication adherence in post-acute myocardial infa rct ion patients . METHODS A total 44 patient with post-acute myocardial infa rct ion were recruited from the in-patient department , Police General Hospital . The participants were r and om assigned into control group and experimental group . The control group received conventional care while the experimental group attended a four-week self-efficacy enhancement program , which included motivation , skill practice , and monitoring skills . The mean self-efficacy score between groups was assessed . The pill count was used to measure medication adherence . Correlations between self-efficacy and medication adherence were examined . Data were analyzed using descriptive statistic , Pearson 's correlation , and t-test . RESULTS The mean score on medication adherence of the experiment group who attended the self-efficacy enhancement program was significantly greater than the control group ( t=-2.77 ; df=21 ; p=0.01 ) . The mean scores of self-efficacy between the experimental and control group were 35.73 ( SD=4.11 ) and 35.41 ( SD=3.78 ) . The correlations between self-efficacy and medication adherence were significantly ( r=1.00 , p=0.00 ) . CONCLUSION The effectiveness of self-efficacy enhancement program was effective in improving medication adherence in Thai post-acute myocardial infa rct ion Background : Short hospital stays for patients with acute coronary syndromes ( ACSs ) reduce the opportunity for risk factor intervention during admission . After discharge , cardiac rehabilitation can decrease the recurrence of coronary events by up to 25 % . However , it remains underused . Objectives : The aim of this study was to determine whether a nursing intervention focused on individual ACS patients ’ perceptions of their disease and treatment would increase rehabilitation enrollment after discharge . Method : A total of 242 ACS patients admitted to a specialized tertiary cardiac center were r and omized to either the intervention or usual care ( n = 121 in both groups ) . The intervention included one nurse – patient meeting before discharge with 2 additional contacts over the 10 days after discharge ( mean duration = 40 minutes per contact ) . The primary outcome was enrollment in a free rehabilitation program offered to all participants 6 weeks after discharge . Secondary outcomes included illness perceptions ; family support ; anxiety level ; medication adherence ; and cardiac risk factors including lack of exercise , smoking , body mass index , and diet . Results : The sample was composed of a majority of male , married workers who experienced a myocardial infa rct ion or unstable angina without severe complications . The mean hospital stay in both groups was 3.6 days . There was a significantly higher rate of rehabilitation enrollment in the intervention group ( 45 % ) than in the control group ( 24 % ; p = .001 ) . For the secondary outcomes , only the personal control dimension of illness perceptions was improved significantly with the intervention . Discussion : Progressive , individualized interventions by nurses result ed in greater rehabilitation enrollment , thereby potentially improving long-term outcome Objective To quantify the impact of a practical , hospital-based nurse-coordinated prevention programme on cardiovascular risk , integrated into the routine clinical care of patients discharged after an acute coronary syndrome , as compared with usual care only . Design RESPONSE ( R and omised Evaluation of Secondary Prevention by Outpatient Nurse SpEcialists ) was a r and omised clinical trial . Setting Multicentre trial in secondary and tertiary healthcare setting s. Participants 754 patients admitted for acute coronary syndrome . Intervention A nurse-coordinated prevention programme , consisting of four outpatient nurse clinic visits , focusing on healthy lifestyles , biometric risk factors and medication adherence , in addition to usual care . Main outcome measures The main outcome was 10-year cardiovascular mortality risk as estimated by Systematic Coronary Risk Evaluation at 12 months follow-up . Secondary outcomes included Framingham Coronary Risk Score at 12 months , in addition to changes in individual risk factors . Risk factor control was classified as ‘ poor ’ if 0 to 3 factors were on target , ‘ fair ’ if 4 to 6 factors were on target , and ‘ good ’ if 7 to 9 were on target . Results The mean Systematic Coronary Risk Evaluation at 12 months was 4.4 per cent ( SD 4.5 ) in the intervention group and 5.4 per cent ( SD 6.2 ) in the control group ( p=0.021 ) , representing a 17.4 % relative risk reduction . At 12 months , risk factor control classified as ‘ good ’ was achieved in 35 % of patients in the intervention group compared with 25 % in the control group ( p=0.003 ) . Attendance to the nurse-coordinated prevention programme was 92 % . In the intervention group , 86 rehospitalisations were observed against 132 in the control group ( relative risk reduction 34.8 % , p=0.023 ) . Conclusions The nurse-coordinated hospital-based prevention programme in addition to usual care is a practical , yet effective method for reduction of cardiovascular risk in patients with coronary disease . Our data suggest that the counselling component of the programme may lead to a reduction in hospital readmissions . Trial Registration trialregister.nl Identifier TC1290 Objective To evaluate usefulness of non-physician health workers ( NPHW ) to improve adherence to medications and lifestyles following acute coronary syndrome ( ACS ) . Methods We r and omized 100 patients at hospital discharge following ACS to NPHW intervention ( n = 50 ) or st and ard care ( n = 50 ) in an open label study . NPHW was trained for interventions to improve adherence to medicines – antiplatelets , β-blockers , renin – angiotensin system ( RAS ) blockers and statins and healthy lifestyles . Intervention lasted 12 months with passive follow-up for another 12 . Both groups were assessed for adherence using a st and ardized question naire . Results ST elevation myocardial infa rct ion ( STEMI ) was in 49 and non-STEMI in 51 , mean age was 59.0 ± 11 years . 57 % STEMI were thrombolyzed . On admission majority were physically inactive ( 71 % ) , consumed unhealthy diets ( high fat 77 % , high salt 58 % , low fiber 57 % ) and 21 % were smokers/tobacco users . Coronary revascularization was performed in 90 % ( percutaneous intervention 79 % , bypass surgery 11 % ) . Drugs at discharge were antiplatelets 100 % , β-blockers 71 % , RAS blockers 71 % and statins 99 % . Intervention and control groups had similar characteristics . At 12 and 24 months , respectively , in intervention vs control groups adherence ( > 80 % ) was : anti platelets 92.0 % vs 77.1 % and 83.3 % vs 40.9 % , β blockers 97.2 % vs 90.3 % and 84.8 % vs 45.0 % ) , RAS blockers 95.1 % vs 82.3 % and 89.5 % vs 46.1 % , and statins 94.0 % vs 70.8 % and 87.5 % vs 29.5 % ; smoking rates were 0.0 % vs 12.5 % and 4.2 % vs 20.5 % , regular physical activity 96.0 % vs 50.0 % , and 37.5 % vs 34.1 % , and healthy diet score 5.0 vs 3.0 , and 4.0 vs 2.0 ( p < 0.01 for all ) . Intervention vs st and ard group at 12 months had significantly lower mean systolic BP , heart rate , body mass index , waist : hip ratio , total cholesterol , triglyceride , and LDL cholesterol ( p < 0.01 ) . Conclusions NPHW-led educational intervention for 12 months improved adherence to evidence based medicines and healthy lifestyles . Efficacy continued for 24 months with attrition Objectives To investigate the impact of cardiologist-coordinated intensive follow-up on the long-term prognosis of percutaneous coronary intervention in Chinese patients . Methods We recruited 964 patients who had acute coronary syndrome and underwent successful percutaneous coronary intervention in the First Hospital Affiliated to Henan University of Science and Technology , China . Participants were r and omly assigned into the intensive follow-up ( n = 479 ) and usual follow-up group ( control group , n = 485 ) . They received secondary prevention education during hospitalization and telephone follow-ups after discharge . The control group received telephone calls from nurses , while the intensive follow-up group received telephone calls and medical consultations from cardiologists . Both groups were followed up for 36 months . Results ( 1 ) At 36 months , the proportions of all-cause death , cardiac death and cumulative major adverse cardiovascular events ( MACEs ) were 5.3 % , 4.4 % and 18.6 % in the intensive follow-up group . These events were significantly lower than in the control group ( 10.1 % , 9.3 % and 28.8 % ( p = 0.004 , p = 0.003 and p < 0.001 ) . ( 2 ) Multivariable Cox regression analysis identified intensive follow-up as an independent predictor of survival , cardiac death-free survival and MACE-free survival . ( hazard ratio ( HR ) = 0.487 , 95 % confidence interval ( CI ) 0.298–0.797 , p = 0.004 ; HR = 0.466 , 95 % CI 0.274–0.793 , p = 0.005 ; HR = 0.614 , 95 % CI 0.464–0.811 , p = 0.001 ) . Kaplan – Meier analysis revealed that patients in the intensive follow-up groups had longer survival ( log rank = 8.565 , p = 0.003 ) , cardiac death-free survival ( log rank = 8.769 , p = 0.003 ) and MACE-free survival ( log rank = 15.928 , p < 0.001 ) . ( 3 ) The average medical cost was significantly less in the intensive follow-up group , especially the cost for re-hospitalization ( US$ 582.74 ± 1753.20 vs. US$ 999.32 ± 2434.57 , p = 0.003 ) . The bleeding events were similar . ( 4 ) Patients in the intensive follow-up group had significantly better controls of cardiovascular risk factors and medication adherence . Conclusions A cardiologist-coordinated intensive follow-up program markedly decreased cardiovascular risk factors , reduced medical costs , promoted medication adherence and improved the long-term prognosis of patients after percutaneous coronary intervention in the Chinese population PURPOSE Cardiac rehabilitation ( CR ) is beneficial for those who attend , but alternative models for nonattenders need investigation . We tested the effectiveness of modular prevention on risk factors in survivors of acute coronary syndrome ( ACS ) not accessing CR . METHODS We r and omly allocated ACS survivors not accessing CR to a control group ( n = 72 ) receiving conventional care or modular group ( n = 72 ) who participated in risk factor modules on the basis of patient-centered care and collaborative goal setting to systematic ally lower risk factors . We also recruited a consecutive reference group of ACS survivors participating in CR ( n = 64 ) . Blinded measurements of risk factors and global risk were completed at baseline and 3 months . RESULTS Although well matched for risk factor level and prevalence at baseline , by 3 months , the modular group had significantly reduced risk factor level in comparison with controls for most risk factors including total cholesterol ( 158 ± 3.9 vs 186 ± 3.9 mg/dL , P < .001 ) , systolic blood pressure ( 133.5 ± 2.0 vs 144.4 ± 2.4 mm Hg , P < .01 ) , body mass index ( 28.9 ± 0.7 vs 31.0 ± 0.7 kg/m2 , P = .02 ) , and physical activity ( 1,187 ± 164 vs 636 ± 115 metabolic equivalents [METS]/kg/min , P < .01 ) . Also at 3 months , fewer patients in the modular group smoked than in the control group ( 6 % vs 23 % , P < .01 ) and were in the moderate to high-risk category of the Long-Term Intervention with Pravastatin in Ischemic Disease ( LIPID ) score ( 40 % vs 59 % , P = .02 ) . Although the modular group had higher risk factors at baseline , they achieved similar mean levels as the CR group at 3 months . CONCLUSIONS Patient-centered modular prevention significantly improves coronary risk profile in comparison with conventional care and provides an effective alternative for the large numbers of ACS survivors not accessing CR One hundred three first-time myocardial infa rct ion ( MI ) patients were r and omly assigned to either an experimental or a control condition . Patients completed a cardiac rehabilitation program during hospitalization ad were interviewed to assess intentions to follow regimen prescriptions , attitudes toward the prescriptions , coping methods , and he perceived beliefs of others concerning their intentions . Patients were visited at home 30 days after discharge and reassessed on each of the above variables except that their behavior was substituted for intentions and societal adjustment was assessed . The experimental group was given an intervention program which included a discussion of assessment data , identification of problems , and establishment of goals . The assessment was repeated 60 days after discharge . No differences were found between experimental and control groups for either medical regimen adherence or societal adjustment . There was a significant decrease in mean scores for all variables from hospital to 30 days for both groups , but no change from 30 to 60 days . Attitudes and perceived beliefs of others were predictive of adherence , and it was concluded that these variables need to be included in any rehabilitation program Two-years postinfa rct ion , the effect of a nursing intervention at 30 days postinfa rct ion , and intentions , attitudes , and perceived beliefs of others on regimen compliance of myocardial infa rct ion patients was investigated . The sample was comprised of 51 patients ( E = 29 , C = 22 ) who participated in a five-phase study over 2 years . No differences were found between experimental and control groups for regimen compliance to activity , stress , and medication prescriptions . The experimental group was significantly more compliant to the diet prescription than the control group . The control group was significantly more compliant than the experimental group with cessation from smoking . Perceived beliefs of others were predictive of compliance for all regimen prescriptions at 2 years . Attitude was also predictive of compliance with the diet , smoking , and stress regimens Context Patients sometimes have difficulty following complicated treatment regimens . Contribution In this trial , 314 low-income patients with congestive heart failure were r and omly assigned to a pharmacist intervention or usual care . The pharmacist assessed patient knowledge and provided instructions about medication use . During the 9-month intervention , patients in the intervention group had greater medication adherence than patients in the usual care group ( 79 % vs. 68 % ) . These differences dissipated within 3 months of stopping the intervention . Patients in the intervention group also had fewer exacerbations result ing in emergency department visits or hospitalizations than patients in the usual care group . Implication Ongoing educational intervention by a pharmacist can improve medication adherence and outcomes in patients with heart failure . The Editors In the United States , 5 million people have heart failure , with total health care costs exceeding $ 29 billion ( 1 ) . These costs are largely derived from expensive exacerbations that require emergency visits and hospitalizations ( 1 , 2 ) . Regularly administered cardiovascular medications may preserve cardiac function , improve quality of life , and reduce risk for costly exacerbations . However , patients sometimes do not adhere to prescribed instructions and have poor outcomes ( 35 ) . Research ers have estimated that approximately 50 % of patients with chronic illnesses do not take their medications as prescribed ( 6 ) . Reasons for nonadherence include lack of patient knowledge , skills , and support to appropriately self-manage complicated medication regimens ( 7 , 8) . Although chronic disease management programs abound , few studies have rigorously tested interventions aim ed at improving patient adherence to prescribed medications and their effect on health outcomes ( 9 , 10 ) . We conducted a r and omized clinical trial to assess the effect of a pharmacist intervention on patients who are socioeconomically disadvantaged and medically vulnerable . We hypothesized that the intervention would improve adherence to heart failure medications , reduce exacerbations requiring emergency department visits or hospitalization , improve disease-specific quality of life , increase patient satisfaction , and reduce health care costs . Methods Design Overview The methods for our r and omized trial are described elsewhere ( 1113 ) . We recruited patients from the general medicine and cardiology practice s of Wishard Health Services , Indianapolis , Indiana , which serves socioeconomically disadvantaged and medically vulnerable patients . The study was conducted from February 2001 to June 2004 . Patients took part in the study for 12 months and received 9 months of active intervention by the pharmacist or usual care followed by 3 months of postintervention assessment . Patients in the usual care and intervention groups visited the same pharmacy location , but the intervention pharmacist was instructed to have no contact with patients in the usual care group . The institutional review boards of Indiana UniversityPurdue University and the University of North Carolina at Chapel Hill approved this study . Setting and Patients Indiana University Medical Group , Indianapolis , is an academic primary care group practice composed of primary and specialty care clinics affiliated with Wishard Health Services . Faculty physicians , residents , and nurse practitioners provide care to 13000 adults ( mean age , 57 years [ SD , 15 ] ; 60 % women ; 50 % African American ) . Annually , these patients make approximately 50000 visits to practice s , 72000 visits to emergency departments , and 135000 visits to pharmacies and have 16000 hospitalizations . We recruited patients from 4 identical general medicine practice s , 1 cardiology practice , and Wishard Memorial Hospital . Practice s met in half-day sessions per week that were attended by 2 or 3 faculty members and 3 to 5 residents or fellows from each practice . Faculty physicians practice d 1 to 5 half-days per week , whereas fellows practice d 1 to 2 half-days per week and residents attended the practice 1 half-day per week . Out patients of Wishard Health Services fill their prescriptions at central or de central ized outpatient pharmacies located at the ambulatory care center or at 1 of several satellite pharmacies stationed at neighborhood clinics . Fully stocked de central ized pharmacies serviced all study patients . From February 2001 to January 2003 , the study pharmacy was located in a building adjacent to the ambulatory care center . From February 2003 to June 2004 , the study pharmacy was moved to a space adjacent to the general medicine practice s in the ambulatory care center . Two pharmacists and 1 technician were stationed at the pharmacy . The study pharmacist was instructed to service patients in the intervention group only , and a second pharmacist serviced patients in the usual care group and filled prescriptions to be delivered to patients at outlying clinics . The technician filled prescriptions and read electronic adherence monitors . Weekly lists of eligible patients were created by using the Regenstrief Medical Record System ( Regenstrief Institute , Indianapolis , Indiana ) ( 14 , 15 ) . We invited clinical ly stable patients from general internal medicine practice s , a cardiology clinic , and Wishard Memorial Hospital ( at discharge ) to participate in the study . Of 3034 patients with a diagnosis of heart failure , 1512 met criteria for enrollment . Patients were eligible if they were 50 years of age or older ; planned to receive all of their care , including prescribed medications , at Wishard Health Services ; had a diagnosis of heart failure confirmed by their primary care physician ; regularly used at least 1 cardiovascular medication for heart failure ( angiotensin-converting enzyme [ ACE ] inhibitor or angiotensin-receptor blocker , -adrenergic antagonist , diuretic , digoxin , or aldosterone antagonist ) ; were not using or were not planning to use a medication container adherence aid ( for example , a pill box ) ; had access to a working telephone ; and could hear within the range of normal conversation . We excluded patients with dementia . Patients received their prescription medications through state and local assistance plans at no cost . Thus , cost of medicines was not a deterrent to adherence . R and omization A trained interviewer conducted a baseline interview at enrollment . Interviewers were blinded to patients ' study status and played no role in the delivery of the intervention . Interviewers contacted a central ized data manager at the end of each interview to determine the patient 's study assignment , which was otherwise concealed . We r and omly assigned patients , without blocking or stratification , to receive the pharmacy intervention or usual care by using a univariate discrete distribution from the IMSL Fortran Library 's subroutine RNGDA pseudor and om number generator ( Absoft Corp. , Rochester Hills , Michigan ) ( 16 ) . We r and omly assigned more patients to the usual care group so that this group could also be a prospect i ve cohort for study ing risk factors associated with the clinical deterioration of heart failure . Of the 314 patients included in the study , 229 were recruited from the general internal medicine practice s , 15 from the cardiology clinic , and 70 on discharge from the Wishard Memorial Hospital . The numbers of patients assigned to the intervention and usual care groups did not differ by recruitment site ( P= 0.83 ) . Intervention A pharmacist delivered the intervention by using a protocol ( Appendix Table 1 ) that included a baseline medication history of all prescription and over-the-counter drugs and dietary supplements taken by patients , which patients brought with them to the baseline interview , and the results of an assessment of patient medication knowledge and skills ( 7 , 8) . The pharmacist dispensed enough of the patient 's medications to last approximately 2 months . Appendix Table 1 . Pharmacist 's Intervention Protocol * When medications were dispensed , the pharmacist provided patient-centered verbal instructions and written material s about the medications ( 11 , 13 , 17 ) by using a schema for instruction that has been tested ( 18 , 19 ) . We assigned each medication category an icon ( for example , the icon for ACE inhibitors was a red ace of hearts ) . The same icon appeared on the container label and lid and on the written patient instructions . Written instructions were aim ed at patients with low health literacy and contained an easy-to-follow timeline to remind patients when to take their medications ( 13 ) . The pharmacist monitored patients ' medication use , health care encounters , body weight , and other relevant data by using a study data base ( 20 , 21 ) . Information about patients was communicated as needed to clinic nurses and primary care physicians by face-to-face visits , telephone , paging ( physician only ) , and e-mail ( physician only ) . Technicians supported the pharmacist 's dispensing efforts within the pharmacy throughout the study . We incorporated costs therein into the economic analysis . Pharmacists serviced patients in the usual care group who were not associated with the intervention or the study . An interdisciplinary team of investigators that included pharmacists with advanced training in patient education and cardiovascular pharmacotherapy , a geriatrician , a cardiologist with expertise in heart failure , a behavioral scientist , and a cognitive psychologist trained the intervention pharmacist . The intervention pharmacist also studied guidelines for treating heart failure ( 22 ) , key concepts in the pharmaceutical care of older adults , communication techniques , and the pharmacotherapy of the cardiovascular drugs for heart failure . All pharmacists at Wishard Health Services were aware of the study and were instructed on how to h and le and redirect intervention patients who inadvertently arrived at their pharmacy . Usual Care Patients in the usual care group were aware of the purpose of the study , and their primary care BACKGROUND Nonadherence to cardiovascular medications is a significant public health problem . This r and omized study evaluated the effect on medication adherence of linking hospital and community pharmacists . METHODS Hospitalized patients with coronary artery disease discharged on aspirin , β-blocker , and statin who used a participating pharmacy were r and omized to usual care or intervention . The usual care group received discharge counseling and a letter to the community physician ; the intervention group received enhanced in-hospital counseling , attention to adherence barriers , communication of discharge medications to community pharmacists and physicians , and ongoing assessment of adherence by community pharmacists . The primary end point was self-reported use of aspirin , β-blocker , and statin at 6 months postdischarge ; the secondary end point was a ≥ 75 % proportion of days covered ( PDC ) for β-blocker and statin through 6 months postdischarge . RESULTS Of 143 enrolled patients , 108 ( 76 % ) completed 6-month follow-up , and 115 ( 80 % ) had 6-month refill records . There was no difference between intervention and control groups in self-reported adherence ( 91 % vs 94 % , respectively , P = .50 ) . Using the PDC to determine adherence to β-blockers and statins , there was better adherence in the intervention versus control arm , but the difference was not statistically significant ( 53 % vs 38 % , respectively , P = .11 ) . Adherence to β-blockers was statistically significantly better in intervention versus control ( 71 % vs 49 % , respectively , P = .03 ) . Of 85 patients who self-reported adherence and had refill records , only 42 ( 49 % ) were also adherent by PDC . CONCLUSIONS The trend toward better adherence by refill records with the intervention should encourage further investigation of engaging pharmacists to improve continuity of care IMPORTANCE Adherence to cardioprotective medication regimens in the year after hospitalization for acute coronary syndrome ( ACS ) is poor . OBJECTIVE To test a multifaceted intervention to improve adherence to cardiac medications . DESIGN , SETTING , AND PARTICIPANTS In this r and omized clinical trial , 253 patients from 4 Department of Veterans Affairs medical centers located in Denver ( Colorado ) , Seattle ( Washington ) ; Durham ( North Carolina ) , and Little Rock ( Arkansas ) admitted with ACS were r and omized to the multifaceted intervention ( INT ) or usual care ( UC ) prior to discharge . INTERVENTIONS The INT lasted for 1 year following discharge and comprised ( 1 ) pharmacist-led medication reconciliation and tailoring ; ( 2 ) patient education ; ( 3 ) collaborative care between pharmacist and a patient 's primary care clinician and /or cardiologist ; and ( 4 ) 2 types of voice messaging ( educational and medication refill reminder calls ) . MAIN OUTCOMES AND MEASURES The primary outcome of interest was proportion of patients adherent to medication regimens based on a mean proportion of days covered ( PDC ) greater than 0.80 in the year after hospital discharge using pharmacy refill data for 4 cardioprotective medications ( clopidogrel , β-blockers , 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors [ statins ] , and angiotensin-converting enzyme inhibitors or angiotensin receptor blockers [ ACEI/ARB ] ) . Secondary outcomes included achievement of blood pressure ( BP ) and low-density lipoprotein cholesterol ( LDL-C ) level targets . RESULTS Of 253 patients , 241 ( 95.3 % ) completed the study ( 122 in INT and 119 in UC ) . In the INT group , 89.3 % of patients were adherent compared with 73.9 % in the UC group ( P = .003 ) . Mean PDC was higher in the INT group ( 0.94 vs 0.87 ; P < .001 ) . A greater proportion of intervention patients were adherent to clopidogrel ( 86.8 % vs 70.7 % ; P = .03 ) , statins ( 93.2 % vs 71.3 % ; P < .001 ) , and ACEI/ARB ( 93.1 % vs 81.7 % ; P = .03 ) but not β-blockers ( 88.1 % vs 84.8 % ; P = .59 ) . There were no statistically significant differences in the proportion of patients who achieved BP and LDL-C level goals . CONCLUSIONS AND RELEVANCE A multifaceted intervention comprising pharmacist-led medication reconciliation and tailoring , patient education , collaborative care between pharmacist and patients ' primary care clinician and /or cardiologist , and voice messaging increased adherence to medication regimens in the year after ACS hospital discharge without improving BP and LDL-C levels . Underst and ing the impact of such improvement in adherence on clinical outcomes is needed prior to broader dissemination of the program . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00903032 OBJECTIVE Pharmacologic treatment for secondary prevention of coronary heart disease ( CHD ) is critical to prevent adverse clinical outcomes . In a r and omized controlled trial , we compared antiplatelet and statin adherence among patients with CHD who received : ( 1 ) text messages ( TM ) for medication reminders and education , ( 2 ) educational TM only , or ( 3 ) No TM . METHODS A mobile health intervention delivered customized TM for 30 days . We assessed and analyzed medication adherence with electronic monitoring devices [ Medication Event Monitoring System ( MEMS ) ] by one-way ANOVA and Welch tests , two-way TM response rates by t-tests , and self-reported adherence ( Morisky Medication Adherence Scale ) by Repeated Measures ANOVA . RESULTS Among 90 patients ( 76 % male , mean age 59.2 years ) , MEMS revealed patients who received TM for antiplatelets had a higher percentage of correct doses taken ( p=0.02 ) , percentage number of doses taken ( p=0.01 ) , and percentage of prescribed doses taken on schedule ( p=0.01 ) . TM response rates were higher for antiplatelets than statins ( p=0.005 ) . Self-reported adherence revealed no significant differences among groups . CONCLUSION TM increased adherence to antiplatelet therapy demonstrated by MEMS and TM responses . PRACTICE IMPLICATION S Feasibility and high satisfaction were established . Mobile health interventions show promise in promoting medication adherence BACKGROUND Secondary prevention is not adequately implemented after myocardial infa rct ion ( MI ) . We assessed the effect on quality of care and prognosis of a long-term , relatively intensive rehabilitation strategy after MI . METHODS We conducted a multicenter , r and omized controlled trial in patients following st and ard post-MI cardiac rehabilitation , comparing a long-term , reinforced , multifactorial educational and behavioral intervention with usual care . A total of 3241 patients with recent MI were r and omized to a 3-year multifactorial continued educational and behavioral program ( intervention group ; n = 1620 ) or usual care ( control group ; n = 1621 ) . The combination of cardiovascular ( CV ) mortality , nonfatal MI , nonfatal stroke , and hospitalization for angina pectoris , heart failure , or urgent revascularization procedure was the primary end point . Other end points were major CV events , major cardiac and cerebrovascular events , lifestyle habits , and drug prescriptions . RESULTS End point events occurred in 556 patients ( 17.2 % ) . Compared with usual care , the intensive intervention did not decrease the primary end point significantly ( 16.1 % vs 18.2 % ; hazard ratio [ HR ] , 0.88 ; 95 % confidence interval [ CI ] , 0.74 - 1.04 ) . However , the intensive intervention decreased several secondary end points : CV mortality plus nonfatal MI and stroke ( 3.2 % vs 4.8 % ; HR , 0.67 ; 95 % CI , 0.47 - 0.95 ) , cardiac death plus nonfatal myocardial infa rct ion ( 2.5 % vs 4.0 % ; HR , 0.64 ; 95 % CI , 0.43 - 0.94 ) , and nonfatal MI ( 1.4 % vs 2.7 % ; HR , 0.52 ; 95 % CI , 0.31 - 0.86 ) . A marked improvement in lifestyle habits ( ie , exercise , diet , psychosocial stress , less deterioration of body weight control ) and in prescription of drugs for secondary prevention was seen in the intervention group . CONCLUSION The GOSPEL Study is the first trial to our knowledge to demonstrate that a multifactorial , continued reinforced intervention up to 3 years after rehabilitation following MI is effective in decreasing the risk of several important CV outcomes , particularly nonfatal MI , although the overall effect is small . TRIAL REGISTRATION Clinical Trials.gov Identifier : NCT00421876 Background Cardiac rehabilitation includes interventions aim ed at facilitating physical , psychological and emotional recovery following the acute phase of myocardial infa rct ion ( AMI ) . To date , optimal cardiac rehabilitation program duration and frequency of patient contact has yet to be identified . Objective The present study was performed to evaluate the effects of two different strategies of secondary prevention ( 2 years , multifactorial continued educational and behavioral intervention versus usual care ) implemented into a cardiac rehabilitation setting on several cardiovascular endpoints indicating cardiovascular functional exercise capacity and coronary risk profile in patients with recent AMI . Methods This was a prospect i ve r and omized study including 52 postinfa rct ion patients . Initially , all patients were enrolled in a 3-month outpatient cardiac rehabilitation program . Thereafter , they were r and omly subdivided into two groups ( I = intervention group ; C = control group ) , each composed of 26 patients , and followed for 24 months . Results At the end of the 3-month outpatient cardiac rehabilitation program , both groups showed a significant ( P < 0.05 ) improvement in cardiopulmonary parameters ( maximal oxygen consumption , maximal workload ) and in cardiovascular risk profile ( BMI , lipid profile ) . During the 24-month study period , group I showed stabilization or even improvement ( P < 0.05 ) of both cardiopulmonary parameters and cardiovascular risk profile , whereas group C patients showed a deterioration or significant impairment ( P < 0.05 ) of the same parameters . Clinical events occurred in 27 % of patients in the control group ( n = 7 ) and in 11 % in the training group ( n = 3 ) ( P < 0.05 ) . Conclusion Long-term , multifactorial educational and behavioral intervention maintained for 2 years in a multicomprehensive cardiac rehabilitation setting represents a valid strategy for improving long-term cardiovascular functional capacity and cardiovascular risk profile in postinfa rct ion patients BACKGROUND The presence of depression after an acute coronary syndrome ( ACS ) is associated with worse prognosis and lower adherence to risk-reducing behaviors . We reported earlier that an enhanced depression care intervention reduces depression symptoms and major adverse cardiac events . This study evaluates the impact of the depression intervention on health behavior and blood pressure control . METHODS Between 2005 and 2008 , 157 patients who remained persistently depressed 3 months after ACS were r and omized to a 6-month depression intervention ( initial patient preference for problem-solving therapy and /or pharmacotherapy , followed by stepped care ; 80 patients ) or to usual care ( 77 patients ) . At r and omization , and then 2 , 4 , and 6 months later , patients were asked if they ( 1 ) missed taking their aspirin ; ( 2 ) followed a heart healthy diet ; ( 3 ) exercised regularly ; and ( 4 ) used tobacco products . Blood pressure was measured before r and omization and 6 months later . RESULTS At the end of the intervention , there was no significant improvement in the percentage of intervention compared to control group patients who adhered to aspirin ( + 3 % versus -1 % , P = .23 ) , followed a healthy diet ( + 10 % versus + 8 % , P = .39 ) , exercised regularly ( + 5 % versus + 4 % , P = .65 ) , abstained from tobacco ( -3 % versus -1 % , P = .77 ) , or had controlled blood pressure ( + 6 % versus + 16 % , P = .26 ) . CONCLUSION Despite improving depression , enhanced depression care after an ACS did not improve health behavior or blood pressure control compared to usual care . Research is needed to test whether adding an adherence intervention to enhanced depression care can improve adherence and cardiovascular prognosis in depressed patients post-ACS This r and omized controlled trial examined a discharge nursing intervention aim ed at promoting self-regulation of care for early discharge interventional cardiology patients . The purpose of this study was to compare medication adherence , patient satisfaction , use of urgent care , and illness perception in patients with cardiovascular disease undergoing interventional revascularization procedures who receive usual care and those who receive a discharge nursing intervention Background The application of disease management algorithms by physician extenders has been shown to improve therapeutic adherence in selected population s. It is unknown whether this strategy would improve adherence to secondary prevention goals after acute coronary syndromes ( ACSs ) in a largely indigent county hospital setting . Methods Patients admitted for ACS were r and omized at the time of discharge to usual follow-up care versus the same care with the addition of a physician extender visit . Physician extender visits were conducted according to a treatment algorithm based on contemporary practice guidelines . Groups were compared using the primary end point of achievement of low-density lipoprotein treatment goals at 3 months after discharge and achievement of additional evidence -based practice goals . Results One hundred forty consecutive patients were r and omized . A similar proportion of patients returned for study follow-up in both groups at 3 months ( 54 [79%]/68 in the usual care group vs 57 [79%]/72 in the intervention group ; P = 0.97 ) . Among those completing the 3-month visit , a low-density lipoprotein cholesterol level less than 100 mg/dL was achieved in 37 ( 69 % ) of the usual care patients compared with 35 ( 57 % ) of those in the intervention group ( P = 0.43 ) . There was no statistical difference in implementation of therapeutic lifestyle changes ( smoking cessation , cardiac rehabilitation , or exercise ) between groups . Prescription rates of evidence -based therapeutics at 3 months were similar in both groups . Conclusion The implementation of a post-ACS clinic run by a physician extender applying a disease management algorithm did not measurably improve adherence to evidence -based secondary prevention treatment goals . Despite initially high rates of evidence -based treatment at discharge , adherence with follow-up appointments and sustained implementation of evidence -based therapies remains a significant challenge in this high-risk cohort Objective To evaluate the efficacy of a programme of home blood pressure measurement ( HBPM ) on therapeutic compliance in mild-to-moderate hypertension . Design A prospect i ve controlled multicentre clinical trial . Setting Forty primary care centres in Spain , with a duration of 6 months . Patients A total of 250 patients with newly diagnosed or uncontrolled hypertension were included . Interventions The patients were r and omly selected and distributed in two groups : ( 1 ) the control group ( CG ) who received st and ard health intervention ; ( 2 ) the intervention group ( IG ) : the patients in this group received an OMRON in their homes for a programme of HBPM . Main outcome measure Four visits were scheduled , for the measurement of blood pressure ( BP ) . They were provided with an electronic monitor for measuring compliance ( monitoring events medication system ; MEMS ) . Therapeutic compliance was defined as a drug consumption of 80–110 % . A number of variables were calculated using the MEMS . The mean BP were calculated and the percentage of controlled patients . Results A total of 200 patients completed the study ( 100 in each group ) . Compliance was observed in 74 and 92 % , respectively , in the CG and IG [ 95 % confidence interval ( CI ) 63.9–84.1 and 86.7–97.3 ; P = 0.0001 ] , the mean percentage compliances were 87.6 and 93.5 % ( 95 % CI 81.2–94 and 80.7–98.3 ; P = 0.0001 ) , the percentages of correct days were 83.6 and 89.4 % , the percentages of subjects who took the medication at the prescribed time were 79.89 and 88.06 % , and the levels of therapeutic cover were 86.7 and 93.1 % . The number needed to treat to avoid one case of non-compliance was 5.6 patients . The differences in the mean decreases in BP were significant for diastolic BP , with a greater decrease observed in the IG . Conclusions An HBPM programme using electronic monitors is effective in improving compliance in arterial hypertension , measured using the MEMS BACKGROUND Lowering plasma lipid levels in patients in the months following hospital discharge for a myocardial infa rct ion ( MI ) is clearly beneficial if recurrent cardiac events and mortality are to be prevented ; traditionally , however , there has been a large gap between guidelines and levels achieved in routine practice . OBJECTIVES AND METHODS A r and omized , open-label clinical trial was conducted to assess the impact of nurse-centred surveillance and treatment in achieving nationally recognized lipid targets in post-MI patients . This program had the following features : systematic telephone follow-up of patients discharged from the University of Sherbrooke ( Sherbrooke , Quebec ) after an MI ; systematic lipid testing three months after discharge ; close liaison with , and guidance of , patients ' primary care physicians to intervene on results of this test if targets were not obtained ; and continued monitoring of patients until lipid profiles consistent with consensus targets were achieved . The impact of this approach was tested and compared with that of a control group that continued to be followed by a primary care physician for up to 18 months . RESULTS A total of 127 patients were r and omly assigned into an intervention group ( n=64 ) or a control group ( n=63 ) . The intervention group was followed by telephone for an average ( + /-SD ) of 4.4+/-2.0 months post-MI . At this point , when intervention was optimized , the mean low-density lipoprotein cholesterol ( LDL-C ) level was 2.19+/-0.65 mmol/L in the intervention group , and 87.3 % of patients had LDL-C levels of less than 2.5 mmol/L. Patients from both experimental groups returned at 12 months and 18 months post-MI for a new blood lipid assessment . In total , 12.5 % of patients in each group were lost to follow-up . At 12 months and 18 months , the mean LDL-C level was not different between the two groups , nor was there a significant difference in the proportion of patients achieving LDL-C levels of less than 2.5 mmol/L ( 51.6 % in the intervention group and 65 % in the control group at 18 months ; P>0.05 ) . When the combined end point of an LDL-C level of less than 2.5 mmol/L , a triglyceride level of less than 2.0 mmol/L and a total cholesterol to high-density lipoprotein cholesterol ratio of less than 4.0 was considered , the proportion of patients achieving this composite at 18 months was low and not different between the two groups ( 23.4 % in the intervention group and 38.3 % in the control group ; P>0.05 ) . Over 95 % of patients in both groups were on a lipid-lowering medication , and more than 90 % had complied with their medication regimen at 18 months . CONCLUSIONS This trial did not support the role of nurse-managers and a system of telephone-based contacts to ensure the continuity of care and aggressive intervention when considering cardiovascular risk factors in post-MI patients . This trial also re-emphasized the important remaining treatment gap in secondary prevention of coronary artery disease , particularly if composite lipid end points are to be targeted Objective To investigate the feasibility and potential impact of a pharmacy care intervention , involving motivational interviews among patients with acute coronary syndrome , on adherence to medication and on health outcomes . Methods This article reports a prospect i ve , interventional , controlled feasibility/pilot study . Seventy one patients discharged from a London Heart Attack Centre following acute treatment for a coronary event were enrolled and followed up for 6 months . Thirty two pharmacies from six London boroughs were allocated into intervention or control sites . The intervention was delivered by community pharmacists face-to-face in the pharmacy , or by telephone . Consultations were delivered as part of the New Medicine Service or a Medication Usage Review . They involved a 15–20 min motivational interview aim ed at improving protective cardiovascular medicine taking . Results At 3 months , there was a statistically significant difference in adherence between the intervention group ( M=7.7 , SD=0.56 ) and the control group ( M=7.0 , SD=1.85 ) , p=0.026 . At 6 months , the equivalent figures were for the intervention group M=7.5 , SD=1.47 and for the controls M=6.1 , SD=2.09 ( p=0.004 ) . In addition , there was a statistically significant relationship between the level of adherence at 3 months and beliefs regarding medicines ( p=0.028 ) . Patients who reported better adherence expressed positive beliefs regarding the necessity of taking their medicines . However , given the small sample size , no statistically significant outcome difference in terms of recorded blood pressure and low density lipoprotein-cholesterol was observed over the 6 months of the study . Conclusions The feasibility , acceptability and potentially positive clinical outcome of the intervention were demonstrated , long with a high level of patient acceptability . It had a significant impact on cardiovascular medicine taking adherence . But these findings must be interpreted with caution . The intervention should be tested in a larger trial to ascertain its full clinical utility . Trial registration number Clinical Trials.gov identifier : NCT01920009 BACKGROUND Patients with ST-segment elevation myocardial infa rct ion ( STEMI ) have traditionally been hospitalized for 5 to 7 days to monitor for serious complications such as heart failure , arrhythmias , reinfa rct ion , and death . The Zwolle Primary Percutaneous Coronary Intervention ( PCI ) Index is an externally vali date d risk score that has been used to identify low-risk STEMI patients who have undergone primary PCI and can safely be discharged from hospital within 72 hours . Previous studies have shown that many low-risk patients remain in hospital significantly longer . METHODS We r and omly assigned 54 low-risk STEMI patients treated with primary or rescue PCI to 1 of 2 groups . Patients in the intervention group ( n = 27 ) were actively targeted for early hospital discharge ( 48 - 72 hours ) and received outpatient follow-up with an advanced practice nurse ( APN ) . In the control group ( n = 27 ) , discharge planning and follow-up were left to the treating physician , and there was no added nursing intervention . The 2 primary outcomes of this pilot study were to demonstrate feasibility and safety . Secondary outcomes included compliance with medications , smoking cessation , attendance at cardiac rehabilitation , and quality of life , measured in both groups at 6 weeks time . RESULTS In the intervention group , 74 % of patients were discharged within 72 hours , 100 % had follow-up with the APN within 3 days ( 74 % in person , 26 % by phone ) , and 100 % had > /= 3 APN follow-ups in total , meeting our prespecified criteria for feasibility . The median length of stay was 55 hours in both groups . There were no deaths in either group , and there was no difference in rehospitalization between patients in the intervention and control groups ( 8 % vs 4 % , P = .56 ) . There was no difference in rates of medication compliance , smoking cessation , attendance at cardiac rehabilitation , or quality of life between the 2 groups , although our small pilot study was not powered to detect a difference in these outcomes . CONCLUSION In low-risk STEMI patients treated with primary or rescue PCI , a strategy of early hospital discharge facilitated by close nursing follow-up is feasible . Although our study did not identify differences in compliance or quality of life between the 2 groups , it did provide a functional study design for a larger trial powered to detect these important clinical end points Objective : To determine the effect of a new CHOICE ( Choice of Health Options In prevention of Cardiovascular Events ) programme on cardiovascular risk factors in acute coronary syndrome ( ACS ) survivors . Design : Single-blind r and omised controlled trial . Setting : Tertiary referral hospital in Sydney Australia . Patients : 144 ACS survivors who were not accessing st and ard cardiac rehabilitation . Data were also collected on a further 64 ACS survivors attending st and ard cardiac rehabilitation . Intervention : The CHOICE group ( n = 72 ) participated in a brief , patient-centred , modular programme comprising a clinic visit plus telephone support , encompassing m and atory cholesterol lowering and tailored preferential risk modification . The control group ( n = 72 ) participated in continuing conventional care but no central ly coordinated secondary prevention . Main outcome measures : Values for total cholesterol , systolic blood pressure , smoking status and physical activity . Results : CHOICE and control groups were well matched at baseline . At 12 months , the CHOICE group ( n = 67 ) had significantly better risk factor levels than controls ( n = 69 ) for total cholesterol ( TC ) ( mean ( SEM ) 4.0 ( 0.1 ) vs 4.7 ( 0.1 ) mmol/l , p<0.001 ) , systolic blood pressure ( 131.6 ( 1.8 ) vs 143.9 ( 2.3 ) mm Hg , p<0.001 ) , body mass index ( 28.9 ( 0.7 ) vs 31.2 ( 0.7 ) kg/m2 , p = 0.025 ) and physical activity ( 1369.1 ( 167.2 ) vs 715.1 ( 103.5 ) METS/kg/min , p = 0.001 ) as well as a better knowledge of risk factor targets . Also at 1 year , fewer CHOICE participants ( 21 % ) had three or more risk factors above widely recommended levels then controls ( 72 % ) ( p<0.001 ) . Conclusions : Participation in a brief CHOICE programme significantly improved the modifiable risk profiles and risk factor knowledge of ACS survivors over 12 months . CHOICE is an effective alternative for dealing with the widespread underuse of existing secondary prevention programmes . Trial registration number : IS RCT |
11,505 | 27,325,204 | Community detoxification had high completion rates and was reported to be safe .
Compared to patients undergoing facility based detoxification , those who underwent community detoxification had better drinking outcomes .
Community detoxification was cheaper than facility based detoxification and generally had good acceptability by various stakeholders .
IMPLICATION S For certain patients , community detoxification should be considered as a viable option to increase access to care . | ISSUES Despite the potential advantages of community detoxification for alcohol dependence , in many countries the available re sources are mostly focused on specialist services that are re source -intensive , and often difficult to access because of financial or geographical factors .
The aim of this systematic review is to synthesis e the existing literature about the management of alcohol detoxification in the community to examine its effectiveness , safety , acceptability and feasibility . | AIMS Home detoxification is a recognized method of treating problem drinkers within their own home environment . The aim of this research is to determine whether a relatively brief psychological intervention adds to its effectiveness . METHODS A pragmatic trial with 91 participants r and omly assigned to either the psychological intervention or treatment as usual . Community Psychiatric Nurses were trained to administer the brief psychological intervention involving motivational interviewing , coping skills training and social support . A manual was developed in order to st and ardize the training and implementation . RESULTS At the 3 month and 12 month follow-up the psychological intervention result ed in significant positive changes in alcohol consumption , abstinent days , social satisfaction , self-esteem and alcohol-related problems . Further , a cost analysis confirmed that the psychological intervention was a ninth of the cost of inpatient treatment . CONCLUSIONS Adding a psychological intervention to a home detoxification programme was successful and cost-effective The purpose of this study was to compare the cost-effectiveness of conventional outpatient treatment for alcoholic patients ( CT ) with this same conventional treatment plus home visits ( HV ) , a new proposal for intervention within the Brazilian outpatient treatment system . A cost-effectiveness evaluation alongside a 12-week r and omized clinical trial was performed . We identified the re sources utilized by each intervention , as well as the cost according to National Health System ( SUS ) , Brazilian Medical Association ( AMB ) tables of fees , and others based on 2005 data . The incremental cost-effectiveness ratio ( ICER ) was estimated as the main outcome measure – abstinent cases at the end of treatment . There were 51.8 % abstinent cases for HV and 43.1 % for CT , a clinical ly relevant finding . Other outcome measures , such as quality of life , also showed significant improvements that favored HV . The baseline scenario presented an ICER of USD 1,852 . Sensitivity analysis showed an ICER of USD 689 ( scenario favoring HV ) and USD 2,334 ( scenario favoring CT ) . The HV treatment was found to be cost-effective according to the WHO Commission on Macroeconomics and Health The Home Detoxification Service ( HDS ) established in central Scotl and was introduced in response to a high admission rate of problem drinkers to the acute psychiatric wards in Bellsdyke Hospital . This paper reports the results of a comparison of two types of management for people referred to the HDS by local general practitioners ( family doctors ) . Ninety-five patients referred to the HDS were r and omly allocated to two groups of differing treatment intensities . With one group , the home detoxification ( HD ) programme was utilized and with the other , minimal intervention ( MI ) strategies were employed . Post-treatment outcome information collected after 6 months was examined in relation to drinking behaviour , changes in levels of alcohol-related problems and uptake of on-going support from other alcohol agencies . The majority of patients in both treatment groups demonstrated some degree of improvement in relation to these criteria and the most striking factor was that patients in the HD group remained abstinent twice as long after treatment as those in the MI group In this study , 20 subjects who had home detoxification with supervision and support from the Western Australian Alcohol and Drug Authority Community Nursing Service were matched with 20 subjects who had inpatient detoxification in the Authority 's detoxification facility . Subjects were interviewed between nine and 22 months ( mean 15.5 months ) after detoxification to compare client outcomes and the costs of home and inpatient detoxification . The results indicate that , for suitable clients , home detoxification was at least as beneficial as inpatient detoxification and that it was achieved at a much lower cost than inpatient care |
11,506 | 27,408,608 | Conclusion Due to the limitations of this systematic review , results can only be applied to a subset of athletes ( trained male cyclists ) .
For those , we could observe a potential ergogenic benefit of carbohydrate supplementation especially in a concentration range between 6 and 8 % when exercising longer than 90 min | Background Carbohydrate supplements are widely used by athletes as an ergogenic aid before and during sports events .
The present systematic review and meta- analysis aim ed at synthesizing all available data from r and omized controlled trials performed under real-life conditions . | This study examined the effectiveness of ingesting a carbohydrate or carbohydrate + medium-chain triglycerides ( MCT ) on metabolism and cycling performance . Eight endurance-trained men [ peak O(2 ) uptake = 4.71 + /- 0.09 ( SE ) l/min ] completed 35 kJ/kg as quickly as possible [ time trial ( TT ) ] while consuming 250 ml/15 min of either a 6 % ( wt/vol ) carbohydrate solution ( C ) , a 6 % carbohydrate + 4.2 % MCT solution ( C+M ) , or a sweet placebo ( P ) . Time to complete the set amount of work was reduced in both C and C+M compared with P by 7 and 5 % , respectively ( C : 166 + /- 7 min ; C+M : 169 + /- 7 min ; P : 178 + /- 11 min ; P < 0.01 ) . Plasma glucose concentration was maintained at or above resting values throughout both C and C+M trials but decreased ( P < 0.05 ) below resting values in P at the completion of the TT . The estimated rate of carbohydrate oxidation was not different during the first 90 min of exercise but thereafter was reduced ( P < 0.05 ) in P and was maintained in both C and C+M. These data demonstrate that carbohydrate ingestion during exercise improves 100-km TT performance compared with a sweet placebo , but the addition of MCT does not provide any further performance enhancement This study analyzed the effect of caffeine ingestion on performance during a repeated- measures , 100-km , laboratory cycling time trial that included bouts of 1- and 4-km high intensity epochs ( HIE ) . Eight highly trained cyclists participated in 3 separate trials ' placebo ingestion before exercise with a placebo carbohydrate solution and placebo tablets during exercise ( Pl ) , or placebo ingestion before exercise with a 7 % carbohydrate drink and placebo tablets during exercise ( Cho ) , or caffeine tablet ingestion before and during exercise with 7 % carbohydrate ( Caf ) . Placebo ( twice ) or 6 mg.kg(-1 ) caffeine was ingested 60 min prior to starting 1 of the 3 cycling trials , during which subjects ingested either additional placebos or a caffeine maintenance dose of 0.33 mg.kg(-1 ) every 15 min to trial completion . The 100-km time trial consisted of five 1-km HIE after 10 , 32 , 52 , 72 , and 99 km , as well as four 4-km HIE after 20 , 40 , 60 , and 80 km . Subjects were instructed to complete the time trial and all HIE as fast as possible . Plasma ( caffeine ) was significantly higher during Caf ( 0.43 + /- 0.56 and 1.11 + /- 1.78 mM pre vs. post Pl ; and 47.32 + /- 12.01 and 72.43 + /- 29.08 mM pre vs. post Caf ) . Average power , HIE time to completion , and 100-km time to completion were not different between trials . Mean heart rates during both the 1-km HIE ( 184.0 + /- 9.8 Caf ; 177.0 + /- 5.8 Pl ; 177.4 + /- 8.9 Cho ) and 4-km HIE ( 181.7 + /- 5.7 Caf ; 174.3 + /- 7.2 Pl ; 175.6 + /- 7.6 Cho ; p < .05 ) was higher in Caf than in the other groups . No significant differences were found between groups for either EMG amplitude ( IEMG ) or mean power frequency spectrum ( MPFS ) . IEMG activity and performance were not different between groups but were both higher in the 1-km HIE , indicating the absence of peripheral fatigue and the presence of a central ly-regulated pacing strategy that is not altered by caffeine ingestion . Caffeine may be without ergogenic benefit during endurance exercise in which the athlete begins exercise with a defined , predetermined goal measured as speed or distance Most studies investigating the effects of acute carbohydrate ( CHO ) ingestion on post-exercise cytokine responses have involved fasted athletes . This study characterised the effects of acute CHO beverage ingestion preceded by consumption of a CHO-containing pre-exercise meal . Sixteen highly-trained male cyclists/triathletes ( age : 30.6 + /- 5.6 y ; V O ( 2max ) : 64.8 + /- 4.7 ml . kg . min ( -1 ) [ mean + /- SD ] ) undertook two cycle ergometry trials involving r and omised consumption of a 10 % CHO beverage ( 15 mL . kg ( -1 ) . hr ( -1 ) ) or water ( H (2)O ) . Trials were undertaken 2 h after a breakfast providing 2.1 g CHO . kg ( -1 ) body mass ( BM ) ( 48 kJ . kg ( -1 ) BM ) and consisted of 100 min steady state cycle ergometry at 70 % V O ( 2max ) followed by a time trial of approximately 30 min duration . Blood sample s were collected pre- , post- and 1 h post-exercise for measurement of Interleukin (IL)-6 , IL-8 , IL-10 and IL-1ra . Time-trial performance was not substantially different between CHO and H (2)O trials ( 4.5 % , p = 0.42 ) . Neither IL-6 nor IL-8 responses were substantially reduced in the CHO compared to the H (2)O trial . There was a substantial reduction in IL-10 ( 32 % , p = 0.05 ) and IL-1ra ( 43 % , p = 0.02 ) responses at 1 h post-exercise with CHO compared to H (2)O ingestion . In conclusion , the previously shown attenuating effects of CHO ingestion during exercise on cytokine responses appear reduced when athletes consume a CHO-containing pre-exercise meal The study examined the effect of carbohydrate ingestion on exercise performance capacity . Nine male cyclists performed two separate trials at 70 % VO2max for 60 min followed by a maximal ride for 10 min . During trials subjects were fed either an 8 % glucose solution ( CHO ) or a placebo solution ( PL ) , which were administered at rest and during and immediately after submaximal exercise . Statistical analyses indicated that glucose levels at rest increased significantly 15 min after the ingestion of CHO compared to PL . At 30 and 60 min during submaximal exercise , plasma glucose levels decreased significantly in the CHO but not in the PL trial . Following the performance ride , glucose levels increased significantly only during the CHO test trial . Free fatty acids did not change significantly during testing trials . The maximal performance ride results showed that in the CHO trial , a significantly greater external work load was accomplished compared to the PL trial . It is concluded that CHO ingestion improves maximal exercise performance after prolonged exercise PURPOSE Five days of a high-fat diet produce metabolic adaptations that increase the rate of fat oxidation during prolonged exercise . We investigated whether enhanced rates of fat oxidation during submaximal exercise after 5 d of a high-fat diet would persist in the face of increased carbohydrate ( CHO ) availability before and during exercise . METHODS Eight well-trained subjects consumed either a high-CHO ( 9.3 g x kg(-1 ) x d(-1 ) CHO , 1.1 g x kg(-1 ) x d(-1 ) fat ; HCHO ) or an isoenergetic high-fat diet ( 2.5 g x kg(-1 ) x d(-1 ) CHO , 4.3 g x kg(-1 ) x d(-1 ) fat ; FAT-adapt ) for 5 d followed by a high-CHO diet and rest on day 6 . On day 7 , performance testing ( 2 h steady-state ( SS ) cycling at 70 % peak O(2 ) uptake [ VO(2peak ) ] + time trial [ TT ] ) of 7 kJ x kg(-1 ) ) was undertaken after a CHO breakfast ( CHO 2 g x kg(-1 ) ) and intake of CHO during cycling ( 0.8 g x kg(-1 ) x h(-1 ) ) . RESULTS FAT-adapt reduced respiratory exchange ratio ( RER ) values before and during cycling at 70 % VO(2peak ) ; RER was restored by 1 d CHO and CHO intake during cycling ( 0.90 + /- 0.01 , 0.80 + /- 0.01 , 0.91 + /- 0.01 , for days 1 , 6 , and 7 , respectively ) . RER values were higher with HCHO ( 0.90 + /- 0.01 , 0.88 + /- 0.01 ( HCHO > FAT-adapt , P < 0.05 ) , 0.95 + /- 0.01 ( HCHO > FAT-adapt , P < 0.05 ) ) . On day 7 , fat oxidation remained elevated ( 73 + /- 4 g vs 45 + /- 3 g , P < 0.05 ) , whereas CHO oxidation was reduced ( 354 + /- 11 g vs 419 + /- 13 g , P < 0.05 ) throughout SS in FAT-adapt versus HCHO . TT performance was similar for both trials ( 25.53 + /- 0.67 min vs 25.45 + /- 0.96 min , NS ) . CONCLUSION Adaptations to a short-term high-fat diet persisted in the face of high CHO availability before and during exercise , but failed to confer a performance advantage during a TT lasting approximately 25 min undertaken after 2 h of submaximal cycling We evaluated the effect of carbohydrate ( CHO ) loading on cycling performance that was design ed to be similar to the dem and s of competitive road racing . Seven well-trained cyclists performed two 100-km time trials ( TTs ) on separate occasions , 3 days after either a CHO-loading ( 9 g CHO . kg body mass(-1 ) . day(-1 ) ) or placebo-controlled moderate-CHO diet ( 6 g CHO . kg body mass(-1 ) . day(-1 ) ) . A CHO breakfast ( 2 g CHO/kg body mass ) was consumed 2 h before each TT , and a CHO drink ( 1 g CHO . kg(.)body mass(-1 ) . h(-1 ) ) was consumed during the TTs to optimize CHO availability . The 100-km TT was interspersed with four 4-km and five 1-km sprints . CHO loading significantly increased muscle glycogen concentrations ( 572 + /- 107 vs. 485 + /- 128 mmol/kg dry wt for CHO loading and placebo , respectively ; P < 0.05 ) . Total muscle glycogen utilization did not differ between trials , nor did time to complete the TTs ( 147.5 + /- 10.0 and 149.1 + /- 11.0 min ; P = 0.4 ) or the mean power output during the TTs ( 259 + /- 40 and 253 + /- 40 W , P = 0.4 ) . This placebo-controlled study shows that CHO loading did not improve performance of a 100-km cycling TT during which CHO was consumed . By preventing any fall in blood glucose concentration , CHO ingestion during exercise may offset any detrimental effects on performance of lower preexercise muscle and liver glycogen concentrations . Alternatively , part of the reported benefit of CHO loading on subsequent athletic performance could have result ed from a placebo effect It is presently unclear whether the reported ergogenic effect of a carbohydrate ( CHO ) mouth rinse on cycling time-trial performance is affected by the acute nutritional status of an individual . Hence , the aim of this study was to investigate the effect of a CHO mouth rinse on a 60-min simulated cycling time-trial performance commenced in a fed or fasted state . Twelve competitive male cyclists each completed 4 experimental trials using a double-blinded Latin square design . Two trials were commenced 2 h after a meal that contained 2.5 g·kg(-1 ) body mass of CHO ( FED ) and 2 after an overnight fast ( FST ) . Prior to and after every 12.5 % of total time during a performance ride , either a 10 % maltodextrin ( CHO ) or a taste-matched placebo ( PLB ) solution was mouth rinsed for 10 s then immediately expectorated . There were significant main effects for both pre-ride nutritional status ( FED vs. FST ; p < 0.01 ) and CHO mouth rinse ( CHO vs. PLB ; p < 0.01 ) on power output with an interaction evident between the interventions ( p < 0.05 ) . The CHO mouth rinse improved mean power to a greater extent after an overnight fast ( 282 vs. 273 W , 3.4 % ; p < 0.01 ) compared with a fed state ( 286 vs. 281 W , 1.8 % ; p < 0.05 ) . We concluded that a CHO mouth rinse improved performance to a greater extent in a fasted compared with a fed state ; however , optimal performance was achieved in a fed state with the addition of a CHO mouth rinse The effects of a commercial sports drink on performance in high-intensity cycling was investigated . Nine well-trained subjects were asked to complete a set amount of work as fast as possible ( time trial ) following 24 h of dietary ( subjects were provided with food , energy 57.4+/-2.4 kcal/kg and carbohydrate 9.1+/-0.4 g/kg ) and exercise control . During exercise , subjects were provided with 14 mL/kg of either 6 % carbohydrate-electrolyte ( CHO-E ) solution or carbohydrate-free placebo ( P ) . Results showed that subjects ' performances did not greatly improve ( time , 62:34+/-6:44 min : sec ( CHO-E ) vs. 62:40+/-5:35 min : sec ( P ) ; average power output , 283.0+/-25.0 W ( CHO-E ) vs. 282.9+/-29.3 W ( P ) , P > 0.05 ) while consuming the sports drink . It was concluded that CHO-E consumption throughout a 1-h time trial , following a pre-exercise dietary regimen design ed to optimize glucose availability , did not improve time or power output to a greater degree than P in well-trained cyclists The well-established ergogenic benefit of ingesting carbohydrates during single-discipline endurance sports has only been tested once within an Olympic-distance ( OD ) triathlon . The aim of the present study was to compare the effect of ingesting a 2:1 maltodextrin/fructose solution with a placebo on simulated OD triathlon performance . Six male and 4 female amateur triathletes ( age , 25 ± 7 years ; body mass , 66.8 ± 9.2 kg ; peak oxygen uptake , 4.2 ± 0.6 L·min(-1 ) ) completed a 1500-m swim time-trial and an incremental cycle test to determine peak oxygen uptake before performing 2 simulated OD triathlons . The swim and cycle sections of the main trials were of fixed intensities , while the run section was completed as a time-trial . Two minutes prior to completing every quarter of the cycle participants consumed 202 ± 20 mL of either a solution containing 1.2 g·min(-1 ) of maltodextrin plus 0.6 g·min(-1 ) of fructose at 14.4 % concentration ( CHO ) or a sugar-free , fruit-flavored drink ( PLA ) . The time-trial was 4.0 % ± 1.3 % faster during the CHO versus PLA trial , with run times of 38:43 ± 1:10 min : s and 40:22 ± 1:18 min : s , respectively ( p = 0.010 ) . Blood glucose concentrations were higher in the CHO versus PLA trial ( p < 0.001 ) , while perceived stomach upset did not differ between trials ( p = 0.555 ) . The current findings show that a 2:1 maltodextrin/fructose solution ( 1.8 g·min(-1 ) at 14.4 % ) ingested throughout the cycle section of a simulated OD triathlon enhances subsequent 10-km run performance in triathletes We determined the effects of varying daily carbohydrate intake by providing or withholding carbohydrate during daily training on endurance performance , whole body rates of substrate oxidation , and selected mitochondrial enzymes . Sixteen endurance-trained cyclists or triathletes were pair matched and r and omly allocated to either a high-carbohydrate group ( High group ; n = 8) or an energy-matched low-carbohydrate group ( Low group ; n = 8) for 28 days . Immediately before study commencement and during the final 5 days , subjects undertook a 5-day test block in which they completed an exercise trial consisting of a 100 min of steady-state cycling ( 100SS ) followed by a 7-kJ/kg time trial on two occasions separated by 72 h. In a counterbalanced design , subjects consumed either water ( water trial ) or a 10 % glucose solution ( glucose trial ) throughout the exercise trial . A muscle biopsy was taken from the vastus lateralis muscle on day 1 of the first test block , and rates of substrate oxidation were determined throughout 100SS . Training induced a marked increase in maximal citrate synthase activity after the intervention in the High group ( 27 vs. 34 micromol x g(-1 ) x min(-1 ) , P < 0.001 ) . Tracer-derived estimates of exogenous glucose oxidation during 100SS in the glucose trial increased from 54.6 to 63.6 g ( P < 0.01 ) in the High group with no change in the Low group . Cycling performance improved by approximately 6 % after training . We conclude that altering total daily carbohydrate intake by providing or withholding carbohydrate during daily training in trained athletes results in differences in selected metabolic adaptations to exercise , including the oxidation of exogenous carbohydrate . However , these metabolic changes do not alter the training-induced magnitude of increase in exercise performance A number of recent research studies have demonstrated that providing glucose and fructose together in a beverage consumed during exercise results in significantly higher oxidation rates of exogenous carbohydrate ( CHO ) than consuming glucose alone . However , there is insufficient evidence to determine whether the increased exogenous CHO oxidation improves endurance performance . The purpose of this study was to determine whether consuming a beverage containing glucose and fructose ( GF ) would result in improved cycling performance compared with an isocaloric glucose-only beverage ( G ) . Nine male competitive cyclists ( 32.6 + /- 5.8 years , peak oxygen uptake 61.5 + /- 7.9 ml x kg(-1 ) x min(-1 ) ) completed a familiarization trial and then 2 simulated 100-km cycling time trials on an electronically braked Lode cycle ergometer separated by 5 - 7 d. During the r and omly ordered experimental trials , participants received 36 g of CHO of either G or GF in 250 ml of water every 15 min . All 9 participants completed the 100-km time trial significantly faster when they received the GF beverage than with G ( 204.0 + /- 23.7 vs. 220.6 + /- 36.6 min ; p = .023 ) . There was no difference at any time point between trials for blood glucose or for blood lactate . Total CHO oxidation increased significantly from rest during exercise but was not statistically significant between the GF and G trials , although there was a trend for CHO oxidation to be higher with GF in the latter stages of the time trial . Consumption of a CHO beverage containing glucose and fructose results in improved 100-km cycling performance compared with an isocaloric glucose-only beverage Numerous studies have shown that ingesting carbohydrate in the form of a drink can improve exercise performance by maintaining blood glucose levels and sparing endogenous glycogen stores . The effectiveness of carbohydrate gels or jellybeans in improving endurance performance has not been examined . On 4 separate days and 1 - 2 hr after a st and ardized meal , 16 male ( 8 ; 35.8 + /- 2.5 yr ) and female ( 8 ; 32.4 + /- 2.4 yr ) athletes cycled at 75 % VO(2peak ) for 80 min followed by a 10-km time trial . Participants consumed isocaloric ( 0.6 g of carbohydrate per kg per hour ) amounts of r and omly assigned sports beans , sports drink , gel , or water only , before , during , and after exercise . Blood glucose concentrations were similar at rest between treatments and decreased significantly during exercise with the water trial only . Blood glucose concentrations for all carbohydrate supplements were significantly , p < .05 , higher than water during the 80-min exercise bout and during the time trial ( 5.7 + /- 0.2 mmol/L for sports beans , 5.6 + /- 0.2 mmol/L for sports drink , 5.7 + /- 0.3 mmol/L for gel , and 4.6 + /- 0.3 mmol/L for water ) . There were no significant differences in blood glucose between carbohydrate treatments . The 10-km time trials using all 3 carbohydrate treatments were significantly faster ( 17.2 + /- 0.6 min for sports beans , 17.3 + /- 0.6 min for sports drink , and 17.3 + /- 0.6 min for gel ) than water ( 17.8 + /- 0.7 min ) . All carbohydrate-supplement types were equally effective in maintaining blood glucose levels during exercise and improving exercise performance compared with water only This study examined the effect of carbohydrate ingestion on metabolic and performance-related responses during and after a simulated 1 h cycling time trial . Eight trained male cyclists ( VO2 peak = 66.5 ml kg-1 min-1 ) rode their own bicycles mounted on a windload simulator to imitate real riding conditions . At a self-selected maximal pace , the cyclists performed two 1 h rides ( separated by 7 days ) and were fed either an 8 % carbohydrate or placebo solution . The beverages were administered 25 min before ( 4.5 ml kg-1 ) and at the end ( 4.5 ml kg-1 ) of the ride . With carbohydrate feeding , plasma glucose tended ( P = 0.21 ) to rise before the time trial . Compared with rest , the plasma glucose concentration decreased significantly ( P < 0.05 ) at the end of both rides , with no statistically significant difference being observed between treatments . Thereafter , plasma glucose increased significantly ( P < 0.05 ) at 15 and 30 min into recovery and was significantly higher at 30 min during the carbohydrate trial compared with the placebo trial . No significant changes in plasma free fatty acids were observed during the ride . However , a significant increase ( P < 0.05 ) in free fatty acids was found at 15 and 30 min into recovery , with no difference between trials . Mean power output was significantly ( P < 0.05 ) greater during the carbohydrate compared with the placebo trial ( mean + /- S.E. : 277 + /- 3 and 269 + /- 3 W , respectively ) . The greater distance covered in the carbohydrate compared with the placebo trial ( 41.5 + /- 1.06 and 41.0 + /- 1.06 km , respectively ; P < 0.05 ) was equivalent to a 44 s improvement . We conclude that pre-exercise carbohydrate ingestion significantly increases endurance performance in trained cyclists during a 1 h simulated time trial . Although the mechanism for this enhancement in performance with carbohydrate ingestion can not be surmised from the present results , it could be related to a higher rate of carbohydrate oxidation , or to favourable effects of carbohydrate ingestion on the central component of fatigue The purpose of this study was to compare the effects of a carbohydrate-electrolyte plus caffeine , carnitine , taurine , and B vitamins solution ( CE+ ) and a carbohydrate-electrolyte-only solution ( CE ) vs. a placebo solution ( PLA ) on cycling performance and maximal voluntary contraction ( MVC ) . In a r and omized , double-blind , crossover , repeated- measures design , 14 male cyclists ( M + /- SD age 27 + /- 6 yr , VO2max 60.4 + /- 6.8 ml x kg-1 x min(-1 ) ) cycled for 120 min submaximally ( alternating 61 % + /- 5 % and 75 % + /- 5 % VO2max ) and then completed a 15-min performance trial ( PT ) . Participants ingested CE+ , CE , or PLA before ( 6 ml/kg ) and every 15 min during exercise ( 3 ml/kg ) . MVC was measured as a single-leg isometric extension ( 70 degree knee flexion ) before ( pre ) and after ( post ) exercise . Rating of perceived exertion ( RPE ) was measured throughout . Total work accumulated ( KJ ) during PT was greater ( p < .05 ) in CE+ ( 233 + /- 34 ) than PLA ( 205 + /- 52 ) but not in CE ( 225 + /- 39 ) vs. PLA . MVC ( N ) declined ( p < .001 ) from pre to post in PLA ( 988 + /- 213 to 851 + /- 191 ) and CE ( 970 + /- 172 to 870 + /- 163 ) but not in CE+ ( 953 + /- 171 to 904 + /- 208 ) . At Minutes 60 , 90 , 105 , and 120 RPE was lower in CE+ ( 14 + /- 2 , 14 + /- 2 , 12 + /- 1 , 15 + /- 2 ) than in PLA ( 14 + /- 2 , 15 + /- 2 , 14 + /- 2 , 16 + /- 2 ; p < .001 ) . CE+ result ed in greater total work than PLA . CE+ , but not PLA or CE , attenuated pre-to-post MVC declines . Performance increases during CE+ may have been influenced by lower RPE and greater preservation of leg strength during exercise in part as a result of the hypothesized effects of CE+ on the central nervous system and skeletal muscle This study examined the effect of increased blood glucose availability on glucose kinetics during exercise . Five trained men cycled for 40 min at 77 + /- 1 % peak oxygen uptake on two occasions . During the second trial ( Glu ) , glucose was infused at a rate equal to the average hepatic glucose production ( HGP ) measured during exercise in the control trial ( Con ) . Glucose kinetics were measured by a primed continuous infusion of D-[3 - 3H]glucose . Plasma glucose increased during exercise in both trials and was significantly higher in Glu . HGP was similar at rest ( Con , 11.4 + /- 1.2 ; Glu , 10.6 + /- 0.6 micromol . kg-1 . min-1 ) . After 40 min of exercise , HGP reached a peak of 40.2 + /- 5.5 micromol . kg-1 . min-1 in Con ; however , in Glu , there was complete inhibition of the increase in HGP during exercise that never rose above the preexercise level . The rate of glucose disappearance was greater ( P < 0.05 ) during the last 15 min of exercise in Glu . These results indicate that an increase in glucose availability inhibits the rise in HGP during exercise , suggesting that metabolic feedback signals can override feed-forward activation of HGP during strenuous exercise PURPOSE AND METHODS To investigate the effect of glucose infusion on glucose kinetics and performance , six endurance cyclists ( VO2max = 61.7 + /- 2.0 ( mean + /- SE ) mL x kg(-1 ) x min(-1 ) ) completed two performance trials in which they had to accomplish a set amount of work as quickly as possible ( 991 + /- 41 kJ ) . Subjects were infused with either glucose ( 20 % in saline ; carbohydrate ( CHO ) ) at a rate of 1 g x min(-1 ) or saline ( 0.9 % saline ; placebo ( PLA ) ) . It was hypothesized that time trial performance would be unaffected by the infusion of glucose , as endogenous stores of CHO would not be limiting in the PLA trial . RESULTS Plasma glucose concentration increased from 4.8 + /- 0.1 mmol x L(-1 ) to 5.9 + /- 0.3 mmol x L(-1 ) during the PLA trial and from 4.9 + /- 0.1 mmol x L(-1 ) at rest to 12.4 + /- 1.1 mmol x L(-1 ) during the CHO trial . These values were significantly higher at all time points during the CHO trial compared with PLA ( P < 0.001 ) . In the final stages of the time trial , Rd in the PLA trial was 49 + /- 5 micromol x kg(-1 ) x min(-1 ) compared with 88 + /- 7 micromol x kg(-1 ) x min(-1 ) in the CHO trial ( P < 0.05 ) . Despite these differences , there was no difference in performance time between PLA and CHO ( 60.04 + /- 1.47 min , PLA , vs 59.90 + /- 1.49 min , CHO , respectively ) . Infused carbohydrate oxidation in the last 25 % of the CHO trial was at least 675 + /- 120 micromol x kg(-1 ) and contributed 17 + /- 4 % to total carbohydrate oxidation . CONCLUSION The results demonstrate that glucose infusion had no effect on 1-h cycle time-trial performance , despite an increased availability of plasma glucose for oxidation and evidence of increased glucose uptake into the tissues A recent study from our laboratory has shown that a mixture of glucose and fructose ingested at a rate of 1.8 g/min leads to peak oxidation rates of approximately 1.3 g/min and results in approximately 55 % higher exogenous carbohydrate ( CHO ) oxidation rates compared with the ingestion of an isocaloric amount of glucose . The aim of the present study was to investigate whether a mixture of glucose and fructose when ingested at a high rate ( 2.4 g/min ) would lead to even higher exogenous CHO oxidation rates ( > 1.3 g/min ) . Eight trained male cyclists ( VO2max : 68+/-1 ml/kg per min ) cycled on three different occasions for 150 min at 50 % of maximal power output ( 60+/-1 % VO2max ) and consumed either water ( WAT ) or a CHO solution providing 1.2 g/min glucose ( GLU ) or 1.2 g/min glucose+1.2 g/min fructose ( GLU+FRUC ) . Peak exogenous CHO oxidation rates were higher ( P<0.01 ) in the GLU+FRUC trial compared with the GLU trial ( 1.75 ( SE 0.11 ) and 1.06 ( SE 0.05 ) g/min , respectively ) . Furthermore , exogenous CHO oxidation rates during the last 90 min of exercise were approximately 50 % higher ( P<0.05 ) in GLU+FRUC compared with GLU ( 1.49 ( SE 0.08 ) and 0.99 ( SE 0.06 ) g/min , respectively ) . The results demonstrate that when a mixture of glucose and fructose is ingested at high rates ( 2.4 g/min ) during 150 min of cycling exercise , exogenous CHO oxidation rates reach peak values of approximately 1.75 g/min PURPOSE AND METHOD To investigate the possible role of carbohydrate ( CHO ) receptors in the mouth in influencing exercise performance , seven male and two female endurance cyclists ( VO(2max ) 63.2 + /- 2.7 ( mean + /- SE ) mL.kg*(-1).min(-1 ) ) completed two performance trials in which they had to accomplish a set amount of work as quickly as possible ( 914 + /- 40 kJ ) . On one occasion a 6.4 % maltodextrin solution ( CHO ) was rinsed around the mouth for every 12.5 % of the trial completed . On the other occasion , water ( PLA ) was rinsed . Subjects were not allowed to swallow either the CHO solution or water , and each mouthful was spat out after a 5-s rinse . RESULTS Performance time was significantly improved with CHO compared with PLA ( 59.57 + /- 1.50 min vs 61.37 + /- 1.56 min , respectively , P = 0.011 ) . This improvement result ed in a significantly higher average power output during the CHO compared with the PLA trial ( 259 + /- 16 W and 252 + /- 16 W , respectively , P = 0.003 ) . There were no differences in heart rate or rating of perceived exertion ( RPE ) between the two trials ( P > 0.05 ) . CONCLUSION The results demonstrate that carbohydrate mouth rinse has a positive effect on 1-h time trial performance . The mechanism responsible for the improvement in high-intensity exercise performance with exogenous carbohydrate appears to involve an increase in central drive or motivation rather than having any metabolic cause . The nature and role of putative CHO receptors in the mouth warrants further investigation The purpose of this study was to determine the effect of carbohydrate supplementation on finishing time of a realistically simulated 80 mile bicycle time trial . Fourteen trained cyclists pedalled at self-selected pace on their own bicycles on windload simulators . Two trials were performed one week apart . Each trial was preceded by two days of prescribed diet , with a final feeding 3 - 4 h prior to exercise . Following each 10 mile segment , subjects ingested either a non-caloric placebo ( PL ) or the carbohydrate maltodextrin supplement ( MD ; 5 % maltodextrin + 2 % fructose ) at dosage of 0.25 g.kg-1 body weight ( mean intake rate , total : 37 g.h-1 , 148 g ) in a double blind , counter-balanced design . Mean ( + /- SEM ) finishing times were faster by 5 % with MD ( 241.0 + /- 2.1 minutes versus 253.2 + /- 2.1 minutes ) , p < 0.05 . With MD , serum glucose levels rose sharply after 40 miles and were significantly higher than PL ( p < 0.05 ) . Final glucose values were 6.0 + /- 0.2 mmol.l-1 and 4.1 + /- 0.2 mmol.l-1 for MD and PL , respectively . With MD , free fatty acid levels were significantly lower ( p < 0.05 ) , and riders sustained higher average intensity over the entire distance . At the finish , intensities were 64.7 + /- 1.9 % VO2max and 55.3 + /- 1.9 % VO2max for GP and PL , respectively . Mean carbohydrate oxidation was significantly higher ( p < 0.05 ) for MD , 2.01 + /- 0.2 g.min-1 and 1.64 + /- 0.2 g.min-1 for MD and PL , respectively . These data show that ingestion of MD , during ultraendurance exercise , in comparison to PL , decreases the time to finish a self-paced bicycle time trial Carbohydrate-electrolyte ( CE ) feedings have been shown to improve endurance performance at moderate intensities ( 60 - 75 % VO2max ) and or more than 2 h duration . The effects of CE feedings during high intensity exercise ( i.e. > or = 80 % VO2 max ) of shorter duration ( approximately 1 h ) are less clear . Therefore the purpose of the present study was to investigate the effect of the ingestion of a 7.6 % CE solution during exercise on time trial cycling performance of approximately 1 h. This type of performance testing has been shown to be more reproducible ( coefficient of variation 3.35 % ) than the traditional exercise test to exhaustion . On two occasions and in r and om order nineteen endurance trained cyclists completed an exercise test requiring the accomplishment of a set amount of work as fast as possible ( time trial ) under strictly st and ardized conditions . As the start and during the trials they drank in total 14 ml/kg of either a 7.6 % CE solution or artificially flavored and colored water ( placebo ) . Time to complete the set amount of work was significantly reduced and thus performance was significantly increase ( p < 0.001 ) with the CE drink by 2.3 % . Time to complete the set amount of work was 58.74 + /- 0.52 min with CE and 60.15 + /- 0.65 min with placebo ( p < 0.001 ) . Average workload during the time trials was 297.5 + /- 1.4W and 291.0 + /- 10.3 W , respectively . Subjects exercised at 76.4 + /- 0.7 % of their maximal work rate ( Wmax ) with CE and at 74.8 % Wmax with placebo ( p < 0.001 ) . It was concluded tht also in relative short term ( 1h ) high intensity ( 75 % Wmax ) cycling exercise ingestion of a carbohydrate-electrolyte solution compared to placebo improves performance The purpose of this study was to examine the influences of a carbohydrate ( CHO ) mouth rinse on self-selected running speeds during a 30-min treadmill run . Ten endurance-trained men performed 2 trials , each involving a 10-min warm-up at 60 % VO2max followed by a 30-min run . The run was performed on an automated treadmill that allowed the spontaneous selection of speeds without manual input . Participants were asked to run at speeds that equated to a rating of perceived exertion of 15 , mouth rinsing with either a 6 % CHO or taste-matched placebo ( PLA ) solution . In addition to recording self-selected speeds and total distance covered the authors assessed the runners ' subjective feelings . The total distance covered was greater during the CHO than during the PLA trial ( p < .05 ) . Faster speeds selected during the first 5 min of exercise corresponded with enhanced feelings of pleasure when mouth rinsing with the CHO solution . Mouth rinsing with a CHO solution increased total distance covered during a self-selected 30-min run in comparison with mouth rinsing with a color- and taste-matched placebo PURPOSE To determine whether combined ingestion of maltodextrin and fructose during 150 min of cycling exercise would lead to exogenous carbohydrate oxidation rates higher than 1.1 g.min . METHODS Eight trained cyclists VO2max : 64.1 + /- 3.1 mL.kg.min ) performed three exercise trials in a r and om order . Each trial consisted of 150 min cycling at 55 % maximum power output ( 64.2+/-3.5 % VO2max ) while subjects received a solution providing either 1.8 g.min of maltodextrin ( MD ) , 1.2 g.min of maltodextrin + 0.6 g.min of fructose ( MD+F ) , or plain water . To quantify exogenous carbohydrate oxidation , corn-derived MD and F were used , which have a high natural abundance of C. RESULTS Peak exogenous carbohydrate oxidation ( last 30 min of exercise ) rates were approximately 40 % higher with combined MD+F ingestion compared with MD only ingestion ( 1.50+/-0.07 and 1.06+/-0.08 g.min , respectively , P<0.05 ) . Furthermore , the average exogenous carbohydrate oxidation rate during the last 90 min of exercise was higher with combined MD+F ingestion compared with MD alone ( 1.38+/-0.06 and 0.96+/-0.07 g.min , respectively , P<0.05 ) . CONCLUSIONS The present study demonstrates that with ingestion of large amounts of maltodextrin and fructose during cycling exercise , exogenous carbohydrate oxidation can reach peak values of approximately 1.5 g.min , and this is markedly higher than oxidation rates from ingesting maltodextrin alone When ingested at high rates ( 1.8 - 2.4 g·min(-1 ) ) in concentrated solutions , carbohydrates absorbed by multiple ( e.g. , fructose and glucose ) vs. single intestinal transporters can increase exogenous carbohydrate oxidation and endurance performance , but their effect when ingested at lower , more realistic , rates during intermittent high-intensity endurance competition and trials is unknown . Trained cyclists participated in two independent r and omized crossover investigations comprising mountain-bike races ( average 141 min ; n = 10 ) and laboratory trials ( 94-min high-intensity intervals followed by 10 maximal sprints ; n = 16 ) . Solutions ingested during exercise contained electrolytes and fructose + maltodextrin or glucose + maltodextrin in 1:2 ratio ingested , on average , at 1.2 g carbohydrate·kg(-1)·h(-1 ) . Exertion , muscle fatigue , and gastrointestinal discomfort were recorded . Data were analysed using mixed models with gastrointestinal discomfort as a mechanism covariate ; inferences were made against substantiveness thresholds ( 1.2 % for performance ) and st and ardized difference . The fructose-maltodextrin solution substantially reduced race time ( -1.8 % ; 90 % confidence interval = ±1.8 % ) and abdominal cramps ( -8.1 on a 0 - 100 scale ; ±6.6 ) . After accounting for gastrointestinal discomfort , the effect of the fructose-maltodextrin solution on lap time was reduced ( -1.1 % ; ±2.4 % ) , suggesting that gastrointestinal discomfort explained part of the effect of fructose-maltodextrin on performance . In the laboratory , mean sprint power was enhanced ( 1.4 % ; ±0.8 % ) with fructose-maltodextrin , but the effect on peak power was unclear ( 0.7 % ; ±1.5 % ) . Adjusting out gastrointestinal discomfort augmented the fructose-maltodextrin effect on mean ( 2.6 % ; ±1.9 % ) and peak ( 2.5 % ; ±3.0 % ) power . Ingestion of multiple transportable vs. single transportable carbohydrates enhanced mountain-bike race and high-intensity laboratory cycling performance , with inconsistent but not irreconcilable effects of gut discomfort as a possible mediating mechanism Seven well-trained male cyclists were studied during 105 min of cycling ( 65 % of maximal oxygen uptake ) and a 15-min " performance ride " to compare the effects of 4- and 8-h preexercise carbohydrate ( CHO ) feedings on substrate use and performance . A high CHO meal was given 1 ) 4-h preexercise ( M-4 ) , 2 ) 8-h preexercise ( M-8 ) , 3 ) 4-h preexercise with CHO feedings during exercise ( M-4CHO ) , and 4 ) 8-h preexercise with CHO feedings during exercise ( M-8CHO ) . Blood sample s were obtained at 0 , 15 , 60 , 105 , and 120 min and analyzed for lactate , glucose , insulin , and glycerol . Total work output during the performance ride was similar for the M-4 ( 217,893 + /- 13,348 N/m ) and M-8 trials ( 216,542 + /- 13,905 ) and was somewhat higher for the M-4CHO ( 223,994 + /- 14,387 ) and M-8CHO ( 224,702 + /- 15,709 ) trials ( P = 0.059 , NS ) . Glucose was significantly elevated throughout exercise , and insulin levels were significantly elevated at 15 and 60 min during M-4CHO and M-8CHO compared with M-4 and M-8 trials . Glycerol levels were significantly lower during the CHO feeding trials compared with placebo and were not significantly different during exercise when the subject had fasted an additional 4 h. The results of this study suggest that when preexercise meals are ingested 4 or 8 h before submaximal cycling exercise , substrate use and performance are similar This study examined effects of ingesting a 10 % carbohydrate ( CHO ) drink ( CI ) or placebo ( PI ) at 500 ml/h on total ( splanchnic ) glucose appearance ( endogenous+exogenous ; Ra ) , blood glucose oxidation , and muscle glycogen utilization in 14 male endurance-trained cyclists who rode for 180 min at 70 % of maximal O2 uptake after CHO loading [ starting muscle glycogen 203 + /- 7 ( SE ) mmol/kg wet wt ] . Total CHO oxidation was similar in CI and PI , but Ra increased significantly during the trial in both groups with CI reaching a plateau after 75 min . Ra was significantly greater in CI than in PI at the end of exercise . Blood glucose oxidation also increased significantly during the trial to a plateau in CI and was significantly higher in CI than in PI at the end of exercise . However , mean endogenous Ra was significantly lower in CI than in PI throughout exercise , as was oxidation of endogenous blood glucose , which remained almost constant in CI and reached 43 + /- 8 and 73 + /- 13 mumol.min-1.kg fat-free mass-1 in CI and PI , respectively , at the end of exercise . At 0.83 g/min of CHO ingestion , 0.77 + /- 0.03 g/min was oxidized . Muscle glycogen utilization was identical in both groups and was higher during the 1st h of exercise . ( ABSTRACT TRUNCATED AT 250 WORDS PURPOSE The aim of this study was to investigate the influence of mouth rinsing a CHO-electrolyte ( CHO-E ) solution on 1-h running performance . A second study determined whether mouth rinsing a CHO-E solution altered the blood glucose and plasma insulin concentrations at rest . METHODS After a 13-h fast , 10 endurance-trained male runners completed two 1-h performance runs on an automated treadmill while mouth rinsing 25 mL of either a 6.4 % CHO-E ( C ) or placebo ( P ) solution immediately before and at 15-min intervals during the 1-h run . An additional 10 healthy active males followed the same mouth rinsing procedure during a 1-h resting period . Finger prick blood sample s were obtained for the determination of blood glucose and plasma insulin concentrations . RESULTS Runners covered 211 m ( 90 % confidence intervals = 42 - 380 m , P = 0.048 ) further during the C trial ( 14,298 ± 685 m , mean ± SD ) in comparison with the P trial ( 14,086 ± 732 m ) . There was no change in blood glucose concentrations during the 1-h run ( P : pre = 4.3 ± 0.2 mmol·L(-1 ) , post = 4.3 ± 0.3 mmol·L(-1 ) ; C : pre = 4.3 ± 0.4 mmol·L(-1 ) , post = 4.3 ± 0.3 mmol·L(-1 ) ) . At rest , there was no change in blood glucose ( P : 4.3 ± 0.1 mmol·L(-1 ) , C : 4.3 ± 0.2 mmol·L(-1 ) ) or plasma insulin ( P : 6.2 ± 1.1 mU·L(-1 ) , CHO : 5.9 ± 1.0 1.1 mU·L(-1 ) ) concentrations ( P > 0.10 ) . CONCLUSIONS Mouth rinsing a 6.4 % CHO-E solution was associated with increased distance covered during a 1-h performance run in comparison to mouth rinsing a placebo solution . Mouth rinsing a CHO-E was not associated with changes in blood glucose concentration during exercise or at rest |
11,507 | 19,794,221 | We concluded that intra-articular corticosteroids reduce knee pain for at least 1 week and that intra-articular corticosteroid injection is a short-term treatment of a chronic problem | We performed a systematic review of the current literature to determine the efficacy and duration of intra-articular corticosteroid injection in reducing pain caused by knee osteoarthritis and to determine whether the type of corticosteroid used affected these results . | OBJECTIVE --To assess the efficacy of a single intra-articular injection of triamcinolone hexacetonide ( THA ) in knee osteoarthritis ( OA ) and examine factors which may relate to treatment efficacy . METHODS --Eighty four patients with clinical and radiographic evidence of knee OA were recruited and r and omly allocated to receive either THA ( 20 mg in 1 ml ) or placebo ( 0.9 % normal saline , 1 ml ) . Follow up assessment s evaluated the following outcome variables : patient opinion of overall change in the treated knee , visual analogue pain score ( VAS ) , distance walked in one minute ( WD ) , and Health Assessment Question naire modified for lower limb function ( HAQ ) . RESULTS --Seventy eight percent of THA and 49 % of placebo treated patients reported overall improvement at week 1 ( p < 0.05 ) . At week 6 , improvement was reported in 57 % and 55 % of patient groups , respectively . VAS improved in both groups at week 1 ( THA , p < 0.001 ; placebo , p < 0.05 ) and week 6 ( both p < 0.01 ) . Improvement in VAS was significantly greater among THA treated patients at week 1 only ( p < 0.01 ) . Subgroup analysis of THA treated patients revealed greater improvement in VAS among patients with clinical evidence of an effusion ( p < 0.05 ) , and those who had synovial fluid successfully aspirated at the time of injection ( p < 0.01 ) . WD improved in THA treated patients at week 1 ( p < 0.001 ) , and in both groups at week 6 ( THA , p < 0.001 ; placebo , p < 0.01 ) . Improvements in HAQ were seen in THA patients only at weeks 1 and 6 ( p < 0.05 ) . Regression analysis did not identify any additional clinical , radiographic , or synovial fluid characteristics which influenced the response . CONCLUSIONS --THA provided short term pain relief in knee OA . Increased benefit was associated with both clinical evidence of joint effusion and successful aspiration of synovial fluid at the time of injection Background : Since the good effect of intra‐articular injections of the 5‐HT3 receptor antagonist tropisetron in patients with arthritides and activated osteoarthritis has already been demonstrated in pilot studies , the effect of tropisetron is compared with that of methylprednisolone here . Objectives : In a double‐blind study , 34 patients with gonarthritides or activated osteoarthritis ( 18 patients with rheumatoid arthritis , 16 patients with osteoarthritis ) were treated with a single intra‐articular injection of 10 mg tropisetron ( 18 patients ) or 40 mg methylprednisolone ( 16 patients ) . Before treatment as well as one and three weeks later , the intensity of rest pain and pain following exercise was measured with the visual analog scale ( VAS ) for pain and the clinical findings in the knee joint were recorded . Results : By means of the intra‐articular tropisetron treatment , the inflammatory joint process with arthritides and activated arthroses could be influenced in a similar way as with corticosteroid treatment . No significant differences were detected . Conclusion : According to the results presented here , the intra‐articular treatment with the 5‐HT3 receptor antagonist tropisetron in patients with gonarthritides and activated arthroses was about equally effective as those for treatment with corticosteroids . Therefore , it can be used as an alternative in patients for whom concomitant diseases like diabetes and hypertension make it difficult to use corticosteroids . Whether increasing the tropisetron dose may further improve the results remains to be determined in future studies OBJECTIVES : To show whether intra-articular steroid injections are effective in osteoarthritis ; to determine factors that predict response ; and to determine whether injection has a beneficial effect on muscle strength . METHODS : Double blind , placebo controlled , crossover study in 59 patients with symptomatic osteoarthritis of the knee . Outcome measure- Primary outcome measure : change in visual analogue score for pain at three weeks . Predictors of response analysed using logistic regression with a 15 % decrease in pain score at three weeks defining response . RESULTS : Intra-articular methyl prednisolone acetate produced a significant reduction in visual analogue pain score at three weeks compared to both baseline ( median change -2.0 mm , interquartile range -16.25 to 4.0 ) and placebo ( median 0.0 mm , interquartile range -9.0 to 6.25 ) . No clinical predictors of response could be identified . Muscle strength was not significantly improved in the short term by intra-articular injection . CONCLUSIONS : Intra-articular corticosteroids are effective for short term relief of pain in osteoarthritis but predicting responders is not possible . There may be a place for their more widespread use Hyaluronic acid is a natural component of cartilage and is considered not only as a lubricant in joints but also as playing a physiological role in the trophic status of cartilage . Hyalectin , a selected fraction of hyaluronic acid extracted from cocks ' combs , has exhibited efficacy in animal models of osteoarthritis . To assess the efficacy and tolerability of intra-articular injections of hyalectin , we conducted a prospect i ve , r and omized , placebo-controlled trial of 1 years ' duration in 110 patients with painful hydarthrodial osteoarthritis of the knee . At entry and once a week for 3 weeks , aspiration of the knee effusion and intra-articular injections of either hyalectin 20 mg ( H ) or its vehicle ( C ) were performed . The vehicle acted as the control treatment . Four weeks after the last injection , the improvement was greater in the H group compared with the C group ( pain : -35.5 + /- 26.4 mm vs -25.8 + /- 21.4 , P = 0.03 , Lequesne 's functional index : -3.8 + /- 4.3 vs -2.3 + /- 3.3 , P = 0.03 ) . During the 1 year follow-up , the need to perform supplementary local therapies ( joint fluid aspiration because of painful hydarthrodial episodes and /or local corticosteroid injections ) was more frequent in group C ( 44 % vs 30 % , P = 0.03 ) . Moreover , at the final visit , the physician 's overall assessment of efficacy was in favor of H ( 77 % vs 54 % , P = 0.01 ) and the improvement in the functional index was greater in group H ( -4.4 + /- 5.1 vs -2.7 + /- 4.1 , P = 0.05 ) . This study suggests that intra-articular injections of hyalectin may ( 1 ) improve clinical condition and ( 2 ) have a long-term beneficial effect in patients with osteoarthritis of the knee Background : Although both corticosteroid and hyaluronic acid injections are widely used to palliate the symptoms of knee osteoarthritis , little research involving a comparison of the two interventions has been done . We tested the hypothesis that there are no significant differences between Hylan G-F 20 ( Synvisc ) and the corticosteroid betamethasone sodium phosphate-betamethasone acetate ( Celestone Soluspan ) in terms of pain relief or improvement in function , as determined by vali date d scoring instruments . Methods : One hundred patients with knee osteoarthritis were r and omized to receive intra-articular injection of either Hylan G-F 20 or the corticosteroid , and they were followed for six months . The patients treated with Hylan G-F 20 received one course of three weekly injections . The patients treated with the corticosteroid received one injection at the time of enrollment in the study , and they could request one more injection any time during the study . An independent , blinded evaluator assessed the patients with the Western Ontario and McMaster University Osteoarthritis Index ( WOMAC ) , a modification of the Knee Society rating system , and the visual analog pain scale . Results : Both the group treated with the corticosteroid and the group treated with Hylan G-F 20 demonstrated improvements from baseline WOMAC scores ( a median decrease from 55 to 40 points and from 54 to 44 points , respectively ; p < 0.01 for both ) . The scores according to the Knee Society system did not significantly improve for the patients who received the corticosteroid ( median , 58 to 70 points ; p = 0.06 ) or for those who received Hylan G-F 20 ( median , 58 to 68 points ; p = 0.15 ) . The scores on the visual analog scale improved for patients receiving Hylan G-F 20 ( median , 70 to 52 mm ; p < 0.01 ) but not for the patients who received the corticosteroid ( median , 64 to 52 mm ; p = 0.28 ) . However , no significant differences between the two treatment groups were found with respect to the WOMAC , Knee Society system , or visual analog scale results . Women demonstrated a significant improvement in only one of the six possible outcome -treatment combinations ( the WOMAC scale ) , whereas men demonstrated significant improvements in five of the six outcomes ( all measures except the Knee Society rating system ) . Conclusions : No differences were detected between patients treated with intra-articular injections of Hylan G-F 20 and those treated with the corticosteroid with respect to pain relief or function at six months of follow-up . Women demonstrated significantly less response to treatment than men did for both treatments on all three outcome scales . Such significant gender-related differences warrant further investigation . Level of Evidence : Therapeutic study , Level I-1b ( r and omized controlled trial [ no significant difference but narrow confidence intervals ] ) . See Instructions to Authors for a complete description of levels of evidence OBJECTIVE To evaluate the efficacy of joint lavage and intraarticular steroid injection , alone and in combination , in the treatment of patients with symptomatic knee osteoarthritis ( OA ) . METHODS Ninety-eight patients with painful tibiofemoral OA were enrolled in a prospect i ve , r and omized , controlled , 2 x 2 factorial- design trial of 6 months ' duration . The 4 treatment groups consisted of 1 ) intraarticular placebo ( 1.5 ml of 0.9 % normal saline ) , 2 ) intraarticular corticosteroids ( 3.75 mg of cortivazol in 1.5 ml ) , 3 ) joint lavage and intraarticular placebo , and 4 ) joint lavage and intraarticular corticosteroid . Outcome measures evaluated at baseline , week 1 , week 4 , week 12 , and week 24 included severity of pain ( 100-mm visual analog scale [ VAS ] ) , global status ( 100-mm VAS ) , and Lequesne 's functional index . RESULTS No interaction between steroid injection and joint lavage was demonstrated . Patients who had undergone joint lavage had significantly improved pain VAS scores at week 24 ( P = 0.020 ) . In contrast , corticosteroid injection had no long-term effect ( P = 0.313 ) ; corticosteroid injection was associated with a decrease in pain only at week 1 ( P = 0.003 ) and week 4 ( P = 0.020 ) . After week 4 , Lequesne 's functional index was not significantly improved regardless of the assigned treatment . CONCLUSION Compared with placebo , both treatments significantly relieved pain but did not improve functional impairment . The effects of the 2 treatments were additive . Cortivazol provided short-term relief of pain ( up to week 4 ) . The effects of joint lavage persisted up to week 24 OBJECTIVE To evaluate the safety and efficacy of long-term intraarticular ( IA ) steroid injections for knee pain related to osteoarthritis ( OA ) . METHODS In a r and omized , double-blind trial , 68 patients with OA of the knee received IA injections of triamcinolone acetonide 40 mg ( 34 patients ) or saline ( 34 patients ) into the study knee every 3 months for up to 2 years . The primary outcome variable was radiologic progression of joint space narrowing of the injected knee after 2 years . Measurements of minimum joint space width were performed by an automated computerized method on st and ardized fluoroscopically guided radiographs taken with the patient st and ing and with the knee in a semiflexed position . The clinical efficacy measure of primary interest was the pain subscale from the Western Ontario and McMaster Universities OA Index ( WOMAC ) . Efficacy measures of secondary interest were the total score on the WOMAC , physician 's global assessment , patient 's global assessment , patient 's assessment of pain , range of motion ( ROM ) of the affected knee , and 50-foot walking time . Clinical symptoms were assessed just before each injection . RESULTS At the 1-year and 2-year followup evaluations , no difference was noted between the two treatment groups with respect to loss of joint space over time . The steroid-injected knees showed a trend toward greater symptom improvement , especially at 1 year , for the WOMAC pain subscale , night pain , and ROM values ( P = 0.05 ) compared with the saline-injected knees . Using area under the curve analyses , knee pain and stiffness were significantly improved throughout the 2-year study by repeated injections of triamcinolone acetonide , but not saline ( P < 0.05 ) . CONCLUSION Our findings support the long-term safety of IA steroid injections for patients with symptomatic knee OA . No deleterious effects of the long-term administration of IA steroids on the anatomical structure of the knee were noted . Moreover , long-term treatment of knee OA with repeated steroid injections appears to be clinical ly effective for the relief of symptoms of the disease The aim of this study was to compare the effectiveness of triamcinolone hexacetonide ( THA ) and methylprednisolone acetate ( MPA ) , given via the intra-articular route at equipotent dosage to patients with symptomatic knee OA with effusion , in a double-blind r and omized comparative trial . Consecutive hospital-referred patients who fulfilled the American College of Rheumatology criteria for knee OA ( clinical and radiographic ) were r and omly allocated to receive either THA 20 mg ( 1 ml ) or MPA 40 mg ( 1 ml ) . All patients had synovial fluid aspirated from their knee joint at the time of injection . Assessment s were made at 0 , 3 and 8 weeks by a second operator , thus blinding both patient and assessor . Outcomes measured at each visit were : knee pain in the previous 48 h ( expressed on a 100 mm visual analog scale ; VAS ) , stair climb time ( SCT ) and Lequesne index score ( LEQ ) . Changes in VAS , SCT and LEQ were compared between the groups using a Student ’s paired t test . Fifty-seven patients were studied ( 44 female , 13 male ) with a mean age of 62.5 years . Both steroids gave significant pain relief ( VAS ) at week 3 ( p<0.01 ) but only MPA showed an effect on VAS and LEQ scores at week 8 compared to baseline ( p<0.05 ) . THA was more effective than MPA at pain reduction at week 3 ( p<0.01 ) ; this difference was lost at week 8 ( p=0.17 ) . There was no significant difference between the two drugs in functional endpoints ( SCT , LEQ ) at either 3 or 8 weeks . Both THA and MPA offer at least temporary symptomatic benefit in knee OA . THA is more effective than MPA at week 3 , but its effect is lost by week 8 . MPA still has an effect at week 8 Background Intra-articular knee injections are routinely performed in clinical practice without documenting intra-articular placement . Hypothesis A small amount of air to an intra-articular knee injection produces an audible “ squishing ” sound with range of motion . Study Design Prospect i ve nonr and omized clinical trial . Methods The study group ( 20 knees from 20 patients ) received an intra-articular injection with a mixture of local anesthetic , corticosteroid , contrast dye , and 1 to 2 cc of air . The control group ( 10 knees from 5 patients ) received extra-articular injections of a mixture of local anesthetic , contrast dye , and 2 cc of air . All knees were examined immediately after injection for a squishing sound with range of motion . Postinjection arthrographic radiographs were taken to verify the actual placement . Result All study group knees and no control group knees had intra-articular contrast by radiograph . Clearly audible squishing sounds were heard in 17 of 20 study knees ( sensitivity of 85 % ) . Squishing sounds were audible in none of the control knees ( specificity of 100 % ) . Conclusion Adding 1 to 2 cc of air to knee injections provides a no-cost , reliable , sensitive , and specific method of confirming accurate placement . Clinical Relevance This simple method is easily reproduced , can confirm accurate placement , and can eliminate extra-articular injection as the reason for clinical response failure The effectiveness of intra-articular administration of kenalog , hydrocortisone , gordox and polyvinylpyrrolidone to patients with gonarthrosis and concurrent synovitis was studied . Kenalog and hydrocortisone were more effective than placebo , while gordox , polyvinylpyrrolidone and placebo had similar effect . Kenalog and hydrocortisone had nearly the same favourable effect in synovitis . Only one patient treated with gordox had side effects . Signs of synovitis were analysed and its most typical symptoms specified Intra-articular steroid therapy for osteoarthritis of the knee has been reassessed by two placebo-controlled trials of 20 mg of triamcinalone hexacetonide in 48 joints . Steroid injections caused a significantly greater reduction in pain and tenderness than placebo , and were preferred by patients . However , the benefits were small and transient . Maximum pain reduction occurred one week after injection , and was accompanied by a fall in the thermographic index suggesting an anti-inflammatory mode of action . Synovial fluid was unafffected by injections , and there was no correlation between synovial fluid cell counts or the radiological grading , and the degree of pain reduction The efficacy of injection of orgotein was compared with that of betamethasone over a one-year period in 419 patients with osteoarthritis of the knee . The criteria for efficacy were the number of recurrences , the rate of persistence in the trial and , secondarily , Lequesne index and the visual analogue scale . Though betamethasone was quicker-acting , the efficacy of orgotein at low doses ( 4 or 8 mg ) was comparable with that of the corticosteroid from Week 4 and up to a year after the beginning of the study , at the cost of a greater number of injections and more numerous local side effects 42 patients with osteoarthrosis with inflammation were included in the study . After r and omization and with single-blind technique , they were given intra-articularly in the knee joint either 20 mg of triamcinolonehexacetonide ( TH ) or 6 mg of the combination betamethasone acetate and betamethasone disodiumphosphate ( BM ) . The patients were studied up to six months after the injection . Initially , week one , two , four and at the time for a possible new injection ; pain , local tenderness and joint range were evaluated . At the control in week one , two and four , a general evaluation of effect was also performed . Duration of effect was defined as patient 's need of a new injection or other therapy during a six-month period . Results . In the evaluation of effect in local tenderness and pain , TH gave a significant better result already after one week . The improvement in joint range was more pronounced with TH . Also in the general evaluation significantly better results were shown with TH . In general evaluation all patients with TH were considered to improve with two weeks treatment . The duration of effect was significantly longer with TH . After three months five patients in the TH group respectively 12 patients in the BM group needed new therapy . The reported side-effects were not considered to be serious . The investigation has shown that TH gives a pronounced effect and long duration which has result ed in that TH is a preferable drug when long effect is needed in the treatment of osteoarthrosis with concomitant inflammation Intra-articular injection of micro-crystalline corticosteroid is used to treat symptomatic osteoarthritis ( OA ) of the knee , but its duration of effect and efficacy are uncertain . From the observation that pain in OA of the knee can often be blocked by infiltration of the soft tissues at the patella margin with local anaesthetic , this study investigated an injection technique in which corticosteroid was infiltrated around the patella . Thirty-eight patients with radiologically demonstrable and painful OA of the knee were treated either with peripatellar or intra-articular methylprednisolone in a r and omised double blind study . Assessment s of response to either injection were made at one week , one month and three months . Eleven of 15 measures improved significantly over time in both groups , but the differences between groups were not statistically significant . Analysis of individual responses showed that the majority of good outcomes were in the peripatellar group . Five patients receiving intra-articular injections but only one receiving a peripatellar injection withdrew because of treatment failure . Peripatellar injection is an alternative method of local administration of corticosteroid which is highly effective in a proportion of patients and merits further evaluation Seventeen patients with painful osteoarthritis ( OA ) of the knee were given an intraarticular injection of corticosteroid while an equal number were given only the suspending vehicle . One wk later the corticosteroid group had significantly less pain than the placebo group but by 4 wk post-injection the difference between the 2 groups was significant . Post-injection flares occurred in both groups suggesting a steroid crystal-induced synovitis was not the cause . Because the additional pain relief afford by the steroid was temporary and the possible deleterious effects of intraarticular steroids , are still debated , their judicious use of OA is advised |
11,508 | 20,814,336 | In conclusion , the efficacy of ECT is significantly superior in patients without previous pharmacotherapy failure as compared with medication-resistant patients .
Because this finding is based on observational studies , it might be caused by a confounding factor , for example , the presence of psychotic features or the duration of the index episode .
Electroconvulsive therapy seems to be an effective treatment for severely depressed patients as well as for patients with previous pharmacotherapy failure | Failure to respond to antidepressants probably is the most common indication for electroconvulsive therapy ( ECT ) .
The literature seems to be divided as to whether medication resistance has a negative influence on the efficacy of subsequent ECT .
Therefore , we performed a systematic review to investigate the effect of previous pharmacotherapy failure on the efficacy of ECT . | OBJECTIVE To test whether pre-electroconvulsive therapy ( ECT ) medication resistance is associated with post-ECT relapse rates . METHOD In a post hoc analysis of data from a large multicenter trial of post-ECT relapse prevention strategies ( conducted from May 1997 to July 2004 ) , we assessed whether response to antidepressant medications prior to ECT for a unipolar nonpsychotic depressive episode ( DSM-IV ) was associated with differential relapse rates after remission with ECT . Baseline ( i.e. , pre-ECT ) medication use was assessed with the Antidepressant Treatment History Form . Following remission with ECT that was stable for 1 week , patients were r and omly assigned to receive 6 months of treatment with either combination lithium carbonate/nortriptyline or continuation ECT . Relapse was assessed with the 24-item Hamilton Rating Scale for Depression . There were 146 patients followed in the first week after remission ( termed the interim week in this study ) , and 73 in the r and omized phase of the study . For the purpose s of this trial , medication resistance is defined as not having responded to at least 1 adequate trial of an antidepressant medication before ECT . RESULTS In the first week after acute remission , 9.8 % of patients not having at least 1 antidepressant medication trial met relapse criteria , while 31.4 % of medication-resistant patients met relapse criteria , a difference that was statistically significant ( p = .026 ) . In the r and omized phase of the study , 34.6 % of non-medication-resistant patients relapsed , while 50.0 % of medication-resistant patients relapsed , a difference that was not significant ( p = .434 ) . CONCLUSION We conclude that nonpsychotic patients who had at least 1 adequate antidepressant medication trial before ECT may be especially prone to early relapse after successful acute remission with ECT BACKGROUND While electroconvulsive therapy ( ECT ) in major depression is effective , cognitive effects limit its use . Reducing the width of the electrical pulse and using the right unilateral electrode placement may decrease adverse cognitive effects , while preserving efficacy . METHODS In a double-masked study , we r and omly assigned 90 depressed patients to right unilateral ECT at 6 times seizure threshold or bilateral ECT at 2.5 times seizure threshold , using either a traditional brief pulse ( 1.5 ms ) or an ultrabrief pulse ( 0.3 ms ) . Depressive symptoms and cognition were assessed before , during , and immediately , two , and six months after therapy . Patients who responded were followed for a one-year period . RESULTS The final remission rate for ultrabrief bilateral ECT was 35 percent , compared with 73 percent for ultrabrief unilateral ECT , 65 percent for st and ard pulse width bilateral ECT , and 59 percent for st and ard pulse width unilateral ECT ( all P's<0.05 after covariate adjustment ) . The ultrabrief right unilateral group had less severe cognitive side effects than the other 3 groups in virtually all primary outcome measures assessed in the acute postictal period , and during and immediately following therapy . Both the ultrabrief stimulus and right unilateral electrode placement produced less short- and long-term retro grade amnesia . Patients rated their memory deficits as less severe following ultrabrief right unilateral ECT compared to each of the other three conditions ( P<0.001 ) . CONCLUSIONS The use of an ultrabrief stimulus markedly reduces adverse cognitive effects , and when coupled with markedly suprathreshold right unilateral ECT , also preserves efficacy . ( Clinical Trials.gov number , NCT00487500 . ) CONTEXT Electroconvulsive therapy ( ECT ) is the most effective biological treatment for major depression . However , there is little agreement about clinical ly useful predictors of acute ECT outcomes . OBJECTIVE To assess whether age , sex , burden of comorbid physical illness , age at onset , history of recurrence , episode duration , chronic depression or comorbid dysthymia , melancholic features , episode severity , and medication resistance are predictors of remission after an acute course of ECT . DESIGN We performed an analysis using data gathered prospect ively in 328 patients with unipolar major depression ( according to Research Diagnostic Criteria ) treated with ECT . The study was conducted from 1993 through 1999 . Patients had a pretreatment score of 21 or higher on the 24-item Hamilton Rating Scale for Depression ( HAM-D ) . Treatment history was assessed using the Antidepressant Treatment History Form . Remission was defined as a 24-item HAM-D score of 10 or less and a 60 % or more relative reduction of the HAM-D score . RESULTS On univariate logistic regression , statistically significant predictors of nonremission were chronic depression/dysthymia , medication resistance , longer episode duration , and younger age . On backward elimination logistic regression , only medication resistance ( OR = 1.67 , 95 % CI = 1.05 to 2.67 ) and chronic depression/ dysthymia ( OR = 1.84 , 95 % CI = 1.06 to 3.21 ) were statistically significant predictors of nonremission . CONCLUSIONS In patients with major depression , lower rates of remission after acute ECT are associated with medication resistance and chronicity , but not with age or burden of physical illness Objective To compare the relative efficacy of electroconvulsive therapy ( ECT ) in psychotic and nonpsychotic patients with unipolar major depression . Methods The outcome of an acute ECT course in 253 patients with nonpsychotic ( n = 176 ) and psychotic ( n = 77 ) unipolar major depression was assessed in the first phase of an ongoing National Institute of Mental Health-supported four-hospital collaborative study of continuation treatments after successful ECT courses . ECT was administered with bilateral electrode placement at 50 % above the titrated seizure threshold . The remission criteria were rigorous : a score ≤10 on the 24-item Hamilton Rating Scale for Depression ( HRSD ) after 2 consecutive treatments , and a decrease of at least 60 % from baseline . Results The overall remission rate was 87 % for study completers . Among these , patients with psychotic depression had a remission rate of 95 % and those with nonpsychotic depression , 83 % . Improvement in symptomatology , measured by the HRSD , was more robust and appeared sooner in the psychotic patients compared with the nonpsychotic patients . Conclusion Bilateral ECT is effective in relieving severe major depression . Remission rates are higher and occur earlier in psychotic depressed patients than in nonpsychotic depressed patients . These data support the argument that psychotic depression is a distinguishable nosological entity that warrants separate treatment algorithms Abstract : This prospect i ve study assessed the influence of resistance to antidepressant pharmacotherapy on the short-term response to subsequent electroconvulsive therapy ( ECT ) . Previous research has shown that patients with medication resistance were less likely to respond to ECT . This finding may be applicable to the population of depressed in patients in The Netherl and s , where ECT is often preceded by several medication trials . Eighty-five patients ( 61 female and 24 male patients ) with DSM-IV criteria for depressive disorder , both with and without mood congruent psychotic features , were included for analysis . Medication resistance was rated with the Antidepressant Treatment History Form . Medication resistance was predefined in accordance with the previous research in this field . When a reduction of at least 50 % on the 17-item version of the Hamilton Rating Scale for Depression ( HRSD ) between pre- and post-ECT is used as response criterion , medication-resistant patients were equally likely to respond to subsequent ECT ( 30/48 = 82.5 % ) than patients without medication resistance ( 30/37 = 81.1 % ) . Even when post-ECT HRSD score ≤7 was used ( full remission ) , there was no significant difference between medication-resistant patients ( 21/48 = 43.8 % ) and patients without medication resistance ( 15/37 = 40.5 % ) . When potential confounding variables were taken into account , these differences remain nonsignificant . In contrast to earlier research , medication resistance does not influence short-term response to subsequent ECT and it can still be of considerable efficacy CONTEXT Electroconvulsive therapy ( ECT ) is highly effective for treatment of major depression , but naturalistic studies show a high rate of relapse after discontinuation of ECT . OBJECTIVE To determine the efficacy of continuation pharmacotherapy with nortriptyline hydrochloride or combination nortriptyline and lithium carbonate in preventing post-ECT relapse . DESIGN R and omized , double-blind , placebo-controlled trial conducted from 1993 to 1998 , stratified by medication resistance or presence of psychotic depression in the index episode . SETTING Two university-based hospitals and 1 private psychiatric hospital . PATIENTS Of 290 patients with unipolar major depression recruited through clinical referral who completed an open ECT treatment phase , 159 patients met remitter criteria ; 84 remitting patients were eligible and agreed to participate in the continuation study . INTERVENTIONS Patients were r and omly assigned to receive continuation treatment for 24 weeks with placebo ( n = 29 ) , nortriptyline ( target steady-state level , 75 - 125 ng/mL ) ( n = 27 ) , or combination nortriptyline and lithium ( target steady-state level , 0.5 - 0.9 mEq/L ) ( n = 28 ) . MAIN OUTCOME MEASURE Relapse of major depressive episode , compared among the 3 continuation groups . RESULTS Nortriptyline-lithium combination therapy had a marked advantage in time to relapse , superior to both placebo and nortriptyline alone . Over the 24-week trial , the relapse rate for placebo was 84 % ( 95 % confidence interval [ CI ] , 70%-99 % ) ; for nortriptyline , 60 % ( 95 % CI , 41%-79 % ) ; and for nortriptyline-lithium , 39 % ( 95 % CI , 19%-59 % ) . All but 1 instance of relapse with nortriptyline-lithium occurred within 5 weeks of ECT termination , while relapse continued throughout treatment with placebo or nortriptyline alone . Medication-resistant patients , female patients , and those with more severe depressive symptoms following ECT had more rapid relapse . CONCLUSIONS Our study indicates that without active treatment , virtually all remitted patients relapse within 6 months of stopping ECT . Monotherapy with nortriptyline has limited efficacy . The combination of nortriptyline and lithium is more effective , but the relapse rate is still high , particularly during the first month of continuation therapy OBJECTIVE To examine the predictive value of resistance to a tricyclic antidepressant ( TCA ) and lithium with respect to the efficacy of subsequent electroconvulsive therapy ( ECT ) . METHOD This open prospect i ve study was conducted in the inpatient depression unit of a university hospital in The Netherl and s. Patients were enrolled in the study from October 1996 to June 2002 and had to meet DSM-IV criteria for major depressive disorder . Eighty-six patients were treated twice weekly with ECT until recovery or no progress during at least 10 bilateral treatments . Patients were maintained drug free during the ECT treatment . Clinical evaluation of depressive symptoms was performed each week ; scores on the 17-item version of the Hamilton Rating Scale for Depression ( HAM-D ) were obtained 1 to 3 days prior to ECT and 1 to 3 days after treatment termination . The primary outcome criterion was defined as the mean difference in HAM-D score before and after ECT for patients who had received adequate treatment with a TCA and lithium compared with patients who had not received adequate treatment with a TCA and lithium . Adequate treatment was defined as 4 weeks taking a predefined plasma level of a TCA ; nonresponders had lithium added to the medication , and the minimal duration of the lithium addition was 3 weeks with a plasma level of at least 0.6 mmol/L. Independent sample s t test was used to analyze this primary outcome criterion . RESULTS According to the primary outcome criterion , patients who had received adequate treatment with a TCA and lithium ( N = 56 ) had a mean difference in HAM-D score pre-ECT and post-ECT of 16.4 compared to a HAM-D score difference of 19.5 in the patient group who had received inadequate treatment with a TCA and lithium ( N = 30 ) . This ine quality in differences in mean HAM-D scores is not significant ( p = .2 ) . CONCLUSION In the present study sample , treatment failure with adequate pharmacotherapy with a TCA and lithium addition appears to be unrelated to outcome following subsequent ECT BACKGROUND Antidepressant medication resistance is the commonest indication for electroconvulsive therapy ( ECT ) in Scotl and . Evidence from the USA suggests that clinical response is reduced for medication resistant patients . The aim of the present study was to establish if the American results were generalisable to routine clinical practice in Edinburgh . METHOD Fifty eligible depressed patients consecutively referred for a new course of bilateral ECT at the Royal Edinburgh Hospital were prospect ively assessed as part of the National Audit of ECT in Scotl and . The patients were categorised into those who had received adequate drug treatment pre-ECT ( and could therefore be classed as medication resistant ) and those who had not , using five operational definitions . The clinical response of the ECT was then compared between groups , using the Montgomery-Asberg Rating Scale for Depression ( MADRS ) and Clinical Global Impression Scale ( CGI ) . RESULTS Patients defined as medication resistant had an identical response to patients who were not defined as medication resistant ( in both groups 60 % met the predetermined criterion for clinical response ) , and this was consistent across the five operational definitions . CONCLUSIONS The hypothesis that medication resistance is associated with a reduced probability of clinical response to ECT was not supported . LIMITATIONS Some patients who were inadequately drug treated might have proven eventually to be medication resistant , which would have obscured a potential difference in clinical response . It is not known how generalisable the results are to clinical practice in the rest of the UK CONTEXT Medication resistance is the leading indication for use of electroconvulsive therapy ( ECT ) in major depression . The practice of stopping antidepressant medications prior to ECT derived from studies in the 1960s and 1970s in nonresistant sample s. There is also continuing controversy regarding the relative efficacy and adverse effects of right unilateral and bilateral ECT . OBJECTIVE To test the hypotheses that , compared with placebo , concomitant treatment with nortriptline or venlafaxine during the ECT course enhances short-term efficacy without a meaningful effect on adverse effects and reduces the rate of post-ECT relapse , and to test the hypotheses that high-dose , right-sided , unilateral ECT is equivalent in efficacy to moderate-dosage bilateral ECT and retains advantages with respect to cognitive adverse effects . DESIGN Prospect i ve , r and omized , triple-masked , placebo-controlled study conducted from 2001 through 2005 . SETTING Three university-based hospitals . PATIENTS Of approximately 750 consecutive patients referred for ECT , 319 with a major depressive episode consented , were r and omized to pharmacological or ECT treatment conditions , and received at least 1 ECT treatment . MAIN OUTCOME MEASURES Scores on the Hamilton Rating Scale for Depression , remission rate following completion of ECT , and selective measures of cognitive adverse effects . RESULTS Treatment with nortriptyline enhanced the efficacy and reduced the cognitive adverse effects of ECT relative to placebo . Venlafaxine result ed in a weaker degree of improvement and tended to worsen cognitive adverse effects . High-dosage right unilateral ECT did not differ or was superior to bilateral ECT in efficacy and result ed in less severe amnesia . CONCLUSIONS The efficacy of ECT is substantially increased by the addition of an antidepressant medication , but such medications may differ in whether they reduce or increase cognitive adverse effects . High-dose , right-sided , unilateral ECT is at least equivalent to moderate-dosage bilateral ECT in efficacy , but retains advantages with respect to cognitive adverse effects OBJECTIVE Traditionally , it has been widely assumed that the likelihood of response to ECT is independent of the adequacy of previous treatment with antidepressant medications . However , recent research has raised the possibility that medication-resistant patients with depression have a poorer clinical ECT outcome than patients who have not failed previous adequate medication trials . METHOD Medication resistance of 100 patients with primary , unipolar , nonpsychotic major depression was evaluated during the index episode with the Antidepressant Treatment History Form . Patients were recruited and treated with ECT at three sites ; st and ardized ECT and clinical assessment procedures were used . Clinical outcome was assessed immediately and 1 week after completion of the ECT course . RESULTS Patients who previously had failed one or more adequate antidepressant medication trials were less likely to respond to subsequent ECT than patients not known to be medication resistant . This finding held within each study site , whether clinical response was assessed categorically or in terms of the magnitude of symptomatic improvement and after the authors accounted for other potential predictors of clinical outcome . Resistance to heterocyclic antidepressants predicted poorer outcome after ECT , while resistance to selective serotonin reuptake inhibitors and monoamine oxidase inhibitors did not show significant predictive relations . CONCLUSIONS While a substantial percentage of medication-resistant patients respond to ECT , clinical outcome in this group is inferior to that of patients without established medication resistance . The predictive power of medication resistance is generalizable across diverse clinical setting s , particularly for heterocyclic antidepressants , which perhaps suggests an overlap in the mechanisms of actions of ECT and this medication class BACKGROUND Clinical trials indicate that electroconvulsive therapy ( ECT ) is the most effective treatment for major depression , but its effectiveness in community setting s has not been examined . METHODS In a prospect i ve , naturalistic study involving 347 patients at seven hospitals , clinical outcomes immediately after ECT and over a 24-week follow-up period were examined in relation to patient characteristics and treatment variables . RESULTS The sites differed markedly in patient features and ECT administration but did not differ in clinical outcomes . In contrast to the 70%-90 % remission rates expected with ECT , remission rates , depending on criteria , were 30.3%-46.7 % . Longer episode duration , comorbid personality disorder , and schizoaffective disorder were associated with poorer outcome . Among remitters , the relapse rate during follow-up was 64.3 % . Relapse was more frequent in patients with psychotic depression or comorbid Axis I or Axis II disorders . Only 23.4 % of ECT nonremitters had sustained remission during follow-up . CONCLUSIONS The remission rate with ECT in community setting s is substantially less than that in clinical trials . Providers frequently end the ECT course with the view that patients have benefited fully , yet formal assessment shows significant residual symptoms . Patients who do not remit with ECT have a poor prognosis ; this underscores the need to achieve maximal improvement with this modality OBJECTIVE To test whether antidepressant medication treatment failure predicts differential remission with electroconvulsive therapy ( ECT ) in nonpsychotic unipolar depression . METHOD Depressed patients diagnosed with the Structured Clinical Interview for DSM-IV receiving ECT were assessed for medication use with the Antidepressant Treatment History Form ( ATHF ) ( N = 345 ) . Response to ECT was assessed with the 24-item Hamilton Rating Scale for Depression . Baseline medication treatment failure was analyzed as a possible predictor of remission status . Date s of study enrollment were from May 1997 to July 2004 . RESULTS Resistance to antidepressant medication as assessed by the ATHF , either taken as a whole or for any individual class of medication , was not predictive of acute remission status with ECT . CONCLUSION Treatment failure with anti-depressant medication does not predict acute remission status with ECT for nonpsychotically depressed patients Twenty-eight of 34 patients with major depression who completed a course of electroconvulsive therapy ( ECT ) and were classified as responders were administered lithium carbonate ( Li ) continuation therapy in the context of an open , prospect i ve study . Twenty-four patients were followed for 6 months or until relapse ; four patients dropped out of follow-up while still in remission . The probability of completing 6 months without relapse ( by survival analysis , including the patients who dropped out as censored observations ) was 65 % . The eight patients who relapsed into depression all did so within 13 weeks . They were characterized by a shorter duration of their index depressive episode , a greater likelihood of having suffered an additional depressive episode in the preceding 12 months , and failure of an adequate trial of antidepressant medication before the ECT course . Novel pharmacological strategies may be needed in the post-ECT continuation therapy of patients who have a prior history of relapse and are demonstrably resistant to antidepressant medication BACKGROUND Controversy persists about the use of right unilateral ( RUL ) and bilateral ( BL ) electroconvulsive therapy ( ECT ) . While RUL ECT results in less severe short-term and long-term cognitive effects , there is concern that it is less efficacious than BL ECT . METHODS In a double-blind study , 80 depressed patients were r and omized to RULECT , with electrical dosages 50 % , 150 % , or 500 % above the seizure threshold , or BL ECT , with an electrical dosage 150 % above the threshold . Depression severity and cognitive functioning were assessed before , during , immediately after , and 2 months after ECT . Compared with baseline , responders had at least a 60 % reduction in symptom scores 1 week after ECT , and were monitored for relapse for 1 year . RESULTS High-dosage RUL and BL ECT were equivalent in response rate ( 65 % ) and approximately twice as effective as low-dosage ( 35 % ) or moderate-dosage ( 30 % ) unilateral ECT . During the week after the r and omized phase , BL ECT result ed in greater impairment than any dosage of unilateral ECT in several measures of antero grade and retro grade memory . Two months after ECT , retro grade amnestic deficits were greatest among patients treated with BL ECT . Thirty-three ( 53 % ) of the 62 patients who responded to ECT relapsed , without treatment group differences . The relapse rate was greater in patients who had not responded to adequate pharmacotherapy prior to ECT and who had more severe depressive symptoms after ECT . CONCLUSION Right unilateral ECT at high dosage is as effective as a robust form of BL ECT , but produces less severe and persistent cognitive effects |
11,509 | 25,771,832 | The majority of studies demonstrated significant impact of comorbidity on survival , reporting poorer survival rates for patients with comorbidities compared to those with no comorbidities . | Treating non-Hodgkin 's lymphoma in patients with comorbidities can be challenging because of possible interactions that may alter the treatment efficacy .
We conducted a systematic review to determine the impact of comorbidities on various outcomes , evaluate the current data , and provide recommendations for future research . | We previously reported that the Charlson Comorbidity Index ( CCI ) was useful for predicting outcomes in patients undergoing allogeneic hematopoietic cell transplantation ( HCT ) . However , the sample size of patients with scores of 1 or more , captured by the CCI , did not exceed 35 % . Further , some comorbidities were rarely found among patients who underwent HCT . Therefore , the current study was design ed to ( 1 ) better define previously identified comorbidities using pretransplant laboratory data , ( 2 ) investigate additional HCT-related comorbidities , and ( 3 ) establish comorbidity scores that were suited for HCT . Data were collected from 1055 patients , and then r and omly divided into training and validation sets . Weights were assigned to individual comorbidities according to their prognostic significance in Cox proportional hazard models . The new index was then vali date d. The new index proved to be more sensitive than the CCI since it captured 62 % of patients with scores more than 0 compared with 12 % , respectively . Further , the new index showed better survival prediction than the CCI ( likelihood ratio of 23.7 versus 7.1 and c statistics of 0.661 versus 0.561 , respectively , P < .001 ) . In conclusion , the new simple index provided valid and reliable scoring of pretransplant comorbidities that predicted nonrelapse mortality and survival . This index will be useful for clinical trials and patient counseling before HCT Chemotherapy is associated with toxicity in elderly patients with potentially curable malignancies , posing the dilemma of whether to intensify therapy , thereby improving the cure rate , or de-escalate therapy , thereby reducing toxicity , with consequent risks for under- or overtreatment . Adequate tools to define doses and combinations have not been identified for lymphoma patients . We conducted a prospect i ve trial aim ed to evaluate the feasibility and efficacy of chemotherapy modulated according to a modified comprehensive geriatric assessment ( CGA ) in elderly ( aged ≥70 years ) patients with diffuse large B-cell lymphoma ( DLBCL ) . In June 2000 to March 2006 , 100 patients were stratified using a CGA into three groups ( fit , unfit , and frail ) , and they received a rituximab plus cyclophosphamide , doxorubicin , vincristine , and prednisone modulated in dose and drugs according to comorbidities and activities of daily living ( ADL ) and instrumental ADL scores . Treatment was associated with a complete response rate of 81 % and mild toxicity : grade 4 neutropenia in 14 % , anemia in 1 % , and neurological and cardiac toxicity in 2 % of patients . At a median follow-up of 64 months , 51 patients were alive , with 5-year disease-free , overall , and cause-specific survival rates of 80 % , 60 % , and 74 % , respectively . Chemoimmunotherapy adjustments based on a CGA are associated with manageable toxicity and excellent outcomes in elderly patients with DLBCL . Wide use of this CGA-driven treatment may result in better cure rates , especially in fit and unfit patients The objective of this study was to develop a prospect ively applicable method for classifying comorbid conditions which might alter the risk of mortality for use in longitudinal studies . A weighted index that takes into account the number and the seriousness of comorbid disease was developed in a cohort of 559 medical patients . The 1-yr mortality rates for the different scores were : " 0 " , 12 % ( 181 ) ; " 1 - 2 " , 26 % ( 225 ) ; " 3 - 4 " , 52 % ( 71 ) ; and " greater than or equal to 5 " , 85 % ( 82 ) . The index was tested for its ability to predict risk of death from comorbid disease in the second cohort of 685 patients during a 10-yr follow-up . The percent of patients who died of comorbid disease for the different scores were : " 0 " , 8 % ( 588 ) ; " 1 " , 25 % ( 54 ) ; " 2 " , 48 % ( 25 ) ; " greater than or equal to 3 " , 59 % ( 18 ) . With each increased level of the comorbidity index , there were stepwise increases in the cumulative mortality attributable to comorbid disease ( log rank chi 2 = 165 ; p less than 0.0001 ) . In this longer follow-up , age was also a predictor of mortality ( p less than 0.001 ) . The new index performed similarly to a previous system devised by Kaplan and Feinstein . The method of classifying comorbidity provides a simple , readily applicable and valid method of estimating risk of death from comorbid disease for use in longitudinal studies . Further work in larger population s is still required to refine the approach because the number of patients with any given condition in this study was relatively small CONTEXT Patients with cancer often have other medical ailments , referred to as comorbidity . Comorbidity may impact treatment decision-making , prognosis , and quality of care assessment . OBJECTIVE To assess whether comorbidity information can provide important prognostic information in a hospital-based cancer registry . DESIGN , SETTING , AND PARTICIPANTS An observational prospect i ve cohort study using comorbidity data collected by trained hospital-based cancer registrars . Comorbidity was obtained through medical record review using the Adult Comorbidity Evaluation 27 , a vali date d chart-based comorbidity instrument . A total of 17,712 patients receiving care between January 1 , 1995 , and January 31 , 2001 , for the primary diagnosis of new cancer of the prostate , lung ( nonsmall cell ) , breast , digestive system , gynecological , urinary system , or head and neck were included . MAIN OUTCOME MEASURE Duration in months of overall survival . RESULTS A total of 19,268 patients were included in the study ; median duration of follow-up was 31 months . Of these patients , 1556 ( 8.0 % ) were excluded due to missing or unknown data . Severity of comorbidity strongly influenced survival in a dose-dependent fashion and the impact of comorbidity was independent of cancer stage . Compared with patients without comorbidity , the adjusted hazard ratio associated with mild comorbidity was 1.21 ( 95 % confidence interval [ CI ] , 1.13 - 1.30 ) , moderate comorbidity was 1.86 ( 95 % CI , 1.73 - 2.00 ) , and severe comorbidity was 2.56 ( 95 % CI , 2.35 - 2.81 ) . Adjusted Kaplan-Meier survival curves revealed that at any point in time the patients with more severe levels of comorbidity had worse survival ( partial chi2(3 ) due to comorbidity , 523.54 ; P<.001 ) . Model discrimination ranged from 0.71 for head and neck to 0.86 for prostate cancers . CONCLUSIONS Comorbidity is an important independent prognostic factor for patients with cancer . The inclusion of comorbidity in hospital-based cancer registries will increase the value and use of observational research High-dose chemotherapy followed by autologous peripheral blood stem cell transplantation is a widely applied treatment for advanced non-Hodgkin lymphoma ( NHL ) , but few studies have analyzed the tolerability and outcomes in older patients compared with younger patients treated in a homogeneous manner . We retrospectively review ed 152 consecutive patients who underwent autologous stem cell transplantation ( ASCT ) following BEAM conditioning ( carmustine , etoposide , cytarabine , and melphalan ) for NHL from January 2000 through August 2004 at our institution . We compared 59 patients age > or = 60 years and 93 patients age < 60 years . Supportive care was identical for all patients . The frequency of comorbidities was similar between both groups . CD34 + cell doses , days to neutrophil recovery , and days to platelet count > 20,000/mm3 were similar in younger and older patients , although days to platelet count > 50,000/mm3 were longer in the older patients ( median 30.0 days versus 22.5 days , P = .01 ) . Patients over the age of 60 were more likely to develop grade III/IV mucositis than their younger counterparts ( 37.7 % versus17.4 % , P = .0063 ) . Otherwise , the frequency of other grade III/IV toxicities were similar between younger and older patients . Treatment-related mortality ( TRM ) was similar between older and younger patients ( 8.5 % versus 5.4 % , P = .45 ) . Although age was not associated with TRM , the Charlson Comorbidity Index Score was significantly correlated with TRM ( P = .03 ) . Median disease-free survival was similar between older and younger patients ( 21.8 months versus 29.9 months , P = .93 ) , as was overall survival ( OS ) ( 47.7 months versus 62.5 months , P = .20 ) . After controlling for age , the Charlson Comorbidity Index Score influenced OS [ P = .013 ] . Overall , our cohort of patients with NHL over the age of 60 who underwent ASCT following BEAM conditioning experienced toxicities and survival similar to their younger counterparts . Comorbidities significantly influenced TRM and OS in this retrospective cohort . Future study should focus on improving tolerability of conditioning and careful prospect i ve evaluation of comorbidities and their association with outcomes Over 60 % of patients aged over 70 years , diagnosed with non‐Hodgkin 's lymphoma ( NHL ) in the Netherl and s have serious comorbidity . We studied the independent influence of comorbidity on choice of treatment , dose reductions , treatment‐related toxicity and prognosis , using data from a r and om sample of 381 patients from the population ‐based Eindhoven Cancer Registry . About 45 % of patients over 60 years of age with NHL had high impact comorbidity at the time of cancer diagnosis . The proportion of patients with aggressive NHL who received chemotherapy decreased from 85 % in patients aged 40–60 years to 70 % in those over 60 years . About 65 % of systematic ally treated patients with aggressive NHL suffered from treatment‐related toxicity . Toxicity appeared to be more common among females and those with high‐intermediate or high International Prognostic Index ( IPI ) risk . Among patients with aggressive NHL , the chance of dying for those with high impact comorbidity was twice as high compared with those without comorbidity . This was independent of the IPI risk . Dose reductions are frequently unavoidable for patients with severe comorbidity , poor performance status or chemotherapy‐related toxicity . Whether the less frequent prescription of ( full dose ) chemotherapy for patients with advanced age and /or with comorbidity is justified remains a question for debate Data on outcome , prognostic factors , and treatment for very elderly non‐Hodgkin lymphomas ( NHL ) is sparse . We conducted a multicentre retrospective analysis of NHL patients ≥80 years ( at diagnosis ) treated between 1999 and 2009 . Detailed characteristics were obtained including geriatric syndromes , activities of daily living ( ADLs ) , and co‐morbidities using the Cumulative Illness Rating Scale‐Geriatrics ( CIRS‐G ) . We identified 303 patients : 170 aggressive NHL ( 84 % B cell/16 % T cell ) and 133 indolent NHL ( 82 % B cell/18 % T cell ) . Median age was 84 years ( 80–95 ) . A geriatric syndrome was present in 26 % of patients , 18 % had ≥1 grade 4 CIRS‐G , and 14 % had loss of ADLs . At 49‐month median follow‐up , 4‐year progression‐free ( PFS ) and overall survival ( OS ) for aggressive NHLs were 31 % and 44 % respectively ( stage I/II : PFS 53 % and OS 66 % ; stage III/IV : PFS 20 % and OS 32 % ; P < 0·0001 and 0·0002 , respectively ) . Four‐year PFS and OS for indolent NHL were 44 % and 66 % respectively , regardless of stage . Multivariate regression analysis identified two key factors that predicted inferior PFS and OS for both NHL groups : lack of CR and loss of ADLs . Prospect i ve studies for very elderly NHL that incorporate geriatric tools , especially ADLs , are warranted PURPOSE The treatment of patients with diffuse large B-cell lymphoma ( DLBCL ) with cardiac comorbidity is problematic , because this group may not be able to receive anthracycline-containing chemoimmunotherapy . We design ed a single-arm phase II multicenter trial of rituximab , gemcitabine , cyclophosphamide , vincristine , and prednisolone ( R-GCVP ) in patients considered unfit for anthracycline-containing chemoimmunotherapy because of cardiac comorbidity . PATIENTS AND METHODS Sixty-one of 62 patients received R-GCVP , administered on day 1 with gemcitabine repeated on day 8 of a 21-day cycle . Median age was 76.5 years . All patients had advanced disease ; 27 ( 43.5 % ) had left ventricular ejection fraction of ≤ 50 % , and 35 ( 56.5 % ) had an ejection fraction of > 50 % and comorbid cardiac risk factors such as ischemic heart disease , diabetes mellitus , or hypertension [ Corrected ] . Primary end point was overall response rate at the end of treatment . RESULTS Thirty-eight patients ( 61.3 % ; 95 % CI , 49.2 to 73.4 ) achieved disease response ( complete response [ CR ] , n = 18 ; undocumented/unconfirmed CR , n = 6 ; partial response , n = 14 ) . Two-year progression-free survival for all patients was 49.8 % ( 95 % CI , 37.3 to 62.3 ) , and 2-year overall survival was 55.8 % ( 95 % CI , 43.3 to 68.4 ) . Thirty-four patients experienced grade ≥ 3 hematologic toxicity . There were 15 cardiac events , of which seven were grade 1 to 2 , five were grade 3 to 4 , and three were fatal , reflecting the poor cardiac status of the study population . CONCLUSION Our phase II multicenter trial showed that the R-GCVP regimen is an active , reasonably well-tolerated treatment for patients with DLBCL for whom anthracycline-containing immunochemotherapy was considered unsuitable because of coexisting cardiac disease PURPOSE To address early and late treatment failures in older patients with diffuse large B-cell lymphoma ( DLBCL ) , we design ed a two-stage r and omized trial of cyclophosphamide , doxorubicin , vincristine , and prednisone ( CHOP ) versus rituximab plus CHOP ( R-CHOP ) , with a second r and om assignment to maintenance rituximab ( MR ) or observation in responding patients . PATIENTS AND METHODS Untreated DLBCL patients who were 60 years or older were r and omly assigned to R-CHOP ( n = 318 ) or CHOP ( n = 314 ) ; 415 responders were r and omly assigned to MR ( n = 207 ) or observation ( n = 208 ) . The primary end point was failure-free survival ( FFS ) . All P values were two sided . RESULTS Three-year FFS rate was 53 % for R-CHOP patients and 46 % for CHOP patients ( P = .04 ) at a median follow-up time of 3.5 years . Two-year FFS rate from second r and om assignment was 76 % for MR compared with 61 % for observation ( P = .009 ) . No significant differences in survival were seen according to induction or maintenance therapy . FFS was prolonged with MR after CHOP ( P = .0004 ) but not after R-CHOP ( P = .81 ) with 2-year FFS rates from second r and om assignment of 77 % , 79 % , 74 % , and 45 % for R-CHOP , R-CHOP + MR , CHOP + MR , and CHOP , respectively . In a secondary analysis excluding MR patients , R-CHOP alone reduced the risks of treatment failure ( P = .003 ) and death ( P = .05 ) compared with CHOP alone . CONCLUSION Rituximab administered as induction or maintenance with CHOP chemotherapy significantly prolonged FFS in older DLBCL patients . After R-CHOP , no benefit was provided by MR . These results , which are consistent with an additive effect of rituximab , suggest that future studies could focus on maintenance strategies with novel agents as well as new induction therapies Purpose The prevalence of elderly and comorbid patients ( pts ) with malignant lymphoma ( ML ) will steadily increase in future . Elderly patients comprise a heterogeneous population . Comprehensive geriatric assessment ( CGA ) is an established diagnostic tool in geriatric medicine . However , the prognostic value in patients with ML is unclear . We sought to establish a relationship between results of CGA and survival time in patients with ML . Methods Newly diagnosed patients with ML and indication for chemotherapeutical treatment were prospect ively recruited in an observational trial . In addition to usual diagnostic work up , a CGA including activities of daily living ( ADL ) , instrumental activities of daily living ( IADL ) and comorbidities was performed . Association of patients ’ characteristics and results of CGA with survival were analysed according to Kaplan – Meier method and in a multivariate Cox-regression analysis . Results About 143 patients were included , median age was 63 years , 63 patients were women . Median follow-up of surviving patients was 62 months . Sixty-six patients died within this time . Advanced age , poor Karnofsky performance status , dependence in ADL and IADL and presence of severe comorbidity were significantly associated with shorter survival time . In a Cox-regression analysis , IADL ( HR 2.1 ; 95 % CI 1.1–3.9 ) and comorbidity ( HR 1.9 ; 95 % CI 0.9–3.9 ) were independent and strongest associated with survival time . Conclusion Results of CGA , such as IADL and comorbidities , are prognostic variables for survival of patients with ML . Results should be vali date d in homogeneous clinical groups and if confirmed included in diagnostic and therapeutic algorithm Abstract In 2003 the Fondazione Italiana Linfomi ( FIL ) started a clinical research program for investigating initial treatment of frail elderly patients with diffuse large B-cell lymphoma ( DLBCL ) identified by Comprehensive Geriatric Assessment ( CGA ) . From 2003 to 2006 , 334 elderly patients underwent CGA assessment , and 99 patients were classified as frail . Frail patients had a median age of 78 years , stage III – IV disease in 62 % and age-adjusted International Prognostic Index ( aaIPI ) of 2–3 in 53 % . Treatment consisted of several different regimens according to physician discretion . After a median follow-up of 36 months , 5-year overall survival ( OS ) was 28 % . In multivariate analysis , aaIPI 2–3 ( p = 0.005 ) and the presence of respiratory comorbidity ( p = 0.044 ) were the only factors that showed independent correlation with OS . Frail patients had a poorer outcome compared with fit patients also if they were treated with rituximab-containing combination chemotherapy ( hazard ratio 2.37 , 95 % confidence interval 1.48–3.78 ; p < 0.001 ) . CGA is a valid tool to prospect ively identify frail subjects among elderly patients with DLBCL The hematopoietic cell transplantation specific comorbidity index ( HCT-CI ) has been developed to identify patients at high risk of mortality after an allograft . Reduced-intensity/non-myeloablative regimens have decreased the non-relapse mortality ( NRM ) in elderly and /or heavily pretreated patients . We performed a retrospective study to assess whether HCT-CI may predict clinical outcomes in a cohort of 203 patients with non-Hodgkin 's ( NHL ; n=108 ) , Hodgkin 's lymphomas ( HL ; n=26 ) , and multiple myeloma ( MM ; n=69 ) , who were transplanted from a human leucocyte antigen (HLA)-matched sibling ( n=121 ) or an unrelated donor ( n=82 ) after a reduced-intensity regimen ( n=154 ) or a low-dose total body irradiation-based non-myeloblative regimen ( n=49 ) . Cumulative incidence of NRM was 5 , 16 and 20 % at 1 year and 6 , 24 and 27 % at 2 years , for patients with an HCT-CI of 0 , 1–2 and ⩾3 , respectively . By multivariate analysis , HCT-CI significantly predicted NRM ( hazard ratio (HR)=1.6 , P=0.03 ) , overall survival ( OS ; HR=1.62 , P<0.001 ) and progression-free survival ( PFS ; HR=1.43 , P=0.002 ) . Moreover , the Karnofsky performance status was also significantly associated with OS and NRM ( HR=1.62 , P<0.001 and HR=2.12 , P=0.04 , respectively ) . Conditioning type did not affect outcome after stratifying patients by HCT-CI . In the light of our study , all future prospect i ve trials of the Gruppo Italiano Trapianti di Midollo ( GITMO ) will include the HCT-CI to stratify patients |
11,510 | 21,856,789 | Serum levels of GH or IGF1 had low diagnostic accuracy .
Several tests with reasonable diagnostic accuracy are available for the diagnosis of GHD in adults . | CONTEXT The diagnostic accuracy of tests used to diagnose GH deficiency ( GHD ) in adults is unclear .
OBJECTIVE We conducted a systematic review and meta- analysis of studies that provided data on the available diagnostic tests . | The insulin tolerance test ( ITT ) is considered the test of choice for the diagnosis of GH deficiency ( GHD ) . However , in patients with contraindications to ITT , alternative provocative tests must be used with appropriate cut-offs . The glucagon stimulation test has proved to be a safe , low-cost and effective means of stimulating GH secretion , and therefore can be considered as a suitable alternative to the ITT . We have studied the GH response to the glucagon test in 33 patients with known pituitary disease , 12 males and 21 females , aged between 21 and 60 yr ( 41.18±9.47 yr ) ; 5 had isolated GHD and 28 had panhypopituitarism . We also evaluated a control group of 25 individuals , matched for age and sex ( 8 males and 17 females ) , aged between 20 and 60 yr ( 39.28±12.10 yr ) . They were selected via the ITT if their peak GH response was > 5.0 ng/ml . GH peak after glucagon was significantly lower in the group of patients compared to the control group ( 0.49±0.85 vs 8.69±5.85 ng/ml , p=0.0001 ) . Receiver-operating characteristic ( ROC ) plot analyses of the control and GHD group showed an area under the curve of 0.982 for GH peak response to glucagon . The response value of 3.0 ng/ml showed the best pair of sensitivity (97%)/specificity ( 88 % ) , and was chosen as the cut-off defining GHD . After evaluation of positive predictive values ( PPV ) and negative predictive values ( NPV ) through simulation of different prevalences of the disease , we concluded that the cut-off point of 3.00 ng/ml maximizes both PPV and NPV ( 100 % ) . In conclusion , we have shown that the glucagon stimulation test has a good performance and great diagnostic accuracy for the diagnosis of GHD OBJECTIVE The glucagon stimulation test ( GST ) like the insulin tolerance test ( ITT ) stimulates both ACTH and GH secretion . However , there are limited data with modern assays on sensitivity and specificity for GST in comparison to ITT . The aim of this study was to evaluate the diagnostic utility of the GST for GH deficiency ( GHD ) and adrenal insufficiency ( AI ) in patients following pituitary surgery . DESIGN AND PATIENTS ITT and GST were performed within 7 days in 49 patients at least 3 months after transsphenoidal surgery . Serum GH and cortisol were measured by Immulite 2000 assay ( Siemens AG ) . Receiver-operating characteristic ( ROC ) analysis was performed to identify the thresholds for GST . RESULTS In ITT , 18/49 cases were classified as AI . ROC analysis revealed a peak cortisol value > 599 nmol/l in GST for adrenal sufficiency with 100 % specificity and 32 % sensitivity , and a peak cortisol < 277 nmol/l with > 95 % specificity and 72 % sensitivity for AI . Of the 49 subjects , 25 ( 51 % ) demonstrated levels between these cut-offs and could not be diagnosed by GST alone with sufficient accuracy . Regarding GHD , 21/49 cases were classified as insufficient by ITT . ROC analysis revealed a cut-off of 2.5 ng/ml with 95 % sensitivity and 79 % specificity . Of the 49 cases , seven ( 14 % ) were discordant in terms of defining GHD , with six subjects being treated for GHD according to GST although being sufficient in ITT . CONCLUSION In our prospect i ve series of patients with pituitary disease , GST is a potential alternative test for the assessment of GH reserve , but is a poor test for ACTH reserve . Test-specific cut-offs should be applied to avoid misinterpretation objective Reduction of plasma free fatty acids leads to enhanced GH response after stimulation by GH‐releasing hormone ( GHRH ) . We studied the clinical usefulness of combined administration of acipimox and GHRH for the diagnosis of GH deficiency In the attempt to define a GH stimulation test with high specificity and reproductibility , few studies have addressed the influence of potential interfering external factors on the test result . We therefore tested the influence of physical activity ( admission to hospital on test morning ) and mild heat exposure on the GH response to l‐arginine stimulation test ( Arg ) and insulin‐tolerance test ( ITT ) BACKGROUND AND OBJECTIVE Publication bias and other sample size effects are issues for meta-analyses of test accuracy , as for r and omized trials . We investigate limitations of st and ard funnel plots and tests when applied to meta-analyses of test accuracy and look for improved methods . METHODS Type I and type II error rates for existing and alternative tests of sample size effects were estimated and compared in simulated meta-analyses of test accuracy . RESULTS Type I error rates for the Begg , Egger , and Macaskill tests are inflated for typical diagnostic odds ratios ( DOR ) , when disease prevalence differs from 50 % and when thresholds favor sensitivity over specificity or vice versa . Regression and correlation tests based on functions of effective sample size are valid , if occasionally conservative , tests for sample size effects . Empirical evidence suggests that they have adequate power to be useful tests . When DORs are heterogeneous , however , all tests of funnel plot asymmetry have low power . CONCLUSION Existing tests that use st and ard errors of odds ratios are likely to be seriously misleading if applied to meta-analyses of test accuracy . The effective sample size funnel plot and associated regression test of asymmetry should be used to detect publication bias and other sample size related effects BACKGROUND Adult growth hormone ( GH ) deficiency must be diagnosed before prescribing therapeutic recombinant human GH . We studied the clinical relevance of a diagnostic strategy for growth hormone deficiency ( GHD ) using IGF-1 determination as a first step . METHODS In 2000 and 2001 , we tested 142 adult patients with hypothalamo-pituitary disorders for somatotropic function using Insulin Tolerance Test ( ITT ) , the reference test for the diagnosis of GHD , with concomitant Insulin-like growth factor-1 ( IGF-1 ) determination , a marker of somatotropic function . Patients were classified as GHD ( peak GH concentration<3 ng/ml with the ITT ) or normal . SETTING Monocenter prospect i ve study in a tertiary referral center . RESULTS GHD was diagnosed in 61 subjects . Using a ROC curve , a threshold IGF-1 concentration of 175 ng/ml yielded a negative predictive value of 89+/-5 % . A diagnostic strategy with IGF-1 determination as the first step followed by ITT for patients with an IGF-1 concentration below 175 ng/ml missed five of the 61 GHD patients , avoided 46/142 ITT and reduced the cost of diagnosis by 15 % . CONCLUSION We propose the use of a strategy consisting of IGF-1 determination followed , if below 175 ng/ml by confirmatory ITT to diagnose GHD in adults Although the use of the insulin tolerance test ( ITT ) for the diagnosis of adult GH deficiency is well established , diagnostic peak GH cut-points for other commonly used GH stimulation tests are less clearly established . Despite that fact , the majority of patients in the United States who are evaluated for GH deficiency do not undergo insulin tolerance testing . The aim of this study was to evaluate the relative utility of six different methods of testing for adult GH deficiency currently used in practice in the United States and to develop diagnostic cut-points for each of these tests . Thirty-nine patients ( 26 male , 13 female ) with adult-onset hypothalamic-pituitary disease and multiple pituitary hormone deficiencies were studied in comparison with age- , sex- , estrogen status- , and body mass index-matched control subjects ( n = 34 ; 20 male , 14 female ) . A third group of patients ( n = 21 ) with adult-onset hypothalamic-pituitary disease and no more than one additional pituitary hormone deficiency was also studied . The primary end-point was peak serum GH response to five GH stimulation tests administered in r and om order at five separate visits : ITT , arginine ( ARG ) , levodopa ( L-DOPA ) , ARG plus L-DOPA , and ARG plus GHRH . Serum IGF-I concentrations were also measured on two occasions . For purpose s of analysis , patients with multiple pituitary hormone deficiencies were assumed to be GH deficient . Three diagnostic cut-points were calculated for each test to provide optimal separation of multiple pituitary hormone deficient and control subjects according to three criteria : 1 ) to minimize misclassification of control subjects and deficient patients ( balance between high sensitivity and high specificity ) ; 2 ) to provide 95 % sensitivity for GH deficiency ; and 3 ) to provide 95 % specificity for GH deficiency . The greatest diagnostic accuracy occurred with the ITT and the ARG plus GHRH test , although patients preferred the latter ( P = 0.001 ) . Using peak serum GH cut-points of 5.1 microg/liter for the ITT and 4.1 microg/liter for the ARG plus GHRH test , high sensitivity ( 96 and 95 % , respectively ) and specificity ( 92 and 91 % , respectively ) for GH deficiency were achieved . To obtain 95 % specificity , the peak serum GH cut-points were lower at 3.3 microg/liter and 1.5 microg/liter for the ITT and ARG plus GHRH test , respectively . There was substantial overlap between patients and control subjects for the ARG plus L-DOPA , ARG , and L-DOPA tests , but test-specific cut-points could be defined for all three tests to provide 95 % sensitivity for GH deficiency ( peak GH cut-points : 1.5 , 1.4 and 0.64 microg/liter , respectively ) . However , 95 % specificity could be achieved with the ARG plus L-DOPA and ARG tests only with very low peak GH cut-points ( 0.25 and 0.21 microg/liter , respectively ) and not at all with the L-DOPA test . Although serum IGF-I levels provided less diagnostic discrimination than all five GH stimulation tests , a value below 77.2 microg/liter was 95 % specific for GH deficiency . In conclusion , the diagnosis of adult GH deficiency can be made without performing an ITT , provided that test-specific cut-points are used . The ARG plus GHRH test represents an excellent alternative to the ITT for the diagnosis of GH deficiency in adults This is the second in a series of five articles Considerable effort has been expended at the interface between clinical medicine and scientific methods to achieve the maximum validity and usefulness of diagnostic tests . This article focuses on the specific kinds of questions that arise in diagnostic research and the study architectures ( the conversions of these clinical questions into appropriate research design s ) used to answer them . As an example we shall take shall take assessment of the value of the plasma concentration of B-type natriuretic peptide ( BNP ) in the diagnosis of left ventricular dysfunction.1 R and omised controlled trials are dealt with elsewhere . As in other forms of clinical research , there are several different ways study ing the potential or real diagnostic value of a physical sign or laboratory test , and each is appropriate to one kind of question and inappropriate for others . Among the possible questions about the relation between a putative diagnostic test and a target disorder ( for example , the concentration of BNP and left ventricular dysfunction ) , four are most relevant . # # # # Summary points Diagnostic studies should match methods to diagnostic questions The keys to validity in diagnostic test studies are Both specificity and sensitivity may change as the same diagnostic test is applied in primary , |
11,511 | 28,783,526 | All selected studies were in English , with significant conceptual similarity of Critical Thinking and dominance in choosing the approached theme during strategies in clinical nursing education with an emphasis on the nursing process .
The most widely used teaching intervention was Problem-Based Learning .
Nursing education mediated by strategies that stimulate CT is considered a positive difference in undergraduate curriculums | OBJECTIVE Identifying the strategies used to promote critical thinking ( CT ) during undergraduate education in nursing courses . | This project , started in 1985 by Dr Infante , is based on theory of the use of the clinical laboratory in nursing education . It fully recognizes the complementary roles of nursing education and nursing service by having practitioners participate as preceptors , role models , and mentors . Six clinical agencies participated in this innovative clinical teaching project with the goal of improving the effectiveness and efficiency of nursing education and nursing practice . It is hypothesized that the synchronization of clinical laboratory experiences with instruction in nursing theory and science and a closer collaboration among faculty , students , and nurse practitioners will give students an appropriate balance of academic and clinical practice perspectives and skills to prepare them effectively to meet the complex health care needs of patients . The subjects were 173 undergraduate baccalaureate nursing students enrolled in an upper-division generic program . For the purpose of testing Infante 's clinical model , the students were r and omly assigned to a control or experimental group for two successive incoming classes of nursing students . Each student 's academic and clinical progression was monitored . Data were gathered using grade point average , a st and ardized test for nursing knowledge ( Mosby Assesstest ; Mosby , St Louis ) , college laboratory practicum , and simulated testing for clinical application skills.2 + Data were analyzed using independent t tests . The findings indicate that the students in the experimental group , who used the experimental clinical model , achieved higher grade point averages , higher scores on the Mosby Assesstest , and higher college laboratory practicum scores than the students in the control group . The findings support the need for further investigation of innovative clinical teaching models BACKGROUND Educational approaches are thought to have facilitative or hindering effects on students ' critical thinking development . The aim of this study was to compare the effects of problem-based learning ( PBL ) and lecturing approaches on the development of students ' critical thinking . METHODS All 79 Year 1 undergraduate nursing students at a university in Hong Kong were r and omly assigned to 1 of 2 parallel courses delivered by either PBL ( n = 40 ) or lecturing ( n = 39 ) over 1 academic year . The primary outcome measure was students ' critical thinking disposition as measured by the California Critical Thinking Disposition Inventory ( CCTDI ) . Individual interviews were also conducted to elicit the students ' perceptions of their learning experience . Data were collected at 4 timepoints spanning 3 years . RESULTS The overall CCTDI and subscale scores for the PBL group were not significantly different from those of the lecture group at the first timepoint ( pretest ) . Compared with lecture students , PBL students showed significantly greater improvement in overall CCTDI ( P = 0.0048 ) , Truthseeking ( P = 0.0008 ) , Analyticity ( P = 0.0368 ) and Critical Thinking Self-confidence ( P = 0.0342 ) subscale scores from the first to the second timepoints ; in overall CCTDI ( P = 0.0083 ) , Truthseeking ( P = 0.0090 ) and Analyticity ( P = 0.0354 ) subscale scores from the first to the third timepoints ; and in Truthseeking ( P = 0.0173 ) and Systematic ity ( P = 0.0440 ) subscale scores from the first to the fourth timepoints . CONCLUSIONS There were significant differences in the development of students ' critical thinking dispositions between those who undertook the PBL and lecture courses , respectively AIMS This paper reports a study examining the effects of adopting concept mapping in problem-based learning scenario discussion s on the improvement of students ' learning outcomes in a nursing course . BACKGROUND Students in Taiwan usually have a high degree of anxiety about whether or not they have learned enough . Problem-based learning is a method of teaching that uses a patient situation or scenario to stimulate students to acquire and apply information to solve problems . Concept mapping can promote problem-solving and critical thinking to help students organize complex patient data , process complex relationships and offer holistic care to patients . METHODS An experimental design was used , with participants r and omly assigned either to a control or experimental group . The experimental group participated in six problem-based learning scenario discussion s during the 16-week semester , while the control group attended a traditional course . RESULTS The experimental group had significantly higher proposition and hierarchy scores for their concept maps compared with the control group . There were no significant differences in the cross-link and example scores between the two groups . In general , the total score difference between the groups did not reach statistical significance levels . Only one student in the experimental group obtained a high score ; most participants in both groups ( over 50 % ) obtained low scores . CONCLUSIONS Concept mapping strategies may be useful for analysis of individual student 's thinking processes for ( 1 ) emphasizing key concepts or main ideas , ( 2 ) underst and ing relationships between different concepts , including cause-effect and part-whole relationships , ( 3 ) review ing propositions , hierarchies and cross-links in a logically scientific way , and ( 4 ) revising concept structures to agree with theory and experience BACKGROUND The importance of critical thinking is well-documented by the American Association of Colleges of Nursing and the National League for Nursing . Reflective writing is often used to increase underst and ing and analytical ability . The lack of empirical evidence about the effect of reflective writing interventions on critical thinking supports the examination of this concept . OBJECTIVES Study objectives were : DESIGN This study used an experimental , pretest-posttest design . SETTING S The setting was two schools of nursing at universities in the southern United States . PARTICIPANTS The convenience sample included 70 fourth-semester students in baccalaureate nursing programs . METHODS R and omly assigned control and experimental groups completed the California Critical Thinking Skills Test ( CCTST ) and the California Critical Thinking Dispositions Inventory Test ( CCTDI ) . The experimental group completed six reflective writing assignments . Both groups completed the two tests again . RESULTS Results showed that the experimental group had a significant increase ( p=0.03 ) on the truthseeking subscale of the CCTDI when compared to the control group . The experimental group 's scores increased on four CCTST subscales and were higher than the control group 's on three CCTST subscales . CONCLUSIONS The results of this study make it imperative for nursing schools to consider including reflective writing-especially assignments based on Paul 's ( 1993 ) model-in nursing courses . If future studies , testing over longer periods of time , show significant increases in critical thinking , those interventions could be incorporated into nursing curriculum and change the way nurse educators evaluate students BACKGROUND Italian Nursing Faculties use a range of tutorial strategies ( laboratory sessions , intensive clinical tutoring , weekly tutoring ) aim ed to enhance nursing students ' diagnostic reasoning : these strategies have different impacts on promoting student critical thinking . By using critical thinking methods , students develop abilities to check , monitor and constantly evaluate the accuracy of the diagnostic reasoning process . However , there is little evidence to show how effective tutorial strategies are on the accuracy of diagnostic reasoning . There is also very little known about the complexity of tutorial strategies because these are made up of several components ( e.g. tutor question ing abilities , the value of the setting , the impact of the environment , the expertise of the tutor and the impact of the Faculty 's philosophy of learning ) , tutorial strategies can not be st and ardised and depend on multiple factors which are difficult to control . OBJECTIVES The objective was to establish a relationship between tutorial strategies orientated to enhance critical thinking and the accuracy of diagnostic reasoning ( i.e. the number of correct answers given by students on simulated cases in two different nursing education context s ) . It was hypothesised that students who had had one laboratory session using intensive tutorial strategies had less probability of making reasoning errors in diagnosing a simulated case than a control group that had weekly tutorials or routine tutoring . DESIGN A double pragmatic experimental study was adopted involving two Italian Nursing Faculties at universities in Verona and Udine . PARTICIPANTS A total of 144 students in the first year of their Nursing Science Degree course were involved ; in Verona , two r and om groups of 41 students were taken ( an intervention group and a control group ) . R and om selection s of 39 students for the intervention group and 29 students for a control group were made from the second campus in Udine . Data analysis was conducted comparing student outcomes in the same faculty ( intra-trial analysis ) and between the two campuses involved ( inter-trial analysis ) . RESULTS The students doing laboratory sessions and intensive clinical tutorials demonstrated fewer errors compared to the control group [ OR 3.75 ; IC 95 % 1.77 - 7.88 ] , although the students who receive routine tutoring , demonstrated higher risk of mistaking the problems of the patient [ OR 0.22 ; IC 0.95 % 0.07 - 0.65 ] . CONCLUSION From intra- and inter-trial analysis of the results , it can be concluded within limits , that those students who had had intensive tutorial strategies aim ed developing critical thinking abilities , formulated fewer wrong hypotheses in the first list they made when confronted with a new nursing case . Faculties should consider these outcomes and develop strategies including intensive tutorial strategies for improving the accuracy of nursing students ' clinical reasoning |
11,512 | 21,078,742 | INTERPRETATION Clinical ly significant benefits of recombinant factor VIIa as a general hemostatic agent in patients without hemophilia remain unproven . | BACKGROUND The benefits and risks of off-label use of recombinant factor VIIa in patients without hemophilia are contested .
We performed a systematic review to assess the effectiveness and safety of such use . | BACKGROUND & AIMS Upper gastrointestinal bleeding ( UGIB ) is a severe and frequent complication of cirrhosis . Recombinant coagulation factor VIIa ( rFVIIa ) has been shown to correct the prolonged prothrombin time in patients with cirrhosis and UGIB . This trial aim ed to determine efficacy and safety of rFVIIa in cirrhotic patients with variceal and nonvariceal UGIB . METHODS A total of 245 cirrhotic patients ( Child-Pugh < 13 ; Child-Pugh A = 20 % , B = 52 % , C = 28 % ) with UGIB ( variceal = 66 % , nonvariceal = 29 % , bleeding source unknown = 5 % ) were r and omized equally to receive 8 doses of 100 microg/kg rFVIIa or placebo in addition to pharmacologic and endoscopic treatment . The primary end point was a composite including : ( 1 ) failure to control UGIB within 24 hours after first dose , or ( 2 ) failure to prevent rebleeding between 24 hours and day 5 , or ( 3 ) death within 5 days . RESULTS Baseline characteristics were similar between rFVIIa and placebo groups . rFVIIa showed no advantage over st and ard treatment in the whole trial population . Exploratory analyses , however , showed that rFVIIa significantly decreased the number of failures on the composite end point ( P = 0.03 ) and the 24-hour bleeding control end point ( P = 0.01 ) in the subgroup of Child-Pugh B and C variceal bleeders . There were no significant differences between rFVIIa and placebo groups in mortality ( 5- or 42-day ) or incidence of adverse events including thromboembolic events . CONCLUSIONS Although no overall effect of rFVIIa was observed , exploratory analyses in Child-Pugh B and C cirrhotic patients indicated that administration of rFVIIa significantly decreased the proportion of patients who failed to control variceal bleeding . Dosing with rFVIIa appeared safe . Further studies are needed to verify these findings Background — Blood loss is a common complication of cardiac surgery . Evidence suggests that recombinant activated factor VII ( rFVIIa ) can decrease intractable bleeding in patients after cardiac surgery . Our objective was to investigate the safety and possible benefits of rFVIIa in patients who bleed after cardiac surgery . Methods and Results — In this phase II dose-escalation study , patients who had undergone cardiac surgery and were bleeding were r and omized to receive placebo ( n=68 ) , 40 & mgr;g/kg rFVIIa ( n=35 ) , or 80 & mgr;g/kg rFVIIa ( n=69 ) . The primary end points were the number of patients suffering critical serious adverse events . Secondary end points included rates of reoperation , amount of blood loss , and transfusion of allogeneic blood . There were more critical serious adverse events in the rFVIIa groups . These differences did not reach statistical significance ( placebo , 7 % ; 40 & mgr;g/kg , 14 % ; P=0.25 ; 80 & mgr;g/kg , 12 % ; P=0.43 ) . After r and omization , significantly fewer patients in the rFVIIa group underwent a reoperation as a result of bleeding ( P=0.03 ) or required allogeneic transfusions ( P=0.01 ) . Conclusions — On the basis of this preliminary evidence , rFVIIa may be beneficial for treating bleeding after cardiac surgery , but caution should be applied and further clinical trials are required because there is an increase in the number of critical serious adverse events , including stroke , in those patients r and omized to receive rFVIIa BACKGROUND Coagulopathy caused by cirrhosis may contribute to excessive bleeding during hepatectomy . We evaluated the hemostatic effect and safety of recombinant factor VIIa ( rFVIIa ) in cirrhotic patients undergoing partial hepatectomy . METHODS Patients were r and omized to rFVIIa 50 or 100 mug/kg or placebo , administered intravenously 10 minutes before surgery and every second hour during surgery . The primary efficacy end points were the proportion of patients receiving red blood cell ( RBC ) transfusions and the amount of RBCs transfused . The RBC transfusion trigger was blood loss of 500 mL. Safety end points included thromboembolic and adverse events . RESULTS No statistically significant effect of rFVIIa treatment on efficacy end points was observed . Serious and thromboembolic adverse events occurred at similar incidences in the study groups . CONCLUSIONS Using blood loss as a transfusion trigger , the efficacy of rFVIIa in reducing the requirement for RBC transfusion was not established in this study . No safety concerns were identified Patients undergoing orthotopic liver transplantation ( OLT ) have excessive blood loss during surgery that requires blood transfusions , leading to increased postoperative morbidity and mortality . We studied the efficacy and safety of activated recombinant factor VII ( rFVIIa ) in reducing transfusion requirements in OLT . This multicenter , r and omized , double-blind , placebo-controlled trial enrolled patients undergoing OLT because of cirrhosis ( Child-Turcotte-Pugh class B or C ) . Patients received a repeated intravenous bolus regimen of rFVIIa 60 or 120 microg/kg or placebo . The primary efficacy endpoint was the total number of red blood cell ( RBC ) units transfused during the perioperative period . A total of 182 patients were analyzed for efficacy and 183 for safety . No significant effect of rFVIIa was observed on the number of RBC units transfused or intraoperative blood loss compared with the placebo group . A significantly higher number of patients in the rFVIIa study groups avoided RBC transfusion . Administration of rFVIIa but not placebo restored the preoperative prolonged prothrombin time to normal value during surgery . Patients receiving rFVIIa and placebo did not experience a significant difference in rate of thromboembolic events . Additionally , there was no statistically significant effect of rFVIIa treatment on hospitalization rate , total surgery time , and the proportion of patients undergoing retransplantation . In conclusion , use of rFVIIa during OLT significantly reduced the number of patients requiring RBC transfusion . There was no increase in thromboembolic events with rFVIIa administration compared with placebo Background and Purpose — Hematoma growth occurs in 38 % of intracerebral hemorrhage ( ICH ) patients scanned by computed tomography ( CT ) within 3 hours of onset . Activated recombinant factor VII ( rFVIIa ) promotes hemostasis at sites of vascular injury and may minimize hematoma growth after ICH . Methods — In this r and omized , double-blind , placebo-controlled , dose-escalation trial , 48 subjects with ICH diagnosed within 3 hours of onset were treated with placebo ( n=12 ) or rFVIIa ( 10 , 20 , 40 , 80 , 120 , or 160 & mgr;g/kg ; n=6 per group ) . The primary endpoint was the frequency of adverse events ( AEs ) . Safety assessment s included serial electrocardiography ( ECG ) , troponin I and coagulation testing , lower extremity Doppler ultrasonography , and calculation of edema : ICH volume ratios . Results — Mean age was 61 years ( range , 30 to 93 ) and 57 % were male . At admission , mean National Institutes of Health Stroke Scale ( NIHSS ) score was 14 ( range , 1 to 26 ) , median Glasgow Coma Scale score was 14 ( range , 6 to 15 ) , and mean ICH volume was 21 mL ( range , 1 to 151 ) . Mean time from onset to treatment was 181 minutes ( range , 120 to 265 ) . Twelve serious AEs occurred , including 5 deaths ( mortality 11 % ) . Six AEs were considered possibly treatment-related , including rash , vomiting , fever , ECG T-wave inversion , and 2 cases of deep vein thrombosis ( placebo and 20-&mgr;g/kg groups ) . No myocardial ischemia , consumption coagulopathy , or dose-related increase in edema : ICH volume occurred . Conclusion — This small phase II trial evaluated a wide range of rFVIIa doses in acute ICH and raised no major safety concerns . Larger studies are justified to determine whether rFVIIa can safely and effectively limit ICH growth BACKGROUND Activated recombinant coagulation factor VII ( rFVIIa ) effectively prevents and controls bleeding in patients with coagulopathy . Data show that rFVIIa may reduce blood loss and eliminate the need for transfusion in patients with normal haemostasis undergoing major surgery . We assessed the efficacy of rFVIIa in patients with normal haemostasis undergoing repair surgery of major traumatic fracture of the pelvis or the pelvis and acetabulum , who were expected to have a large volume of blood loss . METHODS We performed a double-blind , r and omized , placebo-controlled trial involving 48 patients undergoing major pelvic-acetabular surgery . Patients were r and omized to receive an i.v . bolus injection of rFVIIa 90 microg kg(-1 ) or placebo as add-on therapy at the time of the first skin incision . All patients also received intraoperative salvaged red blood cells ( RBC ) . RESULTS There was no significant difference in the total volume of perioperative blood loss , the primary outcome variable , between the rFVIIa and placebo groups . In addition , there were no differences between the two groups in the total volume of blood components , including salvaged RBC transfused , number of patients requiring allogeneic blood components , total volume of fluids infused , total operating time , time taken after entry to the intensive care unit to reach normal body temperature and acid-base status , and time spent in hospital . No adverse events , in particular thromboembolic events , were reported in either group . CONCLUSIONS In patients with normal haemostasis undergoing repair surgery of traumatic pelvic-acetabular fracture , the prophylactic use of rFVIIa does not decrease the volume of perioperative blood loss Orthotopic liver transplantation ( OLT ) can be associated with excessive blood loss . As a result , there may be increased risk of adverse outcomes . Activated recombinant factor VII ( rFVIIa ) has demonstrated the ability to improve hemostasis in a variety of disorders ; however , there has been a limited amount of research into its use in OLT . The purpose of this dose-finding study was to examine the efficacy and safety of rFVIIa in the reduction of bleeding in patients undergoing OLT . In this double-blind trial , patients with end-stage liver disease scheduled for OLT were r and omized to 1 of 4 parallel study groups . They received a single intravenous bolus of rFVIIa ( 20 , 40 , or 80 microg/kg ) or placebo prior to surgery . The primary assessment endpoint was the total number of red blood cell ( RBC ) units transfused perioperatively . Safety was evaluated by adverse events reported . Eighty-three comparable patients were r and omized to receive study product , with 82 ultimately undergoing OLT . There were no significant differences in required RBC units between the placebo and rFVIIa study groups . The number of adverse events was comparable between study groups . In conclusion , rFVIIa has a good safety profile in patients undergoing OLT . However , the doses studied did not have any effect on the number of RBC transfusions required BACKGROUND Recombinant activated factor VII ( factor VIIa ) has prohaemostatic effects in bleeding patients with coagulation abnormalities . We aim ed to test the hypothesis that recombinant factor VIIa could reduce perioperative blood loss in patients with normal coagulation systems . Therefore , we assessed safety and efficacy of this drug in patients undergoing retropubic prostatectomy , which is often associated with major blood loss and need for transfusion . METHODS In a double-blind , r and omised placebo-controlled trial , we recorded blood loss and transfusion requirements in 36 patients undergoing retropubic prostatectomy , who were r and omised to receive an intravenous bolus of recombinant factor VIIa ( 20 microg/kg or 40 microg/kg ) or placebo in the early operative phase . FINDINGS Median perioperative blood loss was 1235 mL ( IQR 1025 - 1407 ) and 1089 mL ( 928 - 1320 ) in groups given recombinant factor VIIa 20 microg/kg and 40 microg/kg , respectively , compared with 2688 mL ( 1707 - 3565 ) in the placebo group ( p=0.001 ) . Seven of twelve placebo-treated patients were transfused , whereas no patients who received 40 microg/kg recombinant factor VIIa needed transfusion . The odds ratio for receiving any blood product in patients treated with recombinant factor VIIa compared with control patients was 0 ( 95 % CI 0.00 - 0.33 ) No adverse events arose . INTERPRETATION An injection of recombinant factor VIIa can reduce perioperative blood loss and eliminate the need for transfusion in patients undergoing major surgery BACKGROUND & AIMS Activated recombinant factor VII ( rFVIIa ) has been shown to be effective in correcting prolonged prothrombin time ( PT ) in cirrhotic patients . The main objective of this study was to evaluate the effect of 4 ( 5 , 20 , 80 , and 120 microg/kg ) doses of rFVIIa on correction of PT and the time to achieve hemostasis in cirrhotic patients with coagulopathy who are undergoing laparoscopic liver biopsy . METHODS Seventy-one patients ( parts I and II ) with advanced liver disease ( Child-Turcotte B or C ) , platelet count > or = 60,000/mm3 , and PT in the range of 3 - 15 seconds above normal were included in the study . Efficacy endpoints were normalization of PT and time to hemostasis . RESULTS PT was corrected to normal levels ( < 13.1 seconds ) in the majority of patients . The duration of normalization of PT was longer in patients treated with higher doses of rFVIIa . Forty-eight ( 74 % ) of 65 patients ( part II ) achieved hemostasis within 10 minutes . No correlation between the time to hemostasis and duration of correction of PT was observed . None of the patients required operative intervention or transfusion of blood/blood products to control bleeding . One thrombotic event and one case of disseminated intravascular coagulation were reported , but both events were considered by the investigator as unlikely to be related to treatment with rFVIIa . CONCLUSIONS The results of this study suggest that treatment with rFVIIa may offer benefit for patients with liver disease undergoing laparoscopic biopsy BACKGROUND Bleeding is a common complication following hematopoietic stem cell transplantation ( HSCT ) and st and ard hemostatic treatment is often ineffective . We conducted a multicentre , r and omized trial of the efficacy and safety of activated recombinant factor VII ( rFVIIa , NovoSeven ) in the treatment of bleeding following HSCT . METHODS 100 patients with moderate or severe bleeding ( 52 gastrointestinal ; 26 hemorrhagic cystitis ; seven pulmonary ; one cerebral ; 14 other ) were included from days + 2 to + 180 post-transplant ( 97 allogeneic ; three autologous ) to receive seven doses of rFVIIa ( 40 , 80 or 160 microg kg(-1 ) ) or placebo every 6 h. The primary efficacy endpoint was the change in bleeding score between the first administration and 38 h. RESULTS No significant effect of increasing rFVIIa dose was observed on the primary endpoint . A post hoc analysis comparing each rFVIIa dose with placebo showed that 80 microg kg(-1 ) rFVIIa improved the bleeding score at the 38 h time point ( 81 % vs. 57 % , P = 0.021 ) . This effect was not seen at 160 microg kg(-1 ) . There were no differences in transfusion requirements across dose groups . There was no trend in the type or number of severe adverse events observed . Six thromboembolic events were observed in the active treatment groups : three during , and three following the 96-h observation period . CONCLUSIONS Despite no overall effect of rFVIIa treatment on primary endpoint , post hoc analysis showed an improvement in the control of bleeding for 80 microg kg(-1 ) rFVIIa vs. st and ard hemostatic treatment . The heterogeneity of the population may have contributed to the lack of an increasing effect with increased dose . Further trials should focus upon identifying the patient population s that may benefit from treatment with rFVIIa BACKGROUND Excision of burn wounds is frequently associated with a large volume of blood loss requiring allogeneic blood transfusion . We conducted a pilot study to investigate the effect of activated recombinant coagulation factor VII ( rFVIIa ) on the reduction of blood transfusion requirements in burn patients undergoing excision and skin grafting . METHODS Eighteen consecutive patients scheduled for the surgery were r and omised to receive either placebo or 40 microg/kg rFVIIa administered at first skin incision , and a second dose ( 40 microg/kg ) at 90 min later . Blood transfusion requirements during , and up to 24h post-surgery per patient and percentage full thickness wound excised were compared . In addition , postoperative complications commonly seen in patients with burns as well as adverse events related to rFVIIa were monitored . RESULTS rFVIIa significantly decreased the total number of units of blood components transfused per patient and percentage full thickness burn wound excised compared with placebo ( 0.9 versus 2.2 , p=0.0013 ) including significant fewer red blood cell units ( 0.5 versus 1.1 , p=0.004 ) . We further observed a trend towards improved graft survival ( p=0.1 ) and a reduction in multiple organ failures ( p=0.08 ) in the rFVIIa-treated group . There were no adverse events , in particular thromboembolic events . CONCLUSION rFVIIa might be useful in decreasing blood transfusion requirements in burn patients undergoing excision and skin grafting Objectives We evaluated the efficacy and safety of recombinant activated factor VII ( rFVIIa ) in children aged < 18 years old with grade II or grade III Dengue hemorrhagic fever ( DHF ) who required blood component therapy for controlling bleeding episodes . Study design Patients were r and omized to the rFVIIa group or placebo group in a ratio of 2 : 1 . rFVIIa or placebo ( 100 μg/kg body weight ) was given by intravenous bolus injection . When bleeding was not effectively controlled , a second dose of rFVIIa or placebo ( 100 μg/kg ) was given 30 min after the first dose . Results Nine and 16 patients received placebo and rFVIIa , respectively . The demographics , bleeding manifestations and grade of DHF were similar for the rFVIIa and placebo groups . Apart from petechiae and ecchymosis , one to four additional bleeding sites were found in each patient , including hematemesis ( n = 15 ) , epistaxis ( n = 14 ) , gum bleeding ( n = 12 ) , melena ( n = 7 ) , hypermenorrhea ( n = 4 ) , hematochezia ( n = 2 ) and hematuria ( n = 2 ) . The mean total dose of rFVIIa ( 138.4 ± 50.9 μg/kg ) and placebo ( 145.4 ± 53.7 μg/kg ) were comparable . The efficacy of bleeding control at 2 h after the first dose was completely ceased ( rFVIIa 75.0 % versus placebo 44.4 % ) , decreased ( rFVIIa 18.7 % versus placebo 11.2 % ) , and unchanged or worsened ( rFVIIa 6.3 % versus placebo 44.4 % ) . Some patients with active bleeding received platelet concentrates 3–12 h after the first dose of rFVIIa or placebo . The subsequent efficacy of bleeding control at 6 , 12 and 24 h was comparable between the two groups . The cumulative use of red blood cells ( rFVIIa 31.3 % versus placebo 33.3 % ) and plasma ( rFVIIa 25 % versus placebo 22 % ) during the 24-h period was not significantly different between the two groups . In contrast , platelet concentrate requirement in the rFVIIa group ( 6.3 % ) was lower than the placebo ( 33.3 % ) . No clinical evidence of thromboembolic complications or mortality as a result of bleeding was observed . Conclusion rFVIIa appears to be a useful adjunctive treatment to blood component transfusion for controlling active bleeding in children with DHF especially when platelet concentrate is not readily available OBJECTIVE Intracerebral hemorrhages , whether spontaneous or traumatic ( tICH ) , often exp and , and an association has been described between hemorrhage expansion and worse clinical outcomes . Recombinant factor VIIa ( rFVIIa ) is a hemostatic agent that has been shown to limit hemorrhage expansion and which , therefore , could potentially reduce morbidity and mortality in tICH . This first prospect i ve , r and omized , placebo-controlled , dose-escalation study evaluated the safety and preliminary effectiveness of rFVIIa to limit tICH progression . METHODS Patients were enrolled if they had tICH lesions of at least 2 ml on a baseline computed tomographic scan obtained within 6 hours of injury . rFVIIa or placebo was administered within 2.5 hours of the baseline computed tomographic scan but no later than 7 hours after injury . Computed tomographic scans were repeated at 24 and 72 hours . Five escalating dose tiers were evaluated ( 40 , 80 , 120 , 160 , and 200 μg/kg rFVIIa ) . Clinical evaluations and adverse events were recorded until Day 15 . RESULTS No significant differences were detected in mortality rate or number and type of adverse events among treatment groups . Asymptomatic deep vein thrombosis , detected on routinely performed ultrasound at Day 3 , was observed more frequently in the combined rFVIIa treatment group ( placebo , 3 % ; rFVIIa , 8 % ; not significant ) . A nonsignificant trend for rFVIIa dose-response to limit tICH volume increase was observed ( placebo , 21.0 ml ; rFVIIa , 10.1 ml ) . CONCLUSION In this first prospect i ve study of rFVIIa in tICH , there appeared to be less hematoma progression in rFVIIa-treated patients ( 80–200 μg/kg ) compared with that seen in placebo treated patients . The potential significance of this biological effect on clinical outcomes and the significance of the somewhat higher incidence of ultrasound-detected deep vein thromboses in the rFVIIa-treated group need to be examined in a larger prospect i ve r and omized clinical trial Background and Purpose — Patients with intracerebral hemorrhage have a high risk of thromboembolic events ( TEs ) due to advanced age , hypertension , atherosclerosis , diabetes , and immobility . Use of recombinant activated factor VII ( rFVIIa ) could increase TEs in high-risk patients . Factor Seven for Acute Hemorrhagic Stroke ( FAST ) trial data were review ed to define the frequency of and risk factors for TE with rFVIIa . Methods — Eight hundred forty-one patients presenting <3 hours after spontaneous intracerebral hemorrhage were r and omized to 20 or 80 & mgr;g/kg of rFVIIa or placebo . Those with Glasgow Coma Scale score < 5 , planned early surgery , coagulopathy , or recent TE were excluded . Myocardial , cerebral , or venous TEs were subject to detailed reporting and expedited local review . Additionally , a blinded Data Monitoring Committee review ed all electrocardiograms , central ly analyzed troponin I values , and CT scans . Results — There were 178 arterial and 47 venous TEs . Venous events were similar across groups . There were 49 ( 27 % ) arterial events in the placebo group , 47 ( 26 % ) in the 20-&mgr;g/kg group , and 82 ( 46 % ) in the 80 & mgr;g/kg group ( P=0.04 ) . Of the myocardial events , 38 were investigator-reported and 103 identified by the Data Monitoring Committee . They occurred in 17 ( 6.3 % ) placebo and 57 ( 9.9 % ) rFVIIa patients ( P=0.09 ) . Arterial TEs were associated with : receiving 80 & mgr;g/kg rFVIIa ( OR=2.14 ; P=0.031 ) , signs of cardiac or cerebral ischemia at presentation ( OR=4.19 ; P=0.010 ) , age ( OR=1.14/5 years ; P=0.0123 ) , and prior use of antiplatelet agents ( OR=1.83 ; P=0.035 ) . Ischemic strokes possibly related to study drug occurred in 7 , 5 , and 8 patients in the placebo , 20 & mgr;g/kg , and 80-&mgr;g/kg groups , respectively . Conclusions — Higher doses of rFVIIa in a high-risk population are associated with a small increased risk of what are usually minor cardiac events . Demonstration of the ability of rFVIIa to improve outcome in future studies should be driven by its effectiveness in slowing bleeding outweighting the risk of a small increase in arterial TEs CONTEXT The US Food and Drug Administration ( FDA ) licensed recombinant human coagulation factor VIIa ( rFVIIa ) on March 25 , 1999 , for bleeding in patients with hemophilia A or B and inhibitors to factors VIII or IX . Use in patients without hemophilia has been increasing since licensure . OBJECTIVE To review serious thromboembolic adverse events ( AEs ) reported to the FDA 's Adverse Event Reporting System ( AERS ) . DESIGN , SETTING , AND PATIENTS The AERS data base was review ed from March 25 , 1999 , through December 31 , 2004 , for thromboembolic AE reports with rFVIIa . The AERS data base includes US and non-US spontaneous AE reports from both approved ( specific indications for patients with hemophilia ) and unlabeled uses . It also includes serious AEs in patients enrolled in postlicensure clinical trials who received rFVIIa . Manufacturer reporting to FDA is m and atory , but primary notification from clinicians and others to FDA or manufacturers is voluntary for spontaneous reports ; therefore , AERS underrepresents actual event occurrences . MAIN OUTCOME MEASURE Reported thromboembolic events occurring in patients administered rFVIIa . RESULTS A total of 431 AE reports for rFVIIa were found , of which 168 reports described 185 thromboembolic events . Seventeen events occurred in patients with hemophilia and 59 occurred in patients enrolled in postlicensure trials . Unlabeled indications accounted for 151 of the reports , most with active bleeding ( n = 115 ) . Reported AEs were thromboembolic cerebrovascular accident ( n = 39 ) , acute myocardial infa rct ion ( n = 34 ) , other arterial thromboses ( n = 26 ) , pulmonary embolism ( n = 32 ) , other venous thromboses ( including deep vein thrombosis ) ( n = 42 ) , and clotted devices ( n = 10 ) . In 36 ( 72 % ) of 50 reported deaths , the probable cause of death was the thromboembolic event . In 144 patients with timing information , 73 events ( 52 % ) occurred in the first 24 hours after the last dose ( 30 events within 2 hours ) . Sixty-four reports ( 38 % ) noted concomitant use of hemostatic agents . Most reports lacked sufficient information to evaluate potential dosage associations . CONCLUSIONS Most reported thromboembolic AEs followed the use of rFVIIa for unlabeled indications and occurred in arterial and venous systems , often result ing in serious morbidity and mortality . Analysis of the relationship between AEs and rFVIIa is hindered by concomitant medications , preexisting medical conditions , confounding by indication , and inherent limitations of passive surveillance . R and omized controlled trials are needed to establish the safety and efficacy of rFVIIa in patients without hemophilia Background : Prevention of bleeding episodes in noncirrhotic patients undergoing partial hepatectomy remains unsatisfactory in spite of improved surgical techniques . The authors conducted a r and omized , placebo-controlled , double-blind trial to evaluate the hemostatic effect and safety of recombinant factor VIIa ( rFVIIa ) in major partial hepatectomy . Methods : Two hundred four noncirrhotic patients were equally r and omized to receive either 20 or 80 & mgr;g/kg rFVIIa or placebo . Partial hepatectomy was performed according to local practice at the participating centers . Patients were monitored for 7 days after surgery . Key efficacy parameters were perioperative erythrocyte requirements ( using hematocrit as the transfusion trigger ) and blood loss . Safety assessment s included monitoring of coagulation-related parameters and Doppler examination of hepatic vessels and lower extremities . Results : The proportion of patients who required perioperative red blood cell transfusion ( the primary endpoint ) was 37 % ( 23 of 63 ) in the placebo group , 41 % ( 26of 63 ) in the 20-&mgr;g/kg group , and 25 % ( 15 of 59 ) in the 80-&mgr;g/kg dose group ( logistic regression model ; P = 0.09 ) . Mean erythrocyte requirements for patients receiving erythrocytes were 1,024 ml with placebo , 1,354 ml with 20 & mgr;g/kg rFVIIa , and 1,036 ml with 80 & mgr;g/kg rFVIIa ( P = 0.78 ) . Mean intraoperative blood loss was 1,422 ml with placebo , 1,372 ml with 20 & mgr;g/kg rFVIIa , and 1,073 ml with 80 & mgr;g/kg rFVIIa ( P = 0.07 ) . The reduction in hematocrit during surgery was smallest in the 80-&mgr;g/kg group , with a significant overall effect of treatment ( P = 0.04 ) . Conclusions : Recombinant factor VIIa dosing did not result in a statistically significant reduction in either the number of patients transfused or the volume of blood products administered . No safety issues were identified BACKGROUND Uncontrolled bleeding is a leading cause of death in trauma . Two r and omized , placebo-controlled , double-blind trials ( one in blunt trauma and one in penetrating trauma ) were conducted simultaneously to evaluate the efficacy and safety of recombinant factor VIIa ( rFVIIa ) as adjunctive therapy for control of bleeding in patients with severe blunt or penetrating trauma . METHODS Severely bleeding trauma patients were r and omized to rFVIIa ( 200 , 100 , and 100 microg/kg ) or placebo in addition to st and ard treatment . The first dose followed transfusion of the eighth red blood cell ( RBC ) unit , with additional doses 1 and 3 hours later . The primary endpoint for bleeding control in patients alive at 48 hours was units of RBCs transfused within 48 hours of the first dose . RESULTS Among 301 patients r and omized , 143 blunt trauma patients and 134 penetrating trauma patients were eligible for analysis . In blunt trauma , RBC transfusion was significantly reduced with rFVIIa relative to placebo ( estimated reduction of 2.6 RBC units , p = 0.02 ) , and the need for massive transfusion ( > 20 units of RBCs ) was reduced ( 14 % vs. 33 % of patients ; p = 0.03 ) . In penetrating trauma , similar analyses showed trends toward rFVIIa reducing RBC transfusion ( estimated reduction of 1.0 RBC units , p = 0.10 ) and massive transfusion ( 7 % vs. 19 % ; p = 0.08 ) . Trends toward a reduction in mortality and critical complications were observed . Adverse events including thromboembolic events were evenly distributed between treatment groups . CONCLUSION Recombinant FVIIa result ed in a significant reduction in RBC transfusion in severe blunt trauma . Similar trends were observed in penetrating trauma . The safety of rFVIIa was established in these trauma population s within the investigated dose range Study Design . R and omized , placebo-controlled , double-blind , multicenter , Phase IIa study . Objective . To assess the safety and efficacy of recombinant-activated Factor VII ( rFVIIa ) in major spinal surgery . Summary of Background . Spinal fusion surgery can cause substantial blood loss and blood product transfusions . Recombinant FVIIa is approved for treatment of bleeding in patients with coagulation abnormalities and has been shown to reduce blood loss and transfusion requirements in surgery in patients with no underlying coagulopathy . Methods . Forty-nine patients undergoing fusion of 3 or more vertebral segments were r and omized and treated on losing 10 % of their estimated blood volume ( with total expected surgical blood loss ≥ 20 % ) and received 3 doses ( 2-hour intervals ) of placebo ( n = 13 ) or 30 , 60 , or 120 & mgr;g/kg rFVIIa ( n = 12 per group ) . The primary endpoint was safety . A priori-defined efficacy endpoints included blood loss and transfusion requirements between placebo and each rFVIIa dose group , adjusted for surgery duration , number of segments fused , and estimated blood volume . Results . Serious adverse events did not occur at any greater frequency in any of the treatment groups . One patient ( 3 × 30 & mgr;g/kg rFVIIa ) with advanced cerebrovascular disease ( undiagnosed , trial exclusion criterion ) died 6 days after surgery due to an ischemic stroke . Mean blood loss was as follows : 2270 mL for placebo ; 1909 , 1262 , and 1868 mL for 3 × 30 , 3 × 60 , and 3 × 120 & mgr;g/kg rFVIIa , respectively ( differences not statistically significant ) . Mean adjusted surgical blood loss was as follows : 2536 mL for placebo ; 1120 , 400 , and 823 mL for 3 × 30 , 3 × 60 , and 3 × 120 & mgr;g/kg rFVIIa , respectively ( P ≤ 0.001 ) . Mean surgical transfusion volume was reduced by 27 % to 50 % with rFVIIa treatment ( not significant ) . The mean adjusted surgical transfusion volume was reduced by 81 % to 95 % with rFVIIa treatment ( P ≤ 0.002 ) . Conclusion . No safety concerns were indicated for the use of rFVIIa in patients at all doses tested ; rFVIIa reduced adjusted blood loss and adjusted transfusions during spinal surgery Background and Purpose Ultra-early hemostatic therapy may improve outcome after intracerebral hemorrhage ( ICH ) by preventing rebleeding and hematoma expansion . We conducted this trial to evaluate the safety of activated recombinant factor VII ( rFVIIa ; NovoSeven ® ) for preventing early hematoma growth in acute ICH . Methods In this multicenter , r and omized , double-blind , placebo-controlled , dose-escalation trial , 40 patients diagnosed with ICH by computed tomography within 3 hours of onset were treated with placebo or 5 , 20 , 40 , or 80 μg/kg of rFVIIa ( n=8 per group ) . Patients with any history of thromboembolic or vaso-occlusive disease were excluded . The primary endpoint was the frequency of adverse events ( AEs ) . Results Mean age was 65 years ( range 34–91 ) and the median admission Glasgow Coma Scale score was 14.5 ( range 6 to 15 ) . Mean ICH volume was 17±19 mL ; nearly three-quarters were located in the basal ganglia ( n=29 ) . The mean interval from onset to treatment was 178±41 minutes . Thirty-three patients experienced 186 AEs , which occurred with similar frequency in the five groups . There were 10 thromboembolic AEs , including one case of deep vein thrombosis ( 20 μg/kg group ) ; one case of cerebral infa rct ion ( placebo ) ; two cases of pulmonary embolism ( 20 and 40 μg/kg groups ) ; and six instances of ischemic ECG changes or cardiac enzyme elevation ( placebo [ n=2 ] , 20 μg/kg [ n=1 ] , 40 μg/kg [ n=1 ] , and 80 μg/kg [ n=2 ] groups ) . No consumption coagulopathy or dose-related increase in edema-to-ICH volume ratio occurred . Conclusions Ultra-early rFVIIa treatment for ICH was associated with a reasonable safety profile in this preliminary study across a wide range of dosages . Further research is warranted to investigate the safety and potential efficacy of rFVIIa for minimizing ICH growth BACKGROUND Receiving an allogeneic transfusion may be an independent predictor of mortality for patients undergoing cardiac surgery . Furthermore , these patients utilize 15 % of all donated blood in the UK . In our unit , 80 % of patients undergoing complex non-coronary cardiac surgery requiring cardiopulmonary bypass ( CPB ) receive an allogeneic transfusion . Activated recombinant FVII ( rFVIIa ) may be effective in reducing this need for transfusion . METHODS Twenty patients undergoing complex cardiac surgery were r and omized to receive rFVIIa or placebo after CPB and reversal of heparin . RESULTS Two patients in the rFVIIa group received 13 units of allogeneic red cells and coagulation products compared with eight patients receiving 105 units of allogeneic red cells and coagulation products in the placebo group ( relative risk of any transfusion 0.26 ; confidence interval 0.07 - 0.9 ; P=0.037 ) . The groups did not differ for adverse events . CONCLUSION Despite major limitations ( underpowered study and prone to type I error ) , we have shown that rFVIIa significantly reduces the need for allogeneic transfusion in complex non-coronary cardiac surgery without causing adverse events BACKGROUND Intracerebral hemorrhage is the least treatable form of stroke . We performed this phase 3 trial to confirm a previous study in which recombinant activated factor VII ( rFVIIa ) reduced growth of the hematoma and improved survival and functional outcomes . METHODS We r and omly assigned 841 patients with intracerebral hemorrhage to receive placebo ( 268 patients ) , 20 microg of rFVIIa per kilogram of body weight ( 276 patients ) , or 80 microg of rFVIIa per kilogram ( 297 patients ) within 4 hours after the onset of stroke . The primary end point was poor outcome , defined as severe disability or death according to the modified Rankin scale 90 days after the stroke . RESULTS Treatment with 80 microg of rFVIIa per kilogram result ed in a significant reduction in growth in volume of the hemorrhage . The mean estimated increase in volume of the intracerebral hemorrhage at 24 hours was 26 % in the placebo group , as compared with 18 % in the group receiving 20 microg of rFVIIa per kilogram ( P=0.09 ) and 11 % in the group receiving 80 microg ( P<0.001 ) . The growth in volume of intracerebral hemorrhage was reduced by 2.6 ml ( 95 % confidence interval [ CI ] , -0.3 to 5.5 ; P=0.08 ) in the group receiving 20 microg of rFVIIa per kilogram and by 3.8 ml ( 95 % CI , 0.9 to 6.7 ; P=0.009 ) in the group receiving 80 microg , as compared with the placebo group . Despite this reduction in bleeding , there was no significant difference among the three groups in the proportion of patients with poor clinical outcome ( 24 % in the placebo group , 26 % in the group receiving 20 microg of rFVIIa per kilogram , and 29 % in the group receiving 80 microg ) . The overall frequency of thromboembolic serious adverse events was similar in the three groups ; however , arterial events were more frequent in the group receiving 80 microg of rFVIIa than in the placebo group ( 9 % vs. 4 % , P=0.04 ) . CONCLUSIONS Hemostatic therapy with rFVIIa reduced growth of the hematoma but did not improve survival or functional outcome after intracerebral hemorrhage . ( Clinical Trials.gov number , NCT00127283 [ Clinical Trials.gov ] . ) A beneficial effect of recombinant activated factor VII ( rFVIIa ) in Child‐Pugh class B and C patients with cirrhosis who have variceal bleeding has been suggested . This r and omized controlled trial assessed the efficacy and safety of rFVIIa in patients with advanced cirrhosis and active variceal bleeding . At 31 hospitals in an emergency setting , 256 patients ( Child‐Pugh > 8 ; Child‐Pugh B = 26 % , C = 74 % ) were r and omized equally to : placebo ; 600 μg/kg rFVIIa ( 200 + 4 × 100 μg/kg ) ; or 300 μg/kg rFVIIa ( 200 + 100 μg/kg ) . Dosing was intravenous at 0 , 2 , 8 , 14 , and 20 hours after endoscopy , in addition to st and ard vasoactive , prophylactic antibiotic , and endoscopic treatment . The primary composite endpoint consisted of failure to control 24‐hour bleeding , or failure to prevent rebleeding or death at day 5 . Secondary endpoints included adverse events and 42‐day mortality . Baseline characteristics were comparable between groups . Administration of rFVIIa had no significant effect on the composite endpoint compared with placebo ( P = 0.37 ) . There was no significant difference in 5‐day mortality between groups ; however , 42‐day mortality was significantly lower with 600 μg/kg rFVIIa compared with placebo ( odds ratio 0.31 , 95 % confidence interval = 0.13–0.74 ) , and bleeding‐related deaths were reduced from 12 % ( placebo ) to 2 % ( 600 μg/kg ) . A marked heterogeneity in the failure rate in all treatment groups was observed across participating centers . Adverse events , including overall thromboembolic events , were comparable between groups . Conclusion : Treatment with rFVIIa had no significant effect on the primary composite endpoint compared with placebo . Therefore , decision on the use of this hemostatic agent in acute variceal bleeding should be carefully considered , because results of this study do not support the routine use of rFVIIa in this setting . Adverse events were comparable across groups . ( HEPATOLOGY 2008 . |
11,513 | 23,930,333 | The systematic review of the available evidence does not provide conclusive support for the existence of a clear association between SES and adherence to ART among adult patients infected with HIV/ AIDS in low- and middle-income countries . | It is not clear what effect socioeconomic factors have on adherence to antiretroviral therapy ( ART ) among patients in low- and middle-income countries .
We performed a systematic review of the association of socioeconomic status ( SES ) with adherence to treatment of patients with HIV/AIDS in low- and middle-income countries . | Background . Regular clinic attendance for antiretroviral ( ARV ) drug refills is important for successful clinical outcomes in HIV management . Methods . Clinic attendance for ARV drug refills and medication adherence using a clinic-based pill count in 392 adult patients receiving antiretroviral therapy ( ART ) in a district hospital in Ug and a were prospect ively monitored over a 28-week period . Results . Of the 2267 total scheduled clinic visits , 40 ( 1.8 % ) were missed visits . Among the 392 clients , 361 ( 92 % ) attended all appointments for their refills ( regular attendance ) . Clinic attendance for refills was statistically significantly associated with medication adherence with regular attendant clients having about fourfold greater odds of achieving optimal ( ≥95 % ) medication adherence [ odds ratio ( OR ) = 3.89 , 95 % CI : 1.48 to 10.25 , exact P = .013 ] . In multivariate analysis , clients in age category 35 years and below were less likely to achieve regular clinic attendance . Conclusion . Monitoring of clinic attendance may be an objective and effective measure and could be a useful adjunct to an adherence measure such as pill counting in re source -constrained setting s. Where human re source constraints do not allow pill counts or other time-consuming measures , then monitoring clinic attendance and acting on missed appointments may be an effective proxy measure Objectives : Antiretroviral treatment ( ART ) scale-up in sub-Saharan Africa has made it possible to investigate the maintenance of adherence to HIV medications . We describe here adherence to ART and identify its correlates in the Cameroonian context . Design : Prospect i ve cohort study in 9 rural district hospitals . Methods : A mixed logistic regression model was used to identify factors associated with adherence to ART in 401 patients with data prospect ively collected on adherence . Results : Although 73 % of patients were adherent after the first month on ART , this proportion decreased to 61 % after 24 months . After adjustment for known factors of adherence to ART ( such as knowledge , motivation and side-effects ) , patients who reported willingness to start ART before initiation , those who were satisfied with information provided by their physicians , and those who implemented reminder methods for ART intake { eg , using an alarm clock , mobile phone , or watch [ odds ratio ( 95 % confidence interval ) ] = 2.45 ( 1.58 to 3.79 ) , but also the help of a relative to remind them or other methods } were more likely to be adherent to ART . Conclusions : Besides highlighting some correlates already known to have an impact on adherence to ART , our findings also underline the need to reinforce the counseling component of follow-up through innovative methods . Accordingly , training and implementation research should encourage the use of medication reminder methods , such as mobile phones , to assure adherence over time and improve long-term response to ART Background . Large-scale , government-based antiretroviral therapy ( ART ) programs in rural areas of re source -poor countries remain largely unevaluated . Methods . We conducted a retrospective review of all patients receiving ART ( n = 399 ) to assess survival and retention in care and a prospect i ve evaluation of patients on ART for at least 6 months ( n = 175 ) . We used 3-day self-report to measure adherence . Results . The probability ( 95 % confidence interval [ CI ] ) of surviving and remaining in care was 0.76 ( 0.72 , 0.81 ) at 1 year . Men and patients with advanced disease were more likely to die or be lost to follow-up . At baseline , 149 ( 85 % ) reported 100 % adherence . Nonadherence was associated with lack of suppression of viral replication ( odds ratio [ OR ] = 4.5 ; 95 % CI : 1.8 , 11.5 ) . Missing a scheduled clinic visit and lack of disclosure of HIV status were associated with nonadherence . Conclusion . Viral suppression was high , but counseling to include HIV disclosure to family and keeping scheduled clinic appointments may improve long-term adherence and treatment outcomes We conducted a prospect i ve cohort study of 496 adults starting antiretroviral treatment ( ART ) to determine the impact of neuropsychiatric symptoms and socioeconomic status on adherence and mortality . Almost 60 % had good adherence based upon pharmacy records . Poor adherence was associated with being divorced , poorer , food insecure , and less educated . Longer travel time to clinic , concealing one 's human immunodeficiency virus ( HIV ) status , and experiencing side effects predicted poor adherence . Over a third of the patients had cognitive impairment and poorer cognitive function was also associated with poor adherence . During follow-up ( mean 275 days ) , 20 % died-usually within 90 days of starting ART . Neuropsychiatric symptoms , advanced HIV , peripheral neuropathy symptoms , food insecurity , and poverty were associated with death . Neuropsychiatric symptoms , advanced HIV , and poverty remained significant independent predictors of death in a multivariate model adjusting for other significant factors . Social , economic , cognitive , and psychiatric problems impact adherence and survival for people receiving ART in rural Zambia Background Access to programmes providing highly active antiretroviral therapy ( HAART ) is recent in Africa . In Senegal , a national initiative was launched in 1998 . The capacity of African patients to adhere to complex antiretroviral treatments ( ARV ) is largely unknown . Methods We assessed adherence and identified the main reasons for treatment interruption in a prospect i ve observational cohort of patients participating in an ARV access programme in Dakar , Senegal . Adherence was estimated each month on the basis of the patients ' stated consumption and on the proportion of the prescribed dose returned unused to the dispensing pharmacy . A total of 158 patients were studied between November 1999 and October 2001 . Results A cross-section analysis showed that the stated level of adherence was high : on average , over the study period , the patients said they had taken 91 % of each monthly dose and that they had taken the full monthly dose during two-thirds of the months studied . Adherence tended to be better among patients who were required to make little or no contribution to the cost of their treatment , through an appropriate pricing structure . Adherence was also better with efavirenz-containing regimens than with indinavir-containing regimens . Conclusion These results show that adherence to HAART can be as high in Africa as that generally observed in industrialized countries , and that the cost and type of drug regimen must be taken into account when design ing ARV access programmes for poor communities Background Participant non-adherence and loss to follow-up can compromise the validity of clinical trial results . An assessment of these issues was made in a 3-year tuberculosis prevention trial among HIV-infected adults in Botswana . Methods and Findings Between 11/2004–07/2006 , 1995 participants were enrolled at eight public health clinics . They returned monthly to receive bottles of medication and were expected to take daily tablets of isoniazid or placebo for three years . Non-adherence was defined as refusing tablet ingestion but agreeing to quarterly physical examinations . Loss to follow-up was defined as not having returned for appointments in ≥60 days . Between 10/2008–04/2009 , survey interviews were conducted with 83 participants identified as lost to follow-up and 127 identified as non-adherent . As a comparison , 252 r and omly selected adherent participants were also surveyed . Multivariate logistic regression analysis was used to identify associations with selected risk factors . Men had higher odds of being non-adherent ( adjusted odds ratio ( AOR ) , 2.24 ; 95 % confidence interval [ 95%CI ] 1.24–4.04 ) and lost to follow-up ( AOR 3.08 ; 95%CI 1.50–6.33 ) . Non-adherent participants had higher odds of reporting difficulties taking the regimen or not knowing if they had difficulties ( AOR 3.40 ; 95%CI 1.75–6.60 ) and lower odds associated with each year of age ( AOR 0.95 ; 95%CI 0.91–0.98 ) , but other variables such as employment , distance from clinic , alcohol use , and underst and ing study requirements were not significantly different than controls . Among participants who were non-adherent or lost to follow-up , 40/210 ( 19.0 % ) reported that they stopped the medication because of work commitments and 33/210 ( 15.7 % ) said they thought they had completed the study . Conclusions Men had higher odds of non-adherence and loss to follow-up than women . Potential interventions that might improve adherence in trial participants may include : targeting health education for men , reducing barriers , clarifying study expectations , educating employers about HIV/AIDS to help reduce stigma in the workplace , and encouraging employers to support employee health . Trial Registration Clinical Trials.gov The anti-retroviral ( ARV ) treatment programme in Nigeria is delivered through selected teaching and mission hospitals at a free/subsidized rate . The government aims to scale up ARV treatment in the country . However , non-adherence to ARV medication can lead to viral resistance , treatment failure , toxicities and waste of financial re sources . This study examined the factors responsible for non-adherence to free/subsidized ARV treatment in south-east Nigeria . The study was cross-sectional and descriptive . Information was collected from 174 patients selected by simple r and om sampling from the register of all patients who had been on anti-retroviral therapy ( ART ) for at least 12 months at the beginning of the study period . Patients were identified during their clinic visits . Information on their socio-demographic profile , ARV treatment and determinants of non-adherence to ARV treatment was obtained from those who gave consent , using pre-tested interviewer-administered question naires . All patients clearly understood the need to take ARV drugs throughout their lives , and what the costs entailed . They understood the need for periodic testing , the probability that complications would develop , cost of transportation to treatment site and the daily treatment regimen . Seventy-five per cent of respondents were not adhering fully to their drug regimen ; the mean number of days that respondents had been off drugs was 3.57 days the preceding month . Reasons for non-adherence included : physical discomfort ( side effects ) ; non-availability of drugs at treatment site ; forgetting to carry drugs during the day ; fear of social rejection ; treatment being a reminder of HIV status ; and selling of own drugs to those unable to enrol in the projects . Being female , under 35 years , single , and having higher educational status were significantly associated with non-adherence . It is important that policy makers and programme managers address the factors responsible for non-adherence when scaling up subsidized ARV treatment in Nigeria and other parts of sub-Saharan Africa The aim of this prospect i ve study ( 20 months ) was to assess HIV patients ' use of Traditional , Complementary and Alternative Medicine ( TCAM ) and its effect on ARV adherence at three public hospitals in KwaZulu-Natal , South Africa . Seven hundred and thirty-five ( 29.8 % male and 70.2 % female ) patients who consecutively attended three HIV clinics completed assessment s prior to ARV initiation , 519 after 6 months , 557 after 12 and 499 after 20 months on antiretroviral therapy ( ART ) . Results indicate that following initiation of ARV therapy the use of herbal therapies for HIV declined significantly from 36.6 % prior to ARV therapy to 8.0 % after 6 months , 4.1 % after 12 months and 0.6 % after 20 months on ARVs . Faith healing methods ( including spiritual practice s and prayer ) declined from 35.8 % to 22.1 % , 20.8 % and 15.5 % , respectively . In contrast , the use of micronutrients ( vitamins , etc . ) significantly increased from 42.6 % to 78.2 % . The major herbal remedies that were used prior to ART were unnamed traditional medicine , followed by imbiza ( Scilla natalensis planch ) , canova ( immune booster ) , izifozonke ( essential vitamins mixed with herbs ) , African potato ( Hypoxis hemerocallidea ) , stametta ( aloe mixed with vitamins and herbs ) and ingwe ( tonic ) . Herbal remedies were mainly used for pain relief , as immune booster and for stopping diarrhea . As herbal treatment for HIV was associated with reduced ARV adherence , patient 's use of TCAM should be considered in ARV adherence management Background Seventy percent of urban population s in sub-Saharan Africa live in slums . Sustaining HIV patients in these high-risk and highly mobile setting s is a major future challenge . This study seeks to assess program retention and to find determinants for low adherence to antiretroviral treatment ( ART ) and drop-out from an established HIV/ART program in Kibera , Nairobi , one of Africa 's largest informal urban settlements . Methods and Findings A prospect i ve open cohort study of 800 patients was performed at the African Medical Research Foundation ( AMREF ) clinic in the Kibera slum . Adherence to ART and drop-out from the ART program were independent outcomes . Two different adherence measures were used : ( 1 ) “ dose adherence ” ( the proportion of a prescribed dose taken over the past 4 days ) and ( 2 ) “ adherence index ” ( based on three adherence questions covering dosing , timing and special instructions ) . Drop-out from the program was calculated based on clinic appointment date s and number of prescribed doses , and a patient was defined as being lost to follow-up if over 90 days had expired since the last prescribed dose . More than one third of patients were non-adherent when all three aspects of adherence – dosing , timing and special instructions – were taken into account . Multivariate logistic regression revealed that not disclosing HIV status , having a low level of education , living below the poverty limit ( US$ 2/day ) and not having a treatment buddy were significant predictors for non-adherence . Additionally , one quarter of patients dropped out for more than 90 days after the last prescribed ART dose . Not having a treatment buddy was associated with increased risk for drop-out ( hazard ratio 1.4 , 95 % CI = 1.0–1.9 ) . Conclusion These findings point to the dilemma of trying to sustain a growing number of people on life-long ART in conditions where prevailing stigma , poverty and food shortages threatens the long-term success of HIV treatment OBJECTIVE To assess the extent to which user fees for antiretroviral therapy ( ART ) represent a financial barrier to access to ART among HIV-positive patients in Yaoundé , Cameroon . METHODS Sociodemographic , economic and clinical data were collected from a r and om sample of 707 HIV-positive patients followed up in six public hospitals of the capital city ( Yaoundé ) and its surroundings through face-to-face interviews carried out by trained interviewers independently from medical staff and medical question naires filled out by prescribing physicians . Logistic regression models were used to identify factors associated with self-reported financial difficulties in purchasing ART during the previous 3 months . FINDINGS Of the 532 patients treated with ART at the time of the survey , 20 % reported financial difficulty in purchasing their antiretroviral drugs during the previous 3 months . After adjustment for socioeconomic and clinical factors , reports of financial difficulties were significantly associated with lower adherence to ART ( odds ratio , OR : 0.24 ; 95 % confidence interval , CI : 0.15 - 0.40 ; P < 0.0001 ) and with lower CD4 + lymphocyte ( CD4 ) counts after 6 months of treatment ( OR : 2.14 ; 95 % CI : 1.15 - 3.96 for CD4 counts < 200 cells/microl ; P = 0.04 ) . CONCLUSION Removing a financial barrier to treatment with ART by eliminating user fees at the point of care delivery , as recommended by WHO , could lead to increased adherence to ART and to improved clinical results . New health financing mechanisms based on the public re sources of national governments and international donors are needed to attain universal access to drugs and treatment for HIV infection The importance of antiretroviral therapy adherence for patients living with HIV/AIDS has been well documented . Despite this critical need , many do not follow prescribed regimens . To examine the barriers that lead to non-adherence , we used cross-sectional survey data from a r and omized controlled intervention trial in northern and north-eastern Thail and . Of the 507 patients that were enrolled in the trial , we analyzed 386 patients on antiretroviral therapy in order to examine the barriers to adherence . In addition to demographic characteristics , depressive symptoms , physical health , access to care , social support , and internalized shame , HIV disclosure and family communication were examined . The correlation analysis revealed that adherence is significantly associated with internalized shame , access to care , depressive symptoms , and family communication . Based on the multiple logistic regression analysis , depressive symptoms , access to care , HIV disclosure , and family communication were significant predictors of adherence . Having depressive symptoms remains a significant barrier to adherence , while access to care , HIV disclosure , and family communication play important positive roles . Our findings underscore the critical importance of addressing these various challenges that can influence adherence to antiretroviral therapy Background : The observation that extremely high levels of medication adherence are required to achieve complete virologic suppression is based largely on studies of treatment-experienced patients receiving HIV protease inhibitor (PI)-based therapy without ritonavir boosting . This study aims to define the level of adherence needed to achieve virologic suppression in patients receiving boosted PI-based highly active antiretroviral therapy ( HAART ) with lopinavir/ritonavir . Methods : HIV-infected adults receiving a regimen containing lopinavir/ritonavir were recruited into a prospect i ve , observational study of the relation between adherence to lopinavir/ritonavir and virologic outcomes . Adherence was measured using the Medication Event Monitoring System ( MEMS ; Aardex , Union City , CA ) . HIV-1 viral load ( VL ) was measured at week 24 . Results : The final study population contained 64 subjects . Eighty percent had AIDS , 97 % received lopinavir/ritonavir before enrollment , and most had more than 7 years of HAART experience . Mean adherence overall was 73 % . Eighty percent and 59 % achieved a VL < 400 copies/mL and a VL < 75 copies/mL , respectively . Mean adherence was 75 % in those achieving a VL < 75 copies/mL. High rates of virologic suppression were observed in all adherence quartiles , including the lowest quartile ( range of adherence : 23.5%-53.3 % ) . Conclusions : Moderate levels of adherence can lead to virologic suppression in most patients taking lopinavir/ritonavir-based HAART INTRODUCTION Cuba has an HIV prevalence of 0.1 % in the population aged 15 to 49 years , very low despite increased incidence in recent years . In 2001 , domestically-produced generic antiretroviral therapy was introduced and there has been complete coverage since 2003 . In 2006 , 1986 people with HIV/AIDS were receiving ART ; by 2009 , that figure reached 5034 . Adherence to antiretroviral therapy is fundamental : nonadherence leads to treatment failure , development of resistance , progression to AIDS , and death . OBJECTIVE Measure levels of treatment adherence and its predictive factors in persons with HIV/AIDS receiving antiretroviral therapy in 2006 in Cuba . METHODS A cross-sectional study was carried out in 2006 of Cuban HIV-positive individuals receiving antiretroviral therapy . A sample size of 876 was calculated using two-stage sampling ( first by strata , and then by simple r and om sampling in each stratum ) . An anonymous structured question naire was administered to participants . Reporting of doses taken on each of the three days and in the week preceding the survey was recoded into five categories . Participants were considered highly adherent if they reported taking ≥95.0 % of their medication as prescribed . Reasons for nonadherence were described and logistic regression modeling used to develop hypotheses on associations between high adherence and its predictive factors . RESULTS Interviews were obtained with 847 individuals , 70.6 % of whom self reported high adherence . There were no significant differences between highly adherent and less adherent patients with regard to sex , place of residence , treatment setting , time of diagnosis , or length of treatment . Variables associated with high adherence were communication with the specialist physician , change in treatment , memory , self-efficacy , as well as commitment to and opinions about treatment . CONCLUSIONS In Cuba , where treatment is free of charge to patients , adherence is good . Treatment adherence might be improved by achieving a closer doctor-patient relationship ; taking measures to motivate patients and promote self-efficacy and commitment to treatment ; publicizing treatment outcomes ; and providing assistance to patients to help them remember their medication schedule . Further studies are required to determine current adherence levels ; and longitudinal research to determine adherence over time Objective : to determine adherence of an indigent African HIV‐infected cohort initiating antiretroviral therapy ( ART ) ; to identify predictors of incomplete adherence ( < 95 % ) and virologic failure ( > 400 HIV RNA copies/ml ) . Design : Prospect i ve monitoring of adherence in a poor HIV‐positive cohort , attending a public sector hospital and receiving ART through phase III studies . Methods : Adherence to ART was determined over 48 weeks by counting tabletreturns . Logistic regression models including age , WHO HIV stage , home language , socio‐economic status , complexity and type of regimen were fitted to determine predictors of incomplete adherence and virologic failure at 48 weeks . Results : 289 patients were recruited between January 1996 and May 2001 . Median ( mean ) adherence of the cohort was 93.5 % ( 87.2 % ) . Three times daily dosing [ risk ratio ( RR ) , 3.07 ; 95 % confidence interval ( CI ) , 1.40–6.74 ] , speaking English ( RR , 0.41 ; 95 % CI , 0.21–0.80 ) and age ( RR , 0.97 ; 95 % CI , 0.94–0.99 ) were independent predictors of incomplete adherence . Socio‐economic status , sex and HIV stage did not predict adherence . Independent predictors of virologic failure included baseline viral load ( RR , 2.57 ; 95 % CI , 1.57–4.22 ) and three times daily dosing ( RR , 2.64 ; 95 % CI , 1.23–5.66 ) , incomplete adherence ( RR , 1.92 ; 95 % CI , 1.10–3.57 ) , age ( RR , 0.96 ; 95 % CI , 0.92–0.99 ) and dual nucleoside therapy ( RR , 2.69 ; 95 % CI , 1.17–6.15 ) . Conclusion : The proportion of individuals achieving viral suppression matched results from the developing world . Speaking the same language as site staff and simplified dosing frequency were beneficial . Socio‐economic status had no impact on adherence and should not be used as a limitation to ART access Although the number of patients receiving antiretroviral ( ARV ) therapy in Central China is exp and ing , little is known about their medication adherence . The purpose of this study was to : ( 1 ) describe adherence prevalence among patients receiving free ARV in south central China ; ( 2 ) identify factors associated with adherence ; ( 3 ) compare 3 self-report measures of adherence in this population . A cross-sectional survey was conducted at seven free treatment sites in Hunan , Hubei , and Anhui Provinces . Adherence measures included direct question ing regarding the number of doses taken in the 7 days prior to interview , the Community Programs for Clinical Research on AIDS ( CPCRA ) Adherence Self-Report question naire , and a 7-day visual analogue scale . Subjects comprised all patients returning for monthly ARV follow-up at each site between April and July 2006 . Among the 308 subjects , 244 ( 79 % ) lived in the countryside . One hundred seventy ( 55 % ) had been on ARV over 1 year . No regimen included a protease inhibitor . Two hundred forty-four ( 80 % ) reported taking more than 90 % of prescribed doses in the previous 7 days . Sixty-four ( 20 % ) subjects reported missing at least 1 dose in that period . The three measures of self-reported adherence were highly correlated . On multivariate analysis , current heroin use ( odds ratio [ OR ] = 2.5 ; 95 % confidence interval [ CI ] 1,6 , p = 0.05 ) and nonuse of reminders such as cell phone alarms , wall charts , or TV programs ( OR 6 ; 95 % CI 3 , 11 ; p = 0.001 ) were associated with 90 % or less adherence . Adherence to ARV in Central China is similar to elsewhere in the world . The 20 % of subjects who reported taking 90 % or fewer doses are of concern in view of the potential for non-nucleoside reverse transcriptase inhibitor resistance and lack of protease inhibitor back-up regimens . Substance abuse treatment will be an essential element of successful AIDS treatment in China . Prospect i ve studies are needed to evaluate the efficacy of reminder devices to improve adherence in this population and to describe the prevalence and incidence of ARV resistance Objectives : This study evaluated the adherence to antiretroviral therapy ( ART ) in 322 Brazilian outpatient services located in seven states providing care to 87 000 patients ( 72 % ) under ART . Methods : A previous study classified the 322 health services into four levels of quality of care . Sixty of them were r and omly chosen on the basis of these levels . A cross-section of 1972 patients under ART visiting these services was interviewed using a structured question naire . Patients who reported taking more than 95 % of the prescribed antiretroviral pills in the past 3 days were considered adherent . The chi-square test was first used to compare the prevalence of non-adherence among two or more categories of variables . A chi-square test for linear trend was used for ordinal variables . Three multivariate models were applied using health services predictors , treatment predictors , and personal characteristics predictors . The predictors were fitted into logistic regression models using backward elimination procedures . Results : The adherence prevalence was 75 % ( 95 % confidence interval 73.08–76.95 ) . The level of quality of care was not associated with non-adherence . The models showed the following predictors of non-adherence : related to health services : services with 100 patients or less and missed appointments ; related to treatment : more complex regimens and a high number of pills ; related to personal characteristics : under 2 years of formal education . Conclusion : The adherence prevalence was similar to the rates currently obtained in developed countries . However , services with few patients need to be carefully monitored to maintain high rates . Care planning that prioritizes patients at risk also needs to be improved |
11,514 | 12,535,466 | Cervical cerclage was associated with mild pyrexia , increased use of tocolytic therapy and hospital admissions but no serious morbidity .
REVIEW ER 'S CONCLUSIONS The use of a cervical stitch should not be offered to women at low or medium risk of mid trimester loss , regardless of cervical length by ultrasound . | BACKGROUND A cervical stitch has been used to prevent preterm deliveries in women with previous second trimester pregnancy losses , or other risk factors such as short cervix on digital or ultrasound examination .
OBJECTIVES To assess effectiveness and safety of prophylactic cerclage ( before the cervix has dilated ) , emergency cerclage ( where cervices have started to shorten and dilate ) and then labour halted , and to determine whether a particular technique of stitch insertion is better than others . | OBJECTIVE The aim of this study was to compare perinatal outcomes of patients with second-trimester ultrasonographic evidence of preterm dilatation of the internal os treated with cerclage versus those of patients not treated with cerclage . STUDY DESIGN From May 1998 through June 1999 patients with ultrasonographic evidence of preterm dilatation of the internal os between 16 and 24 weeks ' gestation were r and omly assigned to receive a McDonald cerclage or no cerclage . Before r and om assignment all patients underwent amniocentesis and urogenital cultures and then received 48 hours of therapy with indomethacin and antibiotics . After treatment each patient was followed up as an outpatient with bed rest and weekly ultrasonographic evaluation . RESULTS Of the 61 patients 31 were r and omly assigned to cerclage and 30 were r and omly assigned to no cerclage . There were no differences between groups with respect to maternal demographic characteristics , risk factors for preterm birth , cervical measurements , rescue procedures , readmission , chorioamnionitis , and abruptio placentae . The mean gestational age at delivery ( 33.5 + /- 6.3 weeks ) and the perinatal death rate ( 12 . 9 % ) in the cerclage group were similar to the mean gestational age at delivery ( 34.7 + /- 4.7 weeks ; P = .4 ) and the perinatal death rate ( 10.0 % ; P = .9 ) in the no-cerclage group . CONCLUSION Treatment with McDonald cerclage of preterm dilatation of the cervix detected ultrasonographically during the second trimester did not improve perinatal outcomes Internal os cerclage for cervical incompetence was performed in 90 patients who had previous McDonald procedure failure ( 70 patients ) or had unfavorable cervical anatomy ( short or lacerated cervix ) for primary McDonald type cerclage ( 20 patients ) . Two different techniques were used : the Shirodkar operation ( n = 44 ) with Mersilene b and , and a simpler new technique ( n = 46 ) . The new technique is characterized by anterior colpotomy for exposure of the internal os , and a 0.6 mm nylon suture encircling the cervix to be tied high in the posterior fornix . The pregnancy outcome for both groups was similar . Late abortions of 8.7 and 11 % and premature deliveries of 13 and 18 % occurred in the new technique and the Shirodkar groups , respectively . The removal of the suture was generally difficult in the Shirodkar group and in eight patients analgesia and sedation were required . In the new technique group , the removal was easier and in only one patient was sedation required ( p less than 0.0001 ) . Severe vaginal discharge was found in 52 % of the Shirodkar patients and none in the other group . Apparently the monofilament nylon suture prevented this side effect . It seems that the new technique is simpler to perform , involves fewer side effects , the removal of the suture is easier , and it is as effective as the Shirodkar procedure OBJECTIVE To compare preterm delivery rates ( before 34 weeks of gestation ) and neonatal morbidity and mortality in patients with risk factors or symptoms of cervical incompetence managed with therapeutic McDonald cerclage and bed rest versus bed rest alone . STUDY DESIGN Cervical length was measured in patients with risk factors or symptoms of cervical incompetence . Risk factors for cervical incompetence included previous preterm delivery before 34 weeks of gestation that met clinical criteria for the diagnosis of cervical incompetence , previous preterm premature rupture of membranes before 32 weeks of gestation , history of cold knife conization , diethylstilbestrol exposure , and uterine anomaly . When a cervical length of < 25 mm was measured before a gestational age of 27 weeks , a r and omization for therapeutic cerclage and bed rest ( cerclage group ) or bed rest alone ( bed rest group ) was performed . The analysis is based on intention to treat . RESULTS Of the 35 women who met the inclusion criteria , 19 were allocated r and omly to the cerclage group and 16 to the bed rest group . Both groups were comparable for mean cervical length and mean gestational age at time of r and omization , mean overall 20 mm and 21 weeks . Preterm delivery before 34 weeks was significantly more frequent in the bed rest group than in the cerclage group ( 7 of 16 vs none , respectively ; P = .002 ) . There was no statistically significant difference in neonatal survival between the groups ( 13 neonates survived in the bed rest group vs all in the cerclage group ) . The compound neonatal morbidity , defined as admission to the neonatal intensive care unit or neonatal death , was significantly higher in the bed rest group than in the cerclage group ( 8 of 16 vs 1 of 19 , respectively ; P = .005 ; RR = 9.5 , 95 % CI , 1.3 - 68.1 ) . CONCLUSIONS Therapeutic cerclage with bed rest reduces preterm delivery before 34 weeks of gestation and compound neonatal morbidity in women with risk factors and /or symptoms of cervical incompetence and a cervical length of < 25 mm before 27 weeks of gestation OBJECTIVE The purpose of this study was to determine the efficacy of cerclage and bed rest versus bed rest-only for the prevention of preterm birth in women with a short cervix found on transvaginal ultrasound examination . STUDY DESIGN Women with > or = 1 of high-risk factors for preterm birth ( > or = 1 preterm birth at < 35 weeks of gestation , > or = 2 curettages , diethylstilbestrol exposure , cone biopsy , Mullerian anomaly , or twin gestation ) were screened with transvaginal ultrasonography of the cervix every 2 weeks from 14 weeks of gestation to 23 weeks 6 days of gestation . Enrollment was offered to both asymptomatic women who were at high risk and who were identified to have short cervix ( < 25 mm ) or significant funneling ( > 25 % ) and nonscreened women who were at low risk and who were identified incidentally . The women who gave written consent were assigned r and omly to receive either McDonald cerclage or bed rest-only . Both groups received similar counseling and treatment . Primary outcome was preterm birth at < 35 weeks of gestation . RESULTS Sixty-one women were assigned r and omly . Forty-seven pregnancies ( 77 % ) were high-risk singleton gestations . Thirty-one women ( 51 % ) were allocated to cerclage , and 30 women ( 49 % ) were allocated to bed rest . There were no differences between the groups in demographic characteristics , risk factors , and cervical variables . Preterm birth at < 35 weeks of gestation occurred in 14 women ( 45 % ) in the cerclage group and in 14 women ( 47 % ) in the bed rest group ( relative risk , 0.94 ; 95 % CI , 0.34 - 2.58 ) . There was no difference in any obstetric or neonatal outcomes . A sub analysis of singleton pregnancies with previous preterm birth at < 35 weeks of gestation and a short cervix of < 25 mm ( n = 31 women ) also revealed no significant difference in recurrent preterm birth at < 35 weeks of gestation ( 40 % vs 56 % ; relative risk , 0.52 ; 95 % CI , 0.12 - 2.17 ) . CONCLUSION Cerclage did not prevent preterm birth in women with a short cervix . These results should be confirmed by larger trials To determine the value of transvaginal sonography in women with a previous history of second trimester miscarriage due to cervical incompetence , 55 patients were subjected to either elective cervical cerclage or follow-up ( every second patient ) with weekly evaluations of the cervix by transvaginal ultrasonography . Emergency cerclage was applied when significant cervical changes were noted . All patients were evaluated with cervical cultures and ultrasound . Women with infection , fibroids , uterine malformations and multiple pregnancies were excluded from the study . The study population was divided in two groups . In group I ( n=27 ) elective cerclage was applied during the 14th week . Women in group II ( n=28 ) were subjected to serial weekly evaluations of the cervix by transvaginal ultrasonograms . In 18 cases emergency cerclage was applied due to significant cervical changes . In group I , labor started before the 33rd week in two cases ( 7.4 % ) , between 33 and 37 weeks in nine ( 33.3 % ) and after the 37th week in 16 cases ( 59.2 % ) . Out of the 18 patients in group II who had cervical cerclage after ultrasonographic evaluation , four ( 22.2 % ) delivered before the 33rd week , three ( 16.6 % ) between 33 and 37 weeks and 11 ( 61.1 % ) after the 37th week . No statistical difference was noted between the two groups referring to pregnancy outcome ( p<0.1 ) . We concluded that ultrasound-guided management despite cervical shortening , does not result in unfavorable pregnancy outcome . A significant number of patients can avoid the operation BACKGROUND Cervical cerclage has been widely used in the past 50 years to prevent early preterm birth and its associated neonatal mortality and morbidity . Results of r and omised trials have not generally lent support to this practice , but this absence of benefit may be due to suboptimum patient selection , which was essentially based on obstetric history . A more effective way of identifying the high-risk group for early preterm delivery might be by transvaginal sonographic measurement of cervical length . We undertook a multicentre r and omised controlled trial to investigate whether , in women with a short cervix identified by routine transvaginal scanning at 22 - 24 weeks ' gestation , the insertion of a Shirodkar suture reduces early preterm delivery . METHODS Cervical length was measured in 47?123 women . The cervix was 15 mm or less in 470 , and 253 ( 54 % ) of these women participated in the study and were r and omised to cervical cerclage ( 127 ) or to expectant management ( 126 ) . Primary outcome was the frequency of delivery before 33 completed weeks ( 231 days ) of pregnancy . FINDINGS The proportion of preterm delivery before 33 weeks was similar in both groups , 22 % ( 28 of 127 ) in the cerclage group versus 26 % ( 33 of 126 ) in the control group ( relative risk=0.84 , 95 % CI 0.54 - 1.31 , p=0.44 ) , with no significant differences in perinatal or maternal morbidity or mortality . INTERPRETATION The insertion of a Shirodkar suture in women with a short cervix does not substantially reduce the risk of early preterm delivery . Routine sonographic measurement of cervical length at 22 - 24 weeks identifies a group at high risk of early preterm birth OBJECTIVE The purpose of this study was to identify the risk factors that are associated with increased neonatal morbidity in patients who were treated for sonographic evidence of internal os dilation and distal cervical shortening during the second trimester . STUDY DESIGN From May 1998 to June 2000 patients between 16 and 24 weeks of gestation with the following sonographic criteria were r and omly assigned to McDonald cerclage or no cerclage : internal os dilation and either membrane prolapse into the endocervical canal at least 25 % of the total cervical length but not beyond the external os or a shortened distal cervix < 2.5 cm . Before r and omization , all patients were treated identically with an amniocentesis , multiple urogenital cultures , and therapy with indomethacin and clindamycin for 48 to 72 hours . Except for the cerclage , all patients were treated identically after r and omization . Multiple variables of perinatal outcome were analyzed . A regression model with gestational age at delivery as the dependent variable was constructed and repeated with neonatal morbidity as the dependent variable . This model was applied to 3 population s : the cerclage group , the no cerclage group , and both groups combined . RESULTS Of the 135 patients , 20 patients declined r and omization , and 2 patients were diagnosed with acute chorioamnionitis . Of the 113 patients remaining , 55 patients were r and omly assigned to the cerclage group , and 58 patients were r and omly assigned to the no cerclage group . There were 8 rescue cerclage procedures ( 4 in each group ) . Regression analysis showed that readmission for preterm labor , chorioamnionitis , and abruption were consistently associated with early gestational age at delivery and increased morbidity . Cerclage did not affect perinatal outcome . CONCLUSION The sonographic findings of second trimester internal os dilation , membrane prolapse , and distal cervical shortening likely represent a common pathway of several pathophysiologic processes . Use of cerclage does not alter any perinatal outcome variables . Increased neonatal morbidity in these patients appears to be associated with sub clinical infection , preterm labor , and abruption OBJECTIVE The objective of this study was to compare different management strategies for women at risk for cervical incompetence . STUDY DESIGN In an ongoing r and omized trial patients with a previous preterm delivery at < 34 weeks ' gestation who met clinical criteria for the diagnosis of cervical incompetence are allocated to receive a prophylactic cerclage ( prophylactic cerclage group ) or not ( observational group ) in a proportion of 1:2 . Transvaginal ultrasonographic follow-up examination of the cervix is performed in both groups . When a patient of the latter group has a cervical length < 25 mm at < 27 weeks ' gestation , a further r and om assignment of therapeutic cerclage or no cerclage is performed . The analysis is by intent to treat . RESULTS Primary r and om assignment allocated 23 women to the prophylactic cerclage group and 44 to the observational group . Both groups were comparable with respect to obstetric history . No significant difference was found between the prophylactic cerclage group and the observational group in preterm delivery at < 34 weeks ' gestation ( 3/23 vs 6/44 , respectively ) and neonatal survival ( 21/23 vs 41/44 , respectively ) . A cervical length < 25 mm was found in 18 patients ( 41 % ) in the observational group at a mean gestational age of 19.1 + /- 2.9 weeks ' gestation . Incidence of preterm delivery at < 34 weeks ' gestation was significantly higher in the group with short cervical length ( 6/18 vs 0/26 ; P = .003 ) . Secondary r and om assignment of the 18 patients with short cervical length allocated 10 to undergo therapeutic cerclage . Preterm delivery at < 34 weeks ' gestation was significantly less frequent in the therapeutic cerclage group ( 1/10 vs 5/8 ) . CONCLUSION Transvaginal ultrasonographic serial follow-up examinations of the cervix in women at risk for cervical incompetence , with secondary intervention as indicated , appears to be a safe alternative to the traditional prophylactic cerclage . Transvaginal ultrasonographic follow-up examination of the cervix can save the majority of women from unnecessary intervention . Placement of a therapeutic cerclage may reduce the incidence of preterm delivery at < 34 weeks ' gestation among high-risk patients OBJECTIVE The purpose of this study was to compare preterm delivery rates and neonatal morbidity/mortality rates for women with cervical incompetence with membranes at or beyond a dilated external cervical os that was treated with emergency cerclage , bed rest plus indomethacin , versus just bed rest . STUDY DESIGN Women with cervical incompetence with membranes at or beyond a dilated external cervical os , before 27 weeks of gestation , were treated with antibiotics and bed rest and r and omly assigned for emergency cerclage and indomethacin or bed rest only . RESULTS Twenty-three women were included ; 13 women were allocated r and omly to the emergency cerclage and indomethacin group , and 10 women were allocated r and omly to the bed rest-only group . Gestational age at time of r and omization was 22.2 weeks in the emergency cerclage and indomethacin group and 23.0 weeks in the bed rest-only group . Mean interval from r and omization until delivery was 54 days in the emergency cerclage and indomethacin group and 20 days in the bed rest-only group ( P=.046 ) . Mean gestational age at delivery was 29.9 weeks in the emergency cerclage and indomethacin group and 25.9 weeks in the bed rest-only group . Preterm delivery before 34 weeks of gestation was significantly lower in the emergency cerclage and indomethacin group , with 7 of 13 deliveries versus all 10 deliveries in the bed rest-only group ( P=.02 ) . CONCLUSIONS Emergency cerclage , indomethacin , antibiotics , and bed rest reduce preterm delivery before 34 weeks compared with bed rest and antibiotics alone To evaluate the efficiency of cerclage or pessary a prospect i ve r and om study has been done from 1982 to 1983 . Pelvic score of Bishop and tocolysis index of Baumgarten were used to define the situation at the beginning . Success has been estimated with help of neonatal parameters ( birth weight , Apgar score and RDS-morbidity ) and final gestational week . Both methods are equal in their effects Summary . A total of 506 women at moderate risk of preterm delivery were r and omly allocated to either cervical cerclage or a control group . Significantly more women in the group allocated to cerclage were admitted to hospital for reasons other than the operation and more received oral toco‐lytic drugs . There were also more caesarean sections and more preterm deliveries in the women allocated to cerclage although the differences between the two groups were small and not statistically significant Fifty patients with cervical incompetence were r and omised to have cervical cerclage either as in patients , spending 3 days in hospital post-procedure on supervised bed rest or as out patients spending the time at home on bed rest . Both groups had a clinical diagnosis of cervical incompetence and both had either McDonald or Shirodkar cerclage with mersilene tape . Both groups were given salbutamol tablets for tocolysis , postoperatively . There were no significant difference in the demographic variables between the groups such as previous cerclage , gestational age at insertion , parity and gestational age at delivery . There were also no significant differences in early complications such as bleeding . Most late complications were also not different , including the spontaneous abortion rate , premature rupture of membranes , cervical dystocia and preterm delivery . However , more patients in the outpatient group had premature contractions ( 26·1 % vs. 4·3 % P = 0·0479 ) . More patients in the inpatient group had a delivery of a live neonate , 86·9 % vs. 78·3 % , but the difference was not statistically significant . In conclusion , out patient cerclage appears to be a valid option , the higher rate of premature contraction in this group is not a cause for concern in view of the similar mean gestational age at delivery What is meant by intention-to-treat ? Why should data be analyzed in controlled trials in a way that all participants are included in the group to which they were r and omly assigned , regardless of whether they completed the intervention given to the group ? In this Tutorial , the logic of the intention-to-treat principle is outlined . It is shown that study results may be biased by excluding patients post hoc thus producing spurious effects that do not exist in the population under study . The intention-to-treat strategy avoids this bias |
11,515 | 30,159,170 | There was no significant difference in the rates of adverse effects .
Conclusions Buprenorphine provided a longer duration of analgesia than morphine .
This in combination with its unique sublingual preparation could prove particularly advantageous in the paediatric population . | Introduction In lab-based studies , buprenorphine appears to have a ceiling effect on respiratory depression but not on analgesia .
There is increasing evidence in adult patients that buprenorphine has no ceiling effect on analgesia or side effects .
The aim of this study was to investigate the efficacy and adverse effects of buprenorphine versus morphine in paediatric acute pain . | OBJECTIVES The Wong-Baker FACES Pain Rating Scale ( WBS ) , used in children to rate pain severity , has been vali date d outside the emergency department ( ED ) , mostly for chronic pain . The authors vali date d the WBS in children presenting to the ED with pain by identifying a corresponding mean value of the visual analog scale ( VAS ) for each face of the WBS and determined the relationship between the WBS and VAS . The hypothesis was that the pain severity ratings on the WBS would be highly correlated ( Spearman 's rho > 0.80 ) with those on a VAS . METHODS This was a prospect i ve , observational study of children ages 8 - 17 years with pain presenting to a suburban , academic pediatric ED . Children rated their pain severity on a six-item ordinal faces scale ( WBS ) from none to worst and a 100-mm VAS from least to most . Analysis of variance ( ANOVA ) was used to compare mean VAS scores across the six ordinal categories . Spearman 's correlation ( rho ) was used to measure agreement between the continuous and ordinal scales . RESULTS A total of 120 patients were assessed : the median age was 13 years ( interquartile range [ IQR ] = 10 - 15 years ) , 50 % were female , 78 % were white , and six patients ( 5 % ) used a language other than English at home . The most commonly specified locations of pain were extremity ( 37 % ) , abdomen ( 19 % ) , and back/neck ( 11 % ) . The mean VAS increased uniformly across WBS categories in increments of about 17 mm . ANOVA demonstrated significant differences in mean VAS across face groups . Post hoc testing demonstrated that each mean VAS was significantly different from every other mean VAS . Agreement between the WBS and VAS was excellent ( rho = 0.90 ; 95 % confidence interval [ CI ] = 0.86 to 0.93 ) . There was no association between age , sex , or pain location with either pain score . CONCLUSIONS The VAS was found to have an excellent correlation in older children with acute pain in the ED and had a uniformly increasing relationship with WBS . This finding has implication s for research on pain management using the WBS as an assessment tool 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 In a r and omized double-blind study of 57 children ( aged 6 months-6 yr ) , pain following lateral thoracotomy was relieved with repeated i.v . doses of morphine 100 or 50 micrograms kg-1 , or buprenorphine 3.0 or 1.5 micrograms kg-1 . The same drug and dosage were continued and cardioventilatory indices , pain intensity and sedation measured for an observation period of 24 h. The sums of the pain intensity differences were equal in all groups . The mean doses for the complete initial analgesia were 230 and 180 micrograms kg-1 with the larger and the smaller bolus doses of morphine and 5.8 and 3.7 micrograms kg-1 with buprenorphine , respectively . The mean duration of action of buprenorphine was slightly but not significantly longer than that of morphine . The total consumption of both morphine and buprenorphine was less when the smaller bolus doses were used . Two patients developed a degree of ventilatory depression following repeated doses of buprenorphine . Buprenorphine was equal to morphine as a postoperative analgesic This study was a prospect i ve , r and omized comparison of the ventilatory effects of equianalgesic single‐doses of morphine , 100 μg/kg , and buprenorphine , 3.0 μg/kg , administered intravenously to 20 children ( 5–8 years of age ) after elective ophthalmic surgery . The decrease in ventilatory rate and acute change in the arteriolar oxygen saturation and the increase in end‐tidal CO2 levels were statistically significantly greater in magnitude and duration after buprenorphine than after morphine . For both drugs , the time , duration and magnitude of ventilatory changes varied appreciably between individuals . No child had apnea or hypoventilation requiring assistance . The authors conclude that acutely administered buprenorphine depresses ventilation to a greater degree than morphine . The maximal ventilatory effect of buprenorphine occurs later than with morphine , and ventilatory depression after buprenorphine may develop late . For safety , all children given opioids intravenously should be observed until they are fully responsive and ventilatory control has stabilized The safety and efficacy of buprenorphine and morphine as postoperative analgesicsfor children were compared in 60 boys and girls 4 to 14 years old having elective orthopedic operations on upper or lower extremities . The drugs were given in a double-blind manner initially intravenously and thereafter by sublingual buprenorphine or intramuscular morphine administered as required to relieve pain until the third postoperative morning . The IV dose needed to achieve complete initial analgesia was 5.2 ± 2.8 μg/kg buprenorphine and 166 ± 100 μg/kg morphine . The duration of effect was significantly longer with buprenorphine than with morphine , 248 ± 314 and 114 ± 109 minutes , respectively ( P = 0.03 ) . The most common side effects were nausea and vomiting ( 28 and 16 % ) and urinary retention ( 21 and 19 % ) in the buprenorphine and morphine groups , respectively . Analgesia with sublingual buprenorphine was as effective and reliable as with intramuscular morphine but a longer duration of action could not be demonstrated The study describes long term ventilatory effects of 50 or 100 micrograms.kg-1 of morphine or 1.5 or 3.0 micrograms.kg-1 of buprenorphine when given in repeated intravenous ( i.v . ) doses , in a double blind fashion , to achieve equal levels of analgesia after thoracotomy . The patients were 56 children , six months to six years of age . Ventilatory rate ( VR ) was measured over the 24 h study period , and arterial carbon dioxide tension ( PaCO2 ) was measured on arrival in the Paediatric Intensive Care Unit ( PICU ) and at 1 , 6 , 12 and 18 h. In the buprenorphine groups VRs progressively decreased during the first 2 h and remained significantly lower ( P < 0.05 ) than in the morphine groups for 7 h. For the rest of the study period there were no differences . The PaCO2 values did not differ significantly at any point . For safety , prolonged observation of children is needed after intravenous administration of buprenorphine to ensure the ventilatory rate has stabilized |
11,516 | 27,486,154 | Conclusions : There is increasing evidence for efficacy , tolerability , and safety of neurostimulation treatments .
rTMS is now a first-line recommendation for patients with MDD who have failed at least 1 antidepressant .
ECT remains a second-line treatment for patients with treatment-resistant depression , although in some situations , it may be considered first line . | Background : The Canadian Network for Mood and Anxiety Treatments ( CANMAT ) conducted a revision of the 2009 guidelines by updating the evidence and recommendations .
The scope of the 2016 guidelines remains the management of major depressive disorder ( MDD ) in adults , with a target audience of psychiatrists and other mental health professionals . | BACKGROUND Suicide attempts and completed suicides are common , yet there are no proven acute medication or device treatments for treating a suicidal crisis . Repeated daily left prefrontal repetitive transcranial magnetic stimulation ( rTMS ) for 4 - 6 weeks is a new FDA -approved treatment for acute depression . Some open-label rTMS studies have found rapid reductions in suicidality . DESIGN This study tests whether a high dose of rTMS to suicidal in patients is feasible and safe , and also whether this higher dosing might rapidly improve suicidal thinking . This prospect i ve , 2-site , r and omized , active sham-controlled ( 1:1 r and omization ) design incorporated 9 sessions of rTMS over 3 days as adjunctive to usual inpatient suicidality treatment . The setting was two inpatient military hospital wards ( one VA , the other DOD ) . PATIENTS Research staff screened approximately 377 in patients , yielding 41 adults admitted for suicidal crisis . Because of the funding source , all patients also had either post-traumatic stress disorder , mild traumatic brain injury , or both . TMS METHODS Repetitive TMS ( rTMS ) was delivered to the left prefrontal cortex with a figure-eight solid core coil at 120 % motor threshold , 10 Hertz ( Hz ) , 5 second ( s ) train duration , 10 s intertrain interval for 30 minutes ( 6000 pulses ) 3 times daily for 3 days ( total 9 sessions ; 54,000 stimuli ) . Sham rTMS used a similar coil that contained a metal insert blocking the magnetic field and utilized electrodes on the scalp , which delivered a matched somatosensory sensation . MAIN OUTCOME MEASURE Primary outcomes were the daily change in severity of suicidal thinking as measured by the Beck Scale of Suicidal Ideation ( SSI ) administered at baseline and then daily , as well as subjective visual analog scale measures before and after each TMS session . Mixed model repeated measures ( MMRM ) analysis was performed on modified intent to treat ( mITT ) and completer population s. RESULTS This intense schedule of rTMS with suicidal in patients was feasible and safe . Minimal side effects occurred , none differing by arm , and the 3-day retention rate was 88 % . No one died of suicide within the 6 month followup . From the mITT analyses , SSI scores declined rapidly over the 3 days for both groups ( sham change -15.3 points , active change -15.4 points ) , with a trend for more rapid decline on the first day with active rTMS ( sham change -6.4 points , active -10.7 points , P = 0.12 ) . This decline was more pronounced in the completers subgroup [ sham change -5.9 ( 95 % CI : -10.1 , -1.7 ) , active -13 points ( 95 % CI : -18.7 , -7.4 ) ; P = 0.054 ] . Subjective ratings of ' being bothered by thoughts of suicide ' declined non-significantly more with active rTMS than with sham at the end of 9 sessions of treatment in the mITT analysis [ sham change -31.9 ( 95 % CI : -41.7 , -22.0 ) , active change -42.5 ( 95 % CI : -53.8 , -31.2 ) ; P = 0.17 ] . There was a significant decrease in the completers sample [ sham change -24.9 ( 95 % CI : -34.4 , -15.3 ) , active change -43.8 ( 95 % CI : -57.2 , -30.3 ) ; P = 0.028 ] . CONCLUSIONS Delivering high doses of left prefrontal rTMS over three days ( 54,000 stimuli ) to suicidal in patients is possible and safe , with few side effects and no worsening of suicidal thinking . The suggestions of a rapid anti-suicide effect ( day 1 SSI data , Visual Analogue Scale data over the 3 days ) need to be tested for replication in a larger sample . TRIAL REGISTRATION Clinical Trials.gov Identifier : NCT01212848 , TMS for suicidal ideation BACKGROUND Theta-burst transcranial magnetic stimulation ( TBS ) has been shown to induce potent and long lasting effects on cortical excitability . In a previous open study , we demonstrated safety , tolerability and antidepressant properties of continuous TBS ( cTBS ) in major depression ( MD ) . The present study was aim ed to evaluate the therapeutic efficacy of cTBS in depressed patients using a double-blind , sham-controlled design . METHODS Twenty nine patients with MD were r and omized to receive either active cTBS to the right dorsolateral prefrontal cortex ( n=15 ) or sham cTBS ( n=14 ) for 10 consecutive work days . After the 10th session , patients who received sham TBS were crossed over to active cTBS which consisted of 10 daily sessions . Patients who received active cTBS continued with the same treatment protocol for additional 10 treatments . Each treatment session consisted of 3600 stimuli at an intensity of 100 % of the active motor threshold . Severity of depression was assessed weekly . RESULTS Overall , there was no significant difference in the degree of clinical improvement between active and sham cTBS groups . However , in patients whose medication status remained unchanged before the trial ( n=8 ) and in those who were medication-free ( n=3 ) , active cTBS result ed in a significantly greater reduction of Hamilton depression scores as compared to sham cTBS . LIMITATIONS A small sample size , confounding effect of medication and short treatment period . CONCLUSIONS Our results suggest that the antidepressant effect of cTBS is modest , yet it might be beneficial to patients nonresponsive to ongoing pharmacological treatment . A direct comparison between cTBS and conventional rTMS protocol s is warranted BACKGROUND Repetitive transcranial magnetic stimulation ( rTMS ) has been shown to be an effective treatment for depression . However , there has been little research to determine optimal parameters for treatment . METHOD This study compared two rTMS treatment regimes for the treatment of major depression . Seventy-seven participants were r and omized to either spaced or daily treatment . Spaced rTMS was given 3 days/week for 6 weeks ( 18 treatments in total ) and daily rTMS was given 5 days/week for 4 weeks ( 20 treatments in total ) . All participants were assessed at baseline and after 4 weeks of treatment . Participants in the spaced treatment group were also assessed after 6 weeks of treatment . All participants were treated at 110 % of the resting motor threshold with high-frequency rTMS ( 10 Hz ) to the left dorsolateral prefrontal cortex ( DLPFC ) followed by low-frequency rTMS to the right DLPFC . RESULTS Participants in the daily treatment group showed more improvement by week 4 than those in the spaced treatment group ; however , both groups had similar improvement by treatment completion . There was significant improvement in both groups in ratings of depression and anxiety , with no significant differences between groups . CONCLUSIONS Our study indicates that the efficacy of rTMS is related to the number of treatments given and that spacing the treatments neither improves nor reduces efficacy BACKGROUND Major depressive disorder ( MDD ) is a significant cause of worldwide disability and treatment resistance is common . High-frequency repetitive transcranial magnetic stimulation ( HF-rTMS ) has emerged as a treatment for MDD , and while efficacious , the daily commitment for typical 4 - 6 weeks of treatment poses a significant challenge . We aim ed to determine the effectiveness and acceptability of an accelerated rTMS protocol for MDD . METHODS In this naturalistic trial , 27 patients with moderate to severe chronic and treatment-resistant MDD were treated with twice-daily HF-rTMS ( 10 Hz ) applied over the left dorsolateral prefrontal cortex for 2 consecutive weeks ( 60,000 pulses ) . The primary outcomes were rates of clinical remission and response ( 16-item Quick Inventory of Depressive Symptomatology post-treatment score ≤ 6 , and ≥ 50 % reduction , respectively ) . Secondary outcomes were self-reported anxious symptoms , depressive symptoms and quality of life , and dropout rates as a proxy for acceptability . RESULTS Ten ( 37.0 % ) patients met criteria for clinical remission and 15 ( 55.6 % ) were classified as responders , with comparable outcomes for both moderate and severe MDD . Clinician-rated improvements in depressive symptoms were paralleled in self-reported depressive and anxious symptoms , as well as quality of life . No patient discontinued treatment . LIMITATIONS This study is limited by short treatment duration that might be lengthened with corresponding improvements in effectiveness , limited duration of follow-up , small sample size , and an open-label design requiring r and omized controlled replication . CONCLUSION An accelerated protocol involving twice-daily sessions of HF-rTMS over the left DLPFC for 2 weeks was effective in treatment-resistant MDD , and had excellent acceptability . Additional research is required to optimize accelerated rTMS treatment protocol s and determine efficacy using sham-controlled trials Ultrabrief pulse width stimulation electroconvulsive therapy ( ECT ) results in less cognitive side-effects than brief pulse ECT , but recent work suggests that more treatment sessions may be required to achieve similar efficacy . In this retrospective analysis of subjects pooled from three research studies , time to improvement was analysed in 150 depressed subjects who received right unilateral ECT with a brief pulse width ( at five times seizure threshold ) or ultrabrief pulse width ( at six times seizure threshold ) . Multivariate Cox regression analyses compared the number of treatments required for 50 % reduction in depression scores ( i.e. speed of response ) in these two sample s. The analyses controlled for clinical , demographic and treatment variables that differed between the sample s or that were found to be significant predictors of speed of response in univariate analyses . In the multivariate analysis , older age predicted faster speed of response . There was a non-significant trend for faster time to 50 % improvement with brief pulse ECT ( p = 0.067 ) . Remission rates were higher after brief pulse ECT than ultrabrief pulse ECT ( p = 0.007 ) but response rates were similar . This study , the largest of its kind reported to date , suggests that fewer treatments may be needed to attain response with brief than ultrabrief pulse ECT and that remission rates are higher with brief pulse ECT . Further research with a larger r and omized and blinded study is recommended The objective of this study was to explore the response rate to high-frequency left-sided repetitive transcranial magnetic stimulation ( rTMS ) in patients who had failed to respond to right-sided low-frequency stimulation , and to investigate whether there was differential efficacy between stimulation at 5 or 10 Hz . Data from two r and omized controlled trials were pooled . In both studies a group of patients were r and omized to receive either 5- or 10-Hz left prefrontal rTMS after failing to respond to right-sided stimulation . These patients received blinded 5- or 10-Hz stimulation ( but without a sham control ) for a period of up to 4 weeks and outcomes were compared . There was a small but significant overall response to left-sided rTMS but no difference in response between the 5- and 10-Hz treatment conditions . There appears to be a significant but modest likelihood of response to left-sided TMS in patients who fail right-sided stimulation , but there is no difference in efficacy between 5- and 10-Hz stimulation CONTEXT Electroconvulsive therapy ( ECT ) is highly effective for treatment of major depression , but naturalistic studies show a high rate of relapse after discontinuation of ECT . OBJECTIVE To determine the efficacy of continuation pharmacotherapy with nortriptyline hydrochloride or combination nortriptyline and lithium carbonate in preventing post-ECT relapse . DESIGN R and omized , double-blind , placebo-controlled trial conducted from 1993 to 1998 , stratified by medication resistance or presence of psychotic depression in the index episode . SETTING Two university-based hospitals and 1 private psychiatric hospital . PATIENTS Of 290 patients with unipolar major depression recruited through clinical referral who completed an open ECT treatment phase , 159 patients met remitter criteria ; 84 remitting patients were eligible and agreed to participate in the continuation study . INTERVENTIONS Patients were r and omly assigned to receive continuation treatment for 24 weeks with placebo ( n = 29 ) , nortriptyline ( target steady-state level , 75 - 125 ng/mL ) ( n = 27 ) , or combination nortriptyline and lithium ( target steady-state level , 0.5 - 0.9 mEq/L ) ( n = 28 ) . MAIN OUTCOME MEASURE Relapse of major depressive episode , compared among the 3 continuation groups . RESULTS Nortriptyline-lithium combination therapy had a marked advantage in time to relapse , superior to both placebo and nortriptyline alone . Over the 24-week trial , the relapse rate for placebo was 84 % ( 95 % confidence interval [ CI ] , 70%-99 % ) ; for nortriptyline , 60 % ( 95 % CI , 41%-79 % ) ; and for nortriptyline-lithium , 39 % ( 95 % CI , 19%-59 % ) . All but 1 instance of relapse with nortriptyline-lithium occurred within 5 weeks of ECT termination , while relapse continued throughout treatment with placebo or nortriptyline alone . Medication-resistant patients , female patients , and those with more severe depressive symptoms following ECT had more rapid relapse . CONCLUSIONS Our study indicates that without active treatment , virtually all remitted patients relapse within 6 months of stopping ECT . Monotherapy with nortriptyline has limited efficacy . The combination of nortriptyline and lithium is more effective , but the relapse rate is still high , particularly during the first month of continuation therapy BACKGROUND Major depressive disorder is a prevalent , disabling , and often chronic or recurrent psychiatric condition . About 35 % of patients fail to respond to conventional treatment approaches and are considered to have treatment-resistant depression ( TRD ) . OBJECTIVE We compared the safety and effectiveness of different stimulation levels of adjunctive vagus nerve stimulation ( VNS ) therapy for the treatment of TRD . METHODS In a multicenter , double blind study , 331 patients with TRD were r and omized to one of three dose groups : LOW ( 0.25 mA current , 130 μs pulse width ) , MEDIUM ( 0.5 - 1.0 mA , 250 μs ) , or HIGH ( 1.25 - 1.5 mA , 250 μs ) . A highly treatment-resistant population ( > 97 % had failed to respond to ≥6 previous treatments ) was enrolled . Response and adverse effects were assessed for 22 weeks ( end of acute phase ) , after which output current could be increased , if clinical ly warranted . Assessment s then continued until Week 50 ( end of long-term phase ) . RESULTS VNS therapy was well tolerated . During the acute phase , all groups showed statistically significant improvement on the primary efficacy endpoint ( change in Inventory of Depressive Symptomatology-Clinician Administered Version [ IDS-C ] ) , but not for any between-treatment group comparisons . In the long-term phase , mean change in IDS-C scores showed continued improvement . Post-hoc analyses demonstrated a statistically significant correlation between total charge delivered per day and decreasing depressive symptoms ; and analysis of acute phase responders demonstrated significantly greater durability of response at MEDIUM and HIGH doses than at the LOW dose . CONCLUSIONS TRD patients who received adjunctive VNS showed significant improvement at study endpoint compared with baseline , and the effect was durable over 1 year . Higher electrical dose parameters were associated with response durability Abstract Objectives . Deep brain stimulation ( DBS ) to the nucleus accumbens ( NAcc-DBS ) has antidepressant effects in patients suffering from treatment-resistant depression ( TRD ) . However , limited information exists regarding the impact of NAcc-DBS on cognitive functioning . The aim of this study was to examine whether NAcc-DBS in patients with TRD has any cognitive effects . Methods . A comprehensive neuropsychological battery was administered to 10 patients with TRD before onset of bilateral NAcc-DBS and after 1 year of DBS stimulation . Neuropsychological testing covered the domains of attention , learning and memory , executive functions , visual perception , and language . Performance was analyzed at baseline and after 1 year of continuous DBS . Results . No evidence was found for cognitive decline following NAcc-DBS comparing test results after 1 year of NAcc-DBS with baseline . However , significantly improved cognitive performance on tests of attention , learning and memory , executive functions and visual perception was found . In addition , there was a general trend towards cognitive enhancement from below average to average performance . These procognitive effects were independent of the antidepressant effects of NAcc-DBS or changes in NAcc-DBS parameters . Conclusions . These results not only support cognitive safety of NAcc-DBS but also stress its beneficial role in augmenting cognitive performance in patients with TRD Theta-burst transcranial magnetic stimulation could modulate cortical excitability and has the potential to treat refractory depression . However , there has been a lack of large r and omized studies of the antidepressant efficacy of different forms of theta-burst stimulation , such as intermittent and continuous theta-burst stimulation . A r and omized sham-controlled study was conducted to investigate antidepressant efficacy of theta-burst stimulation and to compare efficacy among left-prefrontal intermittent theta-burst stimulation , right-prefrontal continuous theta-burst stimulation and a combination of them in patients showing different levels of antidepressant refractoriness . A group of 60 treatment-refractory patients with recurrent major depressive disorder were recruited and r and omized to four groups ( Group A : continuous theta-burst stimulation ; Group B : intermittent theta-burst stimulation ; Group C : a combination of continuous and intermittent theta-burst stimulation ; and Group D : sham theta-burst stimulation ; 15 patients were included in each group ) . After 2 weeks of theta-burst stimulation treatment , depression improved in all groups . Groups B and C had better antidepressant responses ( as reflected by % decreases in depression score ) than Groups A and D ( P = 0.001 , post hoc analysis : B > A , B > D , C > A , and C > D ) , even after controlling for age and refractoriness scores . The mean antidepressant effect was highest in Group C and followed by that in Group B. Additionally , a significant placebo effect was found in patients with low refractoriness ; this disappeared in patients with moderate-to-high refractoriness . A significant correlation existed between refractoriness scores and treatment responses . Treatment refractoriness was a significant factor negatively predicting efficacy of theta-burst stimulation ( P = 0.039 ) . This r and omized sham-controlled study demonstrated that active theta-burst stimulation is a well-tolerated form of repetitive transcranial magnetic stimulation and has good antidepressant efficacy , particularly in depressed subjects within a certain range of treatment refractoriness Major depression is a common mental health problem and associated with significant morbidity and mortality , including impaired social and physical functioning and increased risk for suicide . Electroconvulsive therapy ( ECT ) is highly efficacious in treatment-resistant depressive disorders , but cognitive side effects are frequently associated with the treatment . Magnetic seizure therapy ( MST ) is a form of convulsive therapy , using magnetic fields in order to induce therapeutic seizures . First studies suggested that cognitive side effects of MST , including postictal recovery time , are more benign than those result ing from ECT treatment . In this open-label study we tested the hypothesis that MST is associated with clinical ly significant antidepressant effects in treatment-resistant depression ( TRD ) as an add-on therapy to a controlled pharmacotherapy . Twenty patients suffering from TRD were r and omly assigned to receive either MST or ECT starting from July 2006 until November 2008 . Primary outcome measure was antidepressant response assessed by Montgomery Åsberg Depression Scale . Secondary outcome measures included Hamilton Depression Rating Scale , Hamilton Anxiety Scale , Beck Depression Inventory and 90-Item Symptom Checklist . Antidepressant response ( improvement of 50 % in MADRS ratings ) was statistically significant and of similar size in both treatment groups . Cognitive side effects were observed in neither group . Characteristics in MST- and ECT-induced seizures were comparable , especially regarding ictal activity and postictal suppression . Thus , MST may be a potential alternative to ECT if efficacy and safety are vali date d in larger clinical trials BACKGROUND Repetitive transcranial magnetic stimulation ( rTMS ) of the dorsolateral-prefrontal cortex ( DLPFC ) with conventional figure-of-8 ( = butterfly ) coils has been used as an antidepressant therapeutic tool for almost twenty years . Very recently , an innovative rTMS coil , the so-called double cone coil ( DC ) , was introduced allowing the modulation of the anterior cingulate cortex ( AC ) . We investigated safety and therapeutic effectiveness of this stimulation in a naturalistic clinical setting . METHOD Forty-five patients suffering a moderate to severe depressive episode were r and omized to receive 15 sessions of either conventional rTMS of the left DLPFC ( " butterfly-rTMS " ; 10 Hz ; 2000 stimuli/day , RMT 110 % ) , mediofrontal double cone coil stimulation of the anterior cingulate cortex ( " ACDC-rTMS " with equal parameters ) , or sham-stimulation . The primary outcome was the change in the 21-items Hamilton Rating Scale for Depression ( HAMD ) from baseline to the end of treatment . Secondary outcome measures were changes over the course of the trial regarding the HAMD , the Beck Depression Inventory ( BDI ) , the Clinical Global Impression ( CGI ) and the Global Assessment of Functioning ( GAF ) scales . RESULTS There was a significant group × time interaction effect regarding the primary outcome ( F = 3.269 ; df = 2,37 ; P = 0.049 ) . Post-hoc t-testing revealed a significant effect for the comparison ACDC vs. butterfly at week 3/end of treatment ( T = 2.646 ; df = 26 ; P = 0.014 ) . No severe adverse events occurred during the study . ACDC-stimulation was well tolerated by the majority of patients similar like butterfly-rTMS and sham-stimulation . CONCLUSION This pilot study demonstrated the feasibility of ACDC-rTMS-stimulation as an add-on-treatment for depression . Its clinical effects warrant further investigation in the future Abstract Objectives . Repetitive transcranial magnetic stimulation ( rTMS ) of the left dorsolateral-prefrontal cortex ( DLPFC ) exerts antidepressant effects . In this r and omised controlled clinical trial we aim ed to test the safety and therapeutic efficacy of bilateral theta-burst stimulation ( TBS ) as an add-on therapy to st and ard treatment of major depression . Methods . Fifty-six patients diagnosed with a moderate to severe depressive episode received 15 daily treatments of either rTMS ( 110 % motor-threshold ; rightDLPFC , 1000 stimuli at 1 Hz + leftDLPFC , 1000 stimuli at 10 Hz ) , theta-burst stimulation ( 80 % motor-threshold ; rightDLPFC , continuous TBS , 1200 stimuli + leftDLPFC , intermittent TBS , 1200 stimuli ) , or sham TMS ( N = 17 , sham coil with the TBS protocol ) . Results . There was no significant effect in the primary outcome measures ( change of the 21-item Hamilton Rating Scale for Depression ) . However , there was a tendency towards an increased responder rate at the end of the follow-up period for both active treatments as compared to sham , and this tendency was most pronounced for the TBS group . Conclusions . This pilot study did not reveal significant advantages of bilateral TBS or rTMS over sham treatment as an add-on treatment for major depression . A tendency towards a superior effect of bilateral TBS at the end of the follow-up period may warrant further studies BACKGROUND Conventional rTMS protocol s for major depression commonly employ stimulation sessions lasting > 30 min . However , recent studies have sought to improve costs , capacities , and outcomes by employing briefer protocol s such as theta burst stimulation ( iTBS ) . OBJECTIVE To compare safety , effectiveness , and outcome predictors for DMPFC-rTMS with 10 Hz ( 30 min ) versus iTBS ( 6 min ) protocol s , in a large , naturalistic , retrospective case series . METHODS A chart review identified 185 patients with a medication-resistant major depressive episode who underwent 20 - 30 sessions of DMPFC-rTMS ( 10 Hz , n = 98 ; iTBS , n = 87 ) at a single Canadian clinic from 2011 to 2014 . RESULTS Clinical characteristics of 10 Hz and iTBS patients did not differ prior to treatment , aside from significantly higher age in iTBS patients . A total 7912 runs of DMPFC-rTMS ( 10 Hz , 4274 ; iTBS , 3638 ) were administered , without any seizures or other serious adverse events , and no significant differences in rates of premature discontinuation between groups . Dichotomous outcomes did not differ significantly between groups ( Response/remission rates : Beck Depression Inventory-II : 10 Hz , 40.6%/29.2 % ; iTBS , 43.0%/31.0 % . 17-item Hamilton Rating Scale for Depression : 10 Hz , 50.6%/38.5 % ; iTBS , 48.5%/27.9 % ) . On continuous outcomes , there was no significant difference between groups in pre-treatment or post-treatment scores , or percent improvement on either measure . Mixed-effects modeling revealed no significant group-by-time interaction on either measure . CONCLUSIONS Both 10 Hz and iTBS DMPFC-rTMS appear safe and tolerable at 120 % resting motor threshold . The effectiveness of 6 min iTBS and 30 min 10 Hz protocol s appears comparable . R and omized trials comparing 10 Hz to iTBS may be warranted BACKGROUND Vagus nerve stimulation ( VNS ) alters both concentrations of neurotransmitters or their metabolites and functional activity of central nervous system regions dysregulated in mood disorders . An open trial has suggested efficacy . METHODS This 10-week , acute , r and omized , controlled , masked trial compared adjunctive VNS with sham treatment in 235 out patients with nonpsychotic major depressive disorder ( n = 210 ) or nonpsychotic , depressed phase , bipolar disorder ( n = 25 ) . In the current episode , participants had not responded adequately to between two and six research -qualified medication trials . A two-week , single-blind recovery period ( no stimulation ) and then 10 weeks of masked active or sham VNS followed implantation . Medications were kept stable . Primary efficacy outcome among 222 evaluable participants was based on response rates ( > /=50 % reduction from baseline on the 24-item Hamilton Rating Scale for Depression [ HRSD(24 ) ] ) . RESULTS At 10-weeks , HRSD(24 ) response rates were 15.2 % for the active ( n = 112 ) and 10.0 % for the sham ( n = 110 ) groups ( p = .251 , last observation carried forward [ LOCF ] ) . Response rates with a secondary outcome , the Inventory of Depressive Symptomatology - Self-Report ( IDS-SR(30 ) ) , were 17.0 % ( active ) and 7.3 % ( sham ) ( p = .032 , LOCF ) . VNS was well tolerated ; 1 % ( 3/235 ) left the study because of adverse events . CONCLUSIONS This study did not yield definitive evidence of short-term efficacy for adjunctive VNS in treatment-resistant depression BACKGROUND Although electroconvulsive therapy ( ECT ) is the most effective acute antidepressant intervention , sustained response rates are low . It has never been systematic ally assessed whether psychotherapy , continuation ECT , or antidepressant medication is the most efficacious intervention to maintain initial treatment response . METHODS In a prospect i ve , r and omized clinical trial , 90 in patients with major depressive disorder ( MDD ) were treated with right unilateral ultra-brief acute ECT . Electroconvulsive therapy responders received 6 months guideline -based antidepressant medication ( MED ) and were r and omly assigned to add-on therapy with cognitive-behavioral group therapy ( CBT-arm ) , add-on therapy with ultra-brief pulse continuation electroconvulsive therapy ( ECT-arm ) , or no add-on therapy ( MED-arm ) . After the 6 months of continuation treatment , patients were followed-up for another 6 months . The primary outcome parameter was the proportion of patients who remained well after 12 months . RESULTS Of 90 MDD patients starting the acute phase , 70 % responded and 47 % remitted to acute ECT . After 6 months of continuation treatment , significant differences were observed in the three treatment arms with sustained response rates of 77 % in the CBT-arm , 40 % in the ECT-arm , and 44 % in the MED-arm . After 12 months , these differences remained stable with sustained response rates of 65 % in the CBT-arm , 28 % in the ECT-arm , and 33 % in the MED-arm . CONCLUSIONS These results suggest that ultra-brief pulse ECT as a continuation treatment correlates with low sustained response rates . However , the main finding implicates cognitive-behavioral group therapy in combination with antidepressants might be an effective continuation treatment to sustain response after successful ECT in MDD patients BACKGROUND Multiple open-label trials of deep brain stimulation ( DBS ) for treatment-resistant depression ( TRD ) , including those targeting the ventral capsule/ventral striatum target , have shown encouraging response rates . However , no r and omized controlled trials of DBS for TRD have been published . METHODS Thirty patients with TRD participated in a sham-controlled trial of DBS at the ventral capsule/ventral striatum target for TRD . Patients were r and omized to active versus sham DBS treatment in a blinded fashion for 16 weeks , followed by an open-label continuation phase . The primary outcome measure was response , defined as a 50 % or greater improvement on the Montgomery-Åsberg Depression Rating Scale from baseline . RESULTS There was no significant difference in response rates between the active ( 3 of 15 subjects ; 20 % ) and control ( 2 of 14 subjects ; 14.3 % ) treatment arms and no significant difference between change in Montgomery-Åsberg Depression Rating Scale scores as a continuous measure upon completion of the 16-week controlled phase of the trial . The response rates at 12 , 18 , and 24 months during the open-label continuation phase were 20 % , 26.7 % , and 23.3 % , respectively . CONCLUSION The results of this first r and omized controlled study of DBS for the treatment of TRD did not demonstrate a significant difference in response rates between the active and control groups at the end of the 16-week controlled phase . However , a range of 20 % to 26.7 % of patients did achieve response at any time during the open-label continuation phase . Future studies , perhaps utilizing alternative study design s and stimulation parameters , are needed BACKGROUND In 2001 , the Canadian Psychiatric Association and the Canadian Network for Mood and Anxiety Treatments ( CANMAT ) partnered to produce evidence -based clinical guidelines for the treatment of depressive disorders . A revision of these guidelines was undertaken by CANMAT in 2008 - 2009 to reflect advances in the field . There is renewed interest in refined approaches to brain stimulation , particularly for treatment resistant major depressive disorder ( MDD ) . METHODS The CANMAT guidelines are based on a question -answer format to enhance accessibility to clinicians . An evidence -based format was used with up date d systematic review s of the literature and recommendations were grade d according to Level of Evidence using pre-defined criteria . Lines of Treatment were identified based on criteria that included evidence and expert clinical support . This section on " Neurostimulation Therapies " is one of 5 guidelines articles . RESULTS Among the four forms of neurostimulation review ed in this section , electroconvulsive therapy ( ECT ) has the most extensive evidence , spanning seven decades . Repetitive transcranial magnetic ( rTMS ) and vagus nerve stimulation ( VNS ) have been approved to treat depressed adults in both Canada and the United States with a much smaller evidence base . There is also emerging evidence that deep brain stimulation ( DBS ) is effective for otherwise treatment resistant depression , but this is an investigational approach in 2009 . LIMITATIONS Compared to other modalities for the treatment of MDD , the data based is limited by the relatively small numbers of r and omized controlled trials ( RCTs ) and small sample sizes . CONCLUSIONS There is most evidence to support ECT as a first-line treatment under specific circumstances and rTMS as a second-line treatment . Evidence to support VNS is less robust and DBS remains an investigational treatment BACKGROUND Based on findings that major depressive disorder ( MDD ) is associated to decreased dorsolateral prefrontal cortical ( DLPFC ) activity ; interventions that increase DLPFC activity might theoretically present antidepressant effects . Two of them are cognitive control therapy ( CCT ) , a neurocognitive intervention that uses computer-based working memory exercises , and transcranial direct current stimulation ( tDCS ) , which delivers weak , electric direct currents over the scalp . METHODS We investigated whether tDCS enhanced the effects of CCT in a double-blind trial , in which participants were r and omized to sham tDCS and CCT ( n=17 ) vs. active tDCS and CCT ( n=20 ) . CCT and tDCS were applied for 10 consecutive workdays . Clinical trials.gov identifier : NCT01434836 . RESULTS Both CCT alone and combined with tDCS ameliorated depressive symptoms after the acute treatment period and at follow-up , with a response rate of approximately 25 % . Older patients and those who presented better performance in the task throughout the trial ( possibly indicating greater engagement and activation of the DLPFC ) had greater depression improvement in the combined treatment group . LIMITATIONS Our exploratory findings should be further confirmed in prospect i ve controlled trials . DISCUSSION CCT and tDCS combined might be beneficial for older depressed patients , particularly for those who have cognitive re sources to adequately learn and improve task performance over time . This combined therapy might be specifically relevant in this subgroup that is more prone to present cognitive decline and prefrontal cortical atrophy BACKGROUND To date , antidepressant drugs show limited efficacy , leaving a large number of patients experiencing severe and persistent symptoms of major depression . Previous open-label clinical trials have reported significant sustained improvements with deep brain stimulation ( DBS ) of the subcallosal cingulate gyrus ( SCG ) in patients with severe , chronic treatment-resistant depression ( TRD ) . This study aim ed to confirm the efficacy and measure the impact of discontinuation of the electrical stimulation . METHODS We conducted a 6-month double-blind , r and omized , sham-controlled crossover study in implanted patients with previous severe TRD who experienced full remission after chronic stimulation . After more than 3 months of stable remission , patients were r and omly assigned to 2 treatment arms : the ON-OFF arm , which involved active electrode stimulation for 3 months followed by sham stimulation for 3 months , and the OFF-ON arm , which involved sham stimulation for 3 months followed by active stimulation for 3 months . The primary outcome measure was the difference in the 17-item Hamilton Rating Scale for Depression ( HAMD-17 ) total score between sham and active stimulation . RESULTS We enrolled 5 patients in our trial . A Friedman repeated- measures analysis of variance revealed a significant effect of treatment ( χ(2)1 = 5.0 , p = 0.025 ) in patients with higher depression scores during sham stimulation . At the end of active stimulation , depression was remitted in 4 of 5 patients and none of them had experienced a relapse , whereas at the end of sham stimulation , 2 patients remained in remission , 2 relapsed and 1 showed a progressive worsening without reaching relapse criteria . LIMITATIONS The small sample size limited the statistical power and external validity . CONCLUSION These preliminary findings indicate that DBS of the SCG is an effective and safe treatment for severe forms of TRD and that continuous electrical stimulation is required to maintain therapeutic effects . TRIAL REGISTRATION NCT01268137 ( Clinical Trials.gov ) BACKGROUND While most patients with depression respond to combinations of pharmacotherapy , psychotherapy , and electroconvulsive therapy ( ECT ) , there are patients requiring other treatments . Deep brain stimulation ( DBS ) allows modulation of brain regions that are dysfunctional in depression . Since anhedonia is a feature of depression and there is evidence of dysfunction of the reward system , DBS to the nucleus accumbens ( NAcc ) might be promising . METHODS Ten patients suffering from very resistant forms of depression ( treatment-resistant depression [ TRD ] ) , not responding to pharmacotherapy , psychotherapy , or ECT , were implanted with bilateral DBS electrodes in the NAcc . The mean ( + /-SD ) length of the current episode was 10.8 ( + /-7.5 ) years ; the number of past treatment courses was 20.8 ( + /-8.4 ) ; and the mean Hamilton Depression Rating Scale ( HDRS ) was 32.5 ( + /-5.3 ) . RESULTS Twelve months following initiation of DBS treatment , five patients reached 50 % reduction of the HDRS ( responders , HDRS = 15.4 [ + /-2.8 ] ) . The number of hedonic activities increased significantly . Interestingly , ratings of anxiety ( Hamilton Anxiety Scale ) were reduced in the whole group but more pronounced in the responders . The [18F]-2-fluoro-2-deoxy-D-glucose positron emission tomography data revealed that NAcc-DBS decreased metabolism in the subgenual cingulate and in prefrontal regions including orbital prefrontal cortex . A volume of interest analysis comparing responders and nonresponders identified metabolic decreases in the amygdala . CONCLUSIONS We demonstrate antidepressant and antianhedonic effects of DBS to NAcc in patients suffering from TRD . In contrast to other DBS depression studies , there was also an antianxiety effect . These effects are correlated with localized metabolic changes IMPORTANCE Transcranial direct current stimulation ( tDCS ) trials for major depressive disorder ( MDD ) have shown positive but mixed results . OBJECTIVE To assess the combined safety and efficacy of tDCS vs a common pharmacological treatment ( sertraline hydrochloride , 50 mg/d ) . DESIGN Double-blind , controlled trial . Participants were r and omized using a 2 × 2 factorial design to sertraline/placebo and active/sham tDCS . SETTING Outpatient , single-center academic setting in São Paulo , Brazil . PARTICIPANTS One hundred twenty antidepressant-free patients with moderate to severe , nonpsychotic , unipolar MDD . INTERVENTIONS Six-week treatment of 2-mA anodal left/cathodal right prefrontal tDCS ( twelve 30-minute sessions : 10 consecutive sessions once daily from Monday to Friday plus 2 extra sessions every other week ) and sertraline hydrochloride ( 50 mg/d ) . MAIN OUTCOME MEASURES In this intention-to-treat analysis , the primary outcome measure was the change in Montgomery-Asberg depression rating scale score at 6 weeks ( end point ) . We considered a difference of at least 3 points to be clinical ly relevant . The analysis plan was previously published . Safety was measured with an adverse effects question naire , the young mania rating scale , and cognitive assessment . Secondary measures were rates of clinical response and remission and scores on other scales . RESULTS At the main end point , there was a significant difference in Montgomery-Asberg depression rating scale scores when comparing the combined treatment group ( sertraline/active tDCS ) vs sertraline only ( mean difference , 8.5 points ; 95 % CI , 2.96 to 14.03 ; P = .002 ) , tDCS only ( mean difference , 5.9 points ; 95 % CI , 0.36 to 11.43 ; P = .03 ) , and placebo/sham tDCS ( mean difference , 11.5 points ; 95 % CI , 6.03 to 17.10 ; P < .001 ) . Analysis of tDCS only vs sertraline only presented comparable efficacies ( mean difference , 2.6 points ; 95 % CI , -2.90 to 8.13 ; P = .35 ) . Use of tDCS only ( but not sertraline only ) was superior to placebo/sham tDCS . Common adverse effects did not differ between interventions , except for skin redness on the scalp in active tDCS ( P = .03 ) . There were 7 episodes of treatment-emergent mania or hypomania , 5 occurring in the combined treatment group . CONCLUSIONS AND RELEVANCE In MDD , the combination of tDCS and sertraline increases the efficacy of each treatment . The efficacy and safety of tDCS and sertraline did not differ . TRIAL REGISTRATION clinical trials.gov Identifier : NCT01033084 Whilst the antidepressant properties of repetitive transcranial magnetic stimulation treatment ( rTMS ) have been repeatedly demonstrated , minimal research has investigated the use of rTMS to prevent relapse in patients who have responded to treatment . To address this issue , a large open label trial of a new form of clustered maintenance rTMS was conducted . Thirty-five patients with treatment resistant depression were included . All patients had responded to two courses of rTMS treatment for depression . Following their second course of rTMS , they received clustered maintenance rTMS which involved monthly maintenance sessions of five rTMS treatments over a two day period . The time to relapse and clinical characteristics are described . Twenty-five patients experienced a relapse within the study period , with a mean treatment duration of 10.5 ± 10.3 months . This was substantially longer than their period of wellness following their initial acute treatment without maintenance ( <3 months ) . Ten additional patients continued maintenance until withdrawal from the study without having experienced relapse ( 4 at a mean of 6.2 ± 4.3 months ) or until study end ( 6 patients with mean duration of 12.0 ± 9.7 months ) . Although preliminary , this study suggests that clustered maintenance rTMS has the potential to substantially delay the occurrence of relapse following a successful course of rTMS treatment BACKGROUND The effectiveness of repetitive transcranial magnetic stimulation ( TMS ) is well established while studies of maintenance TMS are lacking . We aim here to determine whether maintenance is associated to a decrease in the relapse rate of depression , following successful acute treatment . METHODS We enrolled 59 consecutive patients with pharmacoresistant depression who have responded ( > 50 % decrease in symptom severity ) up to 6 weeks of acute TMS treatment . These patients received either 20 weeks of maintenance TMS ( n=37 ) or no additional TMS treatment ( n=22 ) . We performed propensity adjusted- analysis to examine the association between the relapse rate over this 20-week period and maintenance TMS . Propensity analysis eliminated differences in baseline characteristics between patient with and without maintenance TMS and approximated the conditions of r and om site-of-treatment assignment . RESULTS At 20 weeks , relapse rate was significantly different between the two groups ( p=0.004 , propensity analysis ): 14 patients in the maintenance TMS group ( 37.8 % ) vs. 18 in the non-maintenance TMS group ( 81.8 % ) , with an adjusted Hazard Ratio (HR)=0.288 ( 0.124 - 0.669 ) . CONCLUSIONS Maintenance TMS was associated with a significantly lower relapse rate in patients with pharmacoresistant depression in routine practice among responders BACKGROUND Although electroconvulsive therapy ( ECT ) has been shown to be extremely effective for the acute treatment of major depression , it has never been systematic ally assessed as a strategy for relapse prevention . OBJECTIVE To evaluate the comparative efficacy of continuation ECT ( C-ECT ) and the combination of lithium carbonate plus nortriptyline hydrochloride ( C-Pharm ) in the prevention of depressive relapse . DESIGN Multisite , r and omized , parallel design , 6-month trial performed from 1997 to 2004 . SETTING Five academic medical centers and their outpatient psychiatry clinics . PATIENTS Two hundred one patients with Structured Clinical Interview for DSM-IV-diagnosed unipolar depression who had remitted with a course of bilateral ECT . INTERVENTIONS R and om assignment to 2 treatment groups receiving either C-ECT ( 10 treatments ) or C-Pharm for 6 months . MAIN OUTCOME MEASURE Relapse of depression , compared between the C-ECT and C-Pharm groups . RESULTS In the C-ECT group , 37.1 % experienced disease relapse , 46.1 % continued to have disease remission at the study end , and 16.8 % dropped out of the study . In the C-Pharm group , 31.6 % experienced disease relapse , 46.3 % continued to have disease remission , and 22.1 % dropped out of the study . Both Kaplan-Meier and Cox proportional hazards regression analyses indicated no statistically significant differences in overall survival curves and time to relapse for the groups . Mean + /- SD time to relapse for the C-ECT group was 9.1 + /- 7.0 weeks compared with 6.7 + /- 4.6 weeks for the C-Pharm group ( P = .13 ) . Both groups had relapse proportions significantly lower than a historical placebo control from a similarly design ed study . CONCLUSIONS Both C-ECT and C-Pharm were shown to be superior to a historical placebo control , but both had limited efficacy , with more than half of patients either experiencing disease relapse or dropping out of the study . Even more effective strategies for relapse prevention in mood disorders are urgently needed BACKGROUND Although transcranial magnetic stimulation ( TMS ) can be an effective acute antidepressant treatment , few studies systematic ally examine persistence of benefit . OBJECTIVE We assessed the durability of antidepressant effect after acute response to TMS in patients with major depressive disorder ( MDD ) using protocol -specified maintenance antidepressant monotherapy . METHODS Three hundred one patients were r and omly assigned to active or sham TMS in a 6-week , controlled trial . Nonresponders could enroll in a second , 6-week , open-label study . Patients who met criteria for partial response ( i.e. , > 25 % decrease from the baseline HAMD 17 ) during either the sham-controlled or open-label study ( n = 142 ) were tapered off TMS over 3 weeks , while simultaneously starting maintenance antidepressant monotherapy . Patients were then followed for 24 weeks in a naturalistic follow-up study examining the long-term durability of TMS . During this durability study , TMS was readministered if patients met prespecified criteria for symptom worsening ( i.e. , a change of at least one point on the CGI-S scale for 2 consecutive weeks ) . Relapse was the primary outcome measure . RESULTS Ten of 99 ( 10 % ; Kaplan-Meier survival estimate = 12.9 % ) patients relapsed . Thirty-eight ( 38.4 % ) patients met criteria for symptom worsening and 32/38 ( 84.2 % ) reachieved symptomatic benefit with adjunctive TMS . Safety and tolerability were similar to acute TMS monotherapy . CONCLUSIONS These initial data suggest that the therapeutic effects of TMS are durable and that TMS may be successfully used as an intermittent rescue strategy to preclude impending relapse One of the major goals of antidepressant treatment is a sustained response and remission of depressive symptoms . Some of the previous studies of vagus nerve stimulation ( VNS ) have suggested antidepressant effects . Our naturalistic study assessed the efficacy and the safety of VNS in 74 European patients with therapy-resistant major depressive disorder . Psychometric measures were obtained after 3 , 12 , and 24 months of VNS . Mixed-model repeated- measures analysis of variance revealed a significant reduction ( P ≤ 0.05 ) at all the 3 time points in the 28-item Hamilton Rating Scale for Depression ( HRSD28 ) score , the primary outcome measure . After 2 years , 53.1 % ( 26/49 ) of the patients fulfilled the response criteria ( ≥50 % reduction in the HRSD28 scores from baseline ) and 38.9 % ( 19/49 ) fulfilled the remission criteria ( HRSD28 scores ≤ 10 ) . The proportion of patients who fulfilled the remission criteria remained constant as the duration of VNS treatment increased . Voice alteration , cough , and pain were the most frequently reported adverse effects . Two patients committed suicide during the study ; no other deaths were reported . No statistically significant differences were seen in the number of concomitant antidepressant medications . The results of this 2-year open-label trial suggest a clinical response and a comparatively benign adverse effect profile among patients with treatment-resistant depression BACKGROUND Daily left prefrontal repetitive transcranial magnetic stimulation ( rTMS ) over several weeks is an FDA approved treatment for major depression . Although rTMS is generally safe when administered using the FDA guidelines , there are a number of side effects that can make it difficult for patients to complete a course of rTMS . Many patients report that rTMS is painful , although patients appear to accommo date to the initial painfulness . The reduction in pain is hypothesized to be due to prefrontal stimulation and is not solely explained by accommodation to the stimulation . METHODS In a recent 4 site r and omized controlled trial ( using an active electrical sham stimulation system ) investigating the antidepressant effects of daily left dorsolateral prefrontal rTMS ( Optimization of TMS , or OPT-TMS ) , the procedural painfulness of TMS was assessed before and after each treatment session . Computerized visual analog scale ratings were gathered before and after each TMS session in the OPT-TMS trial . Stimulation was delivered with an iron core figure-8 coil ( Neuronetics ) with the following parameters : 10 Hz , 120 % MT ( EMG-defined ) , 4 s pulse train , 26 s inter-train interval , 3000 pulses per session , one 37.5 min session per day . After each session , procedural pain ( pain at the beginning of the TMS session , pain toward the middle , and pain toward then end of the session ) ratings were collected at all 4 sites . From the 199 patients r and omized , we had usable data from 142 subjects for the initial 15 TMS sessions ( double-blind phase ) delivered over 3 weeks ( 142 × 2 × 15 = 4260 rating sessions ) . RESULTS The painfulness of real TMS was initially higher than that of the active sham condition . Over the 15 treatment sessions , subjective reports of the painfulness of rTMS ( during the beginning , middle and end of the session ) decreased significantly 37 % from baseline in those receiving active TMS , with no change in painfulness in those receiving sham . This reduction , although greatest in the first few days , continued steadily over the 3 weeks . Overall , there was a decay rate of 1.56 VAS points per session in subjective painfulness of the procedure in those receiving active TMS . DISCUSSION The procedural pain of left , prefrontal rTMS decreases over time , independently of other emotional changes , and only in those receiving active TMS . These data suggest that actual TMS stimulation of prefrontal cortex maybe related to the reduction in pain , and that it is not a non-specific accommodation to pain . This painfulness reduction softly corresponds with later clinical outcome . Further work is needed to better underst and this phenomenon and whether acute within-session or over time painfulness changes might be used as short-term biomarkers of antidepressant response BACKGROUND Electroconvulsive therapy ( ECT ) is an effective treatment for major depression . Optimising efficacy and minimising cognitive impairment are goals of ongoing technical refinements . AIMS To compare the efficacy and cognitive effects of a novel electrode placement , bifrontal , with two st and ard electrode placements , bitemporal and right unilateral in ECT . METHOD This multicentre r and omised , double-blind , controlled trial ( NCT00069407 ) was carried out from 2001 to 2006 . A total of 230 individuals with major depression , bipolar and unipolar , were r and omly assigned to one of three electrode placements during a course of ECT : bifrontal at one and a half times seizure threshold , bitemporal at one and a half times seizure threshold and right unilateral at six times seizure threshold . RESULTS All three electrode placements result ed in both clinical ly and statistically significant antidepressant outcomes . Remission rates were 55 % ( 95 % CI 43 - 66 % ) with right unilateral , 61 % with bifrontal ( 95 % CI 50 - 71 % ) and 64 % ( 95 % CI 53 - 75 % ) with bitemporal . Bitemporal result ed in a more rapid decline in symptom ratings over the early course of treatment . Cognitive data revealed few differences between the electrode placements on a variety of neuropsychological instruments . CONCLUSIONS Each electrode placement is a very effective antidepressant treatment when given with appropriate electrical dosing . Bitemporal leads to more rapid symptom reduction and should be considered the preferred placement for urgent clinical situations . The cognitive profile of bifrontal is not substantially different from that of bitemporal |
11,517 | 30,458,761 | There was low-level evidence that reduced wait time is associated with moderate improvement in workplace participation for patients seeking care for musculoskeletal conditions ; and moderate improvement in exercise tolerance for patients referred to cardiac rehabilitation .
There was inconsistent evidence that improvements in quality of life , patient satisfaction and psychological symptoms may be associated with shorter wait times .
Pain , function and physical activity outcomes were not associated with wait time .
Conclusions This review found low-level evidence suggesting an association between early access to community outpatient services and improvement of some patient outcomes .
Specifically , shorter wait times from referral to first visit for musculoskeletal pain services may improve patient work participation .
Shorter wait times for cardiac rehabilitation may improve patient exercise capacity .
The effects of a short wait time for other patient conditions and patient outcomes , including quality of life , psychological symptoms and patient experience , are inconclusive . | Background Many people wait long periods for community outpatient services .
However little is known about the impact of waiting from referral to first visit on patient outcomes .
The aim of this systematic review is to investigate whether waiting for community outpatient services is associated with adverse effects on patient outcomes . | Background : Dysphagia is common after stroke . The onset time of swallowing rehabilitation following stroke has an important role in the recovery of dysphagia and preventing of its complications , but it was either highly variable or was not stated in previous trials . The aim of this study was investigation effects of onset time of swallowing therapy on recovery from dysphagia following stroke . Methods : Sixty dysphagia patients due to stroke range of age 60 - 74 ( 67.1 ± 3.8 ) , participated in this r and omized clinical trial study . The patients allocated in Early , Medium and Late groups , on the base of initiation of swallowing therapy after the stroke . After basic clinical and video fluoroscopic swallowing study assessment s , traditional swallowing therapy was initiated 3 times per week for 3 months . The outcome measures were North-Western dysphagia patient check sheet , functional oral intake scale , video fluoroscopy , and frequency of pneumonia . Statistical analysis was done by repeated measure ANOVA , Bonferroni and χ2 tests . Results : Three groups of patients in terms of demographic and clinical characteristics were similar in the pre-treatment P > 0.050 . Onset time of swallowing therapy after stroke was effective on swallowing recovery on the main outcome variables . So that in first group patients , recovery was rather than other groups P < 0.050 . Furthermore , the frequency of pneumonia in the early group was less than other groups and in the early group no patients experienced pneumonia P = 0.002 . Conclusion : Our data suggested that early interventions for dysphagia in stroke have an important role in recovery from dysphagia and prevention of complications like aspiration pneumonia Background — Outpatient cardiac rehabilitation ( CR ) decreases mortality rates but is underutilized . Current median time from hospital discharge to enrollment is 35 days . We hypothesized that an appointment within 10 days would improve attendance at CR orientation . Methods and Results — At hospital discharge , 148 patients with a nonsurgical qualifying diagnosis for CR were r and omized to receive a CR orientation appointment either within 10 days ( early ) or at 35 days ( st and ard ) . The primary end point was attendance at CR orientation . Secondary outcome measures were attendance at ≥1 exercise session , the total number of exercise sessions attended , completion of CR , and change in exercise training workload while in CR . Average age was 60±12 years ; 56 % of participants were male and 49 % were black , with balanced baseline characteristics between groups . Median time ( 95 % confidence interval ) to orientation was 8.5 ( 7–13 ) versus 42 ( 35 to NA [ not applicable ] ) days for the early and st and ard appointment groups , respectively ( P<0.001 ) . Attendance rates at the orientation session were 77 % ( 57/74 ) versus 59 % ( 44/74 ) in the early and st and ard appointment groups , respectively , which demonstrates a significant 18 % absolute and 56 % relative improvement ( relative risk , 1.56 ; 95 % confidence interval , 1.03–2.37 ; P=0.022 ) . The number needed to treat was 5.7 . There was no difference ( P>0.05 ) in any of the secondary outcome measures , but statistical power for these end points was low . Safety analysis demonstrated no difference between groups in CR-related adverse events . Conclusions — Early appointments for CR significantly improve attendance at orientation . This simple technique could potentially increase initial CR participation nationwide . Clinical Trial Registration — URL : http://www . clinical trials.gov . Unique identifier : NCT01596036 BACKGROUND Triage liaison physicians ( TLPs ) have been employed in overcrowded emergency departments ( EDs ) ; however , their effectiveness remains unclear . OBJECTIVES To evaluate the implementation of TLP shifts at an academic tertiary care adult ED using comprehensive outcome reporting . METHODS A six-week TLP clinical research project was conducted between December 9 , 2005 , and February 9 , 2006 . A TLP was deployed for nine hours ( 11 AM to 8 PM ) daily to initiate patient management , assist triage nurses , answer all medical consult or transfer calls , and manage ED administrative matters . The study was divided into three two-week blocks ; within each block , seven days were r and omized to TLP shifts and the other seven to control shifts . Outcomes included patient length of stay , proportion of patients who left without complete assessment , staff satisfaction , and episodes of ambulance diversion . RESULTS TLPs assessed a median of 14 patients per shift ( interquartile range , 13 - 17 ) , received 15 telephone calls per shift ( interquartile range , 14 - 20 ) , and spent 17 - 81 minutes per shift consulting on the telephone . The number of patients and their age , gender , and triage score during the TLP and control shifts were similar . Overall , length of stay was decreased by 36 minutes compared with control days ( 4:21 vs. 4:57 ; p = 0.001 ) . Left without complete assessment cases decreased from 6.6 % to 5.4 % ( a 20 % relative decrease ) during the TLP coverage . The ambulance wait time and number of episodes of ambulance diversion were similar on TLP and control days . CONCLUSIONS A TLP improved important outcomes in an overcrowded ED and could improve delivery of emergency medical care in similar tertiary care EDs Study Design . A single blind r and omized controlled trial comparing two models of care for patients with acute simple low back pain . Objectives . To compare two research -based models of care for acute low back pain and investigate the effect of the timing of physical intervention . Summary of Background Data . National guidelines offer conflicting information on the delivery of physical treatment in the management of acute low back pain . The guidelines suggest two different models of care . Direct comparisons between these models are lacking in the literature . The present study aims to compare these approaches to the management of acute low back pain . Methods . Among 804 referred patients , 102 subjects met the specific admission criteria and were r and omly assigned to an “ assess/advise/treat ” group or an “ assess/advise/wait ” group . The intervention consisted of biopsychosocial education , manual therapy , and exercise . Assessment of short-term outcome enables comparison to be made between intervention and advice to stay active . Assessment of long-term outcome enables comparison to be made between early and late intervention . Study outcomes of reported pain ( Visual Analogue Scale ) , functional disability ( the Rol and and Morris Disability Question naire ) , mood ( Modified Zung Self Rated Depression Score , Modified Somatic Perception Question naire , State-Trait Anxiety Inventory ) , general health ( Euroqol ) , and quality of life ( Short Form 36 ) were assessed at baseline , 6 weeks , 3 months , and 6 months . Results . At 6 weeks , the assess/advise/treat group demonstrated greater improvements in disability , mood , general health , and quality of life than patients in the assess/advise/wait group ( P < 0.05 ) . Disability and pain were not significantly different between the groups at long-term follow up ( P > 0.05 ) . However , mood , general health , and quality of life remained significantly better in the assess/advise/treat group ( P < 0.05 ) . Conclusions . At short-term , intervention is more effective than advice on staying active , leading to more rapid improvement in function , mood , quality of life , and general health . The timing of intervention affects the development of psychosocial features . If treatment is provided later , the same psychosocial benefits are not achieved . Therefore , an assess/advise/treat model of care seems to offer better outcomes than an assess/advise/wait model of care Objectives : To assess whether initial patient consult by senior clinicians reduces numbers of patients waiting to be seen as an indirect measure of waiting time throughout the emergency department ( ED ) . Methods : An emergency medicine consultant and a senior ED nurse ( G or F grade ) , known as the IMPACT team , staffed the triage area for four periods of four hours per week , Monday to Friday between 9 am to 5 pm for three months between December 2001 and February 2002 when staffing levels permitted . Patients normally triaged by a nurse in this area instead had an early consultation with the IMPACT team . Data were collected prospect ively on all patients seen by the IMPACT team . The number of patients waiting to be seen ( for triage , in majors and in minors ) was assessed every two hours during the IMPACT sessions and at corresponding times when no IMPACT team was operational . Results : There was an overall reduction in the number of patients waiting to be seen in the department from 18.3 to 5.5 ( p<0.0001 ) at formal two hourly assessment s. The largest difference was seen in minors . Of the patients seen at triage by the IMPACT team , 48.9 % were discharged home immediately after assessment and treatment . With the IMPACT team present , no patient waited more than four hours for initial clinical consult . Conclusions : By using a senior clinical team for initial patient consultation , the numbers of patients waiting fell dramatically throughout the ED . Many patients can be effectively treated and discharged after initial consult by the IMPACT team Objective To evaluate the effectiveness of a structured group education programme on biomedical , psychosocial , and lifestyle measures in people with newly diagnosed type 2 diabetes . Design Multicentre cluster r and omised controlled trial in primary care with r and omisation at practice level . Setting 207 general practice s in 13 primary care sites in the United Kingdom . Participants 824 adults ( 55 % men , mean age 59.5 years ) . Intervention A structured group education programme for six hours delivered in the community by two trained healthcare professional educators compared with usual care . Main outcome measures Haemoglobin A1c levels , blood pressure , weight , blood lipid levels , smoking status , physical activity , quality of life , beliefs about illness , depression , and emotional impact of diabetes at baseline and up to 12 months . Main results Haemoglobin A1c levels at 12 months had decreased by 1.49 % in the intervention group compared with 1.21 % in the control group . After adjusting for baseline and cluster , the difference was not significant : 0.05 % ( 95 % confidence interval −0.10 % to 0.20 % ) . The intervention group showed a greater weight loss : −2.98 kg ( 95 % confidence interval −3.54 to −2.41 ) compared with 1.86 kg ( −2.44 to −1.28 ) , P=0.027 at 12 months . The odds of not smoking were 3.56 ( 95 % confidence interval 1.11 to 11.45 ) , P=0.033 higher in the intervention group at 12 months . The intervention group showed significantly greater changes in illness belief scores ( P=0.001 ) ; directions of change were positive indicating greater underst and ing of diabetes . The intervention group had a lower depression score at 12 months : mean difference was −0.50 ( 95 % confidence interval −0.96 to −0.04 ) ; P=0.032 . A positive association was found between change in perceived personal responsibility and weight loss at 12 months ( β=0.12 ; P=0.008 ) . Conclusion A structured group education programme for patients with newly diagnosed type 2 diabetes result ed in greater improvements in weight loss and smoking cessation and positive improvements in beliefs about illness but no difference in haemoglobin A1c levels up to 12 months after diagnosis . Trial registration Current Controlled Trials IS RCT N17844016 Background : Although effective treatment of depressed patients requires regular follow-up contacts and symptom monitoring , an efficient method for assessing treatment outcome is lacking . We investigated responsiveness to treatment , reproducibility , and minimal clinical ly important difference of the Patient Health Question naire-9 ( PHQ-9 ) , a st and ard instrument for diagnosing depression in primary care . Methods : This study included 434 intervention subjects from the IMPACT study , a multisite treatment trial of late-life depression ( 63 % female , mean age 71 years ) . Changes in PHQ-9 scores over the course of time were evaluated with respect to change scores of the SCL-20 depression scale as well as 2 independent structured diagnostic interviews for depression during a 6-month period . Test-retest reliability and minimal clinical ly important difference were assessed in 2 subgroups of patients who completed the PHQ-9 twice exactly 7 days apart . Results : The PHQ-9 responsiveness as measured by effect size was significantly greater than the SCL-20 at 3 months ( −1.3 versus −0.9 ) and equivalent at 6 months ( −1.3 versus −1.2 ) . With respect to structured diagnostic interviews , both the PHQ-9 and the SCL-20 change scores accurately discriminated patients with persistent major depression , partial remission , and full remission . Test-retest reliability of the PHQ-9 was excellent , and its minimal clinical ly important difference for individual change , estimated as 2 st and ard errors of measurement , was 5 points on the 0 to 27 point PHQ-9 scale . Conclusions : Well-vali date d as a diagnostic measure , the PHQ-9 has now proven to be a responsive and reliable measure of depression treatment outcomes . Its responsiveness to treatment coupled with its brevity makes the PHQ-9 an attractive tool for gauging response to treatment in individual patient care as well as in clinical research Study Design An inception cohort design was used in which 421 patients were evaluated systematic ally with a st and ard battery of psychosocial assessment tests ( Structured Interview for DSM-III-R Diagnosis , Minnesota Multiphasic Personality Inventory , and Million Visual Pain Analog Scale ) within 6 weeks of acute back pain onset . Objectives The present study evaluated the predictive power of a comprehensive assessment of psychosocial and personality factors in identifying acute low back pain patients who subsequently develop chronic pain disability problems ( as measured by job-work status at 1-year follow-up evaluation ) . Summary of Background Data There has been a relative paucity of prospect i ve research in the United States comprehensively evaluating potential psychoscial risk factors that are associated with those injured workers who subsequently fail to return to work and productivity after 1 year because of low back pain disability . Such research has been quite limited because of the time and cost involved in conducting prospect i ve studies . Methods All study patients were symptomatic with lumbar pain syndrome for no more than 6 weeks , These acute patients were tracked every 3 months , culminating in a structured telephone interview being conducted 1 year after the initial evaluation to document return-to-work status . Results Logistic regression analyses , conducted to differentiate between patients who were back at work after 1 year versus patients who were not because of the original back injury , revealed the importance of three psychosocial measures : self-reported pain and disability , scores on Scale 3 of the Minnesota Multiphasic Personality Inventory , and workers ' compensation and personal injury insurance status . The model generated correctly classified 90.7 % of the cases . Results revealed that major psychopathology , such as depression and substance abuse , did not precede or cause the development of chronic pain disability . Conclusions These results show the presence of a robust “ psychosocial disability factor ” that is associated with those injured workers who are likely to develop chronic low back pain disability problems . Based on these data , a statistical algorithm has been generated that can identify those acute patients who will require early intervention to prevent the development of chronic disability . The second major result is that preinjury or concomitant psychopathology does not appear to predispose patients to chronic pain disability , although high rates of psychopathology have been shown in chronic low back pain . Future research should be directed at emotional vulnerability and psychosocial events in the period after the injury that may lead to chronicity INTRODUCTION A number of countries have healthcare systems where access to elective surgery is constrained . The inevitable outcome is wait lists for surgery . The objective of this study is to report cross-sectional health data collected from a broad sample of patients awaiting elective surgery and shed light on potential non-surgical treatments to improve health . RESEARCH DESIGN Prospect i ve cross-sectional survey of patients newly enrolled on the surgical wait list in the Vancouver Coastal Health region . Multivariate regression models were used to estimate the associations between patient characteristics and health , pain and depression . MEASURES Health status instruments were used to measure study participants ' general health , pain , and depression immediately after they were enrolled on the wait list for one of the targeted elective surgeries . RESULTS A majority of patients reported some problems with pain or discomfort , and a large portion reported problems associated with anxiety or depression . Orthopedic patients were significantly more likely to report problems with mobility , usual activities and pain/discomfort . Neurosurgery patients were the most likely to report significant and severe depression . CONCLUSIONS The high rates of pain and depression not only have implication s for patients ' immediate health , but may also affect long-term surgical outcomes . This study draws attention to recognizing a wider array of morbidity , some potentially requiring non-surgical interventions , while patients wait for elective surgery . Policy options include re-examining the surgical triage system and exp and ing surgical capacity to match self-reported health Background Exercise training is an important part of cardiac rehabilitation to reduce morbidity and mortality . Low-intensity exercise training can start as soon as the myocardial infa rct ion ( MI ) patient is stable . Our objective was to evaluate the effect of an early start of exercise training in MI patients . Design A r and omized controlled trial . Methods Thirty-nine MI patients were r and omized to either an early start of exercise training group ( EG ) or to a delayed start control group ( CG ) . The EG participated in an outpatient low-intensity EG ( phase 2a ) two times a week for 4 weeks before entering ordinary exercise training of moderate-to-high intensity ( phase 2b ) . CG entered phase 2b directly after 4 weeks of delay . Primary outcome measure was peak oxygen consumption ( VO2peak ) , measured at baseline , after 4 weeks and after 16 weeks . Secondary outcome measure was health-related quality of life . Results VO2peak did not change from baseline to 4 weeks , either in EG [ 30.6 ± 6.7 ml/kg/min vs. 30.7 ± 6.2 ml/kg/min , not significant ( NS ) ] or CG ( 29.8 ± 6.1 ml/kg/min vs. 30.7 ± 6.2 ml/kg/min , NS ) . After 16 weeks VO2peak increased in both groups to 33.1 ± 7.1 ml/kg/min in EG ( P [ 0.005 ) and 33.0 ml/kg/min ± 8.6 in CG ( P [ 0.005 ) , group differences NSH . Health-related quality of life increased in every domain but physical functioning for both groups ( group differences NS ) . Conclusion An early start of exercise training did not increase VO2peak compared to 4 weeks of delay . For low-risk patients with high motivation for exercise training , home-based walking is an option as a moderate start of cardiac rehabilitation the first weeks after MI BACKGROUND Early therapy intervention for children with disabilities may improve functional outcomes . Access to paediatric rehabilitation services can sometimes be difficult . OBJECTIVES To describe waiting time to receive physical therapy ( PT ) and occupational therapy ( OT ) services at rehabilitation centres for young children with physical disabilities ; to examine factors associated with these waiting times . DESIGN Prospect i ve cohort . SUBJECTS Two hundred and six children with physical disabilities , aged 6 to 72 months , referred in 2002 - 2004 from the Montreal Children 's Hospital and Sainte-Justine Hospital to paediatric rehabilitation centres . MEASURES Data on date of referral , age , gender and diagnosis were obtained from the hospital data bases . Data on date of first PT or OT appointments at the rehabilitation centre , family socio-demographics and disability severity ( WeeFIM ) were obtained during parental interviews . RESULTS Half of the sample waited more than 7 and 11 months for PT and OT services , respectively . Shorter waiting time was significantly associated with younger child 's age and referral to one particular rehabilitation centre . CONCLUSION Children with physical disabilities experience long waiting times for PT and OT rehabilitation services . Strategies to improve timely service delivery are needed Objectives To evaluate the effects of early access ( EA ) to physical therapy treatment for patients with subacute low back pain compared to access with a 4-week waiting list . Design A prospect i ve , r and omized clinical trial . Setting Primary health care . Patients Sixty consecutive patients with subacute low back pain . Interventions Patients were r and omized either to EA within 2 days for physical examination and individualized physical therapy treatment ( n=32 ) or a control group with a 4-week waiting list ( n=28 ) . Outcome Measures Self-administrated question naires were used for assessment at inclusion , at discharge , and at 6 months . Primary outcome measure was pain intensity assessed by Borg category scale for ratings of perceived pain . Secondary outcomes included the Örebro musculoskeletal pain screening question naire , the Rol and and Morris disability question naire , sick-leave , visits to health care , and physical therapy . Results The results showed no significant differences in pain between the groups at discharge . At 6 months , the reduction of pain was significantly greater in the EA group compared to the control group ( P=0.025 ) . Changes in secondary outcome measures were not significantly different between groups . Conclusions This study indicated that EA to physical therapy result ed in greater improvement in perceived pain at 6 months compared to later access . In this study , EA to physical therapy could be introduced by reorganization without additional re sources This study was design ed to evaluate the effects of early physical therapy intervention on treatment outcomes for workers with acute low back injuries . A total of 3867 cases were r and omly selected from the data base of a large occupational health care provider . Cases were assigned to either the early therapy intervention group or one of the two comparison groups on the basis of their delay to physical therapy . The treatment outcomes for the three groups were compared . The results showed that patients in the early therapy intervention had more favorable outcomes than the two comparison groups . Specifically , patients in the early intervention group had fewer physician visits , fewer restricted workdays , fewer days away from work , and shorter case duration . These results provide a strong indication for the effectiveness of early therapy intervention . The financial implication s of the findings is discussed & NA ; Current conceptions of chronic pain clearly suggest that proper care at the acute stage should prevent the development of chronic problems . Patients ( 198 ) seeking help for acute musculoskeletal pain ( MSP ) , e.g. , back and neck pain participated in two studies of the effects of an Early Active intervention which underscored ‘ well ’ behavior and function compared to a Treatment as Usual control group . The quantity of the Early Active treatment was a median of 1 doctor 's appointment and 3 meetings with a physical therapist . Study I concerned patients with a prior history of sick‐listing for MSP , while study II involved patients with no prior history of MSP . Treatment satisfaction , pain experience , activities and sickness absenteeism were assessed before , after and at a 12‐month follow‐up . In study I ( patients with a history of MSP ) , the results showed significant improvements for both groups , but virtually no differences between the groups . Similarly , in study II ( no history of MSP ) both groups demonstrated significant improvements e.g. , for pain intensity and activity levels . However , the Early Active treatment result ed in significantly less sick‐listing relative to the control group . Moreover , the risk of developing chronic ( > 200 sick days ) pain was 8 times lower for the Early Activation group . This investigation shows that relatively simple changes in treatment result in reduced sickness absenteeism for ‘ first‐time ’ sufferers only . Consequently , the content and timing of treatment for pain appear to be crucial . Properly administered early intervention may therefore decrease sick leave and prevent chronic problems , thus saving considerable re sources OBJECTIVE To investigate whether a simple alternative ( specific timely appointments for triage [ STAT ] ) to the more common approach of managing dem and using a waitlist with a triage system could reduce waiting time for a community rehabilitation program ( CRP ) without adverse impacts on patient care . DESIGN A prospect i ve , controlled before- and -after trial . Preintervention and postintervention data were collected for 6 months in 2 consecutive years . STAT was introduced at an intervention site and compared with a control site using a triaged waitlist . SETTING Two musculoskeletal CRP teams within a large metropolitan health service . PARTICIPANTS All patients referred to both sites during periods preintervention ( n=483 ) and postintervention ( n=488 ) . INTERVENTION Under STAT , clinicians created a specified number of assessment times each week based on average referral numbers , and patients were immediately allocated an appointment on referral . MAIN OUTCOME MEASURES The primary outcome was the time from referral to first appointment ; secondary outcomes included program duration , quality -of-life scores ( using the EuroQol EQ-5D ) , and unplanned hospital admissions . RESULTS Waiting time decreased from a mean of 17.5 days to 10.0 days ( P<.01 ) at the intervention site , with no significant change at the control site . Intervention site patients were over 3 times more likely to be seen within 7 days than control site patients ( odds ratio , 3.3 ; 95 % confidence interval , 2.2 - 4.9 ) . Secondary outcomes did not differ significantly between groups . CONCLUSIONS A simple alternative to using a triaged waitlist to manage CRP referrals reduced waiting time without adversely affecting care . Results were sustained over 6 months with no additional re sources |
11,518 | 30,511,324 | Adults using metformin experienced and maintained small decreases in weight irrespective of duration of intervention .
Conclusions The effects of metformin on weight/ BMI vary , with smaller reductions in children than in adults .
This could be because of differences in adherence , daily dosage , and insulin status .
Metformin significantly reduced the progression toward T2DM in adults . | Background Obesity and its related complications are increasing health issues .
Since generally only minor weight loss is obtained with lifestyle intervention , additional pharmacological therapies such as metformin are often used .
Objective We conducted a systematic review to provide an overview of the efficacy of ≥ 6 months of metformin treatment in children and adults with respect to weight , insulin resistance , and progression toward type 2 diabetes mellitus ( T2DM ) . | Objectives . The prevalence of type 2 diabetes in American adolescents has increased markedly during the past generation . Although the factors that contribute to the development of type 2 diabetes are complex and not wholly eluci date d , the triad of severe obesity , hyperinsulinemia , and a family history of type 2 diabetes places a child at an increased risk for development of the disease . Current approaches to the prevention of type 2 diabetes , including dietary counseling and exercise , have had limited success . We reasoned that drugs that increase glucose tolerance in diabetic patients might prove useful in preventing the progression to glucose intolerance in high-risk patients . To that end , we conducted a double-blind , placebo-controlled study of the effects of metformin on body mass index ( BMI ) , serum leptin , glucose tolerance , and serum lipids in obese adolescents with fasting hyperinsulinemia and a family history of type 2 diabetes . Methods . The study population consisted of 29 white and black adolescents aged 12 to 19 years . All had BMI s exceeding 30 kg/m2 . Criteria for enrollment included : 1 ) a fasting insulin concentration exceeding 15 μU/mL ; and 2 ) at least 1 first- or second-degree relative with type 2 diabetes . All patients had fasting plasma glucose concentrations < 110 mg% and hemoglobin A1c concentrations ≤6.0 % . All had normal linear growth and sexual development for age , with no marked hirsutism , severe acne , or menstrual irregularities characteristic of polycystic ovary syndrome . Eight participants had acanthosis nigricans . After baseline laboratory studies including a rapidly sample d intravenous glucose tolerance test , patients were r and omized to receive metformin ( 500 mg twice daily ) or a placebo for a total of 6 months . The effects of metformin on BMI st and ard deviation score , serum leptin , glucose tolerance , and serum lipids were analyzed . The study was double-blinded and included no specific dietary restrictions . Results . Metformin caused a decline of 0.12 st and ard deviation in BMI in study participants ( −1.3 % from baseline ) , and a 5.5 % reduction in serum leptin in girls . In contrast , BMI and serum leptin rose 0.23 st and ard deviation ( 2.3 % ) and 16.2 % , respectively , in the placebo group during the treatment period . Metformin caused a progressive decline in fasting blood glucose ( from a mean of 84.9 to 75.1 mg% ) and a reduction in fasting insulin levels ( from 31.3 to 19.3 μU/mL ) . In contrast , fasting glucose levels in the placebo group rose slightly from 77.2 to 82.3 mg% , and fasting insulin levels did not change . Insulin sensitivity , as assessed by the ratio of fasting insulin to glucose concentrations and the quantitative insulin sensitivity check index ( 1/[log fasting insulin + log fasting glucose ] ) and homeostasis model assessment insulin resistance index ( fasting insulin × fasting glucose/22.5 ) indices , increased slightly in the metformin-treated participants . However , the insulin sensitivity measured using Bergman 's minimal model did not change . There were also no significant changes in glucose effectiveness , hemoglobin A1c , serum lipids , or serum lactate in the metformin or placebo groups . Metformin was tolerated well by the majority of patients . Transient abdominal discomfort or diarrhea occurred in 40 % of treated participants ; there were no episodes of vomiting or lactic acidosis . Conclusions . The treatment of obesity and insulin resistance in adults often proves ineffective because the vicious cycle leading to type 2 diabetes may have become entrenched and , to some extent , may be irreversible . Early detection and therapy of the obese adolescent with a family history of type 2 diabetes may interrupt the cycle of weight gain and insulin resistance that leads to glucose intolerance in adulthood . Through its ability to reduce fasting blood glucose and insulin concentrations and to moderate weight gain , metformin might complement the effects of dietary and exercise counseling and reduce the risk of type 2 diabetes in selected patients The present study is an evaluation of metformin ’s effect on BMI z score , insulin sensitivity , and inflammation and cardiovascular risk factors in prepubertal and pubertal children who are obese . OBJECTIVES : Metformin has shown its effectiveness in treating obesity in adults . However , little research has been conducted in children , with a lack of attention on pubertal status . The objectives were to determine whether oral metformin treatment reduces BMI z score , cardiovascular risk , and inflammation biomarkers in children who are obese depending on pubertal stage and sex . METHODS : This was a r and omized , prospect i ve , double-blind , placebo-controlled , multicenter trial , stratified according to pubertal stage and sex , conducted at 4 Spanish clinical hospitals . Eighty prepubertal and 80 pubertal nondiabetic children who were obese aged 7 to 14 years with a BMI > 95th percentiles were recruited . The intervention included 1 g/d of metformin versus placebo for 6 months . The primary outcome was a reduction in BMI z score . Secondary outcomes comprised insulin resistance , cardiovascular risk , and inflammation biomarkers . RESULTS : A total of 140 children completed the study ( 72 boys ) . Metformin decreased the BMI z score versus placebo in the prepubertal group ( −0.8 and −0.6 , respectively ; difference , 0.2 ; P = .04 ) . Significant increments were observed in prepubertal children treated with metformin versus placebo recipients in the quantitative insulin sensitivity check index ( 0.010 and −0.007 ; difference , 0.017 ; P = .01 ) and the adiponectin – leptin ratio ( 0.96 and 0.15 ; difference , 0.81 ; P = .01 ) and declines in interferon-γ ( −5.6 and 0 ; difference , 5.6 ; P = .02 ) and total plasminogen activator inhibitor-1 ( −1.7 and 2.4 ; difference , 4.1 ; P = .04 ) . No serious adverse effects were reported . CONCLUSIONS : Metformin decreased the BMI z score and improved inflammatory and cardiovascular-related obesity parameters in prepubertal children but not in pubertal children . Hence , the differential response according to puberty might be related to the dose of metformin per kilogram of weight . Further investigations are necessary INTRODUCTION Although the Diabetes Prevention Program and other clinical trials demonstrated the efficacy of intensive lifestyle interventions ( ILI ) and metformin to prevent type 2 diabetes , no studies have tested their comparative effects in pragmatic setting s. This study was design ed to compare the real-world effectiveness of ILI , metformin , and st and ard care among Hispanic women ( Latinas ) with prediabetes . STUDY DESIGN RCT . SETTING / PARTICIPANTS Ninety-two Latinas , who had a mean hemoglobin A1c of 5.9 % , BMI of 33.3 kg/m2 , and waist circumference of 97.4 cm ( 38.3 inches ) , were recruited from an urban community and r and omly assigned to ILI , metformin , or st and ard care using 1:1:1 allocation . Data were collected from 2013 - 2015 and analyzed in 2016 . INTERVENTION The 12-month ILI was adapted from the Diabetes Prevention Program 's ILI and delivered by community health workers ( promotoras ) over 24 sessions . Metformin participants received 850 mg twice daily . Those r and omized to st and ard care continued their regular medical care . MAIN OUTCOME MEASURES Weight and secondary outcomes ( waist circumference , blood pressure , hemoglobin A1c , fasting plasma glucose , insulin , and lipids ) were assessed at baseline and 12 months . RESULTS ILI participants demonstrated significantly greater mean weight loss ( -4.0 kg , 5.0 % ) than metformin ( -0.9 kg , 1.1 % ) and st and ard care participants ( + 0.8 kg , 0.9 % ) ( p<0.001 ) . The difference in weight loss between metformin and st and ard care was not significant . The ILI group experienced a greater reduction in waist circumference than st and ard care ( p=0.001 ) , and a marginal improvement in hemoglobin A1c compared with metformin and st and ard care ( p=0.063 ) . CONCLUSIONS In the first comparative effectiveness trial of diabetes prevention treatments , a 12-month ILI produced significantly greater weight loss than metformin and st and ard care among Latinas with prediabetes . These data suggest that ILI delivered by promotoras is an effective strategy for preventing diabetes in this high-risk group , which may be superior to metformin . Future pragmatic trials involving larger sample s should examine differences in diabetes incidence associated with these treatments This study assessed the efficacy of adding metformin to a structured lifestyle intervention in reducing BMI in obese adolescents with insulin resistance . Obese adolescents ( 25 ) aged 10–16 years with a body mass index ( BMI ) > 95th percentile and insulin resistance ( Homeostasis Model Assessment —HOMA ) > 3.0 were assessed in a community clinic . A structured lifestyle intervention comprising nutritional and exercise education and motivational support in both individual and group sessions was delivered over 6 months . Subjects were r and omized to lifestyle intervention alone or with metformin ( 1500 g daily ) . The primary outcome measures were a change in BMI and modification of metabolic risk factors , including insulin resistance , plasma lipids and adipocytokines . Eleven adolescents receiving lifestyle and metformin intervention and 14 receiving lifestyle alone completed the study . BMI decreased by 1.8 kg/m2 with lifestyle and metformin but did not change with lifestyle alone . HOMA was significantly decreased in the lifestyle intervention group , but not following metformin , while the adiponectin/leptin ratio improved significantly in both groups . Dyslipidemic profiles improved most significantly with metformin . We conclude that metformin in combination with a 6-month structured lifestyle intervention is effective in reducing BMI in obese adolescents but did not improve insulin resistance . Lifestyle intervention , with or without metformin , improved metabolic risk factors such as plasma lipids and adipocytokines OBJECTIVE Metformin can decrease adiposity and ameliorate obesity-related comorbid conditions , including abnormalities in glucose homeostasis in adolescents , but there are few data evaluating the efficacy of metformin among younger children . Our objective was to determine whether metformin treatment causes weight loss and improves obesity-related comorbidities in obese children , who are insulin-resistant . RESEARCH DESIGN AND METHODS This study was a r and omized double-blind placebo-controlled trial consisting of 100 severely obese ( mean BMI 34.6 ± 6.6 kg/m2 ) insulin-resistant children aged 6–12 years , r and omized to 1,000 mg metformin ( n = 53 ) or placebo ( n = 47 ) twice daily for 6 months , followed by open-label metformin treatment for 6 months . All children and their parents participated in a monthly dietitian-administered weight-reduction program . RESULTS Eighty-five percent completed the 6-month r and omized phase . Children prescribed metformin had significantly greater decreases in BMI ( difference −1.09 kg/m2 , CI −1.87 to −0.31 , P = 0.006 ) , body weight ( difference −3.38 kg , CI −5.2 to −1.57 , P < 0.001 ) , BMI Z score ( difference between metformin and placebo groups −0.07 , CI −0.12 to −0.01 , P = 0.02 ) , and fat mass ( difference −1.40 kg , CI −2.74 to −0.06 , P = 0.04 ) . Fasting plasma glucose ( P = 0.007 ) and homeostasis model assessment ( HOMA ) insulin resistance index ( P = 0.006 ) also improved more in metformin-treated children than in placebo-treated children . Gastrointestinal symptoms were significantly more prevalent in metformin-treated children , which limited maximal tolerated dosage in 17 % . During the 6-month open-label phase , children treated previously with placebo decreased their BMI Z score ; those treated continuously with metformin did not significantly change BMI Z score further . CONCLUSIONS Metformin had modest but favorable effects on body weight , body composition , and glucose homeostasis in obese insulin-resistant children participating in a low-intensity weight-reduction program Aims . To observe the rate of conversion from impaired glucose tolerance ( IGT ) to diabetes following lifestyle modification ( LSM ) or a combination of lifestyle and metformin compared to a control population with 18-month followup . Methods . Forty screening camps were organized , which 5000 people attended . Around 2300 persons filled the question naire and 1825 subjects were identified as high risk . Of 1739 subjects who took the oral glucose tolerance test , 317 subjects were identified as IGT . The 317 IGT subjects were r and omized into three groups : control group was given st and ard medical advice , LSM group was given intensive lifestyle modification advice , while LSM + drug group was given intensive lifestyle advice and metformin 500 mg twice daily . Results . At the end , 273 subjects completed the study , giving a compliance rate of 86 % . Total of 47 incident cases of diabetes were diagnosed ( overall incidence was 4 cases per 1000 person-months with the incidence of 8.6 cases in control group , 2.5 cases in the LSM , and 2.3 cases in the LSM + drug groups ) . Conclusions . Study showed that lifestyle intervention had a major impact in preventing diabetes among IGT subjects in this region . Adding drug did not show any improved results . We recommend lifestyle advice and followup should be incorporated in primary health care OBJECTIVE To study whether metformin reduces obesity , homeostasis model assessment for insulin resistance index ( HOMA-IR ) , and the metabolic syndrome ( MtS ) in obese European adolescents in addition to previous unsuccessful lifestyle intervention . DESIGN AND METHODS After 6 months of multiprofessional lifestyle intervention , 70 out of 86 adolescents without improvement in body mass index ( BMI ) and HOMA-IR were r and omized into either the placebo ( n=34 ) or the metformin group ( 2 × 500 mg/day , n=36 ) in addition to ongoing lifestyle intervention for another 6 months . RESULTS Age was 13.8 years , BMI was 33.1 kg/m(2 ) , 65 % were female , and 89 % were Caucasians . During lifestyle intervention alone , BMI and HOMA-IR deteriorated significantly . In the subsequent medication period , HOMA-IR and fasting insulin improved similarly in the placebo and metformin groups ( HOMA-IR decreased 73 vs 54 % respectively in metformin versus placebo ; P=0.048 ) , but BMI remained unchanged . The insulin sensitivity index , however , only improved in the metformin group . High fasting insulin is correlated with a subsequent BMI increase irrespective of the medication . MtS remained unchanged . CONCLUSIONS Obese European adolescents ' insulin sensitivity improved without weight change during placebo or metformin intervention in addition to lifestyle intervention . Most differences did not reach statistical significance , probably due to improved compliance with lifestyle intervention as a placebo effect . In addition , the metformin dose may be too low Background : As adolescents with obesity and insulin resistance may be refractory to lifestyle intervention therapy alone , additional off-label metformin therapy is often used . In this study , the long-term efficacy and safety of metformin versus placebo in adolescents with obesity and insulin resistance is studied . Methods : In a r and omized placebo-controlled double-blinded trial , 62 adolescents with obesity aged 10–16 years old with insulin resistance received 2000 mg of metformin or placebo daily and physical training twice weekly over 18 months . Primary end points were change in body mass index ( BMI ) and insulin resistance measured by the Homeostasis Model Assessment for Insulin Resistance ( HOMA-IR ) . Secondary end points were safety and tolerability of metformin . Other end points were body fat percentage and HbA1c . Results : Forty-two participants completed the 18-month study ( 66 % girls , median age 13 ( 12–15 ) years , BMI 30.0 ( 28.3 to 35.0 ) kg m−2 and HOMA-IR 4.08 ( 2.40 to 5.88 ) ) . Median Δ BMI was + 0.2 ( −2.9 to 1.3 ) kg m−2 ( metformin ) versus + 1.2 ( −0.3 to 2.4 ) kg m−2 ( placebo ) ( P=0.015 ) . No significant difference was observed for HOMA-IR . No serious adverse events were reported . Median change in fat percentage was −3.1 ( −4.8 to 0.3 ) versus −0.8 ( −3.2 to 1.6)% ( P=0.150 ) , in fat mass −0.2 ( −5.2 to 2.1 ) versus + 2.0 ( 1.2–6.4 ) kg ( P=0.007 ) , in fat-free mass + 2.0 ( −0.1 to 4.0 ) versus + 4.5 ( 1.3 to 11.6 ) kg ( P=0.047 ) and in ΔHbA1c + 1.0 ( −1.0 to 2.3 ) versus + 3.0 ( 0.0 to 5.0 ) mmol mol−1 ( P=0.020 ) ( metformin versus placebo ) . Conclusions : Long-term treatment with metformin in adolescents with obesity and insulin resistance results in stabilization of BMI and improved body composition compared with placebo . Therefore , metformin may be useful as an additional therapy in combination with lifestyle intervention in adolescents with obesity and insulin resistance Objective . To assess a comprehensive , intensive lifestyle intervention in combination with metformin extended release ( MXR ) or placebo on body mass index ( BMI ) and risk factors for type 2 diabetes and cardiovascular disease in obese adolescents . Study Design . Sixty-nineobese adolescents ( mean BMI 32.5 ) received a comprehensive lifestyle intervention with structured dietary , physical activity , and behavioral components for 24 months . Subjects were r and omized to 1 of 4 groups : MXR ( 33 ) 2,000 mg daily or placebo , with either moderate or vigorous intensity exercise for the first 3 months . Subsequently the exercise intervention was the same for all 4 groups . Results . Anthropometry measurements did not differ with initial exercise intensity at any time . At 3 months % body fat decreased in all 4 groups ( P < 0.006 ) . BMI and % body fat decreased in the MXR groups , but not the placebo groups , at 6 ( −0.88 , −3.16 ) and 12 months ( −0.56 , −2.34 ) ( P < 0.05 ) . Insulin resistance , fasting blood glucose , and leptin improved in all groups at 6 and 12 months . A high subject attrition rate ( 58 % ) occurred by 24 months . Conclusion . A comprehensive , intensive lifestyle intervention combined with MXR led to a decline in BMI and % body fat at 1 year independent of initial exercise intensity . This trial is registered with Clinical Trials.gov NCT00934570 OBJECTIVE Metformin produced weight loss and delayed or prevented diabetes in the Diabetes Prevention Program ( DPP ) . We examined its long-term safety and tolerability along with weight loss , and change in waist circumference during the DPP and its long-term follow-up . RESEARCH DESIGN AND METHODS The r and omized double-blind clinical trial of metformin or placebo followed by a 7–8-year open-label extension and analysis of adverse events , tolerability , and the effect of adherence on change in weight and waist circumference . RESULTS No significant safety issues were identified . Gastrointestinal symptoms were more common in metformin than placebo participants and declined over time . During the DPP , average hemoglobin and hematocrit levels were slightly lower in the metformin group than in the placebo group . Decreases in hemoglobin and hematocrit in the metformin group occurred during the first year following r and omization , with no further changes observed over time . During the DPP , metformin participants had reduced body weight and waist circumference compared with placebo ( weight by 2.06 ± 5.65 % vs. 0.02 ± 5.52 % , P < 0.001 , and waist circumference by 2.13 ± 7.06 cm vs. 0.79 ± 6.54 cm , P < 0.001 in metformin vs. placebo , respectively ) . The magnitude of weight loss during the 2-year double-blind period was directly related to adherence ( P < 0.001 ) . Throughout the unblinded follow-up , weight loss remained significantly greater in the metformin group than in the placebo group ( 2.0 vs. 0.2 % , P < 0.001 ) , and this was related to the degree of continuing metformin adherence ( P < 0.001 ) . CONCLUSIONS Metformin used for diabetes prevention is safe and well tolerated . Weight loss is related to adherence to metformin and is durable for at least 10 years of treatment AIMS To evaluate the effect of metformin on glucose metabolism , insulin sensitivity and rate of conversion diabetes in people with impaired glucose tolerance ( IGT ) . METHODS Seventy subjects with IGT were r and omized under double-blind conditions to receive either placebo ( n = 37 ) or metformin ( n = 33 ) at a dosage of 250 mg three times daily for a duration of 12 months . Glycaemic control , plasma insulin and other biochemical indexes were assessed before and after 3 , 6 and 12 months . RESULT At 12 months the conversion rate to diabetes was 16.2 % in the placebo group compared to 3.0 % for the metformin group ( P = 0.011 ) . Of subjects treated with metformin for 12 months , 84.9 % became normoglycaemic compared to 51.4 % of those receiving the placebo . Significant improvements in fasting glucose , glucose tolerance and insulin sensitivity were found at 12 months and at intermediate clinic assessment s. CONCLUSIONS Metformin can improve glucose metabolism in IGT patients and may be a treatment option in their management of IGT subjects Aims /hypothesisLifestyle modification helps in the primary prevention of diabetes in multiethnic American , Finnish and Chinese population s. In a prospect i ve community-based study , we tested whether the progression to diabetes could be influenced by interventions in native Asian Indians with IGT who were younger , leaner and more insulin resistant than the above population s. Methods We r and omised 531 ( 421 men 110 women ) subjects with IGT ( mean age 45.9±5.7 years , BMI 25.8±3.5 kg/m2 ) into four groups . Group 1 was the control , Group 2 was given advice on lifestyle modification ( LSM ) , Group 3 was treated with metformin ( MET ) and Group 4 was given LSM plus MET . The primary outcome measure was type 2 diabetes as diagnosed using World Health Organization criteria . Results The median follow-up period was 30 months , and the 3-year cumulative incidences of diabetes were 55.0 % , 39.3 % , 40.5 % and 39.5 % in Groups 1–4 , respectively . The relative risk reduction was 28.5 % with LSM ( 95 % CI 20.5–37.3 , p=0.018 ) , 26.4 % with MET ( 95 % CI 19.1–35.1 , p=0.029 ) and 28.2 % with LSM + MET ( 95 % CI 20.3–37.0 , p=0.022 ) , as compared with the control group . The number needed to treat to prevent one incident case of diabetes was 6.4 for LSM , 6.9 for MET and 6.5 for LSM + MET . Conclusions /interpretationProgression of IGT to diabetes is high in native Asian Indians . Both LSM and MET significantly reduced the incidence of diabetes in Asian Indians with IGT ; there was no added benefit from combining them Abstract Objective : To determine if metformin improves markers of inflammation , thrombosis , and intrahepatic fat contents in children with uncomplicated obesity . Methods : Obese children with normal glucose tolerance but elevated highly sensitive C-reactive protein ( hsCRP ) and /or fibrinogen concentrations ( > 2 st and ard deviations ) were r and omized to structured diet/exercise or diet/exercise and metformin for 6 months . Blood sample s , dual energy X-ray absorptiometry data , and liver magnetic resonance images were obtained . Results : Forty-two of 66 recruited children ( 7–18 years ) completed 6 months . Weight loss was modest but more pronounced in the metformin group ( –4.9±1.0 kg ) than in the diet/exercise group ( –1.7±1.1 kg , p<0.03 ) , whereas hsCRP and fibrinogen decreased more in the diet/exercise pubertal group . Baseline intrahepatic fat was high but decreased only in the diet/exercise ( not metformin ) pubertal group . Conclusions : Six months of metformin therapy improved weight loss and reduced abdominal adiposity , but did not enhance the beneficial effect of diet and exercise on markers related to inflammation , thrombosis , or hepatic fat in obese children with normal glucose tolerance Abstract Aim This study was undertaken to determine whether metformin would ameliorate insulin resistance , reduce weight and waist circumference and improve lipids in obese , but not morbidly obese , euglycemic women . Methods Obese women ( body mass index ( BMI ) ≥ 30 and < 40 kg/m2 and /or waist circumference > 88 cm ) , aged 35–65 were r and omized ( 1:1 ) to metformin 850 mg or identical placebo , twice daily for 26 weeks . The primary outcome was the change in insulin resistance determined by the homeostasis model of assessment ( HOMA-IR ) . Secondary outcomes included fasting insulin , glucose , weight , waist circumference and BMI . Results Of the 125 women screened , 117 enrolled and 100 women , mean age 53 years , were included in the primary intention-to-treat analysis . Metformin result ed in statistically significant between-group difference in the change in HOMA-IR ( change in median − 0.04 vs. placebo + 0.1 , p = 0.018 ) and BMI ( mean change − 1.00 kg/m2 ; 95 % confidence interval ( CI ) 1.37 to − 0.62 vs. placebo mean change 0.00 ; 95 % CI − 0.29 to 0.28 , p < 0.001 ) . Statistically significant reductions in HbA1c ( p = 0.008 ) and fasting insulin ( p = 0.03 ) and a borderline decrease in high density lipoprotein cholesterol ( p = 0.07 ) were also observed for metformin , compared with placebo . No effects were seen for waist circumference , fasting glucose or other lipids . Conclusion Treatment of euglycemic , obese , middle-aged women with metformin 1700 mg per day reduced insulin resistance and weight compared with placebo . Further studies are needed to determine whether the use of metformin will prevent the progression of insulin resistance to type 2 diabetes mellitus in obese women CONTEXT Childhood obesity is increasingly associated with type 2 diabetes ( T2D ) . Metformin reduces the risk for T2D in adult obese nondiabetic patients , but the evidence in obese children and young people is inconclusive . OBJECTIVE The objective of the study was to assess the effect of metformin on body mass index sd score ( BMI -SDS ) , metabolic risk factors , and adipokines . DESIGN This was a prospect i ve , r and omized , double-blind , placebo-controlled trial . SETTING The study was conducted at six pediatric endocrine centers in the United Kingdom . PARTICIPANTS One hundred fifty-one obese children and young people with hyperinsulinemia and /or impaired fasting glucose or impaired glucose tolerance ( metformin : 74 , placebo : 77 ) . The study was comprised of 67.5 % females , 65.6 % postpubertal individuals , and 23.8 % British Asian or Afro-Caribbean participants . The age range was 8 - 18 yr , the mean age was 13.7 ( SD 2.3 ) yr , and the mean BMI -SDS was + 3.4 ( SD 0.5 ) . INTERVENTIONS The intervention included metformin 1 g in the morning and 500 mg in the evening vs. placebo for 6 months . MAIN OUTCOME MEASURE The main outcome measure was a reduction in BMI -SDS at 6 months . Secondary outcomes included insulin and glucose levels from oral glucose tolerance tests , alanine aminotransferase ( ALT ) , and adiponectin to leptin ratio ( ALR ) at 3 and 6 months . RESULTS Metformin was associated with a significant reduction in BMI -SDS compared with placebo at 6 months [ mean difference -0.1 SD ( 95 % confidence interval -0.18 to -0.02 ) , P = 0.02 ] . Significant improvements at 3 months were found in the metformin group : fasting glucose , -0.16 mmol/liter ( -0.31 to -0.00 ) , P = 0.047 ; ALT , 19 % ( 5 - 36 % ) , P = 0.008 ; and ALR , 32 % ( 4 - 67 % ) , P = 0.02 . CONCLUSIONS Metformin therapy has a beneficial treatment effect over placebo for BMI -SDS , fasting glucose , ALT , and ALR ratio at 3 months , with changes in BMI -SDS sustained at 6 months 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 OBJECTIVE To evaluate whether metformin , when added to a program of personal goal setting , improves weight loss and clinical status in obese adolescents . STUDY DESIGN In a r and omized double-blind placebo controlled trial , 85 adolescents with insulin resistance were r and omized to receive metformin ( 70 % ) or placebo ( 30 % ) , along with monthly goal setting for diet and exercise modification . Anthropometric measures , fasting blood analysis , and glucose tolerance tests were performed at baseline and 6 months . RESULTS Mean age was 15.7 years . Mean body mass index ( BMI ) was 39.7 kg/m(2 ) . 71 % were female , 58 % were Hispanic , and 34 % were African-American . 76 % of participants completed the study . Goal setting alone did not result in significant weight loss . In addition , there were no group differences between metformin and placebo in weight loss or measures of glucose metabolism . However , among females taking metformin , there was a significant decrease in BMI not seen in the placebo group . Furthermore , metformin adherence , when accompanied by lifestyle change , was a predictor of BMI decrease of 5 % or more . 60 % of 10 subjects who adhered to metformin and decreased portion size decreased BMI by > 5 % . CONCLUSIONS In this group of predominately minority adolescents , monthly goal setting alone did not lead to weight loss . Although the addition of metformin had no effect on weight loss overall , the agent did significantly increase weight loss among females and weight loss was predicted by degree of metformin adherence . However , weight loss was only found in those participants also reporting lifestyle change , particularly a decrease in portion sizes . These results suggest that metformin may be a useful agent to promote short-term weight loss among girls making modest lifestyle changes OBJECTIVES We report the 10-year effectiveness and within-trial cost-effectiveness of the Diabetes Prevention Program ( DPP ) and its Outcomes Study ( DPPOS ) interventions among participants who were adherent to the interventions . STUDY DESIGN DPP was a 3-year r and omized clinical trial followed by 7 years of open-label modified intervention follow-up . METHODS Data on re source utilization , cost , and quality of life were collected prospect ively . Economic analyses were performed from health system and societal perspectives . Lifestyle adherence was defined as achieving and maintaining a 5 % reduction in initial body weight , and metformin adherence as taking metformin at 80 % of study visits . RESULTS The relative risk reduction was 49.4 % among adherent lifestyle participants and 20.8 % among adherent metformin participants compared with placebo . Over 10 years , the cumulative , undiscounted , per capita direct medical costs of the interventions , as implemented during the DPP , were greater for adherent lifestyle participants ( $ 4810 ) than adherent metformin participants ( $ 2934 ) or placebo ( $ 768 ) . Over 10 years , the cumulative , per capita non-interventionrelated direct medical costs were $ 4250 greater for placebo participants compared with adherent lifestyle participants and $ 3251 greater compared with adherent metformin participants . The cumulative quality -adjusted life-years ( QALYs ) accrued over 10 years were greater for lifestyle ( 6.80 ) than metformin ( 6.74 ) or placebo ( 6.67 ) . Without discounting , from a modified societal perspective ( excluding participant time ) and a full societal perspective ( including participant time ) , lifestyle cost < $ 5000 per QALY-gained and metformin was cost saving compared with placebo . CONCLUSIONS Over 10 years , lifestyle intervention and metformin were cost-effective or cost saving compared with placebo . These analyses confirm that lifestyle and metformin represent a good value for money BACKGROUND Metformin has been proffered as a therapy for adolescent obesity , although long-term controlled studies have not been reported . OBJECTIVE To test the hypothesis that 48 weeks of daily metformin hydrochloride extended release ( XR ) therapy will reduce body mass index ( BMI ) in obese adolescents , as compared with placebo . DESIGN Multicenter , r and omized , double-blind , placebo-controlled clinical trial . SETTING The 6 centers of the Glaser Pediatric Research Network from October 2003 to August 2007 . PARTICIPANTS Obese ( BMI > or = 95th percentile ) adolescents ( aged 13 - 18 years ) were r and omly assigned to the intervention ( n = 39 ) or placebo groups . Intervention Following a 1-month run-in period , subjects following a lifestyle intervention program were r and omized 1:1 to 48 weeks ' treatment with metformin hydrochloride XR , 2000 mg once daily , or an identical placebo . Subjects were monitored for an additional 48 weeks . Main Outcome Measure Change in BMI , adjusted for site , sex , race , ethnicity , and age and metformin vs placebo . RESULTS After 48 weeks , mean ( SE ) adjusted BMI increased 0.2 ( 0.5 ) in the placebo group and decreased 0.9 ( 0.5 ) in the metformin XR group ( P = .03 ) . This difference persisted for 12 to 24 weeks after cessation of treatment . No significant effects of metformin on body composition , abdominal fat , or insulin indices were observed . CONCLUSION Metformin XR caused a small but statistically significant decrease in BMI when added to a lifestyle intervention program . TRIAL REGISTRATION clinical trials.gov Identifiers : NCT00209482 and NCT00120146 CONTEXT Metformin therapy for adults and children with type 2 diabetes is well established . However , its role in the treatment of insulin resistance and obesity in children and adolescents is less clearly defined . OBJECTIVE We assessed the effect of metformin on body composition and insulin sensitivity in pediatric subjects with exogenous obesity . DESIGN AND SETTING Patients referred to a pediatric endocrine clinic were enrolled in a r and omized , double-blind , crossover trial . PATIENTS Twenty-eight patients ( 13 males ) aged 9 - 18 yr participated in the study . INTERVENTION Patients received metformin ( 1 g twice daily ) and placebo for 6 months , each with a 2-wk washout period . MAIN OUTCOME MEASURES Body composition ( anthropometry , dual-energy x-ray absorptiometry , and abdominal magnetic resonance imaging ) , and insulin sensitivity ( Si ; minimal model , fasting insulin and glucose ) were measured at baseline and 6 and 12 months . RESULTS Mean age of subjects at baseline was 12.5 + /- 2.2 yr , median body mass index z-score 2.54 ( range , 1.93 - 2.85 ) . Metformin had a greater treatment effect over placebo for weight ( -4.35 kg , P = 0.02 ) , body mass index ( -1.26 kg/m(2 ) , P = 0.002 ) , waist circumference ( -2.8 cm , P = 0.003 ) , sc abdominal adipose tissue ( -52.5 cm(2 ) , P = 0.002 ) , and fasting insulin ( -2.2 mU/liter , P = 0.011 ) . Si improved in 45 % of subjects while on metformin and 27 % of subjects while on placebo ( P = 0.21 ) . CONCLUSIONS Metformin therapy for obese insulin-resistant pediatric patients results in significant improvement in body composition and fasting insulin . Although improvement in Si was noted in many individuals , Si was a less useful parameter for analysis of group data , possibly because of effects of variable compliance and changing Si during puberty BACKGROUND Childhood obesity-related metabolic derangements are increasing among South Asian population s. Dietary and physical activity plans have limited effect . This study aims to assess the effectiveness of metformin in the management of obesity among 8- to 16-year-old children in Gampaha District of Sri Lanka . MATERIAL S AND METHODS A triple-blinded controlled trial was conducted on 150 obese school children . After 12-hour overnight fast , blood was drawn for fasting blood glucose ( FBG ) and lipid profile . Anthropometry , fat mass ( FM ) , and blood pressure were measured . BMI and insulin resistance were calculated . Children r and omly received either metformin ( 8 - 10 years-500 mg 12 hourly ; 11 - 16 years-1 g 12 hourly ) or placebo . Anthropometry and blood investigations were repeated at 6 and 12 months . Mean difference in outcome measures , adjusted for baseline values , was compared using ANCOVA . RESULTS There were 84/150 boys . Metabolic syndrome was present in 25 ( 16.7 % ) . A statistically significant adjusted mean reduction was observed in the metformin group compared with placebo , in weight ( -0.991 vs. 1.394 , p = 0.000 ) , BMI /Age-st and ard deviation score ( SDS ; -0.287 vs. -0.116 , p = 0.000 ) , % FM/Age-SDS ( -0.092 vs. 0.016 , p = 0.04 ) , systolic blood pressure ( SBP ; -0.415 vs. 0.015 , p = 0.015 ) , total cholesterol ( -0.95 vs. -0.7 , p = 0.001 ) , low-density lipoprotein ( -0.67 vs. -0.45 , p = 0.001 ) , and highly sensitive C-reactive protein ( -1.36 vs. 0.08 , p = 0.013 ) at 6 months , and in BMI /Age-SDS ( -370 vs. -0.222 , p = 0.001 ) , WC/Age-SDS ( -0.473 vs. -0.337 , p = 0.018 ) , SBP ( -0.834 vs. -0.477 , p = 0.023 ) , and triglycerides ( -0.33 vs. -0.14 , p = 0.019 ) at 12 months . CONCLUSIONS Metformin compared with placebo has beneficial effects on anthropometric and metabolic indicators in the management of childhood obesity Background / Objectives Off-label metformin is nowadays frequently used for the treatment of obesity in adolescents . However , studies on long-term metformin treatment in adolescents with obesity are scarce . Therefore , an 18 month open label extension study following an 18 months r and omized placebo-controlled trial ( RCT ) on the efficacy , safety , and tolerability of metformin in adolescents with obesity and insulin resistance was performed . Subjects/ Methods After completion of the RCT , metformin was offered to all participants with a body mass index st and ard deviation score ( BMI -sds ) > 2.3 and Homeostasis Model Assessment for Insulin Resistance ( HOMA-IR ) ≥ 3.4 . Endpoints were change in BMI and HOMA-IR . Results Overall , 31/42 participants completed the extension study ( 74 % girls , median age 14.8 ( 11.6 – 17.9 ) , BMI 31.2 ( 22.3 – 45.1 ) , HOMA-IR 3.4 ( 0.2 – 8.8 ) ) . At start , 22/42 ( 52.4 % ) participants were eligible for metformin of which 13 ( 59.0 % ) agreed with treatment . In participants who continued metformin , an increase was observed in BMI ( + 2.2 ( + 0.2 to + 9.0 ) ) and HOMA-IR ( + 13.7 ( + 1.6 to + 48.3 ) ) . In metformin naive participants , BMI stabilized after an initial decrease ( + 0.5 ( −2.1 to + 5.1 ) ) . For HOMA-IR , a decrease was observed ( −1.1 ( −4.6 to + 1.4 ) ) . Conclusion While metformin treatment in metformin naive participants seems to result in an initial decrease in BMI and HOMA-IR , there is no evidence for sustained effect after prolonged use in adolescents . Limited compliance and /or insufficient dose may explain the differences in long-term effects between adolescents and adults |
11,519 | 20,950,774 | This review gives evidence that higher surgeon volume is associated with better overall survival , lower permanent stoma and APER rates | AIM To clarify the relationship between surgeon caseload and patient outcomes for patients undergoing rectal cancer surgery in order to inform debate about organisation of services . | In the last three decades , since Luft suggested a link between hospital volume and patient outcome , little has changed . Despite great efforts to formally quantify the relationship between volume and cancer survival , much uncertainty remains . It is intuitive that increased experience ( of the surgeon , the hospital or the ancillary staff ) translates to better patient care but closer analysis of the literature uncovers widespread inconsistency in study design question ing validity of conclusions . Although central isation of cancer services would seem beneficial , definitive evidence is only available regarding pancreatic and oesophageal disease and that pertaining to rectal cancer is heterogeneous and often flawed . A majority of evidence suggests better outcome for patients with rectal cancer managed in high volume centres . There are , however , many variables in data collection and interpretation rendering comparison between studies challenging . Definitions of the rectum range from distance from the anal verge ( inherent disagreement e range 10e16 cm ) , to relationship to sacral promontory ( subject to interpreter variation ) , and location of peritoneal reflection ( can not be interpreted endoscopically ) . Many authors fail to differentiate between sigmoid colon and rectum 3 and , those that do demonstrate wide variation . One of the largest studies , ( more than 7000 patients ) from the Californian Cancer Registry offered no description of tumour location . It concluded that patients undergoing surgery at high volume hospitals were less likely to have permanent colostomies and had better survival rates . The diagnosis of rectal cancer was , however , question able as it was based only on a discharge letter , often written by the most junior team member with no reference to true anatomical location . Most US studies are published from a few high volume institutions with a select patient cohort and are based on retrospective analysis of large data bases which , themselves are notoriously inaccurate . The European experience was recently explored by Ptok in a prospect i ve trial of almost 7000 patients undergoing resection for rectal cancer . This is arguably the most complete data set available to date and great effort was made to overcome common biases . A clear definition of the rectum was provided , hospital volume was Background Preoperative radiotherapy reduces recurrence rates after surgery for rectal cancer but other variables may also affect outcome . The Stockholm Rectal Cancer Study Group has conducted two prospect i ve r and omized trials on preoperative radiotherapy in rectal cancer OBJECTIVE To determine whether surgical subspecialty training in colorectal surgery or frequency of rectal cancer resection by the surgeon are independent prognostic factors for local recurrence ( LR ) and survival . SUMMARY BACKGROUND DATA Variation in patient outcome in rectal cancer has been shown among centers and among individual surgeons . However , the prognostic importance of surgeon-related factors is largely unknown . METHODS All patients undergoing potentially curative low anterior resection or abdominoperineal resection for primary adenocarcinoma of the rectum between 1983 and 1990 at the five Edmonton general hospitals were review ed in a historic- prospect i ve study design . Preoperative , intraoperative , pathologic , adjuvant therapy , and outcome variables were obtained . Outcomes of interest included LR and disease-specific survival ( DSS ) . To determine survival rates and to control both confounding and interaction , multivariate analysis was performed using Cox proportional hazards regression . RESULTS The study included 683 patients involving 52 surgeons , with > 5-year follow-up obtained on 663 ( 97 % ) patients . There were five colorectal-trained surgeons who performed 109 ( 16 % ) of the operations . Independent of surgeon training , 323 operations ( 47 % ) were done by surgeons performing < 21 rectal cancer resections over the study period . Multivariate analysis showed that the risk of LR was increased in patients of both noncolorectal trained surgeons ( hazard ratio ( HR ) = 2.5 , p = 0.001 ) and those of surgeons performing < 21 resections ( HR = 1.8 , p < 0.001 ) . Stage ( p < 0.001 ) , use of adjuvant therapy ( p = 0.002 ) , rectal perforation or tumor spill ( p < 0.001 ) , and vascular/neural invasion ( p = 0.002 ) also were significant prognostic factors for LR . Similarly , decreased disease-specific survival was found to be independently associated with noncolorectal-trained surgeons ( HR = 1.5 , p = 0.03 ) and surgeons performing < 21 resections ( HR = 1.4 , p = 0.005 ) . Stage ( p < 0.001 ) , grade ( p = 0.02 ) , age ( p = 0.02 ) , rectal perforation or tumor spill ( p < 0.001 ) , and vascular or neural invasion ( p < 0.001 ) were other significant prognostic factors for DSS . CONCLUSION Outcome is improved with both colorectal surgical subspecialty training and a higher frequency of rectal cancer surgery . Therefore , the surgical treatment of rectal cancer patients should rely exclusively on surgeons with such training or surgeons with more experience CONTEXT Hospitals that treat a relatively high volume of patients for selected surgical oncology procedures report lower surgical in-hospital mortality rates than hospitals with a low volume of the procedures , but the reports do not take into account length of stay or adjust for case mix . OBJECTIVE To determine whether hospital volume was inversely associated with 30-day operative mortality , after adjusting for case mix . DESIGN AND SETTING Retrospective cohort study using the Surveillance , Epidemiology , and End Results (SEER)-Medicare linked data base in which the hypothesis was prospect ively specified . Surgeons determined in advance the surgical oncology procedures for which the experience of treating a larger volume of patients was most likely to lead to the knowledge or technical expertise that might offset surgical fatalities . PATIENTS All 5013 patients in the SEER registry aged 65 years or older at cancer diagnosis who underwent pancreatectomy , esophagectomy , pneumonectomy , liver resection , or pelvic exenteration , using incident cancers of the pancreas , esophagus , lung , colon , and rectum , and various genitourinary cancers diagnosed between 1984 and 1993 . MAIN OUTCOME MEASURE Thirty-day mortality in relation to procedure volume , adjusted for comorbidity , patient age , and cancer stage . RESULTS Higher volume was linked with lower mortality for pancreatectomy ( P=.004 ) , esophagectomy ( P<.001 ) , liver resection ( P=.04 ) , and pelvic exenteration ( P=.04 ) , but not for pneumonectomy ( P=.32 ) . The most striking results were for esophagectomy , for which the operative mortality rose to 17.3 % in low-volume hospitals , compared with 3.4 % in high-volume hospitals , and for pancreatectomy , for which the corresponding rates were 12.9 % vs 5.8 % . Adjustments for case mix and other patient factors did not change the finding that low volume was strongly associated with excess mortality . CONCLUSIONS These data support the hypothesis that when complex surgical oncologic procedures are provided by surgical teams in hospitals with specialty expertise , mortality rates are lower 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 ) PURPOSE : The aim of this study was to analyze the impact of institutions and individual surgeons on long-term prognosis after curative resection of rectal carcinoma . METHODS : We used univariate and multivariate analysis of data from a German prospect i ve , multicenter , patient-care evaluation study . RESULTS : The locoregional recurrence rates and the observed and cancer-related survival rates showed a considerable interinstitutional and intersurgeon variability . Multivariate analysis confirmed the institution and the individual surgeon as significant independent factors influencing locoregional recurrence and survival . There was a statistically highly significant correlation between the rate of locoregional recurrence and survival rate . CONCLUSIONS : The surgeon 's technique and skill has to focus on prevention of locoregional recurrence to achieve good long-term outcome after curative resection for rectal carcinoma . New clinical trials on adjuvant treatment have to include quality assurance for surgery and pathology and documentation of the surgeon ( as local code ) |
11,520 | 25,861,944 | Young adults who consumed AED drank more alcohol and experienced more alcohol-related harm than other drinkers .
There was insufficient evidence to conclude that AED led to increased alcohol consumption or altered the nature of alcohol-related harm .
However , AED consumers reported that AED increased stimulation and alertness , offset fatigue from drinking , and facilitated drinking .
Experimental research also found that combining ED or caffeine with alcohol increased stimulation and alertness , offset alcohol-related fatigue and increased the desire to keep drinking .
It did not change BAC , perceived intoxication , perceived impairment and it did not reverse alcohol-induced impairment on simple psychomotor tasks .
Combining ED/caffeine with alcohol reduced alcohol-induced impairment on some but not all aspects of complex tasks . | BACKGROUND In response to concern about whether mixing caffeinated energy drinks with alcohol ( AED ) increases alcohol consumption and related harm , and the role of industry in this debate , we conducted a comprehensive review of the research evidence on the effects of AED and documented industry involvement in this research . | BACKGROUND Previous research on alcohol mixed with energy drinks ( AmED ) suffers from measurement problems . Missing from the research literature are studies that assess caffeine-alcohol co-ingestion in natural drinking environments . METHODS This field study collected data in a U.S. college bar district from 328 r and omly selected patrons . Anonymous data were obtained from face-to-face interviews and self-administered surveys , and from breath tests . RESULTS Cola-caffeinated alcoholic beverage consumers left bars in a more highly intoxicated state than those who consumed alcohol only . There was no significant difference between the intoxication level of the AmED group and the cola-caffeinated alcoholic beverage group . Results from a multivariate regression model indicated that quantity of caffeinated alcoholic beverage consumption had a significant , positive association with bar patron intoxication after adjusting for potential confounders . CONCLUSIONS Findings indicate that caffeine may have a dose-dependent relationship with alcohol intoxication in the bar/nightclub setting . In addition , results revealed that cola-caffeinated alcoholic drinks may pose similar levels of risk to bar patrons as those associated with AmED beverage consumption . Product labeling requirements about alcohol risks may need to be extended not only to energy drinks , but to caffeinated soft drinks as well Background Energy drink consumption has continued to gain in popularity since the 1997 debut of Red Bull , the current leader in the energy drink market . Although energy drinks are targeted to young adult consumers , there has been little research regarding energy drink consumption patterns among college students in the United States . The purpose of this study was to determine energy drink consumption patterns among college students , prevalence and frequency of energy drink use for six situations , namely for insufficient sleep , to increase energy ( in general ) , while study ing , driving long periods of time , drinking with alcohol while partying , and to treat a hangover , and prevalence of adverse side effects and energy drink use dose effects among college energy drink users . Methods Based on the responses from a 32 member college student focus group and a field test , a 19 item survey was used to assess energy drink consumption patterns of 496 r and omly surveyed college students attending a state university in the Central Atlantic region of the United States . Results Fifty one percent of participants ( n = 253 ) reported consuming greater than one energy drink each month in an average month for the current semester ( defined as energy drink user ) . The majority of users consumed energy drinks for insufficient sleep ( 67 % ) , to increase energy ( 65 % ) , and to drink with alcohol while partying ( 54 % ) . The majority of users consumed one energy drink to treat most situations although using three or more was a common practice to drink with alcohol while partying ( 49 % ) . Weekly jolt and crash episodes were experienced by 29 % of users , 22 % reported ever having headaches , and 19 % heart palpitations from consuming energy drinks . There was a significant dose effect only for jolt and crash episodes . Conclusion Using energy drinks is a popular practice among college students for a variety of situations . Although for the majority of situations assessed , users consumed one energy drink with a reported frequency of 1 – 4 days per month , many users consumed three or more when combining with alcohol while partying . Further , side effects from consuming energy drinks are fairly common , and a significant dose effect was found with jolt and crash episodes . Future research should identify if college students recognize the amounts of caffeine that are present in the wide variety of caffeine-containing products that they are consuming , the amounts of caffeine that they are consuming in various situations , and the physical side effects associated with caffeine consumption BACKGROUND There are popular reports on the combined use of alcohol and energy drinks ( such as Red Bull and similar beverages , which contain caffeine , taurine , carbohydrates , etc . ) to reduce the depressant effects of alcohol on central nervous system , but no controlled studies have been performed . The main purpose of this study was to verify the effects of alcohol , and alcohol combined with energy drink , on the performance of volunteers in a maximal effort test ( cycle ergometer ) and also on physiological indicators ( oxygen uptake , ventilatory threshold , respiratory exchange rate , heart rate , and blood pressure ) , biochemical variables ( glucose , lactate , insulin , cortisol , ACTH , dopamine , noradrenaline , and adrenaline ) , and blood alcohol levels . METHODS Fourteen healthy subjects completed a double-blind protocol made up of four sessions : control ( water ) , alcohol ( 1.0 g/kg ) , energy drink ( 3.57 ml/kg Red Bull ) , and alcohol + energy drink , each 1 week apart . The effort test began 60 min after drug or control ingestion , and the dependent variables were measured until 60 min after the test . RESULTS Heart rate at the ventilatory threshold was higher in the alcohol and alcohol + energy drink sessions in comparison with control and energy drink sessions . Although in comparison to the control session , the peak oxygen uptake was 5.0 % smaller after alcohol ingestion , 1.4 % smaller after energy drink , and 2.7 % smaller after the combined ingestion , no significant differences were detected . Lactate levels ( 30 min after drug ingestion , 30 and 60 min after the effort test ) and noradrenaline levels ( 30 min after the effort test ) were higher in the alcohol and alcohol + energy drink sessions compared with the control session . CONCLUSIONS The performance in the maximal effort test observed after alcohol + energy drink ingestion was similar to that observed after alcohol only . No significant differences between alcohol and alcohol + energy drink were detected in the physiological and biochemical parameters analyzed . Our findings suggest that energy drinks , at least in the tested doses , did not improve performance or reduce alterations induced by acute alcohol ingestion BACKGROUND Well-known reports suggest that the use of energy drinks might reduce the intensity of the depressant effects of alcohol . However , there is little scientific evidence to support this hypothesis . OBJECTIVE AND METHODS The present study aim ed at evaluating the effects of the simultaneous ingestion of an alcohol ( vodka(37.5%v/v ) ) and an energy drink ( Red Bull-3.57 mL/kg ) , compared with those presented after the ingestion of an alcohol or an energy drink alone . Twenty-six young healthy volunteers were r and omly assigned to 2 groups that received 0.6 or 1.0 g/kg alcohol , respectively . They all completed 3 experimental sessions in r and om order , 7 days apart : alcohol alone , energy drink alone , or alcohol plus energy drink . We evaluated the volunteers ' breath alcohol concentration , subjective sensations of intoxication , objective effects on their motor coordination , and visual reaction time . RESULTS When compared with the ingestion of alcohol alone , the ingestion of alcohol plus energy drink significantly reduced subjects ' perception of headache , weakness , dry mouth , and impairment of motor coordination . However , the ingestion of the energy drink did not significantly reduce the deficits caused by alcohol on objective motor coordination and visual reaction time . The ingestion of the energy drink did not alter the breath alcohol concentration in either group . CONCLUSIONS Even though the subjective perceptions of some symptoms of alcohol intoxication were less intense after the combined ingestion of the alcohol plus energy drink , these effects were not detected in objective measures of motor coordination and visual reaction time , as well as on the breath alcohol concentration BACKGROUND Recently , Marczinski and colleagues ( 2013 ) showed that energy drinks combined with alcohol augment a person 's desire to drink more alcohol relative to drinking alcohol alone . The current study replicates the findings of Marczinski and colleagues ( 2013 ) using a robust measure of alcohol craving . METHODS Seventy-five participants aged 18 to 30 years were assigned to an alcohol only or alcohol+energy drink condition in a double-blind r and omized pre- versus posttest experiment . Participants received a cocktail containing either 60 ml of vodka and a Red Bull ( ® ) Silver Edition energy drink ( alcohol+energy drink condition ) or 60 ml of vodka with a soda water vehicle ( alcohol-only condition ) ; both cocktails contained 200 ml of fruit drink . The primary outcome measure was the Alcohol Urge Question naire taken at pretest and at 20 minutes ( posttest ) . Other measures taken at posttest were the Biphasic Alcohol Effects Question naire , the Drug Effects Question naire , and breath alcohol concentration ( BAC ) . RESULTS The alcohol+energy drink condition showed a greater pre- versus posttest increase in urge to drink alcohol compared with the alcohol-only condition ( B = 3.24 , p = 0.021 , d = 0.44 ) . Participants in the alcohol+energy drink condition had significantly higher ratings on liking the cocktail and wanting to drink more of the cocktail , and lower BACs , than the alcohol-only condition . When examined at specific BACs , the effect of the energy drink on the pre- to posttest increase in urge to drink was largest and only significant at BACs of 0.04 - 0.05 ( cf . < 0.04 g/dl).There were no significant differences in stimulation , sedation , feeling the effects of the cocktail , or feeling high . CONCLUSIONS Combining energy drinks with alcohol increased the urge to drink alcohol relative to drinking alcohol alone . More research is needed to underst and what factors mediate this effect and whether it increases subsequent alcohol consumption 1 . The dynamic and kinetic interactions of alcohol and caffeine were studied in a double-blind , placebo controlled , cross-over trial . Treatments were administered to eight healthy subjects in four experimental sessions , leaving a 1 week wash-out period between each , as follows : 1 ) placebo , 2 ) alcohol ( 0.8 g kg-1 ) , 3 ) caffeine ( 400 mg ) and 4 ) alcohol ( 0.8 g kg-1 ) + caffeine ( 400 mg ) . 2 . Evaluations were performed by means of : 1 ) objective measures : a ) psychomotor performance ( critical flicker fusion frequency , simple reaction time and tapping test ) , b ) long latency visual evoked potentials ( ' pattern reversal ' ) ; 2 ) subjective self-rated scales ( visual analogue scales and profile of mood states ) ; 3 ) caffeine and alcohol plasma concentration determinations . 3 . The battery of pharmacodynamic tests was conducted at baseline and at + 0.5 h , + 1.5 h , + 2.5 h , + 4 h and + 6 h. An analysis of variance was applied to the results , accepting a P < 0.05 as significant . The plasma-time curves for caffeine and alcohol were analysed by means of model-independent methods . 4 . Results obtained with caffeine in the objective measures demonstrated a decrease in simple reaction time and an increase in the amplitude of the evoked potentials ; the subjects ' self-ratings showed a tendency to be more active . Alcohol increased simple reaction time and decreased amplitude of the evoked potentials , although the subjects rated themselves as being active . The combination of alcohol + caffeine showed no significant difference from placebo in the objective tests ; nevertheless , the subjective feeling of drunkenness remained . The area under the curve ( AUC ) for caffeine was significantly higher when administered with alcohol . ( ABSTRACT TRUNCATED AT 250 WORDS OBJECTIVES The consumption of alcohol mixed with energy drinks ( AmED ) is popular on college campuses in the United States . Limited research suggests that energy drink consumption lessens subjective intoxication in persons who also have consumed alcohol . This study examines the relationship between energy drink use , high-risk drinking behavior , and alcohol-related consequences . METHODS In Fall 2006 , a Web-based survey was conducted in a stratified r and om sample of 4,271 college students from 10 universities in North Carolina . RESULTS A total of 697 students ( 24 % of past 30-day drinkers ) reported consuming AmED in the past 30 days . Students who were male , white , intramural athletes , fraternity or sorority members or pledges , and younger were significantly more likely to consume AmED . In multivariable analyses , consumption of AmED was associated with increased heavy episodic drinking ( 6.4 days vs. 3.4 days on average ; p < 0.001 ) and twice as many episodes of weekly drunkenness ( 1.4 days/week vs. 0.73 days/week ; p < 0.001 ) . Students who reported consuming AmED had significantly higher prevalence of alcohol-related consequences , including being taken advantage of sexually , taking advantage of another sexually , riding with an intoxicated driver , being physically hurt or injured , and requiring medical treatment ( p < 0.05 ) . The effect of consuming AmED on driving while intoxicated depended on a student 's reported typical alcohol consumption ( interaction p = 0.027 ) . CONCLUSIONS Almost one-quarter of college student current drinkers reported mixing alcohol with energy drinks . These students are at increased risk for alcohol-related consequences , even after adjusting for the amount of alcohol consumed . Further research is necessary to underst and this association and to develop targeted interventions to reduce risk AIM To assess event-level associations between energy drink consumption , alcohol intoxication , and intention to drive a motor vehicle in patrons exiting bars at night . METHOD Alcohol field study . Data collected in a U.S. college bar district from 802 r and omly selected and self-selected patrons . Anonymous interview and survey data were obtained as well as breath alcohol concentration ( BrAC ) readings . RESULTS Results from logistic regression models revealed that patrons who had consumed alcohol mixed with energy drinks were at a 3-fold increased risk of leaving a bar highly intoxicated ( BrAC > or = 0.08g/210L ) , as well as a 4-fold increased risk of intending to drive upon leaving the bar district , compared to other drinking patrons who did not consume alcoholic beverages mixed with energy drinks . DISCUSSION These event-level associations provide additional evidence that energy drink consumption by young adults at bars is a marker for elevated involvement in nighttime risk-taking behavior . Further field research is needed to develop sound regulatory policy on alcohol/energy drink sales practice s of on-premise establishments Rationale Caffeinated alcoholic beverages have been associated with increased risk of alcohol-related harms . However , few studies have examined these combined effects on behavioural control , which is believed to underlie many of the negative effects of alcohol consumption . In addition , studies have often omitted subjective measures , and none have directly assessed the role of caffeine consumer history . Objectives To examine the combined effects of alcohol and caffeine on measures of behavioural control and perceived intoxication in abstinent , light caffeine consumers . Methods Participants ( n = 28 ; 50 % male ) attended four sessions at which they consumed one of the following beverages in a r and omised order : placebo , alcohol alone ( 0.6 g/kg ) , caffeine alone ( 2.0 mg/kg ) , and alcohol/caffeine . They completed measures of mood , intoxication , anxiety and alcohol craving before and after a task battery comprising measures of behavioural control and reaction time performance . Results Caffeine attenuated alcohol-related performance deficits on stop-signal accuracy , had no effect on go – no-go performance deficits , and worsened accuracy on the Stroop task . Caffeine did not influence absolute changes in perceived intoxication but there was suggestion that caffeine may have changed the nature of intoxication with increases in stimulation . Conclusions Caffeine appears to have mixed effects on alcohol intoxication that are task-dependent . We found increased stimulation in the alcohol/caffeine condition , supporting the contention that caffeinated alcoholic beverages enable an individual to drink for longer . Future research should model real world drinking behaviour by examining how these effects change across multiple drink administrations Recent studies suggest that the combination of caffeine-containing drinks together with alcohol might reduce the subjective feelings of alcohol intoxication — the so-called “ masking effect ” . In this study , we aim ed to review the effects of alcohol in combination with caffeine or energy drink with special focus on the “ masking effect ” . Fifty-two healthy male volunteers were analysed concerning breath alcohol concentration and subjective sensations of intoxication using a 18 item Visual Analogue Scale in a r and omised , double-blinded , controlled , four treatments cross-over trial after consumption of ( A ) placebo , ( B ) alcohol ( vodka 37.5 % at a dose of 46.5 g ethanol ) , ( C ) alcohol in combination with caffeine at a dose of 80 mg ( equivalent to one 250 ml can of energy drink ) and ( D ) alcohol in combination with energy drink at a dose of 250 ml ( one can ) . Primary variables were headache , weakness , salivation and motor coordination . Out of four primary variables , weakness and motor coordination showed a statistically significant difference between alcohol and non-alcohol group , out of 14 secondary variables , five more variables ( dizziness , alterations in sight , alterations in walking , agitation and alterations in speech ) also showed significant differences due mainly to contrasts with the non-alcohol group . In none of these end points , could a statistically significant effect be found for the additional ingestion of energy drink or caffeine on the subjective feelings of alcohol intoxication . This within-subjects study does not confirm the presence of a “ masking effect ” when combining caffeine or energy drink with alcohol The present study examined the separate and combined effects of alcohol and caffeine on behavioral control in a context in which preliminary cues signaled the likelihood that a response should be executed or inhibited . Social drinkers ( N = 12 ) performed a cued go/no-go task that measured control as the quick execution of responses to go targets and sudden suppression of responses to no-go targets . Performance was tested under 3 doses of caffeine ( 0.0 mg/kg , 2.0 mg/kg , and 4.0 mg/kg ) in combination with 2 doses of alcohol ( 0.0 g/kg and 0.65 g/kg ) . Alcohol impaired both inhibitory and activational aspects of behavioral control . Caffeine antagonized alcohol effects on response execution but had no effect on inhibitory control . The findings highlight potential differences in how activational and inhibitory aspects of behavioral control respond to drug interactions Caffeine has been shown to reverse some of the performance-impairing effects of ethanol . However , it is not known whether this antagonistic effect of caffeine is mediated by a reduction in sleepiness . The present study assessed physiological alertness/sleepiness , memory , and psychomotor performance following the administration of placebo , ethanol , and caffeine+ethanol combinations . A total of 13 healthy individuals ( 21–35 years old ) underwent four conditions presented in a Latin Square Design : placebo – placebo , ethanol ( 0.5 g/kg)–placebo , ethanol ( 0.5 g/kg)–caffeine 150 mg , and ethanol ( 0.5 g/kg)–caffeine 300-mg . The Multiple Sleep Latency Test ( MSLT ) , psychomotor performance battery , memory test , and mood/sleepiness question naires were administered following each condition . The peak breadth ethanol concentration ( BrEC ) was 0.043±0.0197 % and did not differ among the three caffeine treatments . As expected , ethanol reduced mean latency on the MSLT . The lowest caffeine dose reversed this effect and the highest dose increased mean latency ( greater alertness ) significantly beyond placebo levels . Ethanol also impaired psychomotor performance and memory . The 300-mg caffeine dose restored performance and memory measures to placebo levels . Although visual analog ratings of dizziness were increased by ethanol , they were not diminished by either caffeine dose . In conclusion , Low-dose caffeine prevented the sleepiness and performance impairment associated with a moderate dose of ethanol . Thus , caffeine , similar to other stimulants , can reverse the physiologically sedating effects of ethanol , although other negative effects remain Rationale The present study examined whether caffeine would modify the behavioural effects of alcohol . Objectives The aim of the study was to determine whether caffeine modifies the effects of alcohol on mood and psychomotor performance and to identify possible dose – response and temporal relationships . Methods A double-blind study examined the effects of three successive lager drinks ( 330 ml each ) in the early afternoon on mood and psychomotor performance assessed at 30-min intervals over a 2-h period . Participants carried out a baseline session and were then r and omly assigned to one of six conditions formed by combining three different doses of caffeine ( 0 , 62.5 and 125 mg per drink ) with either no alcohol or 4.3 % alcohol . One hundred and forty-six young adults ( 65 male , 81 female ; age range 18–30 years ) participated in the study . Mood ( alertness , hedonic tone and anxiety ) was assessed before and after performing simple reaction time and choice reaction time tasks . Results Alcohol was associated with higher hedonic tone ( p < 0.005 ) , reduced anxiety ( p < 0.05 ) and reduced alertness ( p < 0.005 ) . Caffeine had no modifying effect on hedonic tone or anxiety . However , the highest dose of caffeine did remove the effect of alcohol on alertness ( p < 0.05 ) . Effects of alcohol and caffeine were found on the performance tasks ( all p values < 0.05 ) but these were independent effects . Conclusions The results from the present study confirm that caffeine does not remove the negative effects of alcohol on performance although high doses counteract the drop in subjective alertness produced by alcohol Caffeinated alcoholic beverage ( CAB ) consumption is a rapidly growing phenomenon among young adults and is associated with a variety of health-risk behaviors . The current study examined whether either caffeinated alcohol or the expectation of receiving caffeinated alcohol altered affective , cognitive , and behavioral outcomes hypothesized to contribute to risk behavior . Young adult social drinkers ( N = 146 ) participated in a single session where they received alcohol ( peak Breath Alcohol Content = .088 g/dL , SD = .019 ; equivalent to about four st and ard drinks ) and were r and omly assigned to one of four further conditions : 1 ) no caffeine , no caffeine expectancy , 2 ) caffeine and caffeine expectancy , 3 ) no caffeine but caffeine expectancy , 4 ) caffeine but no caffeine expectancy . Participants ' habitual CAB consumption was positively correlated with measures of impulsivity and risky behavior , independently of study drugs . Administration of caffeine ( mean dose = 220 mg , SD = 38 ; equivalent to about 2.75 Red Bulls ) in the study reduced subjective ratings of intoxication and reversed the decrease in desire to continue drinking , regardless of expectancy . Caffeine also reduced the effect of alcohol on inhibitory reaction time ( RT ) ( faster incorrect responses ) . Participants not expecting caffeine were less attentive after alcohol , whereas participants expecting caffeine were not , regardless of caffeine administration . Alcohol decreased response accuracy in all participants except those who both expected and received caffeine . Findings suggest that CABs may elevate risk for continued drinking by reducing perceived intoxication , and by maintaining the desire to continue drinking . Simply expecting to consume caffeine may reduce the effects of alcohol on inattention , and either expecting or consuming caffeine may protect against other alcohol-related performance decrements . Caffeine , when combined with alcohol , has both beneficial and detrimental effects on mechanisms known to contribute to risky behavior Unlike other CNS depressants , alcohol intoxication can be associated with increased error rates , coupled with unaffected ( or speeded ) response rates during psychomotor and cognitive processing . The present study examined whether concurrent consumption of caffeine may differentially affect these aspects of alcohol and performance AIMS Marketing that promotes mixing caffeinated ' energy ' drinks with alcoholic beverages ( e.g. Red Bull with vodka ) targets young drinkers and conveys the expectation that caffeine will offset the sedating effects of alcohol and enhance alertness . Such beliefs could result in unwarranted risk taking ( e.g. driving while intoxicated ) . The aim of this study was to assess the acute effects of caffeinated versus non-caffeinated alcoholic beverages on a simulated driving task and attention/reaction time . DESIGN We conducted a 2 × 2 between-groups r and omized trial in which participants were r and omized to one of four conditions : beer and non-alcoholic beer , with and without caffeine added . Caffeine was added in the same proportion as found in a commercially available caffeinated beer ( 69 mg/12 oz of beer at 4.8 % alc . by vol ) . PARTICIPANTS Participants were 127 non-dependent , heavy episodic , young adult drinkers ( age 21 - 30 ) who were college students or recent graduates . The target breath alcohol level was 0.12 g% . MEASURES Driving performance was assessed with a driving simulator ; sustained attention/reaction with the Psychomotor Vigilance Task ( PVT ) . FINDINGS Across the driving and attention/reaction time we found main effects for alcohol , with alcohol significantly impairing driving and sustained attention/reaction time , with mainly large statistical effects ; however , the addition of caffeine had no main or interaction effects on performance . CONCLUSION The addition of caffeine to alcohol does not appear to enhance driving or sustained attention/reaction time performance relative to alcohol alone BACKGROUND There has been a dramatic rise in the consumption of alcohol mixed with energy drinks ( AmED ) in young people . AmED have been implicated in risky drinking practice s and greater accidents and injuries have been associated with their consumption . Despite the increased popularity of these beverages ( e.g. , Red Bull and vodka ) , there is little laboratory research examining how the effects of AmED differ from alcohol alone . This experiment was design ed to investigate if the consumption of AmED alters neurocognitive and subjective measures of intoxication compared with the consumption of alcohol alone . METHODS Participants ( n=56 ) attended 1 session where they were r and omly assigned to receive one of 4 doses ( 0.65 g/kg alcohol , 3.57 ml/kg energy drink , AmED , or a placebo beverage ) . Performance on a cued go/no-go task was used to measure the response of inhibitory and activational mechanisms of behavioral control following dose administration . Subjective ratings of stimulation , sedation , impairment , and level of intoxication were recorded . RESULTS Alcohol alone impaired both inhibitory and activational mechanisms of behavioral control , as evidence d by increased inhibitory failures and increased response times compared to baseline performance . Coadministration of the energy drink with alcohol counteracted some of the alcohol-induced impairment of response activation , but not response inhibition . For subjective effects , alcohol increased ratings of stimulation , feeling the drink , liking the drink , impairment , and level of intoxication , and alcohol decreased the rating of ability to drive . Coadministration of the energy drink with alcohol increased self-reported stimulation , but result ed in similar ratings of the other subjective effects as when alcohol was administered alone . CONCLUSIONS An energy drink appears to alter some of the objective and subjective impairing effects of alcohol , but not others . Thus , AmED may contribute to a high-risk scenario for the drinker . The mix of impaired behavioral inhibition and enhanced stimulation is a combination that may make AmED consumption riskier than alcohol consumption alone OBJECTIVE Studies have shown that expectations of alcohol-induced impairment can produce adaptive responses to alcohol that reduce the degree of behavioral impairment displayed . The present study tested psychomotor performance following combined caffeine and alcohol administration in 42 social drinkers ( 23 men ) . Subjects were led to expect either that caffeine would antagonize alcohol-induced impairment or that it would have no effect . The study tested the hypothesis that drinkers who expected an antagonist effect of caffeine would display greater alcohol impairment than those who expected no antagonist effect . METHOD Groups practice d a pursuit rotor task and received a moderate dose of alcohol ( 0.65 g/kg ) combined with either 4.0 mg/kg caffeine or placebo caffeine . Some groups were led to expect that caffeine would counteract the impairing effect of alcohol and others were led to expect no counteracting effect . Psychomotor performance was then tested over a 3-hour period . RESULTS In accord with the hypothesis , groups led to expect counteracting effects of caffeine displayed greater impairment than those led to expect no counteraction . Caffeine had no significant antagonist effect on alcohol impairment . CONCLUSIONS The findings suggest that compensation for alcohol impairment occurs when drinkers hold clear expectations that the drug will disrupt performance . When no such clear expectation exists , no compensatory response occurs and the impairing effects of alcohol are observed The consumption of alcohol mixed with energy drinks ( AmED ) has become a popular and controversial practice among young people . Increased rates of impaired driving and injuries have been associated with AmED consumption . The purpose of this study was to examine if the consumption of AmED alters cognitive processing and subjective measures of intoxication compared with the consumption of alcohol alone . Eighteen participants ( nine men and nine women ) attended four test sessions where they received one of four doses in r and om order ( 0.65 g/kg alcohol , 3.57 ml/kg energy drink , AmED , or a placebo beverage ) . Performance on a psychological refractory period ( PRP ) task was used to measure dual-task information processing and performance on the Purdue pegboard task was used to measure simple and complex motor coordination following dose administration . In addition , various subjective measures of stimulation , sedation , impairment , and level of intoxication were recorded . The results indicated that alcohol slowed dual-task information processing and impaired simple and complex motor coordination . The coadministration of the energy drink with alcohol did not alter the alcohol-induced impairment on these objective measures . For subjective effects , alcohol increased various ratings indicative of feelings of intoxication . More importantly , coadministration of the energy drink with alcohol reduced perceptions of mental fatigue and enhanced feelings of stimulation compared to alcohol alone . In conclusion , AmED may contribute to a high-risk scenario for a drinker . The mix of behavioral impairment with reduced fatigue and enhanced stimulation may lead AmED consumers to erroneously perceive themselves as better able to function than is actually the case BACKGROUND There has been a dramatic rise in the consumption of alcohol mixed with energy drinks ( AmEDs ) in social drinkers . It has been suggested that AmED beverages might lead individuals to drink greater quantities of alcohol . This experiment was design ed to investigate whether the consumption of AmEDs would alter alcohol priming ( i.e. , increasing ratings of wanting another drink ) compared with alcohol alone . METHODS Participants ( n = 80 ) of equal gender attended 1 session where they were r and omly assigned to receive 1 of 4 doses ( 0.91 ml/kg vodka , 1.82 ml/kg energy drink , 0.91 ml/kg vodka mixed with 1.82 ml/kg energy drink [ AmED ] , or a placebo beverage ) . Alcohol-induced priming of the motivation to drink was assessed by self-reported ratings on the Desire for Drug question naire . RESULTS The priming dose of alcohol increased the subjective ratings of " desire " for more alcohol , consistent with previous research that small doses of alcohol can increase the motivation to drink . Furthermore , higher desire ratings over time were observed with AmEDs compared with alcohol alone . Finally , ratings of liking the drink were similar for the alcohol and AmED conditions . CONCLUSIONS An energy drink may elicit increased alcohol priming . This study provides laboratory evidence that AmED beverages may lead to greater motivation to drink versus the same amount of alcohol consumed alone The author tested the hypothesis that a history of drug-induced antagonism of alcohol impairment would enhance alcohol tolerance in humans . Groups of participants ( N = 21 ) repeatedly performed a psychomotor task under different drug treatments : 0.65 g/kg alcohol , 4 mg/kg caffeine , or both drugs combined . Tolerance to a 0.65 g/kg alcohol dose challenge was then tested . Results showed that a history of combined alcohol and caffeine administrations increased alcohol tolerance compared with an exposure history to either drug alone . The findings contribute to the underst and ing of the complexities of polydrug use history and provide a useful model to examine how alcohol tolerance might be affected by a history of coadministration with other drugs ( e.g. , cocaine and nicotine ) This study shows that reduced intentional control under alcohol can be counteracted by caffeine or an environmental incentive . Four groups of social drinkers ( n = 11 ) received 1 of the following : 0.62 g/kg alcohol ( A ) , alcohol with 4.4 mg/kg caffeine ( AC ) , alcohol with a rewarding monetary incentive ( AR ) , or a placebo ( P ) . They then performed a word stem completion task that provided separate measures of the influence of controlled and automatic processes governing responses . Controlled processes were depressed in Group A compared with Group P , whereas Groups AR and AC did not differ from Group P. Most inappropriate responses were displayed under alcohol alone , fewer with caffeine , and least with incentive . No treatment significantly affected automatic processes AIMS Beliefs about the effects of mixing caffeine and alcohol on hangover or sleep may play a role in motivation to consume these mixtures ; therefore , information is needed about actual effects . We investigated whether intoxication with caffeinated vs. non-caffeinated beer differentially affected perceived sleep quality , sleepiness , and hangover incidence and severity the next morning . METHODS University students ( 89 % ) and recent graduate drinkers were r and omized to receive : ( 1 ) beer with the equivalent of 69 mg caffeine/12 oz glass of regular beer ( n=28 ) or ( 2 ) beer without caffeine ( n=36 ) , in sufficient quantity to attain a BrAC of 0.12g% . After an 8-h supervised sleep period , participants completed measures of hangover , sleep quality , sleep latency and time asleep , and sleepiness . RESULTS While caffeinated beer improved perceived sleep quality , effect sizes were greater for morning alertness than for quality while sleeping , with no effect on sleep latency or total sleep time . No effects were seen on hangover incidence or severity . CONCLUSIONS Mixing caffeine and alcohol does not significantly impair amount of sleep or sleep latency , hangover , or sleepiness the morning after drinking to intoxication in this population The extent to which caffeine antagonizes alcohol-induced impairment of simulated automobile driving at the current lowest legal American limit ( 0.08 % BrAC ) was the focus of this study . Fifteen adults swallowed a capsule ( 0 , 200 , or 400 mg caffeine ) then drank a beverage ( 0.0 or 0.6 g/kg ethanol ) in a within-subject , double-blind , r and omized procedure . Forty-five minutes later , participants completed a test battery of subjective effects scales , dynamic posturography , critical flicker fusion ( CFF ) , choice reaction time ( CRT ) , divided attention ( Stroop test ) , and simulated driving . Alcohol alone increased ratings of ' dizzy ' , ' drug effect ' , and ' high ' , slowed CRT and brake latency , and increased body sway . Caffeine alone increased ratings of ' alert ' and ' jittery ' , but did not significantly affect body sway or psychomotor performance . Both caffeine doses comparably counteracted alcohol impairment of brake latency but not CRT or body sway . Brake latency with either alcohol-caffeine combination remained significantly longer than that with placebo . Stroop and CFF performance were unaffected by any drug condition . The results suggest that caffeine may increase alertness and improve reaction time after alcohol use but will not completely counteract alcohol impairment in a driver The present study was conducted to examine the self-reported ( i.e. , subjective ) and physiological effects of intravenous caffeine in 10 subjects with histories of stimulant drug abuse . Under double-blind conditions , subjects received each dose of caffeine ( 0 , 37.5 , 75 , 150 or 300 mg/70 kg ) twice according to a latin-square design ; injections were 10 sec in duration and separated by at least 24 hr . Effects were measured before injection and repeatedly afterward for 60 min . Caffeine dose-dependently increased ratings of positive mood ( e.g. , increased ratings of drug liking and high ) , which peaked at 2 min after injection and progressively decreased . Caffeine also dose-dependently increased the frequency of stimulant identification s on the Pharmacological Class Identification Question naire ( e.g. , like cocaine , amphetamine ) . Caffeine also produced negative-mood effects ( e.g. , increased ratings of bad effects ) and increases in self-reported desire for cocaine . In contrast to the positive-mood effects , the negative-mood effects were of smaller magnitude and only significant at the highest dose . Caffeine increased reports of unusual smells and tastes . Caffeine decreased heart rate ( 7 bpm ) and skin temperature ( 4 degrees C ) , and increased systolic and diastolic blood pressures ( 8 and 6 mm Hg , respectively ) . The mood effects but not the physiological effects of intravenous caffeine were similar to those previously observed with cocaine in studies using similar methods and subjects . Intravenous caffeine administration may provide a useful model system for investigating factors relevant to the use and abuse of stimulant drugs OBJECTIVE Caffeinated energy drinks-alone or with alcohol-are heavily marketed to young adults , many of whom believe that caffeine counteracts some negative effects of alcohol intoxication . While the effects of caffeine and alcohol have been widely investigated , few studies have examined neuropsychological performance after consumption of a beverage containing both ingredients . METHODS In a double-blind , placebo-controlled design , 27 non-caffeine-deprived female participants were r and omly assigned to consume a caffeinated energy drink alone , one containing alcohol , or a non-alcoholic , non-caffeinated control beverage . Pre- and post-test assessment s were conducted using alternate forms of the Repeatable Battery for the Assessment of Neuropsychological Status ( RBANS ) . RESULTS Participants who consumed the energy drink plus alcohol evidence d significantly lower post-test performance on a global score of neuropsychological status . Specifically , deficits were found in both visuospatial/constructional and language performance scores . While participants who consumed the caffeinated beverage alone trended toward improved attention scores , neuropsychological status did not show meaningful changes from the pre- to post-test . CONCLUSIONS Consumption of an energy drink containing 6 % alcohol by volume negatively influenced performance on a global measure of cognitive functioning BACKGROUND College students who consume caffeinated alcoholic beverages ( CaffAlc ) are at increased injury risk . This study examines the extent to which a sensation-seeking personality accounts for the relationship between consumption of CaffAlc and negative outcomes . METHODS A Web-based survey was administered to stratified r and om sample s of 4907 college students from eight North Carolina universities in Fall 2009 . Sensation seeking was assessed using the Brief Sensation-Seeking Scale ( BSSS ) ( α=0.81 ) . Data were analyzed using linear and logistic regression . RESULTS 3390 students ( 71.2 % ) reported past 30-day drinking , of whom 786 ( 23.2 % ) consumed CaffAlc . CaffAlc past 30-day drinkers had higher BSSS scores ( 3.8 vs. 3.4 ; p<0.001 ) , compared to non-CaffAlc drinkers . Consumption of CaffAlc was associated with more frequent binge drinking ( p<0.001 ) and drunken days in a typical week ( p<0.001 ) , even after adjusting for the BSSS score . CaffAlc students were more likely to be taken advantage of sexually ( adjusted odds ratio [AOR]=1.70 , p=0.012 ) , drive under the influence of alcohol ( AOR=2.00 , p<0.001 ) , and ride with a driver under the influence of alcohol ( AOR=1.87 , p<0.001 ) . Injury requiring medical treatment was more prevalent among CaffAlc students with higher BSSS-8 scores ( interaction p=0.024 ) , even after adjustment for drinking levels and student characteristics . CONCLUSIONS Sensation seeking does not fully account for the increase in risky drinking among college students who consume CaffAlc , nor does it moderate the relationship between CaffAlc and drinking behaviors . Sensation seeking moderates the risk of alcohol-associated injury requiring medical treatment among college students who consume CaffAlc . Those with strong sensation-seeking dispositions are at the highest risk of alcohol-associated injury requiring medical treatment Twelve experienced navigators participated in an experiment to determine the effects of alcohol , caffeine , and an alcohol + caffeine mixture on performance during the following tasks : visual search , the search and location of items on a navigational chart ( chart search ) and the solving of maritime navigational problems . Alcohol ( 75 ml ) produced impairment in performance on visual search ( p < 0.05 ) and navigational problem-solving ( p < 0.01 ) . Caffeine was found to enhance performance on visual search ( p < 0.05 ) but not on the chart search , although a significant correlation was found between performance on the two tests ( p < 0.05 ) . Caffeine was not found to improve the accuracy of navigational problem-solving ( p > 0.05 ) . Neither alcohol nor caffeine had any significant effect on the speed of problem-solving ( p > 0.05 ) OBJECTIVE We examined the sociodemographic correlates of energy drink use and the differences between those who use them with and without alcohol in a representative community sample . METHODS A r and om-digit-dial l and line telephone survey of adults in the Milwaukee , Wisconsin area responded to questions about energy drink and alcohol plus energy drink use . RESULTS Almost one-third of respondents consumed at least one energy drink in their lifetime , while slightly over 25 % used energy drinks in the past year and 6 % were past-year alcohol plus energy drink users . There were important racial/ethnic differences in consumption patterns . Compared to non-users , past-year energy drink users were more likely to be non-Black minorities ; and past-year alcohol plus energy drink users when compared to energy drink users only were more likely to be White and younger . Alcohol plus energy drink users also were more likely to be hazardous drinkers . CONCLUSIONS Our results which are among the first from a community sample suggest a bifurcated pattern of energy drink use highlighting important population consumption differences between users of energy drinks only and those who use alcohol and energy drinks together BACKGROUND Previous laboratory research on alcohol absorption has found that substitution of artificially sweetened alcohol mixers for sucrose-based mixers has a marked effect on the rate of gastric emptying , result ing in elevated blood alcohol concentrations . Studies conducted in natural drinking setting s , such as bars , have indicated that caffeine ingestion while drinking is associated with higher levels of intoxication . To our knowledge , research has not examined the effects of alcohol mixers that contain both an artificial sweetener and caffeine , that is , diet cola . Therefore , we assessed the event-specific association between diet cola consumption and alcohol intoxication in bar patrons . We sought to determine whether putative increases in blood alcohol , produced by accelerated gastric emptying following diet cola consumption , as identified in the laboratory , also appear in a natural setting associated with impaired driving . METHODS We conducted a secondary analysis of data from 2 nighttime field studies that collected anonymous information from 413 r and omly selected bar patrons in 2008 and 2010 . Data sets were merged and recoded to distinguish between energy drink , regular cola , diet cola , and noncaffeinated alcohol mixers . RESULTS Caffeinated alcohol mixers were consumed by 33.9 % of the patrons . Cola-caffeinated mixed drinks were much more popular than those mixed with energy drinks . A large majority of regular cola-caffeinated mixed drink consumers were men ( 75 % ) , whereas diet cola-caffeinated mixed drink consumers were more likely to be women ( 57 % ) . After adjusting for the number of drinks consumed and other potential confounders , number of diet cola mixed drinks had a significant association with patron intoxication ( β = 0.233 , p < 0.0001 ) . Number of drinks mixed with regular ( sucrose-sweetened ) cola and energy drinks did not have significant associations with intoxication ( p > 0.05 ) . CONCLUSIONS Caffeine 's effect on intoxication may be most pronounced when mixers are artificially sweetened , that is , lack sucrose which slows the rate of gastric emptying of alcohol . Risks associated with on-premise drinking may be reduced by greater attention given to types of mixers , particularly diet colas BACKGROUND It has been argued that the excessive consumption of energy drinks ( EDs ) may have serious health consequences , and that may serve as an indicator for substance use and other risky behaviors . The present paper offers a perspective on this topic that remains underexplored on the population of adolescents . METHODS Data were collected via self-administered anonymous question naires from 870 adolescents aged 15 to 19 years who were recruited from a r and om sample of public secondary schools in the geographic area of the Calabria Region , in the South of Italy . RESULTS A total of 616 participants completed the survey for a response rate of 70.8 % . Nearly 68 % of respondents had drunk at least a whole can of ED during their life , and about 55 % reported consuming EDs during the 30 days before the survey . Only 13 % of interviewed adolescents were aware that drinking EDs is the same as drinking coffee , whereas a sizable percentage believed that drinking EDs is the same as drinking carbonated beverages or rehydrating sport drinks . Forty-six percent of adolescents had drunk alcohol-mixed energy drinks ( AmEDs ) during their life , and 63 % of lifetime users admitted drinking AmEDs during the 30 days before the survey . Overall , 210 ( 63.3 % ) had drunk alcohol alone not mixed with EDs during their life , and more than half ( 56.3 % ) reported having consumed it at least once during the 30 days before the survey . Multivariate analysis showed that the factors independently associated with the consumption of AmEDs were the increasing number of sexual partners , being a current smoker , being male , riding with a driver who had been drinking alcohol , and having used marijuana . CONCLUSIONS Comprehensive educational programs among youths focusing on potential health effects of EDs , alcohol , and the combination of the two , design ed to empower the ability to manage these drinking habits , are strongly advisable |
11,521 | 18,074,465 | This meta- analysis demonstrates an overall reduction in mortality with the use of ivIg for the adjunctive treatment of severe sepsis and septic shock in adults , although significant heterogeneity exists among the included trials and this result was not confirmed when only high- quality studies were analyzed . | OBJECTIVES To systematic ally review the literature to assess whether adjunctive therapy with polyclonal intravenous immunoglobulin ( ivIg ) reduces mortality among critically ill adults with severe sepsis and septic shock . | Introduction In this prospect i ve , r and omized controlled study , we aim ed to evaluate the effect of IgM-enriched immunoglobulin treatment on progression of organ failure and septic shock in patients with severe sepsis . Material s and methods Forty-two patients with severe sepsis were enrolled in the study . Patients in the study group ( n = 21 ) received an intravenous immunoglobulin preparation ( Pentaglobin ® ) in addition to st and ard therapy . Pentaglobin ® therapy was commenced on the day of diagnosis of severe sepsis : 5 ml/kg per day Pentaglobin ® ( 38 g/l IgG , 6 g/l IgM , and 6 g/l IgA ) was infused over 6 hours and repeated for 3 consecutive days . Patients in the control group ( n = 18 ) received st and ard sepsis therapy , but no immunoglobulin administration . Blood sample s for procalcitonin ( PCT ) measurements were taken daily for 8 days . Severity of critical illness and development of organ failure were assessed by obtaining daily acute physiological and chronic health evaluation ( APACHE ) II and sequential organ failure assessment ( SOFA ) scores . Results and discussion Procalcitonin levels showed a statistically significant decrease in the Pentaglobin ® group ( P < 0.001 ) ; however , an improvement in SOFA scores could not be demonstrated . Procalcitonin levels and SOFA scores did not change significantly in the control group . Septic shock incidence ( 38 % versus 57 % ) and 28-day mortality rate ( 23.8 % versus 33.3 % ) were found to be similar between the Pentaglobin ® and control groups . The evaluation of serial APACHE II scores did not demonstrate a difference between Pentaglobin ® and control groups either . Conclusion Present data could not demonstrate any beneficial effects of polyclonal immunoglobulin preparation Pentaglobin ® on organ morbidity , septic shock incidence and mortality rate in patients with severe sepsis 35 patients with septic postoperative complications entered a prospect ively r and omized study . The clinical state of these patients was daily determined using the sepsis score described by Elebute and Stoner . Endotoxin and antithrombin III were measured in the plasma using the limulus-amoebocyte-lysat test for endotoxin determination . The septic patients were treated with an immunoglobulin preparation ( Pentaglobin ) administered by the intravenous route . This preparation is enriched in IgM and IgA. Due to the immunoglobulin therapy the endotoxin titres decreased ; simultaneously a reduction of mortality and shortening of time of hospitalization and of mechanical ventilation were observed BACKGROUND It remains uncertain whether the choice of resuscitation fluid for patients in intensive care units ( ICUs ) affects survival . We conducted a multicenter , r and omized , double-blind trial to compare the effect of fluid resuscitation with albumin or saline on mortality in a heterogeneous population of patients in the ICU . METHODS We r and omly assigned patients who had been admitted to the ICU to receive either 4 percent albumin or normal saline for intravascular-fluid resuscitation during the next 28 days . The primary outcome measure was death from any cause during the 28-day period after r and omization . RESULTS Of the 6997 patients who underwent r and omization , 3497 were assigned to receive albumin and 3500 to receive saline ; the two groups had similar baseline characteristics . There were 726 deaths in the albumin group , as compared with 729 deaths in the saline group ( relative risk of death , 0.99 ; 95 percent confidence interval , 0.91 to 1.09 ; P=0.87 ) . The proportion of patients with new single-organ and multiple-organ failure was similar in the two groups ( P=0.85 ) . There were no significant differences between the groups in the mean ( + /-SD ) numbers of days spent in the ICU ( 6.5+/-6.6 in the albumin group and 6.2+/-6.2 in the saline group , P=0.44 ) , days spent in the hospital ( 15.3+/-9.6 and 15.6+/-9.6 , respectively ; P=0.30 ) , days of mechanical ventilation ( 4.5+/-6.1 and 4.3+/-5.7 , respectively ; P=0.74 ) , or days of renal-replacement therapy ( 0.5+/-2.3 and 0.4+/-2.0 , respectively ; P=0.41 ) . CONCLUSIONS In patients in the ICU , use of either 4 percent albumin or normal saline for fluid resuscitation results in similar outcomes at 28 days Objective : To evaluate the effect of intravenous IgMA-enriched immunoglobulin ( ivIGMA ) therapy on mortality in neutropenic patients with hematologic malignancies and sepsis syndrome or septic shock . Design : Multiple-center , prospect i ve r and omized , controlled study . Setting : Six university hospitals in Germany . Patients : Patients were 211 neutropenic patients with sepsis syndrome or septic shock after chemotherapy for severe hematologic disorders between 1992 and 1999 . Interventions : Patients received 1300 mL of ivIGMA ( 7.8 g IgM , 7.8 g IgA , and 49.4 g IgG ) infused intravenously within a period of 72 hrs or human albumin according to the same schedule as ivIGMA . Measurements and Main Results : All-cause mortality at 28 days , sepsis-related mortality at 28 days , all-cause mortality at 60 days , mortality from septic shock , and mortality from microbiologically proven Gram-negative sepsis and septic shock were recorded . Immunoglobulin had no benefit over human albumin . The 28-day mortality rate was 26.2 % and 28.2 % in the ivIGMA and control patients , respectively ( difference , 2.0 % [ 95 % confidence interval , −10.2 to 14.2 percentage points ] ) . Likewise , the 60-day mortality rate did not differ between both arms ( 29.6 % vs. 34.7 % in the ivIGMA and control patients , respectively ) . Mortality rates in patients with sepsis syndrome ( 17.1 % vs. 16.7 % ) and septic shock ( 51.9 % vs. 54.8 % ) were also found to be similar between both groups . Conclusions : Intravenous ivIGMA had no beneficial effects in neutropenic patients with hematologic malignancies and sepsis syndrome and septic shock Thrombocytopenia frequently complicates systemic infection and results from multiple possible mechanisms . We and others have demonstrated that platelet-associated IgG ( PAIgG ) levels are elevated in the majority of patients with septic thrombocytopenia . Corticosteroids may be undesirable as a treatment for thrombocytopenia for patients with severe infection because of their potential for suppressing the immune response . We hypothesized that septic thrombocytopenia is , in most cases , an immune disorder analogous to idiopathic thrombocytopenic purpura ( ITP ) which might respond to intravenous gamma-globulin as a treatment for increasing the platelet count in this disorder . Intravenous immune globulin ( IVIG ) , 400 mg/kg daily for 3 days , was administered in a r and omized double-blind placebo-controlled trial . Twenty-nine patients who developed thrombocytopenia during a documented , septic episode were studied . Patients with disseminated intravascular coagulation ( DIC ) , hypersplenism , or drugs known to cause thrombocytopenia were excluded . Elevated PAIgG levels were documented in 52 % of evaluable patients . Mean platelet counts in the IVIG group rose from 43 K at study entry to 178 K ( 411 % rise ) by Day 9 . In the placebo group platelets rose from 51 K to 125 K ( 261 % rise;P = 0.02 ) . Seventy-seven percent of the IVIG group had a minimum peak rise of 35 K , vs 56 % of the placebo group . Three patients in the placebo group had a serious bleeding episode , vs one in the IVIG group . The use of IVIG to treat septic thrombocytopenia not associated with DIC leads to a more rapid , more sustained , and greater increase in platelet count than placebo . Its use is recommended in the septic patient who is bleeding or is likely to need invasive or surgical procedures The objective of this study was to assess the impact on outcome of adjuvant therapy ( high-dose of immunoglobulin [ Ig ] M-enriched intravenous Ig , IVIG ) in intensive care unit ( ICU ) patients who underwent surgery by abdominal sepsis . This was a prospect i ve , r and omized , double-blind , controlled study set in the medical/surgical ICUs of seven teaching hospitals . Patients with severe sepsis and septic shock of intra-abdominal origin admitted to the ICU within 24 h after the onset of symptoms were included in the study . Polyvalent IgM-enriched Ig ( Pentaglobin ® ; IVIG group ) at a dosage of 7 mL/kg/day for 5 days or an equal amount of 5 % human albumin ( control group ) was r and omized . Fifty-six patients were enrolled . The overall mortality rate was 37.5.% . Twenty patients had shock and 36 had severe sepsis ( the mortality rate was 55.0 % and 25.0 % , respectively ) . In the intent-to-treat analysis , the mortality rate was reduced from 48.1 % in patients treated with antibiotic ( ATB ) plus albumin to 27.5 % ( P = 0.06 ) for patients with ATB plus IVIG . The organ failure score ( 1.0 ± 0.6 vs. 1.2 ± 0.9 ) , organ dysfunction score ( 1.7 ± 1.1 vs. 1.8 ± 1.0 ) , and reoperation rate ( 17.2 % vs. 29.6 % ) were not different between IVIG and control groups , respectively . Eight patients ( 14.3 % ) received inappropriate ATB initial therapy ( IAT ) , and seven died ( 87.5 % ) . IAT was the only variable independently associated with death ( odds ratio , 19.4 ) in a logistic regression model . We conclude that IVIG administration , when used in combination with adequate antibiotics , improved the survival of surgical ICU patients with intra-abdominal sepsis . The initial choice of antibiotic has a dramatic impact on outcome The efficacy and safety of high-dose intravenous polyspecific immunoglobulin G ( IVIG ) as adjunctive therapy in streptococcal toxic shock syndrome ( STSS ) were evaluated in a multicenter , r and omized , double-blind , placebo-controlled trial . The trial was prematurely terminated because of slow patient recruitment , and results were obtained from 21 enrolled patients ( 10 IVIG recipients and 11 placebo recipients ) . The primary end point was mortality at 28 days , and a 3.6-fold higher mortality rate was found in the placebo group . A significant decrease in the sepsis-related organ failure assessment score at days 2 ( P=.02 ) and 3 ( P=.04 ) was noted in the IVIG group . Furthermore , a significant increase in plasma neutralizing activity against superantigens expressed by autologous isolates was noted in the IVIG group after treatment ( P=.03 ) . Although statistical significance was not reached in the primary end point , the trial provides further support for IVIG as an efficacious adjunctive therapy in STSS Summary A multicenter r and omized controlled clinical trial , which was carried out in 10 hospitals in the Federal Republic of Germany between 1979 and 1983 , studied the influence of i.v . immunoglobulin G on the mortality in patients with diffuse acute fibrinopurulent peritonitis . Altogether 288 patients were enrolled in the trial . There was no statistically significant difference in the mortality rates within the treated group ( 46 % ) vs the control group ( 41 % ) . The power of the statistical test to detect a decrease of the mortality by 20 % was calculated to be 0.93 . This result did not change when we eliminated 50 patients not strictly obeying the entrance criteria of the analysis , or when we focused on a subgroup of patients with initial deficiency of immunoglobulin G. Factors influencing mortality were a preceding laparotomy , serum creatinine level above 2 mg/100 ml , and necessity for artificial respiration . These factors , reflecting the surgical situation and the severity of shock , essentially explain the mortality differences observed between the participating hospitals Sixty-two consecutive septic surgical patients receiving st and ard multimodal intensive care unit treatment who developed a sepsis score of 20 or greater ( day 0 ) were r and omized to receive 0.4 g/kg of either intravenous IgG ( 29 patients ) or human albumin ( controls ; 33 patients ) , repeated on days + 1 and + 5 , in a prospect i ve , double-blind , multicenter study . The two groups were similar in age , initial sepsis scores , and acute physiology and chronic health evaluation II score . A significantly lower mortality was recorded in the IgG-treated group ( 38 % ) than in controls ( 67 % ) . Septic shock was the cause of death in 7 % of IgG-treated patients and in 33 % of controls . The results of this study indicate that high-dose IgG improves survival and decreases death from septic shock in surgical patients with a sepsis score of 20 or greater MRC CRASH is a r and omised controlled trial ( IS RCT N74459797 ) of the effect of corticosteroids on death and disability after head injury . We r and omly allocated 10,008 adults with head injury and a Glasgow Coma Scale score of 14 or less , within 8 h of injury , to a 48-h infusion of corticosteroid ( methylprednisolone ) or placebo . Data at 6 months were obtained for 9673 ( 96.7 % ) patients . The risk of death was higher in the corticosteroid group than in the placebo group ( 1248 [ 25.7 % ] vs 1075 [ 22.3 % ] deaths ; relative risk 1.15 , 95 % CI 1.07 - 1.24 ; p=0.0001 ) , as was the risk of death or severe disability ( 1828 [ 38.1 % ] vs 1728 [ 36.3 % ] dead or severely disabled ; 1.05 , 0.99 - 1.10 ; p=0.079 ) . There was no evidence that the effect of corticosteroids differed by injury severity or time since injury . These results lend support to our earlier conclusion that corticosteroids should not be used routinely in the treatment of head injury 59 patients with suspected or verified septicaemia and 87 patients with suspected or verified bacterial pneumonia were treated with either antibiotics alone or antibiotics combined with a pepsin-treated human gamma globulin ( Gamma-Venin ) . The gamma globulin was given intravenously in repeated doses of 0.15 g/kg body weight . Extensive clinical and laboratory investigations were performed repeatedly in a strictly st and ardized fashion . Neither the septicaemia group nor the pneumonia group presented significant differences between treated patients and controls for any of the clinical and laboratory variables studied . Hospital stay , duration of fever and symptoms were also unaffected by the gamma globulin treatment . Subdivision of the material according to aetiology provided no additional information . In 9 patients adverse reactions were seen , e.g. , shock in 2 individuals Objectives : To describe the effectiveness of a comprehensive , interdisciplinary sepsis treatment protocol with regard to both implementation and outcomes and to compare the mortality rates and therapies of patients with septic shock with similar historical controls . Design : Prospect i ve , interventional cohort study with a historical control comparison group . Setting : Urban , tertiary care , university hospital with 46,000 emergency department visits and 4,100 intensive care unit admissions annually . Patients : Inclusion criteria were a ) emergency department patients aged ≥18 yrs , b ) suspected infection , and c ) lactate of > 4 mmol/L or septic shock . Exclusion criteria were a ) emergent operation , b ) prehospital cardiac arrest , and c ) comfort measures only . Time period : protocol , November 10 , 2003 , through November 9 , 2004 ; historical controls , February 1 , 2000 , through January 31 , 2001 . Intervention : A sepsis treatment pathway incorporating empirical antibiotics , early goal -directed therapy , drotrecogin alfa , steroids , intensive insulin therapy , and lung-protective ventilation . Measurements and Main Results : There were 116 protocol patients , with a mortality rate of 18 % ( 11–25 % ) , of which 79 patients had septic shock . Comparing these patients with 51 historical controls , protocol patients received more fluid ( 4.0 vs. 2.5 L crystalloid , p < .001 ) , earlier antibiotics ( 90 vs. 120 mins , p < .013 ) , more appropriate empirical coverage ( 97 % vs. 88 % , p < .05 ) , more vasopressors in the first 6 hrs ( 80 % vs. 45 % , p < .001 ) , tighter glucose control ( mean morning glucose , 123 vs. 140 , p < .001 ) , and more frequent assessment of adrenal function ( 82 % vs. 10 % , p < .001 ) , with a nonstatistically significant increase in dobutamine use ( 14 % vs. 4 % , p = .06 ) and red blood cell transfusions ( 30 % vs. 18 % , p = .07 ) in the first 24 hrs . For protocol patients with septic shock , 28-day in-hospital mortality was 20.3 % compared with 29.4 % for historical controls ( p = .3 ) . Conclusions : Clinical implementation of a comprehensive sepsis treatment protocol is feasible and is associated with changes in therapies such as time to antibiotics , intravenous fluid delivery , and vasopressor use in the first 6 hrs . No statistically significant decrease in mortality was demonstrated , as this trial was not sufficiently powered to assess mortality benefits A r and omized controlled clinical trial was conducted on the effects of immunoglobulin in therapy for infections in 104 intensive care patients . At the first sign of infection , one group of 50 patients received an i.v . preparation of immunoglobulin ( 4 X 100 ml ) combined with antibiotics . The other 54 control patients received antibiotics alone . The most common infections in these patients were pneumonia , septicemia , peritonitis and wound sepsis . Infections were significantly seldom the cause of death , especially in patients with high-risk surgery who had been treated with immunoglobulin ( p less than or equal to 0.05 ) . Likewise ventilation time in the high-risk surgery group averaged only 5.5 days for those receiving immunoglobulin as opposed to 12.7 days in controls ( p less than or equal to 0.01 ) . Whereas the control group , in particular patients with pneumonia , remained in intensive care an average of 21.5 days , those receiving immunoglobulin stayed only 14.8 days ( p less than or equal to 0.01 ) . In general , patients treated with immunoglobulin recovered more rapidly from infections than did controls ( p less than or equal to 0.01 ) The therapeutic use of iv immunoglobulins of the G class in association with antibiotics in patients with severe sepsis is reported . As compared to the r and omized control group of patients treated with antibiotics alone , patient survival was only slightly improved ( from 25 % to 42 % ; NS ) ; however , the defervescence time was significantly shorter ( 10 vs. 16 days ) , and a greater percentage of microbiologically positive cultures became negative ( 40 % vs. 8 % ; p less than .01 ) . The percentage of days on antibiotic treatment during ICU hospitalization was consequently reduced ( 38 % vs. 95 % ; p less than .01 ) . The therapeutic use of iv immunoglobulin G is discussed in terms of antibody substitution and modulation of the immune system Substantial numbers of clinical trials are never reported in print , and among those that are , many are not reported in sufficient detail to enable judgments to be made about the validity of their results . Failure to publish an adequate account of a well- design ed clinical trial is a form of scientific misconduct that can lead those caring for patients to make inappropriate treatment decisions . Investigators , research ethics committees , funding bodies , and scientific editors all have responsibilities to reduce underreporting of clinical trials . An extended use of prospect i ve registration of trials at inception , as well as benefiting clinical research in other ways , could help people to play their respective roles in reducing underreporting of clinical trials Infection is a major cause of morbidity and mortality in critically ill patients . Despite advances in technology , its mortality rate has changed minimally over the past two decades , and new therapies are needed . Polyclonal intravenous immunoglobulin ( IVIG ) has been investigated both as a preventive and a treatment modality for sepsis and septic shock in critically ill adult patients . Prophylaxis with IVIG has been shown to reduce significantly the incidence of infection , particularly pneumonia , in selected postsurgical intensive care patients . However , it does not reduce mortality . The risk-benefit and cost effectiveness of this therapeutic intervention have not been determined , and its routine use is therefore not recommended . Treatment with IVIG has been shown in a number of small trials and a meta- analysis to reduce dramatically sepsis and septic shock mortality . However , a large , unpublished r and omized trial has apparently shown no mortality benefit with this therapy . Despite limited evidence , IVIG has become the st and ard of care for the management of group A streptococcal toxic shock syndrome . At present , clinical equipoise exists for the use of IVIG in the treatment of sepsis and septic shock , and further study is needed |
11,522 | 22,303,416 | After combining the four components and assessing the grade of the evidence , the strength of recommendation of the intervention is established .
This expansion of the GRADE ( Ex- GRADE ) permits the creation of a new instrument that can produce tangible data and possibly bridge the gap between evidence -based research and evidence -based clinical practice | Clinicians use general practice guidelines as a source of support for their intervention , but how much confidence should they place on these recommendations ?
How much confidence should patients place on these recommendations ?
Various instruments are available to assess the quality of evidence of research , such as the revised Wong scale ( R-Wong ) which examines the quality of research design , methodology and data analysis , and the revision of the assessment of multiple systematic review s ( R-AMSTAR ) , which examines the quality of systematic review s. The Grading of Recommendation Assessment , Development , and Evaluation ( GRADE ) Working Group developed an instrument called the GRADE system in order to grade the quality of the evidence in studies and to evaluate the strength of recommendation of the intervention that is proposed in the published article .
The GRADE looks at four factors to determine the quality of the evidence : study design , study quality , consistency , and directness .
In this study , we have quantified both the grading of the quality of evidence and also the strength of recommendation of the original GRADE , hence exp and ing the GRADE . | Aqueous hydrogen peroxide ( H2O2 ) has been used clinical ly at 30 % to 35 % levels to lighten teeth for many years , but the process has required multiple visits . Heat and light have been used empirically in attempts to catalyze H2O2 decomposition and speed tooth lightening . The contribution of bleaching lights ( LumaArch , Optilux 500 , and Zoom ! ) to act as catalysts for lightening teeth was studied in 83 pairs of contralateral anterior maxillary and m and ibular teeth on 15 human subjects . Split-arch design using central s , laterals , and canines on one side treated with bleach plus light , were compared with contralateral teeth using bleach alone . Three research ers trained in the use of the Vitapan 3D-Master Shade Guide took shades with independently agreement within 0.5 value-chroma sum 89 % of the time throughout the study Laboratory tests determined bleach gel chemistry , bleach light output , and effects on the bleaches of light alone and heat alone . Results showed that the three test lights did not lighten teeth more than their bleach gels alone . All teeth lightened to nearly the same degree ( 1.7 color increments ) , but LumaArch required 60 % less time and Zoom ! used 1/3 lower H2O2 concentration . Laboratory tests indicated that the proprietary chemicals mixed into each bleach gel just before use acted as catalysts and were probably responsible for more rapid lightening produced by LumaArch gel , and need for less H2O2 in Zoom ! gel . Neither the heat produced by the accessory lights , nor the light output itself were responsible for catalytic activity with any of the three systems tested . Collectively , the data demonstrate positive effects from chemical catalysts added to bleaching gels . No output from any of the lights result ed in heat or light that catalyzed the gels This study clinical ly evaluated the alteration of color , color stability , dental sensitivity and gingival irritation on patients undergoing dental bleaching using varying bleaching methods and light-activation sources . According to pre-established criteria , 40 patients were selected and r and omly divided into four groups ( n=10 ) : Group 1 - -35 % Hydrogen Peroxide ( HP ) ; Group 2 - -35 % HP plus Halogen Curing Light XL 3000 ( 3M/ESPE ) ; Group 3 - -35 % HP plus Demetron LED ( Kerr ) and Group 4 - -35 % HP plus LED/LASER ( Bio-art ) . For all groups , there were two sessions of bleaching with 35 % HP , with a one week break between sessions . At each bleaching session , three applications of the bleaching gel were used . Two methods of shade evaluation were performed before and after the first week , second week , first month and after six months of the bleaching treatment . These methods were VITA Easyshade Spectrophotometer and Vita Classical Shade Guide . Statistical analysis using ANOVA demonstrated e quality between the participating groups when evaluating the group and time variables . The In-Office dental bleaching treatments of vital teeth with 35 % HP did not prove to be more effective when light sources were used . There was no difference in color stability between groups until the sixth month of evaluation PURPOSE To compare in vitro the bleaching effects obtained with and without the use of the various lights on power bleaching systems . METHODS 19 groups of five tooth specimens were prepared and allocated r and omly to treatments . Only specimens with shade C4 were accepted for the study . Three commercial bleaching products all based on 35 % hydrogen peroxide were used with and without four different light sources . Shade assessment s were made using a Shade Guide ( SG ) , Shade Vision System ( SVS ) and chromometer . RESULTS For SG , all but the light only treatment result ed in measurable improvement in shade ranging from 4.6 to 14.6 shade guide units . Similar findings were apparent with SVS and chromometer . No change was seen in the light only treatments by SVS or SG with very small changes by chromometer . In mean terms with all three gels , least change was noted when there was no light used . For SG , SVS and chromometer data analysis over all treatment groups , excluding light only treatments , revealed highly significant differences . Within bleach product treatment differences were only significant with one gel both with and without light activation . Differences between gels with the same light and no light revealed some significant differences in SG and chromometer data but not SVS . In mean terms the order of efficacy of gels with each light and no light was the same for the majority of data sets BACKGROUND Light-activated bleaching is a method of tooth whitening . The authors conducted a study to compare the whitening effects and tooth temperature changes induced by various combinations of peroxide bleaches and light sources . METHODS The authors r and omly assigned 250 extracted human teeth halves into experimental groups ( n = 10 ) . A placebo gel ( control ) , a 35 percent hydrogen peroxide or a 10 percent carbamide peroxide bleach was placed on the tooth surface and was irradiated with no light ( control ) ; a halogen curing light ; an infrared , or IR , light ; an argon laser ; or a carbon dioxide , or CO2 , laser . Color changes were evaluated immediately , one day and one week after treatment using a value-oriented shade guide and an electronic dental color analyzer . The outer enamel and inner dentin surface temperatures were monitored before and immediately after each 30-second application of light using a thermocouple thermometer . RESULTS Color and temperature changes were significantly affected by an interaction of the bleach and light variables . The application of lights significantly improved the whitening efficacy of some bleach material s , but it caused significant temperature increases in the outer and inner tooth surfaces . The IR and CO2 laser lights caused the highest tooth temperature increases . CONCLUSIONS Dentists performing an in-office bleaching technique with the use of an additional light source to accelerate tooth whitening should consider the specific bleaching agent being used , as well as the potential risks of heating teeth . CLINICAL IMPLICATION S A specific combination of bleach and light that demonstrates good color change and little temperature rise should be selected for in-office tooth bleaching OBJECTIVE Evaluate a light-enhanced in-office tooth whitening system in order to assess tooth color and safety . METHODS Thirty-three adults were r and omly assigned to one of three treatment groups . Professional treatment involved application of a 25 % H(2)O(2 ) gel ( Discus Dental ZOOM ! ) with light enhancement , H(2)O(2 ) gel alone , or the light alone with no peroxide . The 12 anterior teeth were treated three times for 20 minutes each . Efficacy was measured objective ly as L*a*b * color change using digital images , tooth shade was measured , and safety was evaluated immediately after treatment and at posttreatment days 7 and 30 . RESULTS After adjusting for baseline and age , immediate ( end-of-treatment ) means ( SE ) for Deltab * ( yellowness ) were -3.1 ( 0.25 ) for the gel + light , -2.0 ( 0.25 ) for the gel-only group , and -2.4 ( 0.25 ) for the light-only group . Significant ( p < 0.05 ) color rebound was evident at posttreatment day 7 . By day 30 , adjusted means (SE)for Deltab * were -1.7 ( 0.20 ) for the gel + light group , -1.1 ( 0.20 ) for the gel-only group , and -0.5 ( 0.20 ) for the light-only group . Both peroxide groups differed significantly ( p < 0.05 ) from light alone on Deltab * and DeltaL*. In the gel + light group , 91 % of subjects experienced tooth sensitivity , the majority of which was moderate or severe . Adverse events were low in the light-only group . CONCLUSION Use of light enhancement for in-office whitening leads to immediate color change , after which there was significant color and shade rebound within 7 days as well as moderate-to-severe tooth sensitivity during and after treatment . CLINICAL SIGNIFICANCE Increased tooth sensitivity during treatment and appreciable short-term color rebound after treatment may impact the utility of in-office tooth whitening with peroxide and light as a st and -alone esthetic procedure . ( J Esthet Restor Dent 21:336 - 347 , 2009 ) The objective of the present study was to assess the clinical efficacy of a dental bleaching system based on hydrogen peroxide with or without light activation . This r and omized controlled trial evaluated the effect of the light when applied to the hydrogen peroxide by using a split-mouth design with 21 patients , with light activation in one hemi-arch but not in the other . The bleaching agent was QuickWhite 35 % hydrogen peroxide and activation was conducted with a diode lamp ( Luma Cool ) . The Classic Vita Guide was used to score tooth shades . Two consecutive applications of hydrogen peroxide were made to one hemi-arch , each light-activated for 10 min . The other hemi-arch was then identically treated but without light activation . After removal of the bleaching agent , the shade was re-scored and the Wilcoxon signed ranks test was used to compare differences in tooth shade values . The bleaching treatment produced significant shade changes ( P < 0.01 ) in both hemi-arches . After treatment , there were no statistically significant differences between light-treated and non-light-treated tooth types ( central incisors , lateral incisors , and canines ) . However , taking central incisor , lateral incisor , and canine as a group , comparison between each hemi-arch showed a significant effect in the hemi-arch with light activation ( P < 0.05 ) . The use of diode light with a 35 % hydrogen peroxide gel slightly improved the dental bleaching The aim of this clinical study was to evaluate the efficiency of in-office bleaching systems with different light sources for color change and possible side effects such as tooth sensitivity and gingival irritations . Forty healthy volunteers aged 18 years and older ( average age 27.3 years ) , having all their natural healthy teeth in shade A3 or darker on the Vita shade guide , with no restorations on the buccal surfaces and no tooth sensitivity , participated in this study . Participants were r and omly assigned to four groups of ten volunteers . Group 1 received bleaching without light activation ( Opalescence Xtra Boost , Ultradent ) ; group 2 received bleaching ( Laser White 10 , Biolase ) with a diode laser ( 810 nm , 10 W/ Laser Smile , Biolase ) activation ; group 3 received bleaching treatment ( Remewhite , Remedent ) with a plasma arc lamp ( 400–490 nm , 2800 mV/cm2 , Remecure CL15 ) , and group 4 received bleaching with a light emitting diode ( LED ) lamp ( By White accelerator , Ensodent ) according to the manufacturers ’ recommendations . The shade was assessed with a classical Vita shade guide ( Vita Zahnfabrik ) and a digital spectrophotometer ( Vita Easy Shade , Vident ) . The color of teeth was scored at baseline and 1 week after bleaching . Any side effects on teeth or gingiva was recorded by visual analog scale . Results were analyzed statistically , by one-way analysis of variance ( ANOVA ) , Kruskal – Wallis , and Mann – Whitney U tests with Bonferroni correction . All the bleaching techniques result ed in shade change . No significant differences were found in the color change among the four groups with shade guide assessment ( P > 0.05 ) , but spectrophotometer readings exhibited significant differences among the groups ( P < 0.05 ) . The overall shade change values expressed as ΔL , Δa , Δb , ΔE for group 2 was significantly higher than those for the other groups ( P < 0.05 ) . Group 2 also showed lower tooth and gingival sensitivity scores than those of the other groups ( P < 0.05 ) . All techniques result ed in shade change . Although the shade guide evaluation did not exhibit any differences among the bleaching treatment groups , spectrophotometer readings showed different findings . The results obtained by the two methods of evaluation of shade change used in this study were different from each other . Bleaching with diode laser result ed in less tooth and gingival sensitivity than the other bleaching systems . Clinical relevance : in-office bleaching systems used with or without light , lead to a shade change . As bleaching with diode laser result ed in less tooth and gingival sensitivity , it might be preferred among in-office bleaching systems AIM The study aim ed to evaluate the effect of four in-office dental bleaching methods on shade change , color stability , patient satisfaction and postoperative sensitivity . METHODS AND MATERIAL S Forty patients were r and omly divided into four groups ( n=10 ) according to the method of in-office bleaching used : Group A-35 % hydrogen peroxide ( HP ) ; Group B-35 % HP plus BriteSmile and a blue curing light ; Group C-35 % HP plus QuickSmile and an LED curing light ; Group D-35 % HP and a Zoom2 metal halide curing light . For all groups , there was only one session of bleaching with three 20-minute applications of bleaching gel . The shade was evaluated before bleaching , immediately after , and one month after treatment using a VITA Classical Shade Guide . RESULTS Immediately after bleaching there was a significant difference in color change between the four groups , with Group B having the best results . At one month there was no difference between the four groups . Immediate postoperative sensitivity was the least in Group A and the highest for Group B. Patients in Group B were the most satisfied with the outcome of the bleaching procedure . CONCLUSIONS In general , the use of different lights for activation of an in-office bleaching agent did not affect the long-term results . Tooth sensitivity was mild and transient in the study . Patients were satisfied with in-office bleaching . CLINICAL SIGNIFICANCE Using light activation with in-office bleaching seems to increase the efficacy of treatment only for a short period of time This study evaluated the effectiveness of light-curing ( heat conversion ) vs no light-curing ( no heat conversion ) of a 35 % hydrogen peroxide in-office tooth whitening system . Twenty patients with sound medical history ( without tooth sensitivity ) participated in this r and omized , parallel clinical evaluation . Only six maxillary anterior teeth with discoloration and a tooth shade of A3 or darker were selected . Patients received a complete prophylaxis and were evaluated for initial ( baseline ) shade by three independent evaluators , precalibrated at 85 % rater reliability in determining shades before the experiment began . Participants received a 20-minute chairside whitening treatment with a 35 % hydrogen peroxide agent using a reflective resin barrier for gingival isolation . During the whitening treatment , the 35 % hydrogen peroxide agent was light-activated with a halogen curing light on teeth Nos. 6 through 8 ( Group I ) , but was not light-activated on teeth Nos. 9 through 11 ( Group II ) . All patients returned 24 hours after the whitening application for shade evaluation . Although there were isolated instances ( 7 out of 20 patients ) of greater degrees of lightening in the light-curing group , there was no statistically significant difference using the Mann-Whitney U test ( P > .05 ) . This study indicates that light-curing is optional with this 35 % tooth whitening system Recent improvements in the in-office techniques for bleaching teeth have reduced chair time , simplified the procedure and reduced the potential for pulpal inflammation and other side effects . Home bleaching has become very popular , but many patients will still prefer the faster , in-office procedure done by their dentist . This comparison of two 35 percent hydrogen peroxide products confirms that these procedures are effective and should be a part of any practice providing esthetic improvements for its patients OBJECTIVE This study examined whether an ultraviolet light enhanced the whitening efficacy of a peroxide gel containing a photo-Fenton activator . METHODOLOGY Fifty subjects were enrolled into the trial at two geographically separate sites . As directed by the r and omization keys , teeth of half of the study subjects were concurrently exposed to the whitening lamp , while the gel was on their teeth , for a total light exposure of 45 minutes . The other half of the subjects received no light treatment . At each examination , clinical data were collected on the gingival index , shade score , and self-assessed dentinal hypersensitivity . RESULTS Changes in tooth shade were significantly better ( approximately 26 % improvement ; p < 0.05 ) for subjects exposed to the gel and dental whitening lamp ( average = 7.7 shade changes ) compared to subjects exposed to the gel only ( average 6.1 shades ) immediately after treatment . No reports of erythema , desquamation , ulceration of soft tissues , gross changes in teeth , gingiva , or restorations were documented . The relative changes in mean sensitivity scores were similar for both groups , with no significant differences between the Light and No-light groups at any interval . CONCLUSION The whitening effect was improved by approximately 26 % when the Zoom2 dental whitening lamp was used . It was demonstrated that the a photo-Fenton activator used with a bleaching light and 20 % hydrogen peroxide gel is safe and effective for whitening teeth rapidly BACKGROUND The authors tested the adjunctive use of light with a 15 percent peroxide gel as a single-visit , in-office tooth whitening system . METHODS Subject ( N = 87 ) with stained ( > shade D4 , Vita Zahnfabrik , Bad Säckingen , Germany ) anterior teeth were r and omly assigned to test ( peroxide and light ) , peroxide control ( peroxide gel ) or light control ( placebo gel and light ) groups and were treated for one hour . The research ers evaluated tooth shade , color and subject response at baseline and posttreatment and at three and six months posttreatment . RESULTS The initial shade unit reduction of combined light and peroxide treatment ( 8.4 ) was greatest compared with that of peroxide alone ( 5.9 ) and of light alone ( 4.9 ) . Approximately 88 percent of these effects persisted for six months . Lightness was increased and yellowness decreased to a significantly greater extent in the test group than in either control . These findings were corroborated by subject evaluation . One week after treatment , moderate to greatly increased tooth sensitivity occurred in 20 percent of test subjects , 21.7 percent of peroxide control subjects and none of the light control subjects . Neither tooth sensitivity nor gingival redness was present at the three- and six-month visits . CONCLUSIONS Peroxide and light treatment significantly lightened the color of teeth to a greater extent than did peroxide or light alone , with a low and transient incidence of tooth sensitivity . CLINICAL IMPLICATION S Light can increase the tooth-whitening effect of peroxide , thereby increasing the effectiveness of tooth-whitening procedures Tooth whitening has become one of the most popular dental treatments available . This article compares the efficacy of 2 in-office whitening systems using a split-arch , r and omized , parallel , blinded clinical evaluation study . Both in-office tooth whitening systems were effective and there was no significant statistical difference over the 2-week period of observation . The use of light did not demonstrate any benefit over the chemically activated tooth whitening system after a 2-week recall |
11,523 | 29,417,317 | These results confirm that smoking increases the risk of sudden cardiac death . | Smoking is an established risk factor for cardiovascular disease including coronary heart disease and stroke , however , data regarding smoking and sudden cardiac death have not been summarized in a meta- analysis previously .
We therefore conducted a systematic review and meta- analysis to clarify this association . | Background — Few prospect i ve studies have examined quantitative cigarette consumption and smoking cessation on sudden cardiac death ( SCD ) risk with long-term follow-up . Methods and Results — We prospect ively examined the association between cigarette smoking and smoking cessation on the risk of SCD among 101 018 women participating in the Nurses ’ Health Study without known coronary heart disease , stroke , and cancer at baseline 1980 . During 30 years of follow-up , we identified 351 SCD events . Compared with never smokers , current smokers had a 2.44-fold ( 95 % CI , 1.80–3.31 ) increased risk of SCD after controlling for coronary risk factors . In multivariable analyses , quantity of cigarettes smoked daily ( P value for trend , < 0.0001 ) and smoking duration ( P value for trend , < 0.0001 ) were linearly associated with SCD risk among current smokers . Small-to-moderate amounts of cigarette consumption ( 1–14 per day ) were associated with a significant 1.84-fold ( 95 % CI , 1.16–2.92 ) increase in SCD risk and every 5 years of continued smoking was associated with an 8 % increase in SCD risk ( hazard ratio , 1.08 ; 95 % CI , 1.05–1.12 ; P<0.0001 ) . The SCD risk linearly decreased over time after quitting and was equivalent to that of a never smoker after 20 years of cessation ( P value for trend , < 0.0001 ) . Conclusions — In this large prospect i ve cohort of women without coronary heart disease at baseline , a strong dose – response relationship between cigarette smoking and SCD risk was observed , and smoking cessation significantly reduced and eventually eliminated excess SCD risk . This suggests efforts to prevent SCD among women should include aggressive strategies for smoking cessation Sudden cardiac death ( SCD ) generally refers to an unexpected death from a cardiovascular cause in a person with or without preexisting heart disease . The specificity of this definition varies depending on whether the event was witnessed ; however , most studies include cases that are associated with a witnessed collapse , death occurring within 1 hour of an acute change in clinical status , or an unexpected death that occurred within the previous 24 hours.1–3 Further , sudden cardiac arrest describes SCD cases with resuscitation records or aborted SCD cases in which the individual survived the cardiac arrest . The incidence of SCD in the United States ranges between 180 000 and 450 000 cases annually.4 These estimates vary owing to differences in SCD definitions and surveillance methods for case ascertainment.4,5 In recent prospect i ve studies using multiple sources in the United States,6,7 Netherl and s,8 Irel and , 9 and China,10 SCD rates range from 50 to 100 per 100 000 in the general population .3 Despite the need for multiple sources of surveillance to provide a more accurate estimate of SCD incidence , it is clear that the overall burden in the population remains high . Although improvements in primary and secondary prevention have result ed in substantial declines in overall coronary heart disease ( CHD ) mortality over the past 30 years,11,12 SCD rates specifically have declined to a lesser extent.13–16 SCD still accounts for > 50 % of all CHD deaths and 15 % to 20 % of all deaths.17,18 For some segments of the population , rates are not decreasing19 and may actually be increasing.14,19 As a result , SCD prevention represents a major opportunity to further reduce mortality from CHD . Despite major advances in cardiopulmonary resuscitation20 and postresuscitation care , survival BACKGROUND Cigarette smoking is a known risk factor for cardiovascular disease ( CVD ) , but its relationship to the development of hypertension is unclear . Previous epidemiological studies have shown inconsistent results , having demonstrated inverse and positive associations between cigarette smoking and the development of hypertension . METHODS We analyzed 13,529 male participants from the Physicians ' Health Study free of baseline hypertension and CVD who provided information about smoking status . Smoking status was categorized as never , past , or current < 20 cigarettes/day , or current > or = 20 cigarettes/day . Incident hypertension was defined as either the initiation of antihypertensive treatment , self-reported systolic blood pressure ( BP ) > or = 140 mm Hg , or diastolic BP > or = 90 mm Hg . RESULTS Over a median follow-up of 14.5 years , 4,904 men developed hypertension . We modeled the risk of developing hypertension by baseline smoking status adjusting for known risk factors for hypertension or CVD . In a fully adjusted Cox proportional hazards model , we found that compared with never smokers , past smokers and current smokers had corresponding relative risks ( RRs ) of 1.08 and 1.15 of developing hypertension . The risk for smokers did not appear to differ based on number of cigarettes smoked daily . Further , the RR of hypertension was higher for men with normal vs. prehypertensive levels of systolic ( SBP ) or diastolic BP ( DBP ) . CONCLUSIONS This prospect i ve cohort data suggests that cigarette smoking may be a modest but important risk factor for the development of hypertension BACKGROUND Sudden death was found to share the same set of usual risk factors as coronary events and therefore could not be specifically predicted in the population . It appears , however , that parental history of sudden death has not been investigated yet as a risk factor for sudden death . Therefore , we assessed risk factors , including parental sudden death , associated with the occurrence of sudden death in a long-term cohort study . METHODS AND RESULTS We included 7746 men employed by the city of Paris who were 43 to 52 years of age in 1967 to 1972 in the Paris Prospect i ve Study I. Each subject underwent a physical examination and an ECG , provided blood for laboratory tests , and answered question naires administered by trained interviewers who paid particular attention to family medical history . Men with known ischemic cardiac disease were further excluded from analysis . For 95.5 % of the men , vital status was obtained from specific inquiries until retirement , then by death certificates . Resting heart rate , systolic or diastolic blood pressure , tobacco consumption , body mass index , diabetes status , serum cholesterol , and parental history of sudden death were independent factors associated with sudden death during follow-up ( 23 years on average ) . When adjusted for confounding variables , including parental history of myocardial infa rct ion , relative risk of sudden death associated with parental sudden death was 1.80 ( 95 % CI , 1.11 to 2.88 ) . CONCLUSIONS Parental sudden death is an independent risk factor for sudden death in middle-aged men . The existence of familial risk factors for sudden death may help provide better identification of subjects at high risk of and early prevention of sudden death Background —There are few data regarding the determinants of sudden cardiac death ( SCD ) in women , primarily because of their markedly lower rate of SCD compared with men . Nonetheless , existing data , although sparse , suggest possible gender differences in risk factors for SCD . Methods and Results —In this prospect i ve cohort of 121 701 women aged 30 to 55 years at baseline , SCD was defined as death within 1 hour of symptom onset . From 1976 to 1998 , 244 SCDs were identified . Although the risk of SCD increased markedly with age , the percentage of cardiac deaths that were sudden decreased . Most ( 69 % ) women who suffered a SCD had no history of cardiac disease before their death . However , almost all of the women who died suddenly ( 94 % ) had reported at least 1 coronary heart disease risk factor . Smoking , hypertension , and diabetes conferred markedly elevated ( 2.5- to 4.0-fold ) risk of SCD , similar to that conferred by a history of nonfatal myocardial infa rct ion ( relative risk , 4.1 ; 95 % confidence interval , 2.9 to 6.7 ) . Family history of myocardial infa rct ion before age 60 years and obesity were associated with moderate ( 1.6-fold ) elevations in risk . With regard to mechanism , 88 % of SCDs were classified as arrhythmic . In 76 % of these , the first rhythm documented was ventricular tachycardia or ventricular fibrillation . Conclusions —These prospect i ve data suggest that , as in men , coronary heart disease risk factors predict risk of SCD in women and that SCD is usually an arrhythmic death . Therefore , prevention of atherosclerosis or ventricular arrhythmias may reduce the incidence of SCD in women Summary Background Women born around 1940 in countries such as the UK and USA were the first generation in which many smoked substantial numbers of cigarettes throughout adult life . Hence , only in the 21st century can we observe directly the full effects of prolonged smoking , and of prolonged cessation , on mortality among women in the UK . Methods For this prospect i ve study , 1·3 million UK women were recruited in 1996–2001 and resurveyed postally about 3 and 8 years later . All were followed to Jan 1 , 2011 , through national mortality records ( mean 12 woman-years , SD 2 ) . Participants were asked at entry whether they were current or ex-smokers , and how many cigarettes they currently smoked . Those who were ex-smokers at both entry and the 3-year resurvey and had stopped before the age of 55 years were categorised by the age they had stopped smoking . We used Cox regression models to obtain adjusted relative risks that compared categories of smokers or ex-smokers with otherwise similar never-smokers . Findings After excluding 0·1 million women with previous disease , 1·2 million women remained , with median birth year 1943 ( IQR 1938–46 ) and age 55 years ( IQR 52–60 ) . Overall , 6 % ( 66 489/1 180 652 ) died , at mean age 65 years ( SD 6 ) . At baseline , 20 % ( 232 461 ) were current smokers , 28 % ( 328 417 ) were ex-smokers , and 52 % ( 619 774 ) were never-smokers . For 12-year mortality , those smoking at baseline had a mortality rate ratio of 2·76 ( 95 % CI 2·71–2·81 ) compared with never-smokers , even though 44 % ( 37 240/85 256 ) of the baseline smokers who responded to the 8-year resurvey had by then stopped smoking . Mortality was tripled , largely irrespective of age , in those still smoking at the 3-year resurvey ( rate ratio 2·97 , 2·88–3·07 ) . Even for women smoking fewer than ten cigarettes per day at baseline , 12-year mortality was doubled ( rate ratio 1·98 , 1·91–2·04 ) . Of the 30 most common causes of death , 23 were increased significantly in smokers ; for lung cancer , the rate ratio was 21·4 ( 19·7–23·2 ) . The excess mortality among smokers ( in comparison with never-smokers ) was mainly from diseases that , like lung cancer , can be caused by smoking . Among ex-smokers who had stopped permanently at ages 25–34 years or at ages 35–44 years , the respective relative risks were 1·05 ( 95 % CI 1·00–1·11 ) and 1·20 ( 1·14–1·26 ) for all-cause mortality and 1·84 ( 1·45–2·34 ) and 3·34 ( 2·76–4·03 ) for lung cancer mortality . Thus , although some excess mortality remains among these long-term ex-smokers , it is only 3 % and 10 % of the excess mortality among continuing smokers . If combined with 2010 UK national death rates , tripled mortality rates among smokers indicate 53 % of smokers and 22 % of never-smokers dying before age 80 years , and an 11-year lifespan difference . Interpretation Among UK women , two-thirds of all deaths of smokers in their 50s , 60s , and 70s are caused by smoking ; smokers lose at least 10 years of lifespan . Although the hazards of smoking until age 40 years and then stopping are substantial , the hazards of continuing are ten times greater . Stopping before age 40 years ( and preferably well before age 40 years ) avoids more than 90 % of the excess mortality caused by continuing smoking ; stopping before age 30 years avoids more than 97 % of it . Funding Cancer Research UK , Medical Research Council BACKGROUND Risk factors specific to sudden cardiac death ( SCD ) , ie , death within 1 hour after onset of symptoms , have been poorly identified , although recent findings from the present study incriminate heavy drinking and elevated heart rate . This paper examines the relations between a wide range of established and potential risk factors for ischemic heart disease ( IHD ) and SCD to identify independent risk factors for SCD and factors that might particularly or specifically relate to SCD . METHODS AND RESULTS We present a prospect i ve study of a cohort that was drawn from general practice s in 24 British towns of 7735 middle-aged men who were followed up for 8 years . During 8 years of follow-up , the men experienced 488 major IHD events ( nonfatal and fatal ) , of which 117 ( 24 % ) were classified as SCD . Age , preexisting IHD , arrhythmia , systolic blood pressure , blood cholesterol , elevated heart rate ( > or = 90 beats per minute ) , physical activity ( all , P < .05 ) , and , to a lesser extent , smoking ( P = .06 ) , HDL cholesterol ( P < .07 ) , and elevated hematocrit ( > or = 46 % , P < .09 ) emerged as independent risk factors for SCD after adjustment for a wide range of factors . Diabetes was not found to be associated with SCD , and forced expiratory volume in 1 second , body mass index , white blood cell count , and antihypertensive drugs were not associated with risk of SCD after adjustment . When examined in relation to non-sudden IHD deaths and nonfatal myocardial infa rct ion , elevated heart rate , heavy drinking , and arrhythmia emerged as factors that appear to be specific or particular to SCD . These three factors and age and blood cholesterol were associated with an increased risk of SCD in men both with and without preexisting IHD . Physical activity , systolic blood pressure , and current smoking were associated with SCD only in men without preexisting IHD . HDL cholesterol and hematocrit were strong predictors of SCD only in men with preexisting IHD . CONCLUSIONS Three risk factors appear to be specific or particular to the risk of SCD , and these and other risk factors operate differently in patients with versus those without preexisting IHD . These findings have implication s for the causes and prevention of SCD CONTEXT The health and policy implication s of regional variation in incidence and outcome of out-of-hospital cardiac arrest remain to be determined . OBJECTIVE To evaluate whether cardiac arrest incidence and outcome differ across geographic regions . DESIGN , SETTING , AND PATIENTS Prospect i ve observational study ( the Resuscitation Outcomes Consortium ) of all out-of-hospital cardiac arrests in 10 North American sites ( 8 US and 2 Canadian ) from May 1 , 2006 , to April 30 , 2007 , followed up to hospital discharge , and including data available as of June 28 , 2008 . Cases ( aged 0 - 108 years ) were assessed by organized emergency medical services ( EMS ) personnel , did not have traumatic injury , and received attempts at external defibrillation or chest compressions or resuscitation was not attempted . Census data were used to determine rates adjusted for age and sex . MAIN OUTCOME MEASURES Incidence rate , mortality rate , case-fatality rate , and survival to discharge for patients assessed or treated by EMS personnel or with an initial rhythm of ventricular fibrillation . RESULTS Among the 10 sites , the total catchment population was 21.4 million , and there were 20,520 cardiac arrests . A total of 11,898 ( 58.0 % ) had resuscitation attempted ; 2729 ( 22.9 % of treated ) had initial rhythm of ventricular fibrillation or ventricular tachycardia or rhythms that were shockable by an automated external defibrillator ; and 954 ( 4.6 % of total ) were discharged alive . The median incidence of EMS-treated cardiac arrest across sites was 52.1 ( interquartile range [ IQR ] , 48.0 - 70.1 ) per 100,000 population ; survival ranged from 3.0 % to 16.3 % , with a median of 8.4 % ( IQR , 5.4%-10.4 % ) . Median ventricular fibrillation incidence was 12.6 ( IQR , 10.6 - 5.2 ) per 100,000 population ; survival ranged from 7.7 % to 39.9 % , with a median of 22.0 % ( IQR , 15.0%-24.4 % ) , with significant differences across sites for incidence and survival ( P<.001 ) . CONCLUSION In this study involving 10 geographic regions in North America , there were significant and important regional differences in out-of-hospital cardiac arrest incidence and outcome OBJECTIVES We sought to describe the incidence , characteristics and survival of out-of-hospital sudden cardiac arrest ( SCA ) in the Maastricht area of The Netherl and s. BACKGROUND Incidence and survival rates of out-of-hospital SCA in different communities are often based on the number of victims resuscitated by the emergency medical services . Our population -based study in the Maastricht area allows information on all victims of witnessed and unwitnessed SCA occurring outside the hospital . METHODS Incidence , patient characteristics and survival rates were determined by prospect ively collecting information on all cases of SCA occurring in the age group 20 to 75 years between January 1 , 1991 and December 31 , 1994 . Survival rates were related to the site of the event ( at home vs. outside the home ) and the presence or absence of a witness and rhythm at the time of the resuscitation attempt in out-of-hospital SCA . RESULTS Five hundred fifteen patients were included ( 72 % men , 28 % women ) . In 44 % of men and 53 % of women , SCA was most likely the first manifestation of heart disease . In patients known to have had a previous myocardial infa rct ion ( MI ) , the mean interval between the MI and SCA was 6.5 years , with > 50 % having a left ventricular ejection fraction > 30 % . The mean yearly incidence of SCA was 1 in 1,000 inhabitants . Of all deaths in the age groups studied , 18.5 % were sudden . Nearly 80 % of SCAs occurred at home . In 60 % of all cases of SCA a witness was present . Cardiac resuscitation , which was attempted in 51 % of all subjects , result ed overall in 32 ( 6 % ) of 515 patients being discharged alive from the hospital . Survival rates for witnessed SCA were 8 % ( 16 of 208 subjects ) at home and 18 % ( 15 of 85 subjects ) outside the home ( 95 % confidence interval 1 % to 18.8 % ) . CONCLUSIONS The majority of victims of SCA can not be identified before the event . Sudden cardiac arrest usually occurs at home , and the survival of those with a witnessed SCA at home was low compared with that outside the home , indicating the necessity of optimizing out-of-hospital resuscitation , especially in the at-home situation Objective : There is little evidence concerning risk factors for sudden cardiac death ( SCD ) among Asians . Patients and methods : A prospect i ve , nested , case – control study of Japanese patients aged between 30 and 84 years was undertaken using data collected from 26 870 participants in cardiovascular risk surveys conducted in four communities between 1975 and 2005 . The incidence of SCD was ascertained by systematic surveillance , with 239 cases of SCD identified over this period . For each case of SCD , three control patients were selected , matched by age , sex , examination year , follow-up time , and community . Results : Hypertension , diabetes mellitus , smoking , major ST-T abnormalities , left high amplitude R waves , and increased heart rate ( ≥77 beat/min ) were all independently associated with a 1.5–3.2-fold increase in SCD risk , whereas no associations were observed for body mass index and hypercholesterolemia . The population -attributable fraction [ 95 % confidence interval ( CI ) ] was 23.0 % ( 2.9–39.0 ) for hypertension , 15.3 % ( 3.8–25.5 ) for current smoking , 14.5 % ( 8.0–20.5 ) for major ST-T abnormalities , and 8.1 % ( 2.2–13.7 ) for diabetes mellitus . The number of SCD risk factors ( hypertension , diabetes , smoking , and ECG abnormalities ) was positively associated with increased SCD risk . The odds ratio for increased SCD risk with three or more risk factors versus zero risk factors was 5.76 ( 95 % CI 3.20–10.39 ) . Conclusions : Among the Japanese population , hypertension , smoking , major ST-T abnormalities , left high amplitude R waves , and diabetes mellitus were associated with an increased incidence of SCD , whereas there were no associations of body mass index or hypercholesterolemia with SCD incidence OBJECTIVES To investigate the risk of a first myocardial infa rct ion ( MI ) and sudden cardiac death ( SCD ) amongst male snuff users . DESIGN We used a prospect i ve incident case-referent study design nested in the population -based Västerbotten Intervention Program and the Northern Sweden MONICA study . SUBJECTS Tobacco habits and cardiovascular risk factors were assessed at baseline screening and compared in 525 male MI cases ( including 93 SCD cases ) and 1798 matched referents . RESULTS Myocardial infa rct ion occurred on average 4 years and 2 months after the baseline screening . No increased risk for MI was found amongst snuff users without a previous history of smoking compared with nontobacco users after adjustments for body mass index , leisure time physical activity , educational level and cholesterol level ( OR 0.82 ; 95 % CI , 0.46 - 1.43 ) . For snuff users with a previous history of smoking , the adjusted OR was 1.25 ( 95 % CI , 0.80 - 1.96 ) . Significantly increased risk for MI was found in current smokers with or without current snuff use . For SCD cases with survival time<24 h , the adjusted OR for snuff users without previous history of smoking was 1.18 ( 95 % CI , 0.38 - 3.70 ) and for cases with survival time<1 h the OR was 0.38 ( 95 % CI , 0.08 - 1.89 ) . CONCLUSIONS We found no increased risk for MI amongst snuff users without a previous history of smoking . Amongst snuff users with a previous history of smoking , the tendency towards an increased risk for MI may reflect the residual risk from former smoking . This study does not support the hypothesis that the risk for SCD is increased amongst snuff users OBJECTIVES We undertook this study to prospect ively evaluate whether cigarette smoking was associated with an increased risk of developing hypertension . BACKGROUND Smoking is a well-recognized risk factor for cardiovascular disease . Few prospect i ve cohort studies have examined the relationship between smoking and hypertension . METHODS We conducted a prospect i ve cohort study among 28,236 women in the Women 's Health Study who were initially free of hypertension , cardiovascular disease , and cancer . Detailed risk factor information , including smoking status , was collected from self-reported question naires . We used Cox proportional hazards survival models to calculate hazard ratios ( HRs ) and 95 % confidence intervals ( CIs ) of incident hypertension ( defined as either new diagnosis , the initiation of antihypertensive medication , systolic blood pressure > or = 140 mm Hg or diastolic blood pressure > or = 90 mm Hg ) . RESULTS At baseline , 51 % of women were never smokers , 36 % were former smokers , 5 % smoked 1 to 14 cigarettes , and 8 % smoked > or = 15 cigarettes per day . During a median of 9.8 years , there were 8,571 ( 30.4 % ) cases of incident hypertension . The age-adjusted HRs of developing hypertension among never , former , and current smokers of 1 to 14 and > or = 15 cigarettes per day were 1.00 ( reference ) , 1.04 ( 95 % CI 0.99 to 1.09 ) , 1.00 ( 95 % CI 0.90 to 1.10 ) , and 1.10 ( 95 % CI 1.01 to 1.19 ) , respectively . In multivariable models further adjusting for lifestyle , clinical , and dietary variables , the corresponding HRs were 1.00 ( reference ) , 1.03 ( 95 % CI 0.98 to 1.08 ) , 1.02 ( 95 % CI 0.92 to 1.13 ) , and 1.11 ( 95 % CI 1.03 to 1.21 ) , respectively . Among women who smoked > or = 25 cigarettes per day , the multivariable HR was 1.21 ( 95 % CI 1.06 to 1.39 ) . CONCLUSIONS In this large cohort of women , cigarette smoking was modestly associated with an increased risk of developing hypertension , with an effect that was strongest among women smoking at least 15 cigarettes per day BACKGROUND Few studies of adverse health effects from smoking have been conducted in southeastern Asian population s which may exhibit racial , cultural , and smoking behavioral differences that could affect mortality patterns . This study aims to quantify cause-specific mortality risks among cigarette smokers in Taiwan . METHODS The study population for this investigation was derived from two existing prospect i ve study cohorts : a community-based cohort and a cohort composed of civil servants and teachers . Smoking data were obtained by face-to-face interview in the community cohort and by self-administered question naire in the civil servant/teacher cohort . The mortality risks of current smokers , adjusted for age , were compared to those of nonsmokers using Cox 's proportional hazards model and dose-response relationships were examined by variables of smoking intensity and duration . RESULTS Male smokers had significantly higher all-cause mortality than nonsmokers . Cigarette smoking was also significantly associated with increased risks of dying from cancer , cardiovascular disease , respiratory disease , chronic bronchitis , diabetes , peptic ulcer , liver cirrhosis , and kidney disease . In addition , smokers had an increase in risk of fatal injuries from motor vehicle accidents and nonmotor vehicle accidents , as well as cancers of the oral cavity nasopharynx , esophagus , stomach , rectum , liver , and lungs . Risks for women smokers were generally higher than those for men , although this is based on small numbers of smokers . In women , deaths from all causes , all cancers , and cancers of the cervix , liver , and lung , cardiovascular disease , and respiratory disease were also significantly increased . The mean age at death for smokers who died before age 65 from smoking-related diseases was 57.4 years , which represented a loss of 22 years of life expectancy . CONCLUSIONS The pervasive and serious impact of cigarette smoking on the health of Taiwanese can not be underestimated Background : Most sudden cardiac death ( SCD ) events occur in the general population among persons who do not have any prior history of clinical heart disease . We sought to develop a predictive model of SCD among US adults . Methods : We evaluated a series of demographic , clinical , laboratory , electrocardiographic , and echocardiographic measures in participants in the ARIC study ( Atherosclerosis Risk in Communities ) ( n=13 677 ) and the CHS ( Cardiovascular Health Study ) ( n=4207 ) who were free of baseline cardiovascular disease . Our initial objective was to derive a SCD prediction model using the ARIC cohort and vali date it in CHS . Independent risk factors for SCD were first identified in the ARIC cohort to derive a 10-year risk model of SCD . We compared the prediction of SCD with non-SCD and all-cause mortality in both the derivation and validation cohorts . Furthermore , we evaluated whether the SCD prediction equation was better at predicting SCD than the 2013 American College of Cardiology/American Heart Association Cardiovascular Disease Pooled Cohort risk equation . Results : There were a total of 345 adjudicated SCD events in our analyses , and the 12 independent risk factors in the ARIC study included age , male sex , black race , current smoking , systolic blood pressure , use of antihypertensive medication , diabetes mellitus , serum potassium , serum albumin , high-density lipoprotein , estimated glomerular filtration rate , and QTc interval . During a 10-year follow-up period , a model combining these risk factors showed good to excellent discrimination for SCD risk ( c-statistic 0.820 in ARIC and 0.745 in CHS ) . The SCD prediction model was slightly better in predicting SCD than the 2013 American College of Cardiology/American Heart Association Pooled Cohort risk equations ( c-statistic 0.808 in ARIC and 0.743 in CHS ) . Only the SCD prediction model , however , demonstrated similar and accurate prediction for SCD using both the original , uncalibrated score and the recalibrated equation . Finally , in the echocardiographic subcohort , a left ventricular ejection fraction < 50 % was present in only 1.1 % of participants and did not enhance SCD prediction . Conclusions : Our study is the first to derive and vali date a generalizable risk score that provides well-calibrated , absolute risk estimates across different risk strata in an adult population of white and black participants without a clinical diagnosis of cardiovascular disease |
11,524 | 29,520,012 | We found that even though the use of delivery systems provides an advantage over naked AONs , it is not yet possible to select the most promising strategies . | Antisense oligonucleotide (AON)-based therapies hold promise for a range of neurodegenerative and neuromuscular diseases and have shown benefit in animal models and patients .
Success in the clinic is nevertheless still limited , due to unfavourable biodistribution and poor cellular uptake of AONs .
Extensive research is currently being conducted into the formulation of AONs to improve delivery , but thus far there is no consensus on which of those strategies will be the most effective .
This systematic review was design ed to answer in an unbiased manner which delivery strategies most strongly enhance the efficacy of AONs in animal models of heritable neurodegenerative and neuromuscular diseases . | The US National Institute of Neurological Disorders and Stroke convened major stakeholders in June 2012 to discuss how to improve the method ological reporting of animal studies in grant applications and publications . The main workshop recommendation is that at a minimum studies should report on sample -size estimation , whether and how animals were r and omized , whether investigators were blind to the treatment , and the h and ling of data . We recognize that achieving a meaningful improvement in the quality of reporting will require a concerted effort by investigators , review ers , funding agencies and journal editors . Requiring better reporting of animal studies will raise awareness of the importance of rigorous study design to accelerate scientific progress Background Spinal muscular atrophy is an autosomal recessive neuromuscular disorder that is caused by an insufficient level of survival motor neuron ( SMN ) protein . Nusinersen is an antisense oligonucleotide drug that modifies pre – messenger RNA splicing of the SMN2 gene and thus promotes increased production of full‐length SMN protein . Methods We conducted a r and omized , double‐blind , sham‐controlled , phase 3 efficacy and safety trial of nusinersen in infants with spinal muscular atrophy . The primary end points were a motor‐milestone response ( defined according to results on the Hammersmith Infant Neurological Examination ) and event‐free survival ( time to death or the use of permanent assisted ventilation ) . Secondary end points included overall survival and subgroup analyses of event‐free survival according to disease duration at screening . Only the first primary end point was tested in a prespecified interim analysis . To control the overall type I error rate at 0.05 , a hierarchical testing strategy was used for the second primary end point and the secondary end points in the final analysis . Results In the interim analysis , a significantly higher percentage of infants in the nusinersen group than in the control group had a motor‐milestone response ( 21 of 51 infants [ 41 % ] vs. 0 of 27 [ 0 % ] , P<0.001 ) , and this result prompted early termination of the trial . In the final analysis , a significantly higher percentage of infants in the nusinersen group than in the control group had a motor‐milestone response ( 37 of 73 infants [ 51 % ] vs. 0 of 37 [ 0 % ] ) , and the likelihood of event‐free survival was higher in the nusinersen group than in the control group ( hazard ratio for death or the use of permanent assisted ventilation , 0.53 ; P=0.005 ) . The likelihood of overall survival was higher in the nusinersen group than in the control group ( hazard ratio for death , 0.37 ; P=0.004 ) , and infants with a shorter disease duration at screening were more likely than those with a longer disease duration to benefit from nusinersen . The incidence and severity of adverse events were similar in the two groups . Conclusions Among infants with spinal muscular atrophy , those who received nusinersen were more likely to be alive and have improvements in motor function than those in the control group . Early treatment may be necessary to maximize the benefit of the drug . ( Funded by Biogen and Ionis Pharmaceuticals ; ENDEAR Clinical Trials.gov number , NCT02193074 . Objective : To examine safety , tolerability , pharmacokinetics , and preliminary clinical efficacy of intrathecal nusinersen ( previously ISIS-SMNRx ) , an antisense oligonucleotide design ed to alter splicing of SMN2 mRNA , in patients with childhood spinal muscular atrophy ( SMA ) . Methods : Nusinersen was delivered by intrathecal injection to medically stable patients with type 2 and type 3 SMA aged 2–14 years in an open-label phase 1 study and its long-term extension . Four ascending single-dose levels ( 1 , 3 , 6 , and 9 mg ) were examined in cohorts of 6–10 participants . Participants were monitored for safety and tolerability , and CSF and plasma pharmacokinetics were measured . Exploratory efficacy endpoints included the Hammersmith Functional Motor Scale Exp and ed ( HFMSE ) and Pediatric Quality of Life Inventory . Results : A total of 28 participants enrolled in the study ( n = 6 in first 3 dose cohorts ; n = 10 in the 9-mg cohort ) . Intrathecal nusinersen was well-tolerated with no safety/tolerability concerns identified . Plasma and CSF drug levels were dose-dependent , consistent with pre clinical data . Extended pharmacokinetics indicated a prolonged CSF drug half-life of 4–6 months after initial clearance . A significant increase in HFMSE scores was observed at the 9-mg dose at 3 months postdose ( 3.1 points ; p = 0.016 ) , which was further increased 9–14 months postdose ( 5.8 points ; p = 0.008 ) during the extension study . Conclusions : Results from this study support continued development of nusinersen for treatment of SMA . Classification of evidence : This study provides Class IV evidence that in children with SMA , intrathecal nusinersen is not associated with safety or tolerability concerns Nusinersen ( ISIS-SMNRx or ISIS 396443 ) is an antisense oligonucleotide drug administered intrathecally to treat spinal muscular atrophy . We summarize lumbar puncture experience in children with spinal muscular atrophy during a phase 1 open-label study of nusinersen and its extension . During the studies , 73 lumbar punctures were performed in 28 patients 2 to 14 years of age with type 2/3 spinal muscular atrophy . No complications occurred in 50 ( 68 % ) lumbar punctures ; in 23 ( 32 % ) procedures , adverse events were attributed to lumbar puncture . Most common adverse events were headache ( n = 9 ) , back pain ( n = 9 ) , and post – lumbar puncture syndrome ( n = 8) . In a subgroup analysis , adverse events were more frequent in older children , children with type 3 spinal muscular atrophy , and with a 21- or 22-gauge needle compared to a 24-gauge needle or smaller . Lumbar punctures were successfully performed in children with spinal muscular atrophy ; lumbar puncture – related adverse event frequency was similar to that previously reported in children BACKGROUND Mutations in SOD1 cause 13 % of familial amyotrophic lateral sclerosis . In the SOD1 Gly93Ala rat model of amyotrophic lateral sclerosis , the antisense oligonucleotide ISIS 333611 delivered to CSF decreased SOD1 mRNA and protein concentrations in spinal cord tissue and prolonged survival . We aim ed to assess the safety , tolerability , and pharmacokinetics of ISIS 333611 after intrathecal administration in patients with SOD1-related familial amyotrophic lateral sclerosis . METHODS In this r and omised , placebo-controlled , phase 1 trial , we delivered ISIS 333611 by intrathecal infusion using an external pump over 11·5 h at increasing doses ( 0·15 mg , 0·50 mg , 1·50 mg , 3·00 mg ) to four cohorts of eight patients with SOD1-positive amyotrophic lateral sclerosis ( six patients assigned to ISIS 333611 , two to placebo in each cohort ) . We did the r and omisation with a web-based system , assigning patients in blocks of four . Patients and investigators were masked to treatment assignment . Participants were allowed to re-enrol in subsequent cohorts . Our primary objective was to assess the safety and tolerability of ISIS 333611 . Assessment s were done during infusion and over 28 days after infusion . This study was registered with Clinical trials.gov , number NCT01041222 . FINDINGS Seven of eight ( 88 % ) patients in the placebo group versus 20 of 24 ( 83 % ) in the ISIS 333611 group had adverse events . The most common events were post-lumbar puncture syndrome ( 3/8 [ 38 % ] vs 8/24 [ 33 % ] ) , back pain ( 4/8 [ 50 % ] vs 4/24 [ 17 % ] ) , and nausea ( 0/8 [ 0 % ] vs 3/24 [ 13 % ] ) . We recorded no dose-limiting toxic effects or any safety or tolerability concerns related to ISIS 333611 . No serious adverse events occurred in patients given ISIS 333611 . Re-enrolment and re-treatment were also well tolerated . INTERPRETATION This trial is the first clinical study of intrathecal delivery of an antisense oligonucleotide . ISIS 333611 was well tolerated when administered as an intrathecal infusion . Antisense oligonucleotides delivered to the CNS might be a feasible treatment for neurological disorders . FUNDING The ALS Association , Muscular Dystrophy Association , Isis Pharmaceuticals BACKGROUND Nusinersen is a 2'-O-methoxyethyl phosphorothioate-modified antisense drug being developed to treat spinal muscular atrophy . Nusinersen is specifically design ed to alter splicing of SMN2 pre-mRNA and thus increase the amount of functional survival motor neuron ( SMN ) protein that is deficient in patients with spinal muscular atrophy . METHODS This open-label , phase 2 , escalating dose clinical study assessed the safety and tolerability , pharmacokinetics , and clinical efficacy of multiple intrathecal doses of nusinersen ( 6 mg and 12 mg dose equivalents ) in patients with infantile-onset spinal muscular atrophy . Eligible participants were of either gender aged between 3 weeks and 7 months old with onset of spinal muscular atrophy symptoms between 3 weeks and 6 months , who had SMN1 homozygous gene deletion or mutation . Safety assessment s included adverse events , physical and neurological examinations , vital signs , clinical laboratory tests , cerebrospinal fluid laboratory tests , and electrocardiographs . Clinical efficacy assessment s included event free survival , and change from baseline of two assessment s of motor function : the motor milestones portion of the Hammersmith Infant Neurological Exam-Part 2 ( HINE-2 ) and the Children 's Hospital of Philadelphia Infant Test of Neuromuscular Disorders ( CHOP-INTEND ) motor function test , and compound motor action potentials . Autopsy tissue was analysed for target engagement , drug concentrations , and pharmacological activity . HINE-2 , CHOP-INTEND , and compound motor action potential were compared between baseline and last visit using the Wilcoxon signed-rank test . Age at death or permanent ventilation was compared with natural history using the log-rank test . The study is registered at Clinical Trials.gov , number NCT01839656 . FINDINGS 20 participants were enrolled between May 3 , 2013 , and July 9 , 2014 , and assessed through to an interim analysis done on Jan 26 , 2016 . All participants experienced adverse events , with 77 serious adverse events reported in 16 participants , all considered by study investigators not related or unlikely related to the study drug . In the 12 mg dose group , incremental achievements of motor milestones ( p<0·0001 ) , improvements in CHOP-INTEND motor function scores ( p=0·0013 ) , and increased compound muscle action potential amplitude of the ulnar nerve ( p=0·0103 ) and peroneal nerve ( p<0·0001 ) , compared with baseline , were observed . Median age at death or permanent ventilation was not reached and the Kaplan-Meier survival curve diverged from a published natural history case series ( p=0·0014 ) . Analysis of autopsy tissue from patients exposed to nusinersen showed drug uptake into motor neurons throughout the spinal cord and neurons and other cell types in the brainstem and other brain regions , exposure at therapeutic concentrations , and increased SMN2 mRNA exon 7 inclusion and SMN protein concentrations in the spinal cord . INTERPRETATION Administration of multiple intrathecal doses of nusinersen showed acceptable safety and tolerability , pharmacology consistent with its intended mechanism of action , and encouraging clinical efficacy . Results informed the design of an ongoing , sham-controlled , phase 3 clinical study of nusinersen in infantile-onset spinal muscular atrophy . FUNDING Ionis Pharmaceuticals , Inc and Biogen In September 2016,theUSFood and DrugAdministration ( FDA ) approved eteplirsen ( Exondys 51 ) , a new drug for Duchenne muscular dystrophy ( DMD ) , overruling the recommendations of both its scientific staff and its external advisory committee . Duchenne muscular dystrophy is a progressive X-linked genetic disease caused by mutations in a gene that produces the protein dystrophin that helps stabilize muscle fibers . It is usually fatal by the third decade of life . No disease-modifying treatments are available . Eteplirsen offered a promising new therapeutic approach that would correct a mutation in a gene coding for dystrophin , allowing production of a truncated but functional version of the protein . In particular , eteplirsen was design ed to skip exon 51 , which would address the mutations in about 10 % to 15 % of patients with DMD ( an estimated 2000 - 2500 cases in the United States ) . Despite this innovative mechanism , the development of eteplirsen was controversial , starting with its manufacturer-supported pivotal double-blind study , which involved only 12 patients : 8 were r and omized to 2 different eteplirsen doses and 4 were r and omized to placebo for 24 weeks . The latter were then switched to eteplirsen and all were to be followed for an additional 24 weeks . The sample size was substantially smaller than the study sample size in which a similar DMD drug , drisapersen , had been tested in 3 r and omized trials that together enrolled 290 patients . The FDA declined to approve drisapersen in 2015 after these studies showed no clear benefit after 24 weeks in prespecified clinical end points , such as changes in a 6-minute walk test . Those trials also suggested the possibility of safety problems , including renal toxic effects and thrombocytopenia . In the eteplirsen study , by contrast , the primary trial end point was a surrogate measure : an increase in the presence of dystrophin in muscle biopsy specimens . Serial biopsies were performed at 12 , 24 , and 48 weeks , although biopsies were performed on only half the treated patients at each of the 12 and 24-week periods ; all 12 patients were receiving drug treatment by week 48 . The biopsy specimens were analyzed by scientists blinded to the patients ’ group assignments but not blinded to the time receiving treatment.1 In a 2013 publication , the authors reported increases to about 50 % of normal in dystrophincontaining fibers in the biopsy specimens,2 results that were met with enthusiasm by the DMD community . However , these results were based on an immunohistochemical assay that assessed only an increase of newly produced dystrophin compared with baseline values . Quantitative Western blot analysis of a fourth biopsy performed in 11 of the study patients after 3 to 3.5 years of continued open-label extension showed an actual increase to only a mean ( SD ) of 0.9 % ( 0.8 % ) of normal dystrophin levels , far less than what might be expected to provide clinical benefit . A more rigorous , fully blinded re analysis of the immunohistochemical assay organized by the FDA cast further doubt on the initial results .3 The trial also assessed clinical progression . At 24 and 48 weeks , there was no consistent advantage in the 6-minute walk test capacity of patients who received eteplirsen compared with those initially given placebo . However , new post hoc calculations excluded 2 eteplirsentreated patients who deteriorated quickly while receiving therapy ; these analyses suggested a statistically significant advantage for the remaining treated patients . These more selective post hoc analyses were highlighted in the figure displaying this finding in the 2013 article2 and in the manufacturer ’s press release announcing the success of the trial.4 Subsequent evaluation of 6-minute walk test data over 3 to 3.5 years of open-label therapy appeared to be associated with slower rates of decline when compared with a historical cohort , but the problematic nature of historical controls complicated the interpretation . Controversy over eteplirsen came into broader public view when the FDA convened an advisory committee in April 2016 to review these data . That hearing included more than a thous and public attendees and more than 4 hours of comments from patients , families , advocates , scientists , and legislators . The public presentations were frequently emotional , and nearly all of the presenters ( 51 of 52 ) favored drug approval . The advisory committee was generally unimpressed with the efficacy data , although the committee split its vote : 7 members found no evidence that eteplirsen was clinical ly effective in treating DMD ( vs 3 in favor and 3 abstentions ) , and 7 members found that the drug did not produce dystrophin at a level likely to result in clinical benefit ( vs 6 in favor ) . After the meeting , the FDA delayed its decision and requested additional data , including Western blot assays from biopsy specimens in 13 patients from another ongoing study at week 48 . These data showed a mean increase in dystrophin to just 0.2 % to 0.3 % of normal . In September 2016 , another reason for the delay was revealed — disagreement within the FDA about the approval decision . The main FDA scientific review ers all opposed approval , but Janet Woodcock , MD , director of the FDA ’s Center for Drug Evaluation and Research , overruled them , suggesting that the extremely small increase in dystrophin might conceivably translate to clinical benefit.1 She indicated that considering the life-threatening nature of the disease and the lack of reasonable alternative treatments , the FDA should exercise “ the greatest flexibility possible ” under its statutory authority in considering eteplirsen ’s efficacy.1 The internal FDA review staff took the unusual step of appealing to Commissioner Robert Califf , MD , who upheld Woodcock ’s decision.1 Aaron S. Kesselheim , MD , JD , MPH Program on Regulation , Therapeutics , and Law ( PORTAL ) , Division of Pharmacoepidemiology and Pharmacoeconomics , Department of Medicine , Brigham and Women ’s Hospital and Harvard Medical School , Boston , Massachusetts 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 |
11,525 | 28,922,813 | Nevertheless , these studies showed poor sputum conversion rates in patients receiving recommended treatment regimens | Objectives To perform a systematic review and meta- analysis of the level of funding support and the sputum culture conversion rates in pulmonary Mycobacterium avium-intracellulare complex ( P-MAC ) disease in adult patients without cystic fibrosis or HIV infection , treated with recommended antibiotic regimens . | SETTING AND OBJECTIVE Previous reports on small numbers highlighted the need for a prospect i ve study of the clinical features and response to treatment of pulmonary disease caused by Mycobacterium avium-intracellulare ( MAC ) . DESIGN AND METHODS Patients with two positive cultures were r and omised to 2 years of rifampicin and ethambutol or of rifampicin , ethambutol and isoniazid . Clinical , bacteriological and radiological progress was monitored for 5 years . RESULTS Seventy-five patients entered the study . They had a mean age of 64 years ( range 29 - 87 ) and the sexes were balanced . Approximately two-thirds had previous/ co-existing lung disease(s ) . Sputum was positive on direct smear in 56 % , and cavitation was observed in 61 % , most having at least one large cavity . Just under half had bilateral disease and one-third extensive disease . Disease was confined to upper zone(s ) in 25 % . Twenty-seven ( 36 % ) died within 5 years , three because of MAC disease . There were 11 treatment failures and 10 relapses , with no correlation between those and in vitro resistance . Forty-five ( 60 % ) were alive at 5 years , of whom 23 were confirmed cured . CONCLUSION Pulmonary disease caused by MAC is associated with high morbidity and mortality . St and ard susceptibility tests do not correlate with the response of the disease to chemotherapy . Rifampicin and ethambutol , with or without isoniazid , cured 31 % , a result comparable with or better than that found previously with more toxic regimens , but mortality ( 36 % ) remains high . More effective regimens are needed , and management of coexisting illnesses and general health needs to be to maximised RATIONALE Patients with Mycobacterium avium complex pulmonary disease are frequently administered a combination of clarithromycin , ethambutol , and rifampicin . However , rifampicin is known to reduce the serum levels of clarithromycin . It remains unclear whether a reduction in clarithromycin serum levels influences the clinical outcome of the Mycobacterium avium complex pulmonary disease treatment regimen . OBJECTIVES To compare a three-drug regimen ( clarithromycin , ethambutol , and rifampicin ) to a two-drug regimen ( clarithromycin and ethambutol ) for the treatment of Mycobacterium avium lung disease . METHODS In a preliminary open-label study , we r and omly assigned newly diagnosed , but as-yet untreated , patients with disease caused by Mycobacterium avium complex without HIV infection to either the three-drug or the two-drug regimen for 12 months . The primary endpoint was the conversion of sputum cultures to negative after 12 months of treatment . Patient data were analyzed using the intention-to-treat method . MEASUREMENTS AND MAIN RESULTS Of 119 eligible patients , 59 were assigned to the three-drug regimen and 60 to the two-drug regimen . The rate of sputum culture conversion was 40.6 % with the three-drug regimen and 55.0 % with the two-drug regimen ( difference , -14.4 % [ 95 % confidence interval , -32.1 to 3.4 ] ) . The incidence of adverse events leading to the discontinuation of treatment was 37.2 and 26.6 % for the three-drug and the two-drug regimens , respectively . CONCLUSIONS This preliminary study suggests that treatment with clarithromycin and ethambutol is not inferior to treatment with clarithromycin , ethambutol , and rifampicin for Mycobacterium avium complex lung disease . Our findings justify a larger clinical trial to compare long-term clinical outcomes for the two treatment regimens . Clinical trial registered with http://www.umin.ac.jp/english/ ( UMIN000002819 ) SETTING An open clinical trial for the treatment of Mycobacterium avium intracellulare complex ( MAIC ) lung disease in human immunodeficiency virus (HIV)-seronegative patients . OBJECTIVE To assess the efficacy and tolerance of clarithromycin ( 0.75 - 2 g/day ) combined with minocycline ( 200 mg/day ) and clofazimine ( 100 mg/day ) for 15 months . DESIGN The study was carried out from August 1992 to June 1994 by pulmonologists of various French medical centres . The patients to be enrolled were of either sex , over 18 years of age , HIV-seronegative and suffering from MAIC lung disease , with a confirmed bacteriological and radiological diagnosis . Examinations were to be performed after 1 , 2 , 3 , 6 , 9 , 12 and 15 months of treatment . RESULTS Thirty patients were included , 16 males and 14 females . Eight did not complete the study due to deviations from protocol or adverse effects . The remainder completed the study with a post-treatment follow-up of 27 + /- 7 months . Among the 22 evaluable patients , 18 had a history of lung disease . Tolerance to the drugs was generally good , apart from three cases of hepatic disturbances and three cases of ototoxicity , which required a decrease in clarithromycin dosage after a short interruption of treatment . There were 14 treatment successes , seven treatment failures , defined by absence of bacteriologic conversion , and in one patient the disease evolution remains uncertain . CONCLUSION The combination of clarithromycin with minocycline and clofazimine proved effective with persistently negative cultures in 64 % of the patients , and an overall good drug tolerance Background : The difficulty of treatment for pulmonary Mycobacterium avium complex ( MAC ) in Japan . Objectives : To investigate the clinical and microbiological effects of treatment according to the guidelines proposed by the American Thoracic Society and the Japanese Society for Tuberculosis and prospect i ve follow-up studies after the completion of treatment of patients with pulmonary MAC disease . Methods : Analysis of the microbiological effects with regard to sputum conversion rate and the sputum relapsing rate and the clinical effects with regard to clinical symptoms and radiological findings for patients with pulmonary MAC disease treated with a regimen consisting of rifampicin , ethambutol , streptomycin , and clarithromycin over 24 months and follow-up over 12 months . Results : Sixty-five patients with pulmonary MAC disease were enrolled in this trial . In 39 patients , negative sputum conversion was observed within 6 months after the initiation of this regimen , 16 relapsed , and 20 experienced clinical worsening within 1 year after the completion of treatment . Although retreatment with the same regimen or a regimen including new quinolones was carried out for these patients , we could not achieve negative sputum conversion and /or clinical improvement . Conclusions : We believe that the dose of clarithromycin for pulmonary MAC disease may be increased and recommend surgery for patients with a localized lesion at early-stage MAC disease to prevent a high rate of relapse We initiated a prospect i ve trial of an azithromycin-containing regimen for the treatment of human immunodeficiency virus-negative patients with Mycobacterium avium complex ( MAC ) lung disease ; the initial 4 months of therapy were with azithromycin ( 600 mg/d ) alone . The primary study endpoint was microbiological response measured at 4 and 6 months of therapy . Of 29 patients enrolled in the study , 23 completed therapy . Fifty-two percent of these 23 patients were male , and 65 % were smokers . All 23 patients were older than 45 years of age ; 83 % had bilateral disease , and 48 % had fibrocavitary disease . Macrolide (clarithromycin)-susceptible MAC isolates were recovered from these 23 patients before treatment . Cultures of sputum from 38 % of these patients became negative , and the positivity of cultures of sputum from 76 % of these patients was significantly reduced . Sixty-eight percent of sputum cultures were strongly positive ( > 200 colonies ) before therapy , while only 27 % were strongly positive after therapy . Although most patients continued to receive 600 mg of azithromycin/d , the high incidence of gastrointestinal side effects ( 76 % ) and altered hearing ( 41 % ) suggests the need for lower or less frequent dosing . Macrolide ( clarithromycin ) resistance did not develop in any MAC isolates during monotherapy . These results , which demonstrate that azithromycin is active against MAC pulmonary disease , provide a rationale to include this drug in the initial multidrug regimens recommended for the treatment of this disease We initiated a prospect i ve noncomparative trial of treatment for lung disease due to Mycobacterium avium complex ( MAC ) in human immunodeficiency virus-negative patients , with a regimen of clarithromycin ( 1000 mg ) , rifabutin ( 300 - 600 mg ) , and ethambutol ( 25 mg/kg ) administered 3 times per week . Fifty-nine patients were enrolled . Twelve ( 20 % ) were lost to follow-up , and 6 ( 10 % ) developed clarithromycin intolerance . The remaining 41 patients ( 69 % ) completed the initial 6 months of therapy . The sputum of 32 of these patients ( 78 % ) converted to negative . When results were compared with the sputum response rates at 6 months in previous studies with a regimen including daily clarithromycin and regimens including intermittent ( 3 times per week ) azithromycin with the same companion drugs , no differences in treatment responses were evident . Adverse reactions related to rifabutin were a major problem , and for 24 ( 41 % ) of 59 patients the dosage was decreased or the drug was withdrawn . Intermittent ( 3 times per week ) administration of clarithromycin appears to be as effective as daily administration in effecting sputum conversion in pulmonary MAC disease OBJECTIVE To investigate whether the combined therapy according to the guideline proposed by American Thoracic Society ( ATS ) and Japanese Society for Tuberculosis ( JST ) is clinical ly appropriate for Mycobacterium avium complex ( MAC ) pulmonary disease . PATIENTS Seventy-one patients in whom MAC pulmonary disease was diagnosed at Kawasaki Medical School and our associated ten hospitals were prospect ively studied . RESULTS Seventy-one patients with Mycobacterium avium complex ( MAC ) pulmonary disease were 27 males and 44 females with a mean age of 64.4 + /- 10.2 years old . Patients received 400 mg/day or 600 mg/day of clarithromycin plus ethambutol , rifampicin , and initial streptomycin for 12 months . Among 71 patients who received more than 12 months of therapy , 41 patients ( 57.7 % ) converted their sputum to negative within six months after the initiation of this regimen , 16 of 41 patients ( 39.0 % ) relapsed , and 23 of 71 patients ( 32.4 % ) obtained clinical improvement on chest X-ray and /or clinical symptoms . The mortality rate had a comparatively good prognosis with a low incidence of 2.8 % . Although the species of pathogen ( M. avium or M. intracellulare ) did not significantly affect the conversion rate or clinical improvement , the infectious form with or without respiratory underlying disease , the characteristics and extent of lesion on chest X-ray , and the dose of clarithromycin significantly influenced the conversion rate or clinical improvement . There were no problems concerning adverse reactions for this regimen . CONCLUSION This combined therapy , according to the guideline proposed by ATS and JST , was one of the effective treatments compared to the clinical effect of only antituberculous drugs through this study . However , this combined therapy was unsatisfactory compared to the clinical effect for pulmonary tuberculosis . The development of new companion drugs for MAC pulmonary diseases is needed Intermediate results of the first 50 patients treated with clarithromycin ( CLARI ) regimens for Mycobacterium avium-intracellulare ( MAI ) lung disease were evaluated . Patients were HIV negative , and pretreatment isolates were susceptible to CLARI . Patients received CLARI 500 mg twice daily , ethambutol , rifampin ( RMP ) , or rifabutin ( RBT ) and initial streptomycin , and they were treated until culture-negative 1 yr . Eleven of 50 patients ( 22 % ) were dropped in the first 3 mo . Of the remaining 39 patients , 36 ( 92 % ) converted their sputa to negative , and 32 ( 82 % ) remain culture negative to date . This includes 11 of 16 ( 69 % ) with prior drug therapy and 21 of 23 ( 91 % ) with no prior therapy . One or more companion drugs were discontinued in 16 of 39 ( 41 % ) of patients because of adverse events . Isolates from six of 39 patients ( 15 % ) became CLARI-resistant . Of 23 patients who are alive and were culture-negative a mean of 12.0 mo while receiving therapy , all remain culture-negative without therapy a mean of 19.1 mo . Despite reduced CLARI serum levels in patients also receiving RMP , 10 of 13 patients ( 77 % ) receiving this regimen were successfully treated . Although not directly compared with previous regimens , the success of this regimen strongly suggests it is superior to previous non-CLARI-containing regimens OBJECTIVES To revise 2010 guidance on grading the strength of evidence ( SOE ) of the effectiveness of drugs , devices , and other preventive and therapeutic interventions in systematic review s produced by the Evidence -based Practice Center ( EPC ) program , established by the US Agency for Healthcare Research and Quality ( AHRQ ) . STUDY DESIGN AND SETTING A cross-EPC working group review ed authoritative systems for grading SOE [ primarily the approach from the Grading of Recommendations Assessment , Development and Evaluation ( GRADE ) working group ] and conducted extensive discussion s with GRADE and other experts . RESULTS Up date d guidance continues to be conceptually similar to GRADE . Review ers are to evaluate SOE separately for each major treatment comparison for each major outcome . We added reporting bias as a required domain and retained study limitations ( risk of bias ) , consistency , directness , and precision ( and three optional domains ) . Additional guidance covers scoring consistency , precision , and reporting bias , grading bodies of evidence with r and omized controlled trials and observational studies , evaluating single study bodies of evidence , using studies with high risk of bias , and presenting findings with greater clarity and transparency . SOE is grade d high , moderate , low , or insufficient , reflecting review ers ' confidence in the findings for a specific treatment comparison and outcome . CONCLUSION No single approach for grading SOE suits all review s , but a more consistent and transparent approach to reporting summary information will make review s more useful to the broad range of audiences that AHRQ 's work aims to reach . EPC working groups will consider ongoing challenges and modify guidance as needed , on issues such as combining trials and observational studies in bodies of evidence , weighting domains , and combining qualitative and quantitative syntheses Two consecutive , open , prospect i ve trials of intermittent azithromycin ( 600 mg ) , usually given Monday , Wednesday , and Friday ( TIW ) for Mycobacterium avium complex ( MAC ) lung disease were initiated in human immunodeficiency virus-negative patients . Regimen A consisted of TIW azithromycin and daily ethambutol ( 15 mg/kg/day ) , daily rifabutin ( 300 mg/day ) , and initial twice weekly ( BIW ) streptomycin . Regimen B consisted of TIW azithromycin , TIW ethambutol ( 25 mg/kg/dose ) , TIW rifabutin ( 600 mg/dose ) , and initial BIW streptomycin . Of 19 patients enrolled in regimen A who completed at least 6 months of therapy , 14 ( 74 % ) had sputum sample s become culture-negative . Of 39 patients enrolled in regimen B who completed at least 6 months of therapy , 24 ( 62 % ) had sputum conversion . These sputum conversion rates are comparable to previous rates at 6 months in patients receiving daily clarithromycin- or azithromycin-containing regimens . No resistance to azithromycin emerged with either regimen . This is the first study to demonstrate the efficacy of intermittent administration of medication for MAC lung disease A prospect i ve study of the clinical efficacy of an aminoglycoside antibiotic ( streptomycin , SM ) for the treatment of pulmonary Mycobacterium avium complex ( MAC ) disease was carried out . In a multicenter trial , patients with pulmonary MAC disease received protocol -guided combined chemotherapy with or without SM . SM was given to the patients intramuscularly 15 mg/kg three times per week for the initial 3 months and three other antibiotics ( rifampicin , ethambutol , and clarithromycin ) were added and administered for over 24 months after the conversion of MAC strains . From April 1998 to December 2004 , 160 HIV-negative patients were enrolled in this trial . Fourteen patients were found to be ineligible because they could not continue the treatment , and they were excluded from the analysis after r and omization . Seventy-three patients were assigned to receive combined chemotherapy with SM ( group A ) and 73 were assigned to receive combined chemotherapy without SM ( group B ) . The median duration s of treatment were 27.6 months in group A and 28.4 months in group B. The difference in the background s of the groups was not statistically significant . There were no differences in microbiological and radiological findings between the groups , but the sputum conversion rate for pulmonary MAC disease at the completion of treatment was significantly higher in group A than that in group B. Although , there were no significant differences in the sputum relapse rate and clinical improvement including both clinical symptoms and radiological findings , group A showed better initial microbiological response than group B. As for adverse reactions and abnormal laboratory findings , there were no significant differences between the groups . Based on the results of this double-blind r and omized study , we support treatment including SM according to both the American Thoracic Society ( ATS ) and the Japanese Society for Tuberculosis ( JST ) guidelines for patients with pulmonary MAC disease without HIV infection Mycobacterium avium complex infections , common in patients with AIDS as either pulmonary or disseminated disease , are infrequent in patients without AIDS . Participants were 45 HIV-negative patients with lung disease and positive sputum cultures for M avium ; 10 had documented immunocompromise , and 24 had preexisting lung disease . Clarithromycin dosage was 500 to 2,000 mg daily ( mean + /- SD = 1,633 + /- 432 mg ) . The drug was administered either alone ( n = 14 ) or in combination with rifampin ( n = 8) , aminoglycoside ( n = 1 ) , quinolone ( n = 10 ) , clofazimine ( n = 18 ) , isoniazid ( n = 5 ) , ethambutol ( n = 9 ) , pyrazinamide ( n = 1 ) , or minocycline ( n = 6 ) . At 3 months , 36 patients among 39 bacteriologically assessed had negative sputum cultures , 3 had positive culture , 3 were dead , and 3 discontinued treatment . At the end of treatment , 32 patients remained negative , 7 were positive . The success rate was 15 of 22 ( 64 % ) in patients previously treated with antimycobacterial drugs for M avium disease and 17 of 23 ( 74 % ) in new patients . Adverse effects included mild hearing loss ( n = 4 ) , increase in liver enzyme levels ( n = 5 ) , and gastrointestinal pain ( n = 10 , two of whom had to stop treatment ) . Patients stopped treatment after 300 + /- 186 days due to side effects ( 3 ) , death ( 4 ) , or the patient 's ( 5 ) or physician 's decision ( 33 ) . During the follow-up , one patient suffered a relapse with peripheral lymph nodes . A daily dose of 30 mg/kg of clarithromycin in the treatment of M avium infections appears to be effective and safe . Concomitant drug therapy should be assessed for its ability to prevent relapse Forty-six patients with positive sputum cultures for Mycobacterium avium complex and cavitary disease were placed on a 4-drug regimen consisting of isoniazid , rifampin , and ethambutol daily and streptomycin twice weekly . Forty-two ( 91.3 % ) converted their sputum to negative and 4 ( 8.7 % ) failed to convert . All of the 4 nonconverters had prior subtotal gastrectomy . Twenty-two patients were available for long-term follow-up : 12 patients completed 24 months of chemotherapy , all experienced sputum conversion , but 2 reactivated , 1 at 9 and the other at 27 months after termination of chemotherapy . These 2 patients had prior subtotal gastrectomy . Ten patients completed 18 months of chemotherapy with sputum conversion , 2 of these reactivated but had not had prior subtotal gastrectomy . In this group of patients , subtotal gastrectomy appeared to be an adverse risk factor for both initial treatment response and reactivation in pulmonary disease caused by Mycobacterium avium complex INTRODUCTION The impact of pulmonary nontuberculous mycobacterial ( pNTM ) disease on health-related quality of life ( HRQL ) has not been quantified . METHODS We performed a prospect i ve observational study of HRQL in 51 patients with pNTM disease . One generic ( Short-form 36 , version 2 -SF-36 ) , and one pulmonary disease-specific instrument ( St. George 's Respiratory Question naire -- SGRQ ) were administered to each subject . RESULTS Fifty-one patients with pNTM disease from one ambulatory clinic were enrolled . The mean ( sd ) age was 67 ( 10 ) years and 80 % ( 41/51 ) were female . The most common causative NTM was MAC in 84 % ( 43/51 ) followed by Mycobacterium abscessus in 8 % ( 4/51 ) . Radiographic disease type was nodular bronchiectasis in 71 % ( 36/51 ) and fibrocavitary in 22 % ( 11/51 ) . For SF-36 , most raw scores were at least 10 points below Canadian population -based normals , and all normbased scores were below the expected normal value of 50 . For SGRQ , all scores were worse by ≥ 25 points compared with published normals . In multivariable analyses , only FVC and DLCO were significantly associated with SF-36 , and only FVC and emphysema were significantly associated with SGRQ . CONCLUSION Patients with pNTM disease have significantly impaired HRQL that is most closely associated with lung function and not readily explained by age , sex or extra-pulmonary comorbidity RATIONALE Although intermittent , three-times-weekly therapy is recommended for the initial treatment of noncavitary nodular bronchiectatic Mycobacterium avium complex ( MAC ) lung disease , supporting data are limited . OBJECTIVES To evaluate the clinical efficacy of intermittent therapy compared with daily therapy for nodular bronchiectatic MAC lung disease . METHODS A retrospective cohort study of 217 patients with treatment-naive noncavitary nodular bronchiectatic MAC lung disease . All patients received either daily ( n = 99 ) or intermittent therapy ( n = 118 ) that included clarithromycin or azithromycin , rifampin , and ethambutol . MEASUREMENTS AND MAIN RESULTS Modification of the initial antibiotic therapy occurred more frequently in the daily therapy group than in the intermittent therapy group ( 46 vs. 21 % ; P < 0.001 ) ; in particular , ethambutol was more frequently discontinued in the daily therapy group than in the intermittent therapy group ( 24 vs. 1 % ; P ≤ 0.001 ) . However , the rates of symptomatic improvement , radiographic improvement , and sputum culture conversion were not different between the two groups ( daily therapy vs. intermittent therapy : 75 vs. 82 % , P = 0.181 ; 68 vs. 73 % , P = 0.402 ; 76 vs. 67 % , P = 0.154 , respectively ) . In addition , the adjusted proportion of sputum culture conversion was similar between the daily therapy ( 71.3 % ; 95 % confidence interval , 59.1 - 81.1 % ) and the intermittent therapy groups ( 73.6 % ; 95 % confidence interval , 62.9 - 82.2 % ; P = 0.785 ) . CONCLUSIONS These results suggest that intermittent three-times-weekly therapy with a macrolide , rifampin , and ethambutol is a reasonable initial treatment regimen for patients with noncavitary nodular bronchiectatic MAC lung disease . Clinical trial registered with www . clinical trials.gov ( NCT 00970801 ) RATIONALE Mycobacterium avium complex pulmonary disease ( MAC-PD ) is associated with substantial morbidity , and st and ard daily multidrug therapy is difficult to tolerate . OBJECTIVES To characterize response to a three-times-weekly ( TIW ) regimen of clarithromycin , ethambutol , and rifampin . METHODS A 1-yr prospect i ve noncomparative trial of TIW treatment was conducted during 2000 - 2003 in 17 U.S. cities . Participants were 91 HIV-negative adults , diagnosed with moderate to severe MAC-PD , who originally participated in a trial of an inhaled IFN-gamma treatment . Improvement in sputum culture , high-resolution computed tomography ( H RCT ) , and symptoms were assessed . RESULTS Treatment response rates ( and median response times ) were 44 % ( 2 mo or longer ) for culture , 60 % ( 5.5 - 11.5 mo ) for H RCT , and 53 % ( 8.5 mo ) for symptoms . Having noncavitary , compared with cavitary , disease increased culture response by 4.0 times ( 95 % confidence interval [ CI ] , 1.7 - 9.2 ) and H RCT response by 4.9 times ( 95 % CI , 1.9 - 13.0 ) . Culture response was 1.5 times ( 95 % CI , 1.1 - 2.2 ) higher for older subjects and 2.2 times ( 95 % CI , 1.0 - 4.7 ) higher for previously untreated subjects . Being smear-negative increased culture response by 2.3 times ( 95 % CI , 1.1 - 5.2 ) but decreased H RCT response by 4.4 times ( 95 % CI , 1.7 - 11.5 ) . Increasing ethambutol use by 5 mo increased culture response by 1.5 times ( 95 % CI , 1.0 - 2.1 ) but decreased symptom response . Not having chronic obstructive pulmonary disease , bronchiectasis , or poor lung function increased symptom response by 1.9 to 3.9 times . CONCLUSIONS TIW therapy was less effective for MAC-PD patients with cavitary disease and a history of chronic obstructive pulmonary disease , bronchiectasis , or previous treatment for MAC-PD . Further research is needed to study the long-term outcomes of TIW treatment BACKGROUND The treatment of pulmonary disease caused by opportunist mycobacteria is controversial . It is uncertain whether in vitro sensitivity testing predicts clinical response in the way it does forMycobacterium tuberculosis . The literature suggests that the combination of rifampicin ( R ) and ethambutol ( E ) is important whereas isoniazid ( H ) may not be , but to date there have been no published reports of r and omised controlled trials in the treatment of these conditions . The British Thoracic Society has conducted the first such trial , a r and omised study of two regimens in HIV negative patients with pulmonary disease caused by M avium intracellulare (MAC),M malmoense , and M xenopi . METHODS When two positive cultures were confirmed by the Mycobacterium Reference Laboratories for Engl and , Wales and Scotl and , the coordinating physician invited the patient 's physician to enrol the patient . Patients were also recruited from Sc and inavia . R and omisation to 2 years of treatment with RE or REH was performed from lists held in the coordinator 's office . Clinical , bacteriological , and radiological progress was monitored at set intervals up to 5 years . RESULTS From October 1987 to December 1992 , 141 physicians entered 223 patients ( 106 with M malmoense , 75 with MAC , 42 withM xenopi ) . At entry the RE and REH groups were comparable over a range of demographic and clinical features . For each species there was no significant difference between RE and REH in the number of deaths , but when the three species were combined there were fewer deaths from the mycobacterial disease with RE ( 1%v 8 % , p=0.018 , odds ratio 0.10 , exact 95 % CI 0.00 to 0.76 ) . For M malmoense the failure of treatment/relapse rates did not differ appreciably between the regimens , but for MAC there were fewer failures of treatment/relapses with REH ( 16 % v 41 % , p=0.033 ) With M xenopi there was a non-significant trend in the same direction ( 5%v 18 % , p=0.41 ) and when all three species were combined there was a significant difference in favour of REH ( 11%v 22 % , p=0.033 ) . There was no correlation between failure of treatment/relapse and in vitro resistance . M xenopi was associated with the greatest mortality ( 57 % at 5 years ) , MAC was the most difficult to eradicate , and M malmoense had the most favourable outlook ( 42 % known to be alive and cured at 5 years ) . CONCLUSIONS The results of susceptibility tests performed by the modal resistance method do not correlate with the patient 's response to chemotherapy . RE and REH are tolerated better than previous regimens containing second or third line anti-mycobacterial drugs . Treatment ofM malmoense with RE for 2 years is preferable to REH . The addition of H reduces the failure of treatment/relapse rates for MAC and has a tendency to do so also forM xenopi , but there is a suggestion that REH is associated with higher death rates overall . Better regimens are required Sputum conversion rates in Mycobacterium avium-intracellulare ( MAI ) complex lung disease have ranged from only 50 to 80 % despite the use of three to five antituberculosis agents . We initiated a prospect i ve , open , noncomparative trial of initial clarithromycin monotherapy at 500 mg twice a day for 4 months in HIV-negative patients with MAI lung disease . The primary study end point was microbiologic improvement . Of 30 patients enrolled , 20 completed therapy . This latter group was predominantly male ( 60 % ) , smokers ( 70 % ) , older than 45 yr of age ( 90 % ) , infected with Mycobacterium intracellulare ( 70 % ) and with bilateral disease ( 85 % ) . Of 19 patients with pretreatment minimum inhibitory concentrations ( MIC ) for clarithromycin < 16 micrograms/ml , 58 % became sputum-negative , and 21 % showed significant reductions in sputum positivity . Heavily positive sputum cultures ( > 200 colonies ) were reduced from 30 to 47 sample s pretherapy ( 64 % ) to three of 54 ( 6 % ) post-therapy ( p < 0.0001 ) ; 18 of 19 patients ( 95 % ) showed an improvement in sputum cultures , chest radiographs , or both . Only two patients ( 7 % ) discontinued the drug because of adverse events . Only three ( 16 % ) of 19 isolates developed clarithromycin resistance ( MIC > 32 micrograms/ml ) . Clarithromycin-susceptible and -resistant MAI isolates from the same patient had identical DNA large-restriction fragment patterns . Clarithromycin is the first single agent to be shown efficacious in the treatment of MAI lung disease We have investigated the efficacy of a clarithromycin-containing four-drug regimen for Mycobacterium avium complex ( MAC ) pulmonary disease in 46 patients without acquired immunodeficiency syndrome ( AIDS ) . The patients were 14 males and 32 females with a mean age of 60.9 + /- 11.5 yr . Patients received 10 mg/kg/d of clarithromycin plus ethambutol , rifampin , and initial kanamycin and subsequent quinolone for 24 mo . Seven patients ( 15.2 % ) were dropped in the first 6 mo . Among 39 patients who received more than 6 mo of therapy , 28 patients ( 71.8 % ) converted their sputa to negative : 26 of 31 patients ( 83.9 % ) infected with clarithromycin-susceptible strains and two of eight patients ( 25.0 % ) with resistant or intermediate strains . The timing of sputum conversion was 3.6 + /- 1.9 mo , with a range of 2 to 9 mo . The conversion rate was significantly lower in patients who were infected with clarithromycin-resistant or intermediate strains , who had had prior therapy ( 55.0 % versus 89.5 % ) , or who were acid-fast bacilli ( AFB ) smear-positive at entry ( 60.7 % versus 100 % ) . The age and sex of patients , the species of pathogen ( M. avium or M. intracellulare ) , type and extent of the disease , and the use of kanamycin did not significantly affect the conversion rate . Although the regimen was efficacious for newly treated patients , frequent adverse reactions and a low conversion rate of sputum in retreated patients are problems that remain to be solved Ninety-two patients were assessable in 3 consecutive , open , noncomparative , prospect i ve , controlled , single-center trials of the use of multidrug regimens that contain azithromycin for treating pulmonary Mycobacterium avium complex ( MAC ) disease . Azithromycin was provided at a dose of 300 - 600 mg per day with oral companion drugs administered daily ( regimen A , 29 patients ) ; 600 mg 3 times weekly ( t.i.w . ) , with oral companion drugs administered daily ( regimen B , 20 patients ) ; and 600 mg ( t.i.w . ) , with oral companion drugs administered t.i.w . ( regimen C , 43 patients ) . All regimens included rifabutin ( or rifampin ) and ethambutol as companion drugs as well as initial streptomycin . Treatment success was defined as 12 months of negative cultures while on therapy . Treatment failure was defined as sputum culture positivity after at least 6 months of therapy . Of the patients in each regimen who reached study end points , 17 of 29 ( 59 % ) were in regimen A , 11 of 20 ( 55 % ) were in regimen B , and 28 of 43 ( 65 % ) were in regimen C met the treatment success criterion . There were no statistically significant differences in outcome between the 3 regimens . These studies demonstrate the effectiveness of daily and t.i.w . regimens containing azithromycin for treatment of MAC lung disease |
11,526 | 24,230,488 | Dietary prebiotic consumption was found to be associated with subjective improvements in satiety and reductions in postpr and ial glucose and insulin concentrations . | Complex relationships exist between the gut microflora and their human hosts .
Emerging evidence suggests that bacterial dysbiosis within the colon may be involved in the pathogenesis of the metabolic syndrome , type 2 diabetes and CVD .
The use of dietary prebiotic supplements to restore an optimal balance of intestinal flora may positively affect host metabolism , representing a potential treatment strategy for individuals with cardiometabolic disorders .
The present review aim ed to examine the current evidence supporting that dietary prebiotic supplementation in adults has beneficial effects on biochemical parameters associated with the development of metabolic abnormalities including obesity , glucose intolerance , dyslipidaemia , hepatic steatosis and low- grade chronic inflammation . | Objective To highlight the contribution of the gut microbiota to the modulation of host metabolism by dietary inulin-type fructans ( ITF prebiotics ) in obese women . Methods A double blind , placebo controlled , intervention study was performed with 30 obese women treated with ITF prebiotics ( inulin/oligofructose 50/50 mix ; n=15 ) or placebo ( maltodextrin ; n=15 ) for 3 months ( 16 g/day ) . Blood , faeces and urine sampling , oral glucose tolerance test , homeostasis model assessment and impedancemetry were performed before and after treatment . The gut microbial composition in faeces was analysed by phylogenetic microarray and qPCR analysis of 16S rDNA . Plasma and urine metabolic profiles were analysed by 1H-NMR spectroscopy . Results Treatment with ITF prebiotics , but not the placebo , led to an increase in Bifidobacterium and Faecalibacterium prausnitzii ; both bacteria negatively correlated with serum lipopolysaccharide levels . ITF prebiotics also decreased Bacteroides intestinalis , Bacteroides vulgatus and Propionibacterium , an effect associated with a slight decrease in fat mass and with plasma lactate and phosphatidylcholine levels . No clear treatment clustering could be detected for gut microbial analysis or plasma and urine metabolomic profile analyses . However , ITF prebiotics led to subtle changes in the gut microbiota that may importantly impact on several key metabolites implicated in obesity and /or diabetes . Conclusions ITF prebiotics selectively changed the gut microbiota composition in obese women , leading to modest changes in host metabolism , as suggested by the correlation between some bacterial species and metabolic endotoxaemia or metabolomic signatures Background Increased exposure to intestinal bacterial products may contribute to the pathogenesis of non alcoholic steatohepatitis ( NASH ) . Bifidobacteria are predominant bacterial species in the human gut microbiota and have been considered to exert a beneficial effect on human health by maintaining the equilibrium of the resident microbiota . Aims To evaluate the effects of Bifidobacterium longum with fructo-oligosaccharides ( Fos ) in the treatment of NASH . Methods A total of 66 patients were r and omly and equally divided into two groups receiving Bifidobacterium longum with Fos and lifestyle modification ( i.e. , diet and exercise ) versus lifestyle modification alone . The following variables were assessed at −4 ( beginning of the dietary lead-in period ) , 0 ( r and omization ) , 6 , 12 , 18 , and 24 weeks : aspartate transaminase ( AST ) , alanine transaminase ( ALT ) , bilirubin , albumin , total cholesterol , high-density lipoprotein ( HDL ) cholesterol , low-density lipoprotein ( LDL ) cholesterol , triglycerides , fasting plasma glucose , insulin , C-peptide , C-reactive protein ( CRP ) , tumor necrosis factor (TNF)-α , homeostasis model assessment of insulin resistance ( HOMA-IR ) , and serum endotoxins . Liver biopsies were performed at entry and repeated after 24 weeks of treatment . Results At the end of study period , we observed that the Bifidobacterium longum with Fos and lifestyle modification group versus the lifestyle modification alone group showed significant differences in the AST −69.6 versus −45.9 IU/mL ( P < 0.05 ) , LDL cholesterol −0.84 versus −0.18 mmol/L ( P < 0.001 ) , CRP −2.9 versus −0.7 mg/L ( P < 0.05 ) , TNF-α −0.45 versus −0.12 ng/mL ( P < 0.001 ) , HOMA-IR −1.1 versus −0.6 ( P < 0.001 ) , serum endotoxin −45.2 versus −30.6 pg/mL ( P < 0.001 ) , steatosis ( P < 0.05 ) , and the NASH activity index ( P < 0.05 ) . Conclusions Bifidobacterium longum with Fos and lifestyle modification , when compared to lifestyle modification alone , significantly reduces TNF-α , CRP , serum AST levels , HOMA-IR , serum endotoxin , steatosis , and the NASH activity index High cereal fibre intake is associated with reduced risk for type 2 diabetes , but wheat fibre had little or no effect on glycaemic control or oral glucose tolerance in clinical trials lasting 4 - 12 weeks . To explain this discrepancy , we hypothesised that colonic adaptation to increased wheat fibre intake takes many months but eventually results in increased SCFA production and glucagon-like peptide-1 ( GLP-1 ) secretion . Thus , the primary objective was to determine the time-course of the effects of increased wheat fibre intake on plasma acetate , butyrate and GLP-1 concentrations in hyperinsulinaemic human subjects over 1 year . Subjects with fasting plasma insulin > or= 40 pmol/l were r and omly assigned by computer to receive either a high-wheat fibre cereal ( fibre group ; 24 g fibre/d ; twenty assigned ; six dropped out , fourteen included ) or a low-fibre cereal ( control group ; twenty assigned ; six dropped-out , fourteen included ) daily for 1 year . Acetate , butyrate and GLP-1 were measured during 8 h metabolic profiles performed every 3 months . There were no differences in body weight in the fibre group compared with the control group . After 9 months baseline-adjusted mean 8 h acetate and butyrate concentrations were higher on the high-fibre than the control cereal ( P < 0.05 ) . After 12 months on the high-fibre cereal , baseline-adjusted mean plasma GLP-1 was 1.3 ( 95 % CI 0.4 , 2.2 ) pmol/l ( P < 0.05 ) higher than at baseline ( about 25 % increase ) and 1.4 ( 95 % CI 0.1 , 2.7 ) pmol/l ( P < 0.05 ) higher than after 12 months on control . It is concluded that wheat fibre increased SCFA production and GLP-1 secretion in hyperinsulinaemic humans , but these effects took 9 - 12 months to develop . Since GLP-1 may increase insulin sensitivity and secretion , these results may provide a mechanism for the epidemiological association between high cereal fibre intake and reduced risk for diabetes Epidemiological studies have shown an inverse association between dietary intake of whole grains and the risk of chronic disease . This may be related to the ability to mediate a prebiotic modulation of gut microbiota . However , no studies have been conducted on the microbiota modulatory capability of whole-grain ( WG ) cereals . In the present study , the impact of WG wheat on the human intestinal microbiota compared to wheat bran ( WB ) was determined . A double-blind , r and omised , crossover study was carried out in thirty-one volunteers who were r and omised into two groups and consumed daily 48 g breakfast cereals , either WG or WB , in two 3-week study periods , separated by a 2-week washout period . Numbers of faecal bifidobacteria and lactobacilli ( the target genera for prebiotic intake ) , were significantly higher upon WG ingestion compared with WB . Ingestion of both breakfast cereals result ed in a significant increase in ferulic acid concentrations in blood but no discernible difference in faeces or urine . No significant differences in faecal SCFA , fasting blood glucose , insulin , total cholesterol ( TC ) , TAG or HDL-cholesterol were observed upon ingestion of WG compared with WB . However , a significant reduction in TC was observed in volunteers in the top quartile of TC concentrations upon ingestion of either cereal . No adverse intestinal symptoms were reported and WB ingestion increased stool frequency . Daily consumption of WG wheat exerted a pronounced prebiotic effect on the human gut microbiota composition . This prebiotic activity may contribute towards the beneficial physiological effects of WG wheat In rats , oligofructose has been shown to stimulate satiety hormone secretion , reduce energy intake and promote weight loss . The present study aim ed to examine the effect of oligofructose supplementation on appetite profiles , satiety hormone concentrations and energy intake in human subjects . A total of thirty-one healthy subjects ( ten men and twenty-one women ) aged 28 ( SEM 3 ) years with a BMI of 24·8 ( SEM 0·3 ) kg/m(2 ) were included in a r and omised double-blind , cross-over study . The subjects received 10 g oligofructose , 16 g oligofructose or 16 g placebo ( maltodextrin ) daily for 13 d , with a 2-week washout period between treatments . Appetite profile , active glucagon-like peptide 1 ( GLP-1 ) and peptide YY3 - 36 ( PYY ) concentrations and energy intake were assessed on days 0 and 13 of the treatment period . Time × treatment interaction revealed a trend of reduction in energy intake over days 0 - 13 by oligofructose ( P = 0·068 ) . Energy intake was significantly reduced ( 11 % ) over time on day 13 compared with day 0 with 16 g/d oligofructose ( 2801 ( SEM 301 ) v. 3217 ( SEM 320 ) kJ , P < 0·05 ) . Moreover , energy intake was significantly lower with 16 g/d oligofructose compared with 10 g/d oligofructose on day 13 ( 2801 ( SEM 301 ) v. 3177 ( SEM 276 ) kJ , P < 0·05 ) . Area under the curve ( AUC ) for GLP-1 on day 13 was significantly higher with 16 g/d oligofructose compared with 10 g/d oligofructose ( 45 ( SEM 4 ) v. 41 ( SEM 3 ) pmol/l × h , P < 0·05 ) . In the morning until lunch , AUC(0 - 230 min ) for PYY on day 13 was significantly higher with 16 g/d oligofructose compared with 10 g/d oligofructose and placebo ( 409 ( SEM 35 ) v. 222 ( SEM 19 ) and 211 ( SEM 20 ) pg/ml × h , P < 0·01 ) . In conclusion , 16 g/d and not 10 g/d oligofructose may be an effective dose to reduce energy intake , possibly supported by higher GLP-1 and PYY concentrations BACKGROUND A high-carbohydrate , low-fat diet is recommended for the prevention of atherosclerosis , because it reduces plasma cholesterol concentrations . However , such a diet can increase plasma triacylglycerol concentrations -- an undesirable side effect . The addition of nondigestible carbohydrate could reduce the risk of elevated triacylglycerol concentrations . OBJECTIVE The objective was to determine whether the addition of a moderate dose of inulin to a moderately high-carbohydrate diet would decrease hepatic lipogenesis and plasma triacylglycerol concentrations and have a cholesterol-lowering action . DESIGN Eight healthy subjects were studied twice in a double-blind , r and omized , placebo-controlled crossover study after consuming for 3 wk a moderately high-carbohydrate , low-fat diet ( 55 % of total energy ) plus an oral placebo or 10 g high-performance inulin/d . Hepatic lipogenesis and cholesterol synthesis ( deuterated water method ) , plasma lipid concentrations , fatty acid synthase , acetyl-CoA carboxylase 1 , and sterol responsive element binding protein 1c messenger RNA concentrations were measured in adipose tissue at the end of the 2 diet periods . RESULTS Plasma triacylglycerol concentrations and hepatic lipogenesis were lower after inulin than after placebo ingestion ( P < 0.05 ) , but cholesterol synthesis and plasma cholesterol concentrations were not significantly different between the 2 groups . None of the adipose tissue messenger RNA concentrations changed significantly after inulin ingestion . CONCLUSIONS The addition of high-performance inulin to a moderately high-carbohydrate , low-fat diet has a beneficial effect on plasma lipids by decreasing hepatic lipogenesis and plasma triacylglycerol concentrations . These results support the use of nondigestible carbohydrate for reducing risk factors for atherosclerosis BACKGROUND Aging is associated with reduced numbers of beneficial colonic bifidobacteria and impaired immunity . Galactooligosaccharides ( GOSs ) stimulate the growth of bifidobacteria in younger adults , but little is known about their effects in the elderly and their immunomodulatory capacity . OBJECTIVE We assessed the effect of a prebiotic GOS mixture ( B-GOS ) on immune function and fecal microflora composition in healthy elderly subjects . DESIGN In a double-blind , placebo-controlled , crossover study , 44 elderly subjects were r and omly assigned to receive either a placebo or the B-GOS treatment ( 5.5 g/d ) . Subjects consumed the treatments for 10 wk , and then went through a 4-wk washout period , before switching to the other treatment for the final 10 wk . Blood and fecal sample s were collected at the beginning , middle ( 5 wk ) , and end of the test period . Predominant bacterial groups were quantified , and phagocytosis , natural killer ( NK ) cell activity , cytokine production , plasma cholesterol , and HDL cholesterol were measured . RESULTS B-GOS significantly increased the numbers of beneficial bacteria , especially bifidobacteria , at the expense of less beneficial groups compared with the baseline and placebo . Significant increases in phagocytosis , NK cell activity , and the production of antiinflammatory cytokine interleukin-10 ( IL-10 ) and significant reduction in the production of proinflammatory cytokines ( IL-6 , IL-1beta , and tumor necrosis factor-alpha ) were also observed . B-GOS exerted no effects on total cholesterol or HDL-cholesterol production , however . CONCLUSIONS B-GOS administration to healthy elderly persons result ed in positive effects on both the microflora composition and the immune response . Therefore , B-GOS may be a useful dietary c and i date for the enhancement of gastrointestinal health and immune function in elderly persons Short-chain fructooligosaccharides ( FOS ) are prebiotics , which escape digestion in the small intestine and are fermented by the colonic microflora into short-chain fatty acids . Recently , we found that the daily consumption of 20 g FOS decreased basal hepatic glucose production in healthy subjects without any effect on insulin-stimulated glucose metabolism . In this study , we evaluated the effects of the chronic ingestion of FOS on plasma lipid and glucose concentrations , hepatic glucose production and insulin resistance in type 2 diabetics . Type 2 diabetic volunteers ( n = 10 ; 6 men , 4 women ) received either 20 g/d FOS or sucrose for 4 wk in a double-blind crossover design . FOS did not modify fasting plasma glucose and insulin concentrations or basal hepatic glucose production . The plasma glucose response to a fixed exogenous insulin bolus did not differ at the end of the two periods . Erythrocyte insulin binding also did not differ . Serum triacylglycerol , total and HDL cholesterol , free fatty acid , apolipoproteins A1 and B and lipoprotein ( a ) concentrations were not modified by the chronic ingestion of FOS . We conclude that 4 wk of 20 g/d of FOS had no effect on glucose and lipid metabolism in type 2 diabetics Background Inulin has been suggested to have beneficial effects on lipids , especially on triglyceridemia . Few data are available about the effects of inulin on Lipoprotein(a ) , a low-density lipoprotein-like particle considered as an independent risk factor for atherosclerosis . Adding inulin to pasta could be a preventive strategy for delaying the onset of atherosclerosis . Aim of the study was to evaluate the effects of inulin-enriched pasta on lipid profile and on Lipoprotein(a ) in young healthy subjects . Methods Twenty-two young healthy male volunteers entered a r and omized double blind cross-over study consisting of a 2-weeks run-in period , a baseline assessment , two 5-weeks study periods ( 11 % inulin-enriched or control pasta ) , and an 8-weeks wash-out period in between . Serum lipid concentrations were evaluated by routine biochemical analyses and plasma Lipoprotein(a ) concentrations by ELISA . The size of apolipoprotein(a ) isoforms was determined by Western blot and immunodetection . Results Significant differences at baseline and in the treatment groups were found for HDL-cholesterol ( P = 0.004 ) , total cholesterol/HDL-cholesterol ratio ( P = 0.006 ) , triglycerides ( P = 0.04 ) , and Lipoprotein(a ) ( P = 0.02 ) concentrations ( data analyzed by Friedman test ) . Dunn ’s multiple comparison test was used to assess the significance of differences between inulin-enriched pasta diet vs. baseline . HDL-cholesterol concentrations increased by 35.9 % ; total cholesterol/HDL-cholesterol ratio , triglycerides , and Lipoprotein(a ) concentrations decreased by 22.2 , 23.4 , and 16.5 % respectively . Conclusions Inulin-enriched pasta administration induced significant effects on lipid pattern parameters in young healthy volunteers , including a significant reduction in Lipoprotein(a ) concentrations It is thought that diets high in dietary fibre are associated with reduced risk for type 2 diabetes , at least in part because the short-chain fatty acids ( SCFAs ) produced during the colonic fermentation of fibre beneficially influence circulating concentrations of free-fatty acids ( FFAs ) and gut hormones involved in the regulation of blood glucose and body mass . However , there is a paucity of data showing this sequence of events in humans . Thus , our objective was to determine the effect of the fermentable fibre inulin on postpr and ial glucose , insulin , SCFA , FFA , and gut hormone responses in healthy subjects . Overnight fasted healthy subjects ( n = 12 ) were studied for 6 h after consuming 400 mL drinks , containing 80 g high-fructose corn syrup ( 80HFCS ) , 56 g HFCS ( 56HFCS ) , or 56 g HFCS plus 24 g inulin ( Inulin ) , using a r and omized , single-blind , crossover design . A st and ard lunch was served 4 h after the test drink . Glucose and insulin responses after Inulin did not differ significantly from those after 80HFCS or 56HFCS . Serum acetate , propionate , and butyrate were significantly higher after Inulin than after HFCS drinks from 4 - 6 h. FFAs fell at a similar rate after all 3 test drinks , but were lower after Inulin than after 56HFCS at 4 h ( 0.40 + /- 0.06 vs. 0.51 + /- 0.06 mmol*L-1 ; p < 0.05 ) . Compared with 56HFCS , Inulin significantly increased plasma glucagon-like peptide-1 concentrations at 30 min , and reduced ghrelin at 4.5 h and 6 h. The results are consistent with the hypothesis that dietary fibre increases the production of colonic SCFAs , which may reduce type 2 diabetes risk by reducing postpr and ial FFAs and favorably affecting gut hormones , which regulate food intake Apart from the intestinal environment , inulin induces physiological effects , which includes a reduction in glucose and lipid concentrations and modulation of gastrointestinal motility through the release of different peptides . We hypothesized that inulin-enriched pasta may also improve small intestine permeability in relation to zonulin and glucagon-like peptide 2 ( GLP-2 ) levels in healthy young subjects . Twenty healthy , young male volunteers completed a r and omized , double-blind crossover study consisting of a 2-week run-in period and two 5-week study periods ( 11 % inulin-enriched or control pasta ) , with an 8-week washout period in between . The intestinal barrier function was assessed by lactulose-mannitol excretion in urine . Zonulin values and GLP-2 release were evaluated by enzyme-linked immunosorbent assay . In the inulin group , the urinary lactulose recovery was significantly lower than the other 2 groups . There were no significant differences in urinary mannitol levels between groups . Accordingly , the lactulose-mannitol excretion ratio was significantly decreased in the inulin-enriched pasta group compared with the other 2 groups . The inulin-enriched pasta group had significantly lower zonulin serum values and significantly higher GLP-2 basal values when compared with the baseline and control pasta groups . The dietary use of inulin-enriched pasta preserves intestinal mucosal barrier functioning and modulates circulating levels of zonulin and GLP-2 , suggesting that prebiotics could be used in the prevention of gastrointestinal diseases and metabolic disorders Background The purpose of this study was to evaluate the effects of high performance inulin supplementation on blood glycemic control and antioxidant status in women with type 2 diabetes . Methods In a r and omized , triple-blind controlled trial , 49 females ( fiber intake < 30 g/day , 25<body mass index < 35 kg/m2 ) with type 2 diabetes were recruited from the Iran Diabetes Society and from endocrinology and metabolism clinics associated with the Tabriz University of Medical Science . The participants were divided into one of two groups in which the participants either received 10 g/day of inulin ( intervention , n=24 ) or maltodextrin ( control , n=25 ) for 2 months . Fasting blood sample s were obtained and both glycemic control and antioxidant status were determined at baseline and at the end of the study . Results At the end of the study period , there were significant decreases in fasting plasma glucose ( 8.47 % ) , glycosylated hemoglobin ( 10.43 % ) , and malondialdehyde ( 37.21 % ) levels and significant increases in total antioxidant capacity ( 18.82 % ) and superoxide dismutase activity ( 4.36 % ) in the inulin group when compared to the maltodextrin group ( P<0.05 ) . Changes in fasting insulin , homeostasis model assessment of insulin resistance , and catalase activity were not significant in the inulin group when compared with the maltodextrin group . Glutathione peroxidase activity remained unchanged in both groups . Conclusion Inulin supplementation may improve some glycemic and antioxidant indices and decrease malondialdehyde levels in women with type 2 diabetes . Further investigations are needed in order to confirm the positive effects that inulin may have on the glycemic and antioxidant indices of patients with type 2 diabetes Aim Our group has previously shown that the administration of pasta enriched along with the prebiotic inulin induces a significant reduction in triglyceride and glucose levels with a significant delay in gastric emptying ( GE ) rates . This protective effect may occur by affecting the release of a number of gut peptides involved in the control of gastrointestinal motility . The aim of the present study was to evaluate the effects of inulin-enriched pasta on the circulating levels of neurotensin ( NT ) , somatostatin ( SS ) , and corticotropin-releasing factor ( CRF ) in relation to the GE time in young healthy subjects . Methods Twenty healthy young male volunteers completed a r and omized double-blind crossover study consisting of a 2-week run-in period and two 5-week study periods ( 11 % inulin-enriched/control pasta ) , with an 8-week wash-out period in between . Gut peptide concentrations were evaluated by radioimmunoassay . GE time was evaluated by ultrasonography . Results The prebiotic treatment significantly increased the area under the curve ( AUC ) values of both NT and SS ( p < 0.05 Dunn ’s post-test ) . With regard to gastric motility , along with a significant delay in both the final time and T1/2 gastric emptying time , a positive correlation was found between T1/2 and SS AUC values ( r = 0.57 , p = 0.009 ) in the inulin-enriched pasta group . Conclusion These results support the hypothesis that inulin plays an active role in mechanisms affecting the release of these gut peptides , which may modulate the gastric emptying of digesta The purpose of the present study was to establish the prebiotic effect of a new xylo-oligosaccharide ( XOS ) and of an inulin- and -XOS mixture ( INU-XOS ) and to determine their effect on endotoxaemia ( lipopolysaccharides ( LPS ) ) and immune parameters . In this r and omised , parallel , placebo-controlled , double-blind study , sixty healthy volunteers were r and omly assigned to three groups , receiving either 5 g XOS , INU-XOS ( 3 g inulin + 1 g XOS ) or an equivalent weight of wheat maltodextrin ( placebo ) during 4 weeks . Faecal sample s were collected to assess the effects of these products on microbiota , as well as SCFA composition , enzymatic activities and secretory IgA production . Circulating LPS was measured in plasma sample s , and whole blood was incubated with LPS to measure cytokine expression . Consumption of XOS alone increased the faecal concentrations of Bifidobacterium and butyrate and activities of α-glucosidase and β-glucuronidase , while decreasing the concentrations of acetate and p-cresol . Consumption of XOS in combination with inulin did not decrease the concentrations of acetate and p-cresol , but increased in addition the faecal concentrations of total SCFA and propionate . Furthermore , consumption of XOS in combination with inulin decreased LPS concentrations in blood and attenuated LPS-induced increases in gene expression in IL-1β and LPS-induced decreases in gene expression in IL-13 in blood . In conclusion , consumption of XOS alone or in combination with inulin results in beneficial albeit different changes in the intestinal microbiome on a high-fat diet . In addition , consumption of XOS in combination with inulin attenuates the proinflammatory effects of a high-fat diet in the blood of healthy subjects Background Obesity is a major public health problem in many poor countries where micronutrient deficiencies are prevalent . A partial meal replacement may be an effective strategy to decrease obesity and increase micronutrient intake in such population s. The objective was to evaluate the efficacy of a partial meal replacement with and without inulin on weight reduction , blood lipids and micronutrients intake in obese Mexican women . Methods In a r and omized controlled clinical trial 144 women ( 18–50 y ) with BMI ≥ 25 kg/m2 , were allocated into one of the following treatments during 3 months : 1 ) Two doses/d of a partial meal replacement ( PMR ) , 2 ) Two doses/d of PMR with inulin ( PMR + I ) , 3 ) Two doses/d of 5 g of inulin ( INU ) and 4 ) Control group ( CON ) . All groups received a low calorie diet ( LCD ) . Weight , height , hip and waist circumference were measured every 2 weeks and body composition , lipids and glucose concentration and nutrient intake were assessed at baseline and after 3 months . Results All groups significantly reduced weight , BMI , waist and hip circumference . Differences between groups were only observed in BMI and weight adjusted changes : At 45 days PMR group lost more weight than INU and CON groups by 0.9 and 1.2Kg , respectively . At 60 days , PMR + I and PMR groups lost more weight than in INU by 0.7 and 1Kg , respectively . Subjects in PMR , PMR + I and INU significantly decreased triglycerides . Energy intake was reduced in all groups . Fiber intake increased in PMR + I and INU groups . Some minerals and vitamins intakes were higher in PMR and PMR + I compared with INU and CON groups . Conclusion Inclusion of PMR with and without inulin to a LCD had no additional effect on weight reduction than a LCD alone but reduced triglycerides and improved intake of micronutrients during caloric restriction . PMR could be a good alternative for obese population s with micronutrient deficiencies . Clinical Trials . Gov Interest in functional foods is increasing . The aim of the present study was to investigate breads supplemented with functional components . One was bread supplemented with inulin , linseed and soya fibre ( prebiotic bread ) . The other was a prebiotic antioxidant bread ( pre-aox-bread ) , which additionally contained green tea powder , herbs and tomato paste . The effects of these two breads on immunological and antioxidative parameters were compared with control bread ( placebo ) . Twenty smokers and eighteen non-smokers were enrolled in the r and omised parallel study , which consisted of a control period and an intervention period , each lasting for 5 weeks . Daily intake of bread and nutrients did not differ between the intervention and the control period . Most of the twenty-three investigated immunological parameters measured in peripheral blood were unaffected . However , the percentage of CD19 increased after intervention with prebiotic bread , whereas intercellular adhesion molecule-1 ( ICAM-1 ) and CD3+NK+ ( P < 0.05 ) decreased in both intervention arms . The ferric reducing ability of plasma ( FRAP ) was increased after consumption of the pre-aox-bread for non-smokers ( 1256 v. 1147 micromol/l ; P = 0.019 ) and remained unchanged for smokers consuming the pre-aox-bread . All analysed carotenoids ( P < or= 0.001 ) in plasma were increased after the consumption of pre-aox-bread . The concentrations of uric acid and alpha-tocopherol rose after intervention with both breads . ICAM-1 as a marker of stress decreased after consuming the prebiotic bread . In conclusion , increased plasma concentrations of carotenoids and the responses observed with the FRAP assay after intervention with the pre-aox-bread indicate a unique response in terms of antioxidative potentials for this type of functional food INTRODUCTION Inulin and FOS are prebiotics with potential benefit in cardiovascular risk factors . Alpha linolenic acid ( ALA ) is the metabolic precursor of the long chain n-3 fatty acid eicosapentaenoic acid ( 20 : 5n-3 ) , this fatty acid has anti-inflammatory properties . The aim of our study was to evaluate the response of the cardiovascular risk profile in obese patients after inclusion in the diet of an ALA , FOS and inulin enriched-cookie . MATERIAL AND METHODS 36 patients were r and omized in both branches : group I ( inulin , FOS and ALA enriched cookie ) Gullon SL ( ® ) and group II ( control cookie ) . Previous and after 1 month of the treatment , a nutritional and biochemical study was realized . RESULTS 15 patients finished the procotol in each group . In group I , a significantly increase in soluble fiber ( 2.3 ± 0.8 g/day vs 7.7 ± 0.8 g/day : p < 0.05 ) and ALA ( 0.6 ± 0.5 g/day vs 3.8 ± 0.5 g/day ; p < 0.05 ) intakes was detected . In this group a significant decrease of total cholesterol ( 238.1 ± 45.3 mg/dl vs 210.5 ± 38.1 mg/dl : p < 0.05 ) , LDL cholesterol ( 153.6 ± 23.2 mg/dl vs 127.1 ± 27.9 mg/dl : p < 0.05 ) and C reactive protein ( 6.6 ± 1.4 mg/dl vs 4.4 + 7 - 1.8 mg/dl : p < 0.05 ) was reached in males . Anthropometric parameters did not change in both groups . The increase in soluble fiber and ALA dietary intakes did not produce any gastrointestinal adverse effect . CONCLUSION The increase of 2 grams per day of inulin , 3.1 grams per day of FOS and 3.2 grams per day of alpha linolenic ( ALA ) dietary intakes from an enriched-cookie , improved total cholesterol , LDL cholesterol and C reactive protein levels in obese males . As far as we know , this is the first study that has evaluated the effect on risk factors of an ALA enriched cookies Faecal microbial changes associated with ageing include reduced bifidobacteria numbers . These changes coincide with an increased risk of disease development . Prebiotics have been observed to increase bifidobacteria numbers within humans . The present study aim ed to determine if prebiotic galacto-oligosaccharides ( GOS ) could benefit a population of men and women of 50 years and above , through modulation of faecal microbiota , fermentation characteristics and faecal water genotoxicity . A total of thirty-seven volunteers completed this r and omised , double-blind , placebo-controlled crossover trial . The treatments - juice containing 4 g GOS and placebo - were consumed twice daily for 3 weeks , preceded by 3-week washout periods . To study the effect of GOS on different large bowel regions , three-stage continuous culture systems were conducted in parallel using faecal inocula from three volunteers . Faecal sample s were microbially enumerated by quantitative PCR . In vivo , following GOS intervention , bifidobacteria were significantly more compared to post-placebo ( P = 0·02 ) . Accordingly , GOS supplementation had a bifidogenic effect in all in vitro system vessels . Furthermore , in vessel 1 ( similar to the proximal colon ) , GOS fermentation led to more lactobacilli and increased butyrate . No changes in faecal water genotoxicity were observed . To conclude , GOS supplementation significantly increased bifidobacteria numbers in vivo and in vitro . Increased butyrate production and elevated bifidobacteria numbers may constitute beneficial modulation of the gut microbiota in a maturing population BACKGROUND Prebiotics stimulate the growth of bifidogenic bacteria in the gut . The aim of this work was to assess the effects of a prebiotic mixture on the immune response in healthy elderly people . METHODS Healthy free-living elderly people ( age , > or = 70 years ) , receiving a nutritional supplement that provided 1.6 MJ , 15 g of protein , and 50 % of vitamin daily reference values per day , were r and omly assigned to receive a prebiotic mixture ( 6 g/d of a 70 % raftilose and 30 % raftiline mixture ) or placebo ( 6 g of maltodextrin powder ) for 28 weeks . At week 2 of the study , all subjects were vaccinated with influenza and pneumococcal vaccines . At weeks 0 , 2 , and 8 of the study , serum total proteins , albumin , immunoglobulins , saliva secretory immunoglobulin A ( IgA ) , and serum titers of influenza A and B and pneumococcal antibodies were measured . At week 8 , cultured peripheral monocyte cell secretion of interleukin-4 , interferon-gamma , and lymphocyte proliferation , stimulated with phytohemagglutinin and influenza antigen , were measured . RESULTS Sixty-six subjects were considered eligible for the study , and 43 ( 20 receiving prebiotics and 23 receiving placebo ) were considered for final analyses on a per protocol basis . No changes in serum proteins , albumin , immunoglobulins , and secretory IgA were observed . Antibodies against influenza B and pneumococcus increased significantly from weeks 0 to 8 , with no significant differences between groups . Antibodies against influenza A did not increase . No effects of prebiotics on interleukin-4 and interferon-gamma secretion by cultured monocytes were observed . CONCLUSIONS No immunological effects of prebiotics were observed in this study Objective : Arabinoxylan ( AX ) consumption is associated with metabolic improvement during diabetes and with modulation of ghrelin , an orexigenic gut hormone . The effect of AX consumption on ghrelin secretion in disturbed metabolic states is unknown . Therefore , we investigated the postpr and ial responses to AX consumption of serum glucose , insulin and triglycerides and plasma total and acylated ghrelin in subjects with impaired glucose tolerance ( IGT ) . Design : R and omized , single-blind , controlled , crossover intervention trial . Subjects : Seven female and four male adults with IGT , aged 55.5 years , and body mass index ( BMI ) 30.1 kg/m2.Intervention : Subjects received either placebo or 15 g AX supplement for 6 weeks with a 6-week washout period in-between . Main outcome measurements : Postpr and ial responses of serum glucose , insulin and triglycerides , and plasma total and acylated ghrelin after a liquid meal challenge test ( LMCT ) measured at the beginning and at the end of the dietary intervention at −20 , −5 , 0 , 15 , 30 , 45 , 60 , 90 , 120 , 150 , 180 , 210 and 240 min . Results : After LMCT , AX consumption result ed in lower postpr and ial responses in serum glucose , insulin and triglycerides ( P<0.05 ) . Compared to placebo , total plasma ghrelin was also reduced by 42±8 pg/ml ( P<0.001 ) after AX consumption with no difference in plasma acylated ghrelin . Conclusion : AX consumption improved postpr and ial metabolic responses after an LMCT in subjects with IGT and reduced total ghrelin response . However , acylated ghrelin responses were unchanged , suggesting that the acylated ghrelin-mediated orexigenic regulation is not improved as only total plasma ghrelin decreased . Sponsorship : Federal Ministry of Education and Research Germany ( PTJ-BIO/0313042C ) BACKGROUND & AIMS Colonic fermentation of carbohydrates is known to influence gastric and esophageal motility in healthy subjects . This study investigated the effects of colonic fermentation induced by oral administration of fructooligosaccharides ( FOS ) in patients with gastroesophageal reflux disease ( GERD ) . METHODS In the cross-over design used in the study , 9 patients with symptomatic GERD were administered a low-residue diet ( i.e. , 10 g fiber/day ) during 2 , 7-day periods , receiving either 6.6 g of FOS or placebo 3 times daily after meals . Each period was separated by a wash out of at least 3 weeks . On day 7 , esophageal motility and pH were recorded in fasting conditions and after a test meal containing 6.6 g of FOS or placebo . Breath hydrogen concentrations ( reflecting colonic fermentation ) and plasma concentrations of glucagon-like peptide 1 ( GLP-1 ) , peptide YY , and cholecystokinin were monitored . RESULTS Compared with placebo , FOS led to a significant increase in the number of transient lower esophageal sphincter relaxations ( TLESRs ) and reflux episodes , esophageal acid exposure , and the symptom score for GERD . The integrated plasma response of GLP-1 was significantly higher after FOS than placebo . CONCLUSIONS Colonic fermentation of indigestible carbohydrates increases the rate of TLESRs , the number of acid reflux episodes , and the symptoms of GERD . Although different mechanisms are likely to be involved , excess release of GLP-1 may account , at least in part , for these effects OBJECTIVE To evaluate the effect of oral nutritional supplementation with and without oligosaccharides on gut bacteriology , in particular the bifidogenic flora , and on immunology and inflammatory parameters in older persons at risk of malnutrition . DESIGN Prospect i ve , r and omized , double-blind , controlled study . SETTING Division of Geriatric Medicine , St. Louis University , Missouri , United States . PARTICIPANTS Seventy-four community dwelling elderly and /or nursing home subjects ( age superior 70 y ; 84 + /- 7 years ) either undernourished or at risk of undernutrition . INTERVENTION Daily liquid supplements , with ( 1.3 g/250 ml ) and without oligosaccharides ( OS ) for 12 weeks . MEASUREMENTS Nutritional evaluation , serum immunoglobulins , lymphocyte subsets , various cytokines and the endotoxin soluble receptor CD14 ( sCD14 ) in serum , and cytokines specific mRNA in peripheral blood mononuclear cells at baseline and 12 weeks , and fecal bacteriologicy . RESULTS Specific mRNA extracted from blood leucocytes showed a different level of pro-inflammatory gene activation : TNF-alpha mRNA and IL-6 mRNA diminished in the OS group after 12 weeks , while no changes were detected in the control group ( P=0.05 and P=0.04 respectively ) . Serum levels of sCD14 , a product shed by activated macrophages , decreased only in the OS group without reaching statistical significance ( P=0.08 ) . No significant differences were detected in the fecal gut flora or in the nutritional parameters . CONCLUSIONS This study shows that the administration of supplements in older persons at risk of malnutrition may benefit from the addition of prebiotics that can improve the low noise inflammatory process frequently observed in this population Objective : The administration of a fermentable dietary fibre ( oligofructose ) in rats increases satietogenic gut peptides and lowered spontaneous energy intake . The aim of the study was to assess the relevance of those effects of oligofructose on satiety and energy intake in humans . Design : Single-blinded , crossover , placebo-controlled design , pilot study .Subjects : Volunteers included five men and five women aged 21–39 years , BMI ranging from 18.5 to 27.4 kg/m2 , were r and omly assigned as described below . Interventions : Subjects were included in two 2-week experimental phases during which they received either fibre ( oligofructose ( OFS ) ) or placebo ( dextrine maltose ( DM ) ) ; a 2-week washout period was included between crossover phases . In total , 8 g OFS or 8 g DM were ingested twice daily ( 16 g/day in total ) . Energy intake , hunger , satiety , fullness and prospect i ve food consumption were assessed with analogue scales at the end of each experimental phase . Results : During breakfast , OFS significantly increases the satiety ( P=0.04 ) without any difference on other sensations as compared to DM treatment periods . After lunch , no significant differences are observed between treatment period . At dinner , OFS significantly increases satiety ( P=0.04 ) , reduces hunger ( P=0.04 ) and prospect i ve food consumption ( P=0.05 ) . The energy intake at breakfast and lunch are significantly lower ( P=0.01 , 0.03 , respectively ) after OFS treatment than after DM treatment . Total energy intake per day is 5 % lower during OFS than in DM period . Conclusion : Oligofructose treatment increases satiety following breakfast and dinner , reduces hunger and prospect i ve food consumption following dinner . This pilot study presents a rationale to propose oligofructose supplements in the management of food intake in overweight and obese patients .Sponsorship : This project is supported by an FSR grant from the Université catholique de Louvain BACKGROUND Rodent studies show that oligofructose promotes weight loss , stimulates satiety hormone secretion , reduces energy intake , and improves lipid profiles . OBJECTIVE Our objective was to examine the effects of oligofructose supplementation on body weight and satiety hormone concentrations in overweight and obese adults . DESIGN This study was a r and omized , double-blind , placebo-controlled trial . Forty-eight otherwise healthy adults with a body mass index ( in kg/m2 ) > 25 were r and omly assigned to receive 21 g oligofructose/d or a placebo ( maltodextrin ) for 12 wk . Body composition ( by dual-energy X-ray absorptiometry ) ; meal tolerance tests , including satiety hormone response ; food intake ; and subjective appetite ratings were determined . RESULTS There was a reduction in body weight of 1.03 + /- 0.43 kg with oligofructose supplementation , whereas the control group experienced an increase in body weight of 0.45 + /- 0.31 kg over 12 wk ( P = 0.01 ) . A lower area under the curve ( AUC ) for ghrelin ( P = 0.004 ) and a higher AUC for peptide YY ( PYY ) with oligofructose ( P = 0.03 ) coincided with a reduction in self-reported caloric intake ( P < or = 0.05 ) . Glucose decreased in the oligofructose group and increased in the control group between initial and final tests ( P < or = 0.05 ) . Insulin concentrations mirrored this pattern ( P < or = 0.05 ) . Oligofructose supplementation did not affect plasma active glucagon-like peptide 1 secretion . According to a visual analog scale design ed to assess side effects , oligofructose was well tolerated . CONCLUSIONS Independent of other lifestyle changes , oligofructose supplementation has the potential to promote weight loss and improve glucose regulation in overweight adults . Suppressed ghrelin and enhanced PYY may contribute in part to the reduction in energy intake . The trial was registered at clinical trials.gov as NCT00522353 BACKGROUND We have previously shown that gut microbial fermentation of prebiotics promotes satiety and lowers hunger and energy intake in humans . In rodents , these effects are associated with an increase in plasma gut peptide concentrations , which are involved in appetite regulation and glucose homeostasis . OBJECTIVE Our aim was to examine the effects of prebiotic supplementation on satiety and related hormones during a test meal for human volunteers by using a noninvasive micro method for blood sampling to measure plasma gut peptide concentrations . DESIGN This study was a r and omized , double-blind , parallel , placebo-controlled trial . A total of 10 healthy adults ( 5 men and 5 women ) were r and omly assigned to groups that received either 16 g prebiotics/d or 16 g dextrin maltose/d for 2 wk . Meal tolerance tests were performed in the morning to measure the following : hydrogen breath test , satiety , glucose homeostasis , and related hormone response . RESULTS We show that the prebiotic treatment increased breath-hydrogen excretion ( a marker of gut microbiota fermentation ) by approximately 3-fold and lowered hunger rates . Prebiotics increased plasma glucagon-like peptide 1 and peptide YY concentrations , whereas postpr and ial plasma glucose responses decreased after the st and ardized meal . The areas under the curve for plasma glucagon-like peptide 1 and breath-hydrogen excretion measured after the meal ( 0 - 60 min ) were significantly correlated ( r = 0.85 , P = 0.007 ) . The glucose response was inversely correlated with the breath-hydrogen excretion areas under the curve ( 0 - 180 min ; r = -0.73 , P = 0.02 ) . CONCLUSION Prebiotic supplementation was associated with an increase in plasma gut peptide concentrations ( glucagon-like peptide 1 and peptide YY ) , which may contribute in part to changes in appetite sensation and glucose excursion responses after a meal in healthy subjects |
11,527 | 18,387,023 | RESULTS Thus far , few data exist to substantiate the concern that changes in nutrition st and ards in schools lead to a loss in total revenue .
CONCLUSIONS A renewed focus on school policies related to health provides the opportunity for research ers to investigate how nutrition-related policy change can affect , if at all , food service and overall school revenues | BACKGROUND Although great focus has been placed on nutritional and other consequences of changes in food-related policies within schools , few reports exist describing the impact of such changes on school revenue .
This review provides an overview of the few revenue-related studies published recently , as well as information from a sampling of state reports on the subject . | Objectives This study examined associations between high school students ' lunch patterns and vending machine purchases and the school food environment and policies . Methods A r and omly selected sample of 1088 high school students from 20 schools completed surveys about their lunch practice s and vending machine purchases . School food policies were assessed by principal and food director surveys . The number of vending machines and their hours of operation were assessed by trained research staff . Results Students at schools with open campus policies during lunchtime were significantly more likely to eat lunch at a fast food restaurant than students at schools with closed campus policies ( 0.7 days/week vs. 0.2 days/week , p < .001 ) . Student snack food purchases at school were significantly associated with the number of snack machines at schools ( p < .001 ) and policies about the types of food that can be sold . In schools with policies , students reported making snack food purchases an average of 0.5 ± 1.1 days/week as compared to an average of 0.9 ± 1.3 days/week in schools without policies ( p < .001 ) . In schools in which soft drink machines were turned off during lunch time , students purchased soft drinks from vending machines 1.4 ± 1.6 days/week as compared to 1.9 ± 1.8 days/week in schools in which soft drink machines were turned on during lunch ( p = .040 ) . ConclusionS chool food policies that decrease access to foods high in fats and sugars are associated with less frequent purchase of these items in school among high school students . Schools should examine their food-related policies and decrease access to foods that are low in nutrients and high in fats and sugars OBJECTIVE . To assess whether weight-related teasing predicts the development of binge eating , unhealthy weight control behaviors , and frequent dieting among male and female adolescents . METHODS . A prospect i ve study was conducted with an ethnically and socioeconomically diverse sample of 2516 adolescents who completed surveys at both time 1 ( 1998–1999 ) and time 2 ( 2003–2004 ) of the Project EAT ( Eating Among Teens ) study . RESULTS . In 1998–1999 , approximately one fourth of participants reported being teased about their weight at least a few times a year . After adjustment for age , race/ethnicity , socioeconomic status ( SES ) , and BMI , boys who were teased about their weight were more likely than their peers to initiate binge eating with loss of control and unhealthy weight control behaviors 5 years later . The predicted prevalence for incident binge eating behaviors with loss of control among boys who were teased was 4.1 % as compared with 1.4 % for those who were not teased , after adjustment for age , race/ethnicity , SES , and BMI . For unhealthy weight control behaviors at time 2 , the predicted prevalence was 27.5 % among boys who were teased and 19.3 % for boys who were not teased , after adjustment for age , race/ethnicity , SES , and BMI . Girls who were teased were more likely than their peers to become frequent dieters . The predicted prevalence for incident frequent dieting among girls who were teased was 18.2 % as compared with 11.0 % for those who were not teased , after adjustment for age , race/ethnicity , SES , and BMI . CONCLUSIONS . Weight teasing in adolescence predicts disordered eating behaviors at 5-year follow-up . The patterns of these associations differ by gender . Reducing teasing through educational interventions and policies may reduce the level of disordered eating behaviors among youths OBJECTIVES This study examined the effects of pricing and promotion strategies on purchases of low-fat snacks from vending machines . METHODS Low-fat snacks were added to 55 vending machines in a convenience sample of 12 secondary schools and 12 worksites . Four pricing levels ( equal price , 10 % reduction , 25 % reduction , 50 % reduction ) and 3 promotional conditions ( none , low-fat label , low-fat label plus promotional sign ) were crossed in a Latin square design . Sales of low-fat vending snacks were measured continuously for the 12-month intervention . RESULTS Price reductions of 10 % , 25 % , and 50 % on low-fat snacks were associated with significant increases in low-fat snack sales ; percentages of low-fat snack sales increased by 9 % , 39 % , and 93 % , respectively . Promotional signage was independently but weakly associated with increases in low-fat snack sales . Average profits per machine were not affected by the vending interventions . CONCLUSIONS Reducing relative prices on low-fat snacks was effective in promoting lower-fat snack purchases from vending machines in both adult and adolescent population BACKGROUND Our objective was to evaluate the effects of environmental , policy , and social marketing interventions on physical activity and fat intake of middle school students on campus . DESIGN Twenty-four middle schools were r and omly assigned to intervention or control conditions . Baseline measures were collected in spring 1997 , and interventions were conducted during the 1997 - 1998 and 1998 - 1999 school years SETTING /PARTICIPATION : The schools had mean enrollments of 1109 , with 44.5 % nonwhite students . Over 2 years , physical activity interventions were design ed to increase physical activity in physical education classes and throughout the school day . Nutrition interventions were design ed to provide and market low-fat foods at all school food sources , including cafeteria breakfasts and lunches , a la carte sources , school stores , and bag lunches . School staff and students were engaged in policy change efforts , but there was no classroom health education . MAIN OUTCOMES MEASURES Primary outcomes were measured by direct observation and existing records . RESULTS R and omized regression models ( N = 24 schools ) revealed a significant intervention effect for physical activity for the total group ( p < 0.009 ) and boys ( p < 0.001 ) , but not girls ( p < 0.40 ) . The intervention was not effective for total fat ( p < 0.91 ) or saturated fat ( p < 0.79 ) . Survey data indicated that the interventions reduced reported body mass index for boys ( p < 0.05 ) . CONCLUSIONS Environmental and policy interventions were effective in increasing physical activity at school among boys but not girls . The interventions were not effective in reducing fat intake at school . School environmental and policy interventions have the potential to improve health behavior of the student population , but barriers to full implementation need to be better understood and overcome OBJECTIVES We evaluated an environmental intervention intended to increase sales of lower-fat foods in secondary school cafeterias . METHODS Twenty secondary schools were r and omly assigned to either an environmental intervention or a control group for a 2-year period . The intervention increased the availability of lower-fat foods and implemented student-based promotions . RESULTS A steeper rate of increase in sales of lower-fat foods in year 1 ( 10 % intervention vs -2.8 % control , P = .002 ) and a higher percentage of sales of lower-fat foods in year 2 ( 33.6 % intervention vs 22.1 % control , P = .04 ) were observed . There were no significant changes in student self-reported food choices . CONCLUSIONS School-based environmental interventions to increase availability and promotion of lower-fat foods can increase purchase of these foods among adolescents OBJECTIVE This study examined the types and extent of competitive foods available in public high schools in Pennsylvania . DESIGN We developed , pilot tested , and distributed surveys to school foodservice directors in a r and om sample of 271 high schools in Pennsylvania . SUBJECTS Two hundred twenty-eight surveys were returned , for a response rate of 84 % . Statistical analyses were performed : Descriptive statistics were used to examine the extent of competitive food sales in Pennsylvania public high schools . The survey data were analyzed using SPSS software version 11.5.1 ( 2002 , SPSS base 11.0 for Windows , SPSS Inc , Chicago , IL ) . RESULTS A la carte sales provide almost dollar 700/day to school foodservice programs , almost 85 % of which receive no financial support from their school districts . The top-selling a la carte items are " hamburgers , pizza , and s and wiches . " Ninety-four percent of respondents indicated that vending machines are accessible to students . The item most commonly offered in vending machines is bottled water ( 71.5 % ) . While food items are less often available through school stores and club fund-raisers , c and y is the item most commonly offered through these sources . CONCLUSIONS Competitive foods are widely available in high schools . Although many of the items available are low in nutritional value , we found several of the top-selling a la carte options to be nutritious and bottled water the item most often identified as available through vending machines OBJECTIVES This study described the food environment in 20 Minnesota secondary schools . METHODS Data were collected on school food policies and the availability and nutritional content of foods in school à la carte ( ALC ) areas and vending machines ( VMs ) . RESULTS Approximately 36 % and 35 % of foods in ALC areas and in VMs , respectively , met the lower-fat criterion ( < or = 5.5 fat grams/serving ) . The chips/crackers category constituted the largest share of ALC foods ( 11.5 % ) . The median number of VMs per school was 12 ( 4 soft drink , 2 snack , 5 other ) . Few school food policies were reported . CONCLUSIONS The availability of healthful foods and beverages in schools as well as school food policies that foster healthful food choices among students needs greater attention The objectives of this study were to describe the extent , nature , and enforcement of school competitive food policies in Pennsylvania public high schools and to determine if there are differences between school foodservice directors ' and principals ' perceptions of the existence and enforcement of these policies . A survey was distributed to 271 school foodservice directors and 100 principals in a representative , r and om sample of high schools . Two hundred twenty-eight school foodservice directors ( 84 % ) and 79 principals ( 79 % ) returned surveys . Descriptive statistics , chi2 analyses , and a proportions test were done using SPSS statistical software ( SPSS base 11.5 for Windows , 2002 , SPSS Inc , Chicago , IL ) . Few nutrition policies were reported related to setting nutritional st and ards for competitive foods ( 0.5 % to 15.0 % ) . Respondents ' reporting of existence of policies not always enforced ranged from 0 % to 12.8 % . School foodservice directors reported uncertainty about existence of several policies outside their direct domain , but with potential effect on school meals participation . Differences were found between school foodservice directors ' and principals ' reporting of policies , with principals more often reporting policy existence and enforcement . These findings suggest the need for communication , both about existence of policies and chain of comm and in enforcement of policies . Given the local wellness policy provision of the Child Nutrition and WIC Reauthorization Act of 2004 , opportunities exist for nutrition professionals to contribute to development of policies that influence the nutritional quality of school foods |
11,528 | 29,763,978 | Plasma HPV-DNA is a promising tool for surveillance in patients with HPV-related HNSCC , that is , OPSCC , and has a high specificity .
By recent technical advances and by increasing follow-up blood sample s , the sensitivity could likely be improved | BACKGROUND The incidence of human papillomavirus-induced ( HPV+ ) head and neck squamous cell carcinoma ( HNSCC ) , that is , especially oropharyngeal cancers ( OPSCC ) , is increasing , and a significant proportion of patients encounter disease progression .
A simple and sensitive test to identify patients with progression is an unmet need .
OBJECTIVE OF REVIEW To systematic ally review the literature and carry out a meta- analysis of studies , investigating circulating HPV-DNA as a biomarker for disease progression in patients with HNSCC . | BACKGROUND The improved prognosis for patients with human papillomavirus (HPV)-positive head and neck squamous cell carcinoma ( HNSCC ) relative to HPV-negative HNSCC observed in retrospective analyses remains to be confirmed in a prospect i ve clinical trial . METHODS We prospect ively evaluated the association of tumor HPV status with therapeutic response and survival among 96 patients with stage III or IV HNSCC of the oropharynx or larynx who participated in an Eastern Cooperative Oncology Group ( ECOG ) phase II trial and who received two cycles of induction chemotherapy with intravenous paclitaxel and carboplatin followed by concomitant weekly intravenous paclitaxel and st and ard fractionation radiation therapy . The presence or absence of HPV oncogenic types in tumors was determined by multiplex polymerase chain reaction ( PCR ) and in situ hybridization . Two-year overall and progression-free survival for HPV-positive and HPV-negative patients were estimated by Kaplan-Meier analysis . The relative hazard of mortality and progression for HPV-positive vs HPV-negative patients after adjustment for age , ECOG performance status , stage , and other covariables was estimated by use of a multivariable Cox proportional hazards model . All statistical tests were two-sided . RESULTS Genomic DNA of oncogenic HPV types 16 , 33 , or 35 was located within tumor cell nuclei of 40 % ( 95 % confidence interval [ CI ] = 30 % to 50 % ) of patients with HNSCC of the oropharynx or larynx by in situ hybridization and PCR . Compared with patients with HPV-negative tumors , patients with HPV-positive tumors had higher response rates after induction chemotherapy ( 82 % vs 55 % , difference = 27 % , 95 % CI = 9.3 % to 44.7 % , P = .01 ) and after chemoradiation treatment ( 84 % vs 57 % , difference = 27 % , 95 % CI = 9.7 % to 44.3 % , P = .007 ) . After a median follow-up of 39.1 months , patients with HPV-positive tumors had improved overall survival ( 2-year overall survival = 95 % [ 95 % CI = 87 % to 100 % ] vs 62 % [ 95 % CI = 49 % to 74 % ] , difference = 33 % , 95 % CI = 18.6 % to 47.4 % , P = .005 , log-rank test ) and , after adjustment for age , tumor stage , and ECOG performance status , lower risks of progression ( hazard ratio [ HR ] = 0.27 , 95 % CI = 0.10 to 0.75 ) , and death from any cause ( HR = 0.36 , 95 % CI = 0.15 to 0.85 ) than those with HPV-negative tumors . CONCLUSION For patients with HNSCC of the oropharynx , tumor HPV status is strongly associated with therapeutic response and survival Background : Following chemo-radiotherapy ( CCRT ) for human papilloma virus positive ( HPV+ ) locally advanced head and neck cancer , patients frequently undergo unnecessary neck dissection ( ND ) and /or repeated biopsies for abnormal PET-CT , which causes significant morbidity . We assessed the role of circulating HPV DNA in identifying ‘ true ’ residual disease . Methods : We prospect ively recruited test ( n=55 ) and validation ( n=33 ) cohorts . HPV status was confirmed by E7 RT-PCR . We developed a novel amplicon-based next generation sequencing assay ( HPV16-detect ) to detect circulating HPV DNA . Circulating HPV DNA levels post-CCRT were correlated to disease response ( PET-CT ) . Results : In pre-CCRT plasma , HPV-detect demonstrated 100 % sensitivity and 93 % specificity , and 90 % sensitivity and 100 % specificity for the test ( 27 HPV+ ) and validation ( 20 HPV+ ) cohorts , respectively . Thirty-six out of 37 patients ( test and validation cohort ) with complete sample s-set had negative HPV-detect at end of treatment . Six patients underwent ND ( 3 ) and repeat primary site biopsies ( 3 ) for positive PET-CT but had no viable tumour . One patient had positive HPV-detect and positive PET-CT and liver biopsy , indicating 100 % agreement for HPV-detect and residual cancer . Conclusions : We demonstrate that HPV16-detect is a highly sensitive and specific test for identification of HPV DNA in plasma at diagnosis . HPV DNA post-treatment correlates with clinical response IMPORTANCE Human papillomavirus type 16 ( HPV-16 ) is a major causative factor in oropharyngeal squamous cell carcinoma ( OPSCC ) . The detection of primary OPSCC is often delayed owing to the challenging anatomy of the oropharynx . OBJECTIVE To investigate the feasibility of HPV-16 DNA detection in pretreatment and posttreatment plasma and saliva and its potential role as a marker of prognosis . DESIGN , SETTING , AND PARTICIPANTS This is a retrospective analysis of a prospect ively collected cohort . Among a cohort of patients with oropharyngeal and unknown primary squamous cell carcinoma with known HPV-16 tumor status from the Johns Hopkins Medical Institutions and Greater Baltimore Medical Center ( from 1999 through 2010 ) , 93 patients were identified with a complete set of pretreatment and posttreatment plasma or saliva sample s , of which 81 patients had HPV-16-positive tumors and 12 patients had HPV-16-negative tumors . Real-time quantitative polymerase chain reaction was used to detect HPV-16 E6 and E7 DNA in saliva and plasma sample s. MAIN OUTCOMES AND MEASURES Main outcomes included sensitivity , specificity , negative predictive value of combined saliva and plasma pretreatment HPV-16 DNA status for detecting tumor HPV-16 status , as well as the association of posttreatment HPV DNA status with clinical outcomes , including recurrence-free survival and overall survival . RESULTS The median follow-up time was 49 months ( range , 0.9 - 181.0 months ) . The sensitivity , specificity , negative predictive value , and positive predictive value of combined saliva and plasma pretreatment HPV-16 DNA status for detecting tumor HPV-16 status were 76 % , 100 % , 42 % , and 100 % , respectively . The sensitivities of pretreatment saliva or plasma alone were 52.8 % and 67.3 % , respectively . In a multivariable analysis , positive posttreatment saliva HPV status was associated with higher risk of recurrence ( hazard ratio [ HR ] , 10.7 ; 95 % CI , 2.36 - 48.50 ) ( P = .002 ) . Overall survival was reduced among those with posttreatment HPV-positive status in saliva ( HR , 25.9 ; 95 % CI , 3.23 - 208.00 ) ( P = .002 ) and those with HPV-positive status in either saliva or plasma but not among patients with HPV-positive status in plasma alone . The combined saliva and plasma posttreatment HPV-16 DNA status was 90.7 % specific and 69.5 % sensitive in predicting recurrence within 3 years . CONCLUSIONS AND RELEVANCE Using a combination of pretreatment plasma and saliva can increase the sensitivity of pretreatment HPV-16 status as a tool for screening patients with HPV-16-positive OPSCC . In addition , analysis of HPV-16 DNA in saliva and plasma after primary treatment may allow for early detection of recurrence in patients with HPV-16-positive OPSCC |
11,529 | 20,375,876 | Sex education and condom promotion among youth did not increase sexual behaviour as well as risky sexual behaviour . | OBJECTIVE Systematic ally assess the effectiveness of HIV-prevention interventions in changing sexual behaviour of young people ( 10 - 25 years ) in sub-Saharan Africa . | OBJECTIVES The purpose of this study was to test the effects of an education program in Tanzania design ed to reduce children 's risk of human immunodeficiency virus ( HIV ) infection and to improve their tolerance of and care for people with acquired immunodeficiency syndrome ( AIDS ) . METHODS A r and omized controlled community trial including baseline and 12-month follow-up surveys was employed . Public primary schools in the Arusha and Kilimanjaro regions of Tanzania were stratified according to location and r and omly assigned to intervention ( n = 6 ) or comparison ( n = 12 ) conditions . Of the 1063 sixth- grade students ( average age : 13.6 years ) who participated at baseline , 814 participated in the follow-up survey . RESULTS At follow-up , statistically significant effects favoring the intervention group were observed for exposure to AIDS information and communication , AIDS knowledge , attitudes toward people with AIDS , and subjective norms and behavioral intentions toward having sexual intercourse . A consistent positive but nonsignificant trend was seen for attitudes toward having sexual intercourse and for initiation of sexual intercourse during the previous year ( 7 % vs 17 % ) . CONCLUSIONS It is feasible and effective to train local teachers and health workers to provide HIV/AIDS education to Tanzanian primary school children PURPOSE To evaluate an intervention ( based on one which had previously been successful in reducing adolescent human immunodeficiency virus ( HIV ) risk behaviors in the United States ) among adolescents residing in Namibia , a country located in sub-Saharan Africa . METHODS A r and omized trial of a 14-session face-to-face intervention emphasizing abstinence and safer sex was conducted among 515 youth ( median age 17 years ; median grade 11 ) attending 10 secondary schools located in two districts in Namibia . Knowledge , attitudes , intentions , and HIV risk behaviors were assessed at baseline and in the immediate postintervention period . RESULTS Knowledge increased significantly among intervention compared to control youth ( 88 % vs. 82 % ; correct responses , p < .0001 ) . At postintervention follow-up , more intervention than control youth believed that they could be intimate without having sex , could have a girlfriend or boyfriend for a long time without having sex , could explain the process of impregnation , knew how to use a condom , and could ask for condoms in a clinic . Fewer intervention than control youth believed that if a girl refused to have sex with her boyfriend it was permissible for him to strike her , and that condoms took away a boy 's pleasure . More intervention than control youth anticipated using a condom when they did have sex , and fewer expected to drink alcohol . Finally , after intervention , there was a trend for increased condom use . There were significant gender-related differences at baseline , although intervention impact was generally equivalent . CONCLUSIONS These findings provide support for the judicious adaptation of successful Western HIV prevention programs in other cultural setting s. A single intervention approach appears to be effective in short-term follow-up with both genders This study investigated whether there were any changes in knowledge and normative beliefs regarding abstinence and condoms and personal risk perception of acquiring HIV among Zambian secondary -school students who were exposed to a peer sexual health intervention . Schools were r and omly assigned to intervention and control groups . A baseline assessment that measured knowledge , normative beliefs about abstinence and condoms and personal risk perception was conducted in all schools . Students in the intervention group were exposed for a 1-hour- and -45-minute-long in-class peer sexual health intervention . Students in the control schools were exposed to a 1-hour-long in-class peer water purification intervention . A follow-up assessment of students was conducted after the intervention . Logistic regression analyses were conducted to determine whether significant differences between intervention and control groups emerged at follow-up . Relative to students in the control group , knowledge was higher and normative beliefs about abstinence and condoms were significantly more positive among students in the intervention schools . Students in the intervention schools also had a higher personal risk perception of acquiring HIV than students in control schools . These findings show that a school-based peer sexual health intervention implemented in Zambia was effective in increasing knowledge , positive normative beliefs about abstinence and condoms , and personal risk perception PURPOSE The purpose of this study was to evaluate phase I of a theoretically informed media campaign design ed by youth in Zambia to encourage their peers to adopt risk-reduction practice s to protect themselves from sexually transmitted infections and human immunodeficiency virus ( HIV ) . The Helping Each other Act Responsibly Together ( HEART ) campaign conveys information for young people ages 13 to 19 years about sexually transmitted infections , HIV , and acquired immune deficiency syndrome transmission and prevention , and promotes abstinence , a return to abstinence , or consistent condom use as viable risk-reduction practice s. METHODS Separate sample baseline and follow-up design s were used to evaluate phase I of the HEART campaign among adolescents aged 13 to 19 years . The 1999 baseline survey had a sample of 368 male and 533 female adolescents ; the 2000 follow-up survey comprised 496 male and 660 female adolescents . RESULTS Controlling for age , sex , educational attainment , and urban or rural residence , logistic regression analyses demonstrated that , compared with nonviewers , campaign viewers were 1.61 times more likely to report primary or secondary abstinence and 2.38 times more likely to have ever used a condom . The odds ratio of condom use during last sex was 2.1 for respondents who recalled at least 3 television spot advertisements compared with other respondents . CONCLUSIONS The positive correlations between HEART campaign viewership and HIV risk-reduction practice s demonstrate that mediated messages can influence adolescents . The HEART campaign is among a range of programs in Zambia design ed to enable young people to protect their reproductive health . Future research should capture the independent as well as the synergistic effects of multiple campaigns and interventions PURPOSE To determine whether adolescents ' normative beliefs about abstinence and condoms , their personal risk perception , and safer sex practice s changed after the implementation of a peer sexual health education intervention implemented in Zambian secondary schools . METHODS The peer intervention was implemented during the first week of September 2000 in Lusaka , Zambia . A quasi-experimental , longitudinal panel design was used to evaluate its impact . Three schools were r and omly assigned to the intervention condition and two to the control condition . Three rounds of data from male and female adolescents in grade s 10 and 11 were collected at baseline in July 2000 , at first follow-up in the second half of September 2000 , and at second follow-up in early April 2001 . A total of 416 respondents aged 14 - 23 ( at baseline ) were interviewed in all three survey rounds . A mixed-effects logistic regression growth curve analysis was used to calculate adjusted odds ratios to compare intervention and control groups on the outcome variables . RESULTS Student self-reports showed positive changes in normative beliefs about abstinence immediately after the intervention , and these improvements were largely sustained until 6 months after the intervention . Students became more likely to approve of condom use and to intend using condoms immediately after the intervention , but these positive outcomes could not be sustained during the 6 months that followed the intervention . Normative beliefs regarding condom use took longer to develop : these were only observed at 6 months follow-up . Students reported reductions in multiple regular partnerships . There was no change in condom use . CONCLUSIONS A single session school-based peer sexual health intervention result ed in the development of normative beliefs about abstinence that were sustained over a 6-month period . Normative beliefs about condoms took longer to develop . More regular efforts may be required to sustain the approval of , and the intention to use , condoms . The intervention was successful in reducing multiple regular partnerships Objective : To evaluate an HIV risk-reduction intervention among Namibian adolescents . Methods : A r and omized trial of a 14-session face-to-face intervention emphasizing abstinence and safer sexual practice s conducted among 515 youths ( median age 17 years and median grade 11 ) attending 10 secondary schools located in two districts in Namibia . Youths were r and omly assigned to the intervention or control condition at the level of the individual . HIV risk behaviours , intentions and perceptions were assessed at baseline , immediately post-intervention and at 6 and 12 months post-intervention . Results : Among all 515 youths who enrolled in the programme , rates of either abstinence or sex with a condom were not different between control and intervention youths at baseline or in the follow-up period . However , analyses conducted among the subset of youths who were sexually inexperienced at baseline ( n = 255 ) revealed that a higher percentage of intervention youths ( 17 % ) than control youths ( 9 % , P < 0.05 ) remained sexually inexperienced one year later . Moreover , in the immediate post-intervention period , among baseline virgins who subsequently initiated sex , intervention youths were more likely than control youths to use a condom ( 18 versus 10 % , P < 0.05 ) . Additional HIV-related risk behaviours ( failure to discuss previous HIV risk exposure with one 's sexual partner and alcohol use ) , intentions to use condoms , and perceptions of the ability to use condoms were positively affected by the intervention . Conclusions : There is evidence that the ‘ My Future is My Choice ’ ( MFMC ) intervention is reducing HIV risk behaviours among sexually inexperienced participants aged 15–18 . Related risk behaviours and perceptions are also positively impacted by the intervention OBJECTIVE To describe the study design , methods and baseline findings of a behavioural intervention trial aim ed at reducing HIV incidence . METHOD A cluster r and omized-controlled trial ( RCT ) conducted in 70 villages in rural South Africa . A behavioural intervention , Stepping Stones , was implemented in 35 communities in two workshops of 20 men and 20 women in each community who met for 17 sessions ( 50 h ) over a period of 3 - 12 weeks . Individuals in the control arm communities attended a single session of about 3 h on HIV and safer sex . Impact assessment was conducted through two question naire and serological surveys at 12-month intervals . The primary outcome was HIV incidence and secondary measures included changes in knowledge , attitude and sexual behaviours . Qualitative research was also undertaken with 10 men and 10 women from two sites receiving the intervention ( one rural and one urban ) and five men and five women from one village in the control arm . They were interviewed individually three times prior to the workshops and then 9 - 12 months later . RESULTS A total of 2776 participants ( 1409 intervention and 1367 control ) were enrolled at baseline and had an interview , and HIV sero-status was established . HIV baseline prevalence rates in women were 9.8 % in the intervention arm and 12.8 % in the control arm . In men the prevalence was 1.7 % in the intervention arm and 2.1 % in the control arm . Demographic and behavioural characteristics were similar in the two arms . In the intervention groups 59.9 % of participants attended more than 75 % of the sessions . In the control group 66.3 % attended the control session . CONCLUSION This is the third RCT to be conducted in sub-Saharan Africa evaluating a behavioural intervention using HIV incidence as a primary outcome . It is of particular interest as the intervention in question is used in many developing countries . There is good baseline comparability between the study arms and the process data on the workshops suggested that the interventions were feasible and adequately implemented PURPOSE To assess the impact of exposure to life skills education by youth in KwaZulu-Natal Province ( KZN , South Africa ) on knowledge and behaviors associated with the spread of HIV/AIDS . METHODS Data come from a panel study of 2222 youth from several population subgroups in KZN . The youth were aged 14 - 24 years when interviewed in 1999 and 2001 . The intervention was a full coverage life skills education program for all students in middle and secondary schools . Impact was measured as net dose-response relationships between life skills exposure and outcomes . Econometric methods were used to control for nonr and om exposure to life skills education . Outcomes included sexual behavior and condom use indicators . RESULTS Significant effects , albeit modest in magnitude , were observed on selected areas of sexual-reproductive health knowledge and perceived condom self-efficacy , along with larger effects on condom use at first and last sex . No consistent effects on age at sexual initiation , secondary abstinence , or partnering behaviors were observed among these youth . CONCLUSIONS School-based life skills education appears capable of communicating key information and helping youth develop skills relevant to reducing HIV risk . However , the South African national program has yet to be fully implemented , and whether this initiative will result in sustained behavior modification among youth on a sufficient scale to affect the HIV/AIDS epidemic is uncertain PURPOSE To describe the implementation and evaluation of an adolescent reproductive health peer education program in West Africa . The program , known as the West African Youth Initiative ( WAYI ) , was developed to improve knowledge of sexuality and reproductive health , and promote safer sex behaviors and contraceptive use among sexually active adolescents in Nigeria and Ghana . METHODS Between November 1994 and April 1997 , two organizations , the Association for Reproductive and Family Health ( ARFH ) , based in Nigeria , and Advocates for Youth , based in Washington D.C. , supported community-based youth-serving organizations in the two countries to implement peer education projects . Consultants from the African Regional Health Education Centre ( ARHEC ) in Nigeria provided technical assistance in design ing and conducting a quasi-experimental process and outcome evaluation of the projects . RESULTS There were significant differences over time and between intervention and control groups concerning reproductive health knowledge , use of contraceptives in the previous 3 months , willingness to buy contraceptives , and self-efficacy in contraceptive use . CONCLUSIONS Overall , the project provides evidence that peer education is most effective at improving knowledge and promoting attitudinal and behavior change among young people in school setting Objective : The impact of a multicomponent intervention programme on the sexual health of adolescents was assessed in rural Tanzania . Design : A community-r and omized trial . Methods : Twenty communities were r and omly allocated to receive either a specially design ed programme of interventions ( intervention group ) or st and ard activities ( comparison group ) . The intervention had four components : community activities ; teacher-led , peer-assisted sexual health education in years 5–7 of primary school ; training and supervision of health workers to provide ‘ youth-friendly ’ sexual health services ; and peer condom social marketing . Impacts on HIV incidence , herpes simplex virus 2 ( HSV2 ) and other sexual health outcomes were evaluated over approximately 3 years in 9645 adolescents recruited in late 1998 before entering years 5 , 6 or 7 of primary school . Results : The intervention had a significant impact on knowledge and reported attitudes , reported sexually transmitted infection symptoms , and several behavioural outcomes . Only five HIV seroconversions occurred in boys , whereas in girls the adjusted rate ratio ( intervention versus comparison ) was 0.75 [ 95 % confidence interval ( CI ) 0.34 , 1.66 ] . Overall HSV2 prevalences at follow-up were 11.9 % in male and 21.1 % in female participants , with adjusted prevalence ratios of 0.92 ( CI 0.69 , 1.22 ) and 1.05 ( CI 0.83 , 1.32 ) , respectively . There was no consistent beneficial or adverse impact on other biological outcomes . The beneficial impact on knowledge and reported attitudes was confirmed by results of a school examination in a separate group of students in mid-2002 . Conclusion : The intervention substantially improved knowledge , reported attitudes and some reported sexual behaviours , especially in boys , but had no consistent impact on biological outcomes within the 3-year trial period A pre-post test follow-up design was used to test the effects of a systematic ally developed photo-novella ( Laduma ) on knowledge , attitudes , communication and behavioural intentions with respect to sexually transmitted infections , after a single reading by 1168 secondary school learners in South Africa . The reading result ed in an increase in knowledge on the spread of sexually transmitted infections ( STIs ) , change in attitude to condom use and towards people with STIs and /or HIV/AIDS , as well as increased intention to practice safe sex . Laduma did not influence communication about sexually transmitted infections and reported sexual behaviour and condom use . While print media proved to be an effective strategy to reach large numbers of youth and prepare them for adequate preventive behaviours , the study also identified the need to combine print media with other planned theory-based interventions that build confidence and skills to initiate the preventive behaviour A community intervention trial was undertaken in KwaZulu Natal , South Africa to evaluate the effectiveness of a high school drama-in-education programme . Seven pairs of secondary schools were r and omized to receive either written information about HIV/AIDS or the drama programme . Question naire surveys of knowledge , attitude and behaviour were compared before and 6 months after the interventions . One thous and and eighty students participated in the first survey and 699 in the second . Improvements in knowledge ( P=0.0002 ) and attitudes ( P<0.00001 ) about HIV/AIDS were demonstrated in pupils at schools receiving the drama programme when compared to pupils receiving written information alone . These changes were independent of age , gender , school or previous sexual experience . In schools receiving the drama programme , sexually active pupils reported an increase in condom use ( P<0.01 ) . It is important to provide re sources to sustain such programmes and to obtain stronger evidence of effect on behaviour by measuring changes in HIV incidence The evaluation of the Department of Educations ' life skills program on HIV and AIDS prevention among Grade 9 students in 22 r and omly allocated schools in KwaZulu-Natal , South Africa , showed only a significant increase in student knowledge about HIV/AIDS in the intervention group compared with the control group . No effects were found on safe sex practice s ( condom use , sexual intercourse ) or on measures of psychosocial determinants of these practice s ( attitude and self-efficacy ) . A process evaluation among the teachers showed that some implemented the program fully ( seven schools ) and some partially ( four schools ) . An exploratory analysis showed that students who received the full intervention were more positive in their perceptions about sexual behavior and social connectedness ( at 10-month follow-up ) and reported less sex and more condom use ( at 6-month follow-up ) than students in the partial and control groups . These limited effects therefore call for further analysis of the content and implementation strategies used in the classroom Objective : To test the effects of an HIV/AIDS education program . Design : A quasi-experimental , nested cross-sectional design including baseline and 6-month follow-up surveys . Schools , stratified according to location , were r and omly assigned to intervention ( n = 6 ) or comparison conditions ( n = 12 ) . Setting : Public primary schools in Arusha and Kilimanjaro regions , Tanzania . Participants : A total of 2026 sixth and seventh grade pupils ( average age , 14.0 years ) participated at baseline ( 85 % ) and 1785 at follow-up . Intervention : The program was design ed to reduce children 's risk of HIV infection and to improve their tolerance of and care for people with AIDS . Local teachers and health workers attended a 1-week training workshop before implementing the program over a 2–3-month period ( averaging 20 school hours per class ) . Main outcome measures : Self-reported exposure to AIDS information , communication regarding AIDS ; AIDS knowledge , attitudes towards people with AIDS , attitudes towards having sexual intercourse , subjective norms regarding sexual intercourse , and intention to engage in sexual intercourse . Results : Following this program , intervention pupils reported significantly higher scores for the following outcome measures than pupils attending the comparison schools : AIDS information ( 13.1 versus 10.5 ; P= 0.0001 ) , AIDS communication ( 10.9 versus 7.8 ; P= 0.0001 ) AIDS knowledge ( 14.5 versus 11.5 ; P= 0.0001 ) , attitudes towards people with AIDS ( 9.0 versus 6.7 ; P= 0.0008 ) , subjective norms ( 45.5 versus 43.9 ; P= 0.011 ) , and intention ( 1.3 versus 1.4 ; P= 0.020 ) . No program effect was seen for attitudes towards sexual intercourse ( 47.0 versus 46.3 , P=0.44 ) . Conclusions : These results indicate that it is feasible and effective to provide AIDS education for Tanzanian primary school children |
11,530 | 26,661,724 | When evaluated , programs were generally well received , while the long-term maintenance of positive impacts was a challenge . | To date , the impacts of school-based , peer-led nutrition education initiatives have not been summarized or assessed collectively .
This review presents the current evidence , identifies knowledge gaps , and provides recommendations for future research . | OBJECTIVE The objective of the present research was to test the efficacy of Fruit & Veg $ ense sessions in increasing fruit and vegetable consumption . DESIGN A wait-list r and omised controlled trial was conducted ( n 292 ) . Intervention participants attended a Fruit & Veg $ ense session and received newsletters at weeks 2 and 5 after attending the session . All participants completed an FFQ and a question naire measuring knowledge , attitudes , barriers and stage of change for fruit and vegetable consumption at baseline and 6 weeks . SETTING Hunter region of New South Wales , Australia . SUBJECTS Two hundred and ninety-two parents with children of primary school age . RESULTS The intervention group significantly increased its mean consumption of fruit and vegetables by 0·62 servings compared with 0·11 in the control group ( difference of 0·51 , P = 0·001 ) . Compared with the control group , there were significant increases in intervention participants ' knowledge of daily recommended servings ( for fruit and vegetables ) and serving size ( for vegetables ) , improvement in stage of change for vegetable consumption and a decrease in the number of perceived barriers to fruit and vegetable consumption . CONCLUSIONS Fruit & Veg $ ense is efficacious in increasing fruit and vegetable consumption among parents of primary -school children . The study adds significantly to the limited evidence regarding fruit and vegetable interventions and the feasibility of engaging peer educators to deliver community education sessions . A broader implementation trial to test the effectiveness of Fruit & Veg $ ense is recommended This article reports on the outcomes of the Teens Eating for Energy and Nutrition at School ( TEENS ) study , a 2-year intervention study conducted in 16 middle schools with a goal of increasing students ’ intakes of fruits , vegetables , and lower fat foods . Despite positive interim results for students r and omized to intervention schools , the positive effects of the intervention were not seen for the primary outcomes at the end of the 2nd year . Positive effects were seen only for a food choice score ( suggesting that the students usually choose lower versus higher fat foods ) and not for measures of food intake . Future studies may need to take a step back toward more controlled efficacy studies in working with this age-group . In addition , future work may consider the use of peer leaders , more intensive teacher training , ongoing formative assessment , and the testing of more powerful environmental change intervention strategies Peer education has become a popular strategy for health promotion interventions with adolescents , but it has not been used widely in school-based nutrition education . This paper describes and reports on the feasibility of the peer leader component of a school-based nutrition intervention for young adolescents design ed to increase fruit and vegetable intakes and lower fat foods . About 1,000 seventh- grade students in eight schools received the nutrition intervention . Of these , 272 were trained as peer leaders to assist the teacher in implementing the activities . Results from a multicomponent process evaluation based on peer leader and classroom student feedback , direct classroom observation , and teacher ratings and interviews are presented . Results show that peer-led nutrition education approaches in schools are feasible and have high acceptability among peer leaders , classroom students , and teachers OBJECTIVES ( 1 ) To describe promotional activities , particularly student-led , targeting lower-fat à la carte foods that were conducted in secondary schools ; and ( 2 ) to describe the relationships between the number and duration of total promotional activities for lower-fat à la carte foods and cafeteria sales of such foods over two years . DESIGN Promotional activities were implemented in schools that were r and omised to the intervention condition of a larger , two-year , school-based , r and omised , controlled nutrition intervention trial . SETTING Ten Minnesota secondary schools . SUBJECTS Students and school faculty , school food-service and research staff ( measured at the school level ) . RESULTS Over two years , 181 promotions were implemented ( n=49 in Year 1 and n=132 in Year 2 ) . In Year 1 , the number of promotions conducted in schools was significantly associated with percentage lower-fat food sales . In Year 2 , the duration of promotions was significantly associated with percentage lower-fat food sales . CONCLUSIONS Collaborative efforts among students , school food-service staff and research staff can be successful in implementing a large number of nutrition-related , school-wide promotional activities . These efforts can increase the sales of lower-fat foods in à la carte areas of school cafeterias OBJECTIVE We implemented a theory-based r and omized controlled trial ( Living Free of Tobacco , Plus ( LIFT+ ) in ten rural middle schools and assessed impact on tobacco use and fruit/vegetable ( F/V ) intake in 2008 - 2010 . Data on F/V intake at baseline , immediate post intervention , and 1-year follow-up are presented . METHODS Schools were r and omized to intervention or control groups . Goal setting , peer leaders , and class workshops with parent involvement , were intervention features ; community partners were supportive . Seventh grade rs filled out surveys on health behaviors , psycho-social variables , and demographic characteristics . Adjusted models comparing intervention and control conditions were analyzed . RESULTS Sample ( n=1119 ) was 48.5 % female , 50 % White , with a mean age of 12.7 years . Mean F/V servings were significantly higher in intervention schools at immediate post ( 3.19 servings ) and at 1-year ( 3.02 servings ) compared to controls ( 2.90 , 2.69 respectively ) . Knowledge of 5-a-day recommendation was significantly higher in intervention schools at immediate post test ( 75.0 % ) versus controls ( 53.8 % ) but not at 1-year follow-up . CONCLUSIONS Intervention schools reported significantly higher mean F/V servings at post intervention and 1-year , and for knowledge of F/V recommendations at immediate post compared to controls . Higher levels of parent and community involvement may further increase F/V intake in future interventions . Clinical Trials.gov Identifier : NCT01412697 OBJECTIVES We evaluated an environmental intervention intended to increase sales of lower-fat foods in secondary school cafeterias . METHODS Twenty secondary schools were r and omly assigned to either an environmental intervention or a control group for a 2-year period . The intervention increased the availability of lower-fat foods and implemented student-based promotions . RESULTS A steeper rate of increase in sales of lower-fat foods in year 1 ( 10 % intervention vs -2.8 % control , P = .002 ) and a higher percentage of sales of lower-fat foods in year 2 ( 33.6 % intervention vs 22.1 % control , P = .04 ) were observed . There were no significant changes in student self-reported food choices . CONCLUSIONS School-based environmental interventions to increase availability and promotion of lower-fat foods can increase purchase of these foods among adolescents PURPOSE We used principles of community-based participatory research to develop and pilot test a 5-week intervention for middle school students , Students for Nutrition and eXercise ( SNaX ) . SNaX aim ed to translate school obesity-prevention policies into practice with peer advocacy of healthy eating and school cafeteria changes . METHODS A total 425 seventh grade rs ( 63 % of all seventh grade rs ) in the intervention school were surveyed at baseline regarding cafeteria attitudes and sugar-sweetened beverage consumption ; of the 425 students , 399 ( 94 % ) were surveyed again at 1-month post-intervention . School cafeteria records were obtained from two schools : the intervention school and a nonr and omized selected comparison school with similar student socio-demographic characteristics . RESULTS A total of 140 students in the intervention school were trained as peer advocates . In the intervention school , cafeteria attitudes among peer advocates significantly improved over time ( approximately one-third of a st and ard deviation ) , whereas cafeteria attitudes of non-peer advocates remained stable ; the improvement among peer advocates was significantly greater than the pre-post-change for non-peer advocates ( b = .71 , p < .001 ) . Peer advocates significantly reduced their sugar-sweetened beverage intake ( sports and fruit drinks ) , from 33 % before intervention to 21 % after intervention ( p = .03 ) . Cafeteria records indicated that servings of fruit and healthier entrées ( salads , s and wiches , and yogurt parfaits ) significantly decreased in the comparison school and significantly increased in the intervention school ; the magnitude of changes differed significantly between the schools ( p < .001 ) . CONCLUSIONS As compared with the non-peer advocates , peer advocates appeared to benefit more from the intervention . Future research should consider engaging parents , students , and other key community stakeholders to determine acceptable and sustainable cafeteria changes HEALTHY was a multi-center primary prevention trial design ed to reduce risk factors for type 2 diabetes in adolescents . Seven centers each recruited six middle schools that were r and omized to either intervention or control . The HEALTHY intervention integrated multiple components in nutrition , physical education , behavior change and communications and promotion . The conceptual rationale as well as the design and development of the behavior intervention component are described . Pilot study data informed the development of the behavior intervention component . Principles of social learning and health-related behavior change were incorporated . One element of the behavior intervention component was a sequence of peer-led , teacher-facilitated learning activities known as FLASH ( Fun Learning Activities for Student Health ) . Five FLASH modules were implemented over five semesters of the HEALTHY study , with the first module delivered in the second semester of the sixth grade and the last module in the second semester of the eighth grade . Each module contained sessions that were design ed to be delivered on a weekly basis to foster self-awareness , knowledge , decision-making skills and peer involvement for health behavior change . FLASH behavioral practice incorporated individual and group self-monitoring challenges for eating and activity . Another element of the behavior intervention component was the family outreach strategy for extending changes in physical activity and healthy eating beyond the school day and for supporting the student 's lifestyle change choices . Family outreach strategies included the delivery of newsletters and supplemental packages with material s to promote healthy behavior in the home environment during school summer and winter holiday breaks . In conclusion , the HEALTHY behavior intervention component , when integrated with total school food and physical education environmental changes enhanced by communications and promotional campaigns , is a feasible and acceptable mechanism for delivering age-appropriate social learning for healthy eating and physical activity among an ethnically diverse group of middle school students across the United States OBJECTIVE . We design ed and tested a novel health promotion program for elementary schools that was based on peer teaching from older to younger schoolchildren ( “ Healthy Buddies ” ) . SUBJECTS AND METHODS . This prospect i ve pilot study compared the effect of our program ( 2–3 hours/week , 21 weeks ) in 2 Canadian elementary schools ( intervention : n = 232 children , the whole school implementing the program ; control : n = 151 ) . Older students ( 4th through 7th grade ) were given direct instruction from 1 intervention teacher and were paired with younger students ( kindergarten through 3rd grade ) for the whole school year . Students in 4th through 7th grade then acted as teachers for their younger “ buddies . ” All lessons included 3 components of healthy living : nutrition , physical activity , and healthy body image . The students first learned how to be positive buddies and learned the 3 components of a healthy life . Thereafter , they learned how to overcome challenges to living a healthy life . Outcome measures ( intervention and control schools at the beginning and end of the school year ) included vali date d question naires that assessed healthy-living knowledge , behavior and attitude , a 9-minute fitness run , self-competence , body satisfaction , disordered eating symptoms , and anthropometry ( BMI , blood pressure , and heart rate ) . RESULTS . Compared with control students , both older and younger intervention students showed an increase in healthy-living knowledge , behavior , and attitude scores and a smaller increase in systolic blood pressure . BMI and weight increased less in the intervention students in 4th through 7th grade and height more in the intervention students in kindergarten through 3rd grade . CONCLUSIONS . Our student-led curriculum improved knowledge not only in older schoolchildren but also in their younger buddies . It also decreased weight velocity in the older students . Student-led teaching may be an efficient , easy-to-implement way of promoting a healthy lifestyle from kindergarten to 7th grade This article describes perceptions of adolescents involved in peer-led school-based nutrition promotions encouraging lower-fat food purchases and assesses the differences by level of student involvement . Surveys were administered at schools . Data were collected from 397 high school students from 10 Minnesota schools r and omized to the intervention condition of the Trying Alternative Cafeteria Options in Schools study . Students were categorized as highly involved ( n=54 ) or less involved ( n=343 ) based on their level of involvement in promotional activity implementation . Chi 2 tests were conducted to measure the differences between highly-involved and less-involved students in perceptions and attitudes about lower-fat foods . Highly-involved students were significantly more likely than less-involved students to report more healthful eating behaviors and positive attitudes toward lower-fat foods . Student involvement in nutrition interventions should be integrated into programs aim ed at increasing healthful food choices among adolescents |
11,531 | 23,645,295 | This systematic review and meta- analysis demonstrates that behavior therapies based on Habit Reversal Therapy , including the Comprehensive Behavioral Intervention for Tics are effective in reducing tic severity when compared with supportive psychotherapy .
When these behavior therapies are unavailable , Exposure with Response Prevention may also be effective .
Both face-to-face and telehealth delivery methods for behavior therapy improve tic severity , and broader distribution of behavior therapy through increased training or telehealth methods is encouraged . | Opinion statementWhen tics caused by Tourette Syndrome cause meaningful impairment for patients , a comprehensive treatment approach includes education of patients , peers , and family , treatment of comorbid behavioral disorders if present , and consideration of behavior therapy and pharmacotherapy for tics themselves . | Tourette syndrome ( TS ) is characterized by chronic motor and vocal tics . Habit reversal therapy ( HR ) is a behavioral treatment for tics which has received recent empirical support . The present study compared the efficacy of HRT in reducing tics , improving life-satisfaction and psychosocial functioning in comparison with supportive psychotherapy ( SP ) in out patients with TS . In addition , we investigated whether impairments in response inhibition in patients with TS predict response to HR treatment which specifically aims to inhibit tics . Thirty adult out patients with DSM-IV TS were r and omized to 14 individual sessions of HR ( n = 15 ) ; or SP ( n = 15 ) . HR but not SP reduced tic severity over the course of the treatment . Both groups improved in life-satisfaction and psychosocial functioning during active treatment . Reductions in tic severity ( HR ) and improvements in life-satisfaction and psychosocial functioning ( HR and SP ) remained stable at the 6-month follow-up . The extent of pre-treatment response inhibition impairment in the HR group predicted reductions in tic-severity from pre- to post-treatment . Our results suggest that HR has specific tic-reducing effects although SP is effective in improving life-satisfaction and psychosocial functioning . Assessment s of response inhibition may be of value for predicting treatment response to HR OBJECTIVE Cognitive behavior therapy ( CBT ) and medication can be administered in combination in treating tic disorders but there are no studies evaluating the effectiveness of CBT with and without medication . The current study compares the efficacy of CBT in combination with medication and without medication . METHOD CBT was administered in a consecutively referred sample of 76 people diagnosed either with Gilles de la Tourette Syndrome or chronic tic disorder . The sample was divided into a medicated and a non-medicated group . Twenty three were stabilized on medication and 53 were not receiving medication . Measures administered pre- and post-CBT in both groups included : main outcome measure of Tourette Syndrome Global Scale and measures of mood . RESULTS Repeated measures analysis of variance on the initial sample revealed no difference between medicated and non-medicated groups in outcome . A further analysis comparing the 23 receiving medication with 23 not receiving medication matched on baseline clinical variables also yielded no significant group differences , either in treatment outcome on main tic outcome measures or on other clinical ly relevant question naires . DISCUSSION CBT for tic disorders is an effective treatment administered either in combination with medication or alone Comprehensive Behavioral Intervention for Tics ( CBIT ) has been shown to be effective for reducing tics in children with chronic tic disorder . Unfortunately , there remain significant barriers to dissemination . The aim of the current study was to examine the effectiveness of CBIT delivered over videoconference . Twenty children were r and omly assigned to receive CBIT over videoconference or via traditional face-to-face delivery . Results show that both treatment delivery modalities result ed in significant tic reduction with no between group differences . Furthermore , acceptability and therapist-client alliance ratings were strong for both groups . Together , these results suggest that videoconference is a viable option for disseminating CBIT The intentional nature of tics provides the opportunity to apply behavioural interventions aim ed at tic reduction through interruption of stimulus-response sequences . The aim of this study has been to evaluate the effect of exposure and response prevention ( ER ) versus habit reversal ( HR ) in 43 Tourette 's syndrome ( TS ) patients . The three outcome measures were : the Yale Global Tic Severity Scale ( YGTSS ) , 15-min tic frequency registration s monitored at the institute and 15-min home tic frequency registration s. Both treatment conditions result ed in statistically significant improvements on all outcome measures ( p < 0.001 ) . No significant differences were found between the treatment conditions on any of the outcome measures , although there was a tendency in favour of ER on the YGTSS ( p = 0.05 ) . These results suggest that , at least in the short term , TS tic symptoms can be treated effectively with both types of treatment CONTEXT Tourette disorder is a chronic and typically impairing childhood-onset neurologic condition . Antipsychotic medications , the first-line treatments for moderate to severe tics , are often associated with adverse effects . Behavioral interventions , although promising , have not been evaluated in large-scale controlled trials . OBJECTIVE To determine the efficacy of a comprehensive behavioral intervention for reducing tic severity in children and adolescents . DESIGN , SETTING , AND PARTICIPANTS R and omized , observer-blind , controlled trial of 126 children recruited from December 2004 through May 2007 and aged 9 through 17 years , with impairing Tourette or chronic tic disorder as a primary diagnosis , r and omly assigned to 8 sessions during 10 weeks of behavior therapy ( n = 61 ) or a control treatment consisting of supportive therapy and education ( n = 65 ) . Responders received 3 monthly booster treatment sessions and were reassessed at 3 and 6 months following treatment . INTERVENTION Comprehensive behavioral intervention . MAIN OUTCOME MEASURES Yale Global Tic Severity Scale ( range 0 - 50 , score > 15 indicating clinical ly significant tics ) and Clinical Global Impressions-Improvement Scale ( range 1 [ very much improved ] to 8 [ very much worse ] ) . RESULTS Behavioral intervention led to a significantly greater decrease on the Yale Global Tic Severity Scale ( 24.7 [ 95 % confidence interval { CI } , 23.1 - 26.3 ] to 17.1 [ 95 % CI , 15.1 - 19.1 ] ) from baseline to end point compared with the control treatment ( 24.6 [ 95 % CI , 23.2 - 26.0 ] to 21.1 [ 95 % CI , 19.2 - 23.0 ] ) ( P < .001 ; difference between groups , 4.1 ; 95 % CI , 2.0 - 6.2 ) ( effect size = 0.68 ) . Significantly more children receiving behavioral intervention compared with those in the control group were rated as being very much improved or much improved on the Clinical Global Impressions-Improvement scale ( 52.5 % vs 18.5 % , respectively ; P < .001 ; number needed to treat = 3 ) . Attrition was low ( 12/126 , or 9.5 % ) ; tic worsening was reported by 4 % of children ( 5/126 ) . Treatment gains were durable , with 87 % of available responders to behavior therapy exhibiting continued benefit 6 months following treatment . CONCLUSION A comprehensive behavioral intervention , compared with supportive therapy and education , result ed in greater improvement in symptom severity among children with Tourette and chronic tic disorder . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00218777 The present study evaluated the effectiveness of self-monitoring , relaxation training and habit reversal in the treatment of 6 Tourette Syndrome ( TS ) subjects with multiple motor and vocal tics . A counterbalanced design was employed and tic frequencies were measured in the clinic setting using videotapes taken through a one-way mirror . Tics were reduced by an average of 55 % with habit reversal , 44 % with self-monitoring , and 32 % with relaxation training and each behavioral procedure was the most effective treatment for at least one subject . All three treatment approaches may have some utility in the behavioral treatment of TS CONTEXT Tics in Tourette syndrome begin in childhood , peak in early adolescence , and often decrease by early adulthood . However , some adult patients continue to have impairing tics . Medications for tics are often effective but can cause adverse effects . Behavior therapy may offer an alternative but has not been examined in a large-scale controlled trial in adults . OBJECTIVE To test the efficacy of a comprehensive behavioral intervention for tics in adults with Tourette syndrome of at least moderate severity . DESIGN A r and omized controlled trial with posttreatment evaluations at 3 and 6 months for positive responders . SETTING Three outpatient research clinics . PATIENTS Patients ( N = 122 ; 78 males ; age range , 16 - 69 years ) with Tourette syndrome or chronic tic disorder were recruited between December 27 , 2005 , and May 21 , 2009 . INTERVENTIONS Patients received 8 sessions of comprehensive behavioral intervention for tics or 8 sessions of supportive treatment for 10 weeks . Patients with a positive response were given 3 monthly booster sessions . MAIN OUTCOME MEASURES Total tic score on the Yale Global Tic Severity Scale and the Clinical Global Impression-Improvement scale rated by a clinician masked to treatment assignment . RESULTS Behavior therapy was associated with a significantly greater mean ( SD ) decrease on the Yale Global Tic Severity Scale ( 24.0 [ 6.47 ] to 17.8 [ 7.32 ] ) from baseline to end point compared with the control treatment ( 21.8 [ 6.59 ] to 19.3 [ 7.40 ] ) ( P < .001 ; effect size = 0.57 ) . Twenty-four of 63 patients ( 38.1 % ) were rated as much improved or very much improved on the Clinical Global Impression-Improvement scale compared with 4 of 63 ( 6.4 % ) in the control group ( P < .001 ) . Attrition was 13.9 % , with no difference across groups . Patients receiving behavior therapy who were available for assessment at 6 months after treatment showed continued benefit . CONCLUSION Comprehensive behavior therapy is a safe and effective intervention for adults with Tourette syndrome . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00231985 Children ( n = 126 ) ages 9 to 17 years with chronic tic or Tourette disorder were r and omly assigned to receive either behavior therapy or a control treatment over 10 weeks . This study examined acute effects of behavior therapy on secondary psychiatric symptoms and psychosocial functioning and long-term effects on these measures for behavior therapy responders only . Baseline and end point assessment s conducted by a masked independent evaluator assessed several secondary psychiatric symptoms and measures of psychosocial functioning . Responders to behavior therapy at the end of the acute phase were reassessed at 3-month and 6-month follow-up . Children in the behavior therapy and control conditions did not differentially improve on secondary psychiatric or psychosocial outcome measures at the end of the acute phase . At 6-month posttreatment , positive response to behavior therapy was associated with decreased anxiety , disruptive behavior , and family strain and improved social functioning . Behavior therapy is a tic-specific treatment for children with tic disorders OBJECTIVE The authors investigated the efficacy of habit reversal for Tourette 's disorder , which is characterized by multiple motor and vocal tics . METHOD Thirty-two patients with Tourette 's disorder were r and omly assigned to 14 sessions of either habit reversal or supportive psychotherapy . Habit reversal consisted of awareness training , self-monitoring , relaxation training , competing response training , and contingency management . Changes in severity of Tourette 's disorder and psychosocial impairment were investigated over the course of the 14-session treatment for the 29 patients who completed at least eight treatment sessions . RESULTS In contrast to the 13 patients in the supportive psychotherapy group , the 16 patients in the habit reversal group improved significantly . The habit reversal patients remained significantly improved over pretreatment at 10-month follow-up . CONCLUSIONS Habit reversal may be an effective behavioral treatment for Tourette 's disorder |
11,532 | 29,264,505 | There was no substantial effect of receiving hormonal therapy on BMD of the femoral neck , trochanteric region , Ward triangle , or total body BMD .
Conclusion The current evidence does not support using hormonal therapy for the sole purpose of improving bone health in patients with FHA .
There are no data about bisphosphonates in this population | Objective We conducted a systematic review and meta- analysis of studies that evaluated the effect of hormonal therapy [ estrogen therapy including oral contraceptive pills ( OCP ) ] and bisphosphonates in preventing bone loss in patients with functional hypothalamic amenorrhea ( FHA ) . | Anorexia nervosa ( AN ) is prevalent in adolescents and is associated with decreased bone mineral accrual at a time critical for optimizing bone mass . Low BMD in AN is a consequence of nutritional and hormonal alterations , including hypogonadism and low estradiol levels . Effective therapeutic strategies to improve BMD in adolescents with AN have not been identified . Specifically , high estrogen doses given as an oral contraceptive do not improve BMD . The impact of physiologic estrogen doses that mimic puberty on BMD has not been examined . We enrolled 110 girls with AN and 40 normal-weight controls 12 to 18 years of age of similar maturity . Subjects were studied for 18 months . Mature girls with AN ( bone age [ BA ] ≥15 years , n = 96 ) were r and omized to 100 µg of 17β-estradiol ( with cyclic progesterone ) or placebo transdermally for 18 months . Immature girls with AN ( BA < 15 years , n = 14 ) were r and omized to incremental low-dose oral ethinyl-estradiol ( 3.75 µg daily from 0 to 6 months , 7.5 µg from 6 to 12 months , 11.25 µg from 12 to 18 months ) to mimic pubertal estrogen increases or placebo for 18 months . All BMD measures assessed by dual-energy X-ray absorptiometry ( DXA ) were lower in girls with AN than in control girls . At baseline , girls with AN r and omized to estrogen ( AN E + ) did not differ from those r and omized to placebo ( AN E- ) for age , maturity , height , BMI , amenorrhea duration , and BMD parameters . Spine and hip BMD Z-scores increased over time in the AN E+ compared with the AN E- group , even after controlling for baseline age and weight . It is concluded that physiologic estradiol replacement increases spine and hip BMD in girls with AN Introduction The aim of this study was the long-term prospect i ve evaluation of the effects of estroprogestagen ( EP ) therapy on the bone mineral density ( BMD ) of girls with functional hypothalamic amenorrhea ( FHA ) carrying various PvuII and XbaI polymorphisms of ER-α . Material and methods Prospect i ve observation included 84 FHA girls and 50 controls . The FHA patients were subjected to 4-year sequential therapy with 17β estradiol ( 2 mg from the 2nd to 25th day of the menstrual cycle ) and dydrogesterone ( 10 mg from the 16th to the 25th day ) . Hormonal parameters , serum concentration of the bone fraction of alkaline phosphatase ( BALP ) , urine concentration of cross-linked n-telopeptide of type I collagen ( Ntx ) and BMD were determined before and after the treatment . Results Six-month treatment result ed in a marked increase in estradiol ( p = 0.001 ) , testosterone and prolactin levels ( p = 0.01 both ) and a significant decrease in BALP and Ntx ( p = 0.001 both ) . Patients with the PP polymorphism had significantly lower baseline BMD compared to carriers of other polymorphic variants of PvuII ( p = 0.003 ) . A significant increase in BMD was observed throughout the entire therapy period , with no significant differences in the yearly dynamics of BMD changes observed amongst various polymorphic variants and haplotypes of ER-α . Conclusions The EP therapy is effective in the treatment of BMD disorders associated with FHA , and treatment results do not depend on PvuII and XbaI polymorphisms of ER-α Abstract : There is considerable concern about the adverse effects on the skeleton of loss of menstrual function as a result of athletic activity , as well as uncertainty as to how it should be managed clinical ly . In a pilot intervention study 34 elite middle and long-distance runners , aged 18–35 years , with menstrual irregularity due to their athletic activity were r and omized to three groups : ( A ) to receive hormone replacement therapy ( HRT ) and 1000 mg calcium per day ( n= 10 ) , ( B ) to receive 1000 mg calcium per day ( n = 14 ) , ( C ) a control group who received no treatment ( n= 10 ) . Bone mineral density ( BMD ) was measured in the left hip and lumbar spine ( L2–4 ) using dual-energy X-ray absorptiometry . Results were first analyzed according to whether menstruation returned , either naturally or secondary to HRT ( EU ) , and compared with those from subjects who remained amenorrheic ( AM ) . During the first year BMD increased in the EU group in Ward ’s triangle ( 3.8 % ) and the lumbar spine ( 4.1 % ; both P<0.05 ) . BMD fell in the AM group in all regions and the between-group differences were 5.6 % ( p<0.02 ) in Ward ’s triangle , 5.8 % ( p<0.02 ) in L2–4 and 3.9 % in the trochanter ( p<0.05 ) . An ‘ intention to treat ’ analysis was then performed . It was found that the mean relative improvement at 1 year in spinal BMD was only 1.5 % , due to return of menses in some of the controls and withdrawals from treatment in the treatment group . In consequence , a trial design ed to show , with 80 % power and 5 % significance , a measurable benefit in lumbar spine BMD result ing from allocation to HRT treatment would require about 1150 athletes with amenorrhea or oligomenorrhea . These numbers could be reduced substantially to 380 subjects by confining the trial to completely amenorrheic athletes , who in this study were less likely to regain menses . For these and other logistical reasons , an HRT trial in amenorrheic athletes could only be successfully organized through international collaboration . This study illustrates the major effects of treatment withdrawals and instability of menstrual status on the design of longitudinal studies on the bony effects of menstrual dysfunction prior to menopause 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 Osteoporosis is recognized as a common medical complication of anorexia nervosa ( AN ) . The purpose of the current study was to investigate the recovery mechanism of osteoporosis in AN and the effect of medical treatment on the skeletal system . METHOD We conducted a r and omized placebo-controlled study of the effects of etidronate and calcium and vitamin D on bone loss in 41 out patients with the restricting type of AN ( AN-R ) . We measured the tibial speed of sound ( SOS ) before and after 3 months of treatment . RESULTS The bone mineral density ( BMD ) of the tibial SOS change in both the etidronate group and the calcium and vitamin D Group was significantly greater ( p < .001 ) than in the control group . Urine-N-telopeptide cross-links of type I collagen ( NTx ) before and after treatment decreased significantly ( p < .01 ) in the etidronate group . CONCLUSION These findings suggest that both etidronate and calcium and vitamin D are equally efficacious for reversing the degree of osteoporosis in patients with AN OBJECTIVES The objectives of this study were to assess ( 1 ) whether treatment with oral contraceptives , in comparison with medroxyprogesterone and placebo , improved bone mineral in women with hypothalamic amenorrhea and ( 2 ) whether treatment with medroxyprogesterone , in comparison with placebo , improved bone mineral in women with hypothalamic oligomenorrhea . STUDY DESIGN The study was a r and omized , controlled clinical trial . Twenty-four white women , aged 14 to 28 years , with hypothalamic amenorrhea or oligomenorrhea were prospect ively enrolled for a 12-month intervention period . Amenorrheic subjects were r and omized to receive oral contraceptives , medroxyprogesterone , or placebo . Oligomenorrheic subjects were r and omized to receive medroxyprogesterone or placebo . Bone mineral was measured by dual-energy x-ray absorptiometry at baseline and at 6 and 12 months . RESULTS In amenorrheic subjects spine and total body bone mineral measurements at 12 months were greater in the oral contraceptive group than in the medroxyprogesterone and placebo groups when baseline bone mineral measurements , body weight , and age were controlled for ( p < or = 0.05 ) . There were no differences in hip bone mineral calcium and bone mineral density measurements at 12 months among the three groups . In oligomenorrheic subjects there was no detectable improvement in bone mineral associated with medroxyprogesterone use . CONCLUSIONS This study supports the hypothesis that oral contraceptive use in women with hypothalamic amenorrhea will improve lumbar spine and total body bone mineral CONTEXT Anorexia nervosa is complicated by severe bone loss and clinical fractures . Mechanisms underlying bone loss in adults with anorexia nervosa include increased bone resorption and decreased formation . Estrogen administration has not been shown to prevent bone loss in this population , and to date , there are no approved , effective therapies for this comorbidity . OBJECTIVE To determine whether antiresorptive therapy with a bisphosphonate alone or in combination with low-dose transdermal testosterone replacement would increase bone mineral density ( BMD ) in women with anorexia nervosa . DESIGN AND SETTING We conducted a12-month , r and omized , placebo-controlled study at a clinical research center . STUDY PARTICIPANTS Participants included 77 ambulatory women with anorexia nervosa . INTERVENTION Subjects were r and omized to risedronate 35 mg weekly , low-dose transdermal testosterone replacement therapy , combination therapy or double placebo . MAIN OUTCOME MEASURES BMD at the spine ( primary endpoint ) , hip , and radius and body composition were measured by dual-energy x-ray absorptiometry . RESULTS Risedronate increased posteroanterior spine BMD 3 % , lateral spine BMD 4 % , and hip BMD 2 % in women with anorexia nervosa compared with placebo in a 12-month clinical trial . Testosterone administration did not improve BMD but increased lean body mass . There were few side effects associated with either therapy . CONCLUSIONS Risedronate administration for 1 yr increased spinal BMD , the primary site of bone loss in women with anorexia nervosa . Low-dose testosterone did not change BMD but increased lean body mass Anorexia nervosa ( AN ) , a psychiatric disease characterized by chronic starvation , is complicated by severe bone loss ( 1 ) , for which there is no effective , available therapy . Although bone resorption is markedly increased in these patients , estrogen is an ineffective anti-resorptive therapy in the setting of undernutrition . We hypothesized bisphosphonate administration would result in a decrease in bone resorption and an increase in bone density in women with AN and bone loss , despite undernutrition . We therefore administered risedronate 5 mg daily for nine months to 10 women with AN , all of whom had osteopenia ( mean AP spine T score : -2.7 + /- 2 ) and compared NTX and bone density with baseline values and with those from available control data prospect ively followed for the same time period . Bone density increased significantly in patients who received risedronate compared with controls and compared with baseline , despite lack of significant weight gain , for an increase of AP spine bone density of 4.1 + /- 1.6 % at six months and 4.9 + /- 1.0 % at nine months . Bone resorption , as measured by NTX , decreased 23.8 % at one month and 29.6 % at three months , from the high-normal to mid-normal range of young women . Our data suggest that risedronate 5 mg daily administered to women with AN and osteopenia may increase in bone density at the AP spine despite low weight . This is the first study to demonstrate marked increases in bone density in women with AN . Because of the lack of data regarding the safety of such medications in women of reproductive age , bisphosphonates are not approved in the U.S. for premenopausal women other than those receiving glucocorticoids . Further studies are needed to establish the efficacy and safety of bisphosphonate therapy in this population OBJECTIVE To evaluate whether decreasing doses of ethinyl estradiol affect bone loss related to hypothalamic amenorrhea . STUDY DESIGN Sixty-four women with hypothalamic oligoamenorrhea were allocated to two therapy groups : group A ( n = 24 ) received an OC containing 0.030 mg of ethinyl estradiol ( EE ) and 0.15 mg of desogestrel . Group B ( n = 22 ) received an OC containing 0.020 mg of EE and 0.15 mg of desogestrel . Eighteen women who did not wish to use hormonal therapy constituted the control group ( C ) . Calcium , phosphate and osteocalcin were measured basally and at 6 and 12 months of follow-up . Bone mineral density at the lumbar spine was determined before initiation of the study and at 12 months by dual energy X-ray absorptiometry . RESULTS Serum calcium , phosphate and osteocalcin were significantly reduced by both active treatment regimens , whereas no differences were observed in the control group . Bone mineral density at 12 months showed an increase in both therapy groups ( A , 2.4 % ; B , 2.5 % ) , while group C showed a significant decrease ( 1.2 % , P < .05 ) . CONCLUSION Both doses of EE were equally effective in preventing bone loss related to hypoestrogenism in hypothalamic oligoamenorrheic subjects OBJECTIVE To investigate the role of estrogen deprivation and replacement in amenorrheic and nonamenorrheic dancers on hormone therapy and calcium . DESIGN Clinical , placebo-controlled , r and omized trial study .Healthy volunteers in an academic research environment . PATIENT(S ) Fifty-five dancers ( mean age : 22.0 + /- 4.6 , age at menarche : 14.7 + /- 2.3 years ) , including 24 amenorrheics . INTERVENTION(S ) Amenorrheics were r and omized in a controlled trial to receive placebo or Premarin , 0.625 mg for 25 days monthly , with Provera , 10 mg , for 10 of these 25 days ( hormone therapy ) for 2 years . These women were compared to normally menstruating controls . The study participants also received 1250 mg of calcium per day . MAIN OUTCOME MEASURE(S ) Bone mineral density ( BMD ) measured at the foot , wrist , and lumbar spine . Our overall results showed no difference in BMD between the treated or placebo groups , indicating that hormone therapy did not change or normalize BMD when compared to normals . Five patients ( all on placebo ) who resumed menses during the study showed an increase in BMD without normalization . CONCLUSION ( S ) These findings suggest that mechanisms other than hypoestrogenism may be involved with the osteopenia associated with exercise-induced amenorrhea |
11,533 | 30,475,519 | The citation analysis revealed a growing interest for this topic and the papers on thyroid function are the most cited .
In particular , literature show that a specific dosage of isoflavones reduces cardiovascular disease ( from 20 to 100 mg/die ) , may be protective in osteoporosis and muscular fatigue ( from 20 to 80 mg/die ) , may be useful for cancer prevention on endometrium , mammary gl and s and liver ( from 50 to 100 mg/die ) , might improve menopausal symptoms , particularly in reducing the frequency of hot flashes ( from 50 to 120 mg/die ) , can reduce abdominal fat and circulating inflammatory markers ( from 80 to 160 mg/die ) , may ameliorate the possible interaction between endogenous estrogen and thyroid function ( 75 mg/die ) and improve visual memory ( from 50 to 100 mg/die ) | Isoflavones can exert their action on various levels : on cardiovascular system , bone and muscle health , on cancer , on menopausal symptoms , on obesity , on thyroid and on cognitive function .
The aim of this systematic review is to evaluate the multidimensional effects of phytoestrogens in postmenopausal woman , and specifically to explore the impact on scientific literature .
Concerning the research areas , this review has assessed the effectiveness of various activities of isoflavones on welfare of menopausal women . | BACKGROUND Concerns regarding the risk of estrogen replacement have result ed in a significant increase in the use of soy products by menopausal women who , despite the lack of evidence of the efficacy of such products , seek alternatives to menopausal hormone therapy . Our goal was to determine the efficacy of soy isoflavone tablets in preventing bone loss and menopausal symptoms . METHODS The study design was a single-center , r and omized , placebo-controlled , double-blind clinical trial conducted from July 1 , 2004 , through March 31 , 2009 . Women aged 45 to 60 years within 5 years of menopause and with a bone mineral density T score of -2.0 or higher in the lumbar spine or total hip were r and omly assigned , in equal proportions , to receive daily soy isoflavone tablets , 200 mg , or placebo . The primary outcome was changes in bone mineral density in the lumbar spine , total hip , and femoral neck at the 2-year follow-up . Secondary outcomes included changes in menopausal symptoms , vaginal cytologic characteristics , N -telopeptide of type I bone collagen , lipids , and thyroid function . RESULTS After 2 years , no significant differences were found between the participants receiving soy tablets ( n = 122 ) and those receiving placebo ( n = 126 ) regarding changes in bone mineral density in the spine ( -2.0 % and -2.3 % , respectively ) , the total hip ( -1.2 % and -1.4 % , respectively ) , or the femoral neck ( -2.2 % and -2.1 % , respectively ) . A significantly larger proportion of participants in the soy group experienced hot flashes and constipation compared with the control group . No significant differences were found between groups in other outcomes . CONCLUSIONS In this population , the daily administration of tablets containing 200 mg of soy isoflavones for 2 years did not prevent bone loss or menopausal symptoms . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00076050 Objective This study aims to evaluate the effects of soy isoflavones on breast tissue in postmenopausal women . Methods In this r and omized , double-blind , placebo-controlled study , 80 women ( aged ≥45 y and with amenorrhea > 12 mo ) with vasomotor symptoms were r and omized to receive either 250 mg of st and ardized soy extract corresponding to isoflavone 100 mg/day ( n = 40 ) or placebo ( n = 40 ) for 10 months . Breasts were evaluated through mammographic density and breast parenchyma using ultrasound ( US ) at baseline and 10-month follow-up . Independent t test , analysis of variance , Mann-Whitney U test , and & khgr;2 trend test were used in statistical analysis . Results Baseline clinical characteristics showed no significant differences between the isoflavone group and the placebo group , with mean ( SD ) age of 55.1 ( 6.0 ) and 56.2 ( 7.7 ) years , mean ( SD ) menopause duration of 6.6 ( 4.8 ) and 7.1 ( 4.2 ) years , and mean ( SD ) body mass index of 29.7 ( 5.0 ) and 28.5 ( 4.9 ) kg/m2 , respectively ( P > 0.05 ) . The study was completed by 32 women on isoflavone and 34 women on placebo . The groups did not differ in mammographic density or breast parenchyma by US ( P > 0.05 ) . Within each group , the baseline and final moments did not differ in mammography or US parameters significantly ( P > 0.05 ) . Conclusions The use of soy isoflavone extract for 10 months does not affect breast density , as assessed by mammography and US , in postmenopausal women Because soy food consumption may influence breast tissue activity , we examined its effect on the presence of epithelial cells in nipple aspirate fluid ( NAF ) . In a r and omized , crossover design , 82 premenopausal women completed a high-soy and a low-soy diet for 6 mo each , separated by a 1-mo washout period . They provided NAF sample s at baseline , 6 mo , and 13 mo during the midluteal phase of the menstrual cycle . Papanicolaou-stained cytology slides ( for 33 women at baseline , 24 at low-soy , and 36 at high-soy ) were evaluated in women with sufficient NAF . Mixed models evaluated the effect of the high-soy diet on epithelial cytology as compared to baseline and the low-soy diet . At the end of the high-soy diet , cytological subclass had decreased in 8 ( 24 % ) and increased in 3 ( 9 % ) women as compared to baseline , whereas the respective values were 3 ( 14 % ) and 6 ( 29 % ) for the low-soy diet sample s ( P = 0.32 ) . Only the change in subclass indicated a trend in lower cytological class ( P = 0.06 ) . Contrary to an earlier report , the number of NAF sample s with hyperplastic epithelial cells did not increase after a soy intervention in amounts consumed by Asians Background . Risk-benefit issues raised after the WHI have significantly increased the use of alternative treatments for the menopause . Despite this , data regarding the effect of soy isoflavones over mood and menopausal symptoms in high risk population s is still lacking . Objective . To evaluate the effect of soy derived isoflavones over hot flushes , menopausal symptoms and mood in climacteric women with increased body mass index ( BMI ) . Methods . Fifty symptomatic climacteric women aged 40 to 59 with increased BMI ( ≥25 ) were recruited to receive oral 100 mg/day of soy derived isoflavones ( Climasoy ® ) for 3 months . Hot flushes ( frequency/intensity ) , menopausal symptoms ( Menopause Rating Scale [ MRS ] ) and mood ( Hamilton Depressive Rating Scale [ HDRS ] ) were evaluated at baseline and at 90 days . Results . A total of 45 women completed the study . After 3 months of soy isoflavone supplementation hot flushes significantly decreased in percentage , number and severity ( 100 % to 31.1 % ; 3.9 ± 2.3 to 0.4 ± 0.8 and 2.6 ± 0.9 to 0.4 ± 0.8 , respectively , p < 0.001 ) . MRS scores ( total and for subscales ) reflecting general menopausal symptoms also significantly decreased compared to baseline . Regarding mood , after three months total HDRS scores and the rate of women presenting depressed mood ( scores ≥ 8) significantly decreased ( 16.3 ± 5.4 to 6.9 ± 5.2 and 93.3 % to 28.9 % , respectively , p < 0.05 ) . There was no effect on blood pressure levels or BMI values after treatment . Conclusion . In this high risk climacteric population , soy derived isoflavone treatment improved mood as well as vasomotor and general menopausal symptoms . More research is required to determine if the positive effect over mood is a direct or an indirect one through hot flush alleviation OBJECTIVE To investigate the effects of st and ardized soy extract on climacteric symptoms , lipid profiles , bone markers , and serum isoflavone concentration in healthy Taiwanese postmenopausal women . MATERIAL S AND METHODS A multicenter , open-labeled , r and omized , prospect i ve , comparative study design was used . A total of 130 out patients who had undergone natural menopause were r and omly administered either 70 mg or 35 mg soy extract daily for 24 weeks . RESULTS The evidence suggests that the soy extract treatment that was administered to both groups for 1 month could help reduce climacteric scores ( reductions of 19.66 % [ p<0.01 ] and 18.85 % [ p<0.01 ] in the 35 mg and 70 mg groups compared with baseline , respectively ) , and the efficacy was more potent after 6 months of treatment . Soy isoflavone significantly reduced the total cholesterol ( reductions of 4.50 % [ p<0.01 ] and 3.06 % [ p<0.05 ] in the 35 mg and 70 mg groups , respectively ) and low density lipoprotein cholesterol levels ( reductions of 4.67 % [ p<0.05 ] and 5.09 % [ p<0.05 ] in the 35 mg and 70 mg groups , respectively ) in patients with total cholesterol > 200 mg/dL after 6 months of treatment . In patients with high bone turnover ( urinary deoxypyridinoline/creatinine > 7.4 nM/mM ) , soy extract treatment reduced the deoxypyridinoline/creatinine level by 10.53 % ( p<0.05 ) and 11.58 % ( p<0.05 ) in the 35 mg and 70 mg groups , respectively . Serum levels of isoflavone increased in both groups after 6 months of treatment . CONCLUSION Soy extract is highly efficacious at relieving menopausal symptoms and demonstrates a positive effect on the cardiovascular system and skeleton Background and objectives : The potential of soy isoflavones to interfere with thyroid function has been reported . However , there are limited data regarding their effect on thyroid function and autoimmunity in surgical menopausal women . The present study aim ed to evaluate the effect of isoflavones on thyroid function and autoimmunity , menopausal symptoms , serum follicle stimulating hormone ( FSH ) and estradiol levels in oophorectomised women . Methods : A r and omized , double blind , placebo-controlled trial was conducted in 43 oophorectomised women to evaluate the effect of soy isoflavones ( 75 mg/day for 12 wk ) on serum thyroid profile ( free T3 , free T4 , TSH , TBG and anti-TPO antibody titres ) assessed at baseline , 6 and 12 wk after r and omization . Assessment was also done for menopause symptom score ( MSS ) three weekly , and FSH and estradiol levels at baseline and at study completion . Results : There was a significant alteration in free T 3 levels in the group receiving isoflavones ( 4.05 ± 0.36 , 4.12 ± 0.69 and 3.76 ± 0.55 pmol/l at baseline , 6 and 12 wk , respectively ; P=0.02 ) . However , the mean change in various thyroid parameters at 12 wk from baseline was not significantly different between the two groups . MSS was also significantly decreased at 9 and 12 wk from baseline with isoflavones ( 12.47 ± 8.15 , 9.35 ± 5.23 and 9 ± 5.14 at baseline , 9 and 12 wk respectively ; P=0.004 ) with significant improvement in urogenital symptoms compared to placebo . Isoflavones did not significantly affect other parameters during study period . There were no serious adverse events reported and the proportion of patients experiencing adverse events was similar between the two groups . Interpretation and conclusions : Modest reduction in serum free T3 levels in the isoflavone group in the absence of any effect on other thyroid parameters might be considered clinical ly unimportant OBJECTIVE Menopause is associated with broad , though generally not massive changes in a large number of metabolic parameters . The aim of our study was to evaluate the efficacy and tolerability of a combined nutraceutical approach on a large number of cardiometabolic risk markers and menopause symptoms in otherwise healthy , mildly dyslipidemic postmenopausal women . DESIGN / SETTING Forty women were enrolled in the context of a controlled , r and omized , prospect i ve study with parallel groups at the Lipid Clinic of the University of Bologna . INTERVENTION The women were r and omized to treatment with a nutraceuticals containing soy isoflavones ( 60 mg ) and berberine ( 500 mg ) or a placebo at a dosage of one tablet daily between meals for 12 weeks . RESULTS All patients completed the study without significant side effects . Anthropometric measures , blood pressure , HOMA index , and basal homocysteinemia significantly improved in isoflavones-berberine-treated group when compared to the baseline , but not when compared to the placebo-treated patients . Compared to placebo-treated patients , those treated with isoflavones-berberine experienced a significant improvement in plasma lipid and metalloproteinase serum levels , as well as the main menopausal symptoms . CONCLUSION The short-term consumption of a nutraceutical containing isoflavones and berberine was well-tolerated and improved menopausal symptoms , plasma lipid level , and serum levels of matrix metalloproteinases in a cohort of mildly dyslipidemic postmenopausal women when compared with a neutral control Objective This study aims to determine whether long-term isoflavone soy protein ( ISP ) supplementation affects endometrial thickness and rates of endometrial hyperplasia and cancer in postmenopausal women . Methods In this r and omized , double-blind , placebo-controlled trial , 350 postmenopausal women aged 45 to 92 years were r and omized to a total daily dose of 154 mg of ISP or a milk protein – matched placebo for a 3-year period . Women with a surgically absent uterus were excluded from the analysis ( final study population , N = 224 ) . The main outcome measures were as follows : mean change in endometrial thickness on transvaginal ultrasound from baseline until up to 36 months of follow-up and the incidence of endometrial sampling , endometrial hyperplasia , and endometrial cancer . Results A total of 666 visits among 224 participants were evaluated . Treatment groups did not significantly differ on the mean baseline or on-trial changes in endometrial thickness . Of the 103 placebo-treated participants , 7 ( 6.8 % ) underwent endometrial biopsy ; 6 ( 85.7 % ) of these biopsies were benign . One woman in the placebo group was diagnosed with complex endometrial hyperplasia with atypia and underwent hysterectomy . The pathology result from this surgical operation was stage IB endometrial cancer . Of the 121 participants in the soy group , 9 ( 7.4 % ) underwent endometrial biopsy . The results were benign in all nine cases ( 100 % ) . Although the rate of hyperplasia/malignancy was higher in the placebo group ( 14.3 % vs 0 % ) , the difference was not statistically significant . Conclusions Three-year ISP supplementation has no effect on endometrial thickness or on the rates of endometrial hyperplasia and cancer in postmenopausal women Background and Purpose — Although epidemiological and experimental studies suggest that dietary intake of soy may be cardioprotective , use of isoflavone soy protein ( ISP ) supplementation as a primary preventive therapy remains unexplored . We determined whether ISP reduces sub clinical atherosclerosis assessed as carotid artery intima-media thickness progression . Methods — In a double-blind , placebo-controlled trial , 350 postmenopausal women 45 to 92 years of age without diabetes and cardiovascular disease were r and omized to 2 evenly divided daily doses of 25 g soy protein containing 91 mg aglycon isoflavone equivalents or placebo for 2.7 years . Results — Overall , mean ( 95 % CI ) carotid artery intima-media thickness progression rate was 4.77 ( 3.39–6.16 ) & mgr;m/year in the ISP group and 5.68 ( 4.30–7.06 ) & mgr;m/year in the placebo group . Although carotid artery intima-media thickness progression was reduced on average by 16 % in the ISP group relative to the placebo group , this treatment effect was not statistically significant ( P=0.36 ) . Among the subgroup of women who were r and omized within 5 years of menopause , ISP participants had on average a 68 % lower carotid artery intima-media thickness progression rate than placebo participants 2.16 ( −1.10 to 5.43 ) versus 6.79 ( 3.56–10.01 ) & mgr;m/year ( P=0.05 ) . ISP supplementation had a null effect on women who were > 5 years beyond menopause when r and omized . There were no major adverse events from ISP supplementation . Conclusions — ISP supplementation did not significantly reduce sub clinical atherosclerosis progression in postmenopausal women . Subgroup analysis suggests that ISP supplementation may reduce sub clinical atherosclerosis in healthy young ( median age , 53 years ) women at low-risk for cardiovascular disease who were < 5 years postmenopausal . These first trial results of their kind warrant further investigation . Clinical Trial Registration — URL : http://www . clinical trials.gov . Unique identifier : NCT00118846 Objective This study aims to assess the overall safety and potential endometrium-stimulating effects of soy isoflavone tablets consumed ( 3 y ) by postmenopausal women and to determine endometrial thickness response to treatment among compliant women , taking into account hormone concentrations and other hypothesized modifying factors . Methods We r and omized healthy postmenopausal women ( aged 45.8 - 65.0 y ) to placebo control or two doses ( 80 or 120 mg/d ) of soy isoflavones at two sites . We used intent-to-treat analysis ( N = 224 ) and compliant analysis ( > 95 % ; N = 208 ) to assess circulating hormone concentrations , adverse events , and endometrial thickness ( via transvaginal ultrasound ) . Results Median values for endometrial thickness ( mm ) declined from baseline through 36 months . Nonparametric analysis of variance for treatment differences among groups showed no differences in absolute ( or percentage of change ) endometrial thickness ( & khgr;2 P ranged from 0.12 to 0.69 ) or in circulating hormones at any time point . A greater number of adverse events in the genitourinary system ( P = 0.005 ) were noted in the 80 mg/day group compared with the 120 mg/day group , whereas other systems showed no treatment effects . The model predicting endometrial thickness response ( using natural logarithm ) to treatment among compliant women across time points was significant ( P ⩽ 0.0001 ) , indicating that estrogen exposure ( P = 0.0013 ) , plasma 17&bgr;-estradiol ( P = 0.0086 ) , and alcohol intake ( P = 0.023 ) contributed significantly to the response . Neither the 80 mg/day dose ( P = 0.57 ) nor the 120 mg/day dose ( P = 0.43 ) exerted an effect on endometrial thickness across time . Conclusions Our r and omized controlled trial verifies the long-term overall safety of soy isoflavone tablet intake by postmenopausal women who display excellent compliance . We find no evidence of treatment effects on endometrial thickness , adverse events , or circulating hormone concentrations , most notably thyroid function , across a 3-year period Objective Estrogen therapy is , to date , the most effective treatment of menopausal syndrome and also has a favorable effect on lipid profiles . Because of its potential adverse effects , however , a more acceptable alternative therapy needs to be identified . This study examines the effect of soy germ isoflavones on menopausal symptoms and serum lipids . Methods Ninety early postmenopausal Chinese women , aged 45 to 60 years , were r and omly assigned to three treatment groups ( 30 each ) receiving daily doses of 0 ( placebo ) , 84 , and 126 mg of soy germ isoflavones . Hot flush frequency , Kupperman scores , serum 17&bgr;-estradiol , follicle-stimulating hormone , luteinizing hormone , and serum lipids , including triglyceride , total cholesterol , low-density lipoprotein cholesterol , high-density lipoprotein cholesterol , apolipoprotein A-I , and apolipoprotein B100 , were assessed at baseline and at 12 and 24 weeks after treatment . Results Both the frequency of hot flushes and the Kupperman index score decreased in all three treatment groups during the intervention period , but the percentage decreases in both were significantly greater in the two isoflavone groups ( 44.3 ± 19.1 and 57.8 ± 37.4 [ 84 mg isoflavones ] ; 48.5 ± 27.2 and 56.7 ± 26.7 [ 126 mg isoflavones ] ) than in the placebo group ( 27.8 ± 15.5 and 34.6 ± 46.2 ; p < 0.01 ) . There was no significant difference in the changes in estradiol , follicle-stimulating hormone , and luteinizing hormone among the three treatment groups during the study , and no significant differences were observed in the lipid components . Conclusions A daily supplement of 84 or 126 mg soy germ isoflavones may improve menopausal symptoms , although neither dose was found to affect lipid profiles in early postmenopausal Chinese women after 24 weeks of treatment . The favorable effects are unlikely to be associated with female hormones Background and Aim . Cardiovascular risk is increased in women with menopause and metabolic syndrome . Aim of this study was to test the effect of a new supplement formula , combining cocoa polyphenols , myo-inositol , and soy isoflavones , on some biomarkers of cardiovascular risk in postmenopausal women with metabolic syndrome . Methods and Results . A total of 60 women were enrolled and r and omly assigned ( n = 30 per group ) to receive the supplement ( NRT : 30 mg of cocoa polyphenols , 80 mg of soy isoflavones , and 2 gr of myo-inositol ) , or placebo for 6 months . The study protocol included three visits ( baseline , 6 , and 12 months ) for the evaluation of glucose , triglycerides , and HDL-cholesterol ( HDL-C ) , adiponectin , visfatin , resistin , and bone-specific alkaline phosphatase ( bone-ALP ) . At 6 months , a significant difference between NRT and placebo was found for glucose ( 96 ± 7 versus 108 ± 10 mg/dL ) , triglycerides ( 145 ± 14 versus 165 ± 18 mg/dL ) , visfatin ( 2.8 ± 0.8 versus 3.7 ± 1.1 ng/mL ) , resistin ( 27 ± 7 versus 32 ± 8 µg/L ) , and b-ALP ( 19 ± 7 versus 15 ± 5 µg/mL ) . No difference in HDL-C concentrations nor in adiponectin levels between groups was reported at 6 months . Conclusions . The supplement used in this study improves most of the biomarkers linked to metabolic syndrome . This Trial is registered with NCT01400724 Summary The treatment of 300-mg/day isoflavones ( aglycone equivalents ) ( 172.5 mg genistein + 127.5 mg daidzein ) for 2 years failed to prevent lumbar spine and total proximal femur bone mineral density ( BMD ) from declining as compared with the placebo group in a r and omized , double-blind , two-arm design ed study enrolling 431 postmenopausal women 45–65 years old . Introduction This study evaluated the effects of soy isoflavones on bone metabolism in postmenopausal women . Methods Four hundred and thirty-one women , aged 45–65 years , orally consumed 300-mg/day isoflavones ( aglycone equivalents ) or a placebo for 2 years in a parallel group , r and omized , double-blind , two-arm study . Each participant also ingested 600 mg of calcium and 125 IU of vitamin D3 per day . The BMD of the lumbar spine and total proximal femur were measured using dual-energy X-ray absorptiometry at baseline and every half-year thereafter . Serum bone-specific alkaline phosphatase , urinary N-telopeptide of type 1 collagen/creatinine , and other safety assessment s were examined regularly . Results Two hundred out of 217 subjects in the isoflavone group and 199 out of 214 cases in placebo group completed the treatment . Serum concentrations of isoflavone metabolites , genistein and daidzein , of the intervention group were remarkably elevated following intake of isoflavones ( p < 0.001 ) . However , differences in the mean percentage changes of BMD throughout the treatment period were not statistically significant ( lumbar spine , p = 0.42 ; total femur , p = 0.39 ) between the isoflavone and placebo groups , according to the generalized estimating equation ( GEE ) method . A significant time trend of bone loss was observed at both sites as assessed by the GEE method following repeated measurement of BMD ( p < 0.001 ) . Differences in bone marker levels were not significant between the two treatment groups . Conclusion Treatment with 300-mg/day isoflavones ( aglycone equivalents ) failed to prevent a decline in BMD in the lumbar spine or total femur compared with the placebo group We conducted a double-blind , r and omized , placebo-controlled trial to evaluate the effects of soy-derived isoflavone on blood glucose , lipid profiles , and sex hormones related to cardiovascular disease in Korean postmenopausal women . One hundred thirteen postmenopausal women were recruited from the Seoul metropolitan area . To confirm postmenopausal and gynecologic status , the subjects were clinical ly examined by a gynecologist using ultra sound and X-ray . Finally , 85 postmenopausal women whose follicle-stimulating hormone ( FSH ) levels were higher than 40 IU/ml were enrolled . Subjects received either 70 mg isoflavone or placebo capsules daily for 12 weeks . As a result , the values of fasting glucose , insulin and HOMA-IR , as well as those of TC , LDL-C , HDL-C and FFA , were not different between the groups after supplementation . However , triglyceride ( TG ) levels in the treatment group decreased significantly compared with those of the placebo group ( p = 0.0215 ) . The levels of luteinizing hormone ( LH ) significantly decreased in the treatment group ( p = 0.027 ) ; however , the levels of FSH , estrone and estradiol were not changed after intervention . In conclusion , isoflavone supplement of 70 mg/day for 12 weeks decreased blood levels of TG and LH in Korean postmenopausal women OBJECTIVES Evaluate the effect of diet , physical exercise , and a daily oral intake of a soy isoflavones extract ( Fisiogen ( ® ) ) contained 200 mg of Glycine max , which corresponded to 80 mg of isoflavone ( 60.8 mg of genistein , 16 mg of daidzein and 3.2 mg of glicitein ) on leptin and other adipokines plasma levels in healthy obese postmenopausal women . METHODS A multicentric r and omized longitudinal prospect i ve cohort study was conducted in a sample of 87 healthy obese postmenopausal women . Patients were r and omly assigned to a 1200 kcal diet and exercise group ( control group ) or a group of 1200 kcal diet , exercise , and daily oral intake of daily oral intake of a soy isoflavones extract ( Fisiogen ( ® ) ) contained 200 mg of Glycine max , which corresponded to 80 mg of isoflavone ( 60.8 mg of genistein , 16 mg of daidzein and 3.2 mg of glicitein ) ( soy isoflavones group ) along 6 months . Main outcome measures were : anthropometric measures , body composition , leptin , adiponectin , TNF-alpha , homocysteine , C-reactive protein , glucose , insulin , lipid profile and oestradiol serum levels , Kupperman index and Cervantes Scale . RESULTS Mean serum leptin and TNF-alpha levels declined after 6 months in both groups of the study , but only women in the soy isoflavones group showed a significant increase of mean serum levels of adiponectin . CONCLUSIONS Diet , physical exercise and daily oral intake of a soy isoflavones extract ( Fisiogen ( ® ) ) contained 200 mg of Glycine max , which corresponded to 80 mg of isoflavone ( 60.8 mg of genistein , 16 mg of daidzein and 3.2 mg of glicitein ) have a beneficial effect on serum leptin , adiponectin and TNF-α in healthy obese postmenopausal women after 6 months of treatment BACKGROUND Postmenopausal estrogen depletion is a major contributing factor to bone loss . Soy isoflavones have variable effects on the prevention of postmenopausal bone loss , which is possibly related to the specific isoflavone content or the variable equol-producing capacity of individuals . OBJECTIVE We aim ed to determine the effects of the content of isoflavones in a soy supplement and the equol-producing ability of the individual on postmenopausal bone calcium retention . DESIGN The study was a blinded , r and omized , crossover intervention trial in 24 postmenopausal women who were prescreened for their ability to convert daidzein to equol . Women were equilibrated with (41)Ca before the intervention . Interventions were 5 soy isoflavone oral supplements ( 2 doses of a genistein-rich soy supplement and 3 doses of mixed isoflavones in various proportions ) and a bisphosphonate ( risedronate ) . Each intervention was given sequentially for 50 d followed by a 50-d washout period . The percentage of bone calcium retention was determined from the change in urinary (41)Ca : calcium . RESULTS Interventions that ranged from 52 to 220 mg total isoflavones/d increased bone calcium retention between 3.4 % and 7.6 % ( P < 0.05 ) , which was a moderate effect compared with that of risedronate at 15.3 % ( 95 % CI : 7.1 % , 22.7 % ; P = 0.0014 ) . The most-effective soy intervention delivered 105.23 mg total isoflavones/d as genistein , daidzein , and glycitein in their natural ratios and increased bone calcium retention by 7.6 % ( 95 % CI : 4.9 % , 10.2 % ; P < 0.0001 ) . Genistein , at 52.85 mg/d , increased bone calcium retention by 3.4 % ( 95 % CI : 0.5 % , 6.2 % ; P = 0.029 ) ; but there was no benefit at higher amounts ( 113.52 mg/d ) . There was no difference ( P = 0.5 ) in bone calcium retention between equol producers and nonproducers . CONCLUSION Soy isoflavones , although not as potent as risedronate , are effective bone-preserving agents in postmenopausal women regardless of their equol-producing status , and mixed isoflavones in their natural ratios are more effective than enriched genistein . This trial was registered at clinical trials.gov as NCT00244907 A 12-month r and omized double blind controlled trial was conducted among 182 Indonesian postmenopausal women aged 47 to 60 years to determine the effect of 100 mg/day soy isoflavone supplementation on vascular endothelial function such as vascular cell adhesion molecule-1 ( VCAM-1 ) , nitric oxide ( NO ) and malondialdehyde ( MDA ) as oxidative stress marker . The subjects were r and omized to the intervention group receiving tablets consisting of 100 mg soy isoflavones and calcium carbonate 500 mg , and to the control group receiving 500 mg calcium carbonate . The concentrations of VCAM-1 , NO and MDA were measured at baseline , and postsupplementation at 6 months and 12 months . After supplementation , the MDA concentrations were significantly lower in the soy isoflavone group compared with the control group ( p=0.001 ) . The concentrations of VCAM-1 and NO were not affected ( p=0.992 and p=0.759 , respectively ) . In all group the MDA concentration increased compared with baseline concentrations but the relative change of MDA concentrations was significantly lower in the soy isoflavone group compared with the control group . This study demonstrates that supplemental intake of soy isoflavones for 6 months and 12 months had an effect on oxidative stress by decreasing MDA concentration , but did not improve vascular endothelial function Soy foods contain several components , notably , isoflavones and amino acids , that may improve cardiovascular health . We evaluated the long-term effect of soy protein and /or soy isoflavones supplementation on serum lipids and inflammatory markers using a 1-year r and omized , double-blind , placebo-control , clinical trial in 131 healthy ambulatory women older than 60 years . We hypothesized that soy protein , in combination with isoflavones , would have the largest positive effect on coronary heart disease risk factors ( serum lipids and inflammatory markers ) compared with either intervention alone and that , within groups receiving isoflavones , equol producers would have more positive effects on coronary heart disease risk factors than nonequol producers . After a 1-month baseline period , participants were r and omized into 1 of 4 intervention groups : soy protein ( 18 g/d ) and isoflavone tablets ( 105 mg/d isoflavone aglycone equivalents ) , soy protein and placebo tablets , control protein and isoflavone tablets , or control protein and placebo tablets . T Tests were used to assess differences between equol and nonequol producers . Ninety-seven women completed the trial . Consumption of protein powder and isoflavone tablets did not differ among groups , and compliance with study powder and tablets was 79 % and 90 % , respectively . After 1 year , in the entire population , there were either no or little effects on serum lipids and inflammatory markers , regardless of treatment group . Equol producers , when analyzed separately , had significant improvements in total cholesterol/high-density lipoprotein and low-density lipoprotein/high-density lipoprotein ratios ( -5.9 % , P = .02 ; -7.2 % , P = .04 respectively ) . Soy protein and isoflavone ( either alone or together ) did not impact serum lipids or inflammatory markers . Therefore , they should not be considered an effective intervention to prevent cardiovascular disease because of lipid modification in healthy late postmenopausal women lacking the ability to produce equol Objective : Equol is a metabolite of the isoflavone daidzein and may play a critical role in preventing bone loss by soy isoflavones in postmenopausal women . However , results from clinical trials have not been published . The aim of this study was to investigate the effects of equol on bone metabolism and serum sex and thyroid hormone levels in postmenopausal Japanese women . Methods : We performed a 1-year double-blind , r and omized , placebo-controlled trial with natural S-equol supplements for 93 non-equol-producing menopausal Japanese women . Participants were r and omly assigned to four groups receiving the following : placebo , 2 mg of equol supplement per day , 6 mg of equol supplement per day , and 10 mg of equol supplement per day . Results : Equol intervention increased equol concentrations in serum and urine in a dose-dependent manner . Urinary deoxypyridinoline was significantly decreased , with a −23.94 % change in the group that received 10 mg of equol supplement per day as compared with a −2.87 % change in the group that received placebo after 12 months of intervention ( P = 0.020 ) . Thus , 10 mg/day of equol supplement markedly inhibited bone resorption . Treatment with 10 mg/day of equol prevented a decrease in bone mineral density in the entire body in postmenopausal women after 12 months . Sex and thyroid hormone concentrations in serum did not differ among the four groups after intervention . Conclusions : These findings suggest that 10 mg/day of natural S-equol supplementation contributes to bone health in non-equol-producing postmenopausal women without adverse effects Objective The purpose of this study was to assess the effect of soy isoflavone supplementation on quality of life in postmenopausal women . Methods A multicenter , r and omized , double-blind , placebo-controlled 24-month trial was conducted to assess the effect of 80 or 120 mg of daily aglycone hypocotyl soy isoflavone supplementation on quality of life in 403 postmenopausal women using a vali date d Menopause-Specific Quality of Life question naire . Results Menopause-Specific Quality of Life domain scores at 1 year and 2 years were similar to baseline . There were no differences in domain scores among treatment groups . Conclusions Soy isoflavone supplementation offers no benefit to quality of life in postmenopausal women Objective : To assess the safety of a nutraceutical compound containing soy isoflavones and Lactobacillus sporogenes on endometrium , breast and liver function . Setting : Outpatient Menopausal Clinic . Study Design : 130 healthy postmenopausal women suffering from menopausal symptoms were r and omized to receive soy isoflavones 60 mg and Lactobacillus sporogenes 1 billion spores ( group E : 65 women ) or calcium and vitamin D3 ( group C : 65 women ) . Safety of the treatment was assessed at baseline and after 1 year taking into account endometrial thickness , mammographic density , serum levels of transaminases , γ-GT and bilirubin . Efficacy of the treatment was evaluated rating the score of menopausal symptoms at baseline and every 3 months . The statistical analysis was carried out with χ2 , Fisher exact ’s test and ANOVA . Results : After 12 months of treatment mammographic density , endometrial thickness and hepatic function did not show significant differences between groups , while menopausal symptoms were progressively and significantly reduced in severity and frequency during treatment with soy isoflavones plus Lactobacillus sporogenes versus calcium plus vitamin D3 . Conclusion : A 12 months treatment with a nutraceutical compound based on isoflavones and Lactobacillus sporogenes at the recommended doses is safe for endometrium , mammary gl and s and liver function in postmenopausal women OBJECTIVES To compare the effects of daily ingestion of dietary soy supplementation , low-dose hormone therapy ( HT ) and placebo on psychological , somatic and urogenital symptoms in postmenopausal women . STUDY DESIGN A double-blind , r and omized , controlled trial . Sixty healthy , symptomatic , postmenopausal women of 40 - 60 years of age were allocated to use dietary soy supplementation ( containing 90 mg of isoflavone ) or HT ( 1 mg estradiol and 0.5 mg norethisterone acetate ) or placebo . MAIN OUTCOME MEASURES the Menopause Rating Scale ( MRS ) was used to assess menopausal symptoms at baseline and after 16 weeks of treatment . Intention-to-treat analyses were performed using the chi-square test , Fisher 's exact test , the Kruskal-Wallis non-parametric test and analysis of variance ( ANOVA ) . RESULTS No statistically significant differences were found between the groups with respect to baseline clinical and sociodemographic characteristics . The psychological , somatic and urogenital symptoms analyzed in the MRS improved during treatment in all the groups , except for urogenital symptoms in the placebo group in which no significant changes were detected . Comparison between groups revealed a statistically significant improvement in somatic symptoms ( hot flashes and muscle pain ) in the users of HT ( -45.6 % ) and dietary soy supplementation ( -49.8 % ) . Urogenital symptoms ( vaginal dryness ) improved significantly in HT users ( -38.6 % ) and in users of the dietary soy supplementation ( -31.2 % ) . There was no statistically significant difference between the groups with respect to overall MRS score or to scores obtained in the psychological symptoms subscale . CONCLUSION Dietary soy supplementation may constitute an effective alternative therapy for somatic and urogenital symptoms of the menopause BACKGROUND S-equol , a metabolite of the soy isoflavone daidzein , has been proposed as having potential for relief of menopausal symptoms . This study compared the efficacy of the natural S-equol supplement , SE5-OH , with isoflavones for relieving hot flashes and other menopausal symptoms . METHODS An 8-week r and omized , double-blind , active comparator trial with SE5-OH was conducted in postmenopausal women ( aged 45 - 65 years ) , who experienced ≥5 hot flashes/day . Participants ( n=102 ) were assigned to one of four treatment groups : 10 ( n=24 ) , 20 ( n=27 ) , or 40 ( n=25 ) mg S-equol/day or soy isoflavones ( n=26 ) . Participants recorded their hot flash frequency and rated their menopause symptom severity . RESULTS Reductions in hot flash frequency at week 8 were similar for all treatment groups . However , based on analyses of the cumulative effect for the 8-week period , 40 mg/day S-equol had a greater reduction of hot flash frequency compared to isoflavones ( p=0.021 ) . A subgroup analysis further indicated that for subjects with > 8 hot flashes/day at baseline , 20 and 40 mg/day S-equol were superior to isoflavones in reducing hot flash frequency ( p=0.045 and p=0.001 , respectively ) . In addition , 10 and 20 mg/day S-equol improved muscle and joint pain score compared with isoflavones ( p=0.003 and p=0.005 , respectively ) . CONCLUSIONS S-equol , 10 mg/day , appears to be as effective as soy isoflavones at reducing hot flash frequency and more effective for relieving muscle and joint pain in postmenopausal women . S-equol , ≥20 mg/day , alleviates hot flashes to a greater extent than soy isoflavones in those women who experience > 8 hot flashes/day BACKGROUND & AIMS Observational studies note that regular dietary soy protein intake ( 6 - 11 g day(-1 ) ) has a significant association with lower blood lipids ; however , these observations have not been confirmed by clinical trials . This study aim ed to ascertain the effects of moderate intake of soy protein ( 15 g ) with isoflavones or isoflavones alone on serum lipid profiles , inflammatory markers ( C-reactive protein and uric acid ) and composite cardiovascular risk in Chinese postmenopausal , prediabetic women . METHODS AND RESULTS A double-blind r and omised , placebo-controlled trial was conducted among 180 postmenopausal Chinese women with prediabetes or early untreated diabetes , aged 46 - 70 years and , on average , 6.0 years since menopause . Participants were r and omly assigned to one of the three arms to receive 15-g soy protein and 100-mg isoflavone ( Soy group ) , or 15-g milk protein and 100 mg isoflavone ( Iso group ) or 15-g milk protein ( placebo group ) on a daily basis for 6 months . The results showed that no significant difference was observed in serum high-density lipoprotein-cholesterol ( HDL-C ) , low-density lipoprotein-cholesterol ( LDL-C ) , total cholesterol ( TC ) , triaclyglycerol ( TG ) , high sensitive C-reactive protein and a composite 10-year cardiovascular risk between the three groups at both 3 and 6 months . Serum uric acid marginally increased by 1.22 % in the Soy group and decreased by 4.28 % and 4.82 % in the Iso and placebo groups at 3 months ( P = 0.087 ) , but no difference was observed at 6 months ( P = 0.264 ) . CONCLUSION Soy protein with isoflavones or isoflavones alone at the provided dosage showed no significantly beneficial effects on measured cardiovascular risk factors in postmenopausal Chinese women with early hyperglycaemia Objective : To determine the cognitive effects of long-term dietary soy isoflavones in a daily dose comparable to that of traditional Asian diets . Methods : In the double-blind Women 's Isoflavone Soy Health trial , healthy postmenopausal women were r and omly allocated to receive daily 25 g of isoflavone-rich soy protein ( 91 mg of aglycone weight of isoflavones : 52 mg of genistein , 36 mg of daidzein , and 3 mg glycitein ) or milk protein−matched placebo . The primary cognitive endpoint compared between groups at 2.5 years was change from baseline on global cognition , a composite of the weighted sum of 14 neuropsychological test score changes . Secondary outcomes compared changes in cognitive factors and individual tests . Results : A total of 350 healthy postmenopausal women aged 45–92 years enrolled in this trial ; 313 women with baseline and endpoint cognitive test data were included in intention-to-treat analyses . Adherence in both groups was nearly 90 % . There was no significant between-group difference on change from baseline in global cognition ( mean st and ardized improvement of 0.42 in the isoflavone group and 0.31 in the placebo group ; mean st and ardized difference 0.11 , 95 % confidence interval [ CI ] −0.13 to 0.35 ) . Secondary analyses indicated greater improvement on a visual memory factor in the isoflavone group ( mean st and ardized difference 0.33 , 95 % CI 0.06–0.60 ) but no significant between-group differences on 3 other cognitive factors or individual test scores , and no significant difference within a subgroup of younger postmenopausal women . Conclusion : For healthy postmenopausal women , long-term dietary soy isoflavone supplementation in a dose comparable to that of traditional Asian diets has no effect on global cognition but may improve visual memory . Classification of evidence : This study provides Class I evidence that long-term dietary supplementation with isoflavone-rich soy protein does not improve global cognition of healthy postmenopausal women Objective To investigate the effect of a soy isoflavone extract over insulin sensitivity and plasma leptin levels . Methods Eighty postmenopausal women were r and omly assigned to participate for 24 months either to a physical exercise and Mediterranean diet program ( Control group : CG ) or this intervention plus a daily oral intake of a soy isoflavone extract ( Soy isoflavone group : SIG ) . Anthropometry , body composition analysis , blood biochemistry , menopausal symptoms and health-related quality of life were assessed at baseline and every 6 months . Results Sixty-five women completed the protocol with no differences found among groups at baseline in age and time since the menopause . At month 24 , body mass index ( BMI ) was lower in the SIG as compared to the CG . Fat mass , glucose , insulin , HOMA-IR , tumor necrosis factor-α ( TNF-α ) , Kupperman Index and Cervantes Scale values significantly decreased in the SIG as compared to baseline and to CG values . Kupperman scores and serum TNF-α levels significantly decreased in both studied groups . No changes in plasma leptin levels were observed after 24 months within and between groups . When analysis was stratified according to BMI values , changes in the aforementioned parameters displayed a similar trend ; however , the impact over glucose , insulin and HOMA-IR values was more evident among obese women assigned to the SIG . Conclusion Diet , physical exercise and a daily oral intake of soy isoflavones exerted a beneficial effect on the homeostatic model in postmenopausal women which was not related to significant changes in plasma leptin levels , despite a decrease in TNF-α , fat mass and Kupperman values Based on the hypothesis that soy food consumption may influence breast tissue activity , we examined its effect on the production of nipple aspirate fluid ( NAF ) , a possible indicator of breast cancer risk . Of 310 premenopausal women screened , 112 ( 36 % ) produced at least 10 μL of NAF , the minimum for study participation . In a crossover design , we r and omized 96 women to 2 groups who , in reverse order , consumed a high-soy diet with 2 soy servings/d ( 1 serving = 177 mL soy milk , 126 g tofu , or 23 g soy nuts ) and a low-soy diet with <3 servings/wk of soy for 6 mo each separated by a 1-mo washout period . During each diet period , 3 NAF sample s were obtained ( baseline and 3 and 6 mo ) using a FirstCyte Aspirator and 4 urine sample s ( baseline and 1 , 3 , and 6 mo ) were analyzed for isoflavonoids by liquid chromatography t and em MS . Adherence to the study protocol according to 24-h dietary recalls and urinary isoflavonoid excretion was high . The drop-out rate was 15 % ( n = 14 ) ; 82 women completed the intervention . The 2 groups produced similar mean NAF volumes at baseline ( P = 0.95 ) but differed in age and previous soy intake and in their response to the intervention ( P = 0.03 ) . In both groups , NAF volume decreased during the first 3 mo of the high-soy diet period and returned to baseline at 6 mo , but there was no effect of the high-soy diet on NAF volume ( P = 0.50 for diet ; P-interaction = 0.21 for diet with time ) . Contrary to an earlier report , soy foods in amounts consumed by Asians did not increase breast tissue activity as assessed by NAF volume |
11,534 | 30,547,249 | Interventions that applied posture-challenging exercises showed the highest effects .
Conclusions The present review and meta- analysis provide evidence that physical exercise interventions have the potential to significantly reduce fall rate and risk in healthy older adults . | Background The risk of falling and associated injuries increases with age .
Therefore , the prevention of falls is a key priority in geriatrics and is particularly based on physical exercising , aim ing to improve the age-related decline in motor performance , which is crucial in response to postural threats .
Although the benefits and specifications of effective exercise programs have been well documented in pre-post design studies , that is during the treatment , the definitive retention and transfer of these fall-related exercise benefits to the daily life fall risk during follow-up periods remains largely unclear .
Accordingly , this meta- analysis investigates the efficacy of exercise interventions on the follow-up risk of falling . | Abstract Lix and rão , ME , Damas , F , Chacon-Mikahil , MPT , Cavaglieri , CR , Ugrinowitsch , C , Bottaro , M , Vechin , FC , Conceição , MS , Berton , R , and Libardi , CA . Time course of resistance training – induced muscle hypertrophy in the elderly . J Strength Cond Res 30(1 ) : 159–163 , 2016—Extended periods of resistance training ( RT ) induce muscle hypertrophy . Nevertheless , to date , no study has investigated the time window necessary to observe significant changes in muscle cross-sectional area ( CSA ) in older adults . Therefore , this study investigated the time course of muscle hypertrophy after 10 weeks ( 20 sessions ) of RT in the elderly . Fourteen healthy older subjects were r and omly allocated in either the RT ( n : 6 ) or control group ( n : 8) . The RT was composed of 4 sets × 10 repetitions ( 70–80 % 1 repetition maximum [ 1RM ] ) in a leg press machine . The time course of vastus lateralis muscle hypertrophy ( CSA ) was assessed on a weekly basis by mode-B ultrasonography . Leg press muscle strength was assessed by dynamic 1RM test . Our results demonstrated that the RT group increased leg press 1RM by 42 % ( p ⩽ 0.05 ) after 10 weeks of training . Significant increases in vastus lateralis muscle CSA were observed only after 18 sessions of training ( 9 weeks ; p ⩽ 0.05 ; 7.1 % ) . In conclusion , our training protocol promoted muscle mass accrual in older subjects , and this was only observable after 18 sessions of RT ( 9 weeks ) OBJECTIVE To examine the effects of session intensity ( number of slip exposures ) and frequency on the retention of acquired adaptation for prevention of backward balance loss after repeated-slip training . DESIGN A 4-group , r and omized , and controlled study . SETTING Biomechanics research laboratory . PARTICIPANTS Healthy young subjects ( N=46 ; 21 men ) . INTERVENTIONS Twenty-four subjects experienced a high-intensity session of 24 repeated right-side slips ; 12 received additional single-slip sessions at a frequency of 1 week , 2 weeks , and 1 month , whereas the rest got no ancillary training . Another 24 subjects received a low-intensity initial session of a single slip ; 12 received the same high-frequency ancillary training , whereas the rest got none . All groups were retested with a single slip 4 months after the first session . MAIN OUTCOME MEASURES The incidence of backward balance loss , gait stability , and limb support . RESULTS The high-intensity groups , irrespective of ancillary training , displayed similar improvements in all 3 outcome measures . Remarkably , the low-intensity group receiving ancillary training also significantly improved in all measures , with retention comparable to that observed in the other 2 groups . A single-slip exposure without ancillary sessions was insufficient to yield a longer-term effect . CONCLUSIONS Frequent ancillary sessions may be unnecessary for slip-related fall prevention up to 4 months if the initial session intensity is sufficient . Furthermore , the minimum of a single slip may be as effective if the subject is exposed to frequent ancillary sessions Based on finding a strong association between number of impairments and risk of falling in earlier studies , Yale FICSIT investigators are conducting an intervention trial comparing the effectiveness of usual care plus social visits ( SV ) and a targeted risk abatement intervention ( TI ) strategy in reducing falls among at risk community elderly persons . Subjects include members of a participating HMO who are > or = 70 years of age , cognitively intact , not terminally ill , not too physically active , and possess at least one fall risk factor . The targeted risk factors include postural hypotension ; sedative use ; at least four targeted medications ; upper and lower extremity strength and range of motion impairments ; foot problems ; and balance , gait , and transfer dysfunctions . The interventions include medication adjustments , behavioral change recommendations , education and training , and home-based exercise regimens targeting the identified risk factors . The interventions are carried out by the study nurse practitioner and physical therapist in TI subjects ' homes . The SV subjects receive a comparable number of home visits as the TI subjects during which a structured life review is performed by social work students . The primary outcome is occurrence of falls during the 12-month followup . Secondary outcomes include change in mobility performance and fall-related efficacy Abstract Background Both exercise and vitamin D are recommended means to prevent falls among older adults , but their combined effects on fall-induced injuries are scarcely studied . Methods A 2-year follow-up of a previous 2-year r and omized controlled trial with vitamin D and exercise ( Ex ) of 409 older home-dwelling women using a factorial 2 × 2 design ( D−Ex− , D+Ex− , D−Ex+ , D+Ex+ ) . Besides monthly fall diaries , femoral neck bone mineral density ( fn-BMD ) , and physical functioning were assessed at 1 and 2 years after the intervention . Results After the intervention , S-25OHD concentrations declined to baseline levels in both supplement groups . The groups did not differ for change in fn-BMD or physical functioning , except for leg extensor muscle strength , which remained about 10 % greater in the exercise groups compared with the reference group ( D−Ex− ) . There were no between-group differences in the rate of all falls , but medically attended injurious falls reduced in D+Ex− and D−Ex+ groups compared with D−Ex−. However , all former treatment groups had less medically attended injured fallers , HRs ( 95 % CI ) being 0.62 ( 0.39–1.00 ) for D+Ex− , 0.46 ( 0.28–0.76 ) for D−Ex+ , and 0.55 ( 0.34–0.88 ) for D+Ex+ , compared with D−Ex−. Conclusions Exercise-induced benefits in physical functioning partly remained 2 years after cessation of supervised training . Although there was no difference in the rate of all falls , former exercise groups continued to have lower rate of medically attended injured fallers compared with referents even 2 years after the intervention . Vitamin D without exercise was associated with less injurious falls with no difference in physical functioning OBJECTIVES To primarily ascertain the effect of the Otago Exercise Program ( OEP ) on physiological falls risk , functional mobility , and executive functioning after 6 months in older adults with a recent history of falls and to ascertain the effect of the OEP on falls during a 1-year follow-up period . DESIGN R and omized controlled trial . SETTING Dedicated falls clinics . PARTICIPANTS Seventy-four adults aged 70 and older who presented to a healthcare professional after a fall . INTERVENTION The OEP , a home-based program that consists of resistance training and balance training exercises . MEASUREMENTS Physiological falls risk was assessed using the Physiological Profile Assessment . Functional mobility was assessed using the Timed Up and Go Test . Three central executive functions were assessed : set shifting , using the Trail Making Test Part B ; updating , using the verbal digits backward test ; and response inhibition , using the Stroop Color-Word Test . Falls were prospect ively monitored using daily calendars . RESULTS At 6 months , there was no significant between-group difference in physiological falls risk or functional mobility ( P > or= .33 ) . There was a significant between-group difference in response inhibition ( P=.05 ) . A falls histogram revealed two outliers . With these cases removed , using negative binomial regression , the unadjusted incidence rate ratio of falls in the OEP group compared with the control group was 0.56 . The adjusted incidence rate ratio was 0.47 . CONCLUSION The OEP may reduce falls by improving cognitive performance OBJECTIVES To evaluate the long-term effects of a multifactorial fall prevention programme on the incidence of falls requiring medical treatment . STUDY DESIGN A r and omized controlled trial . METHODS Five hundred and ninety-one community-dwelling elderly people ( > or = 65 years ) living in the town of Pori , Finl and with at least one fall during the previous 12 months were r and omized into an intervention group ( n=293 ) and a control group ( n=298 ) . Subjects in the intervention group participated in a multifactorial 12-month fall prevention programme . This study evaluated the incidence of falls requiring medical treatment during the 3-year follow-up period . RESULTS The intervention did not significantly reduce the incidence of falls requiring medical treatment during the 3-year follow-up period [ incidence rate ratio ( IRR ) for the intervention group compared with the control group 0.87 , 95 % confidence interval ( CI ) 0.63 - 1.21 ] . The number of falls requiring medical treatment was lower in the intervention group ( n=32 ) compared with the control group ( n=50 ) ( IRR 0.65 , 95%CI 0.40 - 1.07 ) during the second year of follow-up , but this was not found during the first year ( 48 and 48 falls , respectively ; IRR 1.04 , 95%CI 0.64 - 1.69 ) or the third year ( 44 and 48 falls , respectively ; IRR 0.94 , 95%CI 0.58 - 1.53 ) of follow-up . CONCLUSIONS The multifactorial fall prevention programme did not decrease the incidence of falls requiring medical treatment of fall-prone elderly people during the 3-year follow-up period . However , some positive effect was found during the second year of follow-up ( immediately after the 12-month intervention ) BACKGROUND AND OBJECTIVES To evaluate the incidence of falls according to socio-demographic and health factors , and to determine their physical , psychological and social consequences . SUBJETS AND METHOD : Population -based prospect i ve study , which included a representative cohort of 448 elderly community-dwellers , aged 65 or more living in the city of Mataró ( Spain ) . We made a baseline evaluation , which was repeated after a one-year follow up , consisting of a st and ardized question naire on socio-demographic characteristics , physical activity , tests of physical and cognitive function , history of falls during the previous year , the Falls Efficacy Scale , and associated chronic conditions . Follow-up interviews at intervals of one month over 12 months , consisting of a st and ardized question naire aim ed at detecting and describing any fall occurred during the previous month . RESULTS 25.1 % ( 95 % CI , 18.8 - 31.4 ) of males and 37.0 % ( 95 % CI , 31.2 - 42.8 ) of females fell . Multiple falls were observed in 3.8 % of men and 10.9 % of women . 203 falls were reported , providing a crude incidence rate of 30.9 falls per 100 men-years ( 95 % CI , 23.3 - 41.0 ) and 56.5 falls per 100 women-years ( 95 % CI , 46.5 - 68.8 ) . A positive association with falls was found with age , reduced physical and cognitive function , associated chronic conditions and previous falls . 71.1 % of falls had physical consequences , with 7.7 % of fractures , and 21.7 % needed medical aid . 64.4 % of fallers feared of falling again . CONCLUSIONS Our study shows a pattern of high incidence of falls among the elderly living in the Spanish non-institutionalized community . Our data confirm that adverse consequences derived from the falls are frequent and often severe , which makes falls one of the major problems of elderly people Summary This study showed that about a half of the exercise-induced gain in dynamic balance and bone strength was maintained one year after cessation of the supervised high-intensity training of home-dwelling elderly women . However , to maintain exercise-induced gains in lower limb muscle force and physical functioning , continued training seems necessary . Introduction Maintenance of exercise-induced benefits in physical functioning and bone structure was assessed one year after cessation of 12-month r and omized controlled exercise intervention . Methods Originally 149 healthy women 70–78 years of age participated in the 12-month exercise RCT and 120 ( 81 % ) of them completed the follow-up study . Self-rated physical functioning , dynamic balance , leg extensor force , and bone structure were assessed . Results During the intervention , exercise increased dynamic balance by 7 % in the combination resistance and balance-jumping training group ( COMB ) . At the follow-up , a 4 % ( 95 % CI : 1–8 % ) gain compared with the controls was still seen , while the exercise-induced isometric leg extension force and self-rated physical functioning benefits had disappeared . During the intervention , at least twice a week trained COMB subjects obtained a significant 2 % benefit in tibial shaft bone strength index compared to the controls . A half of this benefit seemed to be maintained at the follow-up . Conclusions Exercise-induced benefits in dynamic balance and rigidity in the tibial shaft may partly be maintained one year after cessation of a supervised 12-month multi-component training in initially healthy elderly women . However , to maintain the achieved gains in muscle force and physical functioning , continued training seems necessary Background : Falls in the elderly are a major health problem . Although exercise programs have been shown to reduce the risk of falls , the optimal exercise components , as well as the working mechanisms that underlie the effectiveness of these programs , have not yet been established . Objective : To test whether the Nijmegen Falls Prevention Program was effective in reducing falls and improving st and ing balance , balance confidence , and obstacle avoidance performance in community-dwelling elderly people . Methods : A total of 113 elderly with a history of falls participated in this study ( exercise group , n = 79 ; control group , n = 28 ; dropouts before r and omization , n = 6 ) . Exercise sessions were held twice weekly for 5 weeks . Pre- and post-intervention fall monitoring and quantitative motor control assessment s were performed . The outcome measures were the number of falls , st and ing balance and obstacle avoidance performance , and balance confidence scores . Results : The number of falls in the exercise group decreased by 46 % ( incidence rate ratio ( IRR ) 0.54 , 95 % confidence interval ( CI ) 0.36–0.79 ) compared to the number of falls during the baseline period and by 46 % ( IRR 0.54 , 95 % CI 0.34–0.86 ) compared to the control group . Obstacle avoidance success rates improved significantly more in the exercise group ( on average 12 % ) compared to the control group ( on average 6 % ) . Quiet stance and weight-shifting measures did not show significant effects of exercise . The exercise group also had a 6 % increase of balance confidence scores . Conclusion : The Nijmegen Falls Prevention Program was effective in reducing the incidence of falls in otherwise healthy elderly . There was no evidence of improved control of posture as a mechanism underlying this result . In contrast , an obstacle avoidance task indicated that subjects improved their performance . Laboratory obstacle avoidance tests may therefore be better instruments to evaluate future fall prevention studies than posturographic balance assessment AIMS To describe the circumstances and consequences of falls reported by community-dwelling older women . METHODS This prospect i ve study collected data for approximately 2 years for women aged > or=70 years at risk for falling who were enrolled in the Fall Evaluation and Prevention Program . RESULTS Participants ( 263 ) completed a median of 24 months of follow-up . A total of 143 participants reported 341 falls ; 70 reported 1 fall , and 73 reported 2 or more . A majority of falls ( 62 % ) occurred in/around the home , primarily during the daytime , and in living rooms or kitchens/dining rooms . Falls frequently occurred while walking , carrying objects , or reaching/leaning . Many falls did not result in injury ( 53 % ) ; however , 31 % result ed in minor injuries , 10 % in moderate injuries , and 6 % in major injuries . Soft tissue injuries were common , and 5 % of falls result ed in fractures . Nine falls result ed in hospitalization . CONCLUSIONS The high rate of injurious falls seen here and the detailed information on activity at the time of the fall emphasize the need to increase awareness of behaviors and the environment to reduce fall risk . Previous studies have identified risk factors for falls , some of which can not be modified , such as age or gender . In contrast , this study describes the activity at the time of the fall : many falls occur in the home environment , some with modifiable circumstances Summary The present study was conducted to determine the effect of 5-month exercise program on the prevention of falls in the elderly . The exercise training , which consisted of calisthenics , body balance training , muscle power training , and walking ability training 3 days/week improved the indices of the flexibility , body balance , muscle power , and walking ability and reduced the incidence of falls compared with non-exercise controls . The present study showed the beneficial effect of the exercise program aim ed at improving flexibility , body balance , muscle power , and walking ability in preventing falls in the elderly . Introduction The present study was conducted to determine the effect of exercise on the prevention of falls in the elderly . Methods Sixty-eight elderly ambulatory volunteers were r and omly divided into two groups : the exercise and control groups . The daily exercise , which consisted of calisthenics , body balance training ( t and em st and ing , t and em gait , and unipedal st and ing ) , muscle power training ( chair-rising training ) , and walking ability training ( stepping ) , were performed 3 days/week only in the exercise group . No exercise was performed in the control group . Results After the 5-month exercise program , the indices of the flexibility , body balance , muscle power , and walking ability significantly improved in the exercise group compared with the control group . The incidence of falls was significantly lower in the exercise group than in the control group ( 0.0 % vs. 12.1 % , P = 0.0363 ) . The exercise program was safe and well tolerated in the elderly . Conclusions The present study showed the beneficial effect of the exercise program aim ed at improving flexibility , body balance , muscle power , and walking ability in preventing falls in the elderly The purpose s of the study were to determine ( 1 ) whether treadmill-slip training could reduce the likelihood of falls during a novel slip in over-ground walking , and ( 2 ) to what extent such ( indirect ) training would be comparable to ( direct ) over-ground-slip training . A treadmill-slip training group ( Group A , n=17 ) initially experienced repeated perturbations on treadmill intended to simulate forward-slip in over-ground walking . Perturbation continued and its intensity reduced when necessary to ensure subjects ' successful adaptation ( i.e. , when they could l and their trailing foot ahead of the slipping foot in at least 3 of 5 consecutive trials ) . They then experienced a novel slip during over-ground walking . Another 17 young adults in Group B experienced an identical novel slip that served as the controls . They then underwent more slip trials during over-ground walking . Their 16th slip trial was analyzed to represent the over-ground-slip training effect . Eight subjects ( 47 % ) in Group A fell upon their first treadmill slip , while all adapted successfully after a minimum of 15 slip trials . Upon the novel slip during over-ground walking , none of them fell in comparison to four subjects ( 23.5 % ) fell in Group B upon the same trial ( p<0.05 ) . Group A 's control of stability , both proactive and reactive , was significantly better than that of Group B 's on their first over-ground slip , while the level of improvement in the control of stability derived from indirect treadmill training was not as strong as that from direct over-ground-slip training , as demonstrated in Group B 's 16th slip trial ( p<0.001 ) . These results clearly demonstrated the feasibility of fall reduction through treadmill-slip training BACKGROUND Falls occur mainly while walking or performing concurrent tasks . We determined whether a music-based multitask exercise program improves gait and balance and reduces fall risk in elderly individuals . METHODS We conducted a 12-month r and omized controlled trial involving 134 community-dwelling individuals older than 65 years , who are at increased risk of falling . They were r and omly assigned to an intervention group ( n = 66 ) or a delayed intervention control group scheduled to start the program 6 months later ( n = 68 ) . The intervention was a 6-month multitask exercise program performed to the rhythm of piano music . Change in gait variability under dual-task condition from baseline to 6 months was the primary end point . Secondary outcomes included changes in balance , functional performances , and fall risk . RESULTS At 6 months , there was a reduction in stride length variability ( adjusted mean difference , -1.4 % ; P < .002 ) under dual-task condition in the intervention group , compared with the delayed intervention control group . Balance and functional tests improved compared with the control group . There were fewer falls in the intervention group ( incidence rate ratio , 0.46 ; 95 % confidence interval , 0.27 - 0.79 ) and a lower risk of falling ( relative risk , 0.61 ; 95 % confidence interval , 0.39 - 0.96 ) . Similar changes occurred in the delayed intervention control group during the second 6-month period with intervention . The benefit of the intervention on gait variability persisted 6 months later . CONCLUSION In community-dwelling older people at increased risk of falling , a 6-month music-based multitask exercise program improved gait under dual-task condition , improved balance , and reduced both the rate of falls and the risk of falling . Trial Registration clinical trials.gov Identifier : NCT01107288 Background and aims : Restricted physical activity as a consequence of chronic disease or injury is a predictor of functional decline . The aim of this study was to test the hypothesis that a 6-month multidimensional training program would have sustained beneficial effects upon the physiological , functional and psychological condition of old women with a recent history of falls . Methods : Participants were 65 home-dwelling women ( 70–90 years ) identified from hospital records as having had an accidental fall . After assessment of muscle strength , balance performance , walking speed , balance confidence , and physical activity level , the participants were r and omly assigned to a control group ( n=33 ) or a training group ( n=32 ) , who performed a multidimensional training program including moderate resistance exercise and balance exercise twice weekly for 6 months . Measurements were repeated after 6 and 12 months . Results : Six months of multidimensional training result ed in significant improvements and between-group differences in isometric knee extension strength ( p<0.05 ) , trunk extension/flexion strength ( p<0.001 ) , habitual/maximal walking speed ( p<0.001 ) and balance performance ( p<0.001 ) . At follow-up , 6 months after intervention , these improvements were preserved in the training group and there was also a significant between-group difference with regard to balance confidence . No between-group differences were found concerning number of falls or physical activity level during the one-year study period . Conclusions : A multi-dimensional training program produced significant improvements in physiological and functional risk factors for falls and disability in women aged 70–90 years with a recent history of falls Abstract Objective : To test the effectiveness of , and explore interactions between , three interventions to prevent falls among older people . Design : A r and omised controlled trial with a full factorial design . Setting : Urban community in Melbourne , Australia . Participants : 1090 aged 70 years and over and living at home . Most were Australian born and rated their health as good to excellent ; just over half lived alone . Interventions : Three interventions ( group based exercise , home hazard management , and vision improvement ) delivered to eight groups defined by the presence or absence of each intervention . Main outcome measure : Time to first fall ascertained by an 18 month falls calendar and analysed with survival analysis techniques . Changes to targeted risk factors were assessed by using measures of quadriceps strength , balance , vision , and number of hazards in the home . Results : The rate ratio for exercise was 0.82 ( 95 % confidence interval 0.70 to 0.97 , P=0.02 ) , and a significant effect ( P<0.05 ) was observed for the combinations of interventions that involved exercise . Balance measures improved significantly among the exercise group . Neither home hazard management nor treatment of poor vision showed a significant effect . The strongest effect was observed for all three interventions combined ( rate ratio 0.67 ( 0.51 to 0.88 , P=0.004 ) ) , producing an estimated 14.0 % reduction in the annual fall rate . The number of people needed to be treated to prevent one fall a year ranged from 32 for home hazard management to 7 for all three interventions combined . Conclusions : Group based exercise was the most potent single intervention tested , and the reduction in falls among this group seems to have been associated with improved balance . Falls were further reduced by the addition of home hazard management or reduced vision management , or both of these . Cost effectiveness is yet to be examined . These findings are most applicable to Australian born adults aged 70–84 years living at home who rate their health as good OBJECTIVES To compare the effectiveness of tai chi and low-level exercise in reducing falls in older adults ; to determine whether mobility , balance , and lower limb strength improved and whether higher doses of tai chi result ed in greater effect . DESIGN R and omized controlled trial . SETTING Eleven sites throughout New Zeal and . PARTICIPANTS Six hundred eighty-four community-residing older adults ( mean age 74.5 ; 73 % female ) with at least one falls risk factor . INTERVENTION Tai chi once a week ( TC1 ) ( n = 233 ) ; tai chi twice a week ( TC2 ) ( n = 220 ) , or a low-level exercise program control group ( LLE ) ( n = 231 ) for 20 wks . MEASUREMENTS Number of falls was ascertained according to monthly falls calendars . Mobility ( Timed-Up- and -Go Test ) , balance ( step test ) , and lower limb strength ( chair st and test ) were assessed . RESULTS The adjusted incident rate ratio ( IRR ) for falls was not significantly different between the TC1 and LLE groups ( IRR = 1.05 , 95 % confidence interval ( CI ) = 0.83 - 1.33 , P = .70 ) or between the TC2 and LLE groups ( IRR = 0.88 , 95 % CI = 0.68 - 1.16 , P = .37 ) . Adjusted multilevel mixed-effects Poisson regression showed a significant reduction in logarithmic mean fall rate of -0.050 ( 95 % CI = -0.064 to -0.037 , P < .001 ) per month for all groups . Multilevel fixed-effects analyses indicated improvements in balance ( P < .001 right and left leg ) and lower limb strength ( P < .001 ) but not mobility ( P = .54 ) in all groups over time , with no differences between the groups ( P = .37 ( right leg ) , P = .66 ( left leg ) , P = .21 , and P = .44 , respectively ) . CONCLUSION There was no difference in falls rates between the groups , with falls reducing similarly ( mean falls rate reduction of 58 % ) over the 17-month follow-up period . Strength and balance improved similarly in all groups over time OBJECTIVE we estimated the cost-effectiveness of a community falls prevention service compared with usual care from a National Health Service and personal social services perspective over the 12 month trial period . DESIGN a cost-effectiveness and cost utility analysis alongside a r and omised controlled trial SETTING community . PARTICIPANTS people over 60 years of age living at home or in residential care who had fallen and called an emergency ambulance but were not taken to hospital . INTERVENTIONS referral to community fall prevention services or usual health and social care . MEASUREMENTS incremental cost per fall prevented and incremental cost per Quality -Adjusted Life Years ( QALYs ) RESULTS a total of 157 participants ( 82 interventions and 75 controls ) were used to perform the economic evaluation . The mean difference in NHS and personal social service costs between the groups was £ -1,551 per patient over 1 year ( 95 % CI : £ -5,932 to £ 2,829 ) comparing the intervention and control groups . The intervention patients experienced on average 5.34 fewer falls over 12 months ( 95 % CI : -7.06 to -3.62 ) . The mean difference in QALYs was 0.070 ( 95 % CI : -0.010 to 0.150 ) in favour of the intervention group . CONCLUSION the community falls prevention service was estimated to be cost-effective in this high-risk group . Current Controlled Trials IS RCT N67535605 . ( controlled-trials.com ) Background Falls are the leading cause of fatal and non-fatal injuries among older adults . Exercise programs appear to reduce fall risk , but the optimal type , frequency , and duration of exercise is unknown . External perturbations such as tripping and slipping are a major contributor to falls , and task-specific perturbation training to enhance dynamic stability has emerged as a promising approach to modifying fall risk . The purpose of this pilot study was 1 ) to determine the feasibility of conducting a large pragmatic r and omized trial comparing a multidimensional exercise program inclusive of the surface perturbation treadmill training ( SPTT ) to multidimensional exercise alone ( St and ard PT ) ; and 2 ) to assess fall outcomes between the two groups to determine whether an effect size large enough to warrant further study might be present . Methods A r and omized pilot study at two outpatient physical therapy clinics . Participants were over age 64 and referred for gait and balance training . Feasibility for a larger r and omized trial was assessed based on the ability of therapists to incorporate the SPTT into their clinical practice and acceptance of study participation by eligible patients . Falls were assessed by telephone interview 3 months after enrollment . Results Of 83 patients who were screened , 73 met inclusion criteria . SPTT was successfully adapted into clinical practice and 88 % of eligible subjects were willing to be r and omized , although 10 % of the SPTT cohort dropped out prior to treatment . The SPTT group showed fewer subjects having any fall ( 19.23 % vs. 33.33 % St and ard PT ; p < 0.227 ) and fewer having an injurious fall ( 7.69 % vs. 18.18 % ; p < 0.243 ) . These results were not statistically significant but this pilot study was not powered for hypothesis testing . Conclusions Physical therapy inclusive of surface perturbation treadmill training appears clinical ly feasible , and r and omization between these two PT interventions is acceptable to the majority of patients . These results appear to merit longer-term study in an adequately powered trial . Trial registration clinical trials.gov : A person 's ability to transfer the acquired improvements in the control of center of mass ( COM ) state stability to slips induced in everyday conditions can have profound theoretical and practical implication s for fall prevention . This study investigated the extent to which such generalization could take place . A training group ( n=8 ) initially experienced 24 right-side slips in blocked- and -r and om order ( from the 1st unannounced , novel slip , S-1 to the last , S-24 ) result ing from release of a low-friction moveable platform in walking . They then experienced a single unannounced slip while walking on an oil-lubricated vinyl floor surface ( V-T ) . A control group ( n=8 ) received only one unannounced slip on the same slippery floor ( V-C ) . Results demonstrated that the incidence of balance loss and fall on V-T was comparable to that on S-24 . In both trials , fall and balance-loss incidence was significantly reduced in comparison with that on S-1 or on V-C , result ing from significant improvements in the COM state stability . The observed generalization indicates that the control of COM stability can be optimally acquired to accommo date alterations in environmental constraints , and it may be broadly coded and easily modifiable within the CNS . Because of such mechanisms , it is possible that the locomotor-balance skills acquired with the aid of low-friction moveable platforms can translate into resisting falls encountered in daily living PURPOSE To determine whether improved functional balance through a Tai Chi intervention is related to subsequent reductions in falls among elderly persons . METHODS Two hundred fifty-six healthy , physically inactive older adults aged 70 - 92 ( mean age + /- SD = 77.48 + /- 4.95 ) , recruited from a local health system in Portl and , OR , participated in a 6-month r and omized controlled trial , with allocation to Tai Chi or exercise stretching control , followed by a 6-month postintervention follow-up . Functional balance measures included Berg balance scale , dynamic gait index , and functional reach , assessed during the 6-month intervention period ( baseline , 3-month , and 6-month intervention endpoint ) and again at the 6-month postintervention follow-up . Fall counts were recorded during the 6-month postintervention follow-up period . Data were analyzed through intention-to-treat analysis of variance and logistic regression procedures . RESULTS Tai Chi participants who showed improvements in measures of functional balance at the intervention endpoint significantly reduced their risk of falls during the 6-month postintervention period , compared with those in the control condition ( odds ratio ( OR ) , 0.27 , 95 % confidence interval ( CI ) , 0.07 - 0.96 for Berg balance scale ; OR , 0.27 , 95 % CI , 0.09 - 0.87 for dynamic gait index ; OR , 0.20 , 95 % CI , 0.05 - 0.82 for functional reach ) . CONCLUSIONS Improved functional balance through Tai Chi training is associated with subsequent reductions in fall frequency in older persons BACKGROUND Among elderly persons , falls account for 87 % of all fractures and are contributing factors in many nursing home admissions . This study evaluated the effect of an easily implemented , low-intensity exercise program on the incidence of falls and the time to first fall among a clinical ly defined population of elderly men and women . METHODS This community-based , r and omized trial compared the exercise intervention with a no-intervention control . The participants were 294 men and women , aged 60 years or older , who had either a hospital admission or bed rest for 2 days or more within the previous month . Exercise participants were scheduled to attend exercise sessions lasting 45 minutes , including warm-up and cool-down , 3 times a week for 8 weeks ( 24 sessions ) . Assessment s included gait and balance measures , self-reported physical function , the number of medications being taking at baseline , participant age , sex , and history of falling . Falls were tracked for 1 year after each participant 's baseline assessment . RESULTS 29 % of the study participants reported a fall during the study period . The effect of exercise in preventing falls varied significantly by baseline physical function level ( p < or = .002 ) . The risk for falls decreased for exercise participants with low baseline physical functioning ( hazard ratio,.51 ) but increased for exercise participants with high baseline physical functioning ( hazard ratio , 3.51 ) . CONCLUSIONS This easily implemented , low-intensity exercise program appears to reduce the risk for falls among elderly men and women recovering from recent hospitalizations , bed rest , or both who have low levels of physical functioning Objective To assess the effectiveness of a two year exercise programme of progressive balance retraining in reducing injurious falls among women aged 75 - 85 at increased risk of falls and injuries and living in the community . Design Pragmatic multicentre , two arm , parallel group , r and omised controlled trial . Setting 20 study sites in 16 medium to large cities throughout France . Participants 706 women aged 75 - 85 , living in their own home , and with diminished balance and gait capacities , r and omly allocated to the experimental intervention group ( exercise programme , n=352 ) or the control group ( no intervention , n=354 ) . Intervention Weekly supervised group sessions of progressive balance training offered in community based premises for two years , supplemented by individually prescribed home exercises . Outcome measures A geriatrician blinded to group assignment classified falls into one of three categories ( no consequence , moderate , severe ) based on physical damage and medical care . The primary outcome was the rate of injurious falls ( moderate and severe ) . The two groups were compared for rates of injurious falls with a “ shared frailty ” model . Other outcomes included the rates of all falls , physical functional capacities ( balance and motor function test results ) , fear of falling ( FES-I ) , physical activity level , and perceived health related quality of life ( SF-36 ) . Analysis was by intention to treat . Results There were 305 injurious falls in the intervention group and 397 in the control group ( hazard ratio 0.81 , 95 % confidence interval 0.67 to 0.99 ) . The difference in severe injuries ( 68 in intervention group v 87 in control group ) was of the same order of magnitude ( 0.83 , 0.60 to 1.16 ) . At two years , women in the intervention group performed significantly better on all physical tests and had significantly better perception of their overall physical function than women in the control group . Among women who started the intervention ( n=294 ) , the median number of group sessions attended was 53 ( interquartile range 16 - 71 ) . Five injurious falls related to the intervention were recorded . Conclusion A two year progressive balance retraining programme combining weekly group and individual sessions was effective in reducing injurious falls and in improving measured and perceived physical function in women aged 75 - 85 at risk of falling . Trial registration Clinical Trials.gov ( NCT00545350 ) In order to compare the characteristics , preventive interventions and outcomes of single and multiple fallers , a retrospective cross-sectional study was conducted in a 680-bed acute-care hospital in Western Australia . Fifty patients falling more than once ( multiple fallers ) were r and omly selected from all patients reported to have fallen between 1 July 1989 and 31 December 1989 , and age-sex matched with 50 patients falling once in the trial period ( single fallers ) . In total , 382 in- patients were reported to have sustained 578 falls in the 6-month trial period . Fifty-two per cent of these falls involved multiple fallers . An analysis of the 100 single and multiple fallers showed that single fallers were more likely to have fallen from their bed ; be discharged home from hospital ; and be clinical ly deteriorating at the time of the fall . Multiple fallers were more likely to be transferred to a long-term nursing facility after discharge from hospital ; suffer blindness/poor vision ; be se date d post fall ; be ordered to be restrained following a fall ; and be hospitalized for longer periods . There was also a tendency for multiple fallers to repeat the type and location of the fall on successive falls . Stepwise logistic regression showed that falling from the bed on the first fall predicted remaining a single faller . Being ordered to be restrained following the first fall and hospitalized for longer periods predicted the patient would fall repeatedly . Further analytical research incorporating an exp and ed number of independent variables is needed to allow confident assertions of causality . To test the effectiveness of preventive measures , a prospect i ve longitudinal study is required Background : Research on older people ’s perception regarding their quality of life and services and supports needed to maintain their independence was identified as a priority for the South Australian Department of Health in 2000–2001 . This population survey was conducted to examine issues that older persons considered important in the areas of housing , transport , finances and information provision . Objective : The aim of this article is to present the characteristics of community-dwelling older adults who reported falling in the previous 12 months . Method : A r and om representative sample of community-dwelling adults , living in South Australia , and aged 65 years and over were selected based on a sample from the electronic white pages telephone directory . Overall , 2,619 interviews were conducted ( 70.5 % response rate ) using Computer-Assisted Telephone Interviewing technology . Results : Approximately 30 % of older adults had experienced a fall in the previous 12 months . The characteristics of people who had fallen included those in the older age groups , with fair or poor general health , whose health had worsened in the last 12 months , with lower socioeconomic status , those born in an English-speaking country , needing assistance at home , and with a home in need of repair . Of the respondents who had experienced a fall in the previous 12 months , 71.8 % did not consider that they were at risk of having another fall . Conclusion : There is a wide range of characteristics associated with community-dwelling older adults over the age of 65 who report falling in the previous 12 months . Perceptions of the risk of falling also vary . All factors need to be considered when targeting interventions to reduce the risk of both initial and multiple falls BACKGROUND the burden of falls and fall-related injuries among older adults is well established . Contention surrounds the effectiveness , and hence value , of multi-component fall prevention interventions delivered in the community . OBJECTIVE using consensus-based analytic guidelines rather than time-to-first fall as the primary endpoint , the objective was to examine the effectiveness of the Whitehorse NoFalls trial on all falls , falls result ing in injury and falls requiring medical care to be sought . DESIGN , SETTING AND PARTICIPANTS the study was a community-based r and omised controlled trial , with 1,090 participants assigned to one of eight groups , these being a combination of one or more of exercise , vision and or home hazard reduction or alternatively assignment to the control group . METHODS using negative binomial regression , the incidence of all falls , falls result ing in injury and those requiring medical care in the intervention groups were examined . Falls were reported using a monthly return calendar . RESULTS exercise alone and in combination with vision and /or home hazard reduction was associated with fewer falls . For falls result ing in injury and the subset requiring medical care , the vision plus exercise intervention was associated with fewer falls . CONCLUSIONS the findings confirm the effectiveness of exercise in preventing falls among community-dwelling older adults and supports contention that multi-component interventions do not prevent more falls than a single intervention . The results highlight the effectiveness of vision plus exercise in preventing more serious falls , a finding which warrants further consideration OBJECTIVE To determine whether a 12-month program of regular exercise can improve balance , reaction time , neuromuscular control , and muscle strength and reduce the rate of falling in older women . DESIGN A r and omized , controlled trial of 12 months duration . SETTING Conducted as part of the R and wick Falls and Fractures Study in Sydney , Australia . PARTICIPANTS One hundred ninety-seven women aged 60 to 85 years ( mean age 71.6 , SD = 5.4 ) who were r and omly recruited from the community . OUTCOME MEASURES Accidental falls , postural sway , reaction time , neuromuscular control , and lower limb muscle strength . MAIN RESULTS Exercise and control subjects were tested before , midway through , and at the end of the trial . At initial testing , exercisers and controls performed similarly in all tests and were well matched in relevant health and lifestyle factors . The mean number of classes attended for the 75 exercise subjects who completed the program was 60.0 ( range 26 - 82 ) . At the end of the trial , the exercise subjects showed improved performance in all five strength measures , in reaction time , neuromuscular control , body sway on a firm surface with the eyes open , and body sway on a compliant surface with the eyes open and closed . In contrast , there were no significant improvements in any of the test measures in the controls . In one test measure , hip flexion strength , the exercisers showed continued improvement throughout the study year . There was no significant difference in the proportion of fallers between the exercise and control subjects . Interesting trends were evident , however , between falls frequency and adherence to the exercise program . CONCLUSIONS These findings show that exercise can produce long-term benefits with regard to improving sensorimotor function in older persons . The findings also suggest that high compliance to an exercise program may reduce falls frequency , although further studies are required to conclusively demonstrate that exercise offers an effective means of preventing falls Means KM , Rodell DE , O’Sullivan PS : Balance , mobility , and falls among community-dwelling elderly persons : Effects of a rehabilitation exercise program . Am J Phys Med Rehabil 2005;84:238–250 . Objective : To assess the short-term effect of an exercise-based rehabilitation intervention on balance , mobility , falls and injuries . Design : This r and omized , controlled trial with repeated measures was performed at an outpatient rehabilitation center . Elderly , ambulatory , community-dwelling volunteers underwent 6 wks of supervised stretching , balance , endurance , coordination , and strengthening exercises . Controls attended seminars . Data were recorded for time and quality performance on a functional obstacle course and for self-reported falls and injuries . Results : From baseline through 6-mo follow-up , participants in the exercise group ( n = 122 ) significantly outperformed those in the control group ( n = 83 ) . The exercise group ’s functional obstacle course quality improved 2.3 % postintervention and 1.57 % at follow-up compared with 0.3 % for the control group for each time period ( P = 0.001 ) . Functional obstacle course completion time improved 7.69 % at postintervention and 8.35 % at follow-up for the exercise group compared with 4.0 % and 3.4 % for the control group . Of baseline fallers in the intervention group , 87 % ( compared with 34.5 % for the controls ) reported no falls in the subsequent 6 mos . Of those reporting injuries in the 6 mos preintervention , 89.7 % in the intervention group ( compared with 55.6 % for controls ) reported no injury at 6 mos postintervention . Conclusions : Our intervention can improve functional performance and protect against falls and fall-related injuries OBJECTIVES To evaluate the effects of a trail-walking exercise ( TWE ) program on the rate of falls in community-dwelling older adults . DESIGN Pilot r and omized controlled trial ( RCT ) . SETTING This trial was conducted in Japan and involved community-dwelling older adults as participants . PARTICIPANTS Sixty participants r and omized into a TWE group ( n=30 ) and a walking ( W ) group ( n=30 ) . INTERVENTION Exercise class combined with multicomponent trail walking program , versus exercise class combined with simple indoor walking program . MEASUREMENT Measurement was based on the difference in fall rates between the TWE and W groups . RESULTS Six months after the intervention , the incidence rate ratio ( IRR ) of falls for the TWE group compared with the W group was 0.20 ( 95 % confidence interval (CI)=0.04 - 0.91 ) ; 12 months after the intervention , the IRR of falls for the TWE group compared with the W group was 0.45 ( 95 % CI=0.16 - 1.77 ) . CONCLUSION The results of this pilot RCT suggest that the TWE program was more effective in improving locomotion and cognitive performance under trail-walking task conditions than walking . In addition , participants who took part in the TWE demonstrated a decrease in the incidence rate of falls 6 months after trial completion . Further confirmation is needed , but this preliminary result may promote a new underst and ing of accidental falls in older adults The isolated effect of balance training on muscle strength of the flexors and extensors of the knee , without accompanying strength training , has not been addressed in the past . Effects of a balance training program alone were compared to a strength training program . Balance and strength training were performed by 15 persons each for 6 weeks including 12 training units of 25 min . Balance training was performed on instability training devices such as rolling board , mini trampoline and large rubber ball . The 15 persons of the strength training group trained on machines for leg curls and on leg presses for 25 min per unit . Measurements for balance were performed with one-leg balance on a narrow edge and a tilting stabilometer for 30 s ; maximum isometric strength was measured using an isokinetic device for each leg separately . The muscular balance between dominant and non-dominant leg was calculated . Strength gain was similar for the flexors and extensors in both groups . One-leg balance improved after balance training ( P < 0.01 ) with a 100 % increase over the strength training group ( P < 0.05 ) and the stabilometer test for each person in the balance ( P < 0.01 ) , but not in the strength training group . In the balance group the initial difference between right and left diminished . The results indicate balance training to be effective for gain in muscular strength , and secondly , in contrast to strength training , equalisation of muscular imbalances may be achieved after balance training The purpose of this study was to determine the effects of Tai Chi exercise among older women . Multiple regression analysis revealed statistically significant improvements in scores for balance ( p < .001 ) , functional mobility ( p < .05 ) , and fear of falling ( p < .001 ) and associated demographic factors . Three months of twice weekly , 30-minute Tai Chi classes was associated with statistically significant improvements in balance and functional mobility and a reduction in the fear of falling in this sample of older women living in retirement communities . T'ai Chi exercises may be an age-appropriate and acceptable form of exercise for older women To study risk factors for falling , we conducted a one-year prospect i ve investigation , using a sample of 336 persons at least 75 years of age who were living in the community . All subjects underwent detailed clinical evaluation , including st and ardized measures of mental status , strength , reflexes , balance , and gait ; in addition , we inspected their homes for environmental hazards . Falls and their circumstances were identified during bimonthly telephone calls . During one year of follow-up , 108 subjects ( 32 percent ) fell at least once ; 24 percent of those who fell had serious injuries and 6 percent had fractures . Predisposing factors for falls were identified in linear-logistic models . The adjusted odds ratio for sedative use was 28.3 ; for cognitive impairment , 5.0 ; for disability of the lower extremities , 3.8 ; for palmomental reflex , 3.0 ; for abnormalities of balance and gait , 1.9 ; and for foot problems , 1.8 ; the lower bounds of the 95 percent confidence intervals were 1 or more for all variables . The risk of falling increased linearly with the number of risk factors , from 8 percent with none to 78 percent with four or more risk factors ( P less than 0.0001 ) . About 10 percent of the falls occurred during acute illness , 5 percent during hazardous activity , and 44 percent in the presence of environmental hazards . We conclude that falls among older persons living in the community are common and that a simple clinical assessment can identify the elderly persons who are at the greatest risk of falling The aim of the present study was to investigate the effects of home-based exercise without home visits on physical function , falls , and bone mineral density in community-dwelling elderly women . Sixty community-dwelling , elderly ( > or = 65 years of age ) women were recruited from a Japanese community . Subjects were r and omly assigned to a home-based exercise group or a control group . The subjects assigned to the home-based exercise group performed home-based exercise without home visits 3 times per week for 6 months in their homes . Assessment s of physical function and bone mineral density were carried out before and after intervention in both groups . Muscle strength , gait velocity , the timed up and go test ( TUGT ) , single leg stance time , the bend reach performance test , and reaction time were measured to assess physical function . The patients ' history of falls was also assessed before and after the 12-month follow-up . To determine bone mineral density , the speed of sound ( SOS ) at the right calcaneus was measured using a quantitative ultrasound device . There were no significant differences between the two groups in baseline characteristics . 82.6 % of subjects completed the prescribed exercise program in the home-based exercise group . Compared to the control group , TUGT improved significantly ( p<0.05 ) in the home-based exercise group . Home-based exercise without home visits can be adopted for community-dwelling elderly women , particularly since no specific place or instructor is needed Background : Falls are common in physically active older people ; however , most intervention studies have been targeted at frail older people . Objective : To evaluate the effectiveness of two intervention techniques for preventing falls in physically active community-dwelling older people . Methods : Two hundred and seventeen people ( 120 men and 97 women ) aged between 70 and 90 years recruited from a health insurance company membership data base were r and omly allocated to receive either a psychomotor intervention focusing on body awareness , body experience and coordination , a fitness intervention focusing on functional skills , strength , endurance and flexibility , or no intervention ( control group).The outcome measures were prospect i ve falls ( number of fallers , number of multiple fallers , number of falls and falls rate ) and measures of physical performance ( Timed Up and Go Test , maximal step length , sit-to-st and time , normal and fast walking speed ) . Results : At the 4-month follow-up , significant improvements in the Timed Up and Go Test and sit-to-st and times were observed for both the psychomotor and fitness intervention groups . During the 12-month follow-up period , 39 % of the participants fell at least once , and 19 % fell on multiple occasions . The proportion of fallers in the fitness intervention group was 23 % less than in the control group ( RR = 0.77 , 95 % CI 0.60–0.97 ) , but no significant reduction in falls was observed in the psychomotor intervention group . Conclusion : A fitness training program improves some aspects of physical performance and reduces falls by 23 % in physically active older people OBJECTIVES The aim of the present study was to evaluate whether a complex course obstacle negotiation exercise ( CC ) , a 24-week exercise program , can reduce falls and fractures in older adults , as compared with a simple course obstacle negotiation exercise ( SC ) . METHODS This trial was carried out on older adults , aged 75 years and above in Japan . In total , 157 participants were r and omized into the CC group ( n = 78 ) and the SC group ( n = 79 ) . Participants were enrolled in the exercise class using the CC program or the SC program for 24 weeks . The outcome measure was the number of falls and fracture rates in CC and SC groups for 12 months after the completion of the 24-week exercise class . RESULTS Two participants ( 2.8 % ) in the CC group and 19 ( 26.0 % ) in the SC group experienced falls during 12 months . During the 12-month follow-up period after the intervention , the incidence rate ratio ( IRR ) of falls in the SC group against the CC group was 9.37 ( 95 % CI = 2.26 - 38.77 ) . One participant ( 1.4 % ) in the CC group and eight ( 10.9 % ) in the SC group had experienced fractures during 12 months after the exercise class . The IRR of fractures in the SC group compared with the CC group was 7.89 ( 95 % CI = 1.01 - 61.49 ) . CONCLUSIONS The results of the present trial show that the participants who received individualized obstacle avoidance training under complex tasks combined with a traditional intervention had a lower incidence rate of falls and fractures during the 12 months after the intervention OBJECTIVE Risk of falling increases as people age , and decreased leg strength and poor balance have been implicated as contributors . Our aims were to:1 ) assess the efficacy of a fall-prevention exercise program on balance and leg strength in women aged 65 to 89 years and 2 ) conduct a 1-year follow-up to determine the effect of exercise on fall rates . METHODS Forty women were classified by falling history and fear of falling and assigned to exercise and control groups using stratified r and omization . We used the Berg Balance Scale , Get-up and Go , Functional Reach , and Wall-Sit Tests to evaluate changes in balance and leg strength before and after a supervised 15-week exercise program ( 31-hr sessions/week ) . We conducted 1-year follow-up telephone interviews and compared the number of falls reported by exercise and control groups . The study used a 2 x 2 ( exercise/control by pretest/post-test ) factorial design with the testing times being a repeated factor , so we used analysis of variance ( ANOVA ) to evaluate differences between the 2 groups across testing times . Power analysis computed a priori with STPLAN software ( Version 4.2 ) showed that a sample size of 40 was necessary to determine statistical differences in balance and leg strength . RESULTS Exercise subjects showed significant improvement on 5 of 14 items ( 5.2 % , p < or = 05 to 34.4 % , p < or = .01 ) in the Berg Balance Scale and on the total score ( 6.8 % , p < or = .05 ) . Leg strength increased significantly ( p < or = .05 ) on post-test as measured by the Wall-Sit Test . Control subjects reported 6 falls and exercise subjects no falls during the follow-up year , but this difference was not significant using Fischer 's exact test ( p=.106 ) . CONCLUSION The exercise program result ed in increased balance and leg strength , but did not result in a significant difference in falls during the follow-up period . Further research with a larger and possibly older sample is needed to more adequately investigate this question . Health care providers who work with older women should provide exercise programs in which balance and leg strength are emphasized Objective : To evaluate the effects of a new , individually adjusted , progressive and specific balance group training programme on fear of falling , step execution , and gait in healthy elderly people with fear of falling and tend to fall . Design : R and omized controlled trial . Setting : The study was conducted in Stockholm County , Sweden . Subjects : Fifty-nine community dwelling elderly people were recruited by advertisement , and allocated at r and om to an intervention group ( n = 38 ) or a control group ( n = 21 ) . Intervention : Individually adjusted , progressive and specific balance group training was given three times a week for three months . The training incorporated elements included in , and required for , independent activities of daily living , and for reactions to loss of balance during dual or multiple tasks . Main measures : Fear of falling was assessed with Falls Efficacy Scale International ( FES-I ) . The reaction time of step execution was measured with the step-execution test , and gait was measured with GAITRite ® . Results : After three months the intervention group showed significant positive changes in the FES-I ( P = 0.008 ) , in the step-execution phase of dual-task performance ( P = 0.012 ) , and in gait at preferred speed during single-task performance ; in cadence ( P = 0.030 ) and , at fast speed , in velocity ( P = 0.004 ) and cadence ( P = 0.001 ) . Significant decreases were also found for the likelihood of depression after participating in the training programme . Conclusion : This new balance training programme is feasible and leads to decreased fear of falling , decreased time for step execution during dual-task performance and increased velocity during fast walking OBJECTIVE The role of exercise in the prevention of falls and fall-related injuries among elderly persons is unclear . The objective of this study was to assess the response to an exercise-based rehabilitation program intended to improve balance and mobility and reduce or prevent falls . DESIGN Pretest-posttest experimental design with repeated measures at baseline , immediately postintervention , and 6 months postintervention . To assess the effect of repeated exposure to our main outcome measure ( the obstacle course ) , half of the participants ( r and omly selected ) were allowed to practice on the obstacle course . SETTING A veterans affairs medical center . PARTICIPANTS Elderly , ambulatory , community-dwelling volunteers recruited from among local out patients at our medical center . INTERVENTION Sixty-five volunteers completed a 6-week supervised low to moderate intensity program of stretching , postural control , endurance walking , and coordination exercises design ed to improve balance and mobility . Participants were divided into 2 groups : 34 participants who did not practice on the obstacle course during their exercise program and 31 participants who practice d on the obstacle course in addition to their otherwise identical exercise program . MAIN OUTCOME MEASURES Performance on a functionally oriented obstacle course and self-reported falls and fall-related injuries . RESULTS No significant performance differences were found between the two groups . After intervention , mean qualitative obstacle course scores improved modestly ( 5 % ) and mean obstacle course completion time decreased by 15 % from baseline . These postintervention pairwise performance differences were clinical ly important but not statistically significant . Relative to baseline levels , postintervention falls and injuries did not change significantly . CONCLUSIONS Our exercise intervention may have the potential to improve functional performance . However , some modifications are necessary to enhance efficacy . The obstacle course may be a useful tool in the evaluation of elderly persons with balance and mobility impairment in the rehabilitation setting To determine how accurately elderly subjects recall recent falls , we studied 304 ambulatory men and women over the age of 60 years who completed a 12-month prospect i ve study of risk factors for falling . We developed a system of weekly follow-up and home visits to record and confirm all falls . During the study , 179 participants suffered at least one fall that was confirmed by home visit . At the end of the study , all subjects were interviewed by telephone about whether they had suffered a fall during the preceding 3 , 6 , or 12 months . Depending on the time period of recall , 13 % to 32 % of those with confirmed falls did not recall falling during the specific period of time . Recall was better for the preceding 12 months than for 3 or 6 months . There were only weak correlations ( r = 0.28 to 0.59 ) between the number of falls that were documented and the number that the subjects recalled during each of these periods . Those with lower scores on the Mini-Mental State Examination were more likely to forget falls . We conclude that elderly subjects often do not recall falls that occurred during specific periods of time over the preceding 3 to 12 months . Research ers and clinicians should consider using methods besides long-term recall for ascertaining and counting falls over specific periods of time Ageing is associated with a higher fatigue resistance during submaximal or maximal fatiguing contractions . The present study aim ed to investigate the contribution of the central and peripheral fatigue to the age-related differences in fatigue development of the plantar flexor muscles . Therefore , the voluntary activation , rest twitch moment and voluntary plantar flexor moment were examined before during as well as 2 , 5 and 10min after a fatiguing task . This consisted of intermittent isometric submaximal plantar flexor contractions at equal intensity for both young and old adults ( considering the age-related differences in muscle inhibition ) . Consequently , possible differences between young and old adults in voluntary activation during the maximal contraction utilised for determining the intensity of the fatiguing task , which can influence fatigue development , have been taken into account . The plantar flexors moment was calculated using inverse dynamics and the voluntary activation was measured using the twitch interpolation technique . Changes in voluntary activation and rest twitch moment during the fatiguing task were used to assess central and peripheral fatigue , respectively . In both young and old adults , peripheral ( approximately 20 % ) as well as central fatigue ( approximately 9 % ) contributed to the time to task failure . Old adults demonstrated greater time to task failure than young ones , but similar voluntary activation behaviour during the fatiguing task . We concluded that , the age-related enhancement in fatigue resistance is not attributable to voluntary activation but is linked to mechanisms located within the working muscle AIMS The aim of the study was to examine the effects of different interventions that are used to prevent falls . These were education , Tai Chi Chuan and education plus Tai Chi Chuan ; the study involved a five-month implantation period and a one-year follow-up period . BACKGROUND With advancing years , a fall can be very serious and an increased number of falls/re-falls among older adults has been noted . Hence , both education about risk factors and balance exercise programs such as Tai Chi Chuan may help to prevent falls . DESIGN This study adopted a r and omised case-controlled design with a two-by-two factorial approach . It included three intervention groups and one control group in a community-based program . METHODS Cluster-r and omised sampling was used and four villages in Taiwan City were selected . Three interventions groups and one control group were involved over five-months from late July 2000-January 2001 and each participant was followed up one year later ( n = 163 ) . RESULTS The intervention involving education plus Tai Chi Chuan result ed in a statistically significant reduction in falls and the risk factors of falls over the five-month intervention . After one-year follow-up , participants receiving any one of the interventions showed a reduction in falls compared with the control group . CONCLUSIONS Tai Chi Chuan was able to improve gait balance significantly . Education may also help participants to prevent falls-by eliminating related risk factors present in their environment . However , it was found that at the one-year follow-up , any one of the three interventions had reduced falls significantly . RELEVANCE TO CLINICAL PRACTICE The prevention of falls among older adults seems to needs multiple interventions . Education plus Tai Chi Chuan has both an immediately and a long-term effect and it is possible that a shorter intervention period using this approach would also be successful OBJECTIVES To evaluate the effectiveness of Tai Chi Chuan in fall prevention in elderly people living at home with a high risk of falling . DESIGN R and omized controlled trial . SETTING Two industrial towns in the western part of the Netherl and s. PARTICIPANTS Two hundred sixty-nine elderly people ( average age 77 ) living at home with a high risk of falling . INTERVENTIONS The intervention group received Tai Chi Chuan training for 1 hour twice a week for 13 weeks ; the control group received usual care . Both groups received a brochure containing general information on how to prevent fall incidents . MEASUREMENTS Primary outcome was the number of falls over 12 months . Secondary outcomes were balance , fear of falling , blood pressure , heart rate at rest , forced expiratory volume during the first second , peak expiratory flow , physical activity , and functional status . RESULTS After 12 months , no lower fall risk in the Tai Chi Chuan group was observed than in the control group ( adjusted hazard ratio=1.16 ; 95 % confidence interval=0.84 - 1.60 ) , and there were no significant intervention effects on the secondary outcome measures . CONCLUSION These results suggest that Tai Chi Chuan may not be effective in elderly people at a high risk of falling who live at home AIMS Evidence -based guidelines recommend a range of treatments for falls and injury prevention . We undertook a r and omised trial of a falls prevention service to screen for falls risk factors and recommend to GPs an evidence d base prescription for falls prevention . METHODS All patients who presented with a fall to the Emergency Department at Flinders Medical Centre over a 22-week period were considered for the study . We excluded patients with dementia , resident in high care or those transferred to other hospitals and outside our catchment area . Of those who consented , we r and omised patients between usual care or to an intervention consisting of a falls risk assessment and writing of an evidence -based prescription faxed to their GP for action . Patients were followed for six months and uptake of advice and fall rates were monitored . RESULTS Four hundred and fifty patients presented with a fall-related attendance and of these 261 patients were eligible for inclusion in the trial . Of these 261 patients , 140 consented and were enrolled in the trial . Over the six months patients in the intervention group were more likely to uptake preventative advice ( OR=12.3 ; 95%CI=4.2 - 35.9 ) . We were unable to show a reduction in falls ( OR= 1.7 ; 95%CI=0.7 - 4.4 ) . CONCLUSIONS A patient centered evidence -based approach is feasible and effective in increasing uptake of falls prevention advice . Long term compliance with advice needs further exploration BACKGROUND Previous studies indicated that a single session of repeated-slip exposure can reduce over 40 % of laboratory-induced falls among older adults . The purpose of this study was to determine to what degree such perturbation training translated to the reduction of older adults ' annual falls risk in their everyday living . METHODS Two hundred and twelve community-dwelling older adults ( ≥65 years old ) were r and omly assigned to either the training group ( N = 109 ) , who then were exposed to 24 unannounced repeated slips , or the control group ( N = 103 ) , who merely experienced one slip during the same walking in the same protective laboratory environment . We recorded their falls in the preceding year ( through self-reported history ) and during the next 12 months ( through falls diary and monitored with phone calls ) . RESULTS With this single session of repeated-slip exposure , training cut older adults ' annual risk of falls by 50 % ( from 34 % to 15 % , p < .05 ) . Those who experienced merely a single slip were 2.3 times more likely to fall during the same 12-month follow-up period ( p < .05 ) than those who experienced the 24 repeated slips . Such training effect was especially prominent among those who had history of falls . CONCLUSION A single session of repeated-slip exposure could improve community-dwelling older adults ' resilience to postural disturbances and , hence , significantly reduce their annual risk of falls Previous studies have reported a decrease in muscle torque per cross-sectional area in old age . This investigation aim ed at determining the influence of agonists muscle activation and antagonists co-activation on the specific torque of the plantarflexors ( PF ) in recreationally active elderly males ( EM ) and , for comparison , in young men ( YM ) . Twenty-one EM , aged 70–82 years , and 14 YM , aged 19–35 years , performed isometric maximum voluntary contractions ( MVC ) . Activation was assessed by comparing the amplitude of interpolated supramaximal twitch doublets at MVC , with post-tetanic doublet peak torque . Co-activation of the tibialis anterior ( TA ) was evaluated as the ratio of TA-integrated EMG ( IEMG ) activity during PF MVC compared to TA IEMG during maximal voluntary dorsiflexion . Triceps surae muscle volume ( VOL ) was assessed using magnetic resonance imaging ( MRI ) , and PF peak torque was normalised to VOL ( PT/VOL ) since the later approximates physiological cross-sectional area ( CSA ) more closely than anatomical CSA . Also , physical activity level , assessed by accelerometry , was significantly lower ( 21 % ) in the elderly males . In comparison to the YM group , a greater difference in PT ( 39 % ) than VOL ( 19 % ) was found in the EM group . PT/VOL and activation capacity were respectively lower by 25 % and 21 % in EM compared to YM , whereas co-activation was not significantly different . In EM PT/VOL correlated with activation ( R2=0.31 , P<0.01 ) . In conclusion , a reduction in activation capacity may contribute significantly to the decline in specific torque in the plantar flexors of elderly males . The hypothesis is put forward that reduced physical activity is partialy responsible for the reduced activation capacity in the elderly Introduction and purpose The longitudinal registration of accidents , including falls , among people aged 65 and older is both time-consuming and expensive . For this reason , a computerised method for telephone accident registration , ‘ Telephone Inquiry System ( TIS ) ’ , was developed and its feasibility ( participation , successful dialogues ) and reliability ( distribution of accidents regarding location , falls requiring medical attention , and falls result ing in fractures ) were evaluated . Method The TIS is an Interactive Voice Response computer system by which people are telephoned and asked about involvement in accidents and falls in a structured automatic dialogue . If people reported involvement in an accident , details about the circumstances were asked personally by telephone . It was tested in two prospect i ve follow-up studies among community dwelling older people aged 65 and older in the Netherl and s between 1994 and 2003 . Results Of the 3,500 and 8,650 people invited to participate in the two studies , 30.1 % and 24.0 % did , respectively . In total , the TIS made 48,966 attempts to have an automatic dialogue with respondents , of which more than 70 % were successful . Sixty percent of the accidents happened in and around the home . Twenty-five percent of the falls required medical attention and at least 3.3 % result ed in a fracture . Conclusions The TIS appears to be a feasible and reliable method for semi-automatically registering accidents among community dwelling older people . Valid comparison of data between countries and communities is made possible because the registration is not influenced by differences in patient flows and the questions and procedures are highly st and ardised . Automatic regisration of falls OBJECTIVES To investigate the effects of a twice-weekly multitarget stepping ( MTS ) task combined with a multicomponent exercise program on stepping accuracy , gaze behavior , fall risk factors , and fall rates . DESIGN R and omized controlled trial . SETTING Community . PARTICIPANTS Community-dwelling adults aged 65 and older in Japan ( N = 264 ) were r and omized into an MTS group ( n = 132 ) and a control group ( n = 132 ) . INTERVENTION Twenty-four weeks of a twice-weekly community-based MTS program in combination with a st and ardized multicomponent exercise program . MEASUREMENTS Number of falls and fall-related fractures during a 12-month follow-up period after completion of the intervention , stepping accuracy , gaze behavior while performing the MTS test , and results of four clinical tests relevant to assessment of risk of falls ( Timed Up and Go ( TUG ) , functional reach ( FR ) , 10-m walking , and Five Chair St and ( 5CS ) ) were measured . RESULTS Thirteen participants ( 11.6 % ) in the MTS group and 39 ( 33.0 % ) in the control group fell during the 12-month follow-up period ( incidence rate ratio = 0.35 , 95 % confidence interval ( CI ) = 0.19 - 0.66 ) . Three participants in the MTS group and 13 in the control group experienced fall-related fractures during the 12-month follow-up period ( relative risk = 0.22 , 95 % CI = 0.06 - 0.80 ) . After the intervention , a subset of participants in the MTS group had significantly greater improvement in stepping accuracy and gaze behavior during the MTS test , and all participants in the MTS group had significantly greater improvement in performing the TUG and 10-m walking ( P < .001 ) . CONCLUSION Participants who performed MTS tests combined with a multicomponent exercise program showed greater improvements in stepping accuracy , gaze behavior , and physical performance in a virtually complex environment . Considering the less-frequent fall rate in the follow-up assessment , these improvements could contribute to preventing falls in community-dwelling older adults Falls are common in elderly people . Possible consequences include serious injuries and the post-fall syndrome , with functional decline and limitation of physical activity . The present r and omized controlled study sought to clarify the benefits of a combined long-term and home-based fall prevention program for elderly Japanese women . The subjects were individuals aged over 73 years , living at home in a western suburb of Tokyo , who had attended a comprehensive geriatric health check . Persons with a marked decline in the basic activities of daily living ( ADL ) , hemiplegia , or those missing baseline data were excluded . Fifty-two subjects who expressed a wish to participate in the trial were r and omized , 28 to an exercise-intervention group and 24 to a control group . Baseline data for age , h and grip force , walking speed , total serum cholesterol , serum albumin , basic ADL , visual and auditory impairments , self-rated health , and experience of falls did not differ significantly between the two groups . Beginning from June 2000 , the intervention group attended a 6-month program of fall-prevention exercise classes aim ed at improving leg strength , balance , and walking ability ; this was supplemented by a home-based exercise program that focused on leg strength . The control group received only a pamphlet and advice on fall prevention . The average rate of attendance at exercise class was 75.3 % ( range , 64 % to 86 % ) . Participants showed significant improvements in t and em walk and functional reach after the intervention program , with enhanced self confidence . At the 8-month follow-up , the proportion of women with falls was 13.6 % ( 3/22 ) in the intervention group and 40.9 % ( 9/22 ) in the control group . At 20 months , the proportion remained unchanged , at 13.6 % in the intervention group , but had increased to 54.5 % ( 12/22 ) in the control group , which showed a statistically significant difference between the two groups ( Fisher ’s exact test ; P = 0.0097 ) . The total number of falls during the 20-month follow-up period was 6 in the intervention group and 17 in the control group . We conclude that a moderate exercise intervention program plus a home-based program significantly decreases the incidence of falls in both the short and the long term , contributing to improved health and quality of life in the elderly BACKGROUND Regular physical activity reduces falls , hip fractures , and all-cause mortality , but physical activity levels are low in older age groups . AIM To evaluate two exercise programmes promoting physical activity among older people . DESIGN AND SETTING Pragmatic three-arm , parallel- design cluster r and omised controlled trial involving 1256 people aged ≥65 years ( of 20 507 invited ) recruited from 43 general practice s in London , Nottingham , and Derby . METHOD Practice s were r and omised to the class-based Falls Management Exercise programme ( FaME ) , the home-based Otago Exercise Program ( OEP ) , or usual care . The primary outcome was the proportion reaching the recommended physical activity target 12 months post-intervention . Secondary outcomes included falls , quality of life , balance confidence , and costs . RESULTS In total , 49 % of FaME participants reached the physical activity target compared with 38 % for usual care ( adjusted odds ratio 1.78 , 95 % confidence interval [ CI ] = 1.11 to 2.87 , P = 0.02 ) . Differences between FaME and usual care persisted 24 months after intervention . There was no significant difference comparing those in the OEP ( 43 % reaching target at 12 months ) and usual-care arms . Participants in the FaME arm added around 15 minutes of moderate-to-vigorous physical activity per day to their baseline level ; this group also had a significantly lower rate of falls ( incident rate ratio 0.74 , 95 % CI = 0.55 to 0.99 , P = 0.042 ) . Balance confidence was significantly improved in both intervention arms . The mean cost per extra person achieving the physical activity target was £ 1740 . Attrition and rates of adverse reactions were similar . CONCLUSION The FaME programme increases self-reported physical activity for at least 12 months post-intervention and reduces falls in people aged ≥65 years , but uptake is low . There was no statistically significant difference in reaching the target , or in falls , between the OEP and usual-care arms |
11,535 | 31,592,511 | Conclusion A positive CRM is associated with a worse prognosis regardless of classification system , T category , tumour type or neoadjuvant therapy | Background The evidence regarding the prognostic impact of a positive circumferential resection margin ( CRM ) in oesophageal cancer is conflicting , and there is global variability in the definition of a positive CRM .
The aim of this study was to determine the impact of a positive CRM on survival in patients undergoing oesophagectomy for oesophageal cancer . | Objective The purpose of this study was to investigate whether a long proximal oesophageal resection margin ( PRM ) is associated with improved survival after oesophagectomy for cancer and to identify the optimal margin to aim for in this patient group . Methods A prospect ively maintained data base identified 174 patients who underwent Ivor-Lewis oesophagectomy for cancer . Demographic , clinical , and pathological data were collected . X-tile software was used to identify the optimal resection point . Two models were analysed : single point resection with comparison of two groups ( short and long ) , and two resection points with three groups ( short , medium , and long ) to provide a range . Results The median PRM was 4.0 cm ( interquartile range : 2.5–6.0 cm ) . After adjustment for significant confounders , multivariable Cox PH analysis demonstrated that the optimal resection margin was 1.7 cm , and in the three-group analysis the optimum PRM was between 1.7 and 3 cm . In the two-group analysis , the long margin had no effect on DFS ( p = 0.37 ) , but carried a significantly improved overall survival ( hazard ratio [ HR ] = 0.46 , 95 % confidence interval [ CI ] 0.25–0.87 , p = 0.02 ) . In the three-group analysis , the medium and long groups had improved OS compared with the short group ( on average 54 % , HR ≥ 0.45 , p ≤ 0.04 ) . The 5-year disease-free and overall survival rates were highest in the medium PRM group ( 48 and 57 % respectively ) . Conclusions Optimal survival following oesophagectomy for cancer is achieved with a PRM > 1.7 cm , but a PRM > 3 cm does not yield a further survival advantage . Thus , the optimal PRM is likely to be between 1.7 and 3 cm Aims Neoadjuvant chemotherapy ( NAC ) remains an important therapeutic option for advanced oesophageal cancer ( OC ) . Pathological tumour regression grade ( TRG ) may offer additional information by directing adjuvant treatment and /or follow‐up but its clinical value remains unclear . We analysed the prognostic value of TRG and associated pathological factors in OC patients enrolled in the Medical Research Council ( MRC ) OE02 trial . Methods and results Histopathology was review ed in 497 resections from OE02 trial participants r and omised to surgery ( S group ; n = 244 ) or NAC followed by surgery [ chemotherapy plus surgery ( CS ) group ; n = 253 ] . The association between TRG groups [ responders ( TRG1–3 ) versus non‐responders ( TRG4–5 ) ] , pathological lymph node ( LN ) status and overall survival ( OS ) was analysed . One hundred and ninety‐five of 253 ( 77 % ) CS patients were classified as ‘ non‐responders ’ , with a significantly higher mortality risk compared to responders [ hazard ratio ( HR ) = 1.53 , 95 % confidence interval ( CI ) = 1.05–2.24 , P = 0.026 ] . OS was significantly better in patients without LN metastases irrespective of TRG [ non‐responders HR = 1.87 , 95 % CI = 1.33–2.63 , P < 0.001 versus responders HR = 2.21 , 95 % CI = 1.11–4.10 , P = 0.024 ] . In multivariate analyses , LN status was the only independent factor predictive of OS in CS patients ( HR = 1.93 , 95 % CI = 1.42–2.62 , P < 0.001 ) . Exploratory subgroup analyses excluding radiotherapy‐exposed patients ( n = 48 ) showed similar prognostic outcomes . Conclusion Lymph node status post‐NAC is the most important prognostic factor in patients with resectable oesophageal cancer , irrespective of TRG . Potential clinical implication s , e.g. adjuvant treatment or intensified follow‐up , reinforce the importance of LN dissection for staging and prognostication OBJECTIVE To assess the clinical significance of circumferential resection margins according to current criteria of the College of American Pathologists ( CAP ) and the Royal College of Pathology ( RCP ) in esophageal and esophagogastric cancer . DESIGN Prospect i ve study . SETTING Single-surgeon data base . PATIENTS One hundred thirty-five patients ( mean age , 64 years ) with T3 tumors who underwent esophageal resection for cancer between 1991 and 2006 . Main Outcome Measure Resection margins criteria and survival . RESULTS Three hundred seventy-four consecutive patients were prospect ively identified from an institutional review board-approved data base between 1991 and 2006 . All patients with T3 tumors ( n = 135 ) had their original pathologic slides reassessed by a single gastrointestinal pathologist . Operative mortality was 0.7 % and mean follow-up was 3.1 years . Follow-up was complete in 81 % of patients . Positive margins were identified in 16 cases in the CAP group vs 83 cases in the RCP group . Five-year Kaplan-Meier survival curves in the CAP group demonstrated a significant ( P < .001 ) difference in survival , whereas the RCP group showed no difference ( P = .20 ) . In comparisons of negative vs positive margins , respectively , median survival in the CAP group ( 29.8 months [ 95 % confidence interval ( CI ) , 22.7 - 36.9 ] vs 8.33 months [ 95 % CI , 4.4 - 12.3 ] ) was significantly different from the RCP group ( 28.47 months [ 95 % CI , 19.7 - 37.2 ] vs 22.23 months [ 95 % CI , 13.6 - 30.8 ] ) . At 60-month follow-up , the positive predictive value with respect to survival was 100 % in the CAP group vs 81 % in the RCP group . Univariate and multivariate analyses identified R1 margins in the CAP group and lymph node ratio as being directly linked to survival . CONCLUSIONS Positive circumferential resection margins are prognostically important and the CAP criteria provide a more clinical ly meaningful assessment . Universal adoption of the CAP system can improve interpretation of international clinical trials and allow more accurate comparisons of outcomes SUMMARY . The failure of adjuvant therapy to significantly improve the prognosis of patients undergoing esophago-gastrectomy for cancer may be because of poor patient selection . We sought prognostic factors that would identify those patients who could benefit from adjuvant therapy . Data on 15 possible prognostic factors were prospect ively collected on 225 patients undergoing esophago-gastrectomy at a single institution , and univariate and multivariate analyzes performed . T , N , M and overall UICC stage , differentiation , involvement of the circumferential resection margin and number of metastatic of lymph nodes were identified as significant prognostic factors by univariate analysis . Multivariate analysis revealed that the completeness of resection ( R-category ) , ratio of metastatic to total nodes resected and the presence of vascular invasion were independently significant prognostic factors . Following R0 or R1 resection , patients with a metastatic to total lymph node ratio > 0.2 and ⁄or the presence of vascular invasion have a poor prognosis , and the effects of adjuvant therapy in these patients should be studied Background Controversy exists over the Sixth Edition of the International Union Against Cancer ( UICC ) TNM staging system for esophageal cancer . Inclusion of additional information such as the number of metastatic lymph nodes and extracapsular lymph node invasion may improve the current staging system and lead to optimization of patient treatment . Methods All patients in Adelaide who underwent resection for esophageal cancer between 1997 and 2007 were identified from a prospect i ve data base . Two independent observers then reexamined all pathology slides from the original resection . Univariate and multivariate analysis was performed to identify significant prognostic factors . The goodness of fit and accuracy of additional prognostic factors were assessed , and the staging system was modified according to this information . Results There were 240 patients ( mean age , 62 years ) who met the inclusion criteria . The 5-year overall survival rate was 36 % ( median , 24 months ) . Only histological grade and a refined pN stage were found to be independent prognostic factors that could then be used to improve current TNM staging . Subdivision of pN stage into three groups ( 0 , 1–2 , and > 2 positive nodes ) showed significant differences in 5-year survival between all three groups : 53 % vs 27 % vs 6 % , respectively ( P < .01 ) . The optimal staging model was the same for patients who received neoadjuvant therapy and surgery ( n = 116 ) , and those who underwent surgery alone ( n = 124 ) . Conclusion A staging model that incorporates a refined pN stage and histological grade appears to be more accurate than the current UICC-TNM staging system . This staging model is still applicable in patients who receive neoadjuvant therapy BACKGROUND For rectal carcinoma , the presence of tumour within 1 mm of the circumferential margin is an important independent prognostic factor for both local recurrence and survival . Similar prospect i ve data have not been reported for oesophageal carcinoma and we wished to ascertain the prognostic importance of this variable following potentially curative resection for oesophageal carcinoma . AIM To prospect ively assess the impact of circumferential margin involvement ( tumour within 1 mm ) following potentially curative resection for oesophageal carcinoma . PATIENTS AND METHODS In a prospect i ve study , resection specimens of 135 patients treated with potentially curative oesophageal resection alone were studied for the presence of tumour within 1 mm of the circumferential margin ( margin positive ) , using inked margins and cross sectional slicing of the specimen . All tumours were also staged using the 1987 UICC TNM classification . Patients were followed for a mean of 19 months , and overall and cancer specific survival analysed . RESULTS The finding of tumour cells within 1 mm of the circumferential margin ( CRM+ ) was a significant and independent predictor of survival following potentially curative oesophageal resection . Overall , 64 ( 47 % ) patients were CRM+ . Median survival in this group was 21 months compared with 39 months in the CRM− group ( p=0.015 ) . The impact of CRM status on survival was only seen in patients with a low nodal metastatic burden ( < 25 % nodes positive ) . The odds ratio for the risk of dying from oesophageal cancer was 2.08 when the CRM was involved ( p=0.013 ) . CONCLUSIONS The presence of tumour within 1 mm of the circumferential margin following potentially curative resection for oesophageal carcinoma is an important independent prognostic variable and should be reported routinely Objective : To evaluate prognostic factors and tumor staging in patients after esophagectomy for cancer . Summary Background Data : Several reports have question ed the appropriateness of the sixth edition of the International Union Against Cancer ( UICC ) TNM guidelines for staging esophageal cancer . Additional pathologic characteristics , besides the 3 basic facets of anatomic spread ( tumor , node , metastases ) , might also have prognostic value . Methods : All patients who underwent resection of the esophagus for carcinoma between January 1995 and March 2003 were extracted from a prospect i ve data base . Univariate and multivariate analysis was performed to identify prognostic factors for survival . The goodness of fit and accuracy of 3 staging models ( UICC-TNM , Korst classification , Rice classification ) predicting survival were assessed . Results : A total of 292 patients ( mean age , 63 years ) underwent esophagectomy . The 5-year overall survival rate was 29 % ( median , 21 months ) . pT- , pN- , pm-stage , and radicality of the resection were independent prognostic factors . Subdivision of T1 tumors into mucosal and submucosal showed significant differences in 5-year survival between both groups : 90 % versus 47 % , respectively ( P = 0.01 ) . Subdivision of pN-stage into 3 groups based on the number of positive nodes ( 0 , 1–2 , and > 3 nodes positive ) or the lymph node ratio ( 0 , 0.01–0.2 , and > 0.2 ) also refined staging ( P = 0.001 and P < 0.001 , respectively ) . The current subclassification of M1 ( M1a and M1b ) is not warranted ( P = 0.41 ) . The staging model of Rice was more accurate than the UICC-TNM classification in predicting survival . Conclusion : This study supports the view that the current ( 6th edition ) UICC-TNM staging model for esophageal cancer needs to be revised BACKGROUND A number of clinicopathological characteristics can influence survival following esophagectomy for cancer . The aim of this study was to determine the factors affecting survival in a consecutive series of patients undergoing esophagectomy for cancer at a single tertiary centre over a 7 year period . MATERIAL S & METHODS We analyzed a prospect i ve data base of 314 consecutive patients ( 247 males and 67 females ) , with a mean age of 62.8 + /- 9.1 years , who underwent esophagectomy for cancer at a single , high-volume centre between January 2000 and June 2007 . The impact of 11 variables on survival following esophagectomy was determined by univariate and multivariate analysis . RESULTS On univariate analysis , gender , ASA grade , blood transfusion , type of cancer , tumor stage , lymph node status , lymphovascular invasion ( LVI ) , longitudinal resection margin ( LRM ) involvement and circumferential resection margin ( CRM ) involvement were significant ( p<0.05 ) negative factors for survival . Multivariate analysis using Cox proportional hazard regression demonstrated that the only independent factors negatively impacting on survival were ASA grade ( p=0.012 ) , tumor stage ( p=0.009 ) , LVI ( p=0.009 ) and LRM involvement ( p=0.031 ) . CONCLUSIONS In the current study we demonstrated that independent variables effecting survival after esophagectomy for cancer were ASA grade , tumor stage , lymphovascular invasion and longitudinal resection margin involvement . Contrary to other studies we did not find CRM involvement to be an independent predictor for survival |
11,536 | 22,513,963 | In terms of postoperative pain , PCB does not improve the control of postoperative pain when it is compared against sedation/analgesia or versus no anaesthesia/no analgesia . | BACKGROUND An incomplete miscarriage occurs when all the products of conception are not expelled through the cervix .
Curettage or vacuum aspiration have been used to remove retained tissues .
The anaesthetic techniques used to facilitate this procedure have not been systematic ally evaluated in order to determine which provide better outcomes to the patients .
OBJECTIVES To assess the effects of general anaesthesia , sedation or analgesia , regional or paracervical block anaesthetic techniques , or differing regimens of these , for surgical evacuation of incomplete miscarriage . | Forty-four patients presenting for evacuation of retained products of conception were anaesthetized with either fentanyl and thiopentone , or alfentanil with etomi date , along with 70 % nitrous oxide in oxygen . There was no difference between the two techniques in indices of immediate recovery ( time to opening eyes and obeying a simple comm and ) , but the rate of return of higher mental functions ( assessed by a coin counting test ) was significantly better using the alfentanil-etomi date technique . There was no statistically significant difference between the techniques for apnoea or abnormal movements during anaesthesia , but alfentanil with etomi date was associated with significantly more pain on injection and a higher frequency of postoperative vomiting ( 40 % ) OBJECTIVE To evaluate pain relief using paracervical nerve block with 1 % lignocaine injection in patients undergoing uterine evacuation by Manual Vacuum Aspiration ( MVA ) for the treatment of incomplete abortion . DESIGN A r and omized double blind clinical trial . SETTING Marie Stopes Health Centre , Nairobi . METHODS One hundred and forty two patients were recruited between September and October 1997 . The intervention was r and om assignment to the study group ( paracervical block with 1 % lignocaine ) or the placebo group ( paracervical block with sterile water for injection ) . Intra and post operative assessment of pain was made using McGills and facial expression scales . RESULTS The untreated group experienced significantly more pain than the treated group , especially lower abdominal pain and backache . The pain was especially marked intraoperatively , less so 30 minutes post-operatively . CONCLUSION Based on the findings of this study , any patient going for manual vacuum aspiration for the treatment of incomplete abortion should be given Paracervical block as it is cost effective , easy to perform and with less side effects One hundred and fifteen patients admitted to Duke University Medical Center from January 1 , 1973 , to December 31 , 1974 inclusive , with the diagnosis of uncomplicated spontaneous incomplete or inevitable abortion were included in a r and omized prospect i ve study . All patients underwent suction curettage under either analgesia or general inhalation anesthesia . Patient response was adjudged regarding comfort and cooperativeness in the group receiving analgesia and postprocedure rehabilitation and discharge times in both groups . Fifteen of 59 patients receiving analgesia only were recorded unanimously as failures . Post-operative ambulation was no more rapid in patients receiving analgesia . Procedure-to-discharge intervals were unrelated to medication modality . There appears to be no advantage to analgesia as far as rehabilitation time , procedure-to-discharge time , and medical complications are concerned Background and objective : This study was design ed to determine which single bolus dose of remifentanil in combination with propofol and nitrous oxide is best to control the haemodynamic , autonomous and somatic responses in patients scheduled for dilatation and curettage of the uterine cervix . We evaluated the adequacy of different bolus doses of remifentanil , associated with propofol and nitrous oxide , for dilatation and curettage in a prospect i ve double-blind study . Methods : After institutional approval and informed consent , 34 healthy females undergoing curettage to remove material from the uterus after spontaneous abortion were r and omized to receive remifentanil 0.5 μg kg−1 intravenously ( i.v . ) ( Group A ; n = 4 ) , 1 μg kg−1 i.v . ( Group B ; n = 15 ) or 1.5 μg kg−1 i.v . ( Group C ; n = 15 ) , with propofol 2 mg kg−1 i.v . in all groups . Anaesthesia was maintained with 60 % nitrous oxide in oxygen . Haemodynamic , somatic and autonomic signs of light anaesthesia were registered to assess the response to surgical stress . Recovery times and Aldrete score were recorded at the end of the procedure . Results : The groups were similar with regard to biometric data and duration of surgery . The poor results using the lowest dose of remifentanil obliged us to ab and on this dose . The total dose of remifentanil was larger in Group C ( 100 ± 5.7 μg vs. 65 ± 4.1 μg in Group B ; P < 0.05 ) , but more patients required extra bolus injections in Group B ( 69 % vs. 38 % in Group C ; P < 0.01 ) . Recovery times were significantly shorter in Group C. Aldrete scores when leaving the operation room was similar . Conclusions : Remifentanil 1.5 μg kg−1 i.v . with propofol 2 mg kg−1 i.v . and 60 % nitrous oxide in oxygen provided the best anaesthetic control with the fastest recovery times OBJECTIVE To estimate the effectiveness of different methods of analgesia among women treated with manual vacuum aspiration for spontaneous abortion . MATERIAL S AND METHODS The 113 patients diagnosed with incomplete abortion and considered c and i date s for manual vacuum aspiration were r and omly assigned to 3 groups of analgesic administration : diclofenac plus paracervical block ; meperidine plus diclofenac ; and meperidine alone . Pain levels were evaluated using the Wong Scale of Pain . RESULTS The mean pain scores for the three groups were : diclofenac and paracervical block 5.4 ; meperidine plus diclofenac 5.0 ; meperidine 5.7 ( P=0.57 ) . Analysis of pain using the levels mild ( 0 - 3 ) , moderate ( 4 - 6 ) , and severe ( 7 - 10 ) showed no statistical significance among the 3 groups of analgesics . Adverse effects were more common in the groups using analgesia containing meperidine . CONCLUSIONS There was no significant difference between the analgesics used among the 3 groups . Most of the patients , regardless of the analgesic used , reported moderate pain OBJECTIVE To compare evacuation under systemic analgesia ( fentanyl and midazolam ) in a treatment room ( ward group ) with evacuation under general anaesthesia in theatre . DESIGN A prospect i ve r and omised clinical trial . SETTING A tertiary medical centre serving a black urban population . SUBJECTS One hundred and forty-two patients with uncomplicated incomplete abortions . INTERVENTION R and omisation into two groups , those for evacuation under systemic analgesia and those for evacuation under general anaesthesia . MAIN OUTCOME MEASURES Both groups were compared in terms of safety , efficacy , acceptability , blood consumption and time delay between admission and evacuation . RESULTS Significantly less blood was used in the ward group ( 37 units for 13 patients ) than in the theatre group ( 65 units for 24 patients ) ( P < 0.03 ) . Significantly less time was taken between admission and evacuation in the ward group ( median 7 hours 15 minutes ) than in the theatre group ( median 12 hours 38 minutes ) ( P < 0.0003 ) . Evacuation under fentanyl and midazolam was safe , effective and acceptable for the majority of patients compared with evacuation under general anaesthesia . CONCLUSION Patients with uncomplicated incomplete abortions ( uterine size equivalent to a pregnancy of 14 weeks ' duration or less ) can undergo evacuation safely and effectively under fentanyl and midazolam and have a significantly smaller chance of requiring a blood transfusion |
11,537 | 26,544,925 | Neither stapler nor scalpel resection followed by h and -sewn closure of the pancreatic remnant for distal pancreatectomy showed any benefit compared to the other method in terms of postoperative pancreatic fistula , overall postoperative mortality or operation time . | BACKGROUND Resections of the pancreatic body and tail reaching to the left of the superior mesenteric vein are defined as distal pancreatectomy .
Most distal pancreatectomies are elective treatments for chronic pancreatitis , benign or malignant diseases , and they have high morbidity rates of up to 40 % .
Pancreatic fistula formation is the main source of postoperative morbidity , associated with numerous further complications .
Research ers have proposed several surgical resection and closure techniques of the pancreatic remnant in an attempt to reduce these complications .
The two most common techniques are scalpel resection followed by h and -sewn closure of the pancreatic remnant and stapler resection and closure .
OBJECTIVES To compare the rates of pancreatic fistula in people undergoing distal pancreatectomy using scalpel resection followed by h and -sewn closure of the pancreatic remnant versus stapler resection and closure . | Pancreatic fistula is a major form of morbidity following pancreatic resection . We conducted a nonr and omized clinical trial comparing the sealing and s and wich techniques of spraying fibrin glue to prevent pancreatic fistula following distal pancreatectomy . The pancreas was transected with a scalpel to identify and suture the main pancreatic duct and its small branches . In the sealing group , fibrin glue was sprayed over the closed pancreatic stump and sutures . Alternatively , in the s and wich group fibrin glue was sprayed so as to cover and join the cut surface of the pancreatic remnant , which was then held closed with sutures . Altogether 111 patients were included in the study ( 90 with gastric cancer , 10 with esophageal cancer , and 11 with pancreatic cancer ) . Patients were nonr and omly assigned to the s and wich or the sealing group . Morbidity was 21.8 % for the patients in the s and wich group versus 33.9 % in the sealing group . Pancreatic fistulas occurred in 9.0 % of the s and wich group versus 26.8 % of the sealing group . The incidence of fistula was thus significantly lower in the s and wich group . The incidence of fistula was also significantly lower in the s and wich group for gastric malignancy patients undergoing extended radical lymphadenectomy down to the paraaortic lymph nodes combined with left adrenalectomy . Of the patients with gastric malignancy , pancreatic fistulas occurred in 9.3 % of the s and wich group versus 25.5 % of the sealing group . The fibrin glue s and wich technique is simple and reliable and should be valuable for complementing other prophylactic methods of preventing pancreatic fistula BACKGROUND A pancreatic fistula is one of the most serious complications in distal pancreatectomy with en bloc celiac axis resection ( DP-CAR ) , because the pancreatic transection is performed on the right side of the portal vein , which results in a large cross-section surface , and because post-pancreatectomy hemorrhage is hard to treat by interventional radiology . Therefore , a procedure to decrease the incidence of postoperative pancreatic fistula is urgently needed . METHODS Twenty-six consecutive patients who underwent DP-CAR between April 2008 and August 2012 were review ed retrospectively . The first 13 consecutive patients underwent DP-CAR with no anastomosis , and the subsequent 13 consecutive patients were treated with Roux-en-Y pancreaticojejunostomy ( PJ ) in a duct-to-mucosa fashion . RESULTS Extremely high amylase levels ( > 4000 IU/l ) of all drainage fluid specimens on postoperative day ( POD ) 1 , 3 and 4 were detected more frequently in cases with no anastomosis ( n = 7 ) compared to those with PJ ( n = 1 ) ( P = 0.056 ) . CONCLUSION The incidence of grade B/C pancreatic fistulas was 15.4 % in cases with isolated Roux-en-Y anastomosis of the pancreatic stump performed in a duct-to-mucosa fashion , and we are currently examining whether this anastomosis method reduces the pancreatic fistula rate in a multicenter , r and omized controlled trial for distal pancreatectomy patients ( Clinical Trials.gov NCT01384617 ) BACKGROUND The purpose of this study was to analyze the short-term outcome and to determine risk factors after distal pancreatectomy ( DP ) . METHODS This prospect i ve single-center study included 61 patients undergoing DP with splenic preservation in 6 ( 10 % ) . The diagnoses included pancreatic adenocarcinoma ( n = 9 ) , neuroendocrine neoplasms ( n = 17 ) , benign neoplasm ( n = 26 ) , pseudocyst ( n = 4 ) , chronic pancreatitis ( n = 2 ) , and other diagnoses ( n = 3 ) . Twelve clinical factors were studied . The chi-square test was used for univariate analysis . RESULTS The median duration of the postoperative hospital stay was 10 days ( range , 5 - 155 days ) . Two patients ( 3 % ) died postoperatively ; 12 patients ( 20 % ) had one or more intra-abdominal complications with reoperation necessary in 3 patients ( 5 % ) : 6 pancreatic fistula ( 10 % ) , 11 intra-abdominal collection s ( 18 % ) , 1 postoperative hemorrhage ( 2 % ) . Univariate analysis showed that a body mass index > 25 kg/m 2 was the only risk factor for intra-abdominal complication ( P = .003 ) . CONCLUSIONS DP is associated with an intra-abdominal morbidity rate of 20 % , which is increased for patients with a body mass index > 25 kg/m 2 HYPOTHESIS Advances in specialized centers for pancreatic diseases have improved surgical morbidity and outcome . In the past , postoperative local complications ( pancreatic fistulae ) were causing most of the mortality . Now , more patients experience postoperative complications related to their comorbidity . DESIGN To report a prospect i ve audit of a single center 's experience with pancreatic resection during an 8-year period . SETTING Tertiary referral center focused on pancreatic diseases . PATIENTS AND INTERVENTIONS Six hundred seventeen consecutive patients underwent pancreatectomy between November 1 , 1993 , and August 31 , 2001 . The series included 468 pancreatic head resections ( 76 % ) , 25 total pancreatectomies ( 4 % ) , 88 left-sided resections ( 14 % ) , and 36 others ( 6 % ) . MAIN OUTCOME MEASURES Morbidity after pancreatic resection . RESULTS Postoperative in-hospital mortality was 1.6 % , and the additional operation rate was 4.1 % . Four patients died of surgical complications and 6 of systemic complications . Systemic morbidity was 18 % and consisted primarily of cardiopulmonary complications ( 13 % ) . The most frequent postoperative complication was delayed gastric emptying ( 14 % ) , which caused significant prolongation of the hospital stay . No patients died of a postoperative pancreatic fistula , which occurred in 3.2 % , and no completion pancreatectomies were necessary . CONCLUSIONS Pancreatic resections can be performed with considerable safety and a low rate of pancreatic complications . More patients die of systemic complications than in the past , which increases the dem and for precise preoperative patient selection . Completion pancreatectomy should no longer be considered in patients with a pancreatic fistula Pancreaticoduodenectomy ( PD ) is still a difficult procedure with significant morbidity . We report 150 consecutive PDs performed during a 3-year period . All the cases have been prospect ively evaluated with regard to the surgical outcome . Mortality in this series was 3/150 ( 2 % ) with a re-operation rate of 5/150 ( 3.3 % ) ; surgical complications were experienced in 57/150 ( 38 % ) . The most frequent complications were collection s in 25/150 ( 16.6 % ) and pancreatic fistulas in 16/150 ( 10.7 % ) . The majority of these complications were conservatively managed : only one abscess and one fistula due to an anastomotic dehiscence required re-operation . The complication most responsible for mortality was haemorrhage secondary to arterial pseudoaneurysms in patients with severe post-operative pancreatitis . The continued high morbidity of PDs is compensated by the ability to treat complications non-operatively , result ing in a surgical risk that should now be considered medium to low in high volume centres Background Pancreatic fistula continues to be a source of significant morbidity following distal pancreatic resections . The technique of pancreatic division varies widely among surgeons , and there is no evidence that identifies a single method as superior . In our practice , the technique of distal pancreatic resection has evolved from cut- and -sew to stapled technique with green and recently white cartridge . The aim of our study was to evaluate the rate of clinical ly significant fistulas [ International Study Group on Pancreatic Fistula ( ISGPF ) grade B or C ] following distal pancreatectomy and to identify variables associated with a low rate of fistula development . Methods Clinical records of all patients who underwent distal pancreatic resections between February 1999 and July 2010 by a single surgeon were retrospectively review ed focusing on the incidence and type of pancreatic fistula as defined by ISGPF . Study variables included age , gender , surgical approach , extent of resection , ASA classification , type of stapler cartridge , use of Seamguard ™ , and ISGPF classification . Statistical analysis was performed using Fisher ’s exact test , and univariate and multivariate logistic regression . Results Sixty-four patients ( median age 60 , range 21–85 ; 54 % male ) underwent distal pancreatic resection ( laparoscopy 50 % vs. open 50 % ) . The most common indications were pancreatic adenocarcinoma ( N = 15 ; 23 % ) and neuroendocrine neoplasms ( N = 14 ; 22 % ) . Clinical ly significant pancreatic fistula developed in 24 % ( N = 15 ) . The rate of fistula with cut- and -sew technique was 36 % ( 4/11 ) , with stapled green cartridge 31 % ( 9/29 ) and only 5 % ( 1/21 ) with stapled vascular cartridge . Univariate logistic regression identified vascular cartridge size ( p = 0.04 , OR 0.11 ) and open stapled technique ( p = 0.05 , OR 0.12 ) as variables significantly associated with a low fistula rate . Both vascular cartridge size ( p = 0.05 , OR 0.10 ) and open stapled technique ( p = 0.04 , OR 0.08 ) remained significant when analyzed by multivariate logistic regression . Division of pancreatic parenchyma with vascular cartridges result ed in significantly ( p = 0.03 , OR 9.0 ) lower fistula rate compared to green cartridges . The use of Seamguard ™ did not affect fistula rate ( 16 % vs. 27 % ; p = 0.34 ) nor did the performance of multivisceral resection vs. distal pancreatectomy/splenectomy alone ( 21 % vs. 23 % , p = 1.0 ) . Conclusion The optimal technique of pancreatic division has not been conclusively established . Dividing the pancreas utilizing vascular ( 2.5 mm ) staple cartridges significantly decreased the rate of clinical ly significant pancreatic fistula and we have changed our practice accordingly . A prospect i ve r and omized trial is necessary to vali date these results BACKGROUND We previously demonstrated that pancreatic transection with a reinforced staple line results in significantly lower fistula rates than when stapling without reinforcement . ( J Gastrointest Surg . 2007;11:345 - 349 ) . Criticism of this initial study focused on the small size of the treated group ( N = 13 ) . We report four more years of experience with this technique with a larger sample size . METHODS This was a before-after trial . Patients included had distal pancreatectomies with stapled stump closure . The main intervention analyzed was staple-line reinforcement with Seamguard . The experimental group consisted of a consecutive series of stapled pancreatectomies with reinforcement performed from 2005 to 2010 . The control group was a consecutive series of stapled pancreatectomies without reinforcement performed between 2003 and 2005 ( previously published ) . The main outcome measure was pancreatic fistula . RESULTS 54 patients were included ; 36 in the experimental group and 18 in the control group . Mean age was 62 ; 50 % were males . The most common diagnoses were adenocarcinoma ( 31 % ) , cystic neoplasm ( 24 % ) , and neuroendocrine tumor ( 22 % ) . There were no mortalities . Postoperative pancreatic leak rate was 39 % in the control group , and 8 % in the experimental group ( P = 0.01 ) . Seven of ten patients with leak required additional drain placement . Development of pancreatic leak result ed in prolonged hospital stays ( 12 vs eight days , P < 0.007 ) . CONCLUSION We demonstrate sustained success of reinforced stapling for pancreatic stump closure . Our technique is straightforward and results in reduced morbidity and cost . Our results suggest that surgical drains may not be needed when this technique is applied Background Surgery is of increasing importance in the treatment and outcome of diseases of the pancreas worldwide . The incidence of pancreatic cancer ( 7—11/ 100,000 per year ) has risen over the last years and surgical resection remains the only option for definite cure . Twenty-five percent of all resections are left of the superior mesenteric vein ( distal pancreatectomy ) and the appropriate closure technique for the pancreatic remnant remains unclear . Pancreatic fistulas are the most common ( 0—40 % ) and relevant postoperative complication . The optimal surgical strategy for pancreatic resection needs to be identified from the large number of surgical procedures available today . Purpose To evaluate the effectiveness of the two most common surgical techniques for distal pancreatectomy : stapler versus h and -sewn closure of the pancreatic remnant . Methods In order to account for the uncertainty and clinical heterogeneity in the management of the pancreatic remnant following distal pancreatectomy , a study protocol is developed on the basis of a retrospective survey of patients in a center of excellence for pancreatic surgery and a systematic review with meta- analysis . Results The DISPACT trial is a multicentered , r and omized , controlled and patient- and observer-blinded trial using a two-group parallel group-sequential superiority design to compare the two techniques mentioned above . It will include approximately 336 r and omized patients at up to 20 centers of excellence in pancreatic surgery , who are undergoing elective distal pancreatectomy for resectable benign , malign , and neuroendocrine tumors , chronic pancreatitis and pseudocysts of the pancreatic body and tail . The combination of the rate of postoperative pancreatic fistula and mortality will be evaluated as the primary endpoint . In addition , a set of general and surgical parameters will be analyzed . Pre-specified treatment manuals and continuous intra-operative ( photo-documentation of surgical procedures and blinded evaluation thereafter ) and on-site monitoring will assure that the treatment of the study patients conforms to protocol and will minimize clinical heterogeneity . Due to uncertainties about the effect sizes of the primary endpoint , an a priori planned interim analysis of the primary endpoint will be conducted after 224 evaluable patients are selected in order to reassess the initially planned sample size . Limitations Since pre-existing evidence was limited our initial sample size calculation is based on uncertain assumptions and may need to be modified in a planned interim analysis . Moreover , since surgical experience remains a potential confounder in surgical trials , learning curve bias has to be taken into account when analyzing the results . Given the participating trial sites , st and ardization of peri- and postoperative treatment represents a major issue of trial conduct . Conclusions A group-sequential study design accounts for the uncertainty of pre-existing evidence . Also , st and ardization of surgical and postoperative care and blinded outcome assessment as well as adjustment for varying surgical expertise will contribute to a high validity and generalizability of the results . Clinical Trials 2008 ; 5 : 534—545 . CONTEXT Resection of the body and tail of the pancreas ( distal pancreatectomy ) is associated with high postoperative morbidity , most of which is due to leakage from the pancreatic transection surface . OBJECTIVE The aim of the current study was to analyze factors which may affect the risk of pancreatic fistula formation . PATIENTS All consecutive distal pancreatectomies prospect ively registered in our hospital data base from 1999 to 2007 were included . Clinical ly relevant pancreatic fistula grade s B and C , defined according to the International Study Group on Pancreatic Fistula ( ISGPF ) definition were assessed . MAIN OUTCOME MEASURES The impact of patient , tumor , surgery , and radiology-related factors on the risk of pancreatic fistula formation were assessed by univariate and multivariate analyses . RESULTS A distal pancreatectomy was performed in 51 patients ( median age : 59 years ; range : 26 - 76 years ) , 22 of whom had malignant and 29 benign or premalignant disease . Pancreatic fistulas were diagnosed in 17 ( 33.3 % ) of the patients . An additional three patients had a local abscess without apparent but assumed pancreatic leakage . Multivariate analysis showed that pancreatic fistulas occurred more frequently after h and suturing of the transection area versus the use of a stapler ( 69.2 % vs. 21.1 % ; OR : 40.4 , 95 % CI : 3.36 - 486 ; P=0.004 ) and a large volume of the pancreatic remnant ( greater , or equal to , 34 cm3 ) increased the subsequent risk of pancreatic fistula ( 57.1 % vs. 20.8 % ; OR : 6.14 , 95 % CI : 1.14 - 39.0 ; P=0.035 ) . CONCLUSIONS Development of pancreatic fistula after distal pancreatectomy remains a challenge . The volume of the remaining pancreas and the technique of closure of the transected pancreas were found to affect this risk , thus allowing future preventive measures to be explored and evaluated in clinical trials Objective The objective of the study was to assess the efficacy of two pancreatic remnant closure techniques following distal pancreatectomy : ( 1 ) stapled or sutured closure versus ( 2 ) stapled or sutured closure plus falciform patch and fibrin glue reinforcement in the setting of a prospect i ve r and omized trial , with the primary endpoint being pancreatic fistula . Summary and Background Data Pancreatic stump leak following left-sided pancreatic resection ( distal pancreatectomy ) remains common . Despite multiple and varied techniques for closure , the reported leak rate varies up to 30 % . A retrospective analysis by Iannitti et al. ( J Am Coll Surg 203(6):857–864 , 2006 ) detected a decreased leak rate in patients receiving a traditional closure buttressed with an autologous falciform ligament patch and fibrin glue . Methods Between April 2008 and October 2011 , all willing patients scheduled to undergo distal pancreatectomy at the authors ' institutions were consented and enrolled at the preoperative office visit . Patients were intraoperatively stratified as having hard or soft gl and s and r and omized to one of two groups : ( 1 ) closure utilizing stapling or suturing ( SS ) versus ( 2 ) stapled or sutured plus falciform ligament patch and fibrin glue ( FF ) . The trial design and power analysis ( α = 0.05 , β = 0.2 , power 80 % , chi-square test ) hypothesized that the FF intervention would reduce the primary endpoint ( pancreatic fistula ) from 30 % to 15 % and targeted an accrual goal of 190 patients . Secondary endpoints included length of postoperative hospital stay , 30-day mortality , hospital readmission , and ISGPF fistula grade ( A , B , and C ) . Results The trial accrued 109 patients , 55 in the SS group and 54 in the FF group . Enrollment was closed prior to the target accrual , following an interim analysis and futility calculation . Due to insufficient enrollment , patients stratified as having a hard gl and were excluded ( n = 8) from analysis , leaving 101 patients in the soft stratum . The overall pancreatic leak rate was 19.8 % ( 20 patients ) for patients with soft gl and s. Patients r and omized to the FF group had a leak rate of 20 % , as compared with 19.6 % in the SS group ( p = 1.000 ) . Fistula grade s in both groups were identical : 1A , 8B , and 1C in the FF group as compared to 1A , 8B , and 1C in the SS group . Complication rates were comparable between the two groups . The median length of postoperative hospital stay was 5 days in both groups . There was a trend towards a higher 30-day readmission rate in the FF group ( 28 % vs. 17.6 % , p = 0.243 ) . Conclusion The addition of a falciform ligament patch and fibrin glue to st and ard stapled or sutured remnant closure did not reduce the rate or severity of pancreatic fistula in patients undergoing distal pancreatectomy ( Clinical Trials.gov NCT00889213 ) Some Authors have suggested the use of human fibrin sealants in pancreatic surgery to prevent fistulas . We performed a prospect i ve r and omized study including 97 patients ( 34F , 63 M ) . Forty six were affected by pancreatic inflammatory diseases and 51 had pancreatic or peripancreatic neoplasms . All the patients were managed by the same surgical staff . Surgical treatment included 30 pancreaticoduodenectomies , 40 pancreatico-jejunostomies , 23 left pancreatic resections and 4 tumour excisions . The patients were r and omized at the moment the surgical treatment was chosen and divided into 2 different groups : group A , including 43 subjects who had intraoperative fibrin sealing , and group B , including 54 patients who had no fibrin sealing during surgery . At the end of the trial , 6 patients in group A ( 13.9 % ) and 6 in group B ( 11.1 % ) developed a pancreatic fistula . No statistically significant difference was detected between the 2 groups . The highest incidence of fistulas was observed in the patients with pancreatic cancer in group A ( 18.7 % ) and in the patients who underwent pancreatico-duodenectomy in group A ( 25.0 % ) Introduction : Pancreatic leak or fistula is the most frequent complication after left pancreatectomy . We performed a single-blinded , parallel-group , r and omized controlled trial comparing stapled left pancreatectomy with stapled left pancreatectomy using mesh reinforcement of the staple line with either Seamguard or Peristrips Dry . Methods : All patients undergoing left pancreatectomy at a large tertiary hospital were eligible for participation . Patients were r and omized to either mesh reinforcement or no-mesh reinforcement intraoperatively after being determined a c and i date for resection . Patients were blinded to the result of their r and omization for 6 weeks . Primary outcome measure was clinical ly significant leak as defined by the ISGPF ( International Study Group on Pancreatic Fistula ) pancreatic leak grading system . Results : One hundred patients were r and omized to either mesh ( 54 ) or no-mesh ( 46 ) reinforcement of their pancreatic transection . There was 1 death in each group . ISGPF grade B and C leaks were seen in 1.9 % ( 1/53 ) of patients undergoing resection with mesh reinforcement and 20 % ( 11/45 ) of patients without mesh reinforcement ( P = .0007 ) . Conclusions : Mesh reinforcement of pancreatic transection line significantly reduces the incidence of significant pancreatic fistula in patients undergoing left pancreatectomy . Trial Registration : Clinical trials.gov : Methods for combining data from several studies exist and appear to be quite useful . None satisfactorily addresses the question of what studies should be combined . This issue is the most serious method ological limitation . Even studies with statistically significant interaction might still be combined if the effect were in the same direction . Thus , substantial scientific input is required as to what criteria must be met by each potential study . Much can be learned from combining or pooling data but it must be done cautiously . Pooling exercises do not replace well design ed prospect i ve clinical trials . Efforts for establishing basic design criteria to allow for multicentre and multicountry trials to be more easily combined might be useful . AIM Description of the indications , surgical technique and postoperative complications of distal pancreatic resection . METHODS We analyzed the prospect ively documented perioperative data of 41 patients undergoing distal pancreatectomy between 1994 and 2001 . Indications for resection were chronic pancreatitis ( n = 21 ) , malignant or benign tumors ( n = 19 ) and others ( n = 1 ) . RESULTS Median operation time was 4.5 hours , a Y-Roux-pancreaticojejunostomy was performed in 66 % . Further organs were resected in 93 % , most frequently in form of splenectomy . A malignant vascular invasion led to positive resection margins in three patients . Mortality was 2 % . Postoperative complications occurred in 41 % with 15 % revealing pancreatic leakage . A relaparotomy was carried out in 20 % . Pancreatic leakage was more frequently seen in the first part of the study period and after oversewing of the pancreatic stump . A new onset diabetes occurred postoperatively in 6 % of the patients . CONCLUSIONS Distal pancreatectomy can be carried out with low mortality , despite a high complication rate . The probability of postoperative diabetes is low . The frequency of pancreatic leakage may be reduced significantly by increasing hospital experience . The management of the pancreatic stump by pancreatojejunostomy should be considered in patients with a high risk of pancreatic leakage OBJECTIVE To evaluate the use of fibrin glue sealing of the pancreatic stump for the prevention of postoperative pancreatic fistulas . DESIGN A prospect i ve , r and omized clinical trial . PATIENTS AND METHODS Fibrin glue is a biologic adhesive consisting of highly concentrated human fibrinogen , thrombin , and factor VIII . Twenty-six of 56 patients who underwent distal pancreatectomy for gastric cancer or pancreatic disease were r and omly assigned to the fibrin glue group . Fibrin glue was applied to the suture line of the pancreatic stump with the ligated main pancreatic duct . Pancreatic fistula was defined as a pancreatic fluid discharge for over 7 post-operative days diagnosed by local findings , with amylase concentration in the discharge fluid more than three times the serum amylase concentration , a level low enough that even a small pancreatic leakage could be diagnosed . RESULTS The overall incidence of pancreatic fistula was 28.6 % . Postoperative pancreatic fistulas occurred in four patients ( 15.4 % ) in the fibrin glue group and 12 ( 40.0 % ) in the control group ( P = .04 ) . The lower pancreatic fistula rate was seen in the fibrin glue group also when analyzing patients with gastric cancer or pancreatic disease only , although there was no statistically significant difference . CONCLUSIONS Intraoperative use of fibrin glue following distal pancreatectomy could prevent pancreatic fistula formation . This method was feasible , safe , and reliable and will complement other prophylactic methods INTRODUCTION Complications after pancreatic resections remain frequent despite a decreasing mortality . Pancreatic leakages represent a relevant part of those complications but data on risk factors for their occurrence are rare . We analyzed our experience with incidence , clinical course , and risk factors of pancreatic leakage in a large patient group . METHODS We analyzed the prospect ively documented perioperative data of 345 patients with pancreatic resections carried out between 1994 and 2001 . Main indications for surgery were chronic pancreatitis ( 57 % ) and malignant tumors ( 37 % ) . The following operations were performed : Whipple 's operation 15 % , pylorus-preserving pancreaticoduodenectomy 53 % , duodenum-preserving pancreatic head resection 19 % , and distal pancreatic resection 13 % . Risk factors were analyzed using uni- and multivariate methods . RESULTS Postoperative mortality and complication rate were 2.9 % and 41 % , respectively . A pancreatic leakage occurred in 9.9 % . In the majority of patients , pancreatic leakage was asymptomatic and controlled by prolonged drainage . However , one fourth of the patients with pancreatic leakage required reoperation . The mortality of pancreatic leakage was 12 % . No patient with chronic pancreatitis died as a consequence of pancreatic leakage . Impaired preoperative renal function was the only risk factor for the occurrence of postoperative pancreatic leakage . CONCLUSIONS Although easily managed in the majority of cases , pancreatic leakage still represents a relevant postoperative complication after pancreatic resection , especially in patients with malignant disease . Because of an increased risk of developing pancreatic leakage , an impaired renal function should be considered specifically in the perioperative management of the patients BACKGROUND The ideal closure technique of the pancreas after distal pancreatectomy is unknown . We postulated that st and ardised closure with a stapler device would prevent pancreatic fistula more effectively than would a h and -sewn closure of the remnant . METHODS This multicentre , r and omised , controlled , parallel group-sequential superiority trial was done in 21 European hospitals . Patients with diseases of the pancreatic body and tail undergoing distal pancreatectomy were eligible and were r and omly assigned by central r and omisation before operation to either stapler or h and -sewn closure of the pancreatic remnant . Surgical performance was assessed with intraoperative photo documentation . The primary endpoint was the combination of pancreatic fistula and death until postoperative day 7 . Patients and outcome assessors were masked to group assignment . Interim and final analysis were by intention to treat in all patients in whom a left resection was done . This trial is registered , IS RCT N18452029 . FINDINGS Between Nov 16 , 2006 , and July 3 , 2009 , 450 patients were r and omly assigned to treatment groups ( 221 stapler ; 229 h and -sewn closure ) , of whom 352 patients ( 177 stapler , 175 h and -sewn closure ) were analysed . Pancreatic fistula rate or mortality did not differ between stapler ( 56 [ 32 % ] of 177 ) and h and -sewn closure ( 49 [ 28 % ] of 175 ; OR 0·84 , 95 % CI 0·53–1·33 ; p=0·56 ) . One patient died within the fi rst 7 days after surgery in the h and -sewn group ; no deaths occurred in the stapler group . Serious adverse events did not differ between groups . INTERPRETATION Stapler closure did not reduce the rate of pancreatic fistula compared with h and -sewn closure for distal pancreatectomy . New strategies , including innovative surgical techniques , need to be identified to reduce this adverse outcome . FUNDING German Federal Ministry of Education and Research Resection of the non‐fibrotic pancreas is prone to postoperative pancreatic fistula because of well preserved exocrine secretions and easily crushed soft parenchyma . The purpose of this study was to evaluate ultrasonic dissection for division of the non‐fibrotic pancreas in distal pancreatectomy Background Pancreatic fistula is a significant problem for patients undergoing distal pancreatectomy with fistula rates up to 61 % . Fistulas lead to substantial morbidity . The study objective was to compare radiofrequency dissector closure with traditional stump closure for distal pancreatectomy . Methods Sixty-two patients underwent distal pancreatectomy at our institution between 2002 and 2011 . Thirty-three patients had traditional stump closure compared with 29 patients who had radiofrequency closure . Fistula rates , operative times , and blood loss were compared . The control patients underwent open operation in 20 ( 60 % ) cases and laparoscopic operation in the remaining 13 ( 40 % ) . Of the patients that underwent radiofrequency closure , 10 ( 35 % ) underwent open operation , and the remaining 19 ( 65 % ) patients underwent laparoscopic operation . Results Fistula occurred in 12 of 33 ( 36 % ) patients with traditional stump closure compared to 3 of 29 ( 10 % ) patients with radiofrequency closure ( p < 0.02 ) . Operative time ( 307 vs. 231 min [ p < 0.002 ] ) and blood loss ( 364–200 mL [ p < 0.02 ] ) were decreased in the radiofrequency closure group . Length of stay decreased from 7.8 to 6.6 days ; however , this was not statistically significant . Conclusions The use of radiofrequency dissector in distal pancreatectomy is effective with low rates of fistula formation . Radiofrequency closure should be studied further in prospect i ve trials BACKGROUND Pancreatic occlusion failure ( POF ) after distal pancreatectomy remains a common source of morbidity . Here , we review our experience with distal pancreatectomy and attempt to identify factors which influence POF rates . PATIENTS AND METHODS One hundred sixty-nine distal pancreatectomies were performed between 2002 and 2007 . Review of the computerized medical records and physician office records was performed for all patients . Univariate and multivariate analyses were performed to determine factors which might influence the incidence of POF . The data set was analysed for factors which might influence the pancreatic occlusion rate . Analysis included patient and disease characteristics including : age , gender , body mass index ( BMI ) , diagnosis , consistency of the pancreas and history of pancreatitis , as well as intra-operative variables including : surgeon , absorbable mesh reinforcement and operative approach . RESULTS POF was the most common peri-operative complication . POF was identified in 32 out of 169 patients ( 19 % ) . Transection technique ( h and sewn , stapled , stapled with mesh ) and procedure complexity were factors associated with differences in POF rates by both univariate and multivariate analyses . POF was identified in 7 out of 70 patients ( 10 % ) when an absorbable mesh was utilized , and 25 of 99 patients ( 25 % ) when mesh was not utilized ( P < 0.02 ) . DISCUSSION These data suggest that a r and omized controlled trial will be required to determine if mesh reinforcement reduces the rate and severity of POF after distal pancreatectomy BACKGROUND The aim of this study is to evaluate the effectiveness of TachoSil sponge on distal pancreatectomy remnant stump in reducing the rate and severity of postoperative pancreatic fistula ( POPF ) . METHODS All consecutive patients requiring distal pancreatectomy were r and omized in 45 centers . The principal end point was onset of " clinical ly relevant " POPF . Univariate and multivariate analyses were search ed for predictive factors . RESULTS Of the 270 patients r and omized ( 134 with TachoSil ; 136 without ) , 150 ( 55.6 % ) patients sustained a POPF [ 74 clinical ly relevant and 76 clinical ly silent ( 27.4 % and 28.1 % ) , respectively ] : no statistically significant difference was found between patients sustaining clinical ly relevant POPF [ 41 ( 30.6 % ) with vs 33 ( 24.3 % ) without TachoSil ( P = .276 ) ] , or overall POPF [ 73 ( 54.5 % ) with vs 77 ( 56.6 % ) without TachoSil , ( P = .807 ) ] , but there were more clinical ly relevant POPF after h and -sewn ( 32.3 % ) versus mechanical closure ( 19.8 % ) ( P = .025 ) and , in case of splenic preservation , after splenic vessel ligation ( 15/32 , 46.9 % ) versus vascular preservation ( 17/72 , 23.6 % ) ( P = .024 ) . H and -sewn pancreatic remnant closure ( P = .023 ) and splenic vessel ligation in splenic preservation ( P = .035 ) were independent predictive factors for the onset of clinical ly relevant POPF . CONCLUSION TachoSil sponge reinforcement of the proximal remnant after distal pancreatectomy reduced neither the rate nor the severity of POPF OBJECTIVE The authors review ed the pathology , complications , and outcomes in a consecutive group of 650 patients undergoing pancreaticoduodenectomy in the 1990s . SUMMARY BACKGROUND DATA Pancreaticoduodenectomy has been used increasingly in recent years to resect a variety of malignant and benign diseases of the pancreas and periampullary region . METHODS Between January 1990 and July 1996 , inclusive , 650 patients underwent pancreaticoduodenal resection at The Johns Hopkins Hospital . Data were recorded prospect ively on all patients . All pathology specimens were review ed and categorized . Statistical analyses were performed using both univariate and multivariate models . RESULTS The patients had a mean age of 63 + /- 12.8 years , with 54 % male and 91 % white . The number of resections per year rose from 60 in 1990 to 161 in 1995 . Pathologic examination results showed pancreatic cancer ( n = 282 ; 43 % ) , ampullary cancer ( n = 70 ; 11 % ) , distal common bile duct cancer ( n = 65 ; 10 % ) , duodenal cancer ( n = 26 ; 4 % ) , chronic pancreatitis ( n = 71 ; 11 % ) , neuroendocrine tumor ( n = 31 ; 5 % ) , periampullary adenoma ( n = 21 ; 3 % ) , cystadenocarcinoma ( n = 14 ; 2 % ) , cystadenoma ( n = 25 ; 4 % ) , and other ( n = 45 ; 7 % ) . The surgical procedure involved pylorus preservation in 82 % , partial pancreatectomy in 95 % , and portal or superior mesenteric venous resection in 4 % . Pancreatic-enteric reconstruction , when appropriate , was via pancreaticojejunostomy in 71 % and pancreaticogastrostomy in 29 % . The median intraoperative blood loss was 625 mL , median units of red cells transfused was zero , and the median operative time was 7 hours . During this period , 190 consecutive pancreaticoduodenectomies were performed without a mortality . Nine deaths occurred in-hospital or within 30 days of operation ( 1.4 % operative mortality ) . The postoperative complication rate was 41 % , with the most common complications being early delayed gastric emptying ( 19 % ) , pancreatic fistula ( 14 % ) , and wound infection ( 10 % ) . Twenty-three patients required reoperation in the immediate postoperative period ( 3.5 % ) , most commonly for bleeding , abscess , or dehiscence . The median postoperative length of stay was 13 days . A multivariate analysis of the 443 patients with periampullary adenocarcinoma indicated that the most powerful independent predictors favoring long-term survival included a pathologic diagnosis of duodenal adenocarcinoma , tumor diameter <3 cm , negative resection margins , absence of lymph node metastases , well-differentiated histology , and no reoperation . CONCLUSIONS This single institution , high-volume experience indicates that pancreaticoduodenectomy can be performed safely for a variety of malignant and benign disorders of the pancreas and periampullary region . Overall survival is determined largely by the pathology within the resection specimen Objective : To evaluate the role of an absorbable fibrin sealant patch ( TachoSil ) in reducing postoperative pancreatic fistula ( POPF ) after distal pancreatectomy ( DP ) . Background : POPF remains the main complication after DP . Methods : This was a prospect i ve , open , r and omized , study in which patients undergoing elective DP were r and omized to st and ard surgical suturing or stapling with or without TachoSil . The primary end point was the incidence of POPF according to International Study Group on Pancreatic Fistula criteria . Amylase level in drainage fluid , number of days until removal of drain , and duration of hospital stay were secondary end points . Results : A total of 275 patients were enrolled at 19 centers over a 2-year period ( TachoSil , n = 145 ; st and ard , n = 130 ) . Twenty percent of procedures were laparoscopic and 21 % were spleen-preserving resections . The incidence of POPF was not significantly different between groups ( TachoSil , 62 % ; st and ard 68 % ; P = 0.267 ) . Grade A fistula rate was similar in both groups ( TachoSil 54 % ; st and ard 55 % ) , whereas the grade B + C fistula rate was 8 % with TachoSil versus 14 % without ( P = 0.139 ) . Amylase drainage level on postoperative day 1 was significantly reduced with TachoSil ( P = 0.025 ) . Median number of days until drainage removal and length of hospital stay were similar in both groups ( 7 and 10 days , respectively ) . Conclusions : The POPF rate was higher than expected when International Study Group on Pancreatic Fistula criteria were strictly applied , although the majority were biochemical fistulas . TachoSil had no significant effect on the rate of POPF , although there was a significant reduction of amylase level in drainage fluid on postoperative day 1 Objective To determine whether temporary occlusion of the main pancreatic duct with human fibrin glue decreases the incidence of intra-abdominal complications after pancreatoduodenectomy ( PD ) or distal pancreatectomy ( DP ) . Summary Background Data To the authors ’ knowledge , there are no r and omized studies comparing outcomes after pancreatic resection with or without main pancreatic duct occlusion by injection of fibrin glue . Of three nonr and omized studies , two reported no fistulas after intracanal injection and ductal occlusion with fibrin glue after PD with immediate pancreatodigestive anastomosis , while another study reported no protective effect of glue injection . Methods This prospect i ve , r and omized , single-blinded , multicenter study , conducted between January 1995 and January 1999 , included 182 consecutive patients undergoing PD followed by immediate pancreatic anastomosis or DP , whether for benign or malignant tumor or for chronic pancreatitis . One hundred two underwent pancreatic resection followed by ductal occlusion with fibrin glue ( made slowly resorbable by the addition of aprotinin ) ; 80 underwent resection without ductal occlusion . The main end point was the number of patients with one or more of the following intra-abdominal complications : pancreatic or other digestive tract fistula , intra-abdominal collection s ( infected or not ) , acute pancreatitis , or intra-abdominal or digestive tract hemorrhage . Severity factors included postoperative mortality , repeat operations , and length of hospital stay . Results The two groups were similar in pre- and intraoperative characteristics except that there were significantly more patients in the ductal occlusion group who were receiving octreotide , who had reinforcement of their anastomosis by fibrin glue , and who had fibrotic pancreatic stumps . However , the rate of patients with one or more intra-abdominal complications , and notably with pancreatic fistula , did not differ significantly between the two groups . There was still no significant difference found after statistical adjustment for these patient characteristic discrepancies , confirming the inefficacy of fibrin glue . The rate of intra-abdominal complications was significantly higher in the presence of a normal , nonfibrotic pancreatic stump and main pancreatic duct diameter less than 3 mm , whereas reinforcement of the anastomosis with fibrin glue or use of octreotide did not influence outcome . In multivariate analysis , however , normal pancreatic parenchyma was the only independent risk factor for intra-abdominal complications . No significant differences were found in the severity of complications between the two groups . Conclusions Ductal occlusion by intracanal injection of fibrin glue decreases neither the rate nor the severity of intra-abdominal complications after pancreatic resection |
11,538 | 32,332,964 | Conclusions Study results suggest that professional dental care may confer some benefit among NVAP patients .
The lack of consistent OCI protocol s , data in hospitalised patients and robust r and omised clinical trials do not allow definitive conclusions about the contribution of OCI in mitigating NVAP risk | Background Healthcare-acquired pneumonias are a significant risk for nursing home and hospital patients .
While oral care interventions ( OCIs ) have been found to be effective in reducing the risk of ventilator-associated pneumonia ( VAP ) , their utility in mitigating non-ventilator-associated pneumonias ( NVAP ) remains unknown .
We performed a structured meta- analysis of r and omised and non-r and omised clinical trials of enhanced oral hygiene procedures on NVAP .
Methods We search ed PubMed and Embase to include clinical trials ( r and omised and non-r and omised ) , and observational ( retrospective and prospect i ve ) and quasi-experimental studies examining the effect of any method of OCI on incidence of NVAP . | Background Nonventilated hospital-acquired pneumonia ( NVHAP ) is a serious nosocomial infection that is increasingly attributed to antibiotic-resistant bacteria . Methods This is a retrospective case-control study comparing patients with and those without NVHAP from January 1 , 2014 to December 31 , 2014 at Barnes-Jewish Hospital , a 1,300-bed urban academic medical center in St. Louis , Missouri . Results One hundred seventy-four consecutive patients with NVHAP were enrolled . A r and om sample of 696 control patients matched by age , sex , race , and hospital admission date were selected from a total of 5,322 potential matched control subjects . NVHAP was pathogen-negative in 98 cases ( 56.3 % ) . Respiratory viruses were identified in 42 patients ( 24.1 % ) , gram-negative bacteria were seen in 25 patients ( 14.4 % ) , and gram-positive bacteria were identified in 20 patients ( 11.5 % ) . Individuals in whom NVHAP developed were more likely to die ( 15.5 % vs 1.6 % ; P < .01 ) , to require intensive care ( 56.3 % vs 22.8 % ; P < .01 ) or mechanical ventilation ( 19.0 % vs 3.9 % ; P < 0.01 ) , and to have a longer hospital length of stay ( 15.9 days [ range , 9.8 - 26.3 days ] vs 4.4 days [ range , 2.9 - 7.3 days ] ; P < 0.01 ) . This case-control study identified a strong association between hospital mortality and NVHAP , with patients who acquired NVHAP having an 8.4 times greater odds of death ( 95 % CI , 5.6 - 12.5 ) . Conclusions The occurrence of NVHAP was associated with significant increases in mortality , the use of intensive care and mechanical ventilation , and hospital length of stay . We also found that respiratory viruses were an important cause of NVHAP . These findings suggest that efforts aim ed at the successful prevention of NVHAP could improve patient outcomes and reduce health-care costs ABSTRACT Hospital-acquired pneumonia ( HAP ) contributes greatly to patient mortality and healthcare costs . Studies have shown that aggressive oral care in intensive care units ( ICUs ) can significantly reduce pneumonia rates , and hospitals have implemented stringent protocol s in this setting . However , little is known about the effectiveness of aggressive oral care in reducing HAP in non – intensive care wards , prompting us to conduct a nonr and omized controlled clinical trial . A structured toothbrushing program was provided to an experimental cohort of patients . A control group received usual care . Patient demographics , toothbrushing frequency , and pneumonia diagnosis were recorded over a 3.5-month period . Difference in pneumonia rates was computed using unadjusted and multivariate logistic regression analyses . No significant difference in pneumonia rates between control and experimental groups was found ( 1.7 % versus 1.8 % ) . Toothbrushing rates increased significantly in the experimental group ( p = .002 ) but fell short of protocol frequency . It became apparent that aggressive toothbrushing program implementation requires nursing-led interdisciplinary involvement , more intensive training , a streamlined documentation system , and efficient compliance tracking . Lessons from this study should be used for future large-scale research . A secondary analysis of these data did , however , suggests that increasing toothbrushing rates may have the potential to reduce pneumonia in the non-ICU acute care setting OBJECTIVES Aspiration of oral secretions and their bacteria is increasingly being recognized as an important factor in pneumonia . We investigated whether oral care lowers the frequency of pneumonia in institutionalized older people . DESIGN Survey . SETTING Eleven nursing homes in Japan . PARTICIPANTS Four hundred seventeen patients r and omly assigned to an oral care group or a no oral care group . INTERVENTION Nurses or caregivers cleaned the patients ' teeth by toothbrush after each meal . Swabbing with povidone iodine was additionally used in some cases . Dentists or dental hygienists provided professional care once a week . MEASUREMENTS Pneumonia , febrile days , death from pneumonia , activities of daily living , and cognitive functions . RESULTS During follow-up , pneumonia , febrile days , and death from pneumonia decreased significantly in patients with oral care . Oral care was beneficial in edentate and dentate patients . Activities of daily living and cognitive functions showed a tendency to improve with oral care . CONCLUSION We suggest that oral care may be useful in preventing pneumonia in older patients in nursing homes 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 evaluate the effectiveness of oral health promotion interventions on clinical oral health . DESIGN Single-blind r and omized controlled trial conducted over 3 weeks of in-hospital rehabilitation . SETTING Stroke rehabilitation ward in Hong Kong . PARTICIPANTS Patients with stroke ( N=102 ) admitted to the rehabilitation ward . INTERVENTIONS Patients were r and omly assigned either : ( 1 ) oral hygiene instruction , ( 2 ) oral hygiene instruction and chlorhexidine mouthrinse , or ( 3 ) oral hygiene instruction , chlorhexidine mouthrinse , and assisted brushing . MAIN OUTCOME MEASURES Dental plaque , gingival bleeding , and oral functional status were assessed at baseline and review . Development of infectious complications were also monitored during the clinical trial . RESULTS Poor oral hygiene and an overall neglect of oral hygiene practice s were observed at baseline . Reductions in dental plaque were significantly greater in the 2 groups receiving chlorhexidine compared with the group receiving oral hygiene instruction alone ( P<.001 ) . Reductions in gingival bleeding scores were 3- to 4-fold greater in groups receiving chlorhexidine . No cases of pneumonia were observed during the course of the clinical trial . CONCLUSIONS The oral health condition of patients may be safeguarded after acute stroke with the use of chlorhexidine mouthrinse in conjunction with a st and ard mechanical plaque removal tool , such as an electric toothbrush . These interventions are acceptable to the majority of patients , and their administration poses a minimal burden to rehabilitation ward staff BACKGROUND Pneumonia remains an important public health problem among elderly nursing home residents . This clinical trial sought to determine if a multicomponent intervention protocol , including manual tooth/gum brushing plus 0.12 % chlorhexidine oral rinse , twice per day , plus upright positioning during feeding , could reduce the incidence of radiographically documented pneumonia among nursing home residents , compared with usual care . METHODS This cluster-r and omized clinical trial was conducted in 36 nursing homes in Connecticut . Eligible residents > 65 years with at least 1 of 2 modifiable risk factors for pneumonia ( ie , impaired oral hygiene , swallowing difficulty ) were enrolled . Nursing homes were r and omized to the multicomponent intervention protocol or usual care . Participants were followed for up to 2.5 years for development of the primary outcome , a radiographically documented pneumonia , and secondary outcome , a lower respiratory tract infection ( LRTI ) without radiographic documentation . RESULTS A total of 834 participants were enrolled : 434 to intervention and 400 to usual care . The trial was terminated for futility . The number of participants in the intervention vs control arms with first pneumonia was 119 ( 27.4 % ) vs 94 ( 23.5 % ) , respectively , and with first LRTI , 125 ( 28.8 % ) vs 100 ( 25.0 % ) , respectively . In a multivariable Cox regression model , the hazard ratio in the intervention vs control arms , respectively , was 1.12 ( 95 % confidence interval [ CI ] , .84 - 1.50 ; P = .44 ) for first pneumonia and 1.07 ( 95 % CI , .79 - 1.46 , P = .65 ) for first LRTI . CONCLUSIONS The multicomponent intervention protocol did not significantly reduce the incidence of first radiographically confirmed pneumonia or LRTI compared with usual care in nursing home residents . CLINICAL TRIALS REGISTRATION NCT00975780 INTRODUCTION The purpose of this point-of-care study was to test the efficacy of a prevention-based oral care protocol in reducing non-ventilator-associated hospital-acquired pneumonia in a neurosurgical population outside the critical care environment . The research ers hypothesized that an enhanced oral care protocol would decrease the incidence of pneumonia . METHODS This quasi-experimental , comparative study took place on an acute neurosurgical unit at a tertiary care trauma hospital in Western Canada . Subjects were non-intubated , care-dependent adults with a primary diagnosis of neurologic injury/insult , and at high risk for pneumonia . The prospect i ve study group comprised 34 subjects ; two subjects were excluded from the study analysis . The retrospective study group comprised 51 subjects . Data were collected for both groups for a six-month period . Retrospective data were collected through chart review . The prospect i ve group were eligible neurosurgical patients who received the enhanced oral care protocol . Data collection tools were developed and diagnostic criteria for hospital-acquired pneumonia were determined . The pneumonia rates between subjects who received st and ard oral care ( retrospective group ) and those who received an enhanced , prevention-based , oral care protocol ( prospect i ve group ) were compared . RESULTS A statistically significant decrease in the pneumonia rate occurred in the prospect i ve group ( p < 0.05 ) . DISCUSSION An enhanced oral care protocol was beneficial in reducing the incidence of non-ventilator-associated hospital-acquired pneumonia . IMPLICATION S Nurses play a vital role in preventing hospital-acquired pneumonia . Foundational nursing practice s , such as regular oral hygiene , are important aspects of care in preventing nosocomial infections and related costs , optimizing health , and promoting quality care OBJECTIVE We evaluated the effectiveness of professional oral health care ( POHC ) given by dental hygienists once a week for 24 months to 141 elderly persons needing daily care and living in 2 nursing homes . STUDY DESIGN Elderly subjects with POHC and without POHC living in 2 nursing homes were examined for 24 months to detect any fevers of 37.8 degrees C or more and the prevalence of fatal aspiration pneumonia . The numbers of Staphylococcus species and C and ida albicans in swab sample s from oral cavities were compared between the POHC group and the non-POHC group . The amounts of methylmercaptan exhaled in the POHC group were determined and compared with those in the non-POHC group . RESULTS The prevalence of fevers of 37.8 degrees C or more in the subjects receiving POHC was significantly lower than in the non-POHC group ( P < .05 ) . We found that the ratio of fatal aspiration pneumonia in the POHC group during the 24 months was significantly lower than in the non-POHC group ( P < .05 ) . Numbers of C albicans species in sample s obtained from the oral cavity after 6 months of POHC were significantly lower than those in the non-POHC group ( P < .01 ) . POHC result ed in the reduction of the presence of Staphylococcus but not to a statistically significant extent . The amounts of methylmercaptan exhaled by the POHC group were significantly less than those of the non-POHC group ( P < .05 ) . CONCLUSION This study showed that POHC administered by dental hygienists to a group of elderly patients needing daily nursing care was associated with a reduction in prevalence of fever and fatal pneumonia Background A point‐prevalence survey that was conducted in the United States in 2011 showed that 4 % of hospitalized patients had a health care – associated infection . We repeated the survey in 2015 to assess changes in the prevalence of health care – associated infections during a period of national attention to the prevention of such infections . Methods At Emerging Infections Program sites in 10 states , we recruited up to 25 hospitals in each site area , prioritizing hospitals that had participated in the 2011 survey . Each hospital selected 1 day on which a r and om sample of patients was identified for assessment . Trained staff review ed medical records using the 2011 definitions of health care – associated infections . We compared the percentages of patients with health care – associated infections and performed multivariable log‐binomial regression modeling to evaluate the association of survey year with the risk of health care – associated infections . Results In 2015 , a total of 12,299 patients in 199 hospitals were surveyed , as compared with 11,282 patients in 183 hospitals in 2011 . Fewer patients had health care – associated infections in 2015 ( 394 patients [ 3.2 % ; 95 % confidence interval { CI } , 2.9 to 3.5 ] ) than in 2011 ( 452 [ 4.0 % ; 95 % CI , 3.7 to 4.4 ] ) ( P<0.001 ) , largely owing to reductions in the prevalence of surgical‐site and urinary tract infections . Pneumonia , gastrointestinal infections ( most of which were due to Clostridium difficile [ now Clostridioides difficile ] ) , and surgical‐site infections were the most common health care – associated infections . Patients ' risk of having a health care – associated infection was 16 % lower in 2015 than in 2011 ( risk ratio , 0.84 ; 95 % CI , 0.74 to 0.95 ; P=0.005 ) , after adjustment for age , presence of devices , days from admission to survey , and status of being in a large hospital . Conclusions The prevalence of health care – associated infections was lower in 2015 than in 2011 . To continue to make progress in the prevention of such infections , prevention strategies against C. difficile infection and pneumonia should be augmented . ( Funded by the Centers for Disease Control and Prevention . BACKGROUND Oral cleansing with chlorhexidine decreases the incidence of nosocomial pneumonia in patients after cardiac surgery . However , evidence of its benefit in ICU patients is conflicting . METHODS Patients admitted to the ICU of an Indian tertiary care teaching hospital were r and omized to twice-daily oropharyngeal cleansing with 0.2 % chlorhexidine or 0.01 % potassium permanganate ( control ) solution . Effects on the incidence of nosocomial pneumonia during ICU stay ( primary outcome ) and length of ICU stay and in-hospital mortality ( secondary outcomes ) were studied . RESULTS Five hundred twelve patients were r and omized to either the chlorhexidine group ( n = 250 ) or the control group ( n = 262 ) . Of the 471 subjects who completed the protocol , nosocomial pneumonia developed in 16 of 224 subjects ( 7.1 % ) in the chlorhexidine group and 19 of 247 subjects ( 7.7 % ) in the control group ( p = 0.82 ; relative risk , 0.93 ; 95 % confidence interval , 0.49 to 1.76 ) ; intention-to-treat analysis of 21 patients in whom the cleansing protocol was not followed revealed similar results . There was no significant difference between the study and control groups in the median day of development of pneumonia ( 5.0 days : interquartile range [ IQR ] , 3.0 to 7.7 vs 5.0 days : IQR , 3.0 to 6.0 , respectively ) , median ICU stay ( 5.0 days : IQR , 3.0 to 8.0 vs 6.0 days : IQR , 3.0 to 8.0 , respectively ) , and mortality ( 34.8 % vs 28.3 % , respectively ) . On subgroup analysis , there was no significant difference in the primary and secondary outcomes in patients on mechanical ventilation , tracheal intubation , and coma ( Glasgow coma scale < or= 8) . During the study period , nosocomial pneumonia developed in fewer subjects ( 35 of 471 subjects [ 7.4 % ] ) than in the 3 months preceding and following the study ( 98 of 452 subjects [ 21.7 % ] ; p < 0.001 ; relative risk , 0.34 ; 95 % confidence interval , 0.24 to 0.49 ) . CONCLUSIONS Oropharyngeal cleansing with 0.2 % chlorhexidine solution was not superior to oral cleansing with the control solution . However , the decreased incidence of nosocomial pneumonia during the study period suggests a possible benefit of meticulous oral hygiene in ICU patients |
11,539 | 19,424,450 | : The evidence from this review does not clearly support one single intervention to optimize medication adherence in older patients . | OBJECTIVE : To review the literature on strategies to optimize medication adherence in community-dwelling older adults and to make recommendations for clinical practice . | The effect of pharmaceutical care on the prevention , detection , and resolution of medication-related problems in high-risk patients in a rural community was studied . Adult patients who received care at clinics in a medically underserved area of Alabama and who were identified as being at high risk of medication-related adverse events were r and omly assigned to a control group or an intervention group . The control group received st and ard medical care , and the intervention group received pharmaceutical care , including a medical record review , a medication history review , pharmacotherapeutic evaluation , and patient medication education and monitoring over a one-year period . A total of 69 patients completed the study ( 33 in the intervention group and 36 in the control group ) . The percentage of patients responding to hypertension , diabetes , dyslipidemia , and anticoagulation therapy increased significantly in the intervention group and declined in the control group . Ratings for inappropriate prescribing improved in all 10 domains evaluated in the intervention group but worsened in 5 domains in the control group . There were no significant differences between the groups at 12 months in health-related quality of life or medication misadventures . Medication compliance scores improved in the intervention group but not in the control group . Medication knowledge increased in the intervention group and decreased in the control group . Pharmaceutical care in a rural , community-based setting appeared to reduce inappropriate prescribing , enhance disease management , and improve medication compliance and knowledge without adversely affecting health-related quality of life Aim : To measure the outcomes of a harmonised , structured pharmaceutical care programme provided to elderly patients by community pharmacists . Method : A r and omised , controlled , longitudinal , clinical trial with repeated measures was performed over an 18‐month period , involving community pharmacies ( 5 intervention and 5 control ) in Northern Irel and . Elderly , ambulatory patients ( ≥ 65 years ) , taking 4 or more prescribed medications were eligible for participation . Patients attending an intervention pharmacy received education on medical conditions , implementation of compliance strategies , rationalising of drug regimens and appropriate monitoring ; patients attending control sites received normal services . A battery of clinical , humanistic and economic outcomes were assessed . Results : A significantly higher proportion of intervention patients were compliant at the end of the 18‐month study and experienced fewer problems with medication compared to control patients ( P < 0.05 ) . There was little impact on quality of life and health care utilisation . Conclusions : Pharmaceutical care provision to community‐dwelling patients result ed in an improvement in medication compliance and evidence of cost‐savings . Future pharmaceutical care studies may benefit from a more focussed selective approach to data collection and outcomes measurement Abstract Objective To investigate the effects of compliance and periodic telephone counselling by a pharmacist on mortality in patients receiving polypharmacy . Design Two year r and omised controlled trial . Setting Hospital medical clinic . Participants 502 of 1011 patients receiving five or more drugs for chronic disease found to be non-compliant at the screening visit were invited for r and omisation to either the telephone counselling group ( n = 219 ) or control group ( n = 223 ) at enrolment 12 - 16 weeks later . Main outcome measures Primary outcome was all cause mortality in r and omised patients . Associations between compliance and mortality in the entire cohort of 1011 patients were also examined . Patients were defined as compliant with a drug if they took 80 - 120 % of the prescribed daily dose . To calculate a compliance score for the whole treatment regimen , the number of drugs that the patient was fully compliant with was divided by the total number of prescribed drugs and expressed as a percentage . Only patients who complied with all recommended drugs were considered compliant ( 100 % score ) . Results 60 of the 502 eligible patients defaulted and only 442 patients were r and omised . After two years , 31 ( 52 % ) of the defaulters had died , 38 ( 17 % ) of the control group had died , and 25 ( 11 % ) of the intervention group had died . After adjustment for confounders , telephone counselling was associated with a 41 % reduction in the risk of death ( relative risk 0.59 , 95 % confidence interval 0.35 to 0.97 ; P = 0.039 ) . The number needed to treat to prevent one death at two years was 16 . Other predictors included old age , living alone , rate of admission to hospital , compliance score , number of drugs for chronic disease , and non-treatment with lipid lowering drugs at screening visit . In the cohort of 1011 patients , the adjusted relative risk for death was 1.61 ( 1.05 to 2.48 ; P = 0.029 ) and 2.87 ( 1.80 to 2.57 ; P < 0.001 ) in patients with compliance scores of 34 - 66 % and 0 - 33 % , respectively , compared with those who had a compliance score of 67 % or more . Conclusion In patients receiving polypharmacy , poor compliance was associated with increased mortality . Periodic telephone counselling by a pharmacist improved compliance and reduced mortality . Trial registration International St and ard R and omised Controlled Trial Number Register : S RCT N48076318 OBJECTIVE To compare patients ' adherence to therapy , expectations , satisfaction with pharmacy services , and health-related quality of life ( HRQOL ) after the provision of pharmaceutical care with those of patients who received traditional pharmacy care . DESIGN R and omized controlled cluster design . SETTING Sixteen community pharmacies in Alberta , Canada . PATIENTS AND OTHER PARTICIPANTS Ambulatory elderly ( > or = 65 years of age ) patients covered under Alberta Health & Wellness 's senior drug benefit plan and who were concurrently using three or more medications according to pharmacy profiles . INTERVENTION Pharmacies were r and omly assigned to either treatment ( intervention ) or control ( traditional pharmacy care ) groups . Patients at treatment pharmacies were recruited into the study , and pharmacists provided comprehensive pharmaceutical care services . Pharmacists at control pharmacies continued to provide traditional pharmacy care . MAIN OUTCOME MEASURES Study participants ' opinions , adherence to therapy , and scores on the Medical Outcomes Study 36-Item Short Form Health Survey ( SF-36 ) . RESULTS Compared with those of patients receiving traditional care , treatment patients ' expectations that their pharmacist would perform activities congruent with pharmaceutical care changed over the study period . Treatment patients ' satisfaction with the constructs " trust , " " evaluation and goal setting , " and " communicates with doctor " were also positively affected . HRQOL and patient adherence were not significantly affected by pharmaceutical care interventions . CONCLUSION Successful implementation of a pharmaceutical care practice model has the potential to increase patients ' satisfaction with their pharmacists ' activities and may increase patients ' expectations that pharmacists will work on their behalf to assist them with their health care needs . If pharmaceutical care affects patients ' HRQOL , instruments more specific than the SF-36 may be needed to detect the differences CONTEXT Poor medication adherence diminishes the health benefits of pharmacotherapies . Elderly patients with coronary risk factors frequently require treatment with multiple medications , placing them at increased risk for nonadherence . OBJECTIVE To test the efficacy of a comprehensive pharmacy care program to improve medication adherence and its associated effects on blood pressure ( BP ) and low-density lipoprotein cholesterol ( LDL-C ) . DESIGN , SETTING , AND PATIENTS A multiphase , prospect i ve study with an observational phase and a r and omized controlled trial conducted at the Walter Reed Army Medical Center of 200 community-based patients aged 65 years or older taking at least 4 chronic medications . The study was conducted from June 2004 to August 2006 . INTERVENTION After a 2-month run-in phase ( measurement of baseline adherence , BP , and LDL-C ) , patients entered a 6-month intervention phase ( st and ardized medication education , regular follow-up by pharmacists , and medications dispensed in time-specific packs ) . Following the intervention phase , patients were r and omized to continued pharmacy care vs usual care for an additional 6 months . MAIN OUTCOME MEASURES Primary end point of the observation phase was change in the proportion of pills taken vs baseline ; secondary end points were the associated changes in BP and LDL-C. Primary end point of the r and omization phase was the between-group comparison of medication persistence . RESULTS A total of 200 elderly patients ( 77.1 % men ; mean [ SD ] age , 78 [ 8.3 ] years ) , taking a mean ( SD ) of 9 ( 3 ) chronic medications were enrolled . Coronary risk factors included drug-treated hypertension in 184 patients ( 91.5 % ) and drug-treated hyperlipidemia in 162 ( 80.6 % ) . Mean ( SD ) baseline medication adherence was 61.2 % ( 13.5 % ) . After 6 months of intervention , medication adherence increased to 96.9 % ( 5.2 % ; P<.001 ) and was associated with significant improvements in systolic BP ( 133.2 [ 14.9 ] to 129.9 [ 16.0 ] mm Hg ; P = .02 ) and LDL-C ( 91.7 [ 26.1 ] to 86.8 [ 23.4 ] mg/dL ; P = .001 ) . Six months after r and omization , the persistence of medication adherence decreased to 69.1 % ( 16.4 % ) among those patients assigned to usual care , whereas it was sustained at 95.5 % ( 7.7 % ) in pharmacy care ( P<.001 ) . This was associated with significant reductions in systolic BP in the pharmacy care group ( -6.9 mm Hg ; 95 % CI , -10.7 to -3.1 mm Hg ) vs the usual care group ( -1.0 mm Hg ; 95 % CI , -5.9 to 3.9 mm Hg ; P = .04 ) , but no significant between-group differences in LDL-C levels or reductions . CONCLUSIONS A pharmacy care program led to increases in medication adherence , medication persistence , and clinical ly meaningful reductions in BP , whereas discontinuation of the program was associated with decreased medication adherence and persistence . TRIAL REGISTRATION clinical trials.gov Identifier : BACKGROUND Noncompliance is a major factor in the morbidity and unnecessary hospital readmissions for patients with heart failure . Several studies have aim ed to reduce rehospitalizations in heart failure patients through a comprehensive , multidisciplinary approach . Medication compliance was rarely measured in these studies or , when it was measured , the method employed was seldom valid . We aim ed at determining the effect of a pharmacist-led intervention on medication compliance in patients with heart failure . METHODS We conducted a r and omized controlled trial into the effect of a pharmacist-led intervention on medication compliance in patients with heart failure ( predominantly New York Heart Association [ NYHA ] II and III ) treated with loop diuretics , presenting to a cardiology outpatient clinic or admitted to hospitals in The Netherl and s. Patients in the intervention group received monthly consultations from their community pharmacist during a 6-month period . Patients in the control group received usual care . Primary endpoint was medication compliance , assessed with a medication event monitoring system , an electronic pill bottle that registers time of opening . Secondary endpoints were the number of rehospitalizations , death , and quality of life . RESULTS A total of 152 patients were r and omized : 74 patients to the intervention arm and 78 patients to the usual care arm . Over the 6-month study period , patients in the intervention group had 140/7656 days without use of loop diuretics compared with 337/6196 days in the usual care group ( relative risk 0.33 [ confidence interval ( CI ) 95 % 0.24 - 0.38 ] ) . Two consecutive days of nondosing occurred on 18/7656 days in the intervention group compared with 46/6196 days in the usual care group ( relative risk 0.32 [ CI 95 % 0.19 - 0.55 ] ) . There were no significant differences in rehospitalizations , mortality , or disease-specific quality of life between groups . CONCLUSIONS A pharmacy-led intervention can improve medication compliance in patients with moderate to severe heart failure , even in those with relatively high compliance . Future interventions should also focus at less compliant patients The objective of this systematic review was to evaluate the impact of pharmacist delivered community-based services to optimise the use of medications for mental illness . Twenty-two controlled ( r and omised and non-r and omised ) studies of pharmacists ' interventions in community and residential aged care setting s identified in international scientific literature were included for review . Papers were assessed for study design , service recipient , country of origin , intervention type , number of participating pharmacists , method ological quality and outcome measurement . Three studies showed that pharmacists ' medication counselling and treatment monitoring can improve adherence to antidepressant medications among those commencing treatment when calculated using an intention-to-treat analysis . Four trials demonstrated that pharmacist conducted medication review s may reduce the number of potentially inappropriate medications prescribed to those at high risk of medication misadventure . The results of this review provide some evidence that pharmacists can contribute to optimising the use of medications for mental illness in the community setting . However , more well design ed studies are needed to assess the impact of pharmacists as members of community mental health teams and as providers of comprehensive medicines information to people with schizophrenia and bipolar Context Many patients have both diabetes and depression . Some hypothesize that treating depression might improve diabetes outcomes . Contribution In this r and omized trial , 12 months of depression care management for depressed patients with diabetes improved depression-related outcomes and increased the frequency of exercise . However , care management did not affect diet , diabetes medication adherence , glucose testing , or glycemic control . Caution s The study sample had reasonably good diabetes control at baseline . Whether patients with poorly controlled diabetes would benefit from depression care is not known . The Editors Major depression and dysthymic disorder affect 5 % to 10 % of older adults seen in primary care setting s ( 1 - 3 ) . Late-life depression is often chronic or recurrent ( 4 - 6 ) and is associated with substantial suffering , functional impairment , and diminished health-related quality of life ( 7 ) . Diabetes mellitus affects 7.8 % of all adults and almost 1 in 5 of those age 60 years and older ( 8) . Individuals with diabetes mellitus have a 2-fold higher rate of major depression than those without diabetes ( 9 , 10 ) . Depression adversely affects the course of coexisting medical illness , contributing to increased symptom burden , functional impairment , and mortality ( 11 , 12 ) . For patients with diabetes mellitus , depression is associated with decreased glycemic control and increased number of micro- and macrovascular complications ( 13 , 14 ) . The mechanism of effect is not understood but may be related to depression-induced abnormalities in neuroendocrine and neurotransmitter function or decreased self-care behaviors ( 15 - 20 ) . Integrating evidence -based depression care for persons with diabetes may improve both depression and diabetes outcomes . Three small r and omized , controlled trials have studied the effect of treatment for depression on affective and glycemic outcomes in patients with depression and diabetes mellitus ( 21 - 23 ) . These studies have consistently shown improvements in affective outcomes , but effects on glycemic control have been mixed . Primary care physicians are well positioned to provide integrated care for depression and diabetes mellitus but face many barriers . Controlled trials report that treatment for depression is efficacious in approximately 70 % of persons who complete treatment compared with 30 % of those who receive placebo ( 24 ) . However , these results are difficult to replicate in routine primary care practice . Barriers to high- quality care include suboptimal recognition ; inconsistent treatment with lack of close follow-up and monitoring ; and organizational barriers , such as brief visits , poor integration with specialty mental health care , competing clinical priorities , and lack of decision support systems ( 25 - 27 ) . Simple interventions , such as depression screening and physician education , have little impact on these barriers and patient outcomes ( 28 - 30 ) . Treatment models that use a depression specialist working collaboratively with primary care physicians have shown clinical ly important improvement in patient outcomes ( 31 - 37 ) . We recently reported robust effects of such a model for older adults with major depression or dysthymia ( 37 ) . In this preplanned analysis , we evaluate the effects on affective and diabetes-specific outcomes . If effective care for depression also benefits adherence to self-care regimens , functional status , and other medical illness outcomes , it would add powerful quality -of-care and economic incentives for the dissemination and maintenance of these models . In addition , if effective care for depression improves self-care behaviors , it may also positively affect other chronic medical illnesses with important self-care components . For this prespecified subgroup analysis , we focused on older adults with clinical depression and coexisting diabetes mellitus . We hypothesized that the collaborative care intervention would improve affective symptoms , functional status , self-care behaviors , and glycemic control . In addition , we hypothesized that effects on glycemic control would be greatest for patients with baseline hemoglobin A1c values of 8.0 % or greater . Methods The Improving MoodPromoting Access to Collaborative Treatment ( IMPACT ) study is a multisite r and omized , controlled trial of a collaborative care intervention program for late-life depression in primary care ( 37 , 38 ) . Institutional review boards at participating sites approved study protocol s , and all participants gave written informed consent . Patients Seven study sites representing 8 diverse health care organizations with a total of 18 primary care clinics in 5 states participated in the study . From July 1999 to August 2001 , depressed older adults were recruited through referrals from primary care practitioners and other clinic staff or through systematic depression screening with a 2-item depression screener adapted from the Primary Care Evaluation of Mental Disorders ( 39 ) . Of the 2190 patients referred to the study , 308 ( 14 % ) declined the initial eligibility screening or additional interviews , 54 ( 3 % ) had incomplete initial screenings , and 202 ( 9 % ) were ineligible because they were younger than 60 years of age or they did not plan to use the participating clinic over the coming 12 months . Of the 32908 patients approached for screening , 5246 ( 16 % ) declined the initial screening or follow-up interviews . A total of 1791 ( 5 % ) of the initial screenings were incomplete and 23233 ( 71 % ) of those screened were not eligible because they did not have one of the core depression symptoms ( 95 % ) or because of logistic reasons such as lack of transportation or access to a telephone ( 5 % ) . The remaining 1626 ( 74 % ) of those referred and 2638 ( 8 % ) of those screened completed a computer-assisted structured clinical interview for Diagnostic and Statistical Manual of Mental Disorders , fourth edition ( DSM-IV ) , to assess whether patients met research diagnostic criteria for major depression or dysthymia ( 40 ) . Inclusion criteria were age 60 years or older , plans to use one of the participating clinics as the main source of general medical care in the coming year , and a diagnosis of current major depression or dysthymic disorder according to the structured clinical interview for DSM-IV . Otherwise eligible persons were excluded because of a current drinking problem ( a score of 2 on the CAGE question naire ) ( 41 ) , a history of bipolar disorder or psychosis ( 38 ) , ongoing treatment with a psychiatrist , or severe cognitive impairment defined by a score less than 3 on a 6-item cognitive screener ( 42 ) . We identified 2102 eligible older adults with major depression or dysthymic disorder , of whom 1801 ( 86 % ) enrolled in the study . As part of the structured baseline interview , enrolled patients were asked Has a doctor or another health care worker diagnosed you with or treated you for high blood sugar or diabetes in the past 3 years ? The 417 patients who endorsed this question are the focus of the diabetes-specific analyses . After the baseline interview , we r and omly assigned participants to the IMPACT intervention or usual care . The r and omization was stratified by recruitment method ( screening or referral ) and clinic . R and omization information was contained in a set of numbered , sealed envelopes for each stratum that were used sequentially for newly enrolled patients at each clinic ( 38 ) . Diagnoses were communicated to enrolled patients and their primary care physicians . Intervention Patients in the intervention group received a 20-minute educational videotape and a booklet about late-life depression and were encouraged to have an initial visit with a depression care manager at the primary care clinic ( 43 , 44 ) . Care managers were nurses or psychologists who were trained for the study as a depression clinical specialist ( 38 , 45 ) . During the initial visit , the depression clinical specialist conducted a clinical and psychosocial history , review ed the educational material s , and discussed patient preferences for depression treatment ( antidepressant medications or psychotherapy ) . New patients and patients needing treatment plan adjustments were discussed with a supervising team psychiatrist and a liaison primary care physician during a weekly team meeting . The depression clinical specialist then worked with the patient and his or her regular primary care provider to establish a treatment plan according to an evidence -based treatment algorithm ( 38 ) . The IMPACT algorithm suggested an initial choice of an antidepressant ( usually a selective serotonin reuptake inhibitor ) or a course of Problem-Solving Treatment in Primary Care ( PST-PC ) , which consisted of 6 to 8 brief sessions of structured psychotherapy for depression , delivered by the depression clinical specialist in primary care ( 46 - 49 ) . For patients who were already receiving antidepressant medications but who were still depressed , the recommendation for partial responders was to increase the dose or augment the antidepressant with a trial of PSTPC ; the recommendation for nonresponders was to switch to a different medication or use a trial of PSTPC . Depression clinical specialists also encouraged patients to increase behavioral activation and referred them to additional health or social services , as clinical ly indicated . The intervention did not specifically address diabetes mellitus or other coexisting medical illnesses . As care managers , depression clinical specialists attempted to follow patients for up to 12 months ; they monitored treatment response with the Primary Care Evaluation of Mental Disorders Patient Health Question naire ( 50 ) and a Web-based clinical information system ( 51 ) . During the acute treatment phase , in-person or telephone follow-up contacts were suggested at least every other week . Patients who recovered from depression ( 50 % reduction in the Patient Health Question naire score and <3 of 9 symptoms of major depression ) were engaged in developing a relapse prevention plan and were then OBJECTIVE to examine the effects and feasibility of educating and empowering older people with ischaemic heart disease using trained senior lay health mentors . DESIGN r and omised controlled trial with blinded evaluation . SETTING Falkirk and District Royal Infirmary . PARTICIPANTS in patients and out patients aged 60 or over attending secondary care with a diagnosis of angina or acute myocardial infa rct ion . Three-hundred and nineteen entered and 289 completed exit assessment s. The intervention group took part in mentoring groups for 1 year , meeting monthly for 2 hours , each led by two trained lay health mentors in addition to st and ard care . MAIN OUTCOME MEASURES primary outcome measures were changes in coronary risk factors , medication usage and actual use of secondary care health services . Secondary outcomes were total and cardiovascular events ; changes in medication compliance , non-medical support requirement , health status and psychological functioning , and social inclusion . RESULTS there were significant improvements in a reported current exercise score ( mean + 0.33 , + 0.02 to + 0.52 ) , in the average time spent walking per week by 72 minutes ( + 1 to + 137 minutes ) , and in the SF36 Physical Functioning Score ( + 6.1 , + 2.4 to + 9.5 ) . There was a 1.0 % reduction in total fat ( 95 % CI -3.0 % to -0.6 % ) and a 0.6 % reduction in saturated fat ( 95 % CI -1.5 % to -0.03 % ) . The intervention group showed reduced outpatient attendance for coronary heart disease ( -0.25 appointments , -0.61 to -0.08 ) . Attendance rates were high . Socio-economic grouping did not affect participation . CONCLUSIONS Lay Health Mentoring is feasible , practical and inclusive , positively influencing diet , physical activity , and health re source utilisation in older subjects with ischaemic heart disease without causing harm BACKGROUND Lack of medication adherence is a common reason for poor control of blood pressure in the community , increasing the risk of heart attacks and strokes . OBJECTIVE To evaluate the effect of nurse-led adherence support for people with uncontrolled high blood pressure compared with usual care . METHODS We recruited 245 women and men with uncontrolled hypertension ( > or = 150/90 mmHg ) from 21 general practice s in Bristol , UK . Participants were r and omized to receive nurse-led adherence support or usual care alone . Main outcome measures were adherence to medication ( ' timing compliance ' ) and blood pressure . RESULTS Mean baseline timing compliance ( + /- SD ) was high in both the intervention ( 90.8 + /- 15.6 % ) and the control group ( 94.5 + /- 7.6 % ) . There was no evidence of an effect of the intervention on timing compliance at follow-up ( adjusted difference in means -1.0 % ; 95 % confidence interval ( CI ) -5.1 to 3.1 ) . There was also no difference at follow-up between the groups with regard to systolic blood pressure ( -2.7 mmHg ; 95 % CI -7.2 to 1.8 ) or diastolic blood pressure ( 0.2 mmHg ; 95 % CI -1.9 to 2.3 ) . Projected costs for the primary care sector per consultation were 6.60 pound sterling for the intervention compared with 5.08 pound sterling for usual care . CONCLUSION In this study , adherence to blood pressure medication was much higher than previously reported . There was no evidence of an effect of nurse-led adherence support on medication adherence or blood pressure compared with usual care . Nurse-led adherence support was also more expensive from a primary care perspective The medical care system is not very effective in modifying health behavior of individuals , in particular , ensuring patient compliance with medication regimens , healthy diets , regular physical activity , and regular health screening , and in the avoidance of substance abuse . Telephone-Linked Care ( TLC ) is a telecommunications technology that enables computer-controlled telephone counseling with patients in their homes . It has been applied to the task of improving a number of different health behaviors . R and omized controlled studies suggest that use of the system for as little as 3 months is associated with improvement in adherence to medication regimens , dietary change in hypercholesterolemia , and increased physical activity among sedentary individuals . Future work involves applying the technology to other important health behaviors , optimally using health behavior theory in the system design , targeting use of TLC to the most appropriate patient groups , incorporating new computer and telecommunications technology into the system , and interfacing TLC into the health care delivery system Objective To assess the effects of pharmacists giving advice to meet patients ’ needs after starting a new medicine for a chronic condition . Method A prospect i ve health technology assessment including a r and omised controlled trial of a pharmacist-delivered intervention to improve adherence using a central ised telephone service to patients at home in Engl and . Patients were eligible for recruitment if they were receiving the first prescription for a newly prescribed medication for a chronic condition and were 75 or older or suffering from stroke , cardiovascular disease , asthma , diabetes or rheumatoid arthritis . Main outcome measures Incidence of non-adherence , problems with the new medicine , beliefs about the new medicine , safety and usefulness of the interventions . Results Five hundred patients consented and were r and omised . At 4-week follow-up , non-adherence was significantly lower in the intervention group compared to control ( 9 % vs. 16 % , P = 0.032 ) . The number of patients reporting medicine-related problems was significantly lower in the intervention group compared to the control ( 23 % vs. 34 % , P = 0.021 ) . Intervention group patients also had more positive beliefs about their new medicine , as shown by their higher score on the “ necessity-concerns differential ” ( 5.0 vs. 3.5 , P = 0.007 ) . The phone calls took a median of 12 min each . Most advice was judged by experts to be safe and helpful , and patients found it useful . Conclusion Overall , these findings show benefits from pharmacists meeting patients ’ needs for information and advice on medicines , soon after starting treatment . While a substantially larger trial would be needed to confirm that the effect is real and sustained , these initial findings suggest the service may be safe and useful to patients OBJECTIVE : To improve medication adherence by reducing self-reported adherence barriers , and to identify medication discrepancies by comparing physician-prescribed and patient-reported medical regimens . DESIGN : Prospect i ve , r and omized , controlled trial . SETTING AND PARTICIPANTS : A single academically affiliated community health center . Eligible patients had type 2 diabetes , had undergone laboratory testing in the year preceding the study , and had visited the clinic in the 6 months preceding the study . INTERVENTION : A pharmacist administered detailed question naires , provided tailored education regarding medication use and help with appointment referrals , and created a summary of adherence barriers and medication discrepancies that was entered into the medical record and electronically forwarded to the primary care provider . MEASUREMENTS : Changes in self-reported adherence rates and barriers were compared 3 months after the initial interview . Intervention patients with medication discrepancies at baseline were assessed for resolution of discrepancies at 3 months . RESULTS : Rates of self-reported medication adherence were very high and did not improve further at 3 months ( 6.9 of 7 d , with all medicines taken as prescribed ; p = 0.3 ) . Medical regimen discrepancies were identified in 44 % of intervention patients , involving 45 doses of medicines . At 3-month follow-up , 60 % of discrepancies were resolved by corrections in the medical record , while only 7 % reflected corrections by patients . CONCLUSIONS : In this community cohort , patients reported few adherence barriers and very high medication adherence rates . Our patient-tailored intervention did not further reduce these barriers or improve self-reported adherence . The high prevalence of medication discrepancies appeared to mostly reflect inaccuracies in the medical record rather than patient errors OBJECTIVE : To assess the effectiveness of mailed hypertension educational material s. DESIGN : Prospect i ve , r and omized , controlled single-blind trial . SETTING : Primary care practice -based research network in which 9 clinics located in Portl and , Oregon participated . PARTICIPANTS : Patients with mildly uncontrolled hypertension as defined as a last blood pressure of 140 to 159/90 to 99 mmHg from query of an electronic medical record data base . INTERVENTIONS : Patients r and omized to intervention were mailed 2 educational packets approximately 3 months apart . The first mailer included a letter from each patient ’s primary care provider . The mailer included a booklet providing an overview of hypertension and lifestyle modification and a refrigerator magnet noting target blood pressure . The second mailing also included a letter from the patient ’s primary care provider , a second educational booklet focused on medication compliance and home blood pressure monitoring , and a blood pressure logbook . The control group consisted of similar patients receiving usual care for hypertension . MEASUREMENTS AND MAIN RESULTS : Patients from each group were r and omly selected for invitation to participate in a study visit to measure blood pressure and complete a survey ( intervention n=162 ; control n=150 ) . No significant difference was found in mean blood pressure between intervention and control patients ( 135/77 mmHg vs 137/77 mmHg ; P=.229 ) . Patients in the intervention arm scored higher on a hypertension knowledge quiz ( 7.48 ± 1.6 vs 7.06 ± 1.6 ; P=.019 ) , and reported higher satisfaction with several aspects of their care . No significant difference was seen in the prevalence of home blood pressure monitoring ownership or use . CONCLUSIONS : In patients with mildly uncontrolled hypertension , educational mailers did not yield a significant decrease in blood pressure . However , significant improvement in patient knowledge , frequency of home monitoring , and satisfaction with care were demonstrated We evaluated a structured pharmaceutical care program for elderly patients ( > 65 yrs ) with congestive heart failure ( CHF ) based on objective measures of disease control , quality of life , and use of health care facilities in a r and omized , controlled , longitudinal , prospect i ve clinical trial . The 42 patients in group A received education from a pharmacist on the disease and its treatment , and lifestyle changes that could help control symptoms . Patients also were encouraged to monitor their symptoms and comply with prescribed drug therapy . If necessary , dosage regimens were simplified in liaison with hospital physicians . The 41 control patients ( group B ) received st and ard care . The following outcome measures were assessed in all patients at baseline ( before the start of the trial ) and at 3 , 6 , 9 , and 12 months : 2-minute walk test , blood pressure , body weight , pulse , forced vital capacity , quality of life [ disease-specific ( Minnesota Living with Heart Failure question naire ) and generic ( SF-36 ) ] , knowledge of symptoms and drugs , compliance with therapy , and use of health care facilities ( hospital admissions , visits to emergency room , emergency calls ) . Patients in group A showed improved compliance with drug therapy , which in turn improved their exercise capacity compared with those in group B ; education on management of symptoms , lifestyle changes , and dietary recommendations were also of benefit . Group A patients significantly improved knowledge of their drug therapy over the 12-month study and had fewer hospital admissions compared with group B patients . They also had improved outcomes compared with group B , despite the small sample s. An extension of this trial to other sites with pooling of results would provide additional evidence of the value of this structured program in elderly patients with CHF INTRODUCTION We study the impact of a pharmacist consult clinic on the care of elderly out patients based on the Health Belief Model that the perceived benefits ( improvement in medication knowledge , clinical status and perception ) and attached barriers ( cost and number of medication and adverse drug reactions ) can influence health behaviour ( medication compliance ) . MATERIAL S AND METHODS A r and omised controlled study of 136 eligible patients with risk factors for non-compliance , using Zelen 's design , was conducted in a hospital-based geriatric outpatient clinic from November 2001 to June 2002 . All patients were assessed for outcome variables at baseline and 2 months later . RESULTS One hundred and twenty-six patients were included in the intention-to-treat analysis . There were 104 pharmacist interventions with a physician acceptance rate of 76 % . There was a significant improvement in medication knowledge with regards to indication ( P = 0.03 ) and the composite dose , frequency and indication score ( P = 0.06 ) , as well as a decrease in residual adverse drug reactions that persisted at month 2 and cost avoidance of dollars 387.28 over 2 months . There was no significant difference in perception , clinical status or decrease in number of medications . The intervention group showed an improvement in adjusted compliance ( odds ration [ OR ] = 2.52 ; 90 % confidence interval [ CI ] , 1.09 to 5.83 ) based on the ordered logistic regression model . Perception of severity of illness at baseline ( OR = 1.30 ; 90 % CI , 1.04 to 1.62 ) , number of medication remembering methods ( OR = 1.87 ; 90 % CI , 1.08 to 3.25 ) and the use of routine habits ( OR = 4.48 ; 90 % CI , 1.51 to 13.28 ) and medication aids ( OR = 3.68 ; 90 % CI , 1.04 to 13.06 ) significantly affected compliance . CONCLUSION The addition of a pharmacist consult clinic to the management of selected geriatric out patients can improve compliance , with the attendant benefits of improving medication knowledge , cost avoidance and reducing residual adverse drug reactions BACKGROUND Older people often do not adhere fully to antidepressant medication . Compliance Therapy improves adherence with antipsychotic medication . OBJECTIVE To adapt Compliance Therapy for use in older depressed patients , to pilot this ' Concordance Therapy ' for feasibility and acceptability and to gain preliminary indications of its efficacy . METHODS R and omised controlled trial ( RCT ) . SETTING Psychiatric services for older people in North London and Essex . PARTICIPANTS A total of 19 older depressed patients . INTERVENTION 10 patients received Concordance Therapy over 3 - 4 sessions . CONTROL 9 patients received treatment as usual . MAIN OUTCOME MEASURE medication adherence at 1 month . SECONDARY OUTCOME MEASURES medication adherence at 3 months ; depression severity , beliefs about medication , quality of life at 1 and 3 months ; patient feedback about the therapy . RESULTS The therapy was acceptable to patients . INTERVENTION patients were more likely to take antidepressants , had a higher quality of life , had less depressive symptomatology and were less likely to be cases of depression at 1 month . Beliefs around antidepressants at 1 month were more positive in the intervention group but this was not the case for medication in general . LIMITATIONS As a pilot , patient numbers were small and the findings did not reach statistical significance . Three patients ( 1 intervention , 2 control ) were in hospital and therefore offered medication at follow-up . CONCLUSION Concordance Therapy for older people prescribed antidepressants is acceptable and feasible and shows sufficient promise of efficacy to justify an adequately powered RCT Context Despite evidence showing that even mild elevation of blood pressure above 140/90 mm Hg puts patients at risk for cardiovascular complications , many patients who are treated for hypertension still have high blood pressure . Contribution The authors sought to improve the blood pressure of patients using a health systems approach . They r and omly assigned providers caring for hypertensive patients to receive a Web link to the Seventh Report of the Joint National Committee on Prevention , Detection , Evaluation , and Treatment of High Blood Pressure ; the Web link and a computer alert notifying them of the patient 's blood pressure ; or the Web link , computer alert , and a letter educating the patient about ways to control his or her blood pressure . Patients of providers r and omly assigned to the third group had greater decreases in blood pressure and were more likely to have a systolic blood pressure less than 140 mm Hg . Caution s The study took place in a Veterans Affairs setting , follow-up blood pressure measures were missing for many patients , and the study was not design ed to detect a mechanism for any observed changes . Implication s A health systems approach that gave providers feedback about their patients ' blood pressure and that gave patients information about ways to control it improved blood pressure control compared with provider education alone . The Editors Currently , more than 50 million persons in the United States have hypertension ( 1 ) . The Seventh Report of the Joint National Committee on Prevention , Detection , Evaluation , and Treatment of High Blood Pressure ( JNC 7 ) promotes blood pressure goals of less than 140/90 mm Hg ( 25 ) . Providers , however , often delay changes in therapy or use higher blood pressure thresholds for the treatment of hypertension ( 2 , 4 , 6 , 7 ) , which leads to a variance in guideline adherence that contributes to a quality gap in care . Despite widespread guideline promotion , 65 % of persons in the United States have poorly controlled hypertension ( 1 , 6 , 8 , 9 ) . Factors contributing to the achievement of hypertension goals include provider decision making and patient adherence to antihypertensive treatment . These factors can be influenced by other factors , such as patient interactions with clinicians , commercial influences , and patient participation in treatment decisions ( 6 , 1017 ) . A review of hypertension goal attainment in primary care ( 18 ) found that interventions with the largest positive change were complex , multifactorial , and involved 4 areas : activities directed at changing clinician behavior , changes to the organization , information enhancement , and educational programs directed at patients . Although these findings suggest opportunities to achieve effective intervention by directing a change at each component ( 2 , 17 , 1923 ) , the impact of each component is less well known . Our aim was 1 ) to improve the quality of care of patients with hypertension at our facility while examining the relative contribution of each aspect of a multifactorial intervention design ed to improve care and 2 ) to show the effects of physician-level clustering on quality assessment . We conducted a cluster r and omized , controlled study to evaluate common components of a multifactorial intervention in veterans with essential hypertension . Methods Study Design and Setting This project was a cluster r and omized , controlled trial design ed to examine the relative contribution of 3 quality improvement interventions of increasing intensity in improving blood pressure control in veterans . This study was the evaluation component of a Veterans Integrated Service Network campaign to improve blood pressure control in patients who are treated in the Tennessee Valley Healthcare System . The health care system comprises 2 teaching hospitals , 2 large community-based outpatient clinics , and 6 small community-based outpatient clinics . There were 523659 outpatient visits made by 69928 veterans during fiscal year 2004 . The institutional review board of V and erbilt University and the VA Tennessee Valley Healthcare System research and development committee for human subjects protection approved this study . Inclusion Criteria We first identified eligible patients and then r and omly assigned providers caring for at least 1 of those patients to receive study interventions . Patients were eligible for inclusion in the study if they were 21 to 90 years of age , filled their medications at Veterans Administration ( VA ) pharmacies , had at least 2 uncontrolled blood pressure measurements in the 6-month baseline period ( systolic blood pressure > 140 mm Hg or diastolic blood pressure 90 mm Hg ) , and were only taking 1 antihypertensive medication . We restricted our study sample to patients with uncontrolled hypertension who were only taking 1 antihypertensive medication because the JNC 7 guidelines propose that most patients with hypertension will require 2 or more medications to achieve their blood pressure goals ( 5 , 12 ) . Therefore , this sample includes patients for whom the quality of hypertension care could be improved . Eligible patients were identified between July and December 2003 by search ing data from the Mid-South Quality Improvement Data warehouse , which are downloaded monthly from Veterans Health Information System and Technology Architecture . The search initially identified 4648 patients with a primary care visit who had a diagnosis of hypertension indicated by International Classification of Diseases , Ninth Revision , Clinical Modification ( ICD-9-CM ) codes 401.1 or 401.9 and who were prescribed only 1 antihypertensive medication ( Figure ) . We excluded 2821 ( 60 % ) patients because they had at least 1 recorded blood pressure reading between July and December 2003 that was at goal ( systolic blood pressure 140 mm Hg and diastolic blood pressure < 90 mm Hg ) . We mailed an assent letter to the remaining 1827 patients in January 2004 asking permission to review their electronic medical record and indicating that their primary provider would potentially receive suggestions to improve their hypertension care . Another 486 patients were excluded after r and omization because they declined chart review ( n= 222 ) or were taking more than 1 antihypertensive medication at the time of chart review ( n= 264 ) . Figure . Study flow diagram . * Excluded providers who cared for patients who declined chart review or those who were taking more than 1 medication at the time of chart review after r and omization . Providers were eligible for r and omization if they provided care for at least 1 patient who fulfilled the eligibility criteria . Providers were classified as attending physicians , resident physicians , or nonphysician clinicians ( nurse practitioner or physician assistant ) and were stratified into providers with at least 30 eligible patients and those with less than 30 eligible patients to help balance the number of patients in each study group . One hundred eighty-two providers were r and omly assigned to study interventions ; after r and omization , 23 providers were additionally excluded because the patients they cared for declined chart review or were taking more than 1 antihypertensive medication at the time of chart review ( Figure ) . Interventions Providers were r and omly assigned to 1 of 3 study groups : provider education only ; provider education and alert ; or provider education , alert , and patient education . All interventions were performed during the week of 14 June through 18 June 2004 , and follow-up continued through 31 December 2004 . Provider Education All providers in the 3 study groups received an e-mail message that explained the planned intervention . Providers who received only the e-mail message were controls for those who received the other 2 more intensive interventions . The e-mail informed providers that they might receive electronic alerts in the computerized patient record requesting reevaluation of a patient 's antihypertensive regimen . It also reported that a letter was being sent to selected patients advocating medication adherence and lifestyle modification to lower blood pressure . The e-mail message included a Web link to the JNC 7 guidelines for the treatment of hypertension ( www.nhlbi.nih.gov/ guidelines /hypertension/jnc7full.pdf ) . The message was sent by the supervisory pharmacist at the VA Tennessee Valley Healthcare System and was signed by the medical director of the network . Provider Education and Alert In the second study group , an alert was added to provider education . The alert was a 1-time patient-specific electronic notification that was sent by the pharmacy to the prescribing provider through each eligible patient 's electronic medical record over a 1-week period in June 2004 . Each time providers signed on to a computer , any medical record that contained an alert was brought to their attention . The alert gave a brief outline of the JNC 7 recommendations ( 5 ) and reminded providers that goal blood pressure should be 140/90 mm Hg or less . It included date s and values of the patient 's last 3 recorded blood pressure measurements and offered the following options : addition of a thiazide or thiazide combination diuretic , addition of another antihypertensive medication , or continuation of current medications and dosages . The alert reminded providers of the available thiazides on the VA formulary and stated that thiazides were contraindicated in patients with renal insufficiency or allergies to sulfa medications . Provider Education , Alert , and Patient Education The third study group combined the provider education and alert described previously with a patient education component . We sent a personalized letter that contained educational information concerning hypertension to each eligible patient in this study group . The letter was labeled Notice : To Veterans with High Blood Pressure and was design ed at an eighth- grade reading level . The letter recommended the use of behavioral strategies , such as medication adherence , low-sodium diet , and exercise , ABSTRACT This trial compared 3 post-hospitalization nursing care models for reducing congestive heart failure ( CHF ) readmission charges during 180-days of follow-up . Subjects received in-person visits at baseline and 60 days plus 1 of 3 care modalities in the interim : ( a ) video-based home telecare ; ( b ) telephone calls ; and ( c ) usual care . CHF-related read-mission charges were > 80 % lower in the telenursing groups compared to usual care , and these groups also had significantly fewer CHF-related emergency visits . In-person visits were more than 3 times longer than telenursing visits ( p < 0.0001 ) , only partially due to added travel time . Patient self-care adherence , medications , health status , and satisfaction did not significantly differ between groups . Telenursing can reduce CHF hospitalizations and allow increased frequency of communication with patients PURPOSE To evaluate the effect of sustained clinical pharmacist interventions involving elderly out patients with polypharmacy and their primary physicians . PATIENTS AND METHODS R and omized , controlled trial of 208 patients aged 65 years or older with polypharmacy ( > or = 5 chronic medications ) from a general medicine clinic of a Veterans Affairs Medical Center . A clinical pharmacist met with intervention group patients during all scheduled visits to evaluate their drug regimens and make recommendations to them and their physicians . Outcome measures were prescribing appropriateness , health-related quality of life , adverse drug events , medication compliance and knowledge , number of medications , patient satisfaction , and physician receptivity . RESULTS Inappropriate prescribing scores declined significantly more in the intervention group than in the control group by 3 months ( decrease 24 % versus 6 % , respectively ; P = 0.0006 ) and was sustained at 12 months ( decrease 28 % versus 5 % , respectively ; P = 0.0002 ) . There was no difference between groups at closeout in health-related quality of life ( P = 0.99 ) . Fewer intervention than control patients ( 30.2 % ) versus 40.0 % ; P = 0.19 ) experienced adverse drug events . Measures for most other outcomes remained unchanged in both groups . Physicians were receptive to the intervention and enacted changes recommended by the clinical pharmacist more frequently than they enacted changes independently for control patients ( 55.1 % versus 19.8 % ; P < 0.001 ) . CONCLUSIONS This study demonstrates that a clinical pharmacist providing pharmaceutical care for elderly primary care patients can reduce inappropriate prescribing and possibly adverse drug effects without adversely affecting health-related quality of life This study was conducted to evaluate the effect of automated telephone patient monitoring and counseling on patient adherence to antihypertensive medications and on blood pressure control . A r and omized controlled trial was conducted in 29 greater Boston communities . The study subjects were 267 patients recruited from community sites who were > or= 60 years of age , on antihypertensive medication , with a systolic blood pressure ( SBP ) of > or= 160 mm Hg and /or a diastolic blood pressure ( DBP ) of > or= 90 mm Hg . The study compared subjects who received usual medical care with those who used a computer-controlled telephone system in addition to their usual medical care during a period of 6 months . Weekly , subjects in the telephone group reported self-measured blood pressures , knowledge and adherence to antihypertensive medication regimens , and medication side-effects . This information was sent to their physicians regularly . The main study outcome measures were change in antihypertensive medication adherence , SBP and DBP during 6 months , satisfaction of patient users , perceived utility for physicians , and cost-effectiveness . The mean age of the study population was 76.0 years ; 77 % were women ; 11 % were black . Mean antihypertensive medication adherence improved 17.7 % for telephone system users and 11.7 % for controls ( P = .03 ) . Mean DBP decreased 5.2 mm Hg in users compared to 0.8 mm Hg in controls ( P = .02 ) . Among nonadherent subjects , mean DBP decreased 6.0 mm Hg for telephone users , but increased 2.8 mm Hg for controls ( P = .01 ) . For telephone system users , mean DBP decreased more if their medication adherence improved ( P = .03 ) . The majority of telephone system users were satisfied with the system . Most physicians integrated it into their practice s. The system was cost-effective , especially for nonadherent patient users . Therefore , weekly use of an automated telephone system improved medication adherence and blood pressure control in hypertension patients . This system can be used to monitor patients with hypertension or with other chronic diseases , and is likely to improve health outcomes and reduce health services utilization and costs AIMS To determine whether a medicine review and education programme influences the compliance and knowledge of older people in general practice . METHODS Older people taking at least three medicines were r and omly allocated to a control or intervention group . Both groups received three visits from a clinical pharmacist : Visit 1 : Assessment and patients ' medicines rationalized in intervention group . Visit 2 : Intervention group given medicines education . Visit 3 : Knowledge and compliance in both groups assessed by structured question naire RESULTS Compliance in the intervention group was 91.3 % , compared with 79.5 % in the control group ( P < 0.0001 ) . The number of intervention group patients correctly underst and ing the purpose of their medicines increased from 58 % to 88 % on the second visit , compared with 67 % to 70 % in the control group ( P < 0.0005 ) . CONCLUSIONS A general practice based medication review and education programme improved medicine compliance and knowledge of older people in the short term This pilot study investigated the effects of three different medication management approaches on medication adherence and re source utilization . Sixty-one participants living in an independent elder community in South Florida were r and omly assigned to one of the three medication management approaches : ( 1 ) a pillbox method , ( 2 ) a voice-activated method , and ( 3 ) self-administration of medications as they had in the past . One outcome was measured by recording the number of doses of medications ingested over a 1- , 3- , and 6-month period . Adherence to medications also was measured by the impact on the medical diagnosis . For example , the hypertensive group was defined adherent by a sustained normotensive pressure . Participants ' medical records were examined as to the number of physician office visits , hospitalizations , and home health visits . There were significant differences in the mean number of doses missed , with the fewest in the voice-activated group to the highest in the self-administration ( control ) group . Additionally , the group that self-administered their own medications had more frequent physician office visits and increased hospitalizations . Because the elder population is prone to medication mismanagement for a variety of reasons , nurses are in a unique position to identify population s at risk and suggest interventions that may improve medication adherence OBJECTIVE To determine whether daily videotelephone or regular telephone reminders would increase the proportion of prescribed cardiac medications taken in a sample of elderly individuals who have congestive heart failure ( CHF ) . METHODS The authors recruited community-dwelling individuals age 65 and older who had the primary or secondary diagnosis of CHF into a r and omized controlled trial of reminder calls design ed to enhance medication compliance . There were three arms : a control group that received usual care ; a group that received regular daily telephone call reminders ; and a group that received daily videotelephone call reminders . Compliance was defined as the percent of therapeutic coverage as recorded by Medication Event Monitoring System ( MEMS ) caps . Subjects were recruited from 2 sources : a large urban home health care agency and a large urban ambulatory clinic of a major teaching hospital . Baseline and post-intervention MOS 36-Item Short-Form Health Survey ( SF-36 ) scores and Minnesota Living with Heart Failure ( MLHF ) scores were obtained . RESULTS There was a significant time effect during the course of the study from baseline to post-intervention ( F[2,34 ] = 4.08 , p < .05 ) . Over time the elderly individuals who were called , either by telephone or videotelephone , showed enhanced medication compliance relative to the control group . There was a trend , but no significant difference between the two intervention groups . Both SF-36 and MLHF scores improved from baseline to post-intervention for all groups . There was no significant change in the SF-36 scores for the sample , but there was a significant change for the MLHF scores ( p < .001 ) . The control group had a significant fall off in the medication compliance rate during the course of the study , dropping from 81 % to 57 % . CONCLUSIONS Telephone interventions are effective in enhancing medication compliance and may prove more cost effective than clinic visits or preparation of pre-poured pill boxes in the home . Technologic advances which enable clinicians to monitor and enhance patient medication compliance may reduce costly and distressing hospitalization for elderly individuals with CHF OBJECTIVE To evaluate the effects of a single-session , interactive computer-based educational program on knowledge , compliance and quality of life in heart failure patients with special emphasis on gender differences . METHODS One hundred and fifty-four patients , mean age 70 years , from five heart failure clinics were r and omised to either receiving only st and ard education ( n=72 ) or st and ard education and additional computer-based education ( n=82 ) . RESULTS Knowledge was increased in both groups after 1 month with a trend towards higher knowledge ( P=0.07 ) in the computer-based group . The increase in knowledge was significantly higher in the computer-based group after 6 months ( P=0.03 ) . No differences were found between the groups with regard to compliance with treatment and self-care or quality of life . The women had significantly lower quality of life and did not improve after 6 months as the men did ( P=0.0001 ) . CONCLUSION Computer-based education gave increased knowledge about heart failure . PRACTICE IMPLICATION S Computers can be a useful tool in heart failure education , but to improve compliance a single-session educational intervention is not sufficient . Gender differences in learning and quality of life should be further evaluated OBJECTIVE To assess a st and ardized and simple educational intervention in overactive bladder ( OAB ) patients to improve compliance with anticholinergic medication , increase the use of concomitant behavioral treatments , and improve patients ' perception of bladder symptoms . MATERIAL S AND METHODS This is a 16-week open-label r and omized trial of tolterodine combined with an education intervention for the experimental group versus tolterodine alone ( no intervention ) for the control group . The setting was in family medicine and urology clinics in Ontario . The participants were male and female adults with OAB symptoms . Both groups received tolterodine prescriptions . The intervention patients received printed information and an explanation about OAB , medication use , and behavioral treatments ( kegel exercise , bladder stretching , fluid regulation ) . The primary outcomes were medication compliance and persistence at 16 weeks . Secondary outcomes were use of behavioral treatments and self-reported severity of symptoms . RESULTS More patients in the intervention group ( experimental ) purchased their prescriptions ( p<0.05 ) . Compliance rate was greater for the intervention group ( 39 % ) , versus the control group ( 31 % ) at 16 weeks although the difference was not significant ( p>0.05 ) . Significantly more patients started and /or continued non-drug treatments in the intervention group ( 82 % ) compared to the control group ( 53 % ) ( p<0.05 ) . Furthermore , more patients in this group reported improvement in severity of bladder symptoms ( p<0.05 ) . CONCLUSIONS The simple education intervention result ed in a greater , but not significant , increase in compliance with medication compared to the control group . It also result ed in a significantly increased use of behavior modification therapies and better self-perception of treatment outcome OBJECTIVE To evaluate a pharmacist-conducted educational and monitoring programme , design ed to promote dietary and lifestyle modification and compliance with lipid-lowering drug therapy , for patients with dyslipidaemia . METHODS This was a prospect i ve , r and omized , controlled study . The participants were 94 adults , with 81 completing the study ( intervention group : 39 ; control group : 42 ) , with a cardiovascular-related diagnosis and discharged from hospital , between April and October 2001 , on lipid-lowering drug therapy . Patients in the intervention group were visited at home monthly by a pharmacist , who educated the patients on the goals of lipid-lowering treatment and the importance of lifestyle issues in dyslipidaemia and compliance with therapy , assessed patients for drug-related problems , and measured total blood cholesterol levels using point-of-care testing . Patients in the control group received st and ard medical care . The main outcome measure was total blood cholesterol levels after 6 months , and an evaluation of patient and general practitioner satisfaction with the programme . RESULTS There was no significant difference in baseline total blood cholesterol levels between the two groups . The reduction over the course of the study in cholesterol levels within the intervention group was statistically significant ( 4.9 + /- 0.7 to 4.4 + /- 0.6 , P<0.005 ) , whereas there was no change within the control group ( P=0.26 ) . At follow-up , 44 % of the intervention group patients and 24 % of the control group patients had cholesterol levels below 4.0 mmol/L ( P=0.06 ) . The reduction in total cholesterol in the intervention group should translate to an expected 21 % reduction in cardiovascular mortality risk and a 16 % reduction in total mortality risk -- more than twice the risk reduction achieved in the control group . In addition , the programme was very well received by the patients and their general practitioners , by satisfaction question naire . CONCLUSION A pharmacist-conducted educational and monitoring intervention improved the outcomes of lipid-lowering drug therapy OBJECTIVE To evaluate the impact of pharmaceutical care on selected clinical and economic outcomes in patients with hypertension or chronic obstructive pulmonary disease ( COPD ) in ambulatory care setting s. DESIGN Clinic patients with hypertension or COPD were r and omly assigned to a treatment group ( pharmaceutical care ) or a control group ( traditional pharmacy care ) over a six-month period . Clinical pharmacists and pharmacy residents conducted the protocol s. There were 133 evaluable patients ( 63 treatment and 70 control ) in the hypertension study arm and 98 evaluable patients ( 43 treatment and 55 control ) in the COPD study arm . SETTING 10 Departments of Veterans Affairs medical centers and 1 academic medical center . INTERVENTIONS Patient-centered pharmaceutical care model ( employing st and ardized care ) implemented by clinical pharmacy residents . MAIN OUTCOME MEASURES Patient knowledge , medication compliance , and health re source use . RESULTS The hypertension treatment group had a significantly greater reduction in systolic blood pressure from visit 1 to visit 5 than did the control group . In the COPD study arm , trends were positive in the treatment group for patients ratings of symptom interference with activities and dyspnea measures . There was a significant difference between the hypertension treatment and control group for compliance . There were no significant changes in compliance scores in the COPD study arm . Mean number of hospitalizations and other health care provider visits was higher for the hypertension control group . For patients with COPD , hospitalizations increased in the control group , and the number of other health care provider visits was higher in the control group . CONCLUSION Pharmacists ' participation in a pharmaceutical care program result ed in disease state improvement in ambulatory patients with hypertension and COPD OBJECTIVE To determine whether pharmaceutical care provided by a pharmacist-managed hypertension clinic results in better treatment outcomes when compared with traditional health care from a primary care physician . DESIGN Prospect i ve , controlled study SETTING Veterans Affairs Medical Center , Philadelphia , Pennsylvania . PATIENTS Fifty six patients with essential hypertension ; 27 were r and omly assigned to the intervention group and 29 to the control group . INTERVENTION Patients in the intervention group were scheduled monthly to meet with a clinical pharmacist who made appropriate changes in prescribed drugs , adjusted dosages , and provided drug counseling in accordance with the hypertension guidelines in the sixth report of the Joint National Committee on the Detection , Evaluation , and Treatment of High Blood Pressure ( JNC VI ) . Patients in the control group received st and ard care from their physicians . The study period was 6 months . MEASUREMENTS AND MAIN RESULTS Treatment outcomes were measured by changes in compliance , blood pressure , and patient satisfaction . The Short Form-36 health survey and a patient satisfaction survey were used to measure changes in patient satisfaction , and a compliance evaluation survey measured compliance . Twenty-one ( 81 % ) patients in the intervention group attained their blood pressure goal of below 140/90 mm Hg at the completion of the study versus only eight ( 30 % ) in the control group ( p < 0.0001 ) . Of 11 patients with diabetes in the intervention group , 10 ( 91 % ) attained their blood pressure goal ( < 130/80 mm Hg ) versus only two ( 12 % ) of 16 patients with diabetes in the control group ( p < 0.0001 ) . No significant differences in patient satisfaction or compliance were reported between the intervention and control groups . CONCLUSIONS Pharmaceutical care improves blood pressure control and results in more patients with hypertension reaching their blood pressure goal Objective This study aim ed to measure the outcomes of a harmonised , structured pharmaceutical care programme provided to elderly patients ( ≥65 years of age ) by community pharmacists in a multicentre international study performed in 7 European countries . Design and setting The study was a r and omised , controlled , longitudinal , clinical trial with repeated measures performed over an 18-month period . A total of 104 intervention and 86 control pharmacy sites participated in the research and 1290 intervention patients and 1164 control patients were recruited into the study .Main outcome measures and results A general decline in health-related quality of life over time was observed in the pooled data ; however , significant improvements were achieved in patients involved in the pharmaceutical care programme in some countries . Intervention patients reported better control of their medical conditions as a result of the study and cost savings associated with pharmaceutical care provision were observed in most countries . The new structured service was well accepted by intervention patients and patient satisfaction with the services improved during the study . The pharmacists involved in providing pharmaceutical care had a positive opinion on the new approach , as did the majority of general practitioners surveyed . The positive effects appear to have been achieved via social and psychosocial aspects of the intervention , such as the increased support provided by community pharmacists , rather than via biomedical mechanisms . Conclusions This study is the first large-scale , multicentre study to investigate the effects of pharmaceutical care provision by community pharmacists to elderly patients . Future research methodology and implementation will be informed by the experience gained from this challenging trial |
11,540 | 21,394,443 | Despite sharing the same spectrum of target receptors with sorafenib and sunitinib , pazopanib is associated with an unexpectedly low risk of HFSR . | Summary Pazopanib is a novel multikinase inhibitor that shares a similar spectrum of target receptors with sorafenib and sunitinib .
We have performed a systematic analysis to investigate the risk of HFSR to pazopanib and compare the difference in incidence between sorafenib , sunitinib , and pazopanib . | Purpose : To evaluate clinical activity and target modulation of v and etanib in women with recurrent ovarian cancer . Experimental Design : A phase II trial of orally administered v and etanib 300 mg daily was design ed to include analyses of target inhibition through paired biopsies and dynamic imaging . Core 18-gauge needle biopsies and dynamic contrast-enhanced magnetic resonance imaging were obtained before initiation of therapy and 6 weeks into therapy . Biopsy sample s were subjected to reverse-phase protein lysate array endpoint analysis . Cytokine concentrations were measured by enzyme-linked immunosorbent assay in serially collected plasma sample s. Results : Twelve patients entered the study , and accrual was terminated in the first stage because of lack of response or disease stabilization beyond 6 months . Adverse events included rash , diarrhea , and prolonged QT interval corrected for heart rate , but not hypertension . Exploratory analyses showed that epidermal growth factor receptor ( EGFR ) phosphorylation was reduced in the eight paired biopsy sets obtained ; vascular endothelial growth factor ( VEGF ) receptor-2 phosphorylation was not consistently affected nor were dynamic contrast-enhanced MRI permeability and flow parameters . Serial plasma VEGF concentrations were variable and did not significantly change in the 11 patients assessed . Conclusions : V and etanib 300 mg daily monotherapy had no significant clinical benefit in this disease setting . Proteomic analysis of paired biopsies detected both phosphorylated-EGFR and phosphorylated-VEGF receptor-2 in ovarian tumor tissue , but only phosphorylated-EGFR was measurably inhibited by v and etanib . Clin Cancer Res ; 16(2 ) ; OBJECTIVE Sorafenib ( Nexavar ) is an oral multi-kinase inhibitor that targets tumor growth and angiogenesis . This phase II study investigated efficacy , safety , and pharmacokinetics of sorafenib in Japanese patients with advanced renal cell carcinoma ( RCC ) . METHODS Nonr and omized , open-label study in Japanese patients with metastatic renal cell carcinoma who had received nephrectomy and failed > /=1 cytokine-containing therapy . The primary endpoint was response rate . Patients received sorafenib 400 mg twice daily ( b.i.d . ) on a continuous dosing schedule . RESULTS A total of 129 patients ( median age 63 years ) were valid for intention-to-treat analyses . Confirmed partial responses were observed in 16 ( 12.4 % ) patients , and investigators assessed that 19 ( 14.7 % ) of the patients achieved a partial response . Stable disease was reported in 93 ( 72.1 % ) patients , and 103 ( 80.5 % ) patients had tumor shrinkage . Median progression-free survival was 224 days and the 25th percentile of overall survival was estimated at 288 days . The most frequently occurring drug-related adverse events ( any grade ) were elevated lipase ( 56 % ) , h and -foot skin reaction ( 55 % ) , alopecia ( 39 % ) , increased amylase ( 38 % ) , rash/desquamation ( 37 % ) , and diarrhea ( 34 % ) . A total of 14 ( 10.7 % ) patients had serious sorafenib-related adverse events , including one adverse event of worst grade 5 ( dyspnea occurred 35 days after the last dose of study medication ) . The C(trough , steady state ) values in RCC patients ( n = 63 ) receiving sorafenib 400 mg b.i.d . were similar to those obtained from a Japanese phase I study involving patients with mixed solid tumors . CONCLUSION Sorafenib showed encouraging efficacy and was well tolerated in Japanese patients with metastatic RCC The objective of this phase II single-arm study was to evaluate the efficacy and safety of pazopanib , a multi-targeted tyrosine kinase inhibitor , against vascular endothelial growth factor receptor (VEGFR)-1 , -2 , and -3 , platelet-derived growth factor receptor-alpha and -beta , and c-Kit , in recurrent glioblastoma . Patients with < or = 2 relapses and no prior anti-VEGF/VEGFR therapy were treated with pazopanib 800 mg daily on 4-week cycles without planned interruptions . Brain magnetic resonance imaging and clinical re assessment were made every 8 weeks . The primary endpoint was efficacy as measured by 6-month progression-free survival ( PFS6 ) . Thirty-five GBM patients with a median age of 53 years and median Karnofsky performance scale of 90 were accrued . Grade 3/4 toxicities included leukopenia ( n = 1 ) , lymphopenia ( n = 2 ) , thrombocytopenia ( n = 1 ) , ALT elevation ( n = 3 ) , AST elevation ( n = 1 ) , CNS hemorrhage ( n = 1 ) , fatigue ( n = 1 ) , and thrombotic/embolic events ( n = 3 ) ; 8 patients required dose reduction . Two patients had a partial radiographic response by st and ard bidimensional measurements , whereas 9 patients ( 6 at the 8-week point and 3 only within the first month of treatment ) had decreased contrast enhancement , vasogenic edema , and mass effect but < 50 % reduction in tumor . The median PFS was 12 weeks ( 95 % confidence interval [ CI ] : 8 - 14 weeks ) and only 1 patient had a PFS time > or = 6 months ( PFS6 = 3 % ) . Thirty patients ( 86 % ) had died and median survival was 35 weeks ( 95 % CI : 24 - 47 weeks ) . Pazopanib was reasonably well tolerated with a spectrum of toxicities similar to other anti-VEGF/VEGFR agents . Single-agent pazopanib did not prolong PFS in this patient population but showed in situ biological activity as demonstrated by radiographic responses . Clinical Trials.gov identifier : NCT00459381 STUDY OBJECTIVE To determine if excretion of sorafenib in sweat is associated with h and -foot skin reaction in patients receiving sorafenib . DESIGN Prospect i ve pilot study . SETTING Outpatient clinic of a cancer research institution . PATIENTS Two patients who were receiving sorafenib and developed a h and -foot skin reaction of at least grade 1 and two healthy subjects ( controls ) . INTERVENTION Sweat production was stimulated in both the patients with h and -foot skin reaction and the healthy subjects by means of pilocarpine iontophoresis . MEASUREMENTS AND MAIN RESULTS Sweat sample s were collected from the patients with h and -foot skin reaction and from the healthy subjects . Using liquid chromatography-t and em mass spectrometry , sorafenib concentrations were measured in the sweat sample s. Sweat sample s from the healthy subjects were spiked with known concentrations of sorafenib to determine the lower limit of quantification of the assay , which was determined to be 5 ng/ml . Sorafenib concentrations in the sample s from the patients with h and -foot skin reaction were undetectable based on the assay 's sensitivity . CONCLUSION Our results suggest that h and -foot skin reaction in patients receiving sorafenib is not associated with excretion of sorafenib in sweat . Further studies are needed to underst and the mechanism of h and -foot skin reaction , a treatment-limiting adverse effect of multikinase inhibitors BACKGROUND We conducted a phase 3 , r and omized , double-blind , placebo-controlled trial of sorafenib , a multikinase inhibitor of tumor-cell proliferation and angiogenesis , in patients with advanced clear-cell renal-cell carcinoma . METHODS From November 2003 to March 2005 , we r and omly assigned 903 patients with renal-cell carcinoma that was resistant to st and ard therapy to receive either continuous treatment with oral sorafenib ( at a dose of 400 mg twice daily ) or placebo ; 451 patients received sorafenib and 452 received placebo . The primary end point was overall survival . A single planned analysis of progression-free survival in January 2005 showed a statistically significant benefit of sorafenib over placebo . Consequently , crossover was permitted from placebo to sorafenib , beginning in May 2005 . RESULTS At the January 2005 cutoff , the median progression-free survival was 5.5 months in the sorafenib group and 2.8 months in the placebo group ( hazard ratio for disease progression in the sorafenib group , 0.44 ; 95 % confidence interval [ CI ] , 0.35 to 0.55 ; P<0.01 ) . The first interim analysis of overall survival in May 2005 showed that sorafenib reduced the risk of death , as compared with placebo ( hazard ratio , 0.72 ; 95 % CI , 0.54 to 0.94 ; P=0.02 ) , although this benefit was not statistically significant according to the O'Brien-Fleming threshold . Partial responses were reported as the best response in 10 % of patients receiving sorafenib and in 2 % of those receiving placebo ( P<0.001 ) . Diarrhea , rash , fatigue , and h and -foot skin reactions were the most common adverse events associated with sorafenib . Hypertension and cardiac ischemia were rare serious adverse events that were more common in patients receiving sorafenib than in those receiving placebo . CONCLUSIONS As compared with placebo , treatment with sorafenib prolongs progression-free survival in patients with advanced clear-cell renal-cell carcinoma in whom previous therapy has failed ; however , treatment is associated with increased toxic effects . ( Clinical Trials.gov number , NCT00073307 [ Clinical Trials.gov ] . ) PURPOSE Given the importance of angiogenesis in soft tissue sarcoma ( STS ) , pazopanib , an oral angiogenesis inhibitor that targets vascular endothelial growth factor receptor and platelet-derived growth factor receptor , was explored in patients with advanced STS . PATIENTS AND METHODS Patients with intermediate- or high- grade advanced STS who were ineligible for chemotherapy or who had received no more than two prior cytotoxic agents for advanced disease , who had documented progression , who had adequate performance status , and who had good organ function were eligible . Pazopanib 800 mg was given daily . The primary end point was progression-free rate at 12 weeks ( PFR(12 weeks ) ) . Secondary end points were response , safety , and overall survival . Four different strata were studied : adipocytic STS , leiomyosarcomas , synovial sarcomas , and other STS types . A Simon two-stage design was applied ( P1 = 40 % ; P0 = 20 % ; alpha = beta = .1 ) for each stratum . Results One hundred forty-two patients were enrolled . The adipocytic STS stratum was closed after the first stage , given insufficient activity ( PFR(12 weeks ) , five [ 26 % ] of19 ) . PFR(12 weeks ) was 18 ( 44 % ) of 41 patients in the leiomyosarcoma cohort , 18 ( 49 % ) of 37 in the synovial sarcomas , and 16 ( 39 % ) of 41 in the other STS types . Compared with historical controls who were treated with second-line chemotherapy , progression-free and overall survivals were prolonged in the three cohorts in which the primary end point was reached . The most frequent drug-related toxicities were hypertension , fatigue , hypopigmentation , and nausea . Other toxicities included liver enzyme elevations , myelosuppression , and proteinuria , all of which were mostly grade s 1 to 2 . The most frequent grade s 3 to 4 toxicities were hyperbilirubinemia ( 6.3 % ) , hypertension ( 7.7 % ) , and fatigue ( 7.7 % ) . CONCLUSION Pazopanib is well tolerated in patients with relapsed , advanced STS and demonstrates interesting activity that warrants additional study in patients with leiomyosarcomas , synovial sarcomas , and other STS types PURPOSE Pazopanib and lapatinib are tyrosine kinase inhibitors that target vascular endothelial growth factor receptor , platelet-derived growth factor receptor , and c-Kit or epidermal growth factor receptor ( EGFR ) and human epidermal growth factor receptor 2 ( HER2/neu ) , respectively . In cervical cancer , EGFR and HER2/neu overexpression and high microvascular density correlate with survival . PATIENTS AND METHODS Patients with measurable stage IVB persistent/recurrent cervical carcinoma not amenable to curative therapy and at least one prior regimen in the metastatic setting were r and omly assigned in a ratio of 1:1:1 to pazopanib at 800 mg once daily , lapatinib at 1,500 mg once daily , or lapatinib plus pazopanib combination therapy ( lapatinib at 1,000 mg plus pazopanib at 400 mg once daily or lapatinib at 1,500 mg plus pazopanib at 800 mg once daily ) . Therapy continued until progression or withdrawal because of adverse events ( AEs ) . Primary end point was progression-free survival ( PFS ) , and secondary end points were overall survival ( OS ) , response rate ( RR ) , and safety . The futility boundary was crossed at the planned interim analysis for combination therapy compared with lapatinib therapy , and the combination was discontinued . RESULTS Of 230 patients enrolled , 152 were r and omly assigned to the monotherapy arms : pazopanib ( n = 74 ) or lapatinib ( n = 78 ) . Most patients ( 62 % ) had recurrent cancer . Pazopanib improved PFS ( hazard ratio [ HR ] , 0.66 ; 90 % CI , 0.48 to 0.91 ; P = .013 ) and OS ( HR , 0.67 ; 90 % CI , 0.46 to 0.99 ; P = .045 ) . Median OS was 50.7 weeks and 39.1 weeks and RRs were 9 % and 5 % for pazopanib and lapatinib , respectively . The only grade 3 AE > 10 % was diarrhea ( 11 % pazopanib and 13 % lapatinib ) . Grade 4 AEs were 9 % ( lapatinib ) and 12 % ( pazopanib ) . CONCLUSION This study confirms the activity of antiangiogenesis agents in advanced and recurrent cervical cancer and demonstrates the benefit of pazopanib based on the prolonged PFS and favorable toxicity profile OBJECTIVE The progression-free and median survival of patients with advanced ovarian cancer has not appreciably improved over the last decade . Novel targeted therapies , particularly antiangiogenic agents , may potentially improve clinical outcomes in patients with ovarian cancer . This phase II , open-label study evaluated oral pazopanib monotherapy in patients with low-volume recurrent ovarian cancer . METHODS Patients with recurrent epithelial ovarian , fallopian tube , or primary peritoneal carcinoma with complete CA-125 response to initial platinum-based chemotherapy and subsequent elevation of CA-125 to ≥ 42 U/mL ( > 2 × ULN ) were treated with pazopanib 800 mg once daily until PD or unacceptable toxicity . This Green-Dahlberg study required 2 CA-125 responses in stage I ( 20 patients ) to proceed to stage II ( 15 patients ) . The primary endpoint was CA-125 response ( ≥ 50 % decrease from baseline , confirmed ≥ 21 days after initial evaluation ) . RESULTS Eleven of 36 patients ( 31 % ) had a CA-125 response to pazopanib , with median time to response of 29 days and median response duration of 113 days . Overall response rate was 18 % in patients with measurable disease at baseline . The most common adverse events leading to discontinuation of study drug were grade 3 ALT ( 8 % ) and AST ( 8 % ) elevation . Only 1 grade 4 toxicity ( peripheral edema ) was reported . CONCLUSIONS Pazopanib monotherapy was relatively well tolerated , with toxicity similar to other small-molecule , oral angiogenesis inhibitors , and demonstrated promising single-agent activity in patients with recurrent ovarian cancer . Further studies evaluating the potential role of pazopanib in patients with ovarian cancer are ongoing PURPOSE AZD2171 is a highly potent oral selective inhibitor of vascular endothelial growth factor ( VEGF ) signaling . This phase I study was design ed to evaluate the safety and tolerability of increasing doses of AZD2171 , with additional assessment s of pharmacokinetics , pharmacodynamics , and efficacy . PATIENTS AND METHODS In part A , 36 patients with solid tumors and liver metastases refractory to st and ard therapies received once-daily oral AZD2171 ( 0.5 to 60 mg ) . Doses were escalated in successive cohorts until the maximum-tolerated dose was identified . In part B , patients with ( n = 36 ) or without ( n = 11 ) liver metastases were r and omly assigned to receive once-daily AZD2171 ( 20 , 30 , or 45 mg ) . In both parts , treatment continued until tumor progression or dose-limiting toxicity ( DLT ) was observed . RESULTS Eighty-three patients received AZD2171 , which was generally well tolerated at doses of 45 mg/d or less ; the most frequently reported dose-related adverse events were diarrhea , dysphonia , and hypertension . The most common DLT was hypertension ( n = 7 ) , which occurred at AZD2171 doses of 20 mg and higher . After a single dose , maximum plasma ( peak ) drug concentration after single-dose administration ( Cmax ) was achieved 1 to 8 hours postdosing with an arithmetic mean half-life associated with terminal slope of a semilogarithmic concentration-time curve ( t1/2 lamda(z ) ) of 22 hours . Pharmacodynamic assessment s demonstrated time- , dose- , and exposure-related decreases in initial area under the curve , defined over 60 seconds post-contrast arrival in the tissue ( iAUC60 ) using dynamic contrast-enhanced magnetic resonance imaging , as well as dose- and time-dependent reductions in soluble VEGF receptor 2 levels . Preliminary evidence of efficacy included two confirmed partial responses and 22 patients with stable disease ; effects on tumor size appeared to be dose related . CONCLUSION Once-daily oral AZD2171 at doses of 45 mg or less was generally well tolerated and was associated with encouraging antitumor activity in patients with a broad range of advanced solid tumors Axitinib is an oral , potent , and selective inhibitor of vascular endothelial growth factor receptor ( VEGFR ) 1 , 2 , and 3 . This phase I study evaluated the safety , pharmacokinetics , pharmacodynamics , antitumor activity , and recommended starting dose of axitinib in patients with advanced solid tumors . Twelve patients received single‐dose axitinib 5 mg and were monitored for ≥48 h. Continuous 5 mg twice‐daily dosing was then initiated . One patient had dose‐limiting toxicity ( grade 3 proteinuria and fatigue ) . Common treatment‐related adverse events were anorexia , fatigue , and diarrhea . Grade 3 treatment‐related adverse events were fatigue and hypertension . Maximum axitinib plasma concentration occurred 1–4 h after steady‐state dosing . Eleven patients experienced thyroid‐stimulating hormone elevation ; time‐course change and fatigue onset appeared to be related in some patients . Significant correlation was observed between thyroid‐stimulating hormone change and area under the plasma concentration – time curve ( AUC ; r = 0.80 , P = 0.005 ) . Axitinib decreased plasma soluble vascular endothelial growth factor receptor 2 ( s‐VEGFR2 ) , with significant correlation between change in s‐VEGFR2 and AUC ( r = −0.92 , P < 0.0001 ) . Fluorodeoxyglucose positron emission tomography revealed a substantial decrease in tumor metabolic activity associated with axitinib . Tumor size decreased in nine patients . The time‐course of thyroid‐stimulating hormone change appeared correlated with fatigue . There were significant correlations between thyroid‐stimulating hormone or s‐VEGFR2 and axitinib exposure . Axitinib 5 mg twice‐daily is the recommended starting dose for Japanese patients . This trial is registered with Clinical Trials.gov , identifier NCT00447005 . ( Cancer Sci 2010 PURPOSE Patients with early-stage , resectable , non-small-cell lung cancer ( NSCLC ) are at risk for recurrent disease , and 5-year survival rates do not exceed 75 % . Angiogenesis inhibitors have shown clinical activity in patients with late-stage NSCLC , raising the possibility that targeting the vascular endothelial growth factor pathway in earlier-stage disease may be beneficial . This proof-of-concept study examined safety and efficacy of short-term , preoperative pazopanib monotherapy in patients with operable stage I/II NSCLC . PATIENTS AND METHODS Patients scheduled for resection received oral pazopanib 800 mg/d for 2 to 6 weeks preoperatively . Tumor response was measured by high-resolution computed tomography , permitting estimation of change in tumor volume and diameter . Gene-expression profiling was performed on 77 pre- and post-treatment lung sample s from 34 patients . RESULTS Of 35 patients enrolled , 33 ( 94 % ) had clinical stage I NSCLC and two ( 6 % ) had clinical stage II NSCLC . Median treatment duration was 16 days ( range , 3 to 29 days ) . Thirty patients ( 86 % ) achieved tumor-volume reduction after pazopanib treatment . Two patients achieved tumor-volume reduction > or = 50 % , and three patients had partial response according to Response Evaluation Criteria in Solid Tumors . Pazopanib was generally well tolerated . The most common adverse events included grade 2 hypertension , diarrhea , and fatigue . One patient developed pulmonary embolism 11 days after surgery . Several pazopanib target genes and other angiogenic factors were dysregulated post-treatment . CONCLUSION Short- duration pazopanib was generally well tolerated and demonstrated single-agent activity in patients with early-stage NSCLC . Several target genes were dysregulated after pazopanib treatment , validating target-specific response and indicating a persistent pazopanib effect on lung cancer tissue . Further clinical evaluation of pazopanib in NSCLC is planned |
11,541 | 28,770,349 | Articular incongruence was a significant predictor for PA .
Conclusions A high prevalence of PA was found in non-osteoporotic patients following a distal radius fracture .
PA following a distal radial fracture was associated with a limited radial deviation and flexion , but not with grip strength .
Articular incongruence predicted PA . | Introduction The objective of this systematic review was to analyze ( 1 ) prevalence of radiological posttraumatic arthritis ( PA ) , ( 2 ) associations of PA with outcome measures and ( 3 ) predictors of PA following distal radius fractures in non-osteoporotic patients . | BACKGROUND Outcome measurement following surgery is increasingly the focus of attention in current health-care debates because of the rising costs of medical care and the large variety of operative options . The purpose of the present study was to correlate quality of life after volar locked plate fixation of unstable intra-articular distal radial fractures with functional and radiographic results as well as with quality -of-life data from population norms . METHODS Fifty-four consecutive patients with intra-articular distal radial fractures and a mean age of sixty-three years were managed with a volar locked plate system . Range of motion , grip strength , and radiographs were assessed at a mean of six years postoperatively . The wrist-scoring systems of Gartl and and Werley and Castaing were adopted for the assessment of objective outcomes . The Disabilities of the Arm , Shoulder and H and and Short Form-36 question naires were completed as subjective outcome measures , and the results were compared with United States and Austrian population norms . RESULTS Functional improvement continued for two years postoperatively . At the time of the latest follow-up , > 90 % of all patients had achieved good or excellent results according to the scoring systems of Gartl and and Werley and Castaing . The results of the Short Form-36 question naire were similar to the United States and Austrian population norms . The mean Disabilities of the Arm , Shoulder and H and score was 5 points at two years , and it increased to 13 points at six years . The twenty patients with radiocarpal arthritis had significantly poorer results in the physical component summary measure of the Short Form-36 question naire ( p = 0.012 ) . CONCLUSIONS The results of the present single-center study show that , following distal radial fracture fixation , wrist arthritis may affect the patient 's subjective well-being , as documented with the Short Form-36 , without influencing the functional outcome . Well- design ed longitudinal clinical trials are needed to confirm the findings of the present investigation in terms of quality of life after surgical treatment of intra-articular distal radial fractures Background Reduced muscular strength in the old age is strongly related to activity impairment and mortality . However , studies evaluating the gender-specific association between muscularity and mortality among older adults are lacking . Thus , the objective of the present study was to examine gender differences in the association between muscular strength and mortality in a prospect i ve population -based cohort study . Methods Data used in this study derived from the Cooperative Health Research in the Region of Augsburg (KORA)-Age Study . The present analysis includes 1,066 individuals ( mean age 76 ± 11 SD years ) followed up over 3 years . H and grip strength was measured using the Jamar Dynamometer . A Cox proportional hazard model was used to determine adjusted hazard ratios of mortality with 95 % confidence intervals ( 95 % CI ) for h and grip strength . Potential confounders ( i.e. age , nutritional status , number of prescribed drugs , diseases and level of physical activity ) were pre-selected according to evidence -based information . Results During the follow-up period , 56 men ( 11 % ) and 39 women ( 7 % ) died . Age-adjusted mortality rates per 1,000 person years ( 95 % CI ) were 77 ( 59–106 ) , 24 ( 13–41 ) and 14 ( 7–30 ) for men and 57 ( 39–81 ) , 14 ( 7–27 ) and 1 ( 0–19 ) for women for the first , second and third sex-specific tertile of muscular strength , respectively . Low h and grip strength was significantly associated with all-cause mortality among older men and women from the general population after controlling for significant confounders . Hazard ratios ( 95 % CI ) comparing the first and second tertile to the third tertle were 3.33 ( 1.53–7.22 ) and 1.42 ( 0.61 - 3.28 ) , respectively . Respective hazard ratios ( 95 % CI ) for mortality were higher in women than in men ( ( 5.23 ( 0.67–40.91 ) and 2.17 ( 0.27–17.68 ) versus 2.36 ( 0.97–5.75 ) and 0.97 ( 0.36–2.57 ) ) . Conclusions Grip strength is inversely associated with mortality risk in older adults , and this association is independent of age , nutritional status , number of prescribed drugs , number of chronic diseases and level of physical activity . The association between muscular strength and all-cause mortality tended to be stronger in women . It seems to be particularly important for the weakest to enhance their levels of muscular strength in order to reduce the risk of dying early A prospect i ve cohort of 120 patients with distal radius fractures completed a baseline evaluation that determined their age , sex , education level , injury compensation status , AO fracture type , prereduction radial shortening , and postreduction radial shortening . Six months later patients self-reported pain and disability using the Patient-Rated Wrist Evaluation , and were tested for physical impairment ( grip , wrist range of motion , and dexterity ) . Univariate and forward stepwise regression analyses agreed that the most influential predictor of pain and disability at 6 months was injury compensation . Patient education level and prereduction radial shortening also contributed predictive information ( R squared = 25 % ) . Wrist impairment was moderately correlated with patient reported pain and disability ( r = 0.50 ) . Both impairment and disability measures are required to fully describe outcomes . Further work is required to delineate additional factors that contribute to outcome Subchondral hematomas have been found with arthroscopy in one third of patients with dislocated distal radial fractures . The aim of the present , prospect i ve study was to determine whether these hematomas might cause radiographic osteoarthrosis . We studied 41 patients ( age 20 - 57 years , 22 women ) with a dislocated distal radial fracture . At the time of fracture , 12 patients had subchondral hematomas in a radiocarpal compartment without a fracture line , as defined by arthroscopy . The 1-year follow-up included clinical and radiographic examinations . At follow-up , radiographic subchondral bone plate changes occurred in unfractured compartments in 8 patients , of whom 7 had had a previous arthroscopically diagnosed subchondral hematoma ( p = 0.02 ) in the same compartment . Of the 8 patients with radiographic changes , 4 had also developed joint space narrowing ( osteoarthrosis ( OA ) grade 1 ) after 1 year and 6 after 3 years . All but 1 had had a hematoma in the same compartment . More importantly , 3 of the 16 patients with entirely extra-articular fractures had subchondral bone plate changes in a compartment corresponding to a previous subchondral hematoma ( p = 0.02 ) . One of these had also developed joint space narrowing . The patients with radiographic changes had a worse outcome , as measured with the Gartl and and Werley wrist score ( p = 0.06 ) . In conclusion , subchondral hematomas in distal radial fractures can lead to early onset of mild OA and worse outcome after 1 year BACKGROUND Reduced muscular strength , as measured by grip strength , has been associated with an increased risk of all-cause and cardiovascular mortality . Grip strength is appealing as a simple , quick , and inexpensive means of stratifying an individual 's risk of cardiovascular death . However , the prognostic value of grip strength with respect to the number and range of population s and confounders is unknown . The aim of this study was to assess the independent prognostic importance of grip strength measurement in socioculturally and economically diverse countries . METHODS The Prospect i ve Urban-Rural Epidemiology ( PURE ) study is a large , longitudinal population study done in 17 countries of varying incomes and sociocultural setting s. We enrolled an unbiased sample of households , which were eligible if at least one household member was aged 35 - 70 years and if household members intended to stay at that address for another 4 years . Participants were assessed for grip strength , measured using a Jamar dynamometer . During a median follow-up of 4.0 years ( IQR 2.9 - 5.1 ) , we assessed all-cause mortality , cardiovascular mortality , non-cardiovascular mortality , myocardial infa rct ion , stroke , diabetes , cancer , pneumonia , hospital admission for pneumonia or chronic obstructive pulmonary disease ( COPD ) , hospital admission for any respiratory disease ( including COPD , asthma , tuberculosis , and pneumonia ) , injury due to fall , and fracture . Study outcomes were adjudicated using source documents by a local investigator , and a subset were adjudicated central ly . FINDINGS Between January , 2003 , and December , 2009 , a total of 142,861 participants were enrolled in the PURE study , of whom 139,691 with known vital status were included in the analysis . During a median follow-up of 4.0 years ( IQR 2.9 - 5.1 ) , 3379 ( 2 % ) of 139,691 participants died . After adjustment , the association between grip strength and each outcome , with the exceptions of cancer and hospital admission due to respiratory illness , was similar across country-income strata . Grip strength was inversely associated with all-cause mortality ( hazard ratio per 5 kg reduction in grip strength 1.16 , 95 % CI 1.13 - 1.20 ; p<0.0001 ) , cardiovascular mortality ( 1.17 , 1.11 - 1.24 ; p<0.0001 ) , non-cardiovascular mortality ( 1.17 , 1.12 - 1.21 ; p<0.0001 ) , myocardial infa rct ion ( 1.07 , 1.02 - 1.11 ; p=0.002 ) , and stroke ( 1.09 , 1.05 - 1.15 ; p<0.0001 ) . Grip strength was a stronger predictor of all-cause and cardiovascular mortality than systolic blood pressure . We found no significant association between grip strength and incident diabetes , risk of hospital admission for pneumonia or COPD , injury from fall , or fracture . In high-income countries , the risk of cancer and grip strength were positively associated ( 0.916 , 0.880 - 0.953 ; p<0.0001 ) , but this association was not found in middle-income and low-income countries . INTERPRETATION This study suggests that measurement of grip strength is a simple , inexpensive risk-stratifying method for all-cause death , cardiovascular death , and cardiovascular disease . Further research is needed to identify determinants of muscular strength and to test whether improvement in strength reduces mortality and cardiovascular disease . FUNDING Full funding sources listed at end of paper ( see Acknowledgments ) Objectives Management of AO type B and C fractures of the distal radius is controversial . This study compares outcomes and complications of AO type B and C fractures of the distal radius treated with volar locked plating and nonoperative methods . Material s and methods Sixty-four patients with fractures of the distal radius ( AO type B and C ) were included in this study , according to inclusion criteria , and were allocated to the volar plating group or nonoperative group by alternate r and omization : 32 patients with odd numbers went into the nonoperative group and the other 32 with even numbers went into the volar plating group . Patients in the nonoperative group were managed with closed reduction of the fracture and plaster cast application under an image intensifier . Those in the volar plating group were managed by open reduction and fixation with a volar locked plate . Preoperative and postoperative serial clinico-radiological follow-up was done . The range of movement , grip strength , functional outcome scores and radiological parameters were compared . Student ’s t-test was used for statistical analysis with significance at p < 0.05 . Results Range of movement and functional scores were significantly ( p < 0.001 ) better in the volar plating group , but the difference in ulnar variance and radial and ulnar deviation was insignificant as compared to the nonoperative group . At 24 months follow-up , the nonoperative group had significantly more cases with malunion , articular incongruity and osteoarthritis . Conclusion In cases of AO type B or C fractures of the distal radius , volar locked plating provides anatomical stable fixation and early mobilization with better clinico-radiological outcome as compared to conservative treatment Introduction We aim ed to evaluate the influence of associated scapholunate ( SL ) and /or lunotriquetral ligament ( LT ) injury on the outcome of distal radius fractures . Material s and methods This prospect i ve study included 40 patients with surgically treated distal radius fracture . Wrist arthroscopy was used to identify associated lesions of the scapholunate and lunotriquetral ligaments and classify them according to Geissler . Patients were divided in two groups by presence ( injured group ) or absence ( intact group ) of associated injury of the SL and /or LT ligament . The patient-rated wrist evaluation ( PRWE ) and the disabilities of the arm , shoulder and h and ( DASH ) question naires were used to evaluate disability 3 and 6 months after injury . Grip strength was also evaluated . Results Wrist arthroscopy identified SL and /or LT injury in 15 patients ( 37.5 % ) . Mean total PRWE score for the intact group was 26.64 at 3 months and 16.22 at 6 months , and 50.47 ( at 3 months ) and 20.7 ( at 6 months ) for the group with ligament injury . Mean DASH scores were 26.03 and 13 at 3 and 6 months for the intact group , and 49.5 and 24.11 for the injured group . Mann – Whitney test results showed significant difference for the PRWE and DASH scores and the grip strength for the two examined groups . Conclusions Patients with distal radius fracture with associated intrinsic ligament injury had worse outcomes than did patients without associated ligamentous injury . Associated injuries of the SL and LT ligament should be considered when treating distal radius fractures , and wrist arthroscopy should be incorporated into the operative protocol AIM To investigate whether radiographic deformities suggesting inadequate reduction would be associated with adverse clinical outcomes . MATERIAL S AND METHODS Consecutive patients over 50 years of age ( n=74 ) with non-operatively managed distal radius fractures were enrolled in a prospect i ve cohort study . They had radiographs at cast removal ( approximately 6 weeks ) and completed DASH ( Disabilities of the Arm , Shoulder and H and ) , SF-12 ( health-related quality of life ) , and satisfaction surveys 6-months post-fracture . A reference-st and ard musculoskeletal radiologist , blinded to outcomes status , measured palmar ( dorsal ) tilt , radial angle , radial height , ulnar height , and intra-articular step and gap . Radiographic indices were correlated to each other and to the various patient-reported outcomes in univariate and multivariate regression analyses . DASH score was the primary study outcome . RESULTS Of the cohort studied ( n=74 , mean age 68.5 years , primarily white women ) , 71 % had at least one " unacceptable " radiographic deformity by traditional criteria . Acceptable reduction varied from 60 - 99 % depending on which single index was reported , and 44 % of patients had more than two indices reported as unacceptable . Despite these radiographic findings , 6-months post-reduction , self-reported disability was low ( DASH=24+/-17 ) , health-related quality of life was near normal , and 72 % were satisfied with their care . No radiographic index of wrist deformity ( alone or in combination ) was significantly correlated to any of the patient-reported outcomes . CONCLUSION Self-reported outcomes in older adults with conservatively managed wrist fractures were not related to the " acceptability " of radiographic fracture reduction . The proportion of acceptable reductions varied by 40 % depending on which index was reported . Consequently , detailed reporting of these indices in older adults with distal radius fracture may be inefficient or perhaps even unnecessary |
11,542 | 18,580,547 | Statistically significant effects were found in favor of NSAIDs compared with placebo , but at the cost of statistically significant more side effects .
There is moderate evidence that NSAIDs are not more effective than paracetamol for acute low back pain , but paracetamol had fewer side effects .
There is moderate evidence that NSAIDs are not more effective than other drugs for acute low back pain .
There is strong evidence that various types of NSAIDs , including COX-2 NSAIDs , are equally effective for acute low back pain .
COX-2 NSAIDs had statistically significantly fewer side effects than traditional NSAIDs .
The evidence from the 65 trials included in this review suggests that NSAIDs are effective for short-term symptomatic relief in patients with acute and chronic low back pain without sciatica .
Furthermore , there does not seem to be a specific type of NSAID , which is clearly more effective than others .
The selective COX-2 inhibitors showed fewer side effects compared with traditional NSAIDs in the r and omized controlled trials included in this review .
However , recent studies have shown that COX-2 inhibitors are associated with increased cardiovascular risks in specific patient population | OBJECTIVES To assess the effects of nonsteroidal anti-inflammatory drugs ( NSAIDs ) and COX-2 inhibitors in the treatment of nonspecific low back pain and to assess which type of NSAID is most effective .
SUMMARY OF BACKGROUND DATA NSAIDs are the most frequently prescribed medications worldwide and are widely used for patients with low back pain .
Selective COX-2 inhibitors are currently available and used for patients with low back pain . | 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 A double-blind , 18-center , balanced trial of diflunisal vs. cyclobenzaprine HCl vs. these two drugs combined vs. placebo produced complete results from 175 patients . They had sought treatment at the cooperating centers for acute painful spasms of the back within a day or two of trauma or strain . Global results over the 7 to 10 days of observations revealed a clinical ly and statistically significant superiority of the combined therapy by Day 4 ( P=0.006 ) and almost all patients recovered within a week to 10 days . A combination therapy with an effective safe analgesic and a true muscle relaxant for less than a week appears to be an excellent relief measure for acute back problems Study Design . Two replicate , 4-week , r and omized , double-blind , placebo-controlled , trials of rofecoxib 25 and 50 mg versus placebo for chronic low back pain . Objectives . To determine the efficacy and safety of two doses of rofecoxib compared to placebo in the treatment of chronic low back pain . Summary of Background Data . Although nonsteroidal anti-inflammatory drugs are commonly prescribed for chronic low back pain , their efficacy is unproven and toxicity can be serious . These studies evaluated the efficacy and tolerability of rofecoxib , a selective COX-2 inhibitor , in the treatment of chronic low back pain . Methods . Patients with chronic low back pain were r and omized 1:1:1 to rofecoxib 25 mg , 50 mg , or placebo once daily . Primary endpoint : Low Back Pain Intensity . Secondary endpoints : Pain Bothersomeness , Global Assessment s of Response to Therapy , Global Assessment of Disease Status , Rol and -Morris Disability Question naire , SF-12 Health Survey , Use of Rescue Acetaminophen , and Discontinuations Due to Lack of Efficacy . Results . Combining both studies , 690 patients were r and omized to placebo ( N = 228 ) , rofecoxib 25 mg ( N = 233 ) , or rofecoxib 50 mg ( N = 229 ) . Mean ( ± SD ) age was 53.4 ( ± 12.9 ) years , pain duration 12.1 ( ± 11.8 ) years , 62.3 % female . Both rofecoxib groups improved significantly . Mean differences from placebo in pain intensity were −13.50 mm , −13.81 mm ( 25 , 50 mg doses ) respectively ( P < 0.001 ) . Both regimens were superior to placebo in eight of nine secondary endpoints . Fifty mg provided no advantage over 25 mg . Both rofecoxib regimens were well tolerated , although 25 mg had a slightly better safety profile . Conclusions . Rofecoxib significantly reduced chronic low back pain in adults and was well tolerated The study objective was to assess the efficacy and patient acceptance of ketorolac as an alternative to meperidine for the treatment of severe musculoskeletal low back pain ( LBP ) . A double blinded prospect i ve trial in a convenience sample of patients > 18 years of age presenting to an urban university hospital emergency department ( ED ) was conducted over a 19-month period . Patients were included if the pain was musculoskeletal in origin and was severe enough to warrant parenteral analgesics . Patients were r and omized to receive 1 mg/kg meperidine intramuscularly ( IM ) or 60 mg ketorolac IM . Pain intensity was measured preadministration and at 60 minutes via a 100 mm Visual Analog Scale ( VAS ) . Outcomes measured at 60 minutes were pain intensity decrease ( PID ) , patient satisfaction , rescue analgesia requirement , sedation level , and adverse effects . Clinical ly significant pain reduction was defined as a PID of at least 13 mm or a reduction in pain of least 30 % . One hundred fifty-five patients were enrolled ( meperidine = 75 , ketorolac = 80 ) and 153 patients completed the study . At 60 minutes the mean PID was 7 mm less in the ketorolac group ( 95 % confidence interval [ CI ] - 15 mm to 2.6 mm ) . Pain reduction of at least 30 % occurred in 63 % of the ketorolac group versus 67 % of the meperidine group ( 95 % CI , odds ratio [ OR ] .43 to 1.61 ) . Rescue analgesia was required in 35 % of the ketorolac group versus 37 % of the meperidine group ( 95 % CI , OR .47 to 1.74 ) . Patient satisfaction was less in the ketorolac group ( ketorolac 68 % satisfied versus meperidine 74 % satisfied ) however this was not significant ( 95 % CI , OR .66 to 2.72 ) . Sedation level and adverse effects were significantly greater in the meperidine group . Ketorolac shows comparable single dose analgesic efficacy to a single moderate dose of meperidine with less sedation and adverse effects in an ED population with severe musculoskeletal LBP . The trend for greater pain reduction and patient satisfaction with meperidine needs further investigation Abstract The efficacy and tolerability of aceclofenac was compared with diclofenac resinate in a double-blind , multicentre r and omised study in patients with acute low back pain suffering from degenerative spinal disorders . The study included 227 patients r and omised to receive either aceclofenac 2 × 100 mg daily or diclofenac resinate 2 × 75 mg daily for up to 10 days . The primary objective was to demonstrate the clinical non-inferiority of the analgesic efficacy of aceclofenac compared with diclofenac resinate , as assessed by changes from baseline in the visual analogue scale ( 0–100 mm ) pain score , at rest and at visit 3 ( final visit on day 's 8–10 ) . Secondary objectives included the time to early cure ( resolution of pain ) and global assessment of tolerability . Mean change in pain score at rest , and as visit 3 , compared with baseline , was 61.6 mm ( SD 24.5 ) for the aceclofenac group ( n = 100 ) and 57.3 mm ( SD 22.8 ) for the diclofenac resinate group ( n = 105 ) in the per- protocol population . Similar changes were observed in the intention-to-treat population . Between-group differences of 4.5 mm and 5.5 mm for the per- protocol and intention-to-treat population s , respectively , demonstrated clinical non-inferiority of aceclofenac compared with diclofenac resinate . Furthermore , there was evidence for superiority of aceclofenac over diclofenac resinate in terms of statistical significance , as the one-sided 97.5 % confidence interval was above −10 mm and 0 mm . In the intention-to treat population , a total of six aceclofenac-treated patients discontinued their medication owing to early cure , compared with only one patient receiving diclofenac resinate . Seventeen aceclofenac- ( 14.9 % ) , and 18 diclofenac resinate-treated patients ( 15.9 % ) reported at least one adverse event . However , the total number of adverse events reported was lower in patients receiving aceclofenac ( 22 versus 31 in the diclofenac resinate group ) . In conclusion , non-inferiority of the analgesic efficacy of aceclofenac compared with diclofenac resinate was demonstrated in patients with localised , uncomplicated acute lumbosacral pain . For the reduction in pain levels from baseline there was also evidence for superiority of aceclofenac compared with diclofenac resinate in terms of statistical significance , although this difference was not considered clinical ly relevant . The results also showed a trend towards a better safety and tolerability profile of aceclofenac over diclofenac resinate from a clinical point of view This study reports on 105 patients with acute low-back pain given tizanidine ( 4 mg three times daily ) plus ibuprofen ( 400 mg three times daily ) or placebo plus ibuprofen ( 400 mg three times daily ) . Patients assessed their pain using visual analogue scales in a daily diary and the doctor assessed their condition at baseline and on days 3 and 7 . Both groups were treated effectively , but earlier improvement occurred in patients given tizanidine/ibuprofen , particularly regarding pain at night and at rest . Doctors assessed the helpfulness of treatment : tizanidine/ibuprofen was significantly better than placebo/ibuprofen at day 3 ( P = 0.05 ) . Significant differences between treatments in favour of tizanidine/ibuprofen occurred in patients with moderate and severe pain at night ( P<0.05 ) , at rest ( P<0.05 ) and those with moderate or severe sciatica ( P<0.05 ) . Significantly more patients given placebo/ibuprofen had gastro-intestinal side-effects compared with tizanidine/ibuprofen ( P = 0.002 ) . This supports previous work in animals showing that tizanidine mediates gastric mucosal protection against anti-inflammatory drugs . More patients given tizanidine/ibuprofen suffered drowsiness and other central nervous system effects ( P = 0.025 ) . In patients with severe acute low-back pain , however , some sedation and bed rest is advantageous . This study shows that tizanidine/ibuprofen is more effective in the treatment of moderate or severe acute low-back pain than placebo and ibuprofen alone Two hundred and sixty patients with lumbago or sciatic pain participated in a multicenter observer-blind r and omized trial to compare the efficacy and tolerability of dipyrone 2.5 g , diclofenac 75 mg , and placebo administered as an intramuscular injection once daily for the duration of one to two days . The effectiveness of the test treatments in relieving sciatic pain was measured by a visual analog scale ( VAS ) before and 30 minutes , 1 , 2 , 3 , 6 and 24 hours after each injection . In addition , the patient 's general well-being was measured on a 5-point rating scale on day 0 , 1 and 2 . At the end of the trial , the patients evaluated the overall efficacy of the study drugs on a 5-point rating scale . Minimal finger-toe distance was measured every day of the trial . Pain intensity on VAS ( primary endpoint ) showed a significantly greater reduction with dipyrone than with diclofenac or placebo between 1 and 6 hours after application ( p < 0.01 ) and at the end of the trial ( after 48 hours ) . Improvement in general well-being and minimal finger-toe distance was greatest in the dipyrone group . 59 % of the patients with dipyrone assessed the overall efficacy as " excellent " or " very good " , compared with 30 % with diclofenac , and 18 % with placebo . Adverse reactions were reported in only 7 patients ( 3 % ) , 4 ( 5 % ) in the dipyrone , 1 ( 1 % ) in the diclofenac , and 2 ( 2 % ) in the placebo group A double-blind trial of azapropazone ( 300 mg . 4-times daily ) and ketoprofen ( 50 mg . 4-times daily ) was carried out in 50 patients with acute backache sufficiently severe to necessitate hospital admission . Of 39 patients who completed the full 3-weeks ' study period , 18 preferred azapropazone therapy , 10 preferred ketoprofen , and 11 showed either preference for the intermediate placebo period or no preference at all . Ten patients suffered from sufficiently severe side-effects with ketoprofen to necessitate their withdrawal from the trial . There were no similar episodes of withdrawal occurring during the azapropazone period The roles of bedrest , antiinflammatory medication , and analgesic medication in the treatment of acute back strain were objective ly analyzed to determine whether they have a measurable effect on the return of patients to full daily activities as well as on the relief of pain . Two hundred patients were studied prospect ively . Each patient had the diagnosis of acute back strain , which was defined as nonradiating low-back pain . The results of the patient 's neurologic examination , straight leg raising test , and lumbosacral spine roentgenograms had to be within normal limits for the patient to be included in the study . The results showed that bedrest , as compared with ambulation , will decrease the amount of time lost from work by 50 % . Bedrest will also decrease the amount of discomfort by 60 % . Analgesic medication , when combined with bedrest , will further decrease the amount of pain incurred , particularly when used in the first three days of the healing process . However , analgesic medication will not allow a more prompt return to work . Antiinflammatory medication , when added to bedrest in the treatment of lumbago , does not provide an advantage over bedrest alone Effective pain relief and patient tolerance and acceptance are essential in outpatient management of mild to moderate pain of acute low back strain . This study evaluated the efficacy , tolerability , and acceptability of diflunisal and acetaminophen with codeine in patients with mild to moderate pain after an initial or recurrent acute low back strain . Both drugs demonstrated equipotent analgesic efficacy ; however , diflunisal was superior to acetaminophen with codeine for patient tolerability and acceptability . The results demonstrated that the study drugs were effective in treating mild to moderate pain caused by acute low back strain in an ambulatory care setting Abstract : Objective : Two r and omised , double-blind , double-dummy trials evaluated the efficacy and tolerability of meloxicam compared with placebo or diclofenac in patients with acute sciatica.¶Subjects : 1021 patients with acute sciatica.¶Treatment and methods : In the first study , 532 patients received meloxicam 7.5 mg , meloxicam 15 mg , or placebo for 7 days . The second study r and omised 489 patients to meloxicam 7.5 mg , meloxicam 15 mg , or diclofenac 150 mg for 14 days.¶ Results : Meloxicam 7.5 mg and 15 mg significantly improved overall pain between baseline and day 7 ( p<0.05 ) compared with placebo . Furthermore , both meloxicam doses showed similar improvements on all primary and secondary efficacy endpoints compared with diclofenac 150 mg . No significant differences in tolerability were observed between any of the treatment groups in either study .¶ Conclusions : Meloxicam ( 7.5 mg or 15 mg ) was well tolerated and was more effective than placebo , and as effective as diclofenac , in acute Thirty-seven patients with chronic back pain were entered into a r and omised , 3-way , double-blind , cross-over comparison of naproxen sodium 550 mg twice daily , diflunisal 500 mg twice daily , and placebo . Each treatment was given for 14 days after a preadmission wash-out week during which only paracetamol was allowed . Patients were assessed on admission and at the end of each treatment with respect to global pain , night pain , pain on movement , and pain on st and ing . Both visual analogue scales and simple descriptive scales were used to measure pain . Side effects were elicited by a nonleading question . Both methods of pain measurement gave similar results and were highly correlated . Naproxen sodium was superior to placebo in relieving global pain and depending on the method of measurement , in relieving night pain and pain on movement . Diflunisal showed no significant differences from placebo . Side effects were similar on all 3 treatments . The final preference of the patients was significantly in favour of the active treatments Pain syndromes of the lumbar spine are one of the main problems in orthopedic practice . The therapeutic effect of NSAIDs is not subject to doubt in this connection . But considering that the application of NSAIDs is frequently associated with side effects , a reduction of dosage would be to the patient 's benefit . Clinical studies have shown that concomitant treatment with vitamins B1 , B6 , B12 and diclofenac leads to a more efficient pain relief than treatment using diclofenac alone and thus provides the possibility of saving NSAIDs . This clinical trial was carried out in order to determine whether these results can also be achieved when a reduced dosage of diclofenac ( 75 mg daily ) is used . 123 patients with acute pain syndromes of the lumbar spine were treated with either B-vitamins and diclofenac or diclofenac alone for a maximum of 7 days . There was the option to terminate therapy in the trial after 3 - 4 days in the case of total pain relief . 45 patients could stop the treatment due to remission of symptoms . 30 patients belonged to the combination therapy group , the other 15 took diclofenac alone ; this difference is statistically significant ( p less than 0.05 ) . All parameters concerning pain relief and movement of the vertebral column showed statistically significant differences in favour of the B-vitamin-diclofenac-combination , too . The results document the positive influence of B-vitamins on painful vertebral syndromes and indicate that B-vitamins contribute to saving of NSAIDs by shortening the treatment time and reducing daily NSAID-dosage A short-term double-blind sequential trial of indomethacin against placebo in the treatment of low back pain , with and without nerve root pain such as sciatica , showed that indomethacin was significantly more effective than placebo in the group with nerve root pain . On the other h and , no difference was found between the treatments in the patients with uncomplicated low back pain . This difference may result from an effect of indomethacin on the inflammatory process around the nerve root which has been shown to be present when this is compressed Thirty patients suffering from painful syndromes of the spine were admitted to a r and omized controlled clinical trial . They were divided into two groups and treated either with transcutaneous electrical nerve stimulation ( TENS ) , one application every other day , for 20 days or with TENS and an ointment containing etofenamate 10 % gel , 3 - 5 cm daily on the day of TENS therapy , and the same dose twice daily on the other days . The associated therapy achieved , when compared with TENS alone , a statistically significant better outcome . Furthermore a marked improvement of symptoms was observed in a shorter period of time . Therapy was well tolerated and in only four cases mild , self-limiting , skin reactions were observed . On the basis of these results the use of etofenamate and TENS could represent a viable alternative to systemic nonsteroidal antiinflammatory drug therapy Several clinical trials have shown that the duration of treatment of painful vertebral syndromes can be shortened by using a combination of vitamins B1 , B6 , B12 and diclofenac instead of diclofenac . In addition , a more efficient pain relief could be achieved by the combination therapy . In order to confirm these results , we compared the clinical efficacy of diclofenac ( 25 mg ) and a combination preparation with diclofenac ( 25 mg ) plus vitamins B1 ( thiamine nitrate 50 mg ) , B6 ( pyridoxine hydrochloride 50 mg ) and B12 ( cyanocobalamin 0.25 mg ) in a multicentric r and omized double-blind study including 418 patients . All patients received 3 x 2 capsules daily for a maximum of 2 weeks . In case of total pain relief , therapy should be discontinued after one week . Data of 376 patients could be evaluated . 53 out of 184 patients receiving the combination and 48 out of 192 patients treated with diclofenac alone could stop therapy due to sufficient pain relief after one week . The evaluation of the " Hoppe Pain Question naire " and the data concerning pain intensity also revealed better results for the combination preparation . The differences in favour of the B-vitamin-diclofenac-combination were statistically significant in patients with severe pain at the beginning of therapy . Considering undesirable side-effects ( symptoms in 70 out of 418 patients ) there were no significant differences between the two medications . This clinical trial provides further evidence that the combination therapy with diclofenac plus B-vitamins is more effective than diclofenac alone for the treatment of painful vertebral syndromes General Practitioners from the United Kingdom produced data on 1,282 patients with acute soft tissue injury treated with either piroxicam ( Feldene ) or matching placebo for a period of up to two weeks . The dosage of piroxicam was 40 mg for the first 2 days and 20 mg daily thereafter . Clinical assessment included pain , swelling , limitation of active and passive movement and overall assessment of efficacy and toleration . Piroxicam was significantly better than placebo in improving patient signs and symptoms , and in its overall efficacy ( P less than 0.001 ) ; 87 % of piroxicam treated patients had excellent or good responses , compared to 53 % of placebo treated patients . On analysis of four of the most commonly occurring diagnoses ( injuries of ankle , knee , shoulder , back ) patients with moderate or severe pain showed a significant improvement on treatment with piroxicam . Physicians ' overall assessment of toleration showed no evidence of differences between treatments . Over 90 % of patients in both treatment groups had good or excellent toleration . Withdrawals due to side effects were 3 % and 2.5 % respectively for piroxicam and placebo treated patients OBJECTIVE To evaluate of the efficacy and safety of 8 hours of continuous , low-level heatwrap therapy administered during sleep . DESIGN Prospect i ve , r and omized , parallel , single-blind ( investigator ) , placebo-controlled , multicenter clinical trial . SETTING Two community-based research facilities . PARTICIPANTS Seventy-six patients , aged 18 to 55 years , with acute , nonspecific low back pain . INTERVENTIONS Subjects were stratified by baseline pain intensity and gender and r and omized to one of the following treatments : evaluation of efficacy ( heatwrap , n=33 ; oral placebo , n=34 ) or blinding ( unheated wrap , n=5 ; oral ibuprofen , n=4 ) . All treatments were administered for 3 consecutive nights with 2 days of follow-up . MAIN OUTCOME MEASURES Primary : morning pain relief ( hour 0 ) on days 2 through 4 ( 0 - 5-point verbal response scale ) . Secondary : mean daytime pain relief score ( days 2 - 4 , hours 0 - 8 ) , mean extended pain relief score ( day 4 , hour 0 ; day 5 , hour 0 ) , muscle stiffness , lateral trunk flexibility , and disability ( Rol and -Morris Disability Question naire ) . RESULTS Heatwrap therapy was significantly better than placebo at hour 0 on days 2 through 4 for mean pain relief ( P=.00005 ) ; at hours 0 through 8 on days 2 through 4 for pain relief ( P<.001 ) ; at hour 0 on day 4 and at hour 0 on day 5 for mean pain relief ( P<.001 ) ; on day 4 in reduction of morning muscle stiffness ( P<.001 ) ; for increased lateral trunk flexibility on day 4 ( P<.002 ) ; and for decreased low back disability on day 4 ( P=.005 ) . Adverse events were mild and infrequent . CONCLUSIONS Overnight use of heatwrap therapy provided effective pain relief throughout the next day , reduced muscle stiffness and disability , and improved trunk flexibility . Positive effects were sustained more than 48 hours after treatments were completed Objective To compare the efficacy of valdecoxib 40 mg q.d . ( with a second dose on day 1 ) with diclofenac 75 mg b.i.d . in the treatment of acute low back pain . Methods This was a multicenter , r and omized , double-blind study . Patients with acute low back pain , class 1a or 2a ( Quebec Task Force ) , with a visual analog scale score ≥50 mm ( on a 100-mm scale ) and moderate to severe pain on a categorical scale , were r and omized to valdecoxib 40 mg q.d . ( with a second dose on day 1 ) or diclofenac 75 mg b.i.d . for 7 days ( 170 patients per group ) . The primary efficacy end point was change in pain intensity ( visual analog scale , mm ) from baseline to day 3 for the per- protocol population . Results Least squares mean reductions in pain intensity from baseline to day 3 were similar for valdecoxib ( −42.02 mm ) and diclofenac ( −41.43 mm ) . Valdecoxib was comparable to diclofenac as the lower limit of the 95 % confidence interval of the estimated difference ( 0.59 mm ; 95 % confidence interval , −3.40 to 4.59 mm ) was within the prespecified noninferiority margin of –10 mm . The overall incidence of adverse events was similar for valdecoxib ( 28 % ) and diclofenac ( 26 % ) . No statistically different moderate or severe upper gastrointestinal adverse events were reported , although they were numerically greater for diclofenac ( 8) than for valdecoxib ( 3 ) . Discussion Valdecoxib 40 mg q.d . ( with a second dose on day 1 ) provides effective relief for acute low back pain , and was at least as efficacious as diclofenac 75 mg b.i.d . , with a nonsignificant but numerically lower incidence of gastrointestinal adverse events Study Design . A prospect i ve , r and omized double-blind comparative trial . Objectives . To evaluate the efficacy and tolerability of nimesulide , a cyclooxygenase (COX)-2–selective anti-inflammatory agent versus ibuprofen in patients with acute lumbosacral back pain . Summary of Background Data . Nonsteroidal anti-inflammatory drugs ( NSAIDs ) have been more effective than placebo in patients with uncomplicated acute low back pain in previous r and omized controlled trials . The efficacy and tolerability of a new COX-2–selective anti-inflammatory drug have not yet been established . Methods . One hundred four patients aged 18–65 years with acute low back pain were enrolled . The patients were r and omly allocated either to oral nimesulide ( 100 mg twice daily for 10 days ) or oral ibuprofen ( 600 mg three times daily for 10 days ) . Outcome measures on a visual analog scale were an average of the pain intensity and the pain relief , stiffness in the back , functional status , and the results of physical examinations . All side effects were recorded at each visit . Results . With both study therapies , there was a clear improvement in all measured parameters of the pain and back function parameters measured from the third day of treatment onward . The patients ’ capacity for daily tasks , showed improvement in both groups ( P < 0.001 ) , but a statistically significant difference was found between the two groups in favor of the nimesulide group ( P < 0.05 ) after 10 days . Nimesulide was more effective than ibuprofen in improved lateral bending measurements ( P = 0.026 ) . Nimesulide and ibuprofen provided similar degrees of improvement in the modified Schober tests and in the pain intensity and back stiffness scores . More gastrointestinal side effects were reported with ibuprofen than nimesulide , and the comparison showed a trend ( P = 0.067 ) . Ten side effects occurred in the nimesulide group in 7 ( 13 % ) patients and 13 in the ibuprofen group in 11 ( 21 % ) patients . Conclusions . The results confirmed that the COX-2–selective inhibitor nimesulide is an effective and well-tolerated agent for use in general practice s to treat acutelow back pain . The incidence of gastrointestinal side effects seems to be lower with nimesulide than with ibuprofen Twenty-eight out patients with chronic severe lumbar pain participated in a double-blind comparative trial on the clinical efficacy of orally administered piroxicam and indomethacin . Half of the patients received indomethacin , 25 mg t.i.d . ; the other half received piroxicam 20 mg in the morning and a placebo at lunchtime and before dinner for six weeks . The patients were examined four times at two-week intervals for their capability to do daily tasks and for total lumbar mobility , forward bending , raising of both legs straight and the subjective assessment of pain . Side effects were recorded on a question naire and with laboratory tests . The overall results of both groups were similar . Thus , piroxicam , 20 mg daily , matches indomethacin , 25 mg t.i.d . , in the treatment of low back pain . The side effects were slight . Treatment with indomethacin was stopped in one case ( erythema and conjunctivitis ) . In the piroxicam group diarrhea , constipation , and pain in the tongue were reported , whereas in the indomethacin group gastrointestinal irritation and tiredness were typical symptoms Patients ( 112 ) with acute low-back pain of recent onset were recruited to this double-blind , r and omized , placebo-controlled parallel group study in general practice to evaluate the efficacy and tolerability of the muscle relaxant , tizanidine . They were treated for 7 days with tizanidine ( 4 mg three times daily ) or matching placebo . Aspirin tablets ( 300 mg ) were taken as required as ‘ rescue ’ medication . Symptoms were assessed by the patient and doctor before treatment , and after 3 and 7 days . Patients recorded pain and aspirin consumption in a daily diary . Both treatments were effective . In patients who had taken no medication prior to entry , aspirin consumption was almost halved in the first 3 days of taking tizanidine compared with placebo ( P = 0.037 ) . Results for pain at rest , pain at night , restriction of movement and pain on movement suggest that tizanidine may give greater improvement , earlier . No serious drug-related adverse events or abnormal biochemistry or haematology were observed in either group . Drowsiness occurred in 22 % of patients taking tizanidine although , in patients with severe acute low-back pain , sedation , analgesia and bed rest might be beneficial and desired . Considerably more patients given aspirin/placebo had gastro-intestinal side-effects ( P = 0.018 ) . In conclusion , tizanidine may reduce the need for analgesics and be useful in the treatment of acute low-back pain In a 2-week , double-blind , parallel , multicenter study , piroxicam ( 20 mg once-daily ) and indomethacin ( 25 mg three times daily ) were compared in the treatment of painful lumbar disorders . A total of 230 patients were evaluated , 116 who received piroxicam and 114 who received indomethacin . While both drugs were highly effective in relieving symptoms , numerical superiority was evident for piroxicam in most efficacy parameters . The difference between treatments was most obvious at the end of the first week , when a greater percentage of patients receiving piroxicam was rated as ' very much improved ' . No serious adverse reactions or clinical laboratory abnormalities were noted for either drug , although fewer gastrointestinal side effects were observed with piroxicam Fifty-six patients entered into an open-label , r and omized study to compare the efficacy and tolerability of diflunisal and naproxen in the treatment of mild to moderate pain associated with acute low back strain . Thirty-three patients completed the two-week study . No patients withdrew because of side effects , and both drugs were well tolerated . Results showed that diflunisal was more effective than naproxen ( 81 % versus 41 % ) in relieving pain . Of the 16 patients taking diflunisal , 13 rated its efficacy as very good or excellent ; six ( 35 % ) of 17 patients taking naproxen rated their drug similarly . Overall , diflunisal rated slightly better in efficacy and tolerability and in improving limitation of function and motion . In addition , diflunisal has a longer duration of action and thus requires less frequent dosing than naproxen In this controlled , r and omized , parallel and open multicentre study , the efficacy and tolerability of a regimen comprising intravenous ( i.v . ) meloxicam followed by oral therapy was compared with a st and ard regimen of intramuscular ( i.m . ) diclofenac followed by oral dosing in patients with acute lumbago . Of a total of 183 patients , 92 were r and omized to receive meloxicam 15 mg i.v . on day 1 followed by 7 days oral treatment with one 15 mg tablet daily , and 91 patients received diclofenac 75 mg i.m . on day 1 followed by 7 days treatment with one 100 mg slow release tablet daily . Pain on movement and limitation of activities were assessed by patients and physicians using question naires . Meloxicam i.v . demonstrated a significantly faster median time of onset of analgesic action ( 30 minutes ) , compared with diclofenac i.m . ( 60 minutes ) . The reduction in pain during movement 30 minutes after injection was also significantly in favour of meloxicam . Assessment s of global efficacy indicated that meloxicam was significantly better than diclofenac as rated by investigators ( p = 0.02 ) and patients ( p = 0.01 ) . Moreover , the rating of investigators and patients for local and global tolerance was significantly in favour of meloxicam ( p < 0.05 ) and improvements in the quality of life were almost significant ( p = 0.053 ) . Fewer adverse events , particularly of a gastrointestinal ( GI ) nature , occurred in the meloxicam group compared with the diclofenac group . This study therefore demonstrates that meloxicam 15 mg i.v . followed by oral therapy is both efficacious and well tolerated in the treatment of acute lumbago , and compares favourably with the st and ard NSAID , diclofenac , in this indication Diflunisal and indomethacin were compared in patients with acute lumbago in a double-blind prospect i ve clinical trial . The dosage of diflunisal was 500 mg twice daily ( d-group ) and the dosage of indomethacin 50 mg three times daily ( i-group ) . Out of 133 patients , 66 were in the d-group and 67 in the i-group . They were followed up for a week . In addition to the patient 's own daily evaluation of pain and functional disability , control visits were performed by the investigators on days 0 , 3 and 7 . Both of the test drugs were effective in the dosages used . Patients ' pain was decreased , functional disability was improved and patients ' subjective evaluation of treatment efficacy was very similar to that of the investigators . There were no differences as to the treatment efficacy , but reports of side-effects were slightly less ( p less than 0.05 ) in the d-group than in the i-group . If patients who had no side-effects were compared , the efficacy of diflunisal was better than indomethacin ( p less than 0.05 ) . It can be said that indomethacin was essentially as effective as diflunisal , but at the expense of an increased frequency of side-effects . In the d-group two patients ( 3 % ) and in i-group six patients ( 9 % ) discontinued the therapy because of side-effects . In acute lumbago rapid relief of pain and other harmful symptoms hastens improvement . For such indications the choice of drug therapy in general practice should be based in particular on considerations of safety and lack of potential side-effects in addition to efficacy The use of nonsteroidal anti-inflammatory drugs ( NSAID ) such as diclofenac for treatment of degenerative rheumatic disorders of the lumbar spine is of great significance in orthopedic practice . Clinical studies have shown that concomitant treatment with vitamins B1 , B6 , B12 and diclofenac provides more efficient pain relief than treatment using diclofenac alone . This study was undertaken in order to determine whether the duration of treatment with diclofenac for lower back pain can be shortened by adding B-vitamins to the therapeutic regimen . From September through December of 1986 , 256 patients participated in a multicenter , controlled , r and omized double-blind trial which compared the clinical efficacy of diclofenac ( 50 mg ) with a combined therapy of diclofenac ( 50 mg ) and vitamins B1 , B6 , and B12 ( thiamine nitrate , pyridoxine hydrochloride , and cyanocobalamine , resp . ; in dosages of 50 mg , 50 mg , and 0.25 mg , resp . ) . Patients were treated with 3 X 1 capsule daily for a maximum of two weeks , having the option to terminate participation in the trial after 1 week in the event of total pain relief . The data of 238 patients were able to be included in the evaluation . 29 patients opted to discontinue therapy due to remission on symptoms . Nineteen ( 65.6 % ) of these patients belonged to the combined therapy group , the other 10 ( 34.4 % ) having taken diclofenac alone ; this difference is statistically significant ( p less than 0.05 ) . An important aspect in the evaluation of therapy was the patient response regarding the improvement of painful symptoms which , in addition to their subjective feedback , was reflected in the test results of the " Hoppe Pain Question naire ( HPQ ) . " All parameters used as a measure of pain relief indicated superior results with the B-vitamin supplemented therapy when compared with results obtained with diclofenac alone . Moreover , after 3 days of therapy the " sensory " pain factor " sharpness " improved significantly . Undesirable side-effects were documented with 39 patients , 14 of them having discontinued therapy for this reason . No statistically significant difference could be determined within this group with regard to therapy . The study results document the positive influence of B-vitamins on painful symptoms and indicate that less NSAID is needed for pain relief when combined with B-vitamins Acute low back pain is a common problem in the emergency department ( ED ) . Effective management of acute pain enhances early rehabilitation and recovery . Given the importance of inflammatory mediators in pain generation and the adverse effects associated with opioids , it is logical to expect that a non-opioid agent with antiinflammatory and analgesic properties would provide excellent analgesia with fewer adverse effects . This double-blind , r and omized , multicenter clinical trial , performed in six university and community hospital EDs , compares the analgesic efficacy and adverse effects of ketorolac to those of acetaminophen-codeine in ED patients with acute musculoskeletal low back pain . Our hypothesis was that ketorolac would provide superior analgesia with fewer adverse effects . One hundred twenty-three patients with acute low back pain were r and omized to receive ketorolac ( KET , N = 63 ) or acetaminophen-codeine ( ACOD , N = 60 ) . Most ( 79 % ) were males , and the mean age was 34.5 years . After baseline clinical assessment , patients were treated with ketorolac ( 10 mg every 4 to 6 h as needed , up to four daily doses ) or acetaminophen-codeine ( 600 mg-60 mg , respectively , every 4 to 6 h as needed , up to six daily doses ) and followed for one week . Pain intensity was assessed on visual analogue and categorical scales . Functional capacity , overall pain relief , and overall medication rating were assessed on categorical scales . Adverse events were documented . Primary outcomes included : 1 ) Pain intensity differences , based on visual analogue scores , for the 0 to 6 h treatment phase . 2 ) Incidence of adverse events . Secondary outcomes included analgesic efficacy , functional capacity , and overall subjective drug evaluation at one week . Both drugs provided substantial pain relief , with maximal effect 2.2 h after oral dosing . There were no significant differences in analgesic efficacy , functional capacity , or overall pain relief between the two groups . Sixteen patients ( 10 KET vs. 6 ACOD , NS ) withdrew prematurely because of drug inefficacy . Patients in the ACOD group reported significantly more adverse drug events and serious adverse drug events . Seven patients --all in the ACOD group -- withdrew from the study because of adverse drug events . Based on comparable efficacy and a superior adverse event profile , ketorolac was preferable to acetaminophen with codeine for the treatment of acute low back pain in the ED Seventy out- patients with acute back pain participated in a double-blind comparative trial of the clinical efficacy and tolerance of orally administered meptazinol and diflunisal . Half of the patients received 200 mg meptazinol or 250 mg diflunisal 4-times daily for up to 3 weeks , depending on the duration of pain . Patients were examined 4 times at 1-week intervals for their capability to do daily tasks , for their capacity for forward bending , thoraco-lumbar torsion , straight leg raising , static hip flexion and sit-ups , and for subjective assessment of pain . Side-effects were recorded on a question naire . Both treatments produced marked improvement in most of the parameters assessed , often within the first week and , overall , the results were similar with the two drugs . Few side-effects were reported and those that were recorded were slight and similar in incidence apart from nausea in 5 meptazinol-treated patients and smarting and burning on urination in 2 patients receiving diflunisal Twenty-seven investigators participated in a double-blind , parallel placebo-controlled trial of piroxicam involving 278 patients with acute low back pain . Therapy commenced within 48 hours of the injury and continued for 7 days . The drug was given in the recommended regimen of 40 mg once daily for the first 2 days and 20 mg once daily thereafter . After 3 days of therapy , piroxicam patients showed a statistically greater amount of pain relief in the lying ( P<0.001 ) , sitting ( P<0.01 ) , and st and ing ( P<0.01 ) positions , but after 7 days the difference between treatments was no longer significant . After 1 week 's therapy , however , the requirement for additional analgesic was significantly lower in the piroxicam group ( P<0.05 ) , and more piroxicam than placebo patients ( 42 versus 28 ) had returned to work ( P<0.05 ) . Toleration was excellent in most patients , with only 13 % of the piroxicam and 17 % of the placebo group reporting adverse effects of mainly mild or moderate severity . The profile of the adverse effects was similar for both treatments . Piroxicam can provide effective relief of acute low-back pain with good toleration ; it should be considered for use in the initial treatment of this condition We evaluated etoricoxib , a novel COX-2-specific inhibitor , in 319 patients with chronic low back pain ( LBP ) in this double-blind , placebo-controlled trial . Patients were r and omized to a 60 mg dose ( n = 103 ) or 90 mg dose ( n = 107 ) of etoricoxib , or placebo ( n = 109 ) , daily for 12 weeks . The primary endpoint was low back pain intensity scale ( Visual Analog Scale of 0- to 100-mm ) time-weighted average change from baseline over 4 weeks . Other endpoints included evaluation over 3 months of low back pain intensity scale , Rol and -Morris Disability Question naire ( RMDQ ) , low back pain bothersomeness scale , patient- and investigator-global assessment s , Patient Health Survey ( MOS SF-12 ) , rescue acetaminophen use , and discontinuation due to lack of efficacy . Etoricoxib provided significant improvement from baseline versus placebo in pain intensity ( 4 weeks : 12.9 mm and 10.3 mm for 60-mg and 90-mg doses , P < .001 for each ; 12 weeks : 10.5 mm and 7.5 mm for 60-mg and 90-mg doses , P = .001 and .018 , respectively ) . Etoricoxib at either dose led to significant improvement in other endpoints , including RMDQ scores , bothersomeness scores and global assessment s. Etoricoxib given once daily provided significant relief of symptoms , and disability associated with chronic LBP that was observed 1 week after initiating therapy , was maximal at 4 weeks , and was maintained over 3 months OBJECTIVE This r and omized , double-dummy , double-blind pilot study of acutely exacerbated low back pain was aim ed to inform a definitive comparison between Doloteffin , a proprietary extract of Harpagophytum , and rofecoxib , a selective inhibitor of cyclo-oxygenase-2 ( COX-2 ) . METHODS Forty-four patients ( phyto-anti-inflammatory drug-PAID-group ) received a daily dose of Doloteffin containing , inter alia , 60 mg of harpagoside for 6 weeks and 44 ( non-steroidal anti-inflammatory drug-NSAID-group ) received 12.5 mg/day of rofecoxib . All were allowed rescue medication of up to 400 mg/day of tramadol . Several outcome measures were examined at various intervals to obtain estimates of effect size and variability that might be used to decide the most suitable principal outcome measure and corresponding numbers required for a definitive study . RESULTS Forty-three PAID and 36 NSAID patients completed the study . Ten PAID and 5 NSAID patients reported no pain without rescue medication for at least 5 days of the 6th week of treatment . Eighteen PAID and 12 NSAID patients had more than a 50 % reduction in the week 's average of their pain scores between the 1st and 6th weeks . The mean percentage decrease from baseline in the pain component of the Arhus Index was 23 ( S.D. 52 ) in PAID and 26 ( S.D. 43 ) in NSAID . The corresponding measures for the overall Arhus Index were 11 ( 31 ) and 16 ( 24 ) and , for the Health Assessment Question naire , 7 ( 8) and 6 ( 7 ) . Tramadol was used by 21 PAID patients and 13 NSAID patients . Fourteen patients in each group experienced 39 adverse effects , of which 28 ( 13 in PAID ) were judged to some degree attributable to the study medications . CONCLUSION Though no significant intergroup differences were demonstrable , large numbers will be needed to show equivalence One hundred and twelve patients with acute mechanical low back pain were r and omly divided into three treatment groups . All patients received ergonomic advice and then either a non-steroidal anti-inflammatory drug or conservative or manipulative types of physiotherapy . Serial assessment s of pain and spinal mobility showed similar response rates in all three treatment groups and no significant difference between therapies . The overall improvement ratings , time off work , and economic cost favoured the group treated with the nonsteroidal anti-inflammatory drug , but this group had a better range of spinal flexion at the onset so firm conclusions regarding the preferred management of these patients in general practice can not be drawn . Treatment failures occurred in all groups highlighting the need for a variety of therapeutic approaches in managing the patient with low back pain To study the natural history of acute sciatica , 208 patients with obvious symptoms and signs of a lumbar radiculopathy ( L5 and S1 ) were examined within 14 days of onset . A concomitant double-blind investigation of the effect of the nonsteroidal anti-inflammatory drug piroxicam was performed . The results measured by visual analog scale and Rol and 's functional tests showed a satisfactory improvement throughout the 4 weeks of observation . The piroxicam-treated group had same results as the control group . Based on question naires at months 3 and 12 approximately 30 % of the patients still complained about back trouble and 19.5 % were out of work after 1 year . Four patients underwent surgery during this period In a controlled multi-center single-blind study , the relative efficacy and tolerance of i.m . injectable preparations of etofenamat(e ) and diclofenac sodium were investigated in 96 patients with acute lumbago . Treatment result ed in obvious improvement in function and reduction in pain , no statistical difference being found between the two drugs . In 43 % of the patients treated with etofenamat(e ) and 27 % of those receiving diclofenac , the final medical report indicated very good therapeutic results . Under etofenamat(e ) i.m . therapy , no side effects occurred , and in no case did treatment have to be discontinued . Under diclofenac , two patients experienced adverse reactions , one allergic exanthema , and the other itching and a sensation of heat . A further patient experienced no improvement after the first injection and discontinued treatment The efficacy of an NSAID ( tenoxicam ) in the treatment of acute low back pain ( LBP ) was assessed in a double blind controlled study by using an objective functional evaluation . Seventy-three patients consulting for acute LBP were r and omized into two groups : Group I was treated with tenoxicam for 14 days and Group II was given a placebo . Trunk function was measured with a computerized isoinertial dynamometric trunk testing device ( Isostation B200 ) . Isometric and dynamic torques , range of motion and movement velocities were measured before treatment and after 14 days . Clinical evaluation was realized by the patient on a pain visual analogue scale ( VAS ) on days 1 , 8 and 15 and by the investigator on a five-point scale on days 8 and 15 . The functional evaluation showed significant differences in favour of the tenoxicam treatment for velocity and extension isometric torque . VAS and investigator evaluations showed a significant difference in favour of tenoxicam on day 8 but no difference on day 15 . This study shows that the use of tenoxicam in acute LBP is of interest . Tenoxicam has an effect on pain during the first part of the treatment and may help to restore full function even if the symptoms have disappeared The marketed formulations of 6 analgesic preparations were compared in the treatment of patients suffering from acute exacerbations of low back pain using a crossover trial of balanced incomplete block design . Sixty out- patients with symptoms result ing from a mechanical or degenerative condition were each prescribed 3 drugs which were administered consecutively for 1 week each . The medications ( and daily dosages ) were coded as A --aspirin ( 3600 mg ) , B --dextropropoxyphene plus paracetamol ( 260 mg plus 2600 mg ) , C --indomethacin ( 150 mg ) , D --mefenamic acid ( 1500 mg ) , E --paracetamol ( 4000 mg ) , and F --phenylbutazone ( 300 mg ) . Daily pain scores were significantly lower ( p less than 0.05 ) during treatment D than during treatments E and B , and significantly lower ( p less than 0.05 ) during treatment A than during treatment B. There were large and significant differences between treatments in the percentages of recommended doses acceptable to the patients and in the number of defaults from the prescribed regimens . The patients chose F and D significantly more ( p less than 0.05 ) often than A. Overall , there were consistently superior performances by mefenamic acid and phenylbutazone with little to choose between the two Study Design . Cohort study . Objectives . To estimate the Minimal Clinical ly Important Change ( MCIC ) of the pain intensity numerical rating scale ( PI-NRS ) , the Quebec Back Pain Disability Scale ( QBPDS ) , and the Euroqol ( EQ ) in patients with low back pain . Summary of Background Data . MCIC can provide valuable information for research ers , healthcare providers , and policymakers . Methods . Data from a r and omized controlled trial with 442 patients with low back pain were used . The MCIC was estimated over a 12-week period , and three different methods were used : 1 ) mean change scores , 2 ) minimal detectable change , and 3 ) optimal cutoff point in receiver operant curves . The global perceived effect scale ( GPE ) was used as an external criterion . The effect of initial scores on the MCIC was also assessed . Results . The MCIC of the PI-NRS ranged from 3.5 to 4.7 points in (sub)acute patients and 2.5 to 4.5 points in chronic patients with low back pain . The MCIC of the QBPDS was estimated between 17.5 to 32.9 points and 8.5 to 24.6 points for (sub)acute and chronic patients with low back pain . The MCIC for the EQ ranged from 0.07 to 0.58 in (sub)acute patients and 0.09 to 0.28 in patients with chronic low back pain . Conclusion . Reporting the percentage of patients who have made a MCIC adds to the interpretability of study results . We present a range of MCIC values and advocate the choice of a single MCIC value according to the specific context A total of 395 male infantry recruits were evaluated in a prospect i ve study of possible risk factors for overexertional back pain and the efficacy of drug treatment regimens for this syndrome . Recruits were classified into subgroups of lumbar or thoracic , and paraspinal or spinous process pain . Recruits were divided into three treatment groups : Ibuprofen , Paracetamol , and no drug treatment . Of the recruits , 18 % were diagnosed as having overexertional back pain during the course of 14 weeks of training . By multivariate analysis low body mass index was found to be a risk factor for overexertional lumbar pain ( p = 0.005 ) and increased lumbar lordosis a risk factor for overexertional thoracic pain ( p = 0.005 ) . Of recruits with overexertional back pain , 65 % were asymptomatic by the end of basic training . There was no statistically significant difference between cure rates according to treatment groups Two groups of 20 patients each , with mild to moderate acute low back pain with associated muscle spasm of ten days ' duration or less , were treated with a combination of cyclobenzaprine and naproxen or naproxen alone in a r and omized , 14-day open-label trial . Cyclobenzaprine was added to the naproxen regimen as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute , painful , musculoskeletal conditions . The clinical characteristics of each study group , including the number of worker 's compensation patients , were comparable . Combination therapy was associated with less objective muscle spasm and tenderness and greater motion of the lumbosacral spine ( P less than 0.05 ) . There were trends toward faster resolution of functional deficits and pain with combined therapy . Combination therapy was associated with more side effects , due primarily to drowsiness from the cyclobenzaprine . The results of this study demonstrated that patients with muscle spasm associated with acute low back strain benefited from the use of combination therapy consisting of a nonsteroidal anti-inflammatory agent ( naproxen ) and a muscle relaxant ( cyclobenzaprine ) In this controlled , single-blind parallel group study , the effect of ibuprofen 1200 mg daily was compared with diclofenac 75 mg daily . Thirty patients entered the study , r and omized into two groups , each group receiving one tablet three times daily for two weeks . A one-week wash-out period ( i.e. a drug-free period during which only physiotherapy was given ) , preceded and followed the treatment on active drug . Assessment s were made by the same clinician throughout who was unaware of the treatment of individual patients . Statistically significant improvement was shown by patients receiving ibuprofen for the degree of pain relief at rest and improvement was also shown for the degree of pain at rest and during exercise , for pain relief during exercise and for spinal flexion . Patients who received diclofenac showed stastistically significant improvement for forward flexion , together with improvement for the degree of pain on exercise . Side-effects were very few Background : Chronic low back pain ( LBP ) is a growing health problem . Non‐steroidal anti‐inflammatory drugs ( NSAIDs ) are used to treat this condition , but have not demonstrated efficacy beyond 2 weeks , and no studies have shown that NSAIDs produce durable improvements in disability . Methods : To evaluate the efficacy and durability of effect of etoricoxib for chronic LBP , a r and omized , double blind , placebo‐controlled trial was conducted at 46 centres . Three hundred and twenty‐five patients with chronic LBP requiring treatment with an NSAID or paracetamol were r and omized 1:1:1 to etoricoxib 60 mg ( n=109 ) , 90 mg ( n=106 ) , or placebo ( n=110 ) , daily for 3 months . Pre‐specified endpoints over 3 months included LBP intensity scale ( visual analog scale 0–100 mm ) time‐weighted average change from baseline , the Rol and –Morris Disability Question naire ( RMDQ ) , the LBP bothersomeness scale , patient and investigator global assessment s , and measures of quality of life . Results : Both etoricoxib groups experienced significant reductions in LBP intensity at 4 weeks versus placebo [ −15.15 mm and −13.03 mm for 60 and 90 mg , respectively , probability (p)<0.001 for each ] , which was maintained over 3 months . Treatment result ed in significant improvement from baseline compared to placebo in RMDQ scores ( etoricoxib 60 mg , −2.82 and 90 mg , −2.38 , p<0.001 for each ) over 12 weeks and most other efficacy endpoints . There were no significant differences between treatments in incidence of adverse events ( AEs ) or discontinuations due to AEs . Conclusion : Etoricoxib provided significant relief of symptoms and disability associated with chronic LBP detected at 1 week , confirmed at 4 weeks , and maintained over 3 months . Reductions in chronic LBP severity corresponded to improvements in physical functioning and quality of life . All treatments were generally well tolerated SUMMARY Objective : We recently reported the efficacy of rofecoxib in two r and omized controlled trials in chronic low back pain ( CLBP ) . The objectives of this report are to present data regarding the onset of efficacy of rofecoxib from these trials and propose methods for reporting onset . Research design and methods : Patients were aged 18 - 75 , with non-radicular CLBP for > 3 months . Patients were r and omized to rofecoxib 25 mg , 50 mg , or placebo once daily for 4 weeks . Assessment s included Low Back Pain and Bothersomeness scales every morning and Relief from Starting Pain after the first dose at 0.5,1 , 2 , 3,4h , bedtime , and next morning . Onset of meaningful relief was measured by Time to Confirmed 50 % Reduction in Pain and Time to Confirmed ' Slightly ' or ' Not At All ' Bothersome Pain . Onset of perceptible pain relief was measured by Time to At Least ' A Little ' Confirmed Pain Relief . Results : 690 patients entered . Significantly more patients treated with rofecoxib had meaningful relief compared to placebo : 60.4,58.4 , and 34.7 % for rofecoxib 25 mg , 50 mg , and placebo ( p < 0.001 ) . Median time to meaningful relief for rofecoxib was 2 days , 1 day sooner than placebo . Rofecoxib was superior to placebo by bedtime after the first dose . Conclusions : Approximately 2/3 of patients achieved meaningful pain relief with rofecoxib compared with 1/3 receiving placebo . Median time to onset of meaningful relief was about 2 days , but superior relief over placebo was seen by bedtime after the first dose . Onset of perceptible pain relief was within 2 h. We propose that measures of onset of analgesic effect include the proportion of patients who achieve meaningful pain relief and in this subgroup , the time-to-onset of confirmed meaningful reduction in pain intensity , time-to-onset of confirmed pain relief , and time to first separation from placebo in the proportion of patients who achieve meaningful pain relief OBJECTIVE To assess efficacy and safety of diclofenac-K 12.5 mg tablets in the treatment of acute low back pain ( low back pain ) . MATERIAL / METHOD A multiple dose , double-blind , double-dummy , r and omized , placebo-controlled , parallel group trial compared diclofenac-K ( 12.5 mg ; n = 124 ) with ibuprofen ( 200 mg ; n = 122 ) and placebo ( n = 126 ) in patients with moderate-to-severe acute low back pain . The treatment consisted of an initial dose of 2 tablets followed by 1 or 2 tablets every 4 - 6 hours as needed ( maximum 6 tablets/day ) for 7 days . The primary efficacy outcome for the initial dose was TOTPAR-3 , the summed total pain relief over the first 3 hours . Secondary initial dose outcomes included TOTPAR-6 , summed pain intensity differences SPID-3 and SPID-6 , time to rescue medication or remedicate , and the End of First Dose global efficacy assessment . The primary efficacy outcome for the flexible multiple dosing regimen was the End of Study global efficacy assessment . Secondary outcomes for multiple dosing included time to rescue medication over the entire study , the End of Day global efficacy assessment s ( daily over Days 1 - 7 ) , pain intensity differences on the VAS measured at Visit 2 and 3 , and change in Eifel algofunctional index . Safety/tolerability was assessed by recording adverse events . RESULTS Diclofenac-K 12.5 mg demonstrated superiority vs placebo on the primary efficacy parameter and almost all secondary initial dose outcomes . With respect to the initial dose , diclofenac-K 12.5 mg was also significantly superior to ibuprofen 200 mg on SPID-3 . Ibuprofen 200 mg was superior to placebo only on the End of First Dose global efficacy assessment . The flexible multiple dosing regimens of diclofenac-K and ibuprofen were both significantly superior to placebo on the End of Study global efficacy assessment , time to rescue medication over the entire study period , the End of Day global efficacy assessment on Days 1 - 2 , pain intensity difference on the VAS at Visit 3 and the Eifel algofunctional index at Visit 3 ( also at Visit 2 in diclofenac-K 12.5 mg group ) . Both active treatments were as well tolerated as placebo . CONCLUSIONS The flexible multiple dosing regimen of diclofenac-K 12.5 mg ( initial dose of 2 tablets followed by 1 - 2 tablets every 4 - 6 hours , max . 75 mg/day ) is an effective and safe treatment of acute low back pain ABSTRACT Background and methods : The efficacy and safety of etoricoxib 60 mg/day in patients with established chronic low back pain ( CLBP ) were compared with those of diclofenac 150 mg/day in a 4‐week , multicentre , r and omized , double-blind , parallel-group trial . Four hundred and forty-six adult patients with CLBP ( Quebec Task Force on Spinal Disorders Class 1 or 2 ) and with worsening pain upon discontinuation of pre- study analgesic medication were enrolled in the study . The study primary efficacy endpoint was change from baseline in Low Back Pain Intensity Scale ( LBP‐IS ) score over the 4‐week treatment period . Secondary and other efficacy endpoints included : changes in Rol and and Morris Disability Question naire ( RMDQ ) , Patient Global Assessment of Response to Therapy ( PGART ) and Low Back Pain Bothersomeness Scale ( LBP-BS ) scores . Early efficacy was assessed using PGART and LBP‐IS scores 4 h after the first dose on the mornings of Days 1 , 2 and 3 . The overall safety and tolerability of etoricoxib 60 mg/day during 4 weeks of treatment were also assessed . Results : The least-squares mean time-weighted change from baseline LBP‐IS score over 4 weeks was –32.94 mm ( 95 % CI –36.25 , –29.63 ) for etoricoxib , indicating substantial efficacy in relief of pain . The treatment difference for the primary outcome was 2.51 mm ( 95 % CI –1.50 , 6.51 ) , fulfilling the prespecified equivalence criterion of 95 % confidence interval wholly within ± 10 mm . Etoricoxib improved all secondary and other efficacy outcomes . There were no statistically significant between-group differences in the proportion of patients with one or more clinical adverse events ( AEs ) ( etoricoxib 35 % , diclofenac 39 % ) , or the proportion of patients who discontinued due to AEs ( etoricoxib 7 % , diclofenac 5 % ) . Conclusions : The results of this study confirm that , for adult patients with CLBP , etoricoxib 60 mg once daily over 4 weeks is effective for relief of pain and improvement of physical function and comparable to high-dose diclofenac 150 mg daily The use of flurbiprofen as an analgesic and anti-inflammatory agent in patients with soft tissue trauma induced by sports injuries , lumbar disk syndrome , or surgery was considered in three clinical trials . In the first study , soft tissue injuries to the lower limb in 51 professional soccer players were treated for six days with 150 mg of flurbiprofen per day or 3.6 g of aspirin per day . The second study compared three weeks of treatment with daily doses of 200 mg of flurbiprofen and 4 g of acetaminophen in 50 patients with acute low back pain . In the third study , 100 postoperative patients were given 400 mg of flurbiprofen per day or 4 g of acetaminophen per day for seven days following total or partial meniscectomy . In all of these trials , flurbiprofen showed excellent analgesic efficacy in reducing pain and swelling , and enhanced the recovery of patients with soft tissue trauma BACKGROUND Valdecoxib , a cyclooxygenase (COX)-2 specific inhibitor , is indicated for relief of the signs and symptoms of rheumatoid arthritis , osteoarthritis , and primary dysmenorrhea . Therapeutic doses of COX-2 specific inhibitors are as effective as nonspecific nonsteroidal anti-inflammatory drugs in reducing inflammatory pain while sparing the gastrointestinal and platelet toxicity associated with nonspecific COX-1 inhibition . OBJECTIVE The aim of this study was to assess the analgesic efficacy and tolerability of valdecoxib 40 mg/d compared with placebo in the treatment of chronic low back pain . METHODS This 4-week , prospect i ve , r and omized , double-blind placebo-controlled , parallel-group study was conducted at 37 centers across the United States and 5 centers in Canada . Patients aged > or = 18 years with chronic low back pain in flare were enrolled . Patients were r and omized to receive valdecoxib 40-mg/d or placebo tablets , once daily for 4 weeks . Patients rated low back pain intensity on a visual analog scale and completed the Rol and -Morris Disability Question naire and the modified Brief Pain Inventory-Short Form ( mBPI-SF ) at each visit . RESULTS Two hundred ninety-three patients were enrolled . The valdecoxib group comprised 148 patients ( 81 women , 67 men ; mean [ SD ] age , 48.6 [ 13.3 ] years ; mean [ SD ] body weight , 86.6 [ 20.9 ] kg ) , and the placebo group included 145 patients ( 85 women , 60 men ; mean [ SD ] age , 48.7 [ 12.6 ] years ; mean [ SD ] body weight , 85.6 [ 19.9 ] kg ) . Of the enrolled patients , 249 completed the study : 134 patients ( 91 % ) who received valdecoxib and 115 patients ( 79 % ) who received placebo . No statistically significant differences in patient baseline characteristics were noted between treatment groups , except in response to 1 mBPI-SF question ; patients in the valdecoxib group reported significantly greater interference in relations with other people due to pain than did those in the placebo group ( P = 0.048 ) . Changes from baseline in low back pain intensity were significantly greater in valdecoxib-treated patients at each assessment ( all , P < 0.001 vs placebo ) . Pain scores on the mBPI-SF indicated significantly greater pain relief with valdecoxib at each assessment ( all , P < or = 0.014 vs placebo ) . Improvements in mean Rol and -Morris Disability Question naire score with valdecoxib were significantly greater than with placebo at each assessment ( all , P < or = 0.003 ) . Although the overall incidence of adverse events ( AEs ) was significantly higher among patients receiving valdecoxib than those receiving placebo ( 35.1 % vs 24.1 % , respectively ; P = 0.042 ) , no significant differences were found between groups for the incidence of any individual AE . Most AEs ( 89 % [ 77/87 total events ] ) were mild or moderate in severity . CONCLUSIONS In this study of patients with chronic low back pain , valdecoxib 40 mg/d provided rapid relief ( within 1 week ) and consistent relief ( over 4 weeks ) . In addition , significant improvement in function and decreased disability were found with valdecoxib compared with placebo Summary A double-blind , between-patient comparison of alclofenac and indomethacin was carried out in 60 patients with low back pain and sciatica . Pain , functional disability and signs of dural irritation ( Lasegue 's sign ) were rated by the clinician before and at the end of each 7-day treatment period , and an overall assessment of treatment effectiveness was made by both clinician and patients .Response to treatment in terms of patient improvement was considered satisfactory with both drugs , but more erratic in those patients with an acute condition . Analysis of pain scores showed a significant tendency for patients with acute or chronic low back pain to improve more with alclofenac than with indomethacin treatment . Overall assessment s by the clinician and patients also indicated signiJcantly greater improvement with alclofenac |
11,543 | 27,411,077 | Current evidence indicates increased likelihood of depleted iron stores in relation to H. pylori infection .
H. pylori eradication therapy , added to iron therapy , might be beneficial in increasing ferritin and hemoglobin levels | BACKGROUND We conducted an up date d systematic review and meta- analysis to examine the prevalence of depleted iron stores among persons infected with Helicobacter pylori compared to uninfected ones .
We also assessed the impact of anti-H. pylori eradication therapy plus iron therapy on ferritin and hemoglobin levels compared to iron therapy alone . | BACKGROUND & AIMS We investigated Helicobacter pylori ( H pylori)-infection as a cause of iron deficiency ( ID ) and iron-deficiency anemia ( IDA ) or treatment failure of iron supplementation . METHODS We r and omized 200 Hp-infected children ( positive urea breath test ) 2 - 5 years of age with IDA ( hemoglobin level < 110 g/L ; serum ferritin level < 12 microg/L ; and soluble transferrin receptor > 8.3 mg/L ) or ID ( serum ferritin level < 12 microg/L or soluble transferrin receptor level > 8.3 mg/L ) to 1 of 4 regimens : 2-week anti-Hp therapy ( amoxicillin , clarithromycin , and omeprazole ) plus 90-day oral ferrous sulfate ( anti-Hp plus iron ) , 2-week anti-Hp therapy alone , 90-day oral iron alone , or placebo . Sixty noninfected children with IDA received iron treatment as negative control . RESULTS Hp-infected children receiving iron had significantly less frequent treatment failure compared with those with no iron in correcting IDA ( 11 % [ 95 % confidence interval ( CI ) , 2%-20 % ] for anti-Hp plus iron , 0 % for iron alone vs 33 % [ 95 % CI , 26%-46 % ] for anti-Hp and 45 % [ 95 % CI , 31%-59 % ] for placebo ; chi(2 ) = 127 ; P < .0001 ) , ID ( 19 % [ 95 % CI , 8%-30 % ] for anti-Hp plus iron , 7 % [ 95 % CI , 0%-14 % ] for iron alone vs 65 % [ 95 % CI , 52%-78 % ] for anti-Hp alone , and 78 % [ 95 % CI , 66%-90 % ] for placebo ; chi(2 ) = 124 ; P < .0001 ) , or anemia ( 34 % [ 95 % CI , 20%-40 % ] for anti-Hp plus iron , 27 % [ 95 % CI , 14%-40 % ] for iron alone vs 65 % [ 95 % CI , 52%-78 % ] for anti-Hp alone and 78 % [ 95 % CI , 66%-90 % ] for placebo ; chi(2 ) = 46 ; P < .0001 ) . Cure rates of IDA , ID , or anemia with iron were comparable with that of the negative control group . Improvements in iron status also were significantly greater in groups with iron . CONCLUSIONS H pylori is neither a cause of IDA/ID nor a reason for treatment failure of iron supplementation in young Bangladeshi children In the present study , we investigated the prevalence of anaemia and Fe deficiency anaemia ( IDA ) and explored the relationship between Helicobacter pylori infection and IDA in adolescent girls . A total of 1037 adolescent girls from Suihua , China were enrolled . Hb , serum ferritin ( SF ) , serum transferrin receptor ( sTfR ) and serum IgG antibodies to H. pylori were measured . Participants with IDA and co-existing H. pylori infection ( n 80 ) who had an intake of > 25 mg/d of Fe were assigned r and omly to the intervention and control groups . Patients in the intervention group were administered a 12-week course of oral EDTA-Na-Fe ( 60 mg Fe/dose , three times a week ) and a 2-week course of colloidal bismuth subcitrate , amoxicillin and metronidazole . Subjects in the control group were administered EDTA-Na-Fe alone . Hb , SF and sTfR were reassessed 3 months after the 12-week regimen ended . Prevalence of anaemia , Fe deficiency ( defined as SF < 12·0 μg/l ) , IDA and H. pylori infection in the population of 1037 was 19.5 , 40.4 , 17.1 and 31.2 % , respectively . The prevalence of H. pylori infection in the IDA group was 46.9 % , while the non-anaemic group had 28.1 % prevalence . A significant increase in Hb and SF and a decrease in sTfR value were found in the intervention group and the H. pylori-negative group . Findings suggest that IDA is still one of the prominent problems in adolescent girls . There is an association between H. pylori infection and IDA . Treatment of H. pylori infection is associated with a more rapid response to oral Fe therapy OBJECTIVE To investigate the association between Helicobacter pylori infection and anaemia . DESIGN Six cross-sectional studies . H. pylori infection was assessed by the [13C]urea breath test using MS or IR analysis . Hb was measured for all countries . Ferritin and transferrin receptors were measured for Argentina , Bolivia , Mexico , and Venezuela . SETTING Health services in Argentina , Brazil and Mexico or public schools in Bolivia , Cuba and Venezuela . SUBJECTS In Argentina , 307 children aged 4 - 17 years referred to a gastroenterology unit ; in Bolivia , 424 r and omly selected schoolchildren aged 5 - 8 years ; in Brazil , 1007 adults ( 157 men , 850 women ) aged 18 - 45 years attending thirty-one primary health-care units ; in Cuba , 996 r and omly selected schoolchildren aged 6 - 14 years ; in Mexico , seventy-one pregnant women in their first trimester attending public health clinics ; in Venezuela , 418 children aged 4 - 13 years attending public schools . RESULTS The lowest prevalence of H. pylori found was among children in Argentina ( 25.1 % ) and the highest in Bolivia ( 74.0 % ) . In Bolivia , Cuba and Venezuela children showed similar prevalence of H. pylori infection as in Brazilian and Mexican adults ( range 47.5 % to 81.8 % ) . Overall anaemia prevalence was 11.3 % in Argentina , 15.4 % in Bolivia , 20.6 % in Brazil , 10.5 % in Cuba and 8.9 % in Venezuela . Adjusted analyses allowing for confounding variables showed no association between H. pylori colonization and anaemia in any study . Hb , ferritin and transferrin receptor levels were also not associated with H. pylori infection in any country . CONCLUSIONS The present study showed no evidence to support the hypothesis that H. pylori contributes to anaemia in children , adolescents , adults or pregnant women in six Latin American countries BACKGROUND Helicobacter pylori infection treatment was found not to reduce the prevalence of iron deficiency or anemia among Alaska Native children at 14 months after treatment initiation . We hypothesized that 14 months was to early to resolve H. pylori-induced gastric damage . Consequently , we conducted a 40-month follow-up . METHODS We enrolled 219 children 7 - 11 years old who had H. pylori infection ( as diagnosed by (13)C-labeled urea breath test ) and iron deficiency ( serum ferritin level , < 22.47 pmol/L ) in a controlled , household-r and omized trial of the effect of treatment of H. pylori on iron deficiency and anemia ( hemoglobin level , < 115 g/L ) . At 40 months , 176 children were evaluated . RESULTS Forty-four ( 52 % ) of 85 children in the intervention group and 53 ( 58 % ) of 91 in the control group had iron deficiency ( adjusted relative risk [ ARR ] , 0.92 [ 95 % confidence interval { CI } , 0.68 - 1.26 ] ) , versus 4 ( 5 % ) and 17(19 % ) , respectively , with both iron deficiency and anemia ( ARR , 0.25 [ 95 % CI , 0.09 - 0.73 ] ) . Reinfection occurred among 33 ( 52 % ) of 64 children who had cleared their infection . H. pylori-negative children had lower prevalences of iron deficiency ( ARR , 0.62 [ 95 % CI , 0.38 - 1.01 ] ) and iron deficiency and anemia ( ARR , 0.22 [ 95 % CI , 0.03 - 1.50 ] ) , compared with H. pylori -positive children . CONCLUSIONS The resolution of H. pylori infection for > 14 months modestly reduced the prevalence of iron deficiency and substantially reduced the prevalence of iron deficiency and anemia . H. pylori likely plays a casual role in hematological outcomes for some children ABSTRACT Iron deficiency anemia is a common public health problem in the Alaska Native population . Yet , a clear etiology has eluded research ers for decades . Previous studies suggested a link betweenHelicobacter pylori infection , gastrointestinal blood loss due to hemorrhagic gastritis , and generalized iron deficiency anemia in adult Alaska Natives . Therefore , we examined the association between the prevalence of H. pylori-specific immunoglobulin G ( IgG ) and serum ferritin levels , a marker of iron deficiency . A r and om sample of 2,080 serum sample s from Alaska Native residents drawn between 1980 and 1986 from residents in 13 regions was selected , and the sample s were stratified by age , sex , and region . Overall , 75 % were positive for H. pylori-specific IgG. The rate of H. pylori seropositivity increased with age ; by age 14 years , 78 % of the residents were positive . There were no gender differences inH. pylori seropositivity . However , marked regional differences were observed . Serum ferritin levels of < 12 ng/ml were found most commonly among persons < 20 years of age and among women of childbearing age . A significant association between low serum ferritin levels and prevalence of H. pylori-specific IgG was found , particularly for people aged less than 20 years . H. pylorimay be a factor contributing to the iron deficiency anemia in the Alaska Native population Background & objectives : Despite routine iron supplementation and promotion of diet modification , iron deficiency anaemia ( IDA ) remains widely prevalent in our antenatal population . Recent studies in pediatric population have highlighted the role of Helicobacter pylori infection in IDA . This study was undertaken to study the effect of eradication therapy in H. pylori infected pregnant women with IDA . Methods : R and omized placebo-controlled double blind clinical trial was done on 40 antenatal women between 14 - 30 wk gestation , with mild to moderate IDA and having H. pylori infection , as detected by stool antigen test . These women were r and omly divided into group I ( n=20 ) : H. pylori treatment group ( amoxicillin , clarithromycin , omeprazole for 2 wk ) and group II ( n=20 ) : placebo group . Both groups received therapeutic doses of iron and folic acid . Outcome measures were improvement in haematological parameters and serum iron profile after 6 wk of oral iron therapy . Results : The prevalence of iron deficiency in pregnant women with mild to moderate anaemia was 39.8 per cent ( 95 % CI 35.7 , 44.3 ) ; and 62.5 per cent ( 95 % CI 52 , 73 ) of these pregnant women with IDA were infected with H. pylori . After 6 wk of therapeutic oral iron and folic acid supplementation , the rise in haemoglobin , packed cell volume , serum iron and percentage transferrin saturation was significantly ( P<0.05 ) higher in the group given H. pylori eradication therapy as compared to the placebo group . Interpretation & conclusions : Our results showed a high occurrence of H. pylori infection in pregnant women with IDA . Eradication therapy result ed in significantly better response to oral iron supplementation among H. pylori infected pregnant women with IDA Ascorbic acid , the reduced form of vitamin C , may protect against gastric cancer and is secreted by the normal stomach . Secretion is impaired in Helicobacter pylori ( H pylori ) associated chronic gastritis . This study examined if eradication of H pylori improves gastric juice ascorbate values . Fasting gastric juice and plasma sample s were collected at endoscopy from patients participating in trials of H pylori eradication for duodenal ulcer disease and intestinal metaplasia before and up to 15 months after attempted eradication . Ascorbic acid and total vitamin C concentrations were determined by high performance liquid chromatography . In 12 patients in whom H pylori was successfully eradicated gastric juice ascorbate and total vitamin C concentrations and the ratio of juice to plasma vitamin C rose after treatment . Analysis after treatment suggested that the rise was greatest in patients with high final plasma vitamin C concentrations , even though these did not change with treatment . By contrast , in 22 patients in whom H pylori eradication was unsuccessful there were no significant changes in juice or plasma concentrations after treatment . It is concluded that successful eradication of H pylori improves secretion of vitamin C into gastric juice . It is speculated that this increases protection against gastric cancer Objectives : We assessed whether Helicobacter pylori eradication was followed by changes in iron stores among non – iron-deficient children . Material s and Methods : Double-blind r and omized intervention trial on 110 asymptomatic 3- to 10-year-olds with H pylori infection assigned to any of the following 4 arms : both quadruple eradication and iron supplementation , either quadruple sequential eradication or iron supplementation , or placebo only . Hemoglobin , transferrin saturation , and serum ferritin were measured at baseline and 8 months later to assess changes according to study arm , H pylori infection status at ≥45 days , and cytotoxin-associated gene product A status . Results : Intent-to-treat ( n = 110 ) and per- protocol ( n = 90 ) analyses revealed no differences across study arms in changes of iron stores . However , we found that those who had their infection eradicated had a 3-fold increased average change from baseline serum ferritin compared with that of children who remained infected ( P < 0.05 ) . Eradication of infection by cytotoxin-associated gene product A negative strains was associated with a larger ferritin increase . Conclusions : In this double-blind r and omized trial , the first among non – iron-deficient , asymptomatic H pylori – infected children living in the contiguous United States , we found no effect of H pylori eradication regarding changes in iron stores . However , those who had their infection eradicated at follow-up had a significantly larger increase in serum ferritin from baseline BACKGROUND Helicobacter pylori infection and iron deficiency are prevalent in disadvantaged population s worldwide . Previous small or uncontrolled studies have reported that successful treatment of H. pylori infection may resolve iron deficiency or anemia . METHODS We screened 68 % of children 7 - 11 years old living in 10 western Alaska villages . The 219 children with iron deficiency ( serum ferritin level , < 22.5 pmol/L [ < 10 microg/L ] ) and H. pylori infection ( diagnosed on the basis of (13)C-labeled urea breath tests ) were enrolled in a household-r and omized , unblinded trial . All children received iron supplementation for 6 weeks ; children in the intervention group also received a 2-week course of treatment for H. pylori infection plus another 2-week course of treatment if the infection had not resolved at 2 months after treatment initiation . RESULTS At 2 months after treatment initiation , 32 % of children in the intervention group and 39 % of children in the control group had iron deficiency . At 14 months after treatment initiation , 65 % of children in the intervention group and 72 % of children in the control group had iron deficiency ( adjusted relative risk [ ARR ] , 0.90 [ 95 % confidence interval [ CI ] , 0.74 - 1.1 ] ) ; in addition , 22 % of children in the intervention group and 14 % of children in the control group had anemia ( ARR , 1.6 [ 95 % CI , 0.86 - 2.9 ] ) . Results were similar when children were compared by H. pylori infection status . CONCLUSIONS In a high-prevalence population , treatment and resolution of H. pylori infection did not improve isolated iron deficiency or mild anemia up to 14 months after treatment initiation AIM To unravel the possible association of malondialdehyde ( MDA ) and fructosamine in anemic H pylori infected patients and to observe the alteration in MDA and fructosamine levels in these patients after treatment for one month . METHODS Fructosamine , MDA and glucose were estimated in 22 anemic H pylori infected patients and 16 healthy controls . Hematological parameters were also evaluated in both the groups using Sysmex-K-100 automated cell counter . The H pylori infected patients were r and omly divided into two groups . H pylori infected patients in Group I received both iron supplementation and anti-H pylori therapy , while patients in Group II received only iron supplementation . All the biochemical and hematological parameters were estimated after one month of treatment . RESULTS In anemic H pylori infected patients , while MDA ( 5.41 + /- 2.16 vs 2.26 + /- 0.50 ; P < 0.05 ) and fructosamine ( 2.64 + /- 0.93 vs 1.60 + /- 0.35 ; P < 0.05 ) were significantly increased , iron ( 32.72 + /- 14.93 vs 110.25 + /- 26.58 ; P < 0.05 ) , hemoglobin ( 6.9 + /- 2.6 vs 12.66 + /- 0.74 ; P < 0.05 ) and ferritin ( 28.82 + /- 16.27 vs 140.43 + /- 30.72 ; P < 0.05 ) levels were significantly decreased compared with the controls . With partial correlation analysis , fructosamine was found to have a significant positive correlation with MDA . In Group I , while MDA level decreased significantly ( 3.11 + /- 1.73 vs 5.50 + /- 2.46 ; P < 0.05 ) , there was a significant increase in iron ( 84.09 + /- 29.51 vs 36.09 + /- 17.81 ; P < 0.05 ) , hemoglobin ( 10.40 + /- 1.11 vs 7.42 + /- 1.90 ; P < 0.05 ) and ferritin ( 116.91 + /- 63.34 vs 30.46 + /- 17.81 ; P < 0.05 ) levels after one month . There was no significant change in the levels of fructosamine in group I after treatment . Similarly , no significant alterations were noted in the levels of MDA , fructosamine , hemoglobin or ferritin in Group II patients after one month of treatment . CONCLUSION An increased level of fructosamine and MDA was found in anemic H pylori infected patients . Present data supports the premise that lipid peroxides per se do play a role in the glycation of plasma proteins . Furthermore , the findings from this study indicate that treatment for both anemia and H pylori infections is required for lowering the levels of lipid peroxides in these patients BACKGROUND AND AIMS We undertook this study to evaluate the effect of Helicobacter pylori eradication and iron supplementation on the iron nutritional status in children with iron deficiency . METHODS Seven hundred and one children from four public schools in Mexico City were screened to evaluate their iron status . Of them , 72 children with iron deficiency or with anemia were included in this study and were tested for H. pylori infection . Those infected were given eradication treatment and were r and omly assigned to daily supplementation for 3 months with ferrous sulfate or placebo . Noninfected children received ferrous sulfate . At the end of the interventions , blood sample s were drawn to evaluate their effects on the nutritional status of iron . RESULTS Thirty eight children with iron deficiency or anemia were infected by H. pylori at baseline . The eradication rate was 86.8 % . Children in whom H. pylori eradication was achieved showed an increase of 0.37g/dL ( 95 % CI -0.02 , 0.75 ) on the hemoglobin mean concentration compared to the noninfected children . Children who achieved H. pylori eradication and received ferrous sulfate supplementation showed an increase of 0.47g/dL ( 95 % CI 0.01 - 0.93 ) on the hemoglobin mean concentration compared to the noninfected children who received iron supplementation . Noninfected children supplemented with ferrous sulfate showed an increase in ferritin concentration of 11.26 ng/mL ( 95 % CI 1.86 - 20.65 ) compared to those who were given the placebo . CONCLUSIONS Our results suggest that the eradication of H. pylori plus iron supplementation increases the pool of functional iron . Iron supplementation increases the storage of iron in school-age children with iron deficiency We evaluated the adverse effect of asymptomatic Helicobacter pylori infection in children on the response to Fe supplementation . One hundred and sixty-nine children aged 1 - 10 years from the urban poor community underwent a [13C]urea breath test for H. pylori and haematological tests at admission and after 8 weeks . Both H. pylori-positive and -negative children were r and omly assigned to receive ferrous fumarate syrup ( 20 mg elemental Fe twice daily ) or placebo for 8 weeks and a single dose of vitamin A ( 33,000 microg ) . Admission findings were compared between H. pylori-positive and -negative children . Response to Fe was compared between Fe-supplemented H. pylori-positive and -negative children . Seventy-nine per cent of the children were aged 1 - 5 years and half of them were boys . In eighty-five H. pylori-positive and eighty-four H. pylori-negative children , the differences in mean Hb ( 112 ( sd 12.6 ) v. 113 ( sd 12.0 ) g/l ) , haematocrit ( 34 ( sd 3.5 ) v. 35 ( sd 3.2 ) % ) and ferritin ( 23.8 v. 21.0 microg/l ) were similar . After 8 weeks of Fe supplementation , mean Hb was 5.3 g/l more ( 95 % CI 1.59 , 9.0 ) and haematocrit was 1.4 % more ( 95 % CI 0.2 , 2.6 ) in H. pylori-negative ( n 44 ) compared with H. pylori-positive ( n 42 ) children . Mean ferritin was similar at admission and improved in both H. pylori-positive and -negative children . Asymptomatic H. pylori infection was not associated with higher rates of anaemia or Fe deficiency in children , but had a significant adverse effect on response to Fe therapy . However , this result is based on exploratory analysis and needs confirmation BACKGROUND A few cases relating H. pylori infection to iron-deficiency anemia have been described recently . We investigated the role of H. pylori infection in iron-deficiency anemia in preadolescent children and adolescents . PATIENTS AND METHODS We conducted a double-blind , placebo-controlled therapeutic trial in 43 subjects ( mean age , 15.4 years ) with iron-deficiency anemia . Endoscopy was performed , and biopsy specimens were examined by urease test and histological analysis . Twenty-two of 25 H. pylori-positive patients were assigned r and omly to three groups . Group A patients were given oral ferrous sulfate and a 2-week course of bismuth subcitrate , amoxicillin , and metronidazole . Group B patients were given placebo for iron and a 2-week course of triple therapy . Group C patients were given oral ferrous sulfate and a 2-week course of placebo . Iron status was reassessed 4 weeks and 8 weeks after the 2-week regimen ended . RESULTS Of the 43 subjects with iron-deficiency anemia , 25 ( 58.1 % ) had H. pylori in the antrum . Group A and B subjects , who received eradication therapy , showed a significant increase in hemoglobin level as compared with group C subjects at 8 weeks after therapy ( p = .0086 ) . CONCLUSIONS Treatment of H. pylori infection was associated with more rapid response to oral iron therapy as compared with the use of iron therapy alone . Such treatment also led to enhanced iron absorption even in those subjects who did not receive oral iron therapy Aims Acute Helicobacter pylori infection is associated with transient hypochlorhydria . In H pylori-associated atrophy , hypochlorhydria has a role in iron deficiency ( ID ) through changes in the physiology of iron-complex absorption . The aims were to evaluate the association between H pylori-associated hypochlorhydria and ID in children . Methods Symptomatic children ( n=123 ) were prospect ively enrolled . Blood , gastric juice and gastric biopsies were taken , respectively , for haematological analyses , pH assessment and H pylori determination , and duodenal biopsies for exclusion of coeliac disease . Stool sample s were collected for parasitology/microbiology . Thirteen children were excluded following parasitology and duodenal histopathology , and five due to impaired blood analysis . Results Ten children were hypochlorhydric ( pH>4 ) and 33 were H pylori positive . In H pylori-positive children with pH>4 ( n=6 ) serum iron and transferrin saturation levels % were significantly lower ( p<0.01 ) than H pylori-positive children with pH≤4 . No differences in ferritin , or total iron binding capacity , were observed . In H pylori-negative children with pH>4 , iron and transferrin saturation were not significantly different from children with pH≤4 . Conclusions Low serum iron and transferrin in childhood H pylori infection is associated with hypochlorhydria . In uninfected children , hypochlorhydria was not associated with altered serum iron parameters , indicating a combination of H pylori infection and /or inflammation , and hypochlorhydria has a role in the aetiology of ID . Although H pylori-associated hypochlorhydria is transient during acute gastritis , this alters iron homeostasis with clinical impact in developing countries with a high H pylori prevalence BACKGROUND Infection with Helicobacter pylori is recognised as a major risk factor for chronic gastritis , peptic ulcer disease and gastric cancer . The association between H. pylori infection and iron deficiency anaemia has been established . Multiple mechanisms have been advocated to explain the relationship between H. pylori and iron status and their association might reduce iron deposit . AIM Aim of this study was to investigate whether H. pylori infection affects iron absorption . METHODS The study was design ed on a prospect i ve basis . Fifty-five subjects underwent upper gastrointestinal endoscopy and biopsy to investigate the presence of H. pylori and , when this was positive , also search of serum anti-CagA was performed . Tests included an oral iron absorption test with the administration of 1 mg/kg of Fe2 + . Iron levels were measured before and 2 h after iron administration ( delta iron ) . H. pylori-positive subjects were administered antibiotic therapy for 1 week and , 2 months later , the oral iron absorption test was repeated and urea-breath test was first performed . RESULTS H. pylori-positive subjects had lower serum level of ferritin and lower delta iron compared to H. pylori-negative subjects . That difference is significant in anaemic women and is independent of the presence of serum anti-CagA antibodies . After H. pylori eradication iron absorption test was similar to those of non-infected subjects . CONCLUSION H. pylori infection impairs iron uptake . That mechanism , together with others , may contribute to the depletion of iron in infected patients OBJECTIVE To report the prevalence rates and correlates for anaemia , iron deficiency ( ID ) and iron-deficiency anaemia ( IDA ) among Inuit preschool-aged children . DESIGN A cross-sectional study assessed iron intake , demographic information , medical history , anthropometrics , Hb , ferritin , C-reactive protein and antibodies to Helicobacter pylori . SETTING Sixteen selected Inuit communities in Nunavut Territory , Canada . SUBJECTS Inuit ( n 388 ) aged 3 - 5 years r and omly recruited from communities . RESULTS Anaemia ( 3 - 4 years : Hb < 110 g/l ; 5 years : Hb < 115 g/l ) was prevalent in 16·8 % of children . The prevalence of ID ( ferritin < 12 μg/l ) was 18·0 % and that of IDA was 5·4 % . When ID was defined as ferritin < 10 μg/l , 10·8 % of children were iron deficient and 3·3 % had IDA . In multiple logistic regression , boys were more likely to be iron deficient ( OR = 2·28 , 95 % CI 1·17 , 8·25 ) , but no other risk factor emerged for ID . Three- to 4-year-olds were less likely than 5-year-olds to have anaemia from causes other than ID ( OR = 0·11 , 95 % CI 0·08 , 0·58 ) . Anaemia from other causes was more common among children residing in crowded homes ( OR = 2·30 , 95 % CI 1·37 , 12·31 ) and those treated for past-year ear infection ( OR = 1·35 , 95 % CI 1·05 , 7·21 ) . CONCLUSIONS The low prevalence of ID and IDA is encouraging , but efforts are still needed to reduce rates as they continue to be higher than general population rates . Household crowding and infections may contribute to anaemia and warrant further research BACKGROUND Helicobacter pylori infection may play a role in iron-deficiency anemia . METHODS In 52 patients with iron-deficiency anemia , H. pylori status was determined using rapid urease test and histology . H. pylori -positive patients were r and omly assigned to receive anti- H. pylori treatment either immediately ( Group I ) or after a delay of one month ( Group II ) ; in addition , all patients received oral ferrous sulfate for three months . Patients testing negative for H. pylori ( Group III ) received only oral ferrous sulfate . Hematological parameters were tested every month . RESULTS Of 52 patients , 32 ( 61.5 % ) had H. pylori infection . At the end of one month , median increase in hemoglobin level was lower in Group II than in Groups I and III ( 1.1 g/dL vs. 3.6 g/dL and 1.9 g/dL , respectively ; p=0.025 ) , as were that in serum iron ( 19 mcg/dL vs. 55.5 mcg/dL and 41 mcg/dL ; p=0.019 ) . During the second month , after H. pylori infection in Group II had been treated , median increase in hemoglobin in this group was comparable to those in Groups I and III ( 3.7 g/dL vs. 2.5 g/dL and 2.5 g/dL. CONCLUSION In patients with iron-deficiency anemia , presence of H. pylori infection is associated with a poorer response to oral iron therapy , which improves with treatment for H. pylori infection |
11,544 | 27,512,624 | The pooled analyses suggested that HSP27 expression was significantly associated with the unfavorable conditions for differentiation degree , lymphatic metastasis , clinical stage , squamous cell carcinoma and tumor size .
However , HSP27 expression had no significant relationship to gender , age and smoking status .
In conclusion , our meta- analysis demonstrates that HSP27 expression may be a strong biomarker to predict both the poor clinicopathological and prognostic characteristics in patients with NSCLC | Numbers of clinical and experimental investigations have provided increasing evidence s to demonstrate that heat shock protein 27 ( HSP27 ) is a qualified predictor for many cancers .
However , no consensus has been reached on its clinicopathological and prognostic significance in patients with non-small cell lung cancer ( NSCLC ) .
Therefore , we performed this systematic meta- analysis to help addressing this issue . | BACKGROUND The results of FASTACT , a r and omised , placebo-controlled , phase 2 study , showed that intercalated chemotherapy and erlotinib significantly prolonged progression-free survival ( PFS ) in patients with advanced non-small-cell lung cancer . We undertook FASTACT-2 , a phase 3 study in a similar patient population . METHODS In this phase 3 trial , patients with untreated stage IIIB/IV non-small-cell lung cancer were r and omly assigned in a 1:1 ratio by use of an interactive internet response system with minimisation algorithm ( stratified by disease stage , tumour histology , smoking status , and chemotherapy regimen ) to receive six cycles of gemcitabine ( 1250 mg/m(2 ) on days 1 and 8 , intravenously ) plus platinum ( carboplatin 5 × area under the curve or cisplatin 75 mg/m(2 ) on day 1 , intravenously ) with intercalated erlotinib ( 150 mg/day on days 15 - 28 , orally ; chemotherapy plus erlotinib ) or placebo orally ( chemotherapy plus placebo ) every 4 weeks . With the exception of an independent group responsible for monitoring data and safety monitoring board , everyone outside the interactive internet response system company was masked to treatment allocation . Patients continued to receive erlotinib or placebo until progression or unacceptable toxicity or death , and all patients in the placebo group were offered second-line erlotinib at the time of progression . The primary endpoint was PFS in the intention-to-treat population . This trial is registered with Clinical Trials.gov , number NCT00883779 . FINDINGS From April 29 , 2009 , to Sept 9 , 2010 , 451 patients were r and omly assigned to chemotherapy plus erlotinib ( n=226 ) or chemotherapy plus placebo ( n=225 ) . PFS was significantly prolonged with chemotherapy plus erlotinib versus chemotherapy plus placebo ( median PFS 7·6 months [ 95 % CI 7·2 - 8·3 ] , vs 6·0 months [ 5·6 - 7·1 ] , hazard ratio [ HR ] 0·57 [ 0·47 - 0·69 ] ; p<0·0001 ) . Median overall survival for patients in the chemotherapy plus erlotinib and chemotherapy plus placebo groups was 18·3 months ( 16·3 - 20·8 ) and 15·2 months ( 12·7 - 17·5 ) , respectively ( HR 0·79 [ 0·64 - 0·99 ] ; p=0·0420 ) . Treatment benefit was noted only in patients with an activating EGFR gene mutation ( median PFS 16·8 months [ 12·9 - 20·4 ] vs 6·9 months [ 5·3 - 7·6 ] , HR 0·25 [ 0·16 - 0·39 ] ; p<0·0001 ; median overall survival 31·4 months [ 22·2-undefined ] , vs 20·6 months [ 14·2 - 26·9 ] , HR 0·48 [ 0·27 - 0·84 ] ; p=0·0092 ) . Serious adverse events were reported by 76 ( 34 % ) of 222 patients in the chemotherapy plus placebo group and 69 ( 31 % ) of 226 in the chemotherapy plus erlotinib group . The most common grade 3 or greater adverse events were neutropenia ( 65 [ 29 % ] patients and 55 [ 25 % ] , respectively ) , thrombocytopenia ( 32 [ 14 % ] and 31 [ 14 % ] , respectively ) , and anaemia ( 26 [ 12 % ] and 21 [ 9 % ] , respectively ) . INTERPRETATION Intercalated chemotherapy and erlotinib is a viable first-line option for patients with non-small-cell lung cancer with EGFR mutation-positive disease or selected patients with unknown EGFR mutation status . FUNDING F Hoffmann-La Roche |
11,545 | 29,026,408 | Most of the studies in the current systematic review demonstrated the favorable effects of camel milk on diabetes mellitus by reducing blood sugar , decreasing insulin resistance and improving lipid profiles | CONTEXT Controlling diabetes , a worldwide metabolic disease , by effective alternative treatments is currently a topic of great interest .
Camel milk is believed to be a suitable hypoglycemic agent in experimental animals and patients with diabetes .
The current systematic review aim ed at evaluating the effect of camel milk on diabetes . | Background : It has been shown that camel milk consumption has a definite decreasing effect on the prevalence of diabetes . However , most of these studies were conducted on patients with type 1 diabetes , whereas studies on patients with type 2 diabetes mellitus ( T2DM ) are limited . In vitro experiments have shown that camel milk was able to decrease blood glucose concentration . Objectives : The purpose of this study was to investigate effects of camel and cow milk on blood sugar , lipid profile , and blood pressure of patients with T2DM . Patients and Methods : In a r and omized single-blinded controlled clinical trial , 20 patients with T2DM were r and omly allocated into two groups . Participants consumed 500 mL of either camel milk ( intervention group ) or cow milk ( control group ) daily for two months . Results : Mean of insulin concentration was significantly increased from 64.59 to 84.03 pmol/L in the camel milk group during the study ( P < 0.05 ) . No significant differences were shown in fasting blood sugar , lipid profile , and blood pressure between the two groups at the end of study . There was significant increase in homeostasis model assessment of insulin resistance ( HOMA-IR ) during the study in both groups , but no significant difference was seen between the two groups . Conclusions : Camel milk increased insulin level in patients with T2DM and might contribute to glycemic control in T2DM Diabetic nephropathy is originally microvascular in nature and is widely considered an important complication of diabetes . The present study was carried out to determine the efficacy of camel milk in controlling diabetic nephropathy . Twenty-four type-1 diabetic patients were r and omly recruited from the outpatient diabetic clinic in PBM Hospital , Bikaner , India . All subjects gave their written consent before participation in the study . Patients with any acute metabolic complications were not included in the study . Eligible patients entered a run-in period of 1 month in which they were oriented to achieve the best possible glycemic control through st and ardized diet , st and ardized exercise regimen and insulin administration . During this period frequent monitoring of blood sugar was performed to maintain euglycemia . At the end of the run-in period , a base line evaluation was performed , then these patients were given camel milk in addition with usual care for six months . Urine microalbumin and blood sugar was measured twice a week before breakfast and dinner . There was a significant improvement in the microalbuminuria ( 119.48 + /- 1.68 to 22.52 + /- 2.68 ; p < 0.001 ) after receiving camel milk for 6 months . A significant reduction in the mean dose of insulin for obtaining glycemic control was achieved ( 41.61 + /- 3.08 to 28.32 + /- 2.66 ; p < 0.01 ) . This study was performed to observe the role of camel milk in controlling microalbuminuria levels in type-1 diabetic patients . It was observed that after adding camel milk to the usual regimen an improvement in microalbuminuria was reached ( 119.48 + /- 1.68 to 22.52 + /- 2.68 ; p < 0.001 ) . This may be due to good glycemic control or to the direct effect of camel milk . The mechanism behind this effect is still unknown Background / Objectives : Hypoglycemic effect of camel milk supplementation in experimental rat model and significant reduction in doses of insulin in type 1 diabetic patients have been observed in our previous studies . This long-term study was undertaken to assess the efficacy , safety and acceptability of camel milk as an adjunct to insulin therapy in type 1 diabetics . Subjects/ Methods : In this 2-year r and omized clinical , parallel design study , 24 type 1 diabetics were enrolled and divided into two groups . Group I ( n=12 ) received usual care , that is , diet , exercise and insulin and Group II ( n=12 ) received 500 ml camel milk in addition to the usual care . Insulin requirement was titrated weekly by blood glucose estimation . Results were analyzed by using the regression technique . Results : In camel milk group , there was decrease in mean blood glucose ( 118.58±19–93.16±17.06 mg/dl ) , hemoglobin A1c levels ( 7.81±1.39–5.44±0.81 % ) and insulin doses ( 32.50±9.99–17.50±12.09 U/day , P<0.05 ) . Out of 12 subjects receiving camel milk , insulin requirement in 3 subjects reduced to zero . There was nonsignificant change in plasma insulin and anti-insulin antibodies in both the groups . Conclusion : It may be stated that camel milk is safe and efficacious in improving long-term glycemic control , with a significant reduction in the doses of insulin in type 1 diabetic patients Most systematic review s rely substantially on the assessment of the method ological quality of the individual trials . The aim of this study was to obtain consensus among experts about a set of generic core items for quality assessment of r and omized clinical trials ( RCTs ) . The invited participants were experts in the field of quality assessment of RCTs . The initial item pool contained all items from existing criteria lists . Subsequently , we reduced the number of items by using the Delphi consensus technique . Each Delphi round comprised a question naire , an analysis , and a feedback report . The feedback report included staff team decisions made on the basis of the analysis and their justification . A total of 33 international experts agreed to participate , of whom 21 completed all question naires . The initial item pool of 206 items was reduced to 9 items in three Delphi rounds . The final criteria list ( the Delphi list ) was satisfactory to all participants . It is a starting point on the way to a minimum reference st and ard for RCTs on many different research topics . This list is not intended to replace , but rather to be used alongside , existing criteria lists There is a traditional belief in the Middle East that regular consumption of camel milk may aid in prevention and control of diabetes . The aim of this work was to evaluate the efficacy of camel milk as an adjuvant therapy in young type 1 diabetics . This 16-week r and omized study enrolled 54 type 1 diabetic patients ( average age 20 years ) selected from those attending the outpatient diabetes clinic of the Menofia University Hospital , affiliated with Egypt 's National Cancer Institute . Subjects were r and omly divided into two groups of 27 patients : one received usual management ( diet , exercise , and insulin ) , whereas the other received 500 mL of camel milk daily in addition to st and ard management . A control group of 10 healthy subjects was also assessed . The following parameters were evaluated at baseline and at 4 and 16 weeks : hemoglobin A1c ( HbA1c ) , human C-peptide , lipid profile , serum insulin , anti-insulin antibodies , creatinine clearance , albumin in 24-hour urine , body mass index , and Diabetes Quality of Life score . The following parameters were significantly different between the usual-management group versus the camel milk group after 16 weeks : fasting blood sugar ( 227.2 + /- 17.7 vs. 98.9 + /- 16.2 mg/dL ) , HbA1c ( 9.59 + /- 2.05[% ] vs. 7.16 + /- 1.84[% ] ) , serum anti-insulin antibodies ( 26.20 + /- 7.69 vs. 20.92 + /- 5.45 microU/mL ) , urinary albumin excretion ( 25.17 + /- 5.43 vs. 14.54 + /- 5.62 mg/dL/24 hours ) , daily insulin dose ( 48.1 + /- 6.95 vs. 23 + /- 4.05 units ) , and body mass index ( 18.43 + /- 3.59 vs. 24.3 + /- 2.95 kg/m(2 ) ) . Most notably , C-peptide levels were markedly higher in the camel milk group ( 0.28 + /- 0.6 vs. 2.30 + /- 0.51 pmol/mL ) . These results suggest that , as an adjunct to st and ard management , daily ingestion of camel milk can aid metabolic control in young type 1 diabetics , at least in part by boosting endogenous insulin secretion |
11,546 | 16,034,869 | The observed rates of intracranial and extracranial hemorrhage were not significantly increased by OAC therapy , but the confidence intervals were wide .
Treatment with adjusted-dose warfarin to achieved INRs of 2 to 3 reduces stroke , disabling or fatal stroke , and death for patients with non-valvular AF .
The benefits were not substantially offset by increased bleeding among these participants in r and omized clinical trials . | BACKGROUND Non-valvular atrial fibrillation ( AF ) is associated with an increased risk of stroke mediated by embolism of stasis-precipitated thrombi from the left atrial appendage .
OBJECTIVES The objective is to characterize the efficacy and safety of oral anticoagulants ( OACs ) for the primary prevention of stroke in patients with chronic AF . | OBJECTIVES To assess the optimal stroke prevention treatment for patients with atrial fibrillation ( AF ) and a low-medium risk ( < or = 4 % ) of stroke . DESIGN A total of 668 patients with persistent or permanent AF , without an indication for full dose and with adequate rate control on sotalol , were r and omized to warfarin 1.25 mg + aspirin 75 mg daily ( W/A , 334 patients ) or no anticoagulation ( C , 334 patients ) . The mean follow-up period was 33 months . The protocol intended to verify a 37 % relative risk reduction provided a 4 % stroke incidence in the C group . RESULTS The stroke incidence was less in the W/A group , although the reduction was not statistically significant ( W/A 9.6 % versus C 12.3 % ) . Four haemorrhagic strokes were identified , two in each group . Secondary end-points were transient ischaemic attacks ( TIA ) ( W/A 3.3 % versus C 4.5 % ) , all cause mortality ( W/A 9.3 % versus C 10.8 % ) , cardiovascular morbidity ( W/A 17.7 % versus C 22.2 % ) and the combination of stroke + TIA ( W/A 11.7 % versus C 16.5 % ) . Bleedings were documented in 19 versus four patients ( W/A 5.7 % versus C 1.2 % ) ( P = 0.003 ) , although none fatal . Sinus rhythm ( SR ) was recorded occasionally in 68 patients ( W/A 9.6 % versus C 10.8 % ) . The stroke incidence tended to be higher in those with SR than without , 16.2 % versus 10.4 % . CONCLUSIONS Our results were inconclusive , but consistent with a small beneficial effect of W/A for reduction of stroke and major vascular events in AF patients at moderate risk . The low-dose regiment produced , however , a significantly increased risk of bleedings . Documented SR occasionally recorded may represent a sub population that warrants full dose warfarin BACKGROUND AND PURPOSE Nonvalvular atrial fibrillation ( AF ) is a strong , independent risk factor for stroke , but the absolute rate of stroke varies widely among AF patients , importantly influencing the potential benefit of antithrombotic prophylaxis . We explore factors associated with ischemic stroke in AF patients taking aspirin . METHODS We performed multivariate logistic regression analysis of 2012 participants given aspirin alone or in combination with low , inefficacious doses of warfarin in the Stroke Prevention in Atrial Fibrillation I-III trials followed for a mean of 2.0 years , during which 130 ischemic strokes were observed . RESULTS Age ( relative risk [RR]=1.8 per decade , P<0.001 ) , female sex ( RR=1.6 , P=0.01 ) , history of hypertension ( RR=2.0 , P<0.001 ) , systolic blood pressure > 160 mm Hg ( RR=2.3 , P<0.001 ) , and prior stroke or transient ischemic attack ( RR=2.9 , P<0.001 ) were independently associated with increased stroke risk . Regular consumption of > /=14 alcohol-containing drinks per week was associated with reduced stroke risk ( adjusted RR=0.4 , P=0.04 ) . Among SPAF III participants , estrogen hormone replacement therapy was associated with a higher risk of ischemic stroke ( adjusted RR=3.2 , P=0.007 ) . With the use of these variables , a risk stratification scheme for primary prevention separated participants into those with high ( 7.1%/y , 22 % of the cohort ) , moderate ( 2.6%/y , 37 % of the cohort ) , and low ( 0.9%/y , 41 % of the cohort ) rates of stroke . Ischemic strokes in low-risk participants were less often disabling ( P<0.001 ) . CONCLUSIONS Patients with AF who have high and low rates of stroke during treatment with aspirin can be identified . However , validation of our risk stratification scheme is necessary before it can be applied with confidence to clinical management . Postmenopausal estrogen replacement therapy and moderate alcohol consumption may additionally modify the risk of stroke in AF , but these findings require confirmation Background Atrial fibrillation in the absence of rheumatic valvular disease is associated with a fivefold to sevenfold increased risk of ischemic stroke . Methods and Main Results . The Stroke Prevention in Atrial Fibrillation Study , a multicenter , r and omized trial , compared 325 mg/day aspirin ( double-blind ) or warfarin with placebo for prevention of ischemic stroke and systemic embolism ( primary events ) , and included 1,330 in patients and out patients with constant or intermittent atrial fibrillation . During a mean follow-up of 1.3 years , the rate of primary events in patients assigned to placebo was 6.3 % per year and was reduced by 42 % in those assigned to aspirin ( 3.6 % per year , p = 0.02 ; 95 % confidence interval , 9–63 % ) . In the subgroup of warfarin-eligible patients ( most less than 76 years old ) , warfarin dose-adjusted to prolong prothrombin time to 1.3-fold to 1.8-fold that of control reduced the risk of primary events by 67 % ( warfarin versus placebo , 2.3 % versus 7.4 % per year , p = 0.01 ; 95 % confidence interval , 27–85 % ) . Primary events or death were reduced 58 % ( p = 0.01 ) by warfarin and 32 % ( p = 0.02 ) by aspirin . The risk of significant bleeding was 1.5 % , 1.4 % , and 1.6%o per year in patients assigned to warfarin , aspirin , and placebo , respectively . Conclusions Aspirin and warfarin are both effective in reducing ischemic stroke and systemic embolism in patients with atrial fibrillation . Because warfarin-eligible patients composed a subset of all aspirin-eligible patients , the magnitude of reduction in events by warfarin versus aspirin can not be compared . Too few events occurred in warfarin-eligible patients to directly assess the relative benefit of aspirin compared with warfarin , and the trial is continuing to address this issue . Patients with nonrheumatic atrial fibrillation who can safely take either aspirin or warfarin should receive prophylactic antithrombotic therapy to reduce the risk of stroke BACKGROUND Atherosclerotic intracranial arterial stenosis is an important cause of stroke . Warfarin is commonly used in preference to aspirin for this disorder , but these therapies have not been compared in a r and omized trial . METHODS We r and omly assigned patients with transient ischemic attack or stroke caused by angiographically verified 50 to 99 percent stenosis of a major intracranial artery to receive warfarin ( target international normalized ratio , 2.0 to 3.0 ) or aspirin ( 1300 mg per day ) in a double-blind , multicenter clinical trial . The primary end point was ischemic stroke , brain hemorrhage , or death from vascular causes other than stroke . RESULTS After 569 patients had undergone r and omization , enrollment was stopped because of concerns about the safety of the patients who had been assigned to receive warfarin . During a mean follow-up period of 1.8 years , adverse events in the two groups included death ( 4.3 percent in the aspirin group vs. 9.7 percent in the warfarin group ; hazard ratio for aspirin relative to warfarin , 0.46 ; 95 percent confidence interval , 0.23 to 0.90 ; P=0.02 ) , major hemorrhage ( 3.2 percent vs. 8.3 percent , respectively ; hazard ratio , 0.39 ; 95 percent confidence interval , 0.18 to 0.84 ; P=0.01 ) , and myocardial infa rct ion or sudden death ( 2.9 percent vs. 7.3 percent , respectively ; hazard ratio , 0.40 ; 95 percent confidence interval , 0.18 to 0.91 ; P=0.02 ) . The rate of death from vascular causes was 3.2 percent in the aspirin group and 5.9 percent in the warfarin group ( P=0.16 ) ; the rate of death from nonvascular causes was 1.1 percent and 3.8 percent , respectively ( P=0.05 ) . The primary end point occurred in 22.1 percent of the patients in the aspirin group and 21.8 percent of those in the warfarin group ( hazard ratio , 1.04 ; 95 percent confidence interval , 0.73 to 1.48 ; P=0.83 ) . CONCLUSIONS Warfarin was associated with significantly higher rates of adverse events and provided no benefit over aspirin in this trial . Aspirin should be used in preference to warfarin for patients with intracranial arterial stenosis BACKGROUND Despite the efficacy of warfarin sodium therapy for stroke prevention in atrial fibrillation , many physicians hesitate to prescribe it to elderly patients because of the risk for bleeding complications and because of inconvenience for the patients . METHODS The Second Copenhagen Atrial Fibrillation , Aspirin , and Anticoagulation Study was a r and omized , controlled trial examining the following therapies : warfarin sodium , 1.25 mg/d ; warfarin sodium , 1.25 mg/d , plus aspirin , 300 mg/d ; and aspirin , 300 mg/d . These were compared with adjusted-dose warfarin therapy ( international normalized ratio of prothrombin time [ INR ] , 2.0 - 3.0 ) . Stroke or a systemic thromboembolic event was the primary outcome event . Transient ischemic attack , acute myocardial infa rct ion , and death were secondary events . Data were h and led as survival data , and risk factors were identified using the Cox proportional hazards model . The trial was scheduled for 6 years from May 1 , 1993 , but due to scientific evidence of inefficiency of low-intensity warfarin plus aspirin therapy from another study , our trial was prematurely terminated on October 2 , 1996 . RESULTS We included 677 patients ( median age , 74 years ) . The cumulative primary event rate after 1 year was 5.8 % in patients receiving minidose warfarin ; 7.2 % , warfarin plus aspirin ; 3.6 % , aspirin ; and 2.8 % , adjusted-dose warfarin ( P = .67 ) . After 3 years , no difference among the groups was seen . Major bleeding events were rare . CONCLUSIONS Although the difference was insignificant , adjusted-dose warfarin seemed superior to minidose warfarin and to warfarin plus aspirin after 1 year of treatment . The results do not justify a change in the current recommendation of adjusted-dose warfarin ( INR , 2.0 - 3.0 ) for stroke prevention in atrial fibrillation In patients with chronic nonrheumatic atrial fibrillation , prophylaxis of peripheral arterial embolism is strongly indicated . LMWHs may be an alternative regimen if contraindications for oral anticoagulants are present . In the present study the effect of LMWH on the incidence of embolism in atrial fibrillation has been studied in 75 consecutive patients in comparison to no specific treatment . Patients received one daily injection of the LMWH CY 216 ( n = 35 ) subcutaneously over a period of 6 months . Patients of the control group ( n = 40 ) were observed over the same period of time . In the group treated with CY 216 , three embolic events ( 8.6 % ) occurred , of which two were localized in the cerebrum . One of these two cerebral embolic events was fatal . In the control group , eight embolic events ( 20 % ) occurred , six of these were intracerebral and , of these , five were fatal . An even more pronounced difference between the groups was observed on evaluation of the patients with preceding cerebral embolism . Of 15 patients treated with LMWH , one extracerebral nonfatal embolism occurred . In the control group three of the seven patients ( 43 % ) experienced fatal reembolism . The results show that in patients with atrial fibrillation one daily subcutaneous injection of LMWH reduces the incidence of arterial embolism to about one third . No adverse effects were observed during the 6-month treatment period with LMWH The Canadian Atrial Fibrillation Anticoagulation Study was a r and omized double-blind placebo-controlled trial to assess the potential of warfarin to reduce systemic thromboembolism and its inherent risk of hemorrhage . As a result of the publication of two other " positive " studies of similar design and objective , this study was stopped early before completion of its planned recruitment of 630 patients . There were 187 patients r and omized to warfarin and 191 to placebo . Permanent discontinuation of study medication occurred in 26 % of warfarin-treated and 23 % of placebo-treated patients . The target range of the international normalized ratio was 2 to 3 . For the warfarin-treated patients , the international normalized ratio was in the target range 43.7 % of the study days , above it 16.6 % of the study days and below it 39.6 % of the study days . Fatal or major bleeding occurred at annual rates of 2.5 % in warfarin-treated and 0.5 % in placebo-treated patients . Minor bleeding occurred in 16 % of patients receiving warfarin and 9 % receiving placebo . The primary outcome event cluster was nonlacunar stroke , non central nervous systemic embolism and fatal or intracranial hemorrhage . Events were included in the primary analysis of efficacy if they occurred within 28 days of permanent discontinuation of the study medication . The annual rates of the primary outcome event cluster were 3.5 % in warfarin-treated and 5.2 % in placebo-treated patients , with a relative risk reduction of 37 % ( 95 % confidence limits , -63.5 % , 75.5 % , p = 0.17 ) . ( ABSTRACT TRUNCATED AT 250 WORDS BACKGROUND Nonrheumatic atrial fibrillation increases the risk of stroke , presumably from atrial thromboemboli . There is uncertainty about the efficacy and risks of long-term warfarin therapy to prevent stroke . METHODS We conducted an unblinded , r and omized , controlled trial of long-term , low-dose warfarin therapy ( target prothrombin-time ratio , 1.2 to 1.5 ) in patients with nonrheumatic atrial fibrillation . The control group was not given warfarin but could choose to take aspirin . RESULTS A total of 420 patients entered the trial ( 212 in the warfarin group and 208 in the control group ) and were followed for an average of 2.2 years . Prothrombin times in the warfarin group were in the target range 83 percent of the time . Only 10 percent of the patients assigned to receive warfarin discontinued the drug permanently . There were 2 strokes in the warfarin group ( incidence , 0.41 percent per year ) as compared with 13 strokes in the control group ( incidence , 2.98 percent per year ) , for a reduction of 86 percent in the risk of stroke ( warfarin : control incidence ratio = 0.14 ; 95 percent confidence interval , 0.04 to 0.49 ; P = 0.0022 ) . There were 37 deaths altogether . The death rate was markedly lower in the warfarin group than in the control group : 2.25 percent as compared with 5.97 percent per year , for an incidence ratio of 0.38 ( 95 percent confidence interval , 0.17 to 0.82 ; P = 0.005 ) . There was one fatal hemorrhage in each group . The frequency of bleeding events that led to hospitalization or transfusion was essentially the same in both groups . The warfarin group had a higher rate of minor hemorrhage than the control group ( 38 vs. 21 patients ) . CONCLUSIONS Long-term low-dose warfarin therapy is highly effective in preventing stroke in patients with non-rheumatic atrial fibrillation , and can be quite safe with careful monitoring CONTEXT Prior risk stratification schemes for atrial fibrillation ( AF ) have been based on r and omized trial cohorts or Medicare administrative data bases , have included patients with established AF , and have focused on stroke as the principal outcome . OBJECTIVE To derive risk scores for stroke alone and stroke or death in community-based individuals with new-onset AF . DESIGN , SETTING , AND PARTICIPANTS Prospect i ve , community-based , observational cohort in Framingham , Mass. We identified 868 participants with new-onset AF , 705 of whom were not treated with warfarin at baseline . Risk scores for stroke ( ischemic or hemorrhagic ) and stroke or death were developed with censoring when warfarin initiation occurred during follow-up . Event rates were examined in low-risk individuals , as defined by the risk score and 4 previously published risk schemes . MAIN OUTCOME MEASURES Stroke and the combination of stroke or death . RESULTS During a mean follow-up of 4.0 years free of warfarin use , stroke alone occurred in 83 participants and stroke or death occurred in 382 participants . A risk score for stroke was derived that included the following risk predictors : advancing age , female sex , increasing systolic blood pressure , prior stroke or transient ischemic attack , and diabetes . With the risk score , 14.3 % of the cohort had a predicted 5-year stroke rate < or = 7.5 % ( average annual rate < or = 1.5 % ) , and 30.6 % of the cohort had a predicted 5-year stroke rate < or = 10 % ( average annual rate < or = 2 % ) . Actual stroke rates in these low-risk groups were 1.1 and 1.5 per 100 person-years , respectively . Previous risk schemes classified 6.4 % to 17.3 % of subjects as low risk , with actual stroke rates of 0.9 to 2.3 per 100 person-years . A risk score for stroke or death is also presented . CONCLUSION These risk scores can be used to estimate the absolute risk of an adverse event in individuals with AF , which may be helpful in counseling patients and making treatment decisions From November , 1985 , to June , 1988 , 1007 out patients with chronic non-rheumatic atrial fibrillation ( AF ) entered a r and omised trial ; 335 received anticoagulation with warfarin openly , and in a double-blind study 336 received aspirin 75 mg once daily and 336 placebo . Each patient was followed up for 2 years or until termination of the trial . The primary endpoint was a thromboembolic complication ( stroke , transient cerebral ischaemic attack , or embolic complications to the viscera and extremities ) . The secondary endpoint was death . The incidence of thromboembolic complications and vascular mortality were significantly lower in the warfarin group than in the aspirin and placebo groups , which did not differ significantly . 5 patients on warfarin had thromboembolic complications compared with 20 patients on aspirin and 21 on placebo . 21 patients on warfarin were withdrawn because of non-fatal bleeding complications compared with 2 on aspirin and none on placebo . Thus , anticoagulation therapy with warfarin can be recommended to prevent thromboembolic complications in patients with chronic non-rheumatic AF Adjusted-dose warfarin is effective for stroke prevention in patients with nonrheumatic atrial fibrillation ( AF ) , but the risk of bleeding is high , especially among the elderly . Fixed minidose warfarin is effective in preventing venous thromboembolism with low risk of bleeding and no need for frequent clinical monitoring . Patients > 60 years with nonrheumatic AF were r and omized in an open-labeled trial to receive fixed minidose warfarin ( 1.25 mg/day ) or st and ard adjusted-dose warfarin ( International Normalized Ratio [ INR ] between 2.0 and 3.0 ) . Primary outcome events were ischemic stroke , peripheral or visceral embolism , cerebral or fatal bleeding , and vascular death . Secondary end points were major bleeding , myocardial infa rct ion , and death . This study was discontinued before completion in light of publication of the Stroke Prevention in Atrial Fibrillation III trial , which indicated that low-intensity fixed-dose warfarin treatment ( i.e. , INR < 1.5 ) was insufficient for stroke prevention in high-risk patients with nonrheumatic AF . From a total of 1,209 considered patients , 303 were r and omized to be studied ( 150 in the minidose group and 153 in the adjusted-dose group ) . Mean follow-up was 14.5 months . The rate of cumulative primary events was 11.1 % ( 95 % confidence intervals [ CI ] 4.0 to 18.2 ) in the fixed minidose group and 6.1 % ( 95 % CI 1.1 to 11.1 ) in the adjusted-dose group ( p = 0.29 ) . The rate of ischemic stroke was significantly higher in the minidose group ( 3.7 % vs 0 % per year , p = 0.025 ) . Major bleedings were more frequent in st and ard treatment group ( 2.6 % vs 1 % per year , p = 0.19 ) . Most thromboembolic complications occurred at INRs < 1.2 , whereas the majority of hemorrhages occurred at INRs > 3.0 . No significant difference in primary outcome events was observed in the abbreviated study . However , the significantly increased occurrence of ischemic stroke in the fixed minidose warfarin group suggests that this regimen does not protect patients with nonrheumatic AF BACKGROUND Nonrheumatic atrial fibrillation is common among the elderly and is associated with an increased risk of stroke . We investigated whether anticoagulation with warfarin would reduce this risk . METHODS We conducted a r and omized , double-blind , placebo-controlled study to evaluate low-intensity anticoagulation with warfarin ( prothrombin-time ratio , 1.2 to 1.5 ) in 571 men with chronic nonrheumatic atrial fibrillation ; 525 patients had not previously had a cerebral infa rct ion , whereas 46 patients had previously had such an event . The primary end point was cerebral infa rct ion ; secondary end points were cerebral hemorrhage and death . RESULTS Among the patients with no history of stroke , cerebral infa rct ion occurred in 19 of the 265 patients in the placebo group during an average follow-up of 1.7 years ( 4.3 percent per year ) and in 4 of the 260 patients in the warfarin group during an average follow-up of 1.8 years ( 0.9 percent per year ) . The reduction in risk with warfarin therapy was 0.79 ( 95 percent confidence interval , 0.52 to 0.90 ; P = 0.001 ) . The annual event rate among the 228 patients over 70 years of age was 4.8 percent in the placebo group and 0.9 percent in the warfarin group ( risk reduction , 0.79 ; P = 0.02 ) . The only cerebral hemorrhage occurred in a 73-year-old patient in the warfarin group . Other major hemorrhages , all gastrointestinal , occurred in 10 patients : 4 in the placebo group , for a rate of 0.9 percent per year , and 6 in the warfarin group , for a rate of 1.3 percent per year . There were 37 deaths that were not preceded by a cerebral end point--22 in the placebo group and 15 in the warfarin group ( risk reduction , 0.31 ; P = 0.19 ) . Cerebral infa rct ion was more common among patients with a history of cerebral infa rct ion ( 9.3 percent per year in the placebo group and 6.1 percent per year in the warfarin group ) than among those without such a history . CONCLUSIONS Low-intensity anticoagulation with warfarin prevented cerebral infa rct ion in patients with nonrheumatic atrial fibrillation without producing an excess risk of major hemorrhage . This benefit extended to patients over 70 years of age |
11,547 | 21,491,379 | A variety of STIs were addressed including HIV and chlamydia .
None of the trials explicitly mentioned HPV or cervical cancer prevention .
Statistically significant effects for behavioural outcomes ( e.g. increasing condom use ) were common , though not universal and varied according to the type of outcome .
There were no statistically significant effects of abstaining from or reducing sexual activity .
There were few statistically significant effects on biological ( STI ) outcomes .
Behavioural interventions for young women which aim to promote sexual behaviours protective of STI transmission can be effective , primarily at encouraging condom use . | BACKGROUND Human papillomavirus ( HPV ) is the key risk factor for cervical cancer .
Continuing high rates of HPV and other sexually transmitted infections ( STIs ) in young people demonstrate the need for effective behavioural interventions .
OBJECTIVES To assess the effectiveness of behavioural interventions for young women to encourage safer sexual behaviours to prevent transmission of STIs ( including HPV ) and cervical cancer . | CONTEXT The female condom remains the only female-initiated method for preventing pregnancy and STDs , including HIV . Innovative methods for promoting its use , and for involving male partners in its use , are needed . METHODS A sample of 217 women and their main male sexual partners were r and omly assigned to one of three study conditions : a six-session relationship-based STD prevention intervention provided to the couple together , the same intervention provided to the woman only or a single-session education control provided to the woman only . Assessment s were conducted at baseline and three months postintervention . Contrast coding was used to examine whether the effects of the two active interventions differed from those of the control intervention , and whether the effects of the two active interventions differed from each other . Regression analyses were used to estimate treatment effects . RESULTS During follow-up , participants in either active intervention were more likely to use a female condom with their study partner and with all partners , and used female condoms at a higher rate with all partners , than individuals assigned to the control intervention ; at the end of three months , they were more likely to intend to use the condom in the next 90 days . No significant differences in outcomes were found between the active intervention groups . CONCLUSIONS Focusing on both a woman and her main male sexual partner is efficacious in increasing female condom use and intention to use among heterosexual couples at risk for HIV and other STDs The efficacy and differential effects of specialized ( S ) and traditional ( T ) AIDS education programs on cognitive , behavioral , and psychological outcomes were investigated . The sample consisted of 858 impoverished African-American and Latina women ( S = 448 , T = 410 ) . At baseline , women in the traditional group reported significantly higher distress , greater knowledge of AIDS , and less problem-focused coping . Significant improvements over the 2-week intervention interval were found for participants of both AIDS education programs for appraisal of threat , concerns , knowledge , and attitudes about AIDS , emotion-focused coping , number of sexual partners , IV and non-IV drug use , depression , and distress . However , multivariate analysis indicated that the traditional group had slightly better posttest scores on concerns , emotion-focused coping , knowledge of AIDS , and number of partners than the specialized group . The specialized group reported greater use of problem-focused coping . These differences do not detract from the substantial improvement found for both groups , but they do reinforce the conclusion that the specialized program was not more effective than its st and ard counterpart Objective : To assess effects of a combined microfinance and training intervention on HIV risk behavior among young female participants in rural South Africa . Design : Secondary analysis of quantitative and qualitative data from a cluster r and omized trial , the Intervention with Microfinance for AIDS and Gender Equity study . Methods : Eight villages were pair-matched and r and omly allocated to receive the intervention . At baseline and after 2 years , HIV risk behavior was assessed among female participants aged 14–35 years . Their responses were compared with women of the same age and poverty group from control villages . Intervention effects were calculated using adjusted risk ratios employing village level summaries . Qualitative data collected during the study explored participants ' responses to the intervention including HIV risk behavior . Results : After 2 years of follow-up , when compared with controls , young participants had higher levels of HIV-related communication ( adjusted risk ratio 1.46 , 95 % confidence interval 1.01–2.12 ) , were more likely to have accessed voluntary counseling and testing ( adjusted risk ratio 1.64 , 95 % confidence interval 1.06–2.56 ) , and less likely to have had unprotected sex at last intercourse with a nonspousal partner ( adjusted risk ratio 0.76 , 95 % confidence interval 0.60–0.96 ) . Qualitative data suggest a greater acceptance of intrahousehold communication about HIV and sexuality . Although women noted challenges associated with acceptance of condoms by men , increased confidence and skills associated with participation in the intervention supported their introduction in sexual relationships . Conclusions : In addition to impacts on economic well being , women 's empowerment and intimate partner violence , interventions addressing the economic and social vulnerability of women may contribute to reductions in HIV risk behavior The research design of the r and omised controlled trial is primarily associated today with medicine . It tends either to be ignored or regarded with suspicion by many in such disciplines as health promotion , public policy , social welfare , criminal justice , and education . However , all professional interventions in people 's lives are subject to essentially the same questions about acceptability and effectiveness . As the social reformers Sidney and Beatrice Webb pointed out in 1932 , there is far more experimentation going on in “ the world sociological laboratory in which we all live ” than in any other kind of laboratory , but most of this social experimentation is “ wrapped in secrecy ” and thus yields “ nothing to science.”1 # # # Summary points Many social scientists argue that r and omised controlled trials are inappropriate for evaluating social interventions , but they ignore a considerable history , mainly in the United States , of the use of r and omised controlled trials to assess different approaches to public policy and health promotion A tradition of experimental sociology was well established by the 1930s , built on the early use of controlled experiments in psychology and education From the early 1960s to early 1980s r and omised experiments were considered the optimal design for evaluating public policy interventions in the United States , and major evaluations using this design were carried out This approach became less popular as policy makers reacted negatively to evidence of “ near zero ” effects Lessons to be learnt about implementing r and omised controlled trials in real life setting s include the difficulty of assessing complex multi-level interventions and the challenge of integrating qualitative data The Webbs argued for a more “ scientific ” social policy , with social scientists being trained in experimental methods and evaluations of social interventions being carried out by independent investigators . They were apparently unaware that a strong tradition in experimental sociology had already been established , mainly in the United States . Investigators examined the 6-month impact of three cognitive-behavioral HIV risk-reduction programs on behavioral factors ( substance use and sexual risk behaviors ) and cognitive and psychological re sources of 325 women who resided in emergency or sober-living shelters and their 308 intimate sexual partners . Participants were r and omized by shelter to a peer-mentored , a nurse case-managed , or a st and ard care HIV risk-reduction program . Significant improvements were observed in all groups in all behavioral factors and cognitive and psychological re sources except for self-esteem . Participants in the peer-mentored and nurse case-managed groups did not differ significantly from the st and ard group in self-esteem , life satisfaction , psychological well-being , use of noninjection drugs , sex with multiple partners , and unprotected sex at 6 months ( n = 633 ) . It was concluded that a st and ard approach by health care professionals appears to effectively modify HIV risk behaviors for a majority of homeless participants and may have important economic and policy implication s. Further , the impact of short-term programs that address psychological vulnerabilities of impoverished population s needs to be studied further The purpose of this study was to document the effectiveness of small group condom motivation education in reducing new and reinfection rates of sexually transmitted diseases ( STD ) among female teenagers . Two hundred and five ( 205 ) female adolescents ( age 13 - 20 ) with a current STD were studied at two sites of a Teen Health Clinic . There were 86 teens in the Study Group and 119 in the Comparison Group . Patients were sample d from December 1992 to July 1993 . The patients in the Study Group received a condom motivation class given by the clinic STD educator in small groups of four or more adolescents . The Comparison Group , comparable in age and ethnicity , received treatment for their STD but did not participate in condom motivation classes . All teens were given treatment and condoms . The sample was followed for 6 months . The total number of patients returning with new infections was 21 ( 14.7 % ) . The total number of patients with reinfections was 14 ( 9.8 % ) . There were no significant differences between the Study and Comparison Group on return rates , new and reinfection rates or on any socio-demographic variables . The comparison of these groups suggests that a specific condom motivation class has minimal effectiveness in urban teens . However , almost 70 % of the teens returned to the clinic for their scheduled visits . It is suggested that adolescent clinics which combine family planning and STD treatment services maintain high client enrollment and therefore may be ideal locations to initiate new and continuous interventions for condom use especially for high risk teens OBJECTIVES Women in impoverished inner-city neighborhoods are at high risk for contracting HIV . A r and omized , multisite community-level HIV prevention trial was undertaken with women living in 18 low-income housing developments in 5 US cities . METHODS Baseline and 12-month follow-up population risk characteristics were assessed by surveying 690 women at both time points . In the 9 intervention condition housing developments , a community-level intervention was undertaken that included HIV risk reduction workshops and community HIV prevention events implemented by women who were popular opinion leaders among their peers . RESULTS The proportion of women in the intervention developments who had any unprotected intercourse in the past 2 months declined from 50 % to 37.6 % , and the percentage of women 's acts of intercourse protected by condoms increased from 30.2 % to 47.2 % . Among women exposed to intervention activities , the mean frequency of unprotected acts of intercourse in the past 2 months tended to be lower at follow-up ( mean = 4.0 ) than at baseline ( mean = 6.0 ) . These changes were corroborated by changes in other risk indicators . CONCLUSIONS Community-level interventions that involve and engage women in neighborhood-based HIV prevention activities can bring about reductions in high-risk sexual behaviors OBJECTIVES We evaluated the efficacy of skills training design ed to increase female condom use among women . METHODS We conducted a r and omized controlled trial of 409 women , recruited from family planning clinics in northern California , who were r and omly assigned to the experimental 4-session female condom skills training intervention or the comparison 4-session women 's general health promotion intervention . Participants received condom use instructions at baseline and male and female condoms during the study . They completed audio computer-assisted self-interviews at baseline and at 3 and 6 months . RESULTS At 3 and 6 months , women in the experimental group were more likely than those in the comparison group to have used the female condom at least once in the prior 3 months . The increase in the percentage of sexual acts protected by female condoms from baseline to the 6-month follow-up was greater for the experimental group . The percentage of sexual acts during which any condom was employed was higher in the experimental group at 6 months . There were no group differences in male condom use . CONCLUSIONS Outcomes suggest that skills training can increase female condom use and protected sexual acts without reducing male condom use among women Background : The Information-Motivation-Behavioral Skills ( IMB ) model of HIV preventive behavior ( 1–4 ) specifies that treatment effects on behavior occur largely as the result of treatment effects on behavioral skills , which follow from effects on information and motivation . Purpose : The objective was to determine whether the variables specified by the IMB model of HIV preventive behavior ( 1–4 ) accounted for the relation between an IMB-based treatment and result ing HIV preventive behavior ( condom use ) . Method : Women ( n = 557 ) living in 18 low-income housing developments in 5 geographically dispersed cities were recruited to participate in an HIV-prevention study . Women ( within housing developments ) were r and omly assigned to receive an IMB-based , HIV risk-avoidance intervention or a comparison intervention . Baseline and posttreatment ( 16 months after baseline ) data were collected on condom use information , motivation ( social norms , attitudes , intentions , and perceived risk ) , enactment of behavioral skills ( condom negotiation and procurement ) , and rates of condom use in the past 2 months . Results : The IMB intervention led to a 12 % to 16 % increase in condom use rates over the course , whereas the comparison intervention led to 2 % decrease . In addition , the IMB treatment led to greater increases in condom use information , in the intentions and social norms components of motivation and the condom procurement and condom conversations components of behavioral skills . The IMB model provided an acceptable fit to the data ( root mean square error of approximation < .05 ) and accounted for 50 % of the variance inposttreatment condom use among the sample . Treatment effects on condom use were almost entirely mediated by the IMB variables ; specifically , motivation and enactment of behavioral skills mediated the intervention ’s impact on condom use . Conclusions : These results provide supporting evidence as to how theoretical variables operate to effect change within a theory-based intervention and provide evidence as to the applicability of a prevailing theory of HIV risk behavior among low-income minority We conducted a cluster-r and omized community intervention trial at Kenyan agricultural sites to measure the impact of female condom introduction on sexually transmitted infection ( STI ) prevalence . We present male and female condom use data here . Six Intervention sites received a community risk-reduction campaign and distribution of female condoms and male condoms , while 6 Control sites received the same campaign with male condoms only . Male and female condom distribution increased throughout follow-up . Self-reported male condom use increased substantially during follow-up to over 60 % of the participants . The proportion of consistent male condom users at Control sites was higher than at Intervention sites , 23 % vs 14 % at 6 months and 24 % vs 22 % at 12 months . At Intervention sites , 11 % and 7 % of women used the female condoms all the time at 6 and 12 months , respectively , while the percentage of female condom non-users grew . Male and female condom use was hindered by male partner objections ; suspicion of the study and the devices among residents ; and bias against condoms by clinic service providers . A large proportion of coital acts remained unprotected during the trial . Our female condom intervention did not reduce STI prevalence , compared with male condom promotion only Abstract Objective : To determine whether a theoretically based sex education programme for adolescents ( SHARE ) delivered by teachers reduced unsafe sexual intercourse compared with current practice . Design : Cluster r and omised trial with follow up two years after baseline ( six months after intervention ) . A process evaluation investigated the delivery of sex education and broader features of each school . Setting : Twenty five secondary schools in east Scotl and . Participants : 8430 pupils aged 13 - 15 years ; 7616 completed the baseline question naire and 5854 completed the two year follow up question naire . Intervention : SHARE programme ( intervention group ) versus existing sex education ( control programme ) . Main outcome measures : Self reported exposure to sexually transmitted disease , use of condoms and contraceptives at first and most recent sexual intercourse , and unwanted pregnancies . Results : When the intervention group was compared with the conventional sex education group in an intention to treat analysis there were no differences in sexual activity or sexual risk taking by the age of 16 years . However , those in the intervention group reported less regret of first sexual intercourse with most recent partner ( young men 9.9 % difference , 95 % confidence interval −18.7 to −1.0 ; young women 7.7 % difference , −16.6 to 1.2 ) . Pupils evaluated the intervention programme more positively , and their knowledge of sexual health improved . Lack of behavioural effect could not be linked to differential quality of delivery of intervention . Conclusions : Compared with conventional sex education this specially design ed intervention did not reduce sexual risk taking in adolescents The efficacy of a behavioral intervention to reduce human immunodeficiency virus ( HIV ) risk behaviors was tested in a r and omized , controlled trial with three high-risk population s at 37 clinics from seven sites across the United States . Compared with the 1855 individuals in the control condition , the 1851 participants assigned to a small-group , seven-session HIV risk reduction program reported fewer unprotected sexual acts , had higher levels of condom use , and were more likely to use condoms consistently over a 12-month follow-up period . On the basis of clinical record review , no difference in overall sexually transmitted disease ( STD ) reinfection rate was found between intervention and control condition participants . However , among men recruited from STD clinics , those assigned to the intervention condition had a gonorrhea incidence rate one-half that of those in the control condition . Intervention condition participants also reported fewer STD symptoms over the 12-month follow-up period . Study outcomes suggest that behavioral interventions can reduce HIV-related sexual risk behavior among low-income women and men served in public health setting s. Studies that test strategies for reducing sexual risk behavior over longer periods of time are needed , especially with population s that remain most vulnerable to HIV infection PURPOSE To evaluate a brief , theoretically guided sexually transmitted disease ( STD ) risk-reduction intervention tailored to college-aged women . METHODS The participants were 78 undergraduate females ( M = 20 years ; 76 % European-American ) who reported inconsistent condom use or multiple sexual partners . Participants were r and omly assigned to one of three groups : ( a ) a one-session intervention based on the information-motivation-behavioral skills ( IMB ) model , ( b ) a one-session information-only intervention ( INFO ) , or ( c ) a wait-list control ( WLC ) group . Consistent with Fisher and Fisher 's ( 1992 ) IMB model , we predicted that risk reduction would be greater when information about HIV was supplemented with motivational enhancement strategies and skills training . To evaluate this hypothesis , groups were compared at the post-intervention assessment and at a 2-month follow-up using analyses of covariance and log odds ratios . RESULTS At the post-intervention assessment , the IMB and INFO groups demonstrated increased STD-related knowledge . At 2-month follow-up , the IMB and INFO groups showed sustained STD-related knowledge , and the IMB group showed reductions in number of sexual partners compared to the WLC group . CONCLUSIONS These results provide partial support for the hypothesis that an IMB model-based intervention leads to reductions in sexual risk behavior and suggest directions for future research OBJECTIVE : To compare the efficacy of a r and omized controlled trial of the Sexual Awareness For Everyone ( SAFE ) behavioral intervention on teenagers ( aged 14 to 18 years ) compared with adult rates of reinfection with Neiserria gonorrhea or Chlamydia trachomatis cervicitis , and to identify behaviors associated with recurrent infection . METHODS : Mexican-American and African-American females with a nonviral sexually transmitted disease ( STD ) were enrolled in SAFE or assigned to the control group . All participants were interviewed and examined at baseline , 6 , and 12 months . The primary outcome variable was reinfection with N. gonorrhea or C. trachomatis . Secondary outcomes were changes in risky sexual behavior . RESULTS : Teens r and omized to participation in SAFE had a statistically lower incidence of recurrent N. gonorrhea and C. trachomatis at 0 to 6 months ( 52 % , P=.04 ) and cumulatively ( 39 % , P=.04 ) compared with teens in the control group . Cumulatively , teens as a group had higher rates of reinfection ( 33.1 % ) than adults ( 14.4 % ) ( P<.001 ) . Adolescent reinfection was explained by unprotected sex with untreated partners ( adjusted odds ratio [ OR ] 5.58 ) , nonmonogamy ( adjusted OR 5.14 ) , and rapid partner turnover ( adjusted OR 2.02 ) . In adults , reinfection was predicted by unprotected sex with untreated partners ( adjusted OR 4.90 ) , unsafe sex ( adjusted OR 2.18 ) , rapid partner turnover ( adjusted OR 3.13 ) , and douching after sex ( adjusted OR 2.14 ) . CONCLUSION : Sexual Awareness for Everyone significantly reduced recurrent STDs in teenagers . Adults and teens r and omized to the SAFE intervention had significant decreases in high-risk sexual behaviors as compared with those in the control group . Although not specifically design ed for teens , the SAFE intervention worked very well in this high-risk population . CLINICAL TRIAL REGISTRATION : www . clinical trials.gov , Clinical Trials.gov , HSC2004415H LEVEL OF EVIDENCE : OBJECTIVE To determine whether condom use among high-risk female adolescents could be increased by a behavioral intervention , with the use of infection with Chlamydia trachomatis as a biomarker of condom practice s. DESIGN Prospect i ve , r and omized , controlled intervention . SETTING Urban family planning and sexually transmitted disease clinics . PARTICIPANTS Two hundred nine female adolescents , aged 15 through 19 years , who were treated for C. trachomatis genitourinary infection , were r and omly assigned to st and ard ( control ) or experimental ( behavioral intervention ) groups . One hundred twelve subjects returned for follow-up 5 to 7 months after enrollment and comprise the study subjects . MEASUREMENTS Subjects completed a multiinstrument question naire measuring sexual behavior , condom practice s , attitudes and beliefs , cognitive complexity , sociodemographics , and motivation at enrollment and follow-up . Endourethral and endocervical sites were sample d for C. trachomatis . RESULTS Among the 112 subjects who returned for repeated examination , those who had received the experimental intervention reported increased use of condoms by their sexual partners for protection against sexually transmitted diseases ( odds ratio = 2.4 ; p = 0.02 ) and for vaginal intercourse ( odds ratio = 3.1 ; p = 0.005 ) at the 6-month follow-up . Multivariable logistic regression analysis controlling for condom use at enrollment demonstrated that the experimental intervention ( odds ratio = 2.8 ; p = 0.03 ) and the higher cognitive complexity ( odds ratio = 4.6 ; p = 0.02 ) independently contributed to greater condom use at follow-up . Despite greater use of condoms among the group who had received the intervention , use remained inconsistent and rates of reinfection with C. trachomatis were not significantly different ( 26 % vs 17 % ; p = 0.3 ) . CONCLUSION Although a brief behavioral intervention among high-risk female adolescents can increase condom use by their sexual partners , incident infection does not appear to be reduced , because condom use remained inconsistent Background Studies assessing the validity attributed to self-reported measures of sexually transmitted diseases ( STDs ) clearly are needed , particularly those used for high-risk population s such as female adolescents , in whom STD prevention is a priority . Goal To determine the accuracy of self-reported STD test results in female adolescents over a relatively brief period ( ≈28 days ) . Study Design A prospect i ve , r and omized , controlled clinical trial of STD/HIV prevention for African American females , ages 14 to 18 , was conducted . Study participants were recruited from medical clinics and school health classes in low-income neighborhoods of Birmingham , Alabama , that had high rates of unemployment , substance abuse , violence , STDs , and teenage pregnancy . Results Of the 522 adolescents enrolled in the trial , 92 % ( n = 479 ) completed baseline STD testing and follow-up surveys . At baseline , 28 % had positive test results for at least one disease : 4.8 % for Neisseria gonorrhoeae , 17.1 % for Chlamydia trachomatis , and 12.3 % for Trichomonas vaginalis . Of the adolescents with negative STD test results , 98.8 % were accurate in their self-report of STD status , as compared with 68.7 % of the adolescents with positive results . Underreporting varied by type of STD . Adolescents who accurately reported their positive STD status were significantly more likely to report their receipt of treatment accurately ( P < 0.001 ) . Conclusions The substantial underreporting of STD incidence in this study suggests that reliance on self-reports of STD history may introduce misclassification bias , potentially leading to false conclusions regarding the efficacy of prevention interventions . This observation highlights the importance of using biologic indicators as outcome measures OBJECTIVE : To determine whether group prenatal care improves pregnancy outcomes , psychosocial function , and patient satisfaction and to examine potential cost differences . METHODS : A multisite r and omized controlled trial was conducted at two university-affiliated hospital prenatal clinics . Pregnant women aged 14–25 years ( n=1,047 ) were r and omly assigned to either st and ard or group care . Women with medical conditions requiring individualized care were excluded from r and omization . Group participants received care in a group setting with women having the same expected delivery month . Timing and content of visits followed obstetric guidelines from week 18 through delivery . Each 2-hour prenatal care session included physical assessment , education and skills building , and support through facilitated group discussion . Structured interviews were conducted at study entry , during the third trimester , and postpartum . RESULTS : Mean age of participants was 20.4 years ; 80 % were African American . Using intent-to-treat analyses , women assigned to group care were significantly less likely to have preterm births compared with those in st and ard care : 9.8 % compared with 13.8 % , with no differences in age , parity , education , or income between study conditions . This is equivalent to a risk reduction of 33 % ( odds ratio 0.67 , 95 % confidence interval 0.44–0.99 , P=.045 ) , or 40 per 1,000 births . Effects were strengthened for African-American women : 10.0 % compared with 15.8 % ( odds ratio 0.59 , 95 % confidence interval 0.38–0.92 , P=.02 ) . Women in group sessions were less likely to have suboptimal prenatal care ( P<.01 ) , had significantly better prenatal knowledge ( P<.001 ) , felt more ready for labor and delivery ( P<.001 ) , and had greater satisfaction with care ( P<.001 ) . Breastfeeding initiation was higher in group care : 66.5 % compared with 54.6 % , P<.001 . There were no differences in birth weight nor in costs associated with prenatal care or delivery . CONCLUSION : Group prenatal care result ed in equal or improved perinatal outcomes at no added cost . CLINICAL TRIAL REGISTRATION : Clinical Trials.gov , www . clinical trials.gov , NCT00271960 LEVEL OF EVIDENCE : We developed and pilot-tested a comprehensive HIV prevention/sexual risk reduction intervention with 54 sexually abstinent girls and estimated the effect of the intervention on three antecedents of sexual risk behavior : information , motivation , and behavioral skills . Girls ages 14 - 18 were r and omized into either ( a ) an AbsPlus intervention or ( b ) a structurally equivalent control group . Assessment s were obtained at baseline and 3 months follow-up using audio computer assisted self-interview . The intervention result ed in a large effect for information ( d = 1.11 ) ; small to large effects for the motivational measures ( d = .34-.88 ) , and a moderate effect for a measure of behavioral skills ( d = .67 ) . The results indicate that antecedents of sexual risk behavior change were improved by a gender-specific theoretically guided intervention OBJECTIVES We evaluated female-condom use among women participating in an HIV/STD intervention design ed to reduce unprotected sex and exp and prevention strategies . METHODS Women ( n = 360 ) were recruited from a family-planning clinic and were r and omized into an 8- or 4-session intervention group or a control group . We conducted follow-up interviews at 1 , 6 , and 12 months . RESULTS At 1 month , the odds ratios of first-time female-condom use were 9.49 ( 95 % confidence interval [ CI ] = 4.01 , 22.20 ) in the 8-session group and 4.39 ( 95 % CI = 1.84 , 10.49 ) in the 4-session group relative to controls . Repeated use ( n = 21 ) was predicted by perceived ability to use , by self and partner satisfaction , by dislike of male condoms , and by previous diaphragm use . CONCLUSIONS Gender sensitive cognitive-behavioral interventions can influence women to try the female condom . To increase long-term use , interventions may need to include self-insertion practice and involvement of male partners OBJECTIVE To determine the effect of an individualized safer sex intervention on condom use and recurrent sexually transmitted disease ( STD ) among female adolescents diagnosed as having an STD . DESIGN R and omized controlled trial . SETTING Urban children 's hospital adolescent clinic and inpatient service . PARTICIPANTS One hundred twenty-three adolescents with cervicitis or pelvic inflammatory disease . INTERVENTION Participants completed a question naire and then were r and omized to receive st and ard STD education or to watch a videotape and have an individualized intervention session . Follow-up question naires were completed at 1 , 3 , 6 , and 12 months . Intervention participants met with an educator at 1 , 3 , and 6 months to discuss interim sexual history and review the intervention . MAIN OUTCOME MEASURES Change in self-reported condom use and recurrence of STD . Other self-reported behaviors , sexual risk knowledge , attitudes toward condoms , and condom use negotiation skills were also assessed . RESULTS At 1 month , compared with control participants , intervention participants had increased sexual risk knowledge and more positive attitudes toward condoms and tended to use condoms more with a nonmain partner . At 6 months , fewer intervention participants than controls had sex with a nonmain sexual partner in the previous 6 months . At 12 months , intervention participants were less likely to have a current main partner and had a lower rate of recurrent STD than controls , but these differences were not significant . CONCLUSIONS This individualized safer sex intervention may improve condom use and decrease the number of partners among adolescent girls who have had an STD . Studies with larger sample s are needed to determine definitive intervention effects on recurrent STD in this high-risk population The long-term effects of two culturally competent AIDS education programs with different content on the risk behavior and AIDS-related knowledge of 410 homeless African American women 2 years after program completion were examined . Participants were members of a larger cohort of impoverished African American and Latina women recruited in Los Angeles from 1989 to 1991 . Of a sub sample of 527 African American women selected r and omly for a 2-year follow-up interview , 410 ( 78 % ) were located and agreed to participate . Women participating in both AIDS education programs reported reduced HIV risk behaviors and demonstrated greatly improved AIDS knowledge at 2-year follow-up ( p < .001 ) . Women in a specialized program were less likely than those in a traditional program to report noninjection drug use at 2 years . Women in the traditional program had significantly better AIDS knowledge at follow-up ( p < .001 ) . These findings suggest that educational programs can produce sustained benefits among impoverished women The effectiveness of an intervention based upon the theories of Ajzen and Tri and is was evaluated among 698 junior and 306 senior high school students . The intervention to juniors was offered by senior students who were trained during a course integrated into the school curriculum . Respondents in the control and experimental groups completed a question naire at baseline and 9 months after the program . Compared to junior respondents in the control group , those in the experimental group positively modified their attitude , perceived behavioral control , personal normative beliefs , perceived role beliefs , anticipated regret and intention with respect to postponing sexual intercourse and with respect to condom use , as well as perceived self-efficacy to negotiate both behaviors . Compared to senior respondents in the control group , those in the experimental group showed a significant positive modification of all the above variables except perceived behavioral control ( indirect measure ) , anticipated regret and intention with respect to postponing sexual intercourse . At post-test , seniors in the experimental group were more likely to use condoms on a regular basis than those in the control group . Program effects occurred among both sexes , but a few differences in response were observed among males and females . Results suggest this type of theory-based program is effective in modifying psychosocial variables related to postponing sexual intercourse and related to condom use among adolescents . Personal involvement in design ing intervention appears to be effective in modifying the behavior of peer educators OBJECTIVES This study examined the efficacy of a relationship-based HIV/sexually transmitted disease prevention program for heterosexual couples and whether it is more effective when delivered to the couple or to the woman alone . METHODS Couples ( n = 217 ) were recruited and r and omized to ( 1 ) 6 sessions provided to couples together ( n = 81 ) , ( 2 ) the same intervention provided to the woman alone ( n = 73 ) , or ( 3 ) a 1-session control condition provided to the woman alone ( n = 63 ) . RESULTS The intervention was effective in reducing the proportion of unprotected and increasing the proportion of protected sexual acts . No significant differences in effects were observed between couples receiving the intervention together and those in which the woman received it alone . CONCLUSIONS This study demonstrates the efficacy of a relationship-based prevention program for couples at risk for HIV infection BACKGROUND This paper aims to describe factors associated with HIV sero-status in young , rural South African women and the relationship between intimate partner violence ( IPV ) and HIV . METHODS A total of 1295 sexually active female volunteers , aged 15 - 26 , from 70 villages were recruited to participate in a cluster r and omized controlled trial of an HIV behavioural intervention . The main measures were HIV sero-status , and IPV and sexual practice s measured using a question naire administered during baseline interviews . RESULTS About 12.4 % of women had HIV and 26.6 % had experienced more than one episode of physical or sexual IPV . After adjusting for age , HIV infection was associated with having three or more past year partners [ odds ratio ( OR ) 2.39 ; 95 % confidence interval ( 95 % CI ) 1.48 - 3.85 ] , sex in past 3 months ( OR 3.33 ; 95 % CI 1.87 - 5.94 ) , a partner three or more years older ( OR 1.69 ; 95 % CI 1.16 - 2.48 ) , and a more educated partner ( OR 1.91 ; 95 % CI 1.30 - 2.78 ) . IPV was associated with HIV in two-way analyses ( OR 1.56 ; 95 % CI 1.08 - 2.23 ) , but the effect was non-significant after adjusting for HIV risk behaviours . The experience of IPV was strongly associated with past year partner numbers , time of last sex , and partner 's education ; it was also marginally associated with partner age difference . Adverse experiences in childhood , including sexual abuse , increased the likelihood of having more past year partners ( OR 1.43 ; 95 % CI 1.21 - 1.69 ) . CONCLUSIONS IPV was strongly associated with most of the identified HIV risk factors . Our findings provide further evidence of links between IPV and HIV among women and the importance of joint prevention OBJECTIVE The objective of the study was to determine whether a transtheoretical model-tailored expert system intervention increases dual- method contraceptive use , compared with a nontailored educational intervention . STUDY DESIGN We performed a r and omized clinical trial of 542 women at high risk for sexually transmitted infections ( STIs ) and unintended pregnancy . The intervention group received computer-based tailored feedback using a multimedia program . The control group received general contraceptive information and nontailored advice . RESULTS Participants in the intervention group were more likely to report use of dual contraceptive methods during follow-up ( adjusted hazard rate ratio 1.70 , 95 % confidence interval 1.09 , 2.66 ) , compared with controls . However , there were no differences in the rates of incident STI or unintended pregnancy between the 2 groups . CONCLUSIONS The computer-based transtheoretical model-tailored intervention result ed in a 70 % increase in reported dual- method contraceptive use in a group of women at high risk for STIs and unintended pregnancy . Inconsistent use of dual methods may explain the lack of effect on unintended pregnancy rates and incident STIs Objectives To evaluate the prophylactic efficacy of the human papillomavirus ( HPV ) quadrivalent vaccine in preventing low grade cervical , vulvar , and vaginal intraepithelial neoplasias and anogenital warts ( condyloma acuminata ) . Design Data from two international , double blind , placebo controlled , r and omised efficacy trials of quadrivalent HPV vaccine ( protocol 013 ( FUTURE I ) and protocol 015 ( FUTURE II ) ) . The trials were to be 4 years in length , and the results reported are from final study data of 42 months ’ follow-up . Setting Primary care centres and university or hospital associated health centres in 24 countries and territories around the world . Participants 17 622 women aged 16 - 26 years enrolled between December 2001 and May 2003 . Major exclusion criteria were lifetime number of sexual partners ( > 4 ) , history of abnormal cervical smear test results , and pregnancy . Intervention Three doses of quadrivalent HPV vaccine ( for serotypes 6 , 11 , 16 , and 18 ) or placebo at day 1 , month 2 , and month 6 . Main outcome measures Vaccine efficacy against cervical , vulvar , and vaginal intraepithelial neoplasia grade I and condyloma in a per protocol susceptible population that included subjects who received all three vaccine doses , tested negative for the relevant vaccine HPV types at day 1 and remained negative through month 7 , and had no major protocol violations . Intention to treat , generally HPV naive , and unrestricted susceptible population s were also studied . Results In the per protocol susceptible population , vaccine efficacy against lesions related to the HPV types in the vaccine was 96 % for cervical intraepithelial neoplasia grade I ( 95 % confidence interval 91 % to 98 % ) , 100 % for both vulvar and vaginal intraepithelial neoplasia grade I ( 95 % CIs 74 % to 100 % , 64 % to 100 % respectively ) , and 99 % for condyloma ( 96 % to 100 % ) . Vaccine efficacy against any lesion ( regardless of HPV type ) in the generally naive population was 30 % ( 17 % to 41 % ) , 75 % ( 22 % to 94 % ) , and 48 % ( 10 % to 71 % ) for cervical , vulvar , and vaginal intraepithelial neoplasia grade I , respectively , and 83 % ( 74 % to 89 % ) for condyloma . Conclusions Quadrivalent HPV vaccine provided sustained protection against low grade lesions attributable to vaccine HPV types ( 6 , 11 , 16 , and 18 ) and a substantial reduction in the burden of these diseases through 42 months of follow-up . Trial registration s NCT00092521 and NCT00092534 This study evaluates the efficacy of Keepin ' It Safe , a theory-based , gender-specific , CD-ROM-mediated HIV prevention program for urban , early adolescent girls . Intervention effects were examined in a r and omized , pretest-posttest wait-list control-group design . Changes in HIV/AIDS knowledge , protective attitudes , and skills for reducing HIV risk-related sexual behaviors were tested using linear regression models that were controlled for baseline values of each outcome . Recruited through youth services agencies located in the greater New York City area , study participants comprised 204 adolescent girls aged 11 - 14 years . Girls exposed to Keepin ' It Safe , relative to wait-list control girls , increased their HIV/AIDS knowledge , perceived efficacy and enjoyment of abstinence , perceived efficacy and enjoyment of condoms , and sexual assertiveness , suggesting that a theory-based , gender-specific , CD-ROM-mediated HIV prevention program can enhance knowledge , protective attitudes , and skills for reducing HIV risk-related sexual behaviors among urban early-adolescent girls Objective To measure the impact on sexually transmitted infection ( STI ) prevalence of a female condom introduction and risk-reduction program at Kenyan agricultural sites . Design We conducted a cluster-r and omized trial to determine whether a replicable , community-level intervention would reduce STI prevalence . Methods Six matched pairs of tea , coffee and flower plantations were identified . The six intervention sites received an information/motivation program with free distribution of female and male condoms , and six control sites received only male condoms and related information . Participants were tested for cervical gonorrhea and chlamydia by ligase chain reaction on urine specimens , and vaginal trichomoniasis by culture , at baseline , 6 and 12 months . Results Participants at intervention ( n = 969 ) and control sites ( n = 960 ) were similar ; baseline STI prevalence was 23.9 % . Consistent male condom use was more than 20 % at 12 months . Consistent female condom use was reported by 11 and 7 % of intervention site women at 6 and 12 months . Unadjusted STI prevalence was 16.5 and 17.4 % at 6 months , and 18.3 and 18.5 % at 12 months , at the intervention and control sites , respectively . Logistic regression models confirmed the null effect of the female condom intervention . Conclusions Female condom introduction did not enhance STI prevention at these sites . It is unclear which aspects of the intervention – STI education , condom promotion , case management – were associated with decreased STI prevalence from baseline to follow-up OBJECTIVE To test the efficacy of 2 programs design ed to reduce high-risk behaviors among inner-city African American youth . DESIGN Cluster r and omized trial . SETTING Twelve metropolitan Chicago , Ill , schools and the communities they serve , 1994 through 1998 . PARTICIPANTS Students in grade s 5 through 8 and their parents and teachers . INTERVENTIONS The social development curriculum ( SDC ) consisted of 16 to 21 lessons per year focusing on social competence skills necessary to manage situations in which high-risk behaviors occur . The school/community intervention ( SCI ) consisted of SDC and school-wide climate and parent and community components . The control group received an attention-placebo health enhancement curriculum ( HEC ) of equal intensity to the SDC focusing on nutrition , physical activity , and general health care . MAIN OUTCOME MEASURES Student self-reports of violence , provocative behavior , school delinquency , substance use , and sexual behaviors ( intercourse and condom use ) . RESULTS For boys , the SDC and SCI significantly reduced the rate of increase in violent behavior ( by 35 % and 47 % compared with HEC , respectively ) , provoking behavior ( 41 % and 59 % ) , school delinquency ( 31 % and 66 % ) , drug use ( 32 % and 34 % ) , and recent sexual intercourse ( 44 % and 65 % ) , and improved the rate of increase in condom use ( 95 % and 165 % ) . The SCI was significantly more effective than the SDC for a combined behavioral measure ( 79 % improvement vs 51 % ) . There were no significant effects for girls . CONCLUSIONS Theoretically derived social-emotional programs that are culturally sensitive , developmentally appropriate , and offered in multiple grade s can reduce multiple risk behaviors for inner-city African American boys in grade s 5 through 8 . The lack of effects for girls deserves further research INTRODUCTION The aim of this study was to investigate the knowledge , attitudes and behaviour of university students regarding acquired immunodeficiency syndrome ( AIDS ) and the human immunodeficiency virus ( HIV ) . METHODS A r and omised controlled trial of 530 university students was done using peer-adult facilitators . Participants completed a question naire before and after the intervention , which was a four-hour group session . A prevention programme was developed by local experts , health educators and peer facilitators . The peer-adult-led programme was design ed to provide a conceptual model of HIV risk reduction through information , motivational and behavioural skills , a harm reduction module and health promotion theme . RESULTS The main outcome measured was the level of knowledge , attitudes and behaviour scores . The results suggest that relative to the control group , participants in the intervention group had higher levels of knowledge ( 30.37 vs. 25.40 ; p-value is 0.001 ) and a better attitude ( 12.27 vs. 10.84 ; p-value is 0.001 ) . However , there was no difference in the behavioural score ( 9.47 vs. 9.41 ; p-value is 0.530 ) . The correlation between the level of knowledge and age and the level of education was found in the intervention group , but not in the control group ( p-value is 0.01 ) . Attitude and gender were found to be correlated in the intervention group only ( p-value is 0.01 ) . CONCLUSION Our programme was successful in increasing knowledge and improving attitudes towards AIDS and HIV . However , it did not improve risk-taking behaviour . Peer-adult-led educational programmes for youth using various interactional activities , such as small group discussion s , poster activity and empathy exercises , can be successful in changing the prevailing youth perceptions of AIDS and HIV Objective To assess the short- and long-term impact of a 6-month pilot intervention program on condom use among prostitutes in Accra , Ghana . Design The 4-year prospect i ve study follows-up cohorts enrolled in the intervention in 1987 and 1988 , comparing condom use in 1991 with that among a comparison group not enrolled in the intervention . Setting The community-based intervention was initiated in Accra , Ghana in 1987 . Participants Self-identified female prostitutes who volunteered participation . InterventionThe educational intervention used local health workers to train and support selected prostitutes to be health educators and condom distributers to their peers . Outcome measures Self-reported condom use with clients . Results Reported condom use increased dramatically between 1987 and 1988 during the first 6 months of the intervention . In 1991 , after 3 years of program relapse , 107 ( 43 % ) of the 248 women who had enrolled in 1987 or 1988 were still in prostitution and located for interview . Their level of condom use in 1991 was higher than pre-enrollment but similar to use among prostitutes never enrolled . Sixty-four per cent of those followed-up reported always using condoms with clients in 1991 . These ‘ always users ' were more likely to have maintained informal contact with project staff , know that HIV can be transmitted by healthy clients , and report that clients frequently initiate condom use . Conclusions Findings support the development of long-range educational strategies that recognize the career longevity of prostitutes , available channels for informal program diffusion , individual changes in condom use over time , and the role of clients in condom negotiation Background : A r and omized controlled trial of SAFE , a cognitive/behavioral intervention , revealed that it significantly reduces reinfection and behavioral risks among participants compared with controls . However , studies suggest that depression may moderate intervention efficacy among affected persons because of impaired information processing , failure to recognize risk , or inability to change behavior . Goal : We evaluated SAFE efficacy among depressed and nondepressed Mexican- and African American women after comparing initial risk factors by depression status . We further explored intervention effects in moderately and severely depressed women . Study Design : We stratified 477 participants ( 249 intervention , 228 controls ) according to their depression status at baseline determined by CES-D scores . Using & khgr;2 and multivariate logistic regression , we evaluated differences in reinfection and behavioral risk at 6-month , 12-month , and 1-year cumulative follow-ups between groups within baseline depression strata . Results : At baseline , 74.4 % of women were depressed and had significantly greater levels of behavioral risks than nondepressed women . At follow-up intervals , behavioral risks and reinfection rates were lower among intervention women compared with controls regardless of depression status . For example , at 1-year follow-up reinfection rates were 15.2 % in nondepressed intervention women versus 21.4 % in nondepressed controls ( AOR = 0.6 ) , and 18.6 % in depressed intervention women versus 27.3 % in depressed controls ( AOR = 0.6 ) . Moreover , reinfection was consistently lower among moderately and severely depressed intervention women than controls ( moderately depressed : 19.3 % vs. 27.2 % , AOR = 0.6 ; severely depressed : 17.9 % vs. 27.5 % , AOR = 0.6 ) . Conclusions : Despite significantly greater behavioral risk among depressed women at baseline , SAFE was equally successful in reducing reinfection and high-risk behavior among depressed and nondepressed participants OBJECTIVE To evaluate the efficacy of a parent-based sexual-risk prevention program for African American preadolescents . DESIGN R and omized controlled trial . SETTING Community-based study conducted in Athens , Georgia ; Atlanta , Georgia ; and Little Rock , Arkansas from 2001 to 2004 . PARTICIPANTS From 1545 inquiries , 1115 African American parent-preadolescent dyads ( child , aged 9 - 12 years ) formed the analytic sample . INTERVENTION Participants were r and omized into 1 of 3 study arms : enhanced communication intervention ( five 2 1/2-hour sessions ) , single-session communication intervention ( one 2 1/2-hour session ) , and general health intervention ( control , one 2 1/2-hour session ) . OUTCOME MEASURES Continuous measures of parent-preadolescent sexual communication and parental responsiveness to sex-related questions at preintervention , postintervention , and at 6- and 12-month follow-ups ; and dichotomous measure of preadolescent sexual risk ( having engaged in or intending to engage in sexual intercourse at 12-month follow-up ) . RESULTS Using intent-to-treat participants , differences of mean change from baseline for continuous measures and relative risk for the dichotomous measure of sexual risk were calculated . Participants in the enhanced intervention had higher mean changes from baseline scores , indicating more sexual communication and responsiveness to sexual communication at each assessment after intervention for all continuous measures than those in the control intervention and single-session intervention . Preadolescents whose parents attended all 5 sessions of the enhanced intervention had a likelihood of sexual risk at the 12-month follow-up of less than 1.00 relative to those whose parents attended the control ( relative risk , 0.65 ; 95 % confidence interval , 0.41 - 1.03 ) and single-session ( relative risk , 0.62 ; 95 % confidence interval , 0.40 - 0.97 ) interventions . CONCLUSIONS These results provide preliminary evidence for the efficacy of a parenting program design ed to teach sexual communication skills to prevent sexual risk in preadolescents . TRIAL REGISTRATION ; clinical trials.gov Identifier : NCT00137943 A significant number of college women are at risk for alcohol-exposed pregnancy ( AEP ) owing to binge drinking paired with using contraception ineffectively . This article describes a r and omized controlled trial of a one-session motivational interviewing-based intervention to reduce AEP risk among college women and presents 1-month outcomes demonstrating the early impact of this intervention . There were 228 female students from a mid-Atlantic urban university enrolled in the trial . Eligibility criteria were being in the age range of 18 - 24 years and being at risk for AEP . Risk for AEP was defined as having sexual intercourse with a man in the past 90 days while using contraception ineffectively ( no use , incorrect use of an effective method , or use of an ineffective method only ) ; drinking at risky levels was defined as engaging in at least one binge in the past 90 days or consuming an average of eight st and ard drinks per week . One-month outcome data were available for 212 of the 228 enrolled women ( a follow-up rate of 93 % ) , with complete data available for 105 women assigned to the control condition and 94 assigned to the intervention condition . At 1-month follow-up , 15 % of the control subjects and 25 % of the intervention women reported no risk drinking , a significant difference favoring the intervention group . Significantly fewer control subjects ( 48 % ) used effective contraception at 1-month follow-up as compared with intervention women ( 64 % ) , chi(2)(1 ) = 5.1 , p < .03 . Significantly more intervention women ( 74 % ) were no longer at risk for AEP at 1 month as compared with control subjects ( 54 % ) , chi(2)(1 ) = 8.15 , p < .005 . Factors that were associated with continued AEP risk at 1-month follow-up were a higher number of st and ard drinks per day consumed in the month prior to baseline ( odds ratio , 1.1 ) and assignment to the control condition ( odds ratio , 2.9 ) . The risks of unintended pregnancy and AEP among drinking women in college merit greater prevention efforts . The results of this study show the promise of one preventive intervention that warrants additional study Women with persistent HPV infections have increased risk of progressive CIN lesions . Transmission of HPV between sexual partners might maintain viral infection and , consequently , may influence the clinical course of CIN . We investigated the effect of condom use on regression of CIN lesions and on clearance of HPV . Women with CIN and their male sexual partners were r and omized for condom use ( condom group n = 72 and noncondom group n = 76 ) . They were conservatively managed and followed every 3–6 months by colposcopy , cytology and HPV testing by GP5+/6 + PCR . Baseline cervical biopsy specimens were taken . Median follow‐up time for women was 15.2 months ( range 3.0–85.4 ) . Outcomes of interest were clinical regression of CIN at colposcopy and clearance of HPV . Outcomes were assessed in 64 women of the condom group and 61 women of the noncondom group . Women in the condom group showed a 2‐year cumulative regression rate of 53 % vs. 35 % in the noncondom group ( p = 0.03 ) . The 2‐year cumulative rates of HPV clearance were 23 % vs. 4 % , respectively ( p = 0.02 ) . Although lower regression rates were found if women were HPV‐positive and had ≥CIN2 lesions at baseline , effects of condom use were found both in women with CIN1 and in women with ≥CIN2 lesions . Condom use promotes regression of CIN lesions and clearance of HPV . © 2003 Wiley‐Liss , This study sought to empirically evaluate the extent and impact of cross-contamination on the effects of a STI/HIV intervention trial previously shown to be effective in reducing high-risk sexual behaviors among African – American adolescent females . Participants were recruited through community health agencies in the Southeastern United States and comprised 522 sexually active 14- to 18- year-old African – American females who completed self-administered question naires and face-to-face interviews at baseline , 6- and 12-month time points . Participants were r and omized to a STI/HIV risk reduction group or a general health promotion group . The STI/HIV intervention group participated in four group sessions addressing constructs such as HIV knowledge , communication , condom use self-efficacy and condom use behaviors . The control group participated in four group sessions focused on general health topics . The study setting afforded multiple opportunities for cross-talk between intervention and control group participants . Consistent condom use , defined as condom use during every vaginal sex act , was the primary outcome measure . Other outcome measures included various sexual behaviors , observed condom application skills and psychosocial variables associated with HIV preventive behaviors . Approximately 73 % of participants reported some level of cross-talk . Linear and binary GEE models assessing the impact of the STI/HIV intervention on contaminated vs. uncontaminated control group participants indicated no differential effects of the intervention . Furthermore , equivalence tests demonstrated that contaminated and uncontaminated control groups were equivalent . Findings from this study provide empirical evidence suggesting that behavioral and psychosocial outcomes may be resistant to cross-contamination in r and omized controlled trials testing safer sex interventions among African – American adolescent females Behavioral interventions based on the Protection Motivation Theory ( PMT ) have been demonstrated to reduce HIV risk behavior among mid- and older adolescents in different setting s across the globe but have not been evaluated among Caribbean nations and have received limited evaluation among pre-adolescents . To determine ( 1 ) the effectiveness among pre-adolescents in The Bahamas of a PMT-based HIV prevention program “ Focus on Youth in the Caribbean ” ( FOYC ) and ( 2 ) the role of the targeted PMT constructs in intervention effect . 1,360 sixth grade youth ( 10–11 years of age ) from 15 urban schools in New Providence , The Bahamas were r and omized by school to receive either FOYC or a control condition . Data collected at baseline , 6 and 12 months post intervention were analyzed . A five-step scheme was used to assess sexual behavior progression , ranging from “ 1 ” = “ a virgin without intention to have sex ” to “ 5 ” = “ having sex without a condom ” . Group-based trajectory analysis was utilized in assessing the program effect . Two sexual behavior progression patterns were detected : slow progressors and quick progressors . Receiving FOYC reduced the likelihood for adolescents to become quick progressors ( adjusted OR = 0.77 , 95 % CI : 0.64–1.00 ) . The observed effectiveness was especially impacted by a subset of the targeted PMT constructs . FOYC effectively delays sexual risk among Bahamian pre-adolescents . The group-based trajectory analysis provides an analytical approach for assessing interventions among adolescents with low rates and diverse progression patterns of sexual activity OBJECTIVES To evaluate the efficacy of an intervention to reduce incident sexually transmitted disease ( STD ) and enhance STD/human immunodeficiency virus (HIV)-preventive behaviors and psychosocial mediators . DESIGN A r and omized controlled trial of an HIV prevention program . SETTING Clinic-based sample in Atlanta , Georgia . PARTICIPANTS African American adolescent females ( N = 715 ) , aged 15 to 21 years , seeking sexual health services . Participants completed an audio computer-assisted self-interview and provided self-collected vaginal specimens for STD testing . Intervention Intervention participants received two 4-hour group sessions and 4 telephone contacts over a 12-month period , targeting personal , relational , sociocultural , and structural factors associated with adolescents ' STD/HIV risk , and were given vouchers facilitating male partners ' STD testing/treatment . Main Outcome Measure Incident chlamydial infections . RESULTS Over the 12-month follow-up , fewer adolescents in the intervention had a chlamydial infection ( 42 vs 67 ; risk ratio [ RR ] , 0.65 ; 95 % confidence interval [ CI ] , 0.42 to 0.98 ; P = .04 ) or recurrent chlamydial infection ( 4 vs 14 ; RR , 0.25 ; 95 % CI , 0.08 to 0.83 ; P = .02 ) . Adolescents in the intervention also reported a higher proportion of condom-protected sex acts in the 60 days preceding follow-up assessment s ( mean difference , 10.84 ; 95 % CI , 5.27 to 16.42 ; P < .001 ) and less frequent douching ( mean difference , -0.76 ; 95 % CI , -1.15 to -0.37 ; P = .001 ) . Adolescents in the intervention were also more likely to report consistent condom use in the 60 days preceding follow-up assessment s ( RR , 1 . 41 ; 95 % CI , 1.09 to 1.80 ; P = .01 ) and condom use at last intercourse ( RR , 1.30 ; 95 % CI , 1.09 to 1.54 ; P = .005 ) . Intervention effects were observed for psychosocial mediators of STD/HIV-preventive behaviors . CONCLUSION Interventions for African American adolescent females can reduce chlamydial infections and enhance STD/HIV-preventive behaviors and psychosocial mediators of STD/HIV-preventive behaviors . Trial Registration clinical trials.gov Identifier : NCT00633906 Abstract Objective : To assess the effectiveness of a teacher led intervention to improve teenagers ' knowledge about emergency contraception . Design : Cluster r and omised controlled trial . Setting : 24 mixed sex , state secondary schools in Avon , south west Engl and . Participants : 1974 boys and 1820 girls in year 10 ( 14 - 15 year olds ) . Intervention : Teachers gave a single lesson on emergency contraception to year 10 pupils . The teachers had previously received in-service training on giving the lesson . The pupils were actively involved during the lesson . Main outcome measures : Question naires distributed to pupils at baseline and six months after the intervention assessed their knowledge of the correct time limits for hormonal emergency contraception and for use of the intrauterine device as emergency contraception , the proportion of pupils who were not virgins , the proportion who had used emergency contraception , and the pupils ' intention to use emergency contraception in the future . Results : The proportion of pupils knowing the correct time limits for both types of emergency contraception was significantly higher in the intervention group than in the control group at six months ' follow up ( hormonal contraception : proportion of boys 15.9 % higher ( 95 % confidence interval 6.5 % to 25.3 % ) , girls 20.4 % ( 10.4 % to 30.4 % ) ; intrauterine device used as emergency contraception : boys 4.2 % ( 0.7 % to 7.7 % ) , girls 10.7 % ( 0.4 % to 21.0 % ) . The number of pupils needed to be taught for one more pupil to know the correct time limits was six for boys and five for girls . The intervention and control groups did not differ in the proportion of pupils who were not virgins , in the proportion who had used emergency contraception , and in the proportion intending to use emergency contraception in the future . Conclusions : The intervention significantly improved the proportion of boys and girls knowing the correct time limits for both types of emergency contraception . The intervention did not change the pupils ' sexual activity or use of emergency contraception . What is already known on this topic Use of condoms as a sole method of contraception is increasing Emergency contraception — either hormonal or the intrauterine device used as emergency contraception — can be used when condoms or other methods fail or are not used Awareness of emergency contraception in school pupils is high , but knowledge of specific details , such as the time period within which it can be used , is poor What this study adds A single lesson on emergency contraception given by teachers who had previously been trained improves the proportion of pupils aware of the correct time limits for use of both types of emergency contraception Such a lesson does not increase sexual activity or use of emergency Objective To assess the impact of Stepping Stones , a HIV prevention programme , on incidence of HIV and herpes simplex type 2 ( HSV-2 ) and sexual behaviour . Design Cluster r and omised controlled trial . Setting 70 villages ( clusters ) in the Eastern Cape province of South Africa . Participants 1360 men and 1416 women aged 15 - 26 years , who were mostly attending schools . Intervention Stepping Stones , a 50 hour programme , aims to improve sexual health by using participatory learning approaches to build knowledge , risk awareness , and communication skills and to stimulate critical reflection . Villages were r and omised to receive either this or a three hour intervention on HIV and safer sex . Interviewers administered question naires at baseline and 12 and 24 months and blood was tested for HIV and HSV-2 . Main outcome measures Primary outcome measure : incidence of HIV . Other outcomes : incidence of HSV-2 , unwanted pregnancy , reported sexual practice s , depression , and substance misuse . Results There was no evidence that Stepping Stones lowered the incidence of HIV ( adjusted incidence rate ratio 0.95 , 95 % confidence interval 0.67 to 1.35 ) . The programme was associated with a reduction of about 33 % in the incidence of HSV-2 ( 0.67 , 0.46 to 0.97 ; P=0.036)—that is , Stepping Stones reduced the number of new HSV-2 infections over a two year period by 34.9 ( 1.6 to 68.2 ) per 1000 people exposed . Stepping Stones significantly improved a number of reported risk behaviours in men , with a lower proportion of men reporting perpetration of intimate partner violence across two years of follow-up and less transactional sex and problem drinking at 12 months . In women desired behaviour changes were not reported and those in the Stepping Stones programme reported more transactional sex at 12 months . Conclusion Stepping Stones did not reduce incidence of HIV but had an impact on several risk factors for HIV — notably , HSV-2 and perpetration of intimate partner violence . Trial Registration Clinical Trials NCT00332878 BACKGROUND Adolescent girls in the United States and around the world are at a heightened risk for sexually transmitted diseases ( STDs ) , including human immunodeficiency virus ( HIV ) . OBJECTIVE To determine the efficacy of a skill-based HIV/STD risk-reduction intervention in reducing self-reported unprotected sexual intercourse among African American and Latino adolescent girls . DESIGN R and omized controlled trial with 3- , 6- , and 12-month follow-ups . SETTING AND PARTICIPANTS Sexually experienced African American and Latino adolescent girls recruited from the adolescent medicine clinic of a children 's hospital serving a low-income inner-city community ( N = 682 , mean age , 15.5 years ) ; 88.6 % were retained at the 12-month follow-up . INTERVENTIONS Three 250-minute interventions based on cognitive-behavioral theories and elicitation research : an information-based HIV/STD intervention provided information necessary to practice safer sex ; a skill-based HIV/STD intervention provided information and taught skills necessary to practice safer sex ; or a health-promotion control intervention concerned with health issues unrelated to sexual behavior . MAIN OUTCOME MEASURES Primary outcome measure was self-reported frequency of unprotected sexual intercourse ; secondary outcomes included the frequency of sexual intercourse while intoxicated , the number of sexual partners , biologically confirmed STDs , and theoretical mediator variables , including the intention to use condoms , beliefs about using condoms , and condom-use knowledge . RESULTS No differences between the information intervention and the health control intervention were statistically significant . Skills-intervention participants ( mean [ SE ] , 2.27 [ 0.81 ] ) reported less unprotected sexual intercourse at the 12-month follow-up than did information-intervention participants ( mean [ SE ] , 4.04 [ 0.80 ] ; P = .03 ) , or health control-intervention participants ( mean [ SE ] , 5.05 [ 0.81 ] ; P = .002 ) . At the 12-month follow-up , skills-intervention participants ( mean [ SE ] , 0.91 [ 0.05 ] ) reported fewer sexual partners ( P = .04 ) compared with health control-intervention participants ( mean [ SE ] , 1.04 [ 0.05 ] ) and were less likely to test positive for STD ( mean [ SE ] , 10.5 % [ 2.9 % ] ) than were health control-intervention participants ( mean [ SE ] , 18.2 % [ 2.8 % ] ; P = .05 ) . No differences in the frequency of unprotected sexual intercourse , the number of partners , or the rate of STD were observed at the 3- or 6-month follow-up between skill-intervention participants and information-intervention or health control-intervention participants . CONCLUSION Skill-based HIV/STD interventions can reduce sexual risk behaviors and STD rate among African American and Latino adolescent girls in clinic setting Background Peer-led sex education is widely believed to be an effective approach to reducing unsafe sex among young people , but reliable evidence from long-term studies is lacking . To assess the effectiveness of one form of school-based peer-led sex education in reducing unintended teenage pregnancy , we did a cluster ( school ) r and omised trial with 7 y of follow-up . Methods and Findings Twenty-seven representative schools in Engl and , with over 9,000 pupils aged 13–14 y at baseline , took part in the trial . Schools were r and omised to either peer-led sex education ( intervention ) or to continue their usual teacher-led sex education ( control ) . Peer educators , aged 16–17 y , were trained to deliver three 1-h classroom sessions of sex education to 13- to 14-y-old pupils from the same schools . The sessions used participatory learning methods design ed to improve the younger pupils ' skills in sexual communication and condom use and their knowledge about pregnancy , sexually transmitted infections ( STIs ) , contraception , and local sexual health services . Main outcome measures were abortion and live births by age 20 y , determined by anonymised linkage of girls to routine ( statutory ) data . Assessment of these outcomes was blind to sex education allocation . The proportion of girls who had one or more abortions before age 20 y was the same in each arm ( intervention , 5.0 % [ 95 % confidence interval ( CI ) 4.0%–6.3 % ] ; control , 5.0 % [ 95 % CI 4.0%–6.4 % ] ) . The odds ratio ( OR ) adjusted for r and omisation strata was 1.07 ( 95 % CI 0.80–1.42 , p = 0.64 , intervention versus control ) . The proportion of girls with one or more live births by 20.5 y was 7.5 % ( 95 % CI 5.9%–9.6 % ) in the intervention arm and 10.6 % ( 95 % CI 6.8%–16.1 % ) in the control arm , adjusted OR 0.77 ( 0.51–1.15 ) . Fewer girls in the peer-led arm self-reported a pregnancy by age 18 y ( 7.2 % intervention versus 11.2 % control , adjusted OR 0.62 [ 95 % CI 0.42–0.91 ] , weighted for non-response ; response rate 61 % intervention , 45 % control ) . There were no significant differences for girls or boys in self-reported unprotected first sex , regretted or pressured sex , quality of current sexual relationship , diagnosed sexually transmitted diseases , or ability to identify local sexual health services . Conclusion Compared with conventional school sex education at age 13–14 y , this form of peer-led sex education was not associated with change in teenage abortions , but may have led to fewer teenage births and was popular with pupils . It merits consideration within broader teenage pregnancy prevention strategies . Trial registration : IS RCT N ( IS RCT N94255362 ) Criminally involved adolescents engage in high levels of risky sexual behavior and alcohol use , and alcohol use may contribute to lack of condom use . Detained adolescents ( n = 484 ) were r and omized to ( 1 ) a theory-based sexual risk reduction intervention ( GPI ) , ( 2 ) the GPI condition with a group-based alcohol risk reduction motivational enhancement therapy component ( GPI + GMET ) , or ( 3 ) an information-only control ( INFO ) . All interventions were presented in same-sex groups in single sessions lasting from 2 to 4 hr . Changes to putative theoretical mediators ( attitudes , perceived norms , self-efficacy , and intentions ) were measured immediately following intervention administration . The primary outcomes were risky sexual behavior and sexual behavior while drinking measured 3 months later ( 65.1 % retention ) . The GPI + GMET intervention demonstrated superiority over both other conditions in influencing theoretical mediators and over the INFO control in reducing risky sexual behavior . Self-efficacy and intentions were significant mediators between condition and later risky sexual behavior . This study contributes to an underst and ing of harm reduction among high-risk adolescents and has implication s for underst and ing circumstances in which the inclusion of GMET components may be effective CONTEXT Given levels of unintended pregnancy and STDs , an effective counseling intervention is needed to improve women 's consistent use of effective prevention methods . METHODS A sample of 764 women aged 16 - 44 who were at risk of unintended pregnancy were enrolled in a r and omized controlled trial in North Carolina in 2003 - 2004 . Intervention participants received pregnancy and STD prevention counseling , adapted from motivational interviewing , both at enrollment and two months later ; controls received only a session of general health counseling . Levels of contraceptive use ( categorized as high , low or none on the basis of the effectiveness of the method and the consistency of use ) and barriers to use were measured at two , eight and 12 months ; chi-square tests were used to compare selected outcomes between the groups . Rates of unintended pregnancy and chlamydia infection were assessed over the study period . RESULTS At baseline , 59 % of all participants reported a high level of contraceptive use , 19 % a low level and 22 % nonuse . At two months , the proportions of intervention and control participants who had improved their level of use or maintained a high level ( 72 % and 66 % , respectively ) were significantly larger than the proportions who had reported a high level of use at baseline ( 59 % and 58 % , respectively ) . No significant differences were found between the groups at 12 months , or between baseline and 12 months for either group . During the study , 10 - 11 % of intervention and control participants became pregnant , 1 - 2 % received a chlamydia diagnosis and 7 - 9 % had another STD diagnosed . CONCLUSIONS Repeated counseling sessions may be needed to improve contraceptive decision-making and to reduce the risk of unintended pregnancy and STDs Background and Objectives : Condom use is one of the most important preventive measures sex workers can take to reduce the risk of becoming infected with a sexually transmitted disease . However , a client may refuse to use a condom when requested . Some sexually transmitted disease prevention programs are recommending that sex workers use spermicide as an alternative prophylaxis when a condom is refused , yet little is known about the effect of this recommendation on prophylactic condom use . Goal : To determine if using spermicide , either in conjunction with condoms or as a backup , influenced overall condom use among a group of sex workers at high risk of sexually transmitted diseases in Santa Fe de Bogota , Colombia . Study Design : Participants were assigned r and omly to one of three condom use groups : use of condoms only ( Condoms Only ) , use of condoms and spermicides concurrently ( Condom and Spermicide ) , or use of spermicide when condoms were refused ( Spermicide as a Backup ) . A total of 199 sex workers entered the study and were asked to return for follow‐up every 2 weeks for a period of 12 weeks . Results : Women assigned to the Spermicide as a Backup group used a condom for an average of 78.1 % of their reported acts of intercourse , compared with an average of 94.5 % in the Condom Only and 92.3 % in the Condom and Spermicide groups . However , women in the Spermicide as a Backup group used a condom or spermicide for an average of 96.9 % of their acts of intercourse . Condoms were used for every intercourse act by less than 5 % of the women in the Spermicide as a Backup group , compared with 50.7 % in the Condom Only group and 41.2 % in the Condom and Spermicide group ( P 0.001 ) . When condoms were not used , client refusal was the primary reason reported . The incidence of sexually transmitted diseases and other urogenital inflammations in all groups was lower than expected . Conclusions : Among Colombian sex workers , condom use declined substantially when women were instructed to use spermicides if they were unable to persuade their partner to use a condom . However , these same women usually used the study spermicide as an alternate prophylaxis CONTEXT . Rates of rapid second births among low-income black adolescent mothers range from 20 % to 50 % . Most efforts to prevent rapid second births have been unsuccessful . OBJECTIVES . There were 4 objectives : ( 1 ) to examine whether a home-based mentoring intervention was effective in preventing second births within 2 years of the adolescent mother 's first delivery ; ( 2 ) to examine whether greater intervention participation increased the likelihood of preventing a second birth ; ( 3 ) to examine whether second births were better predicted from a risk practice perspective or a family formation perspective , based on information collected at delivery ; and ( 4 ) to examine how risk practice s or family formation over the first 2 years of parenthood were related to a second birth . DESIGN . We conducted a r and omized , controlled trial of a home-based intervention curriculum , based on social cognitive theory , and focused on interpersonal negotiation skills , adolescent development , and parenting . The curriculum was delivered biweekly until the infant 's first birthday by college-educated , black , single mothers who served as mentors , presenting themselves as “ big sisters . ” The control group received usual care . Follow-up evaluations were conducted in the homes 6 , 13 , and 24 months after recruitment . METHODS . Participants were recruited from urban hospitals at delivery and were 181 first time , black adolescent mothers ( < 18 years of age ) ; 82 % ( 149 of 181 ) completed the 24-month evaluation . RESULTS . Intent-to-treat analyses revealed that control mothers were more likely than intervention mothers to have a second infant . The complier average causal effect was used to account for variability in intervention participation . Having ≥2 intervention visits increased the odds of not having a second infant more than threefold . Only 1 mother who completed ≥6 visits had a second infant . At delivery of their first infant , mothers who had a second infant were slightly older ( 16.7 vs 16.2 years ) and were more likely to have been arrested ( 30 % vs 14 % ) . There were no differences in baseline contraceptive use or other measures of risk or family formation . At 24 months , mothers who had a second infant reported high self-esteem , positive life events , and romantic involvement and residence with the first infant 's father . At 24 months , there were no differences in marital rates ( 2 % ) , risk practice s , or contraceptive use between mothers who did and did not have a second infant . Mothers who did not have a second infant were marginally more likely to report no plans for contraception in their next sexual contact compared with mothers who had a second infant ( 22 % vs 8 % , respectively ) . CONCLUSIONS . A home-based intervention founded on a mentorship model and targeted toward adolescent development , including negotiation skills , was effective in preventing rapid repeat births among low-income , black adolescent mothers . The effectiveness of the intervention could be seen after only 2 visits and increased over time . There were no second births among mothers who attended ≥8 sessions . There was no evidence that risk behavior or contraceptive use was related to rapid second births . There was some evidence that rapid second births among adolescent mothers were regarded as desirable and as part of a move toward increasing autonomy and family formation , thereby undermining intervention programs that focus on risk avoidance . Findings suggest the merits of a mentoring program for low-income , black adolescent mothers , based on a relatively brief ( 6–8 sessions ) curriculum targeted toward adolescent development and interpersonal negotiation skills BACKGROUND One in four abortions in the UK is undertaken for women who have had one before . Women undergoing abortion in Edinburgh were targeted for improved contraceptive advice and provision in this r and omized trial . METHODS Between November 2001 and May 2002 , women recruited at assessment for abortion were r and omized at admission to receive specialist contraceptive advice and enhanced provision ( 316 women ) or st and ard care ( 297 women ) . R and omization was based on the week of admission . Contraceptive use 16 weeks after abortion was assessed by question naire and subsequent abortions by review of the hospital records 2 years later . RESULTS Women receiving specialist advice and enhanced provision were more likely to leave the hospital with contraception ( 271 versus 115 , P < 0.001 ) , which was more likely to be a long-acting method ( 141 versus 78 , P < 0.001 ) than women receiving st and ard care . Four months later , there was no significant difference in contraceptive prevalence or continuation , but women in the intervention group were more likely to be using contraceptive implants ( 32 versus 6 , P < 0.001 ) . Two years later , 14.6 % of women in the intervention group ( 44/302 ) and 10 % of controls ( 27/268 ) had undergone another abortion in the same hospital ( P = 0.267 ) . CONCLUSIONS Specialist contraceptive advice and enhanced provision had a short-lived effect on contraceptive uptake and increased the use of long-acting methods but did not appear to reduce repeat abortions OBJECTIVE To evaluate the efficacy of a community-based social skills human immunodeficiency virus ( HIV ) prevention intervention to enhance consistent condom use . DESIGN A r and omized , single-blind controlled trial . SETTING Bayview-Hunter 's Point neighborhood of San Francisco , Calif , a predominantly African-American community that is economically disadvantaged . PARTICIPANTS A sample of 128 sexually active , heterosexual , African-American women 18 through 29 years of age was recruited using street outreach techniques . Participants completed a structured baseline interview ; 100 women ( 78.1 % ) completed 3-month follow-up interviews . INTERVENTION Women r and omized to the social skills intervention completed five sessions that emphasized ethnic and gender pride , HIV risk-reduction information , sexual self-control , sexual assertiveness and communication skills , proper condom use skills , and developing partner norms supportive of consistent condom use . Women r and omized to the HIV education condition participated in a single session that provided HIV risk-reduction information . Women r and omized to the delayed HIV education control condition received no HIV risk-reduction information until all follow-up interviews were completed . MAIN OUTCOME MEASURES Consistent condom use , HIV risk-reduction knowledge , sexual self-control , sexual assertiveness , sexual communication , and partner norms supportive of consistent condom use . RESULTS Compared with the delayed HIV education control condition , women in the social skills intervention demonstrated increased consistent condom use ( adjusted odds ratio [ OR ] , 2.1 ; 95 % confidence interval [ CI ] , 1.03 to 4.15 ; P = .04 ) , greater sexual self-control ( adjusted OR , 1.9 ; 95 % CI , 1.00 to 3.60 ; P = .05 ) , greater sexual communication ( adjusted OR , 4.1 ; 95 % CI , 1.67 to 10.01 ; P = .002 ) , greater sexual assertiveness ( adjusted OR , 1.8 ; 95 % CI , 1.01 to 3.27 ; P = .05 ) , and increased partners ' adoption of norms supporting consistent condom use ( adjusted OR , 2.1 ; 95 % CI , 1.08 to 3.87 ; P = .03 ) . No statistically significant differences in outcome variables were observed between the HIV education condition relative to the delayed HIV education control condition . CONCLUSION Community-based HIV risk-reduction programs that are gender relevant and culturally sensitive and provide social skills training can effectively enhance consistent condom use Studies design ed to evaluate HIV and STD prevention interventions often involve r and om assignment of groups such as neighborhoods or communities to study conditions ( e.g. , to intervention or control ) . Investigators who design group-r and omized trials ( GRTs ) must take the expected intraclass correlation coefficient ( ICC ) into account in sample size estimation to have adequate power ; however , few published ICC estimates exist for outcome variables related to HIV and STD prevention . The Prevention Options for Women Equal Rights ( POWER ) study was a GRT design ed to evaluate a campaign to increase awareness and use of condoms among young African American and Hispanic women . The authors used precampaign and postcampaign data from the POWER study to estimate ICCs ( unadjusted and adjusted for covariates ) for a variety of sexual behavior and other variables . To illustrate the impact of ICCs on power , the authors present sample -size calculations and demonstrate how ICCs of differing magnitude will affect estimates of required sample size This r and omized clinical trial examined the relative efficacy of a relationship-based HIV/STI prevention intervention for women and their regular male sexual partners at 12 months post-intervention . A total of 217 couples were r and omized to ( 1 ) a six-session intervention provided to the woman and her sexual partner together ( n = 81 ) ; ( 2 ) the same intervention provided to the woman alone ( n = 73 ) ; or ( 3 ) a one-session health information education “ control ” provided to the woman alone ( n = 63 ) . Findings suggest the intervention was efficacious in reducing unprotected sex at 12 months post-intervention , compared with the education control group . No significant differences were observed when comparing whether couples received the intervention together or when the woman received it alone In a r and omized trial , the effect of preabortion counseling was evaluated and contraceptive use postabortion described . The 420 women , who were assigned into either an intervention group ( n = 210 ) or a control group ( n = 210 ) , were followed-up 4 - 6 months later , a total of 148 and 128 women in each respective group . No significant difference was found between the two groups regarding contraceptive use after abortion ( 86 % , 85 % ) , which indicates no immediate intervention effect . The women , in both groups , who had previously undergone abortion were less likely to use contraception . The main contraceptive methods used by intervention and control groups were oral contraceptives ( 61 % and 58 % , respectively ) and injectables ( 12 % and 11 % ) . Choice of method was mainly based on women 's prior perception of effectiveness and convenience of use . A majority of the women in both groups could not specify their contraceptive plans . A postr and omization ine quality regarding age , education and parity in the two groups had , however , to be taken into account . Intensive contraceptive counseling before abortion may not be effective , but those who are at higher risk of unplanned pregnancy need special attention Heterosexual contact with intravenous drug users accounts for a growing proportion of cases of acquired immunodeficiency syndrome ( AIDS ) among women . In an earlier study design ed to reduce sexual risk behavior , the authors r and omly assigned 91 methadone maintained women to information-only or skills-building conditions . Modest outcomes favored participants in the skills-building group . In this 15-month followup of 62 remaining study participants , skills-training group members were more likely than controls to use condoms . In comparison with controls , members in the skills-building group felt more comfortable talking about safe sex , perceived themselves as more able to reduce their exposure to AIDS , but were more likely to attribute AIDS risk to luck . No associations were found between group condition and number of sexual partners or frequency of buying and carrying condoms . Some gains associated with a group intervention tended to be maintained over time , indicating that preventive interventions composed of multiple sessions and conducted in treatment setting s may have promise as useful strategies to prevent human immunodeficiency virus ( HIV ) infection . Nevertheless , decay was evident in other domains , suggesting that prevention specialists should consider booster sessions or other means of maintaining changes in risk behavior BACKGROUND Although condom promotion schemes have been widely piloted in UK general practice s , there have been no rigorous evaluations of their effectiveness . OBJECTIVES To see if a practice -based sexual health education intervention increases the number of women having smears who are given condoms and advice on avoiding STDs . To see if this low cost intervention affects subsequent condom use . METHOD We conducted a cluster r and omized trial of condom promotion in 1382 women aged < 35 years attending 28 South London general practice s for cervical smear tests . RESULTS More women in intervention than control practice s reported receiving advice on avoiding sexually transmitted infections ( 27 % versus 10 % ) and being given condoms ( 28 % versus 1 % , P < 0.05 ) . However , there was no difference in subsequent condom use , even in the 22 % of women reporting > /=2 sexual partners in the previous year . CONCLUSIONS To provide evidence of effectiveness , future interventions may need to be more intensive or focus on higher risk groups OBJECTIVES We examined the efficacy of an HIV prevention intervention among African American female adolescents reporting a history of gender-based violence . METHODS In this analysis of a subgroup of participants involved in a r and omized controlled trial , consistent condom use , psychosocial mediators associated with HIV-preventive behaviors , and presence of sexually transmitted diseases were assessed at 6- and 12-month follow-ups . The intervention emphasized ethnic and gender pride , HIV knowledge , condom attitudes , healthy relationships , communication , and condom use skills . RESULTS Relative to the comparison condition , participants r and omized to the intervention reported using condoms more consistently , had fewer episodes of unprotected vaginal sex , engaged in a greater proportion of protected intercourse acts , were more likely to have used a condom during their most recent intercourse , were less likely to have a new sexual partner , were less likely to have a sexually transmitted disease , and demonstrated more proficient condom skills . CONCLUSIONS Given the substantial prevalence of gender-based violence among female adolescents and the associations observed between gender-based violence , HIV risk , and HIV infection , it is essential that HIV interventions involving young women address partner violence BACKGROUND African-American and Hispanic women are disproportionately affected by sexually transmitted diseases , including the acquired immunodeficiency syndrome ( AIDS ) . In the effort to reduce infection rates , it is important to create and evaluate behavioral interventions that are specific to the target population s. METHODS We enrolled women with nonviral sexually transmitted diseases in a r and omized trial of a sex- and culture-specific behavioral intervention . The intervention consisted of three small-group sessions of three to four hours each design ed to help women recognize personal susceptibility , commit to changing their behavior , and acquire necessary skills . The control group received st and ard counseling about sexually transmitted diseases . The design of the intervention was based on the AIDS Risk Reduction Model and ethnographic data on the study population s. Participants in both groups underwent screening , counseling , and an interview before r and omization and at the 6- and 12-month follow-up visits . The principal outcome variable was subsequent chlamydial or gonorrheal infection , which was evaluated on an intention-to-treat basis by logistic-regression analysis . RESULTS A total of 424 Mexican-Americans and 193 African-American women were enrolled ; 313 were assigned to the intervention group and 304 to the control group . The rate of participation in the intervention was 90 percent . The rates of retention in the sample were 82 and 89 percent at the 6- and 12-month visits , respectively . Rates of subsequent infection were significantly lower in the intervention group than in the control group during the first 6 months ( 11.3 vs. 17.2 percent , P=0.05 ) , during the second 6 months ( 9.1 vs. 17.7 percent , P=0.008 ) , and over the entire 12-month study period ( 16.8 vs. 26.9 percent , P=0.004 ) . CONCLUSIONS A risk-reduction intervention consisting of three small-group sessions significantly decreased the rates of chlamydial and gonorrheal infection among Mexican-American and African-American women at high risk for sexually transmitted disease There is an urgent need for the development and implementation of effective and feasible behavioral HIV and STD interventions . The purpose of the present r and omized controlled trial was to evaluate the effectiveness of a single-session , skill-based sexual risk reduction intervention for women . Participants were assessed at baseline and at 1 month and 3 months following the intervention on measures of AIDS knowledge , behavioral intentions , self-efficacy , and sexual risk behavior . Compared with women in an AIDS-education-only condition , women receiving the skill-based intervention reported significantly higher rates of condom use at 3-month follow-up . Results suggest that brief sexual risk reduction programs are feasible and effective within a community setting An intervention combining AIDS information with condom eroticization , condom normalization , and communication skills training was found to increase both AIDS-related knowledge and condom use among Canadian college students . 112 unmarried female undergraduates ( mean age , 18 years ) were r and omly assigned to this combination intervention ( n = 49 ) , an information-only intervention ( n = 44 ) , or a pre-test/post-test control group ( n = 19 ) . 80 % of students had engaged in vaginal intercourse and 14 % in anal intercourse . 84 % of coitally active women had engaged in unprotected intercourse in the past year and 48 % had not used condoms consistently with any sexual partner . Condom use in the pre-intervention period was associated with positive attitudes toward the method and the perception that condom use was normative among peers . One month after the interventions , both the combination and information groups , but not controls , showed an increase over baseline in AIDS-related knowledge . However , among the 36 students who were coitally active in the 1-month periods before and after the intervention , only the combination intervention was associated with increased condom use . In the combination group , the percentage of episodes of intercourse protected by condoms increased from an average of 21.8 % in the month preceding the study to 50 % during the 4-week follow-up period . Due to the small sample size and design of the study , it was not possible to determine which component of the multifaceted educational intervention was most responsible for this change This study evaluates the effectiveness of two strategies — communication and condom skills training — for increasing condomprotected sex in a sample of 510 high-risk women ages 17 to 61 . Baseline and 3- and 6-month postintervention interview data were gathered in three cities participating in a r and omized trial of a six-session , group skill-building intervention . This analysis was conducted for the entire sample and for six subgroups categorized by age , single or multiple partners , and history of childhood sexual abuse . The dependent variable was the odds ratio of protected sex acts at each follow-up . Structural equation modeling was used to estimate effects for two intervention pathways . The pathway through condom skills increased the odds of protected sex for the intervention group ( χ2 difference = 35 , df = 2 , p < .05 ) as well as for all subgroups . The pathways through communication were significant for the intervention group ( χ2 difference = 23 , df =3 , p < .05 ) but fully effective only for participants under 30 and participants who reported childhood sexual abuse . The effectiveness of both pathways diminished at 6 months . WINGS demonstrates that condom skills training can increase protected sex for a heterogeneous group of women . Further research needs to examine how such skill training translates into use of condoms by male partners . To increase the duration of intervention effects , booster sessions may need to be incorporated A primary prevention , behavioral intervention design ed to reduce HIV risk behavior was tested in a r and omized , controlled trial with single , inner-city women . A total of 935 women were r and omly assigned to 1 of 3 conditions : a small group , 6-session communally oriented HIV prevention intervention ; a yoked general health promotion intervention control ; or a st and ard care control . Both interventions involved the interactive use of videotapes by live group leaders . The HIV prevention intervention , in particular , result ed in significant positive effects on self-reported and behaviorally assessed safer-sex behavior . Women in the HIV prevention group showed reduced point prevalences of medically tested sexually transmitted diseases at follow-up in some comparisons OBJECTIVES To assess the consequences of human immunodeficiency virus ( HIV ) counseling and testing for seronegative women in terms of sexual behavior and psychological outcomes . DESIGN The design is prospect i ve and longitudinal , using repeated measures . Participants were interviewed at recruitment , 2 weeks later ( when tested women received results ) , and 3 months later . SETTING Four community health clinics in southern Connecticut ; all provide HIV counseling and testing and other specialized and primary health care services . STUDY PARTICIPANTS A sequential sample of women were recruited for two study groups : those seeking HIV counseling and testing ( n = 152 ) , and a comparison group never tested for HIV ( n = 78 ) , matched by clinic , race , and age . MAIN OUTCOME MEASURES A composite measure of sexual risk was developed , based on sexual activity , condom use , and partner risk factors . Psychometrically valid and reliable measures of general psychological functioning and acquired immunodeficiency syndrome (AIDS)--specific psychological indicators were also used . RESULTS Average level of sexual risk was lower for tested than nontested women at all three interviews . For both groups , there was no significant change in sexual risk from baseline to 3-month follow-up . At the individual level , there was no difference in the number of women who decreased or increased sexual risk . For tested women , intrusive thoughts about AIDS and estimated chance of getting AIDS decreased after counseling and testing . CONCLUSIONS Behavioral and psychological consequences of HIV counseling and testing for women at risk for HIV were limited . These results have implication s for further prevention interventions Objective : To evaluate the efficacy of a theory-based tailored minimal self-help intervention to increase condom use among young women at risk for HIV/sexually transmitted disease ( STD ) . Design : R and omized controlled trial on an intent-to-treat basis in two managed care plans , in Washington state and North Carolina , with follow-up at 3 and 6 months . Participants : A proactively recruited sample of 1210 heterosexually active , non-monogamous , non-pregnant women , aged 18–24 years recruited June 1999–April 2000 ; 85 % completed the 6-month follow-up . Method : Arm 1 received usual care . Arm 2 received a mailed computer-generated self-help magazine , individually tailored on survey items including stage of readiness to use condoms , barriers to condom use , partner type ; condom sample s and a condom-carrying case were included in the packet ; this was followed 3 months later by a tailored ‘ booster ’ newsletter . The a priori 6-month main outcomes were percentage of women using condoms during the previous 3 months ( overall and by partner type ) and proportion of total episodes of intercourse during which condoms were used in the previous 3 months . Results : Relative to usual care , intervention group women reported significantly more condom use overall [ adjusted odds ratio ( OR ) , 1.86 ; 95 % confidence interval ( CI ) , 1.32–2.65 ; P = 0.0005 ] and with recent primary partners ( OR , 1.97 ; 95 % CI , 1.37–2.86 ; P = 0.0003 ) . They also reported using condoms for a higher proportion of intercourse episodes ( 52.7 % versus 47.9 % ; P = 0.05 ) . Significantly more intervention women carried condoms , discussed condoms with partners , and had higher self-efficacy to use condoms with primary partners . Conclusions : Tailored cognitive/behavioral minimal self-help interventions hold promise as HIV/STD prevention strategies for diverse population s of young at-risk women PURPOSE This study was undertaken to determine whether the Adult Identity Mentoring ( AIM ) project successfully promotes abstinence , delays initiation of sex , and decreases intention to engage in sex . METHODS Twenty middle school classes of African-American seventh grade rs were r and omly assigned to receive either the AIM intervention or a st and ard health education control curriculum . The AIM is a 10-session curriculum based on the theory of possible selves . Class exercises encourage students to articulate a possible future self-identity and to develop self-promotion skills . Surveys about sexual activity were conducted before the intervention , 19 weeks after baseline , and again at 1 year after the intervention . RESULTS Hierarchical logistic regression analyses showed significant effects for the intervention on sexual intentions , abstinence , and a trend toward fewer virgins initiating intercourse for the first time , 19 weeks after baseline . Specifically , students who received the intervention showed decreased intention to engage in sex and increased abstinence compared with students not receiving the intervention . Effects for 1-year follow-up , with smaller sample size , showed only that AIM male participants maintained the significant abstinence effect . CONCLUSIONS A new intervention , AIM was evaluated among African-American seventh grade rs . This program , by focusing students on positive future selves , effectively modified sexual risk without directly providing instruction on sexually explicit topics Background : South Africa has the world ’s fastest growing AIDS epidemic . There is an urgent need for effective HIV risk reduction interventions in South Africa . Objective : The objective of this study was to develop and test the potential efficacy of a brief theory-based HIV prevention counseling intervention for sexually transmitted infection ( STI ) clinic patients in South Africa . Method : STI clinic patients in Cape Town ( N = 228 ) were assessed at baseline and r and omized to receive either : 1 ) a single 60-minute session motivational/skills-building HIV risk reduction counseling intervention or 2 ) a 20-minute HIV information/education session . Participants completed 1- and 3-month follow ups with 80 % retention . Results : The 60-minute motivational/skills risk reduction counseling demonstrated significantly greater risk reduction practice s , lower rates of unprotected intercourse , and greater likelihood of receiving HIV testing after the intervention . Conclusions : Brief theory-based HIV prevention counseling may significantly reduce HIV risk behaviors for STI clinic patients in South Africa Objective : We recently showed efficacy of an intervention to increase condom use among female sex workers ( FSWs ) in Tijuana and Ciudad Juarez , situated on the Mexico-United States border . We determined whether increases in condom use were predicted by social cognitive theory and injection drug user status among women r and omized to this intervention . Methods : Four hundred nine HIV-negative FSWs aged ≥18 years having unprotected sex with clients within the prior 2 months received a brief individual counseling session integrating motivational interviewing and principles of behavior change ( ie , HIV knowledge , self-efficacy for using condoms , and outcome expectancies ) . Results : Increases in self-efficacy scores were associated with increases in percent condom use ( P = 0.008 ) , whereas outcome expectancies were not . Female sex workers who inject drugs ( FSW-IDUs ) increased condom use with clients but not to the same extent as other FSWs ( P = 0.09 ) . Change in HIV knowledge was positively associated with change in percent condom use among FSW-IDUs ( P = 0.03 ) but not noninjection drug users . Conclusions : Increases in self-efficacy significantly predicted increased condom use among FSWs , consistent with social cognitive theory . Increased HIV knowledge was also important among FSW-IDUs , but their changes in condom use were modest . Enhanced interventions for FSW-IDUs are needed , taking into account realities of substance use during sexual transactions that can compromise safer sex negotiation OBJECTIVES We tested the efficacy of brief HIV/sexually transmitted disease ( STD ) risk-reduction interventions for African American women in primary care setting s. METHODS In a r and omized controlled trial , 564 African American women recruited at a Newark , NJ , inner-city women 's health clinic were assigned to a 20-minute one-on-one HIV/STD behavioral skill-building intervention , 200-minute group HIV/STD behavioral skill-building intervention , 20-minute one-on-one HIV/STD information intervention , 200-minute group HIV/STD information intervention , or 200-minute health intervention control group . Primary outcomes were self-reported sexual behaviors in the previous 3 months ; secondary outcome was STD incidence . RESULTS At 12-month follow-up , participants in the skill-building interventions reported less unprotected sexual intercourse than did participants in the information interventions ( Cohen 's d [d]=0.23 , P=.02 ) , reported a greater proportion of protected sexual intercourse than did information intervention participants ( d=0.21 , P=.05 ) and control participants ( d=0.24 , P=.03 ) , and were less likely to test positive for an STD than were control participants ( d=0.20 , P=.03 ) . CONCLUSIONS This study suggests that brief single-session , one-on-one or group skill-building interventions may reduce HIV/STD risk behaviors and STD morbidity among inner-city African American women in primary care setting CONTEXT African American adolescent girls are at high risk for human immunodeficiency virus ( HIV ) infection , but interventions specifically design ed for this population have not reduced HIV risk behaviors . OBJECTIVE To evaluate the efficacy of an intervention to reduce sexual risk behaviors , sexually transmitted diseases ( STDs ) , and pregnancy and enhance mediators of HIV-preventive behaviors . DESIGN , SETTING , AND PARTICIPANTS R and omized controlled trial of 522 sexually experienced African American girls aged 14 to 18 years screened from December 1996 through April 1999 at 4 community health agencies . Participants completed a self-administered question naire and an interview , demonstrated condom application skills , and provided specimens for STD testing . Outcome assessment s were made at 6- and 12-month follow-up . INTERVENTION All participants received four 4-hour group sessions . The intervention emphasized ethnic and gender pride , HIV knowledge , communication , condom use skills , and healthy relationships . The comparison condition emphasized exercise and nutrition . MAIN OUTCOME MEASURES The primary outcome measure was consistent condom use , defined as condom use during every episode of vaginal intercourse ; other outcome measures were sexual behaviors , observed condom application skills , incident STD infection , self-reported pregnancy , and mediators of HIV-preventive behaviors . RESULTS Relative to the comparison condition , participants in the intervention reported using condoms more consistently in the 30 days preceding the 6-month assessment ( unadjusted analysis , intervention , 75.3 % vs comparison , 58.2 % ) and the 12-month assessment ( unadjusted analysis , intervention , 73.3 % vs comparison , 56.5 % ) and over the entire 12-month period ( adjusted odds ratio , 2.01 ; 95 % confidence interval [ CI ] , 1.28 - 3.17 ; P = .003 ) . Participants in the intervention reported using condoms more consistently in the 6 months preceding the 6-month assessment ( unadjusted analysis , intervention , 61.3 % vs comparison , 42.6 % ) , at the 12-month assessment ( unadjusted analysis , intervention , 58.1 % vs comparison , 45.3 % ) , and over the entire 12-month period ( adjusted odds ratio , 2.30 ; 95 % CI , 1.51 - 3.50 ; P<.001 ) . Using generalized estimating equation analyses over the 12-month follow-up , adolescents in the intervention were more likely to use a condom at last intercourse , less likely to have a new vaginal sex partner in the past 30 days , and more likely to apply condoms to sex partners and had better condom application skills , a higher percentage of condom-protected sex acts , fewer unprotected vaginal sex acts , and higher scores on measures of mediators . Promising effects were also observed for chlamydia infections and self-reported pregnancy . CONCLUSION Interventions for African American adolescent girls that are gender-tailored and culturally congruent can enhance HIV-preventive behaviors , skills , and mediators and may reduce pregnancy and chlamydia infection OBJECTIVES We examined the efficacy of a brief behavioral intervention to promote condom use among female sex workers in Tijuana and Ciudad Juarez , Mexico . METHODS We r and omized 924 female sex workers 18 years or older without known HIV infection living in Tijuana and Ciudad Juarez who had recently had unprotected sex with clients to a 30-minute behavioral intervention or a didactic control condition . At baseline and 6 months , women underwent interviews and testing for HIV , syphilis , gonorrhea , and chlamydia . RESULTS We observed a 40 % decline in cumulative sexually transmitted illness incidence ( P = .049 ) in the intervention group . Incidence density for the intervention versus control groups was 13.8 versus 24.92 per 100 person-years for sexually transmitted illnesses combined ( P = .034 ) and 0 versus 2.01 per 100 person-years for HIV ( P < .001 ) . There were concomitant increases in the number and percentage of protected sex acts and decreases in the number of unprotected sex acts with clients ( P < .05 ) . CONCLUSIONS This brief behavioral intervention shows promise in reducing HIV and sexually transmitted illness risk behaviors among female sex workers and may be transferable to other re source -constrained setting OBJECTIVES Interventions to lower HIV risk behavior among drug users have concentrated on reduction of high risk injection practice s. Less attention has been directed to non-injecting drug users and drug-involved women . Female non-injecting drug users ( e.g. , women who abuse alcohol or crack cocaine ) are also at substantial risk for sexual transmission of HIV due to multiple partners , partners who self-inject and share needles , exchange of sex for drugs , coerced sex , high rates of sexually transmitted diseases , and low rates of condom use . This study compared the effectiveness of an educational intervention ( EC ) against the behavior skills training intervention ( BST ) in reducing sexual risk behavior among women ( N = 117 ) court-ordered into inpatient drug treatment . METHODS Participants were assessed at baseline , post intervention , and 2 months after discharge from the drug treatment facility . RESULTS Women in both conditions reported high rates of sexual risk behavior prior to the intervention . Women in both conditions had more positive attitudes toward HIV prevention and reported greater partner agreement with condom use at the post intervention assessment . However , these changes were not maintained at follow-up for women in the EC condition , whereas women in BST continued to show improvement post discharge . Women in the BST condition showed marked , while women in EC showed little improvement in communication skills and no improvement in condom application skill . At follow-up , women in both conditions had reduced drug use and drug-related high risk sex activities . BST women had increased their condom use while women in EC evidence d a decrease . Condom use increased from 35.7 % to 49.5 % of vaginal intercourse occasions for BST women and decreased from 28.8 % to 15.8 % for women in EC . CONCLUSIONS Results suggest a brief skills training intervention embedded in drug treatment programs can reduce sexual risk for HIV-infection after discharge HIV/AIDS disproportionately affects young women of color . Young women who use hormonal contraception are less likely to use condoms . Brief , inexpensive HIV-prevention interventions are needed for high-volume clinics . This study was a r and omized clinical trial of two interventions : ( a ) a video made for this study and ( b ) an adaptation of Project RESPECT counseling . Four hundred Black and Latina teenage women completed a question naire about their sexual behaviors and were r and omly assigned to ( a ) see the video , ( b ) get counseling , ( c ) see the video and get counseling , or ( d ) receive usual care . At 3-month follow-up , those who saw the video and received counseling were 2.5 times more likely to have used a condom at last intercourse with their main partner than teens in the usual care group . These differences did not persist at 12-month follow-up . This suggests that a brief intervention can positively affect condom use in the short term PURPOSE One-quarter of adolescent mothers bear another child within 2 years , compounding their risk of poorer medical , educational , economic , and parenting outcomes . Most efforts to prevent rapid subsequent birth to teenagers have been unsuccessful but have seldom addressed motivational processes . METHODS We conducted a r and omized trial to determine the effectiveness of a computer-assisted motivational intervention ( CAMI ) in preventing rapid subsequent birth to adolescent mothers . Pregnant teenagers ( N = 235 ) , aged 18 years and older who were at more than 24 weeks ’ gestation , were recruited from urban prenatal clinics serving low-income , predominantly African American communities . After completing baseline assessment s , they were r and omly assigned to 3 groups : ( 1 ) those in CAMI plus enhanced home visit ( n = 80 ) received a multi-component home-based intervention ( CAMI+ ) ; ( 2 ) those in CAMI−only ( n = 87 ) received a single component home-based intervention ; ( 3 ) and those in usual-care control ( n = 68 ) received st and ard usual care . Teens in both intervention groups received CAMI sessions at quarterly intervals until 2 years ’ postpartum . Those in the CAMI+ group also received monthly home visits with parenting education and support . CAMI algorithms , based on the transtheoretical model , assessed sexual relationships and contraception-use intentions and behaviors , and readiness to engage in pregnancy prevention . Trained interventionists used CAMI risk summaries to guide motivational interviewing . Repeat birth by 24 months ’ postpartum was measured with birth certificates . RESULTS Intent-to-treat analysis indicated that the CAMI+ group compared with the usual-care control group exhibited a trend toward lower birth rates ( 13.8 % vs 25.0 % ; P = .08 ) , whereas the CAMI-only group did not ( 17.2 % vs 25.0 % ; P = .32 ) . Controlling for baseline group differences , the hazard ratio ( HR ) for repeat birth was significantly lower for the CAMI+ group than it was with the usual-care group ( HR = 0.45 ; 95 % CI , 0.21–0.98 ) . We developed complier average causal effects models to produce unbiased estimates of intervention effects accounting for variable participation . Completing 2 or more CAMI sessions significantly reduced the risk of repeat birth in both groups : CAMI+ ( HR = 0.40 ; 95 % CI , 0.16–0.98 ) and CAMI−only ( HR = 0.19 ; 95 % CI , 0.05–0.69 ) . CONCLUSIONS Receipt of 2 or more CAMI sessions , either alone or within a multicomponent home-based intervention , reduced the risk of rapid subsequent birth to adolescent mothers This study evaluated the effects of peer counseling in a culturally specific adolescent pregnancy prevention program for African American females . A r and om pretest and multiple posttest experimental and comparison group design was used to obtain data on a sample of 63 female African American adolescents , ages 12 to 16 , who lived in four public housing developments . Descriptive data and tests of significance revealed that none of the participants who received peer counseling became pregnant within three months of the intervention . Findings revealed a statistically significant increase in reproductive and other self-related knowledge topics among the experimental group when comparing pretest and eight-week posttest scores . Most participants had not had sexual intercourse ; the average age of sexual onset was 12 years in the experimental group and 11 years in the controls . Design ing and implementing culturally specific adolescent pregnancy prevention programs for adolescents younger than age 11 and /or before sexually active seems appropriate College students are engaging in high rates of behavior related to risk of infection from Human Immunodeficiency Virus ( HIV ) and other sexually transmitted diseases ( STDs ) . A cognitive-behavioral skills training program for heterosexual college females focused on sexual assertiveness skills and the reduction of risk-related behaviors was design ed and evaluated compared with an education-only program . Participants completed pre-intervention , post-intervention , and one-month follow-up assessment s of : ( a ) HIV/STD-related knowledge and beliefs ; ( b ) sexual , alcohol , and drug-related behaviors ; and ( c ) sexual assertiveness role-plays . Skills training participants compared to education-only participants scored higher on sexual assertiveness skills , specific knowledge of HIV infection , and self-efficacy to perform lower risk sexual behaviors and reported a reduction in risk-related behaviors at post-intervention and follow-up assessment s. The effectiveness of behavioral skills in HIV risk-reduction programs for college students is discussed CONTEXT Advance provision of emergency contraception ( EC ) may increase timely access and improve effectiveness , but the impact on adolescent sexual and contraceptive behaviors is not known . OBJECTIVE To determine whether adolescents given advance EC have higher sexual and contraceptive risk-taking behaviors compared to those obtaining it on an as-needed basis . DESIGN AND SETTING R and omized trial conducted at urban , hospital-based adolescent clinic in Pittsburgh , PA , from June 1997 to June 2002 . PARTICIPANTS 301 predominantly minority , low-income , sexually active adolescent women , age 15 - 20 years , not using long-acting contraception . INTERVENTIONS Advance EC vs instruction on how to get emergency contraception . OUTCOME MEASURES Self-reported unprotected intercourse and use of condoms , EC , and hormonal contraception ascertained by monthly 10-minute telephone interviews for 6 months post-enrollment . Reported timing of EC use after unprotected intercourse . RESULTS At both 1- and 6-month followup interviews , there were no differences between advance EC and control groups in reported unprotected intercourse within the past month or at last intercourse . At 6 months , more advance EC participants reported condom use in the past month compared to control group participants ( 77 % vs 62 % , P=0.02 ) , but not at last intercourse ( advance EC 83 % vs control 78 % , P=0.34 ) . There were no significant differences by group in hormonal contraception use reported by advance EC or control groups in the past month ( 44 % vs 53 % , P=0.19 ) or at last intercourse ( 48 % vs 58 % , P=0.20 ) . At the first followup , the advance group reported nearly twice as much EC use as the control group ( 15 % vs 8 % , P=0.05 ) but not at the final followup ( 8 % vs 6 % , P=0.54 ) . Advance EC group participants began their EC significantly sooner ( 11.4 hours vs 21.8 hours , P=0.005 ) . CONCLUSIONS Providing advance EC to adolescents is not associated with more unprotected intercourse or less condom or hormonal contraception use . In the first month after enrollment , adolescents provided with advance EC were nearly twice as likely to use it and began EC sooner , when it is known to be more effective The effectiveness of an HIV prevention intervention for low-income African American women between the ages of 20 and 44 years was assessed . The hypothesis was that at 3 , 6 , and 9 months , treatment intervention women would have significantly greater increase from baseline on self-efficacy , condom use knowledge , protective sexual behavior , prevention community behavior , and perceived HIV vulnerability compared with the control intervention women . Using an interrupted time series design , one of two geographically distinct but demographically similar communities was r and omly assigned to the treatment intervention . A total of 280 women participated . Hierarchical linear modeling revealed no differences at pretest for the treatment and control women . Compared with control women , treatment women significantly increased self-efficacy , protective sexual behavior , condom knowledge , and prevention community behavior . A slight decline in protective sexual behavior at 9 months may indicate that a linear pattern of change may not be appropriate to describe sexual behavioral change A longitudinal r and omized design was used to evaluate the impact of a theoretically based , st and -alone interactive video intervention on 300 urban adolescent girls ' ( a ) knowledge about sexually transmitted diseases ( STDs ) , ( b ) self-reported sexual risk behavior , and ( c ) STD acquisition . It was compared to two controls , representing high- quality informational interventions . One used the same content in book form ; the other used commercially available brochures . Following r and omization , the interventions were administered at baseline , with booster sessions at 1 , 3 , and 6 months . Self-reports revealed that those assigned to the interactive video were significantly more likely to be abstinent in the first 3 months following initial exposure to the intervention , and experienced fewer condom failures in the following 3 months , compared to controls . Six months after enrollment , participants in the video condition were significantly less likely to report having been diagnosed with an STD . A non-significant trend in data from a clinical PCR assay of Chlamydia trachomatis was consistent with that finding The Integrative Model of Behavioral Prediction ( IM ) provides guidelines for the development of successful HIV/STD interventions , yet few HIV prevention programs have identified which components of the IM have been associated with successful behavioral outcomes . Using structural equation modeling , this study examines in detail how components of the IM assessed prior to , and immediately after , the delivery of an intervention are associated with reported condom use 3 months later among participants in Project RESPECT , a multisite r and omized controlled trial testing HIV/STD risk reduction strategies among clients attending public health clinics for sexually transmitted diseases . Overall , the IM predicted condom use at 3 months ; there were , however , variations in the relative contribution of differing IM components as a function of gender and type of sexual partner as well as the type of intervention the participant had received The National Institute of Mental Health Multisite HIV Prevention Trial was a trial of an intervention to reduce sexual HIV risk behaviors among 3,706 low-income at-risk men and women at 7 U.S. research sites . The intervention , based on social-cognitive theory and design ed to influence behavior change by improving expected outcomes of condom use and increasing knowledge , skills , and self-efficacy to execute safer sex behaviors , was effective relative to a control condition in reducing sexual risk behavior . At 3 months after completion of the intervention , measures of these potential mediators were higher in the intervention than in the control condition . Although the effect of the intervention on sexual risk behavior was significantly reduced when the variables were controlled statistically , supporting the hypothesis of their mediation of the intervention effect , most of the effect remained unexplained , indicating the influence of unmeasured factors on outcome In battling HIV , many interventionists advocate the use of hierarchical messages that present multiple prevention options in order of decreasing effectiveness . The purpose of the present study was to determine if hierarchical messages provide women with additional prevention options without reducing the perceived efficacy of and willingness to use the primary method mentioned ( in this case , male condoms ) . African American and Mexican American women between 18 and 32 years of age ( n=112 ) at risk for HIV were r and omly assigned to receive either a male-condom-only message ( use male condoms ) or a hierarchical message ( use male condoms ; if not , use female condoms ; if not , use spermicide ) . Compared with women in the male-condom-only condition , a significantly smaller percentage of women who received the hierarchical message perceived male condoms as highly effective against HIV . Women currently not using male condoms who received the hierarchical , rather than the male-condom-only , message were less likely to consider using male condoms in the future . Among current male condom users , however , the hierarchical message did not influence intent to use male condoms . These data point to the need for examining both the intended and unintended effects of hierarchical health care messages CONTEXT Whereas the female condom has been evaluated in many hypothetical acceptability or short-term use studies , there is little information about its suitability for the prevention of sexually transmitted diseases ( STDs ) or HIV over extended periods of time . METHODOLOGY As part of a six-month prospect i ve follow-up study of 1,159 STD clinic patients , clients were interviewed during their initial visit , exposed to a behavioral intervention promoting condoms , given a physical examination and provided with instructions on completing a sexual diary . Potential predictors of trying the female condom were evaluated using logistic regression , and three condom-use groups ( exclusive users of female condoms , exclusive users of male condoms and users of both types of condoms ) were compared using multinomial regression . RESULTS Among 895 women who reported having engaged in vaginal intercourse during the study period , one-half had sex with only one partner , while one-quarter each had two partners or three or more partners . A total of 731 women reported using the female condom at least once during the follow-up period--85 % during the first month of follow-up . Multiple logistic regression analyses indicated that employed women and those with a regular sexual partner at baseline were significantly more likely to try the female condom . By the end of the follow-up period , 8 % of participants had used the female condom exclusively , 15 % had used the male condom exclusively , 73 % had used both types of condom and 3 % had used no condoms . Twenty percent of women who tried the female condom used it only once and 13 % used it twice , while 20 % used 5 - 9 female condoms and 32 % used 10 or more . Consistent condom users ( N=309 ) were predominantly users of both types of condom ( 75 % ) , and were less often exclusive users of the male condom ( 18 % ) or the female condom ( 7 % ) . According to a multivariate analysis , women who used the female condom exclusively or who mixed condom types were more likely to be black , were more likely to be employed and were more likely to have a regular partner than were users of the male condom . CONCLUSIONS Women at risk of STDs find the female condom acceptable and will try it , and some use it consistently . Mixing use of female condoms and male condoms may facilitate consistent condom use . The female condom may improve an individual 's options for risk reduction and help reduce the spread of STDs The research ers sought to explore and describe the demographic , cognitive , psychosocial , and behavioral factors associated with the continued risky behavior of a convenience sample of homeless and drug-addicted women two to four weeks after they had completed an AIDS education program . The sample included 942 crack users and 767 women who had multiple sex partners . Analyses revealed that impoverished women who maintained multiple sexual partners were less likely to be in drug recovery programs than in homeless shelters . They were more likely to share needles and be involved sexually with male injection drug users compared with impoverished women who did not maintain multiple sexual partners . Persistent crack users were older than those who reported cessation of crack use , were more often African American , and were more likely to have sex partners who were injecting drug users . Women who demonstrated less improvement in depression and distress scores , concerns , use of affective coping , appraisal of threat , and social support were more likely to maintain crack use and multiple partners . The study 's implication s for the design of intervention programs aim ed at risk reduction based on ethnicity are discussed BACKGROUND Improvement of sex education in schools is a key part of the UK government 's strategy to reduce teenage pregnancy in Engl and . We examined the effectiveness of one form of peer-led sex education in a school-based r and omised trial of over 8000 pupils . METHODS 29 schools were r and omised to either peer-led sex education ( intervention ) or to continue their usual teacher-led sex education ( control ) . In intervention schools , peer educators aged 16 - 17 years delivered three sessions of sex education to 13 - 14 year-old pupils from the same schools . Primary outcome was unprotected ( without condom ) first heterosexual intercourse by age 16 years . Analysis was by intention to treat . FINDINGS By age 16 years , significantly fewer girls reported intercourse in the peer-led arm than in the control arm , but proportions were similar for boys . The proportions of pupils reporting unprotected first sex did not differ for girls ( 8.4 % intervention vs 8.3 % control ) or for boys ( 6.2 % vs 4.7 % ) . Stratified estimates of the difference between arms were -0.4 % ( 95 % CI -3.7 % to 2.8 % , p=0.79 ) for girls and -1.4 % ( -4.4 % to 1.6 % , p=0.36 ) for boys . At follow-up ( mean age 16.0 years [ SD 0.32 ] ) , girls in the intervention arm reported fewer unintended pregnancies , although the difference was borderline ( 2.3 % vs 3.3 % , p=0.07 ) . Girls and boys were more satisfied with peer-led than teacher-led sex education , but 57 % of girls and 32 % of boys wanted sex education in single-sex groups . INTERPRETATION Peer-led sex education was effective in some ways , but broader strategies are needed to improve young people 's sexual health . The role of single-sex sessions should be investigated further Objective . The authors used data from a larger study to evaluate the long-term effects of a peer advocate intervention on condom and contraceptive use among HIV-infected women and women at high risk for HIV infection . Methods . HIV-infected women in one study and women at high risk for HIV infection in a second study were selected from the Women and Infants Demonstration Project and assigned to a st and ard or an enhanced HIV prevention treatment group . The enhanced intervention included support groups and one-on-one contacts with peer advocates tailored to clients ' needs . The authors interviewed women at baseline and at 6- , 12- and 18-months , and measured changes in consistency of condom and contraceptive use and in self-efficacy and perceived advantages and disadvantages of condom and contraceptive use . Results . Of HIV-infected women , the enhanced group had improved consistency in condom use , increased perceived advantages of condom use , and increased level of self-efficacy compared with the st and ard group . Of women at risk , the enhanced intervention group at six months maintained consistent condom use with a main partner and perceived more benefit of condom use compared with the st and ard group . These differences diminished at 12 months . Conclusions . The enhanced intervention was generally effective in the HIV+ study . In the at-risk study , however , intervention effects were minimal and short-lived . Factors related to the theory , intervention design , and sample characteristics help explain these differences BACKGROUND Prostitution is the most important source of transmission of AIDS and sexually transmitted diseases in Asia . We developed and evaluated the sustainability of an intervention to increase condom use and reduce gonorrhea among brothel-based sex workers in Singapore . The intervention focused on developing sex workers ' negotiation skills , educating clients , and mobilizing support from peers and health staff in promoting condom use . METHODS A pretest-posttest design with one intervention site ( n = 124 ) and another comparable control site ( n = 122 ) was maintained for 5 months followed by a time series design to follow up the intervention group for 2 years . RESULTS At 5 months , the intervention group improved significantly in negotiation skills and were almost twice as likely as controls to always refuse unprotected sex ( adjusted rate ratio 1.90 , 95 % CI 1.22 - 2.94 ) . Gonorrhea incidence declined considerably by 77.1 % in the intervention group compared with 37.6 % in the controls . Consistent refusals of unprotected sex in the intervention group increased from 44.4 % at baseline to 65.2 % at 5 months , 73.6 % at 1 year , and 90.5 % at 2 years with a corresponding decline in gonorrhea . CONCLUSION Sustained condom use with a corresponding decline in gonorrhea was achieved by a behavioral and environmental intervention for sex workers The purpose of this study was to develop and pilot-test an interactive CD-ROM aim ed at the prevention of sexually transmitted infections ( STIs ) in female adolescents . The CD-ROM includes prevention information , models skills for negotiating abstinence and consistent condom use , teaches media literacy , and allows the user to choose a culturally appropriate host to guide them through the CD-ROM . Forty-seven female adolescents attending a health department clinic were r and omized to receive the CD-ROM plus an educator-led didactic session versus the didactic session alone . The CD-ROM was highly acceptable and feasible for use among female adolescents in the clinic setting . Hispanic and African American adolescents were more likely to choose hosts of the same race/ethnicity to guide them through the CD-ROM . HIV/STI knowledge increased significantly and nearly all adolescents intended to use condoms at next intercourse after viewing the CD-ROM . However , there were no significant differences measured between CD-ROM and comparison groups BACKGROUND The aim of this interim analysis of a large , international phase III study was to assess the efficacy of an AS04 adjuvanted L1 virus-like-particle prophylactic c and i date vaccine against infection with human papillomavirus ( HPV ) types 16 and 18 in young women . METHODS 18,644 women aged 15 - 25 years were r and omly assigned to receive either HPV16/18 vaccine ( n=9319 ) or hepatitis A vaccine ( n=9325 ) at 0 , 1 , and 6 months . Of these women , 88 were excluded because of high- grade cytology and 31 for missing cytology results . Thus , 9258 women received the HPV16/18 vaccine and 9267 received the control vaccine in the total vaccinated cohort for efficacy , which included women who had prevalent oncogenic HPV infections , often with several HPV types , as well as low- grade cytological abnormalities at study entry and who received at least one vaccine dose . We assessed cervical cytology and subsequent biopsy for 14 oncogenic HPV types by PCR . The primary endpoint -- vaccine efficacy against cervical intraepithelial neoplasia ( CIN ) 2 + associated with HPV16 or HPV18 - -was assessed in women who were seronegative and DNA negative for the corresponding vaccine type at baseline ( month 0 ) and allowed inclusion of lesions with several oncogenic HPV types . This interim event-defined analysis was triggered when at least 23 cases of CIN2 + with HPV16 or HPV18 DNA in the lesion were detected in the total vaccinated cohort for efficacy . Analyses were done on a modified intention-to-treat basis . This trial is registered with the US National Institutes of Health clinical trial registry , number NCT00122681 . FINDINGS Mean length of follow-up for women in the primary analysis for efficacy at the time of the interim analysis was 14.8 ( SD 4.9 ) months . Two cases of CIN2 + associated with HPV16 or HPV18 DNA were seen in the HPV16/18 vaccine group ; 21 were recorded in the control group . Of the 23 cases , 14 ( two in the HPV16/18 vaccine group , 12 in the control group ) contained several oncogenic HPV types . Vaccine efficacy against CIN2 + containing HPV16/18 DNA was 90.4 % ( 97.9 % CI 53.4 - 99.3 ; p<0.0001 ) . No clinical ly meaningful differences were noted in safety outcomes between the study groups . INTERPRETATION The adjuvanted HPV16/18 vaccine showed prophylactic efficacy against CIN2 + associated with HPV16 or HPV18 and thus could be used for cervical cancer prevention This pilot study evaluated whether brief safer sex interventions for women partners of male injection drug users significantly influenced perceptions of partner risk , human immunodeficiency virus ( HIV ) knowledge , correct condom usage , and self-reported consistent safer sex ( abstinence or 100 % of vaginal-penile intercourse acts protected by male or female condoms ) . The study also examined the impact of pretest assessment on those variables since pretest assessment may challenge participants ' current knowledge , safer sex practice s , and partner communication techniques . The study r and omly assigned participants to pretest or no pretest assessment . Each group was also assigned r and omly to a presentation modality : ( 1 ) safer sex pamphlet review only , ( 2 ) pamphlet review with demonstration of several safer sex alternatives , or ( 3 ) pamphlet review with skills practice to mastery with one safer sex alternative of the woman 's choice . For the last two conditions , a 35-minute interactive session covered prevention efficacy of safer sex methods for HIV , sexually transmitted infections , pregnancy , correct use , eroticization , local cost and availability , and partner objections . At 7 weeks postintervention , a higher proportion of women who took pretest assessment reported consistent safer sex ( 66.7 % ) compared to those without pretests ( 55.6 % ) . Assignment to the interactive interventions ( skills or demonstration ) had little additional impact over pretest assessment for these women . Among women who did not take pretests , the interactive interventions had strong effects ; 76.9 % reported consistent safer sex versus 33.3 % in the pamphlet review group . There were additional specific effects for pretest assessment on HIV knowledge and partner risk perception and for interactive intervention on correct condom usage . Brief interventions appear to have some positive short-term effects . Pretest assessment may be an important component of brief interventions Background HIV infection has increased within the Latina community more than in any other ethnic or racial group within the United States . Latinas comprise only 13 % of the U.S. population , yet they account for 20 % of the cumulative reported cases of AIDS . Objectives The purpose of the study was to evaluate a r and omized culturally tailored intervention to prevent high-HIV-risk sexual behaviors for Latina women residing in urban areas . Methods Mexican and Puerto Rican women ( 18–44 years of age ; N = 657 ) who were sexually active during the previous 3 months were recruited and r and omized into intervention and control groups . The intervention , facilitated by bilingual , bicultural , trained Latina women , consisted of culturally tailored sessions on underst and ing their bodies , HIV/AIDS and sexually transmitted diseases , condoms ( myths and use ) , negotiating safer sex practice s , violence prevention , and partner communication . Bivariate and multivariate analyses assessed changes from baseline . Results The intervention improved HIV knowledge , partner communication , risk-reduction behavioral intentions , and condom use , and decreased perceived barriers to condom use . Discussion The efficacy of a culturally-sensitive intervention to reduce HIV/AIDS-risk behaviors in Latina women was demonstrated in the current study As part of the evaluation of a community-level HIV prevention program for women , this study examined predictors of exposure to print media and community outreach and assessed the relationship between exposure to the intervention and condom use behavior . Data from interviews with 479 women r and omly selected from the intervention community in 1995 and 1996 were examined . Analysis of demographic and risk characteristics were conducted to identify predictors of exposure to the project 's HIV prevention messages . Additionally , logistic regression analyses were conducted to examine the effects of intervention exposure on condom use , controlling for factors related to exposure . The results revealed that the print media campaign reached the largest number of women . However , women at highest risk did not have high rates of exposure to print media , but had greater exposure to outreach . Exposure to print media had an effect on increased communication with a main partner about condom use , but was not significantly related to condom use last time had sex . There were no significant main effects for exposure to outreach on condom use behavior . An important finding of this analysis was that each intervention strategy was successful in reaching a different portion of the target population and that exposure had differential effects on the condom use behavior of particular segments of the target population Objective . To ascertain any changes in sexual behavior and attitudes as an indication of the impact of intensified information activities aim ing at decreasing the risk of spread of sexually transmitted diseases among university students In this sexually transmitted infection ( STI ) prevention study , we compared the efficacy of the Well Woman Program ( WWP ) , a nurse practitioner-directed , culturally specific , intensive intervention , to minimal intervention ( MI ) , brief lecture , and referral to usual care , in a community-based r and omized controlled trial . African American women having past STIs and residing in high-risk communities were r and omly assigned to the two groups . STI outcome was measured at baseline and three later points . A r and om effects logistic longitudinal regression model showed that , at baseline , approximately 75 % of participants tested positive for an STI , predominantly trichomoniasis . At month 15 , the estimated probability of a WWP participant having an STI was 20 % less than an MI participant . Better STI outcomes were due to the intensive individualized intervention OBJECTIVES This study compares 3- and 6-month outcomes of a woman-focused HIV intervention for crack abusers , a revised National Institute on Drug Abuse st and ard intervention , and a control group . METHODS Out-of-drug-treatment African American women ( n = 620 ) who use crack participated in a r and omized field experiment . Risk behavior , employment , and housing status were assessed with linear and logistic regression . RESULTS All groups significantly reduced crack use and high-risk sex at each follow-up , but only woman-focused intervention participants consistently improved employment and housing status . Compared with control subjects at 6 months , woman-focused intervention participants were least likely to engage in unprotected sex ; revised st and ard intervention women reported greatest reductions in crack use . CONCLUSIONS A woman-focused intervention can successfully reduce risk and facilitate employment and housing and may effectively reduce the frequency of unprotected sex in the longer term OBJECTIVES We sought to determine whether an HIV prevention program bundled with group prenatal care reduced sexually transmitted infection ( STI ) incidence , repeat pregnancy , sexual risk behavior , and psychosocial risks . METHODS We conducted a r and omized controlled trial at 2 prenatal clinics . We assigned pregnant women aged 14 to 25 years ( N = 1047 ) to individual care , attention-matched group care , and group care with an integrated HIV component . We conducted structured interviews at baseline ( second trimester ) , third trimester , and 6 and 12 months postpartum . RESULTS Mean age of participants was 20.4 years ; 80 % were African American . According to intent-to-treat analyses , women assigned to the HIV-prevention group intervention were significantly less likely to have repeat pregnancy at 6 months postpartum than individual-care and attention-matched controls ; they demonstrated increased condom use and decreased unprotected sexual intercourse compared with individual-care and attention-matched controls . Subanalyses showed that being in the HIV-prevention group reduced STI incidence among the subgroup of adolescents . CONCLUSION HIV prevention integrated with prenatal care result ed in reduced biological , behavioral , and psychosocial risks for HIV Few studies have addressed recruitment and retention of participants in preventive interventions directed at human immunodeficiency virus ( HIV ) , and these generally have not focused on women . In this study , part of the Women in Group Support ( WINGS ) project , we examine the experience of three sites in recruiting 444 high-risk women for a small group intervention to reduce risky sexual behavior . The intervention included six structured sessions , followed by a continuing series of client-focused , drop-in sessions . Incentives for participants included child care , food , and transportation tokens . Attendees at each structured session also received a cash incentive of $ 10-$20 . Forty-six percent of the women were recruited from community sources , 35 % from clinics , and 19 % from drug programs . Across all recruitment sources , almost a third of the women reported having had a sexually transmitted disease ( STD ) in the past year , 88%-94 % reported a risky male partner ( who , they believed , had sex with other partners or with sex workers , was an injecting drug user , or was HIV positive ) , and 10%-36 % reported trading sex for money or drugs . During 18 months of recruitment , each site averaged 34 screening interviews monthly to secure 8 eligible women a month who completed baseline interviews and reported for r and omization . The average number of paid sessions attended by participants was five of six ( 83 % ) . Average attendance at unpaid sessions was 1 of 12 ( 8 % ) . Key facilitators to recruitment and retention included linkages with community agencies and monetary incentives . Our findings suggest that research ers and community service providers need to explore alternative strategies to paying women for attending group sessions ( e.g. , incorporating group interventions into existing program requirements ) and balance these against the costs and recruitment effectiveness BACKGROUND In October 1999 , we began to measure the effect of a single round of screening by testing for human papillomavirus ( HPV ) , cytologic testing , or visual inspection of the cervix with acetic acid ( VIA ) on the incidence of cervical cancer and the associated rates of death in the Osmanabad district in India . METHODS In this cluster-r and omized trial , 52 clusters of villages , with a total of 131,746 healthy women between the ages of 30 and 59 years , were r and omly assigned to four groups of 13 clusters each . The groups were r and omly assigned to undergo screening by HPV testing ( 34,126 women ) , cytologic testing ( 32,058 ) , or VIA ( 34,074 ) or to receive st and ard care ( 31,488 , control group ) . Women who had positive results on screening underwent colposcopy and directed biopsies , and those with cervical precancerous lesions or cancer received appropriate treatment . RESULTS In the HPV-testing group , cervical cancer was diagnosed in 127 subjects ( of whom 39 had stage II or higher ) , as compared with 118 subjects ( of whom 82 had advanced disease ) in the control group ( hazard ratio for the detection of advanced cancer in the HPV-testing group , 0.47 ; 95 % confidence interval [ CI ] , 0.32 to 0.69 ) . There were 34 deaths from cancer in the HPV-testing group , as compared with 64 in the control group ( hazard ratio , 0.52 ; 95 % CI , 0.33 to 0.83 ) . No significant reductions in the numbers of advanced cancers or deaths were observed in the cytologic-testing group or in the VIA group , as compared with the control group . Mild adverse events were reported in 0.1 % of screened women . CONCLUSIONS In a low-re source setting , a single round of HPV testing was associated with a significant reduction in the numbers of advanced cervical cancers and deaths from cervical cancer This study assessed the short- and long-term effect of a gender-specific group intervention for women on unsafe sexual encounters and strategies for protection against HIV/STD infection . Family planning clients ( N = 360 ) from a high HIV seroprevalence area in New York City were r and omized to an eight-session , a four-session or a control condition and followed at one , six and 12 months post-intervention . Using an intention-to-treat analysis , women who were assigned to the eight-session group had about twice the odds of reporting decreased or no unprotected vaginal and anal intercourse compared to controls at one month ( OR = 1.93 , 95 % confidence interval [ CI ] = 1.07 , 3.48 , p = 0.03 ) and at 12-month follow-up ( OR = 1.65 , 95 % CI = 0.94 , 2.90 , p = 0.08 ) . Relative to controls , women assigned to the eight-session condition reported during the previous month approximately three- and -a-half ( p = 0.09 ) and five ( p < 0.01 ) fewer unprotected sex occasions at one- and 12-month follow-up , respectively . Women in the eight-session group also reduced the number of sex occasions at both follow-ups , and had a greater odds of first time use of an alternative protective strategy ( refusal , outercourse , mutual testing ) at one-month follow-up . Results for the four-session group were in the expected direction but overall were inconclusive . Thus , gender-specific interventions of sufficient intensity can promote short- and long-term sexual risk reduction among women in a family planning setting OBJECTIVES The main purpose of this study is to compare sexually transmitted disease ( STD ) prevalence in cohorts of women with and without access to female condoms . METHODS Six matched pairs of communities were identified from Kenya tea , coffee and flower plantations . One community within each pair was r and omly selected to receive the female condom intervention . Approximately 160 eligible women were enrolled at each site . Female condom communities underwent an education program on use of female and male condoms and STDs , comprising group meetings , puppetry and other folk media , and training of clinic service providers and community outreach workers . Control communities received similar information on use of male condoms ( freely available at all sites ) . At baseline , participants were tested for cervical gonorrhea and chlamydia and vaginal trichomoniasis , to be repeated at 6 and 12 months . The study has 80 % power to detect a 10 % prevalence difference , assuming an aggregate STD prevalence of 20 % with 25 % loss to follow-up and intracluster correlation of 0.03 . RESULTS Among 1929 women at baseline , the mean age was 33.1 years ; 78 % had never used a male condom . The prevalences of gonorrhea , chlamydia and trichomoniasis were 2.6 % , 3 . 2 % and 20.4 % , respectively ( 23.9 % overall ) . The intracluster correlation based on these data was near zero . CONCLUSIONS Comparable pairs of study sites have been selected . STD prevalence is sufficiently high , and the variation between sites is acceptably low . The study is feasible as design ed PURPOSE To measure the relative impact of a school-based human immunodeficiency virus (HIV)- , sexually transmitted disease (STD)- , and pregnancy-prevention intervention on sexual risk-taking behaviors of different subgroups of students . METHODS Twenty schools were r and omly assigned to receive Safer Choices or a st and ard knowledge-based HIV-education program . Safer Choices was design ed to reduce unprotected sex by delaying initiation of sex , reducing its frequency , or increasing condom use . Its five components included : school organization , an intensive curriculum with staff development , peer re sources and school environment , parent education , and school-community linkages . A total of 3869 9th- grade students were tracked for 31 months . Results are presented for initiation of sex , frequency of unprotected sex , number of unprotected sexual partners , condom use , and contraceptive use . These results are presented separately by gender , race/ethnicity , prior sexual experience , and prior sexual risk-taking . Statistical analyses included multilevel , repeated measures logistic and Poisson regression models . RESULTS Safer Choices had one or more positive behavioral effects on all subgroups . On four outcomes that could be affected by condom use , it had a greater impact on males than on females . It had greater effects on Hispanics , including a delay in sexual activity , than on other racial/ethnic groups . Its greatest overall effect was an increase in condom use among students who had engaged in unprotected sex before the intervention . CONCLUSIONS Safer Choices reduced one or more measures of sexual risk taking over 31 months among all groups of youth , and was especially effective with males , Hispanics , and youth who engaged in unprotected sex and thus were at higher risk for HIV , other STD infections and pregnancy African American adolescent females continue to be at disproportionate high risk for HIV infection . A repeated measures quasi-experimental comparison group design compared an HIV risk-reduction intervention delivered by mothers with an HIV risk-reduction intervention delivered by health professionals and with a health promotion intervention delivered by mothers . The three interventions were r and omly assigned to one of three geographical distinct sites . A convenience sample of 553 low-income African American adolescent girls with a baseline age of 11 to 14 years participated in the study . The results revealed that over a 6-month period , compared to girls in the health promotion intervention , the girls in the HIV risk-reduction interventions had significant higher scores on HIV transmission knowledge , condom attitudes , and self-efficacy to use condoms . The implication is mothers who receive appropriate training may be able to deliver HIV risk reduction to their daughters as well as health professionals A pre-posttest , r and omized pilot study evaluated the effect of two selective prevention interventions on knowledge , attitudes , intentions , and behaviors to prevent and /or reduce substance use and risky sexual behaviors among 50 predominantly Mexican-American , low-income young women . Women were r and omly assigned to either a risk and resilience workshop or a health information correspondence course . Comparison tests using t tests and chi-square analyses were conducted to determine the baseline equivalence and pre- and posttest effects of the interventions . Both interventions had consistently similar effects . Neither significantly decreased use of alcohol or cigarettes . Both interventions significantly improved attitude , sexual self-efficacy , and resilience scores . Contraceptive use increased among women in partnered relationships , and both condom use and contraceptive use increased among sexually active , single young women . Both interventions also had significant positive effects on reported ability to discuss pre caution s to prevent human immunodeficiency virus/acquired immunodeficiency syndrome with sexual partners . Study limitations and implication s for clinical practice and future research are provided A community-based sample of disadvantaged African American women ( n = 445 ) was recruited to participate in 1 of 3 theoretically driven experimental interventions based on either the theory of gender and power , social learning theory , or cognitive behavioral theory . Intervention outcomes were compared with a waiting list control condition . From baseline to postintervention , women in the experimental interventions showed differential change on cognitive indices ( knowledge and attitudes ) and skill acquisition ( partner negotiation skills , correct condom application , lubricant selection , and information-provision to social networks ) whereas control participants were unchanged . Women in the 3 experimental interventions also completed follow-up assessment s for 1 year following the interventions . In all 3 experimental conditions , condom use increased relative to the control group and there were no differences between the experimental interventions . Women who participated in one of the theoretically grounded interventions continued to increase condom use over the following year . Women entering new relationships reported significantly more condom use than did women who remained in ongoing relationships . The findings suggest that intervention models that have proven effective for women who engage in high-risk behavior may be less effective for women in established relationships for whom risk is primarily derived from the extrarelationship behavior of their partners A three-year longitudinal intervention study was implemented to reduce high-risk drug and sexual behaviors in methadone-dependent African American women . Participants were recruited from four inner-city methadone maintenance programs and r and omly assigned either to an eight-week peer counseling and leadership training group or to a control group . The 107 trainees and 97 controls completed pretests and posttests at two , four , and seven months . This paper focuses on final data related to the subjects ' sexual beliefs , attitudes , knowledge , and behaviors that put them at risk for HIV/AIDS . Reasons for not using condoms are categorized and discussed . Despite the women 's awareness of the seriousness of AIDS , perceived powerlessness to negotiate condom use , negative attitudes about the use of condoms , influence of drugs , and unavailablility of condoms interfered with safer sex practice s. The inability of education alone to prevent many high-risk sexual behaviors suggests that more serious consideration be given to exp and ed distribution of condoms as well as needle exchange programs and legalization of illicit drugs Although most women infected with HIV are intravenous drug users , some contact the virus through sexual contact with IV drug users . To reach at-risk women , public health officials must develop a range of prevention strategies . One approach , skills training , holds promise as a means of altering risk-related sexual behavior . In this study , 91 women methadone patients were pretested and r and omly assigned to an information-only control control group or a skills-building intervention group . Skills-building intervention consisted of five sessions of small groups in which participants identified their own high risk sexual behaviors , discussed their negative associations with condoms , and practice d skills which involved asking partners to use condoms . Compared with members of the control group , respondents in the intervention group reported that they initiated discussion of sexual issues with their partners more frequently , felt more comfortable talking with them about safer sex , and reported using and carrying condoms more frequently . The high rates of attendance and program retention by skills-building participants suggest that such groups may be supportive and useful in the design of risk reduction and drug abuse treatment programs . The modest outcomes of this study underscore the difficulty of altering risk behavior but also serve as a basis for future AIDS prevention studies ABSTRACT This study prospect ively evaluates the effect of child-bearing motivation and contraceptive attitudes on consistency of condom use among at-risk women enrolled in an HIV prevention intervention . Women ( age 15–40 , 85 % African-American ) were recruited from homeless shelters , drug treatment facilities , and public housing developments and assigned to st and ard or enhanced intervention conditions . Among the eligible study group of nonsterilized women with a main partner ( n = 312 ) , 24.4 % wanted to have a baby at baseline ; 43.5 % believed their partner wanted them to have a baby . Women who reported a desire for a baby , compared to all others , were less likely to be at a higher level of condom consistency six months later ( OR = 0.66 ; .48–.90 ) . Women who perceived partner support for contraceptive use showed a higher level of condom consistency ( OR = 1.20 ; 1.03–1.41 ) at 6-month follow-up . Many women in this study wanted to have a baby and this desire interfered with subsequent consistency of condom use . We also found that condom use increased toward consistency of use among women whose partner supported contraceptive use . HIV prevention interventions should include screening for reproductive motivation , so that prevention messages can be tailored to the realities of women 's lives . Women who want a baby can be educated about disease prevention in the context of pregnancy planning and linked with appropriate services . Women who want to avoid childbearing can be given messages that emphasize the contraceptive benefits of condom use and that help strengthen partner support The purpose of this study was to test the effectiveness of an AIDS education intervention for methadone-dependent , African American women . The women were r and omly assigned to experimental ( n=107 ) or control ( n=97 ) group . The experimental group participated in a peer counseling and leadership training program conducted by two experienced nurse counselors over an 8-week period , followed by 8 weeks of reinforcement . The program was design ed to reduce AIDS high-risk sexual behavior , increase self-esteem , decrease depressive affect , and increase the women 's community-based AIDS prevention communication activities . A total of 130 women completed all phases of the study , including longitudinal Posttests at 2 , 4 , and 7 months after enrollment . Compared to the control group , there were statistically significant differences in three of the outcomes for the experimental group : The experimental group reported an increased number of safer sexual behaviors ( p=.029 ) , showed decreases in depression ( p=.001 ) , and reported engaging in more AIDS-related , community-based communication activities regarding prevention ( p=.005 ) Many over-the-counter microbicidal contraceptive methods reduce the risk of acquiring sexually transmitted diseases . This pilot project compared the use of female controlled barrier methods in an extremely high-risk population of low-income drug abusing women following an intervention design ed to promote HIV risk reduction and barrier use . An HIV transmission risk reduction interactive intervention emphasizing self-esteem , assertiveness and sexual negotiation was offered to 41 drug dependent women . Participants were r and omly assigned to one of two conditions , a male and female condom condition or a male and female condom plus N-9 products ( vaginal suppositories , film , gel ) condition . Results from the three-month follow-up period suggest that there may be a synergistic effect of availability of multiple protective methods on the overall rate of protective behaviours . The use of the male condom for penile/vaginal sex increased from 19 % at study entry to 27 % during the three-month follow-up period . The total protected sexual episode rate , calculated to include use of the other protective barriers distributed , was 60 % . Thus , the condom use rate was not found to decrease because of the availability of alternative methods of protection . Future research should address the use of microbicidal products to empower women to prevent STD/HIV transmission Objectives . This study evaluated the long-term effectiveness of Safer Choices , a theory-based , multi-component educational program design ed to reduce sexual risk behaviors and increase protective behaviors in preventing HIV , other STDs , and pregnancy among high school students . Methods . The study used a r and omized controlled trial involving 20 high schools in California and Texas . A cohort of 3869 ninth- grade students was tracked for 31 months from fall semester 1993 ( baseline ) to spring semester 1996 ( 31-month follow-up ) . Data were collected using self-report surveys administered by trained data collectors . Response rate at 31-month follow-up was 79 % . Results . Safer Choices had its greatest effect on measures involving condom use . The program reduced the frequency of intercourse without a condom during the three months prior to the survey , reduced the number of sexual partners with whom students had intercourse without a condom , and increased use of condoms and other protection against pregnancy at last intercourse . Safer Choices also improved 7 of 13 psychosocial variables , many related to condom use , but did not have a significant effect upon rates of sexual initiation . Conclusions . The Safer Choices program was effective in reducing important risk behaviors for HIV , other STDs , and pregnancy and in enhancing most psychosocial determinants of such behavior The purpose s of this pilot study were ( a ) to assess the feasibility of a community-based , small group HIV risk reduction intervention with adolescent girls , and ( b ) to obtain preliminary evidence of the efficacy of this theoretically-guided intervention using a controlled design . The feasibility of the intervention was demonstrated by successfully implementing it with 33 sexually-active , single girls . Preliminary evidence of the efficacy of the intervention was obtained using a r and omized trial with 62 sexually-active , single girls . Data obtained at a 3-month follow-up assessment showed that girls who received the HIV-related intervention improved their HIV-related knowledge and enhanced their motivation for risk reduction compared to girls who received a control ( health promotion ) intervention . Effect sizes suggest that the HIV intervention also reduced several risk behaviors ( e.g. , vaginal sex without a condom , giving oral sex , and alcohol and drug use before sex ) . Challenges to implementation and suggestions for intervention enhancement are discussed This research examined the impact of including a supportive person on the outcomes of two culturally sensitive AIDS education programs , an education-only ( traditional ) program and a program combining education with self-esteem and coping enhancement ( specialized ) . Research participants in this quasi-experimental study included 241 homeless women , who were r and omly assigned by residence ( drug treatment program or shelter ) to one of four treatment groups . The outcomes measured at baseline , 6 , and 12 months were risk behaviors , cognitive factors , and psychological functioning . Study results demonstrated significant improvements at both 6 and 12 months for the entire sample in all psychological , behavioral and cognitive outcome variables except active coping . Women in the specialized program improved more on AIDS knowledge and reduction in non-injection drug use than did those in the traditional program , but their active coping scores declined . Participation of a supportive person did not appear to have any effect on outcome Objective To compare the seroincidence of HIV infection among female sex workers in Abidjan , Côte d'Ivoire before and during an intervention study to control sexually transmitted diseases ( STD ) and to study the effect of two STD diagnosis and treatment strategies on the prevalence of STD and on the seroincidence of HIV infection . Method A screening facility for STD and HIV had been available since October 1992 for female sex workers . From June 1994 , women who were HIV seronegative or HIV-2 positive during the screening could enroll in the intervention study in which participants reported once a month to a confidential clinic where they received health education , condoms and STD treatment if indicated . Women in the study were r and omized either to a basic STD diagnosis and treatment strategy , which included a gynecologic examination when symptomatic , or to an intensive strategy that included a gynecologic examination regardless of symptoms . An outcome assessment every 6 months included a gynecologic examination , HIV serology and laboratory tests for STD . Results Of 542 women enrolled in the study , 225 ( 42 % ) had at least one outcome assessment . The HIV-1 seroincidence rate during the intervention study was significantly lower than before the study ( 6.5 versus 16.3 per 100 person-years;P = 0.02 ) . During the study , the HIV-1 seroincidence rate was slightly lower in the intensive than in the basic strategy ( 5.3 versus 7.6 per 100 person-years;P = 0.5 ) . Conclusion National AIDS control programs should consider adopting as policy the type of integrated approach used in this intervention study for HIV prevention in female sex workers OBJECTIVE To assess the effectiveness of a community-based HIV prevention intervention for adolescents in terms of its impact on ( 1 ) HIV and Herpes simplex virus type 2 ( HSV-2 ) incidence and on rates of unintended pregnancy and ( 2 ) reported sexual behaviour , knowledge and attitudes . METHODS Cluster r and omised trial of a multi-component HIV prevention intervention for adolescents based in rural Zimbabwe . Thirty communities were selected and r and omised in 2003 to early or deferred intervention implementation . A baseline bio-behavioural survey was conducted among 6791 secondary school pupils ( 86 % of eligibles ) prior to intervention implementation . RESULTS Baseline prevalences were 0.8 % ( 95 % CI : 0.6 - 1.0 ) for HIV and 0.2 % ( 95 % CI : 0.1 - 0.3 % ) for HSV-2 . Four girls ( 0.12 % ) were pregnant . There was excellent balance between study arms . Orphans who made up 35 % of the cohort were at increased risk of HIV [ age-sex adjusted odds ratio 3.4 ( 95 % CI : 1.7 - 6.5 ) ] . 11.9 % of young men and 2.9 % of young women reported that they were sexually active ( P < 0.001 ) ; however , there were inconsistencies in the sexual behaviour data . Girls were less likely to know about reproductive health issues than boys ( P < 0.001 ) and were less likely to have used and to be able to access condoms ( P < 0.001 ) . CONCLUSION This is one of the first rigorous evaluations of a community-based HIV prevention intervention for young people in southern Africa . The low rates of HIV suggest that the intervention was started before this population became sexually active . Inconsistency and under-reporting of sexual behaviour re-emphasise the importance of using externally vali date d measures of sexual risk reduction in behavioural intervention studies Objective : The objective of this study was to compare 2 interventions promoting condoms and vaginal microbicides to prevent sexually transmitted disease ( STD ) . Study : Women ( N = 427 ) attending an STD clinic were r and omly assigned to 2 clinician-delivered interventions and followed up monthly to assess condom/microbicide use and incidence of gonorrhea , chlamydia , and syphilis . Results : During follow up , condom use rates were 69 % ( enhanced ) and 49 % ( basic ) and microbicide use rates were 44 % and 29 % , respectively . STD rates did not significantly differ between intervention groups . Perfect condom use ( regardless of intervention arm ) was associated with a 3-fold decrease in STD rates ( relative risk [ RR ] , 0.3 ; 95 % confidence interval [ CI ] , 0.1–0.8 ) . Using a vaginal microbicide during ≥50 % of the acts of intercourse was associated with reduced STD rates ( RR , 0.5 ; 95 % CI , 0.3–1.0 ) across intervention groups and condom use categories . Conclusions : The enhanced intervention increased use of condoms and vaginal microbicide ; however , STD rates did not decrease because a protective effect was seen only among perfect barrier users , and the enhanced intervention only modestly increased perfect use Sexually transmitted infection ( STI ) , including AIDS disproportionately affects minority women with a history of physical or sexual abuse . The objective of this study was to evaluate the efficacy of gender- and culture-specific behavioural interventions and interactive STI counselling for high-risk minority women with a history of physical or sexual abuse over two years . African- and Mexican-American women with a non-viral STI were enrolled in a r and omized trial . Follow-up screens and interviews occurred at six months and one and two years . The primary outcome was subsequent infection with chlamydia and /or gonorrhoea . Secondary analysis of primary outcomes was made by self-reported physical or sexual abuse . Logistic regression was utilized on an intention-to-treat basis . Baseline data from 853 women were included ; the retention rate was 91 % . Infection rates were higher in abused women in Year 1 ( 29 % vs. 23.8 % , P=0.12 ) , Year 2 ( 23.4 % vs.17.6 % , P=0.03 ) and cumulatively ( 43.8 % vs. 33.0 % , P=0.003 ) . Unadjusted association between abuse and reinfection was stronger for adolescents ( < 19 years ) than adults in Year 1 ( 42.7 % vs. 30.8 % , P=0.03 ) , Year 2 ( 32.7 % vs. 22.0 % , P=0.03 ) and cumulatively ( 59.4 % vs. 43.3 % , P=0.004 ) . Corresponding rates for adults were Year 1 ( 17.8 % vs. 17.0 % , P=0.84 ) , Year 2 ( 17.4 % vs. 12.7 % , P=0.23 ) and cumulatively ( 30.7 % vs. 22.3 % , P=0.08 ) . Reinfection rates were further stratified by adolescence and substance use . Abused adolescents had consistently higher reinfection than non-abused adolescents and abused adults . In conclusion , risk-reduction interventions decreased infective episodes with chlamydia and /or gonorrhoea in the two-year study period for non-abused women . Abused women , particularly adolescents and substance users , had increased episodes in these study periods A multicomponent intervention to increase condom use in sexually active young women was design ed , implemented , and evaluated in a r and omized experiment . Participants were 198 unmarried female college students ( mean age = 18.6 years ) who received a 1-session condom promotion intervention or a control ( stress management ) intervention . The condom promotion intervention led to increased self-reported condom use up to 6 months following intervention as well as positive changes in perceived benefits of condom use , affective attitudes toward condom use and condom users , perceived acceptance of sexuality , control over the sexual encounter , perceived self-efficacy for condom use , and intentions to use condoms . Mediational analysis illustrated the mechanisms of the condom promotion intervention effects , linking psychological constructs affected by the intervention ( perceived benefits , acceptance of sexuality , control over the sexual encounter , attitudes toward condoms , and self-efficacy for condom use ) to condom use intentions OBJECTIVE This study reports the results of a behavior change intervention offered to women at high risk for human immunodeficiency virus ( HIV ) infection seen in an urban primary health care clinic . METHODS Participants were 197 women r and omly assigned to either an HIV/acquired immunodeficiency syndrome ( AIDS ) risk reduction group or a comparison group . Women in the HIV/AIDS intervention group attended five group sessions focusing on risk education ; skills training in condom use , sexual assertiveness , problem solving , and risk trigger self-management ; and peer support for change efforts . Women in the comparison group attended sessions on health topics unrelated to AIDS . RESULTS At the 3-month follow-up , women in the HIV/AIDS intervention group had increased in sexual communication and negotiation skills . Unprotected sexual intercourse had declined significantly and condom use had increased from 26 % to 56 % of all intercourse occasions . Women in the comparison group showed no change . CONCLUSIONS Socially disadvantaged women can be assisted in reducing their risk of contracting HIV infection . Risk reduction behavior change interventions should be offered routinely in primary health care clinics serving low-income and high-risk patients A prospect i ve cohort study was conducted among chronic injecting and crack cocaine drug using women . The hypothesis tested was that participation in a st and ard-plus-innovative intervention was more likely to produce behavior change than participation in a st and ard intervention . St and ardized intervention protocol s and corresponding instruments were design ed . Data were collected on drug and sex risk behaviors at baseline and six-month follow-up intervals . The level of behavioral change in two intervention arms -- st and ard and a st and ard-plus-innovative intervention -- was measured by composite sex risk and drug risk scores using the generalized estimating equation approach . The results show that on four risk measures the enhanced intervention was significantly associated with positive change in both drug use and sexual behavior : less frequent drug use , less drug use during sex , and more frequent condom use during particular frequencies for specific types of sexual activities . Public health interventions are effective when targeting specific risk behaviors through interventions tailored to prevent HIV and reduce risk behaviors among specific cultural and gender groups The objective of this pilot study was to examine the effectiveness of a postpartum educational intervention aim ed at increasing compliance with oral contraception ( OCs ) and decreasing repeat pregnancies in young , African American women in the year following an unplanned pregnancy . In this longitudinal study , 43 young , pregnant women attending Prentice Ambulatory Care , Northwestern Hospital , were enrolled and 33 were r and omized to receive an antepartum , multicomponent intervention consisting of counseling , a videotape about OCs and written material or resident-physician counseling ( usual care ) . Question naire data were collected at enrollment , immediately following the intervention , at 6 weeks , 6 months and 12 months . At 1 year , 25 women remained in the study . More women in the intervention group were not pregnant and still using contraception , and were able to successfully switch contraceptive methods compared to women in the control group . There was no decrease in repeat pregnancy in the intervention group at 1 year compared to the control group . Our intervention result ed in a sustained increase in knowledge of OCs throughout the study period . However , more is needed to promote postpartum contraceptive compliance and decrease repeat pregnancies in young , low-income African Americans with unintended pregnancies This paper evaluates and contrasts the effectiveness of two culturally sensitive AIDS education programs developed by the UCLA AIDS Nursing Network and delivered to 213 impoverished Latina homeless or drug-addicted women in Los Angeles . The Comprehensive Health Seeking and Coping Paradigm guided the program , which was implemented by specially trained Latina nurses and outreach workers . A quasi-experimental design was employed where women were r and omized by site into Specialized ( N = 82 ) and Traditional ( N = 131 ) programs . Repeated measures ANOVAS and log-linear models were used to evaluate improvement over a two-week period for women in both groups and to identify interactions with program type . Two-week posttest analyses were also conducted to assess program effectiveness , controlling for baseline values of the measure in question , nonequivalency between groups at baseline , and selected demographic characteristics , including acculturation . Results indicated that women in both AIDS education programs improved significantly in cognitive , behavioral , and psychologic outcomes Sustaining effective school-based prevention programs is critical to improving youth and population -based health . This article reports on results from the Aban Aya Sustainability Project , an effort to sustain a school-based prevention program that was tested via a r and omized trial and targeted violence , drug use , and risky sex-related behaviors among a cohort of 5th- grade African American children followed through 10th grade . Sustainability project health educators trained parent educators to deliver the Aban Aya prevention curriculum in five schools , and project research ers studied the result ant curricular implementation and relations between the research and school-based teams . Study results showed uneven implementation across the five schools that we largely attributed to parent educator preparation and parent educator-health educator relations . These and related results are discussed to answer the study 's primary research question : How viable was the sustainability project 's parent-centered approach to sustaining a school-based prevention program This manuscript describes the r and omized clinical trial titled Stage-Matched Intervention to Increase Dual Method Use or Project PROTECT . Project PROTECT compared two approaches to promote the use of dual methods of contraception among high-risk women . The intervention arm received tailored individualized feedback based on the Transtheoretical Model of Behavior Change using a computer-based multimedia program . The control arm received general information on contraception . The primary outcomes of this trial were 1 ) self-reported use of dual methods of contraception and 2 ) the biological outcomes of an unintended pregnancy or an incident or recurrent sexually transmitted disease . In this report , we describe the significance and background of the problem , the specific aims of the study , study organization , patient selection , r and omization , outcome variables , data collection , procedures used for follow-up and testing , primary and secondary outcomes , and statistical analyses . We also describe participant characteristics and procedures used to assure patient safety and trial monitoring OBJECTIVES This study assessed the effectiveness of a sexually transmitted disease (STD)/HIV behavior change intervention in increasing women 's use of the female condom . METHODS A total of 604 women at high risk for STDs and HIV in New York City , Baltimore , Md , and Seattle , Wash , enrolled in a r and omized controlled trial of a small-group , skills-training intervention that included information and skills training in the use of the female condom . RESULTS In a logistic regression , the strongest predictors of use were exposure to the intervention ( odds ratio [ OR ] = 5.5 ; 95 % confidence interval [ CI ] = 2.8 , 10.7 ) , intention to use the female condom in the future ( OR = 4.5 ; 95 % CI = 2.4 , 8.5 ) , having asked a partner to use a condom in the past 30 days ( OR = 2.3 ; 95 % CI = 1.3 , 3.9 ) , and confidence in asking a partner to use a condom ( OR = 1.9 ; 95 % CI = 1.1 , 3.5 ) . CONCLUSIONS Clinicians counseling women in the use of the female condom need to provide information , demonstrate its correct use with their clients , and provide an opportunity for their clients to practice skills themselves Objectives : This study assessed whether participant baseline characteristics modified the effects of a skill-based intervention promoting condom use . Study : The r and omized , controlled trial enrolled 427 women from a sexually transmitted disease clinic in Birmingham , Alabama . The main outcome measures : consistent ( 100 % ) and problem-free ( correct , no breakage or slippage ) condom use were verified by sexual diary self-report and contraceptive product counts . Results : The enhanced intervention group had a 60 % higher consistent condom use rate compared to the basic group ( risk ratio [ RR ] , 1.6 ; 95 % confidence interval [ CI ] , 1.4–1.8 ) . There was no statistically significant difference between groups in relationship to problem-free , consistent use ( RR , 1.0 ; 95 % CI , 0.9–1.1 ) . A binomial regression analysis identified the following factors as significant modifiers of intervention effectiveness on consistent condom use : intention to use condoms next time , early-age sexual debut , marital status combined with place of intercourse , and substance use before sex . Conclusions : The results suggest that participant baseline characteristics can be modifiers of intervention effectiveness A flexible , risk-reduction approach , as compared with a single method approach , may increase sexually transmitted disease (STD)/HIV protection for women attending STD clinics . A brief intervention was tested in an observational study of 292 STD clinic patients in three distinct cohorts . These included subjects counseled on ( 1 ) the " women 's safer sex hierarchy of prevention methods " ( hierarchy cohort , n = 118 ) , including the female condom ( FC ) , male condom ( MC ) , diaphragm , cervical cap , and spermicides , ( 2 ) MC only ( n = 62 ) , or ( 3 ) FC ( n = 112 ) only . We evaluate method use and level of protection achieved at 6-month follow-up among the women in the hierarchy cohort and compare the level of unprotected sex across the three cohorts , using ordinal logistic regression analyses and an imputation procedure to account for attrition . In the hierarchy cohort , the MC , FC , spermicidal film , foam , suppository , and diaphragm were used with main partners by 80%,46 % , 37 % , 28 % , 17 % , and 5 % of women , respectively . Spermicides were used frequently , mainly in conjunction with condoms . As compared with hierarchy subjects , both MC cohort subjects ( OR = 2.3 , p = 0.01 ) and FC cohort subjects ( OR = 1.6 , p = 0.11 ) were more likely to report 100 % unprotected sex . The tendency for subjects to move toward higher levels of protection was observed most strongly in the hierarchy group . Hierarchical-type counseling , compared with single method counseling , leads to increased protection during sex among women at high risk of STD/HIV infection and should be implemented in STD clinics This study evaluated All4You ! , a theoretically based curriculum design ed to reduce sexual risk behaviors associated with HIV , other STDs , and unintended pregnancy among students in alternative schools . The study featured a r and omized controlled trial involving 24 community day schools in northern California . A cohort of 988 students was assessed four times during an 18-month period using a self report question naire . At the 6-month follow-up , the intervention reduced the frequency of intercourse without a condom during the previous 3 months , the frequency of intercourse without a condom with steady partners , and the number of times students reported having intercourse in the previous 3 months . It also increased condom use at last intercourse . These behavioral effects were no longer statistically significant at the 12- and 18-month follow-ups . The All4You ! intervention was effective in reducing selected sexual risk behaviors among students in alternative school setting s ; however , the effects were modest and short term Behavioral change reduces risk of HIV infection and development of AIDS . We compared 206 inner-city women who were r and omly assigned to a 4-session AIDS-prevention group or to one of two controls , a health-promotion group or a no-intervention group . AIDS-prevention and health-promotion groups provided information , behavioral competency training , and social support . Only the AIDS-prevention group focused on AIDS-specific knowledge and skills . The AIDS-prevention group produced moderate , consistent increases in knowledge and safer sex behaviors in comparison with either the health-promotion or no-intervention group . Self-report and objective changes were sustained 6 months after intervention for both African-American and European-American women The goal of this study was to assess the impact of peer education and single-session educational lectures on HIV/AIDS knowledge and attitude change among university students ( n = 157 male , n = 230 female ; mean age = 20 ) on the campuses of two metropolitan state universities in Ankara , Turkey . The students were r and omly selected to participate in peer education ( n = 204 ) , single-session lecture ( n = 74 ) or wait-list control ( n = 109 ) groups . Statistical analyses reveal significant differences in knowledge and attitudes , personal behavior , and awareness of HIV/AIDS . Both the peer education and HIV/AIDS lecture strategies were more effective in eliciting change in student 's knowledge and attitudes than the control condition ( p > .05 ) . Male and female students in both experimental groups showed higher attitude scores compared with all students in the control group OBJECTIVES This study evaluated the long-term effectiveness of Draw the Line/Respect the Line , a theoretically based curriculum design ed to reduce sexual risk behaviors among middle school adolescents . METHODS The r and omized controlled trial involved 19 schools in northern California . A cohort of 2829 sixth grade rs was tracked for 36 months . RESULTS The intervention delayed sexual initiation among boys , but not girls . Boys in the intervention condition also exhibited significantly greater knowledge than control students , perceived fewer peer norms supporting sexual intercourse , had more positive attitudes toward not having sex , had stronger sexual limits , and were less likely to be in situations that could lead to sexual behaviors . Psychosocial effects for girls were limited . CONCLUSIONS The program was effective for boys , but not for girls OBJECTIVE We present baseline sexually transmitted disease ( STD ) prevalence rates from an ongoing intervention trial at Kenyan agricultural sites . METHODS After gaining the cooperation of management , we identified six matched pairs of tea , coffee , and flower plantations and enrolled approximately 160 women at each site . Six intervention sites received an information programme and distributed female and male condoms , while six control sites received male condoms only and similar information about them . At clinic visits , we tested participants for cervical gonorrhoea ( GC ) and Chlamydia trachomatis ( CT ) by ligase chain reaction on urine specimens , and Trichomonas vaginalis ( TV ) by culture . The study has 80 % power to detect a 10 % prevalence difference during follow up , assuming a combined STD prevalence of 20 % , 25 % loss to follow up and intracluster correlation coefficient ( ICC ) of 0.03 . RESULTS Participants at intervention and control sites ( total 1929 ) were similar at baseline . Mean age was 33 years , the majority were married , more than half currently used family planning , 78 % had never used male condoms , and 9 % reported more than one sexual partner in the 3 months before the study . Prevalences of GC , CT , and TV were 2.6 % , 3.2 % , and 20.4 % respectively ( 23.9 % overall ) , and were similar at intervention and control sites . The ICC for STD prevalence was 0.0011 . Baseline STD was associated with unmarried status , non-use of family planning , alcohol use , and more than one recent sexual partner , but the highest odds ratio was 1.5 . CONCLUSIONS Baseline results confirm a high prevalence of trichomoniasis and bacterial STD at these Kenyan rural sites . Improved STD management is urgently needed there . Our ongoing female condom intervention trial is feasible as design ed BACKGROUND Little is known about pregnancy rates among sex workers ( SWs ) or the factors that predispose SWs to this risk . We aim ed to estimate the pregnancy incidence rate among Madagascar SWs participating in an intervention trial promoting use of male and female condoms and assess the influence of various predictive factors on pregnancy risk . METHODS SWs from two study clinics in Madagascar participated in a r and omized trial to assess the effect of peer education and clinic-based counseling on use of male and female condoms and prevalence of sexually transmitted infections ( STIs ) . Women were seen every 2 months for up to 18 months ; they received structured interviews at every visit , and physical exams at baseline and every 6 months thereafter . Site staff recorded information on pregnancies during interviews ; pregnancy data were then merged with trial data for this analysis . RESULTS Of 935 SWs in the analysis population , 250 became pregnant during follow-up . The cumulative probability of pregnancy was 0.149 at 6 months and 0.227 at 12 months . Comparable proportions of nonpregnant and pregnant SWs reported using highly effective contraception at baseline ( approximately 16 % ) ; these users were younger and were more consistent condom users . Method switching and discontinuation were frequent . In multivariate analysis , nonuse of effective contraceptives and any self-reported unprotected sex were associated with higher incidence of pregnancy . Approximately 51 % of women delivered , 13 % reported a spontaneous abortion , 13 % reported an induced abortion and 23 % had missing pregnancy outcomes . CONCLUSIONS Women traditionally targeted for STI/HIV preventive interventions need more comprehensive reproductive health services . In particular , SWs could benefit from targeted family planning counseling and services OBJECTIVES To introduce the female condom ( FC ) among sex workers ( SWs ) in China . METHODS We adopted the intervention study method . The 315 participating SWs were r and omly assigned to an intervention group ( 155 SWs ) or a control group ( 160 SWs ) . RESULTS The rate of SWs who reported liking FC increased from 60.0 % pre-intervention to 93.5 % post-intervention , and the rate of SWs who considered that their clients could accept FC increased from 27.1 % to 92.3 % . After the intervention , 93.5 % expressed that their sexual satisfaction had increased with their familiarity with FC and 97.4 % expressed that they would use it in the future . CONCLUSIONS The underst and ing and use of FC can be greatly improved through active intervention-i.e . medical workers providing SWs with FC Background Project SAFE , a gender- and culture-specific cognitive – behavioral intervention , was one of the few interventions to have demonstrated a significant reduction in sexually transmitted infections in a r and omized , controlled trial . Goal We evaluated intervention efficacy in 379 Mexican Americans and 170 African Americans ; and in a subset of 477 women , explored ethnic differences in the relationships over time between attitudes/beliefs about relationships , reported sexual behavior , and infection . Study Design Women were question ed intensively at baseline , 6 , and 12 months . We used stratified analyses and multivariate regression to evaluate ethnic differences and the role of behavior in explaining ethnic differences in infection . Results African Americans had higher overall infection rates ( 29.0 % vs. 18.3 % ) than Mexican Americans , but the intervention efficacy was similar ( odds ratios , 0.58 and 0.54 , respectively ) . African Americans reported more douching after sex , less mutual monogamy , and more rapid partner turnover . However , Mexican Americans appeared slightly more likely to have sex with an untreated partner , and there was no difference in risky sex . African Americans reported greater difficulty finding partners and reported attitudes more compatible with nonmonogamy . Conclusions Despite substantial ethnic differences in attitudes/beliefs , behaviors , and infection rates , the intervention had a comparable impact on both Mexican Americans and African Americans A component analysis of a behavioral HIV risk reduction intervention was conducted among 87 women recruited from an inner-city community . Women were r and omly assigned to an intervention consisting of ( a ) sexual communication skills training , ( b ) self-management skills training , ( c ) a combination of sexual communication and self-management skills , or ( d ) HIV education and risk sensitization . Results showed that all 4 intervention conditions increased AIDS knowledge and intentions to reduce risk behaviors . Communication skills training result ed in higher rates of risk reduction conversations and risk refusals . However , the combined skills training condition showed the lowest rates of unprotected sexual intercourse at the 3-month follow-up . This study is the first to experimentally control HIV risk reduction elements in an analysis of a skills-based HIV prevention intervention This r and omized clinical trial evaluated an HIV-risk reduction ( HIV-RR ) intervention based on the information-motivation-behavioral skills model . At baseline , 102 women ( M age = 29 years ; 88 % African American ) completed a survey regarding HIV-related knowledge , risk perceptions , behavioral intentions , and risk behavior . Participants were then assigned to either the HIV-RR intervention or a health-promotion control group . Postintervention and follow-up data indicated that women in the HIV-RR program enhanced their knowledge and strengthened their risk reduction intentions relative to controls . Moreover , HIV-RR women who expressed " imperfect " intentions also increased their condom use , talked more with partners about condom use and HIV testing , and were more likely to have refused unprotected sex BACKGROUND Few cognitive-behavioral interventions have focused on preventing sexually transmitted infections ( STIs ) and unintended pregnancies ( UPs ) in young , sexually active women in a single study . Military recruit training provides a well-defined , national , nonclinic sample in which to evaluate such an intervention . METHODS All female Marine recruits ( N=2,288 ) in training were approached . Of these , 2,157 ( 94.3 % ) voluntarily agreed and were r and omly assigned , by platoons , to participate in cognitive-behavioral interventions to prevent STIs or UPs or to prevent physical training injuries and cancer . Participants completed self-administered question naires and were screened for pregnancy , Chlamydia trachomatis , Neisseria gonorrhoeae , and Trichomonas vaginalis at baseline and , on average , 1 and 14 months postintervention . RESULTS A higher proportion of the control group had a postintervention STI or UP [ odds ratio (OR)=1.41 , 95 % confidence interval (CI)=1.01 - 1.98 ] . Among participants who had no history of STIs or pregnancy , but who engaged in risky sexual behaviors just before recruit training , the control group was more likely to acquire a postintervention STI ( OR=3.24 , CI=1.74 - 6.03 ) . Among participants who were not sexually experienced at baseline , the control group was more likely to have casual ( OR=2.05 , 95 % CI=1.04 - 4.08 ) and multiple ( OR=1.87 , 95 % CI=1.01 - 3.47 ) sexual partners postintervention . CONCLUSIONS This r and omized controlled trial indicates that cognitive-behavioral interventions are effective for reducing behavioral risk and preventing STIs and UPs in young , sexually active women who are not seeking health care Introduction Effective public health interventions to reduce the incidence of sexually transmitted disease ( STD ) , including HIV , among women are urgently needed . Methods A r and omized trial among STD clinic patients of two types of counseling regarding methods to reduce disease transmission : a ` hierarchical ' message ( HP ) , with counseling on male condoms , female condoms , diaphragms , cervical caps , and spermicides ( three formulations ) and a single method message ( SM ) covering male condoms only or female condoms only . For this analysis , 1591 subjects received one of three educational messages at the central public STD clinic in Philadelphia . Disease incidence data for up to 6 months following the index visit were extracted from the clinic 's electronic data base . The primary outcome was STD reinfection : laboratory-confirmed trichomonas infection and /or clinical diagnoses of at least one of four STD . Rates were based on the full sample of r and omized women ( full sample ) and on the subset who spontaneously returned between 22 days and 183 days following their initial visit ( returners ) . Results Rates of trichomonas infection ( SM 2.5 % full sample and 12.9 % returners versus HP 2.4 % full sample and 11.5 % returners ) and clinical diagnoses ( SM 6.3 % full sample and 39.7 % returners versus HP 6.9 % full sample and 41.2 % returners ) did not differ across the two arms of the r and omized trial , both as a straight percentage and in survival analysis ( P = .81 ) . Conclusion At least in this single-session intervention trial , increasing choices in protection for women did not produce a change in disease risk compared with single- method approaches Pregnant injecting drug users were r and omly assigned to : ( i ) individually receive a six-session cognitive-behavioural intervention in addition to their usual methadone maintenance treatment ( intervention condition ( I ) ( n = 40 ) ) ; or ( ii ) their usual methadone maintenance treatment only ( control condition ( C ) ( n = 40 ) ) . There was no change in drug use per se in either group after the intervention . However , at 9-month follow-up the I group had significantly reduced some HIV risk-taking behaviours ( in particular injecting risk behaviours ) . The I group reduced the needle risk associated both with " typical " use ( drug use in the month before interview ) and " binge " use ( drug use in the month nominated as the heaviest month of drug use in the previous 6 months ) . The intervention had no effect on sexual risk behaviours . The finding of reduced injecting risk behaviour following the six-session intervention suggests that such an intervention may be of benefit for individuals persisting with injecting risk behaviours despite methadone maintenance treatment and the availability of sterile injection equipment There is lack of barrier method use among sex workers ( SWs ) in China . Our objective was to find new ways to introduce female condoms ( FCs ) among SWs , and to increase knowledge of , support for , and use of this method in this population . We used the intervention study method and provided the SWs of experimental groups with information , education , and communication on FCs and provided them with FCs . We recruited 330 SWs as the participants of the study in Enping City , China . The selected 330 SWs were r and omly divided into the experimental group ( 165 SWs to use female condom ) and the others into the reference group ( 165 SWs to use male condom ) . Question naires were used to evaluate the intervention study . At the end of our study , 15 SWs were lost of follow-up , so only 315 were included in the analysis . After intervention , about 97 % of SWs in the intervention group expressed that they would use FC in the future . The rate of SWs who reported liking FC increased from 60 % at pre-intervention to 94 % at post-intervention . The rate of SWs who considered their clients could accept FC increased from 27 % to 92 % , and the rate of SWs who were willing to recommend FC to others increased from 19 % to 70 % . In comparison with the first several uses , during last several uses about 80 % of SWs expressed that it became easier to use FC . Our intervention increased knowledge of , positive attitudes towards , and correct use of FC in this population of SWs There is an urgent need in sub-Saharan Africa to develop more effective methods of HIV prevention , including improved strategies of sexually transmitted infection ( STI ) prevention or an HIV vaccine . The efficacy of these strategies may be tested through clinical trials within cohorts at high risk for STI and HIV , such as female commercial sex workers . For ethical reasons , st and ard HIV prevention services , including access to free condoms , risk-reduction counseling , and STI therapy , will generally be offered to all study subjects . Because study subjects would often not otherwise have access to these prevention services , it is possible that enrollment in such clinical trials will itself reduce incidence rates of STI and HIV below expected levels , reducing the power to test the efficacy of the r and omized intervention . We show that the provision of st and ard HIV prevention services as part of a r and omized STI/HIV prevention trial is temporally associated with a dramatic reduction in sexual risk-taking , and that this reduction is directly associated with reduced STI incidence . This finding should be considered in the design of clinical trials with an endpoint of HIV incidence , in particular HIV preventive vaccine trials OBJECTIVES A human immunodeficiency virus ( HIV ) intervention trial for women at high risk for acquired immunodeficiency syndrome and attending an urban clinic was reported previously . The behavioral group intervention was shown to increase condom use behaviors significantly . This study retrospectively assessed the intervention 's cost-effectiveness . METHODS St and ard methods of cost and cost-utility analysis were used . RESULTS The intervention cost was just over $ 2000 for each quality -adjusted life-year saved ; this is favorable compared with other life-saving programs . However , the results are sensitive to changes in some model assumptions . CONCLUSIONS Under most scenarios , the HIV prevention intervention was cost-effective OBJECTIVES The purpose of this study was to assess the effects of an HIV antibody testing , counseling and education programme on the knowledge and practice s of low-income Los Angeles Latina women . METHODS The study design was prospect i ve and longitudinal involving pre-test , post-test and retest measures over a 2-year period . The study employed an experimental group and a comparison group which did not receive the intervention . The study group was comprised of a convenience sample of 508 low-income Latina women who were recruited from the Public Health Service nutrition programme for women , infants and children ( WIC ) . The comparison group ( n = 51 ) was recruited from the same setting . A battery of instruments was selected to measure HIV knowledge and practice s , the social support received , self-esteem , the level of acculturation and sociodemographic characteristics . The instruments were administered at pre-test , 2 weeks post-test and 1 year retest . The HIV antibody serostatus was assessed at pre-test and retest . An intervention protocol based on cultural competence , women as traditional health care givers and the major transmission categories was provided after the pre-test and was reinforced post-test . Finally , qualitative data were collected from the focus group participants ( n = 55 ) to evaluate the intervention protocol . RESULTS The participants in the study made significant improvements in HIV knowledge and reported condom use practice s from pre-test to post-test that were retained on retest . The comparison group subjects did not make significant pre-test-post-test improvements on these measures . CONCLUSIONS It should be noted that the changes in practice s made by the study group did not necessarily reduce their risk of HIV infection or transmission and were not related to the demonstrated knowledge and skills improvement . Of special significance to programme planners , educators and research ers , both the quantitative and qualitative data revealed problem areas with the intervention protocol related to cultural norms and the possible fragmentation of information based on the behavioral transmission categories 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 AIM This paper is a report of the findings of a study to examine the effects of application of the Contraceptive Behavior Change model on knowledge , attitudes , perceived benefits and barriers , self-efficacy ( SE ) , stages of change ( SOC ) and contraceptive behaviours . BACKGROUND Unintended pregnancy is a global issue ; it is also a concern for the military , as it impacts on mission readiness . Effective sexuality education programmes are needed but , to date , an evaluation of existing programmes using a conceptual model is lacking in the health literature . METHOD A sample of 198 single , junior enlisted females was r and omly recruited from United States of America Navy ships . An experimental design was adopted . The experimental group received two class sessions , 2 months apart , while the control group received none . The variables measured were : knowledge , attitudes , perceived benefits and barriers , SE , SOC and contraceptive behaviours . Data were collected on three separate occasions at 2-month intervals over a 4-month period in 2004 - 2005 . RESULTS Initially , a striking lack of knowledge was evident among study participants . The experimental groups ' knowledge increased statistically significantly with repeated interventions , while the control group 's knowledge did not change over the same period . Both groups started with no pregnancies , and at the end of the study , the pregnancy rate between the two groups was statistically significant : experimental group 0 % , and control group 14 % . CONCLUSIONS The intervention led to increased knowledge , which in turn led to avoidance of pregnancy . The proposed model was appropriate for the evaluation and consequently can be considered as an effective tool to use for development or refinement of existing programmes PURPOSE To evaluate effects of a 6-month social marketing campaign on awareness of , attitudes toward and use of female as well as male condoms for 15 - 25 year-old-women . METHODS Using a time-space sampling methodology , we conducted a cross-sectional survey of 3407 women at pre-campaign in 12 western U.S. neighborhoods on female and male condom awareness , attitudes , and use . Six of the 12 study neighborhoods were r and omly selected to receive the POWER social marketing campaign design ed to impact condom knowledge , attitudes , and use . The campaign was followed with another cross-sectional survey of 3,003 women in all 12 study neighborhoods on condom knowledge , attitudes , use and awareness of POWER material s. We compared pre- and post-campaign surveys to determine the efficacy of POWER and conducted post hoc analyses on post-campaign data to determine if exposure to POWER was related to higher levels of positive condom attitudes and norms and condom use . RESULTS We found no differences between neighborhoods with and without the POWER campaign with regard to our primary outcomes . To diagnose reasons for this null effect , we examined outcomes post hoc examining the influence of POWER exposure . Post hoc analyses show some evidence that exposure to POWER was associated with condom use . In the context of the nested trial , this raises concerns that post test only evaluations are limited . CONCLUSIONS Establishing the efficacy of a social marketing campaign is challenging . This group r and omized trial showed a null effect . Social marketing campaigns may need to have more media channels and saturation before they can show behavioral effects . Using a nested design with r and omization at the community level and probability sampling introduces rigor not commonly seen in evaluations of social marketing campaigns PURPOSE To evaluate , by gender , the impact of a structured , comprehensive risk reduction intervention with and without boosters on human immunodeficiency virus ( HIV ) knowledge , attitudes and behaviors in incarcerated youth ; and to determine predictors of increasing HIV knowledge and reducing high-risk attitudes and behaviors . METHODS This r and omized controlled trial involved participants completing structured interviews at 1 , 3 , and 6 months . Repeated measures analysis of variance was used to analyze changes over time . The study was conducted in secure custody facilities and in the community . The study sample comprising 391 incarcerated youth , 102 female and 289 male aged 12 - 18 , formed the voluntary sample . Participants were r and omly assigned to one of three conditions : education intervention ; education intervention with booster ; or no systematic intervention . The outcome and predictor measures included the Rosenberg Self-Esteem Scale , Youth Self Report , Drug Use Inventory , and HIV Knowledge , Attitudes and Behavior Scale . RESULTS The 6-month retention rate was 59.6 % . At 6 months , males in the education and booster groups sustained increases in knowledge scores ( p < 0.001 ) . Females in these groups sustained increased condom attitude scores ( p = 0.004 ) . Males in the booster group sustained increased prevention attitude scores ( p = 0.017 ) . Females in the booster group reported more consistent condom use ( odds ratio [ OR ] = 4.20 ; 95 % confidence interval [ CI ] = 1.81 , 9.77 ) . Age , gender , drug use , and psychological profiles were predictive of outcome . CONCLUSIONS The intervention and boosters led to gender-specific improvements in knowledge , attitudes , and condom use . Result variations by gender underline the importance of gender issues in prevention interventions . Predictors of success were identified to inform future HIV education interventions |
11,548 | 23,807,104 | Pretraining and additional practice improved outcomes but , again , took longer .
Limited evidence suggests that mastery learning SBME is superior to nonmastery instruction but takes more time | PURPOSE Competency-based education requires individualization of instruction .
Mastery learning , an instructional approach requiring learners to achieve a defined proficiency before proceeding to the next instructional objective , offers one approach to individualization .
The authors sought to summarize the quantitative outcomes of mastery learning simulation-based medical education ( SBME ) in comparison with no intervention and nonmastery instruction , and to determine what features of mastery SBME make it effective . | & NA ; To increase cardiopulmonary arrest survival , the American Heart Association developed basic and advanced cardiac life support ( ACLS ) courses that expose participants to realistic learning situations . This experimental study compared results of two ACLS classes on measures of knowledge ( content exam ) and resuscitation skills ( performance exam ) . Both the control and experimental groups consisted of physicians , nurses , emergency medical technicians , respiratory therapists , and advanced health care providers . The control group used low‐fidelity simulation ( LFS ) ; the experimental group was exposed to enhanced realism via high‐fidelity simulation ( HFS ) . The findings showed a positive correlation between enhanced practice and learning but no significant correlation between posttest and skills test scores for the LFS and HFS groups . The HFS group did score higher on both cognitive and behavioral tests , but the difference was not statistically significant . Participants from both groups indicated satisfaction with their forms of simulation experience and course design . In addition , participants ' self‐confidence to care for a victim of cardiopulmonary arrest was increased after completing their course ; profession and work experience had no effect on responses . The largest difference noted was in verbal responses to course satisfaction . The experimental group stated that learning using HFS was enjoyable and adamantly recommended that ACLS should only be taught using HFS . Further study is required to assess if practicing beyond the course enhances short‐ and long‐term retention of ACLS techniques Background Virtual reality ( VR ) simulators and Web-based instructional videos are valuable supplemental training re sources in surgical programs , but it is unclear how to optimally integrate them into minimally invasive surgical training . Methods Medical students were r and omized to proficiency-based training on VR laparoscopy and endoscopy simulators by two different methods : proctored training ( automated simulator feedback plus human expert feedback ) or independent training ( simulator feedback alone ) . After achieving simulator proficiency , trainees performed a series of laparoscopic and endoscopic tasks in a live porcine model . Prior to their entry into the animal lab , all trainees watched an instructional video of the procedure and were r and omly assigned to either observe or not observe the actual procedure before performing it themselves . The joint effects of VR training method and procedure observation on time to successful task completion were evaluated with Cox regression models . Results Thirty-two students ( 16 proctored , 16 independent ) completed VR training . Cox regression modeling with adjustment for relevant covariates demonstrated no significant difference in the likelihood of successful task completion for independent versus proctored training [ Hazard Ratio ( HR ) 1.28 ; 95 % Confidence Interval ( CI ) 0.96–1.72 ; p = 0.09 ] . Trainees who observed the actual procedure were more likely to be successful than those who watched the instructional video alone ( HR 1.47 ; 95 % CI 1.09–1.98 ; p = 0.01 ) . Conclusions Proctored VR training is no more effective than independent training with respect to surgical performance . Therefore , time-consuming human expert feedback during VR training may be unnecessary . Instructional videos , while useful , may not be adequate substitutes for actual observation when trainees are learning minimally invasive surgical procedures Background With increasing pressure to use operating room time efficiently , opportunities for residents to learn fiberoptic orotracheal intubation in the operating room have declined . The purpose of this study was to determine whether fiberoptic orotracheal intubation skills learned outside the operating room on a simple model could be transferred into the clinical setting . Methods First-year anesthesiology residents and first- and second-year internal medicine residents were recruited . Subjects were r and omized to a didactic-teaching-only group ( n = 12 ) or a model-training group ( n = 12 ) . The didactic-teaching group received a detailed lecture from an expert bronchoscopist . The model-training group was guided , by experts , through tasks performed on a simple model design ed to refine fiberoptic manipulation skills . After the training session , subjects performed a fiberoptic orotracheal intubation on healthy , consenting , anesthetized , paralyzed female patients undergoing elective surgery with predicted “ easy ” laryngoscopic intubations . Two blinded anesthesiologists evaluated each subject . Results After the training session , the model group significantly outperformed the didactic group in the operating room when evaluated with a global rating scale ( P < 0.01 ) and checklist ( P < 0.05 ) . Model-trained subjects completed the fiberoptic orotracheal intubation significantly faster than didactic-trained subjects ( P < 0.01 ) . Model-trained subjects were also more successful at achieving tracheal intubation than the didactic group ( P < 0.005 ) . Conclusion Fiberoptic orotracheal intubation skills training on a simple model is more effective than conventional didactic instruction for transfer to the clinical setting . Incorporating an extraoperative model into the training of fiberoptic orotracheal intubation may greatly reduce the time and pressures that accompany teaching this skill in the operating room BACKGROUND This study compares a laparoscopic skill training protocol without proficiency targets to the same protocol with explicit targets and notification of progress . METHODS Fourteen surgery interns were r and omized into 2 groups . The intervention group received task-specific proficiency criteria to guide practice . The control group did not . After training , participants were evaluated by blinded faculty during laparoscopic cholecystectomy . RESULTS The control group met significantly fewer of the 7 LapSim ( Surgical Science Sweden AB , Gotëborg ) targets ( mean = 1.14 ) than the intervention group ( mean = 7.00 ; P = .001 ) and significantly fewer of the 5 video trainer targets ( mean = .86 ) than the intervention group ( mean = 5.00 ; P = .001 ) . Ratings of depth perception , bimanual dexterity , efficiency , tissue h and ling , autonomy , and overall competence were higher for the intervention group . Effect sizes ranged from medium to large ( .394-.981 ) , indicating an impact of the proficiency-based training protocol . CONCLUSIONS Delineation of proficiency targets with reporting of progress improves interns ' practice results , and appears to have a positive effect on their early operating room ( OR ) performance of laparoscopic cholecystectomy Training on a video trainer or computer-based minimally invasive surgery trainer leads to improved benchtop laparoscopic skill . Recently , improved operative performance from practice on a video trainer was reported . The purpose of this study was three fold : ( a ) to compare psychomotor skill improvement after training on a virtual reality ( VR ) system with that after training on a video-trainer , ( VT ) ( b ) to evaluate whether skills learned on the one training system are transferable to the other , and ( c ) to evaluate whether VR or VT training improves operative performance . For the study , 50 junior surgery residents completed baseline skill testing on both the VR and VT systems . These subjects then were r and omized to either a VR or VT structured training group . After practice , the subjects were tested again on their VR and VT skills . To assess the effect of practice on operative performance , all second-year residents ( n = 19 ) were evaluated on their operative performance during a laparoscopic cholecystectomy before and after skill training . Data are expressed as percentage of improvement in mean score/time . Analysis was performed by Student 's paired t-test . The VR training group showed improvement of 54 % on the VR posttest , as compared with 55 % improvement by the VT group . The VR training group improved more on the VT posttest tasks ( 36 % ) than the VT training group improved on the VR posttest tasks ( 17 % ) ( p < 0.05 ) . Operative performance improved only in the VR training group ( p < 0.05 ) . Psychomotor skillsimprove after training on both VR and VT , and skills may be transferable . Furthermore , training on a minimally invasive surgery trainer , virtual reality system may improve operative performance during laparoscopic cholecystectomy BACKGROUND We have previously shown that reaching expert performance on an fundamentals of laparoscopic surgery (FLS)-type simulator model for laparoscopic suturing results in measurable improvement during an actual operation ; trained novices , however , demonstrate inferior operative performance compared with experts . We hypothesized that simulator training under more difficult and realistic conditions would enhance the operative performance of novices . STUDY DESIGN Medical students ( n=32 ) participated in an IRB-approved , r and omized , controlled trial . All participants were pretested in laparoscopic suturing on a previously vali date d porcine Nissen model and were r and omized into three groups : group I ( n=6 ) received no training , group II ( n=13 ) trained on the FLS videotrainer model until a previously published proficiency score ( 512 ) was achieved on 2 consecutive and 10 additional attempts , group III ( n=13 ) trained to the same goal but had to practice in a constrained space , with a shorter suture , starting with a dropped needle , and listening to operating room noise . Training workload was measured with the vali date d NASA-TLX ( Task Load Index ) question naire after each training session . All groups were posttested on the porcine model . Results were compared using ANOVA ; p < 0.05 was considered significant . RESULTS All group II and III participants reached the training goal . At posttesting , group II and group III participants performed similarly , but substantially better than group I did ( 210+/-140 versus 218+/-139 versus 0+/-0 , respectively ; p < 0.001 ) . Compared with group II , group III participants trained longer ( 329+/-71 minutes versus 239+/-69 minutes , p < 0.001 ) , performed more repetitions ( 81+/-15 versus 59+/-14 , p < 0.001 ) , and their workload improved less by the end of training ( 5 % versus 23 % , p < 0.001 ) . CONCLUSIONS Proficiency-based simulator training reliably results in improved operative performance . Although increasing the level of training difficulty increased trainees ' workload , the strategy we used in this study did not enhance their operative performance . Other methods for curriculum optimization are needed Background The content validity of currently available inanimate simulation models is question able , because some tasks seem too far from clinical reality . The aim of this study was to vali date a simulation model with six tasks commonly used in clinical practice ( 6-TSM ) for the acquisition of psychomotor skills in minimally invasive surgery ( MIS ) . Methods This was a prospect i ve r and omized trial comparing the 6-TSM to a previously described three-task training method ( 3-TTM ) . All first , second , and third postgraduate year surgical residents were eligible . The 6-TSM included clipping and dividing of a vessel , excision of lesion , appendectomy , mesh repair , suturing perforation , and h and -sewn anastomosis . The outcome measures of 6-TSM included accuracy error , tissue damage , sliding knot , leak , operating time , and dangerous movements . After completion of training , 6-TSM and 3-TTN residents were tested by the Minimally Invasive Surgical Trainer — Virtual Reality ( MIST-VR ) . Criterion-related and construct validity , responsiveness , test – retest , and interrater reliability were assessed . Results During six months , 17 residents underwent training with the 6-TSM or the 3-TTM as allocated . The mean duration of training with 6-TSM and 3-TTM was similar ( 7.8 vs 8.1 h ) . The criterion-related validity of the 6-TSM was shown by significantly increased skill improvement in the 6-TSM residents , as compared with the 3-TTM residents at MIST-VR . Construct validity the of 6-TSM was shown by the finding that the experts ’ baseline was superior to the residents ’ baseline . The responsiveness of the 6-TSM was shown by the significantly increased skill improvement of the 6-TSM residents in sliding knot , leak , and operating time . The test – retest reliability of the 6-TSM was good ( > 0.80 ) , except for accuracy error and dangerous movements ( Cronbach ’s intraclass correlation coefficient α : 0.57 , p < 0.0001 ; 0.62 , p < 0.0001 , respectively ) . The interrater reliability of the 6-TSM was good ( > 0.80 ) except for leak ( Kendall ’s concordance coefficient tau_b:0.76 , p = 0.06 for h and -sewn anastomosis ) and dangerous movements ( tau_b:0.72 , p = 0.08 for suturing perforation and tau_b:0.68 , p = 0.10 for h and -sewn anastomosis ) . The perresident cost for 6-TSM was $ 769 . Conclusions The 6-TSM is a valid and reliable learning tool for surgical residents ’ acquisition of laparoscopic motor skills PURPOSE Repetitive practice of laparoscopic suturing and knot tying can facilitate surgeon proficiency in performing this reconstructive technique . We compared a silicone model and pelvic trainer to a virtual reality simulator in the learning of laparoscopic suturing and knot tying by laparoscopically naïve medical students , and evaluated the subsequent performance of porcine laparoscopic cystorrhaphy . MATERIAL S AND METHODS A total of 20 medical students underwent a 1-hour didactic session with video demonstration of laparoscopic suturing and knot tying by an expert laparoscopic surgeon . The students were r and omized to a pelvic trainer ( 10 ) or virtual reality simulator ( 10 ) for a minimum of 2 hours of laparoscopic suturing and knot tying training . Within 1 week of the training session the medical students performed laparoscopic closure of a 2 cm cystotomy in a porcine model . Objective structured assessment of technical skills for laparoscopic cystorrhaphy was performed at the procedure by laparoscopic surgeons blinded to the medical student training format . A video of the procedure was evaluated with an objective structured assessment of technical skills by an expert laparoscopic surgeon blinded to medical student identity and training format . The medical students completed an evaluation question naire regarding the training format after the laparoscopic cystorrhaphy . RESULTS All students were able to complete the laparoscopic cystorrhaphy . There was no difference between the pelvic trainer and virtual reality groups in mean + /- SD time to perform the porcine cystorrhaphy at 40 + /- 15 vs 41 + /- 10 minutes ( p = 0.87 ) or the objective structured assessment of technical skills score of 8.8 + /- 2.3 vs 8.2 + /- 2.2 ( p = 0.24 ) , respectively . Bladder leak occurred in 3 ( 30 % ) of the pelvic trainer trained and 6 ( 60 % ) of the virtual reality trained medical student laparoscopic cystorrhaphy procedures ( Fisher exact test p = 0.37 ) . The only significant difference between the 2 groups was that 4 virtual reality trained medical students considered the training session too short compared to none of those trained on the pelvic trainer ( p = 0.04 ) . CONCLUSIONS There is no significant difference between the pelvic trainer and virtual reality trained medical students in proficiency to perform laparoscopic cystorrhaphy in a pig model , although both groups require considerably more training before performing this procedure clinical ly . The pelvic trainer training may be more user-friendly for the novice surgeon to begin learning these challenging laparoscopic skills OBJECTIVES The objective of the study was to compare the learning and retention rates of resident physicians trained in posterior epistaxis management with nasal gauze packing on a simulation model following two training methods . METHODS This was a prospect i ve , repeated- measures study . An objective , criterion-referenced performance st and ard , consisting of the number of major steps completed in the proper sequence , and the number of minor steps completed within a specified time , was used by an evaluator to assess performances . Subjects underwent two pretraining assessment s 1 week prior to and the day of training and then were r and omized to one of two training methods : the traditional " observation " method or a " pause- and -perfect " method . After training , both groups repeated the procedure until meeting the performance st and ard . Subjects were retested 1 and 3 months after training . RESULTS Twenty-eight subjects participated . Baseline performance measures were similar between groups and did not change prior to training . During performance testing , experimental subjects completed a greater percentage of major steps ( 84 % ) and minor steps ( 86 % ) in less time ( 25 minutes ) than the controls ( 65 and 68 % , in 35 minutes ) during the first attempt . All subjects met the st and ard within three attempts . There were no differences in major and minor steps completed between the two groups at either 1 week or 3 months after training , but performance times were shorter in the experimental group . After 3 months , 13 % of control and none of experimental subjects met the performance st and ard . CONCLUSIONS The pause- and -perfect training method produced more rapid progress toward a performance st and ard during the initial attempt and better performance times after 3 months than the traditional , observational training method . Without further practice , this skill deteriorated after 3 months with both methods of training Background Haptics is an expensive addition to virtual reality ( VR ) simulators , and the added value to training has not been proven . This study evaluated the benefit of haptics in VR laparoscopic surgery training for novices . Methods The Simbionix LapMentor II haptic VR simulator was used in the study . R and omly , 33 laparoscopic novice students were placed in one of three groups : control , haptics-trained , or nonhaptics-trained group . The control group performed nine basic laparoscopy tasks and four cholecystectomy procedural tasks one time with haptics engaged at the default setting . The haptics group was trained to proficiency in the basic tasks and then performed each of the procedural tasks one time with haptics engaged . The nonhaptics group used the same training protocol except that haptics was disengaged . The proficiency values used were previously published expert values . Each group was assessed in the performance of 10 laparoscopic cholecystectomies ( alternating with and without haptics ) . Performance was measured via automatically collected simulator data . Results The three groups exhibited no differences in terms of sex , education level , h and dominance , video game experience , surgical experience , and nonsurgical simulator experience . The number of attempts required to reach proficiency did not differ between the haptics- and nonhaptics-training groups . The haptics and nonhaptics groups exhibited no difference in performance . Both training groups outperformed the control group in number of movements as well as path length of the left instrument . In addition , the nonhaptics group outperformed the control group in total time . Conclusion Haptics does not improve the efficiency or effectiveness of LapMentor II VR laparoscopic surgery training . The limited benefit and the significant cost of haptics suggest that haptics should not be included routinely in VR laparoscopic surgery training BACKGROUND Proficiency-based training in laparoscopic suturing and knot tying translates to the operating room , but little is known about the durability of acquired skill . The purpose of this study was to determine the effect of maintenance training on skill retention after demonstration of proficiency . STUDY DESIGN Medical students ( n=18 ) with no previous laparoscopic or simulator experience were enrolled in an IRB-approved r and omized controlled trial . All subjects trained to proficiency ( score of 512 , based on time and errors ) on a previously vali date d suturing model ( Fundamentals of Laparoscopic Surgery videotrainer ) . Subjects were then r and omized to a control group , which received no additional training , and an ongoing training group , which trained again to proficiency at 1 and 3 months ( immediately after testing ) . Simulator testing was repeated at 2 weeks , 1 month , 3 months , and 6 months after initial training . No subject had interval operative experience . RESULTS Both groups demonstrated excellent skill retention during followup ; performance scores , reported as means+/-SD , were 488+/-57 versus 482+/-55 at 2 weeks ( p = ns ) , 483+/-81 versus 491+/-64 at 1 month ( p = ns ) , 467+/-75 versus 470+/-67 at 3 months ( p = ns ) , and 462+/-62 versus 492+/-43 at 6 months ( p=0.02 ) for the control versus ongoing training groups , respectively . At 6 months , the ongoing training group showed better skill retention ( 95 % versus 90 % ; p=0.02 ) and a trend for achieving the proficiency level ( 33 % versus 18 % ; p=0.2 ) more often than the control group . CONCLUSIONS Although proficiency-based training results in excellent skill retention , ongoing training substantially enhances performance and minimizes skill loss . Curricula should incorporate training that fosters maintenance of proficiency STUDY OBJECTIVES To determine the effect of manikin-only training on field success of endotracheal intubation by paramedics . DESIGN Prospect i ve evaluation of individual field endotracheal intubation success rates for paramedics after they participated in a manikin-only or a manikin-plus-cadaver training program . TYPES OF PARTICIPANTS Paramedics responding to emergency calls involving adult medical or trauma victims . INTERVENTIONS All participants were trained using a controlled manikin training program ; then , half were r and omly selected for additional instruction using fresh human cadavers . MEASUREMENTS AND MAIN RESULTS Individuals trained using only the manikin program had mean + /- SD individual success rates of 82 + /- 32 % , and individuals who received additional cadaver training had mean individual success rates of 83 + /- 31 % . Overall success rates for the two groups were 86 % for the manikin-only group and 85 % for the manikin-plus-cadaver-trained group . The sample size was not adequate to allow rejection of the null hypothesis . CONCLUSION Paramedics trained in endotracheal intubation using a systematic manikin-only teaching program can attain acceptable individual success rates in the actual field setting BACKGROUND The purpose of this study was to determine the impact of instructor feedback and video tutorials on skill acquisition during proficiency-based laparoscopic suturing training . METHODS Performance data from a prospect ively maintained data base were review ed for three groups of novices ( n = 34 medical students ) who completed the same proficiency-based laparoscopic suturing curriculum on a Fundamentals of Laparoscopic Surgery-type videotrainer model as part of two separate institutional review board-approved , r and omized controlled trials . Group I ( n = 9 ) watched the video tutorial once and received intense feedback during each training session ; Group II ( n = 13 ) watched the video tutorial once and received limited feedback ( < 10 min per session ) ; Group III ( n = 12 ) watched the video tutorial several times and also received limited feedback ( < 10 min per session ) . Feedback was given by the same instructor and was quantified on a 0 ( none ) to 4 ( extensive ) Likert scale . RESULTS Baseline characteristics were similar for all groups . All participants achieved the proficiency level ( 512 ) on two consecutive attempts . Group III required the shortest training time and number of repetitions to reach proficiency , with statistically significant differences compared with Group I ( P < 0.02 ) . This strategy led to a cost savings of $ 139 per trainee . CONCLUSIONS Limited instructor feedback appears to be superior to intense feedback during proficiency-based laparoscopic simulator training . Coupled with video tutorials , this type of feedback may accelerate learning and improve re source utilization by minimizing the need for instructor involvement BACKGROUND Laparoscopic suturing is an advanced skill that is difficult to acquire . Simulator-based skills curricula have been developed that have been shown to transfer to the operating room . Currently available skills curricula need to be optimized . We hypothesized that mastering basic laparoscopic skills first would shorten the learning curve of a more complex laparoscopic task and reduce re source requirements for the Fundamentals of Laparoscopic Surgery suturing curriculum . STUDY DESIGN Medical students ( n = 20 ) with no previous simulator experience were enrolled in an IRB-approved protocol , pretested on the Fundamentals of Laparoscopic Surgery suturing model , and r and omized into 2 groups . Group I ( n = 10 ) trained ( unsupervised ) until proficiency levels were achieved on 5 basic tasks ; Group II ( n = 10 ) received no basic training . Both groups then trained ( supervised ) on the Fundamentals of Laparoscopic Surgery suturing model until previously reported proficiency levels were achieved . Two weeks later , they were retested to evaluate their retention scores , training parameters , instruction requirements , and cost between groups using t-test . RESULTS Baseline characteristics and performance were similar for both groups , and 9 of 10 subjects in each group achieved the proficiency levels . The initial performance on the simulator was better for Group I after basic skills training , and their suturing learning curve was shorter compared with Group II . In addition , Group I required less active instruction . Overall time required to finish the curriculum was similar for both groups ; but the Group I training strategy cost less , with a savings of $ 148 per trainee . CONCLUSIONS Teaching novices basic laparoscopic skills before a more complex laparoscopic task produces substantial cost savings . Additional studies are needed to assess the impact of such integrated curricula on ultimate educational benefit STUDY OBJECTIVE This study was conducted to determine the natural history of airway management skill decay and examine the effect of independent practice and periodic feedback on airway management skill maintenance . METHODS This prospect i ve , r and omized controlled study conducted at Dalhousie University in Halifax , Nova Scotia , Canada , between November 1997 and September 1998 . A convenience sample of 84 health sciences students with no prior airway management experience was used . Participants were trained using an advanced airway manikin and then were r and omly assigned to control ( n=24 ) , periodic feedback only ( n=30 ) , and independent practice plus periodic feedback ( n=30 ) groups . Performance was measured by a 52-point weighted checklist at 0 , 16 , 25 , and 40 weeks after the initial program . RESULTS Group scores were analyzed using a mixed-model repeated- measures analysis of variance and Bonferroni-adjusted P values . Overall group ( P = .0002 ) and time ( P = .0001 ) effects were significant . At time 0 , there was no statistical difference in mean scores between groups ( range 45.0 to 45.2 ) . Control group performance fell over the first time interval ( 0 to 16 weeks ) ( mean score=34.0 , P = .002 ) and remained lower at all intervals without further significant change . Scores in the independent practice plus feedback group revealed no significant changes over time and were significantly higher than the control group throughout . Performance in the periodic feedback only group showed a nonsignificant trend to improved performance over the control group . CONCLUSION Airway management skill performance declines early after initial training . Independent practice combined with periodic feedback was effective in maintaining performance scores in an advanced airway management simulation . Periodic evaluation with feedback alone showed a nonsignificant trend toward improvement over control As a result of experimental evidence on skills acquisition of industrial and dental tasks , the concept of utilizing analytical training methods in psychomotor medical education was investigated in this study on “ everting square suture ” technique used in plastic surgery procedures . Based on attitude question naires and film analysis , three simulation training models were developed and compared as to training effectiveness against the “ traditional ” training method ( practice on a pig 's foot ) currently in use at a number of Medical Schools . The three proposed training models consisted of : 1 . Electromechanical training simulator using the progressive parts training method . 2 . Perceptual training through film viewing and fault analysis . 3 . The combination of ( 1 ) and ( 2 ) above . Thirty-six medical students with no prior exposure to wound closure techniques participated as subjects . These students were r and omly divided into four groups ( three experimental and one control ) . Intergroup comparisons were attained by having subjects from the experimental groups , subsequent to training , practice on porcine skin by placing 35 sutures similar to that of the traditional group . Time , quality , heart rate variability , chin-EMG , neck-EMG and plantar skin conductance data were collected throughout the task and used as evaluation measures . Results indicate that : 1 . All three experimental training methods provided for significantly better quality performance levels ( from 14.2 to 177.1 percent better ) than the traditional training group . Group 1 attained the highest results . 2 . The subjects on the experimental traininggroup had briefer training time ( ranging between 1.4 to 3.1 times less ) than the “ traditional ” group . 3 . The subjects in the experimental training groups had less psychophysiological stress during task performance than did the subjects in the conventional training group OBJECTIVE To assess the effects of mental practice on surgical performance . BACKGROUND Increasing concerns for patient safety have highlighted a need for alternative training strategies outside the operating room . Mental practice ( MP ) , " the cognitive rehearsal of a task before performance , " has been successful in sport and music to enhance skill . This study investigates whether MP enhances performance in laparoscopic surgery . METHODS After baseline skills testing , 20 novice surgeons underwent training on an evidence -based virtual reality curriculum . After r and omization using the closed envelope technique , all participants performed 5 Virtual Reality ( VR ) laparoscopic cholecystectomies ( LC ) . Mental practice participants performed 30 minutes of MP before each LC ; control participants viewed an online lecture . Technical performance was assessed using video Objective Structured Assessment of Technical Skills-based global ratings scale ( scored from 7 to 35 ) . Mental imagery was assessed using a previously vali date d Mental Imagery Question naire . RESULTS Eighteen participants completed the study . There were no intergroup differences in baseline technical ability . Learning curves were demonstrated for both MP and control groups . Mental practice was superior to control ( global ratings ) for the first LC ( median 20 vs 15 , P = 0.005 ) , second LC ( 20.5 vs 13.5 , P = 0.001 ) , third LC ( 24 vs 15.5 , P < 0.001 ) , fourth LC ( 25.5 vs 15.5 , P < 0.001 ) and the fifth LC ( 27.5 vs 19.5 , P = 0.00 ) . The imagery for the MP group was also significantly superior to the control group across all sessions ( P < 0.05 ) . Improved imagery significantly correlated with better quality of performance ( ρ 0.51–0.62 , Ps < 0.05 ) . CONCLUSIONS This is the first r and omized controlled study to show that MP enhances the quality of performance based on VR laparoscopic cholecystectomy . This may be a time- and cost-effective strategy to augment traditional training in the OR thus potentially improving patient care AIM OF THE STUDY Cricoid pressure is recommended during positive pressure ventilation CPR and during anaesthesia when there is a risk of regurgitation . Studies suggest that cricoid pressure is frequently applied incorrectly placing patients at risk of regurgitation . Simulation training has been shown to improve the performance of cricoid pressure on a simulator , but whether simulation training improves the clinical performance of cricoid pressure was unknown . The aim of our study was to determine if simulator training improved the clinical performance of cricoid pressure . METHODS 101 medical students and nursing staff were recruited and r and omised to receive cricoid pressure simulator training with or without force feedback . Subjects then applied cricoid pressure to an anaesthetised patient while st and ing on a force plate . The main outcome measure was the number of subjects who applied a mean force of 20 - 30N during their trial . RESULTS Significantly more subjects ( 20/53 , 38 % ) in the feedback group applied force in the appropriate range ( 20 - 30N ) compared to the control group ( 9/48 , 19 % ) ( p=0.035 , chi square test ) . The feedback group applied significantly higher forces than did the control group ( p=0.029 , Mann-Whitney U test ) . CONCLUSION Simulation training with force feedback significantly improved the performance of cricoid pressure in the clinical setting . Simulation training should be used more frequently to train and maintain resuscitation skills STUDY OBJECTIVES To evaluate a teaching protocol comparing a critical care attending to a housestaff team in training medical interns in initial airway management skills using a computer-controlled patient simulator ( CPS ) and scenario-based simulation training ( SST ) . DESIGN Prospect i ve , r and omized , controlled , unblinded trial . SETTING Internal medicine residency training program in an urban teaching hospital . PARTICIPANTS Forty-nine starting internal medicine interns in July 2003 , all of whom had been certified in advanced cardiac life support in June 2003 . INTERVENTIONS All interns were tested and scored with a CPS while responding to a st and ardized respiratory arrest scenario . R and om allocation to either training by a single experienced teaching attending or by a housestaff team occurred immediately following testing . All interns were retested using the same scenario 6 weeks following the initial training , and their clinical performance of airway management was scored during actual patient events throughout the year . MEASUREMENTS Initial airway management was divided into specific scorable steps . For each intern , individual step scores and total scores were recorded before and after training . For 10 consecutive months following training , intern airway management scores were recorded for actual patient airway events . RESULTS All starting medical interns demonstrated poor initial airway management skills . SST was effective in improving these skills , both on retesting with the patient simulator and in actual patient situations . Interns trained by a housestaff team performed as well as interns trained by the attending . CONCLUSIONS SST is effective in training medical interns , and the results are equivalent whether the training is provided by an experienced teaching attending or by a housestaff training team |
11,549 | 21,249,648 | Traditional slings seem to be as effective as minimally invasive slings , but had higher rates of adverse effects .
Tradional sling procedures appeared to confer a similar cure rate in comparison to open retropubic colposuspension , but the long term adverse event profile is still unclear . | BACKGROUND Traditional suburethral slings are surgical operations used to treat women with symptoms of stress urinary incontinence .
OBJECTIVES To determine the effects of traditional suburethral slings on stress or mixed incontinence in comparison with other management options . | PURPOSE As part of a continuous quality control effort to measure the interrater reliability of urodynamic studies performed at multiple centers , we compared agreement levels for urodynamic studies between central and local physician review ers . We report interrater reliability findings for the filling cystometrogram . MATERIAL S AND METHODS Following a satisfactory interrater reliability study among 4 central physician review ers in 33 tracings 36 urodynamic study tracings from 9 Urinary Incontinence Treatment Network continence treatment centers and 13 Urinary Incontinence Treatment Network certified urodynamic study testers were r and omly selected for review . These tracings were originally interpreted by 11 local physician review ers using st and ardized Urinary Incontinence Treatment Network interpretation guidelines . Each of the 4 central physician review ers review ed 9 r and omly assigned tracings and none review ed tracings from his or her center . Local and central physician review ers were instructed to categorize values as invalid if specified technical quality assurance st and ards were not met or the signal pattern suggested implausible values because of technical deficiencies . An intraclass correlation coefficient was calculated for continuous ( numerical ) variables and a kappa statistic was calculated for qualitative values with acceptable agreement defined a priori as an intraclass correlation coefficient of greater than 0.6 . RESULTS Filling cystometrogram baseline pressure , Valsalva leak point pressure , and volume and pressure measurements at maximum cystometric capacity had excellent intraclass correlation coefficients of 0.74 to 0.99 . There were no significant differences between local and central physician review er means , indicating excellent agreement . CONCLUSIONS With proper quality control measures in place and a set of st and ardized interpretive guidelines excellent interrater reliability between local and central physician review er can be achieved for numerical cystometrogram variables Abstract Objective : To compare tension-free vaginal tape with colposuspension as primary treatment for stress incontinence . Design : Multicentred r and omised comparative trial . Setting : Gynaecology or urology departments in 14 centres in the United Kingdom and Eire , including university teaching hospitals and district general hospitals . Participants : 344 women with urodynamic stress incontinence ; 175 r and omised to tension-free vaginal tape and 169 to colposuspension Main outcome measures : Assessment before treatment and at six months postoperatively with the SF-36 , the Bristol female lower urinary tract symptoms question naire , the EQ-5D health question naire , a one week urinary diary , one hour perineal pad test , cystometry , and , in some centres , urethral profilometry . Results : 23 women in the colposuspension group and 5 in the vaginal tape group withdrew before surgery . No significant difference was found between the groups for cure rates : 115 ( 66 % ) women in the vaginal tape group and 97 ( 57 % ) in the colposuspension group were objective ly cured ( 95 % confidence interval for difference in cure −4.7 % to 21.3 % ) . Bladder injury was more common during the vaginal tape procedure ; postoperative complications , in particular delayed resumption of micturition , were more common after colposuspension . Operation time , duration of hospital stay , and return to normal activity were all longer after colposuspension than after the vaginal tape procedure . Conclusion : Surgery with tension-free vaginal tape is associated with more operative complications than colposuspension , but colposuspension is associated with more postoperative complications and longer recovery . Vaginal tape shows promise for the treatment of urodynamic stress incontinence because of minimal access and rapid recovery times ; cure rates at six months were comparable with colposuspension . What is already known on this topic Few r and omised trials exist on surgery for stress incontinence Systematic review s suggest that colposuspension is associated with cure rates of up to 90 % Case series of tension-free vaginal tape suggest cure rates of about 85 % , with rapid return to normal activity What this study adds At six months the tension-free vaginal tape procedure is as effective as colposuspension for the primary treatment of stress incontinence Operative complications were more common with vaginal tape , but duration of hospital stay and return to normal activity were shorter than with colposuspension Postoperative complications were more common after OBJECTIVE To compare peri-operative complications , pain , and the immediate functional results of the sub-urethral sling procedure for urinary stress incontinence by the retropublic and transobturator routes , using a non-elastic polypropylene sub-urethral sling . PATIENTS AND METHODS This prospect i ve , multicentre study involved 88 women undergoing the sub-urethral sling procedure for stress urinary incontinence ( SUI ) . The retropubic route ( RPR ) and the transobturator route ( TOR ) were used in respectively 42 and 46 cases . The characteristics of the women in the RPR and TOR groups were as follows : mean age ( + /-st and ard deviation ) 56.8+/-12 years and 53.4+/-10 years , respectively ; mean BMI : 25+/-4 and 26+/-4 ; mean parity : 2.1+/-0.9 and 2+/-1 children ; post-menopausal status : 66.7 % and 58.7 % ; prior surgery for SUI : 7.1 % and 6.5 % ; and prior hysterectomy : 21.4 % and 26.1 % . None of these characteristics differed significantly between the groups . Likewise , pre-operative urinary functional status ( SUI stage , and pollakiuria , nocturia and urgency rates ) was similar in the two groups . RESULTS Mean hospital stay and overall morbidity rate were not significantly different between the RPR and TOR groups . Mean operating time was longer in the RPR group . Bladder injury was significantly more frequent in the RPR group and vaginal injury was significantly more frequent in the TOR group . Pain scores were significantly lower in the TOR group . The objective functional results at one month did not differ between the groups . Quality of life , evaluated with question naires and numerical rating scales , was similarly improved in the two groups . DISCUSSION The suburethral sling procedure was less painful by the TOR route than by the RPR route . Bladder injury , haematomas and abscesses were only observed in the RPR group , while vaginal injury only occurred in the TOR group . The immediate functional results of the two approaches were similar Introduction and hypothesisThis study aims to analyze comparatively the efficacy and safety of synthetic transobturatory and aponeurotic retropubic slings , in the treatment of stress urinary incontinence ( SUI ) in women . Methods Patients were separated in a r and omized way . Twenty-one patients were su bmi tted to the operatory correction by the transobturatory sling technique , whereas 20 patients were operated by the retropubic sling technique . All patients were su bmi tted to complete physical exam and urodynamic test . The “ T ” test and the Mann – Whitney U test were applied to establish comparisons between the two groups . Patients were followed-up for 12 months . Results Healing rate was 90.5 % ( 19/21 ) and 95 % ( 19/20 ) , respectively after 12 months . The transobturatory group presented lesser complications rate than the retropubic group . Conclusions The transobturatory and the aponeurotic slings techniques were equally effective for the treatment of SUI . The transobturatory sling has shown fewer complications and lesser surgical time than the aponeurotic sling technique Background : The aim of this study is to evaluate the outcome of an innovative , minimally invasive sling technique with autologous tissue in women with concomitant incontinence and anterior vaginal wall prolapse ( AVWP ) . Material s and Methods : Fifty-six women with stress urinary incontinence ( SUI ) or mixed urinary incontinence and AVWP were r and omly assigned into two groups : In Group A ( 26 patients ) , anterior colporrhaphy ( Kelly placation ) and sling placement using a strip of anterior vaginal wall were performed , and in Group B ( 30 patients ) , transvaginal mesh correction of AVWP and tension-free vaginal tape ( TVT ) insertion ( retropubic – craniocaudal route ) using polypropylene mesh were carried out . The patients were followed-up for over 18 months and were assessed objective ly using a 48 h frequency-volume chart , a 48 h pad test and a st and ardized stress test . Related surgical complications and outcomes were recorded and compared . Results : Surgical cure rates for Group A and Group B at the first ( 3 days ) and last ( 18 months ) post-operative visits were 62 % and 84 % ; and 54 % , and 72 % , respectively ( P = 0.09 and 0.31 ) . Complications occurred in 9 patients ( 44 % ) of Group B , but only 3 patients ( 12 % ) in Group A. Conclusion : Vaginal sling surgery using an anterior vaginal wall strip can improve SUI and in comparison with propylene mesh is associated with lower complication rates . Although , the surgical success rate of this technique is lower than T-Sling , larger studies with selected patients will help assess the suitable patients for this pelvic reconstructive surgery PURPOSE We examined preoperative and postoperative patient related factors associated with continence status up to 7 years after surgery for stress urinary incontinence . MATERIAL S AND METHODS Women r and omized to Burch colposuspension or fascial sling surgery and assessed for the primary outcome of urinary continence 2 years after surgery were eligible to enroll in a prospect i ve observational study . Survival analysis was used to investigate baseline and postoperative factors in the subsequent risk of stress urinary incontinence , defined as self-report of stress urinary incontinence symptoms , incontinence episodes on a 3-day diary or surgical re-treatment . RESULTS Of the women who participated in the r and omized trial 74 % ( 482 of 655 ) were enrolled in the followup study . Urinary continence rates decreased during a period of 2 to 7 years postoperatively from 42 % to 13 % in the Burch group and from 52 % to 27 % in the sling group , respectively . Among the baseline factors included in the first multivariable model age ( p = 0.03 ) , prior stress urinary incontinence surgery ( p = 0.02 ) , menopausal status ( 0.005 ) , urge index ( 0.006 ) , assigned surgery ( p = 0.01 ) and recruiting site ( p = 0.02 ) were independently associated with increased risk of incontinence . In the final multivariable model including baseline and postoperative factors , Burch surgery ( p = 0.01 ) , baseline variables of prior urinary incontinence surgery ( p = 0.04 ) , menopausal status ( p = 0.03 ) and postoperative urge index ( p < 0.001 ) were each significantly associated with a greater risk of recurrent urinary incontinence . CONCLUSIONS Preoperative and postoperative urgency incontinence symptoms , Burch urethropexy , prior stress urinary incontinence surgery and menopausal status were negatively associated with long-term continence rates . More effective treatment of urgency urinary incontinence in patients who undergo stress urinary incontinence surgery may improve long-term overall continence status Introduction and hypothesisThe purpose of this study is to describe risk factors for post-operative urinary tract infection ( UTI ) the first year after stress urinary incontinence surgery . Methods Multivariable logistic regression analyses were performed on data from 1,252 women r and omized in two surgical trials , Stress Incontinence Surgical Treatment Efficacy trial ( SISTEr ) and Trial Of Mid-Urethral Slings ( TOMUS ) . Results Baseline recurrent UTI ( rUTI ; ≥3 in 12 months ) increased the risk of UTI in the first 6 weeks in both study population s , as did sling procedure and self-catheterization in SISTEr , and bladder perforation in TOMUS . Baseline rUTI , UTI in the first 6 weeks , and PVR > 100 cc at 12 months were independent risk factors for UTI between 6 weeks and 12 months in the SISTEr population . Few ( 2.3–2.4 % ) had post-operative rUTI , precluding multivariable analysis . In women with pre-operative rUTI , successful surgery ( negative cough stress test ) at 1 year did not appear to decrease the risk of persistent rUTI . Conclusions Pre-operative rUTI is the strongest risk factor for post-operative UTI OBJECTIVE To compare the efficacy of surgically managing stress urinary incontinence ( SUI ) with tension-free vaginal tape ( TVT ) and autologous fascia lata pubovaginal sling ( Lata ) . METHODS Sixty-seven patients suffering from SUI entered this prospect i ve study . The patients were divided into two groups r and omly , 48 in TVT group and 19 in Lata group . The average follow-up time post-operation was 20 months in TVT group and 37 months in Lata group . RESULTS The operating time was ( 27 + /- 5 ) min in TVT and ( 125 + /- 13 ) min in Lata . The volume of blood loss during surgery was : ( 27 + /- 6 ) ml in TVT and ( 67 + /- 11 ) ml in Lata . The post-operative recovery period in the hospital was : TVT , 1.8 days and Lata , 7.2 days . The differences between the two groups for these three parameters were statistically significant ( P < 0.01 ) . The 3-month cure rate post-operations was 94 % ( 45/48 ) for TVT and 95 % ( 18/19 ) for Lata . The surgical complications included 1 case of vesical perforation and 2 cases of overactive bladder in TVT group . CONCLUSIONS TVT and Lata are both effective and safe surgical treatments for stress urinary incontinence . TVT has the benefits of being minimally invasive with a shorter operating time and a quicker recovery for the patients . A disadvantage is that the tape used in TVT is expensive , making the operation rather costly . Lata on the other h and is cheaper and may result in fewer complications , but the operation is not as easy for the patient OBJECTIVES The aim of this study was to compare the long-term success rates , complication rates and patient satisfaction rates for Pelvicol pubovaginal sling ( Bard ) versus TVT ( Gynecare ) in surgical treatment of urodynamic stress incontinence ( USI ) in women . DESIGN Prospect i ve r and omized cohort trial . SETTING District General Hospital , South West of Engl and . METHODS One hundred and forty-two women with urodynamic stress incontinence were r and omized to either surgical procedure ( Pelvicol = 74 , TVT = 68 ) with median follow-up of 36 month . A postal question naire was sent to all women and the response rate was excellent at approximately 90 % in both groups . RESULTS Cure of incontinence , as identified by a quality of life improvement > 90 % , and /or patient-determined continent status as dry , were comparable in both groups . When the cure rates were adjusted assuming the non-respondents as failures the figures were almost identical ( p > 0.05 ) . Preoperative continence pad usage was similar for both groups . Overall , a postoperative significant decrease in pad score was noted in both groups ( p = 0.01 ) but there was no significant difference between the groups ( p > 0.05 ) . Statistical analysis failed to detect significant differences between both groups as regards complication rates such as frequency , nocturia , de-novo urgency or dyspareunia . CONCLUSION Pelvicol sling is a safe procedure in the surgical management of USI with similar success rate and patient satisfaction rate to TVT up to three years of follow-up Please cite this paper as : Guerrero K , Emery S , Wareham K , Ismail S , Watkins A , Lucas M. A r and omised controlled trial comparing TVTTM , PelvicolTM and autologous fascial slings for the treatment of stress urinary incontinence in women . BJOG 2010;117:1493–1503 OBJECTIVE The purpose of this study was to determine whether race/ethnicity affects urinary incontinence ( UI ) severity and bother in women who undergo surgery for stress incontinence . STUDY DESIGN We used baseline data from participants in the Stress Incontinence Surgical Treatment Efficacy trial . UI severity was measured by the number of leakage episodes during a 3-day urinary diary and by urodynamic evaluation . UI bother was measured with the Urogenital Distress Inventory . Race/ethnicity classification was based on self-report . RESULTS Of the 654 women , 72 women ( 11 % ) were Hispanic ; 480 women ( 73 % ) were non-Hispanic white ; 44 women ( 6.7 % ) were non-Hispanic black , and 58 women ( 8.9 % ) were of other race/ethnicity . No differences were seen in any UI severity measures . Non-Hispanic white women had the lowest Urogenital Distress Inventory scores on bivariate analysis , which was explained by socioeconomic status , body mass index , and age on multivariate analysis . CONCLUSION Factors other than racial/ethnic differences underlie variations in UI symptoms and bother in this group of women who sought surgery for stress incontinence Purpose : To compare short-term results of autologous pubovaginal sling and synthetic transobturator ( TOT ) SAFYRE sling in the treatment of female stress urinary incontinence ( SUI ) . Methods : Twenty women referred for surgical treatment of SUI were assigned r and omly to autologous pubovaginal sling or synthetic TOT sling . Inclusion criteria were primary treatment of SUI and urodynamic study showing SUI without detrusor overactivity . Pre- and postoperative quantification of the severity of incontinence was done by pad test and a vali date d question naire ( King ’s Health Question naire ) . Results : There were no differences in patients ’ mean age , parity , body mass index , rate of postmenopausal state , pelvic floor defects and mean Valsalva leak point pressure in the preoperative urodynamic study . Mean operating time ( 21.1 ± 3.8 vs. 69.5 ± 23.7 min ; P<0.001 ) and hospital stay ( 28.8 ± 8.4 vs. 44.4 ± 5.8 h ; P<0.001 ) was shorter in the TOT than the autologous group . The postoperative pad test ( 39.4 ± 12.5 vs. 8.4 ± 5.2 g ; P=0.01 ) and the absent in the improvement in the quality of life were significantly higher in the TOT group . Conclusion : Our initial results suggest that the synthetic TOT technique had worse effectiveness for treating female SUI compared to autologous pubovaginal sling PURPOSE Acellular cross-linked porcine dermis is a potential substitute for rectus fascia as a sling material with the advantage of decreased morbidity . However , the long-term efficacy is unknown . We compared the 3-year efficacy of PD vs autologous rectus fascia as a sling material for pubovaginal sling surgery in the treatment of urodynamic stress incontinence . MATERIAL S AND METHODS Between July 2000 and December 2001 a total of 101 consecutive , nonr and omized patients with USI underwent a PD ( 51 ) or RF ( 50 ) sling procedure . Patients were assessed at 6 weeks , and at 3 , 6 and 12 months postoperatively . Urodynamic study was repeated in cases of treatment failure . A detailed survey question naire was mailed to all patients at least 36 months after surgery and all responders were then retested by telephone interview by a blinded assessor . The primary outcome measure was patient perceived success rate ( cured or improved ) at least 36 months after PVS . Secondary outcome measures were patient satisfaction 36 months after surgery , durability of success with time and reoperation rate . RESULTS Complete data were available on 94 patients ( 48 treated with PD and 46 treated with RF sling ) . The groups were well matched for age , leak point pressure , prior incontinence surgery and urge symptoms . Pubovaginal sling was successful ( cured or improved ) in 37 ( 80.4 % ) patients treated with RF but in only 26 ( 54 % ) patients treated with PD 36 months after surgery ( Fisher 's exact test p = 0.009 ; 95 % CI 8.03 , 44.4 ) . Treatment failure occurred by 9 months after RF and by 24 months after PD sling procedure . Repeat urodynamic study showed USI to be the cause of treatment failure in 18 ( 37.5 % ) of 20 patients treated with PD but in only 3 ( 6.5 % ) of 8 patients treated with RF . CONCLUSIONS We have shown that use of the PD sling , although reducing early morbidity , results in a significantly inferior long-term cure rate in comparison to the RF sling . Therefore , acellular cross-linked porcine dermis should not be used as a substitute for rectus fascia OBJECTIVE Objective of the study was to compare the efficacy and the complications of tension-free vaginal tape ( TVT ) and Burch colposuspension in the treatment of female genuine stress incontinence ( GSI ) . METHODS In this controlled , prospect i ve , r and omized study , participated 35 patients who underwent Burch colposuspension and 36 patients that underwent TVT procedure . Patients with prolapse more than first degree , previous surgical treatment of stress urinary incontinence ( SUI ) and detrusor instability were excluded from the study . RESULTS The operative time for TVT was significantly shorter compared to BC . The severity and duration of postoperative pain for TVT was significantly less compared to BC . The necessary time for return to normal activity was 10 days for TVT and 21 days for BC . The cure rate after 24 months of follow-up was as follows : TVT : 84 % and BC : 86 % , while the improvement was 7 % for TVT and 6 % for BC . CONCLUSIONS TVT and Burch colposuspension are equally effective in the management of female GSI at two years follow-up . TVT procedure requires much less operative time , has much shorter hospitalization time , with significantly less postoperative pain and faster return to normal daily activities than Burch colposuspension PURPOSE We characterized continence , satisfaction and adverse events in women at least 5 years after Burch urethropexy or fascial sling with longitudinal followup of r and omized clinical trial participants . MATERIAL S AND METHODS Of 655 women who participated in a r and omized surgical trial comparing the efficacy of the Burch and sling treatments 482 ( 73.6 % ) enrolled in this long-term observational study . Urinary continence status was assessed yearly for a minimum of 5 years postoperatively . Continence was defined as no urinary leakage on a 3-day voiding diary , and no self-reported stress incontinence symptoms and no stress incontinence surgical re-treatment . RESULTS Incontinent participants were more likely to enroll in the followup study than continent patients ( 85.5 % vs 52.2 % ) regardless of surgical group ( p<0.0001 ) . Overall the continence rates were lower in the Burch urethropexy group than in the fascial sling group ( p=0.002 ) . The continence rates at 5 years were 24.1 % ( 95 % CI 18.5 to 29.7 ) vs 30.8 % ( 95 % CI 24.7 to 36.9 ) , respectively . Satisfaction at 5 years was related to continence status and was higher in women undergoing sling surgery ( 83 % vs 73 % , p=0.04 ) . Satisfaction decreased with time ( p=0.001 ) and remained higher in the sling group ( p=0.03 ) . The 2 groups had similar adverse event rates ( Burch 10 % vs sling 9 % ) and similar numbers of participants with adverse events ( Burch 23 vs sling 22 ) . CONCLUSIONS Continence rates in both groups decreased substantially during 5 years , yet most women reported satisfaction with their continence status . Satisfaction was higher in continent women and in those who underwent fascial sling surgery , despite the voiding dysfunction associated with this procedure PURPOSE Evaluate the impact autologous fascial sling ( AFS ) and tension-free vaginal tape ( TVT ) procedures on quality -of-life in incontinent women . MATERIAL S AND METHODS Forty-one women were r and omly distributed into two groups . Group G1 ( n = 21 ) , underwent AFS and group G2 ( n = 20 ) TVT implant . The clinical follow up was performed at 1 , 6 , 12 and 36 months . RESULTS TVT operative time was significantly shorter than AFS . Cure rates were 71 % at 1 month , 57 % at 6 and 12 months in G1 . In G2 , cure rates were 75 % at 1 month , 70 % at 6 months and 65 % at 12 months ; there was no significant difference between groups . As regards the satisfaction rate , there was no statistical difference between groups . Analysis of quality of life at 36 months revealed that there was no significant difference between groups . CONCLUSION Similar results between AFS and TVT , except for operative time were shorter in TVT Abstract Purpose : To evaluate tailored polypropylene ( prolene ) mesh , anterior rectus sheath , and vaginal wall slings positioned under the mid-urethra , to treat stress urinary incontinence ( SUI ) in women , as SUI is a common pathological condition causing considerable distress and compromising social , physical , psychological , and sexual health , and for which surgical treatment remains controversial . Patients and methods : This prospect i ve r and omised study included 32 patients with SUI , evaluated by SEAPI ( Stress , Emptying , Anatomy , Protection , and Instability ) symptom score and urodynamics . According to sling material , 12 patients had tailored prolene mesh , 12 had anterior rectus sheath and eight had anterior vaginal wall slings . Operative variables ( intraoperative bleeding , duration , complications and hospital stay ) were documented , and postoperative complications and continence status were assessed . The follow-up was 12–18 months . Results : Patients who received tailored prolene mesh slings had a lower operative duration and hospital stay , and less intraoperative bleeding . Postoperative complications , e.g. urinary retention and urgency , were < 12 % , with no significant differences . There was no significant difference among the three studied groups in the success rate ( 75 % , 67 % and 75 % ) . Conclusions : Tailored prolene mesh , anterior rectus sheath and the vaginal wall sling are good alternatives to treat SUI in women , with comparable results in a short-term follow up . The surgeon ’s experience and the patient ’s clinical circumstances should be considered when choosing a sling material , as success rates are comparable , being slightly better for the prolene sling in operative duration , bleeding and hospital stay Introduction and hypothesisThe aim of this study was to determine whether preoperative voiding detrusor pressures were associated with postoperative outcomes after stress incontinence surgery . Methods Opening detrusor pressure , detrusor pressure at maximum flow ( pdet Qmax ) , and closing detrusor pressure were assessed from 280 valid preoperative urodynamic studies in subjects without advanced prolapse from a multicenter r and omized trial comparing Burch and autologous fascia sling procedures . These pressures were compared between subjects with and without overall success , stress-specific success , postoperative detrusor overactivity , and postoperative urge incontinence using independent sample t tests . Results There were no clinical ly or statistically significant differences in mean preoperative voiding detrusor pressures in any comparison of postoperative outcomes . Conclusions We found no evidence that preoperative voiding detrusor pressures predict outcomes in women with stress predominant urinary incontinence undergoing Burch or autologous fascial sling procedures Objective . To determine baseline variables associated with urgency urinary incontinence ( UUI ) in women presenting for stress urinary incontinence ( SUI ) surgery . Methods . Baseline data from two r and omized trials enrolling 1,252 women were analyzed : SISTEr ( fascial sling versus Burch colposuspension ) and TOMUS ( retropubic versus transobturator midurethral sling ) . Demographic data , POP-Q measures , and vali date d measures of symptom severity and quality of life were collected . Charlson Comorbidity Index ( CCI ) and Patient Health Question naire-9 were measured in TOMUS . Multivariate models were constructed with UUI and symptom severity as outcomes . Results . Over two-thirds of subjects reported bothersome UUI at baseline . TOMUS patients with more comorbidities had higher UDI irritative scores ( CCI score 0 = 39.4 , CCI score 1 = 42.1 , and CCI score 2 + = 51.0 , P = 0.0003 ) , and higher depression scores were associated with more severe UUI . Smoking , parity , prior incontinence surgery/treatment , prolapse stage , and incontinence episode frequency were not independently associated with UUI . Conclusions . There were no modifiable risk factors identified for patient-reported UUI in women presenting for SUI surgery . However , the direct relationships between comorbidity level , depression , and worsening of UUI/urgency symptoms may represent targets for preoperative intervention . Further research is necessary to eluci date the pathophysiologic mechanisms that explain the associations between these medical conditions and bladder function OBJECTIVE The aim of this study was to compare a modified Burch procedure with a suburethral sling for the treatment of stress incontinence complicated by a low-pressure urethra . STUDY DESIGN Thirty-six women with stress incontinence , low-pressure urethra , and urethral hypermobility ( straining cotton swab angle > /=30 degrees ) were r and omly assigned to undergo either a modified Burch procedure ( n = 19 ) or a suburethral sling ( n = 17 ) . Objective and subjective cure rates at 3 months after the operation were the primary outcome measures . Comparisons of group means were performed with the Student t test for independent groups , and proportions were compared with the Fisher exact test . RESULTS After the operation the 2 groups had statistically similar cure rates and voiding function . Urethral closure pressure , pressure transmission ratios , and maximum detrusor pressure during voiding were significantly higher in the sling group . CONCLUSION At 3 months there were no clinical ly significant differences between the groups treated with suburethral sling and modified Burch procedures AIMS Many parameters have been utilized to try to estimate severity of stress urinary incontinence ( SUI ) . Valsalva leak point pressure ( VLPP ) measurements , have been proposed as a reliable means of gauging the severity of SUI during urodynamic studies ( UDS ) . Certain , non-invasive , measures of incontinence severity have been proposed , but the correlation of these measures with VLPP is not known . In addition , the correlation of other important UDS measures and VLPP has not been evaluated . In this study we sought to define the relationship between demographic characteristics , physical exam findings , and non-sphincteric UDS measures with VLPP in a large multicenter r and omized surgical trial comparing Burch urethropexy and fascial sling for the treatment of SUI . MATERIAL S AND METHODS Pre-surgical , st and ardized urodynamic measures were obtained in all participants in the Stress Incontinence Treatment Efficacy Trial ( SISTEr ) trial . All UDS were assessed for quality assurance and protocol compliance . VLPP was assessed using a < 8 Fr water transducer catheter during grade d Valsalva maneuvers at 200 ml , and then at 100 ml intervals and bladder capacity if no SUI was noted earlier . Only data from women who had SUI on at least two of three consecutive valsalva maneuvers was utilized for this analysis . Delta VLPP was determined as the average value , and the baseline vesical pressure was subtracted from the absolute vesical pressure to arrive at the reported VLPP value . Independent variables studied to assess their relationship to VLPP value included demographic characteristics ( age , number of pregnancies , # vaginal deliveries , hormone usage , previous hysterectomy , previous SUI surgery ) , physical exam parameters [ body mass index-- BMI , Pelvic Organ Prolapse-Quantified POPQ stage , POPQ Aa measurement , Q-tip angle ( rest ) and Q-tip angle ( strain ) , and change in angle ] , and other urodynamic parameters ( volume of first leakage , volume at first sensation , presence of detrusor overactivity , maximum cystometric capacity -- MCC , maximum flow rate -- Q(max ) , and detrusor pressure at maximum flow rate -- pdet . Q(max ) ) . RESULTS Among the 655 women r and omized , 424 were found to have evaluable VLPPs . Thirty-four had stage 3 or 4 prolapse and were excluded from the VLPP analysis . The remaining 390 women had a mean VLPP of 81.1 cm H(2)O. On bivariate analysis , there were significant positive associations with VLPP and BMI ( P = 0.026 ) , Q-tip straining angle ( P = 0.0002 ) change in Q-tip angle ( P = 0.0046 ) , MCC ( P < 0.0001 ) and pdet . Q(max ) ( P = 0.0003 ) . Age was negatively associated with VLPP ( P < 0.0001 ) . For categorical values , lower POPQ stage ( 0/1 ) , post menopausal status , and use of hormones were all associated with lower VLPP values . For example , patients with stage 2 had , on the average , VLPP values that were more than 10 cm H(2)O greater than those with stage 0/1 . On multivariate analysis , however , only lower age , greater BMI , greater MCC , greater pdet . Q(max ) , and lower Q(max ) were found to be independent associated with higher delta VLPP . CONCLUSIONS Advancing age , lower BMI , higher maximum flow rate , and lower voiding pressures are all independently associated with lower VLPP in women undergoing surgery for SUI . Lower voiding pressures and higher flow rates among women with more severe SUI may reflect the chronic loss of urethral resistance associated with SUI . Interestingly , urethral hypermobility as assessed by Q-tip testing angle does not achieve a statistically significant association with VLPP on multivariate testing when controlling for POP-Q stage . Thus , as clinical ly suspected , the Q-tip test is not predictive of VLPP in women with urethral hypermobility and SUI OBJECTIVE To determine reference urodynamic values for preoperative urodynamic studies in women undergoing surgery for pure or predominant stress urinary incontinence ( SUI ) . MATERIAL S AND METHODS Six hundred fifty-five women with pure or predominant SUI were enrolled in a multicenter surgical trial and were r and omized to undergo a Burch or autologous fascia sling procedure as part of the Urinary Incontinence Treatment Network ( UITN ) Stress Incontinence Surgical Treatment Efficacy Trial ( SISTEr ) . Preoperative free uroflowmetry , filling cystometry , and pressure flow studies were performed in all women using a st and ardized research protocol and st and ardized urodynamic interpretation guidelines . We define the normal range of urodynamic values in this population as the values that encompass 95 % of the results . RESULTS In 655 women undergoing filling cystometry in the st and ing position , baseline vesical and abdominal pressures were between 12 and 60 cm H(2)O. The upper limit of detrusor pressure increase during bladder filling to maximum cystometric capacity was 16 cm H(2)O. Ten percent of women who qualified for stress incontinence surgery with a positive cough stress test on physical exam did not demonstrate urodynamic stress incontinence ( USI ) and less than 10 % of subjects in this study demonstrated detrusor overactivity . CONCLUSIONS Results from a large cohort of women with SUI are now available for quantitative plausibility assessment s or as reference values when interpreting urodynamic studies PURPOSE To compare the results of Pubovaginal sling and Vaginal wall sling for the treatment of stress urinary incontinence in females . MATERIAL AND METHOD Between February 2001 and December 2001 , a r and omized controlled trial was done to compare safety and efficacy of pubovaginal sling versus vaginal wall sling in the management of women with urinary incontinence . Fifteen women 42 - 68 years old ( mean age 51.3 years ) were treated with fascial sling ( group A ) and 11 women 45 - 60 years old ( mean age 50.4 years ) with vaginal wall sling ( group B ) . Twenty-one patients had type II SUI and 5 patients had type III SUI ( ISD ) ; none had pre-operative detrusor instability . Measures of outcome included efficacy based on SEAPI-QMN , post-operative presence of stress or urge incontinence , frequency of complications , operative time , post-operative pain , length of hospitalization , length of clean intermittent catheterization ( CIC ) time and mean global evaluation . RESULTS All patients were followed for at least 3 months after surgery ( median 7 months ) . A total of 20 and 6 women received spinal and general anesthesia , respectively . SEAPI-QMN decreased from a median of 6.3 to 0.8 for group A and from 6.1 to 0.9 for group B. No patient in either group had persistent stress incontinence . Urge incontinence was present in 2 of group A patients and 1 of group B patients . No serious post-operative complications were encountered in both groups . Post-operative pain and operative times for group B patients were significantly lower than for group A patients . Length of hospitalization , length of CIC time and mean global evaluation were not significantly different between the two groups . CONCLUSION In the short-term , both pubovaginal sling and vaginal wall slings were effective in the treatment of women with SUI . However , the use of vaginal wall sling result ed in significantly shorter operative times and lower post-operative pain compared with pubovaginal sling . Therefore , the vaginal wall sling should be the prefered treatment for SUI Abstract The objective of this study was to compare porcine dermal sling ( Pelvicol ™ implant , Bard ) with tension-free vaginal tape ( TVT ) in the surgical treatment of stress incontinence . One hundred and forty-two women with genuine stress incontinence ( GSI ) were r and omly assigned to either Pelvicol ™ implant pubovaginal sling ( n=74 ) or TVT ( n=68 ) . They were followed up at a minimum of 6 months ( range 6–24 months ) , with a median follow-up of 12 months . The majority ( n=109 ) of procedures were carried out in a day surgery unit . The median operation time was 35 minutes ( range 15–60 ) in the TVT group and 30 minutes ( range 20–80 ) in the Pelvicol ™ implant group ; 81 % of the TVT group and 77 % of the Pelvicol ™ implant group were able to void urine within 24 hours , and had insignificant residual bladder volumes . The prevalence of postoperative symptomatic voiding dysfunction was 3.4 % after TVT and 1.4 % after Pelvicol ™ implant . Nine percent of the TVT group developed de novo urge incontinence and 6 % of the Pelvicol ™ implant group had de novo urge incontinence 6 months after the procedure . Postoperative evaluation was done at the outpatient department , and a postal question naire was also completed to determine subjective continence status . The patient-determined cure rate was 85 % in the TVT group and 89 % in the Pelvicol ™ implant group . The Pelvicol ™ implant sling had a comparable patient- determined success rate with TVT and should be considered in the surgical treatment of women with genuine stress incontinence Introduction and hypothesisThe unexpected absence of urodynamic stress incontinence ( USI ) in women planning surgery for stress urinary incontinence ( SUI ) is a challenge to surgeons . We examined the prevalence and clinical and demographic factors associated at baseline ( preoperatively ) with the unexpected absence of USI among study participants of two multicenter r and omized clinical trials of surgery for treating SUI . Methods Women with SUI symptoms and positive stress tests on physical examination enrolled in two separate clinical trials — one comparing the autologous fascial sling with the Burch colposuspension [ Stress Incontinence Surgical Treatment Efficacy Trial ( SISTEr ) , and the other comparing the retropubic mid-urethral sling with the transobturator midurethral sling [ Trial of Mid-Urethral Slings (TOMUS)]—were evaluated for USI preoperatively . The association of clinical , demographic , and urodynamic parameters was examined in women without USI in univariate and multivariate analyses . Results Overall , 144 of 1,233 women ( 11.7 % ) enrolled in the two studies showed no USI . These women had a significantly lower mean volume at maximum cystometric capacity than those with USI ( 347.5 vs. 395.8 in SISTEr , p = 0.012 ) , ( 315.2 vs. 358.2 in TOMUS , p = 0.003 ) and a lower mean number of daily accidents reported on a 3-day diary ( 2.2 vs 2.7 in SISTEr , p = 0.030 ) ( 1.7 vs 2.7 in TOMUS , p < 0.001 ) . Additionally , those without demonstrable USI were more likely to have Pelvic Organ Prolapse Quantification ( POP-Q ) stage III/IV ( 31.7 % vs 14.4 % in SISTEr , p = 0.002 ) , ( 15.5 % vs 6.9 % in TOMUS , p = 0.025 ) . SUI severity as recorded on the Urogenital Distress Inventory ( UDI ) correlated strongly with the presence of USI in both studies . Conclusions We observed that about one of eight women planning surgery for SUI does not show USI . Stage 3/4 POP was strongly associated with the unexpected absence of USI . A diminished urodynamic bladder capacity among women who did not display USI may reflect an inability to reach the limits of capacity during urodynamics , at which these women normally leak AIM The efficacy , safety and hospital costs of the tension-free vaginal tape procedure were compared with the pubovaginal sling operation . METHODS A total of 60 women urodynamically diagnosed as having stress or mixed urinary incontinence were operated on using either the tension-free vaginal tape or pubovaginal sling operation in a prospect i ve manner . Preoperative characteristics of the women were not significantly different for the groups . The women were followed for up to 24 months . RESULTS In the tension-free vaginal tape group , the operation time was shorter , numbers of analgesics postoperatively required were less and hospital charges were less expensive compared to those in the pubovaginal sling operation ( P < 0.01 ) . Kaplan-Meier survival analysis showed a marginal significant difference ( P = 0.059 ) in the objective cumulative cure rates at 24 months between the groups receiving the former ( 70.3 % ) and latter ( 48.3 % ) procedures . Subjective cure rates were not significantly different ( P = 0.101 ) . In both groups , an improvement in quality of life was significant and surgical complications were identical . De novo urge incontinence developed in 6 % and 10 % in the former and latter , respectively . CONCLUSIONS The tension-free tape was significantly superior to the pubovaginal sling in terms of operation time , postoperative pain , and hospital charges , but not in cure rates . A longer follow up with a larger sample size is necessary to draw definite conclusions PURPOSE We assessed the relationships among severity measures of urinary incontinence in women with stress predominant symptoms enrolled in a r and omized clinical trial comparing 2 surgical techniques ( Burch colposuspension vs pubovaginal sling ) for stress urinary incontinence . MATERIAL S AND METHODS A total of 655 women underwent a st and ardized preoperative assessment that included the Medical , Epidemiological and Social Aspects of Aging question naire , Urogenital Distress Inventory , Incontinence Impact Question naire , 3-day voiding diary , 24-hour pad test , a supine empty bladder stress test and Valsalva leak point pressure measurements . Correlations were estimated using Spearman correlation coefficients and 95 % confidence intervals . T tests at alpha=0.05 were conducted to compare the distributions of the continuous severity measure between patients with positive and negative supine empty bladder stress test . RESULTS Baseline mean scores on Medical , Epidemiological and Social Aspects of Aging , Urogenital Distress Inventory and Incontinence Impact Question naire were 25.8 , 151 and 171 , respectively . Mean incontinence episode frequency and pad weight were 3.2 per day and 43.5 gm , respectively . Supine empty bladder stress test was positive in 218 patients , and 428 patients had valid Valsalva leak point pressure measurements with a mean Valsalva leak point pressure of 80 cm H(2)O. Weak to moderate correlations were observed between Medical , Epidemiological and Social Aspects of Aging , incontinence episode frequency , pad weight , Incontinence Impact Question naire and Urogenital Distress Inventory . On the other h and , Valsalva leak point pressure correlated poorly with all variables measured . The sensitivity and specificity of the supine empty bladder stress test to predict intrinsic sphincter dysfunction were 49 % and 60 % , respectively . CONCLUSIONS Urinary incontinence severity measures correlate moderately with each other at best . While Medical , Epidemiological and Social Aspects of Aging demonstrated stronger correlations with the other measures of severity and quality of life , Valsalva leak point pressure did not . Supine empty bladder stress test did not demonstrate a clinical ly significant association among severity measures OBJECTIVE : To estimate costs for incontinence management , health-related quality of life , and willingness to pay for incontinence improvement in women electing surgery for stress urinary incontinence . METHODS : A total of 655 incontinent women enrolled in the Stress Incontinence Surgical Treatment Efficacy Trial , a r and omized surgical trial . Baseline out-of-pocket costs for incontinence management were calculated by multiplying self-report of re sources used ( supplies , laundry , dry cleaning ) by national re source costs ( $ 2006 ) . Health-related quality of life was estimated with the Health Utilities Index Mark 3 . Participants estimated willingness to pay for 100 % improvement in incontinence . Potential predictors of these outcomes were examined by using multivariable linear regression . RESULTS : Mean age was 52±10 years , and mean number of weekly incontinence episodes was 22±21 . Mean and median ( 25 % , 75 % interquartile range ) estimated personal costs for incontinence management among all women were $ 14±$24 and $ 8 ( interquartile range $ 3 , $ 18 ) per week , and 617 ( 94 % ) women reported any cost . Costs increased significantly with incontinence frequency and mixed compared with stress incontinence . The mean and median Health Utilities Index Mark 3 scores were 0.73±0.25 and 0.84 ( interquartile range 0.63 , 0.92 ) . Women were willing to pay a mean of $ 118±$132 per month for complete resolution of incontinence , and willingness to pay increased significantly with greater expected incontinence improvement , household income , and incontinent episode frequency . CONCLUSION : Urinary incontinence is associated with substantial costs . Women spent nearly $ 750 per year out of pocket for incontinence management , had a significant decrement in quality of life , and were willing to pay nearly $ 1,400 per year for cure . LEVEL OF EVIDENCE : The aim of this study was to compare the long-term results of a modified Burch procedure with a sling procedure for the treatment of stress incontinence with a low-pressure urethra . Thirty-six women with urodynamic stress incontinence , low-pressure urethra , urethral hypermobility and no significant pelvic organ prolapse were r and omly assigned to undergo either a modified Burch procedure ( n=19 ) or a sling placement ( n=17 ) . Cure of the stress incontinence ( defined as a negative stress test and negative pad-weight test ) was the primary long-term endpoint . Secondary endpoints included subjective cure of stress incontinence ( defined as no incontinence episodes on a 1-week voiding diary ) and voiding function studies . Comparisons of group means were performed with the Mann – Whitney U-test , pooled variance t-tests and separate variance t-tests . Proportions were compared with Fisher 's exact test . A logistic regression analysis was performed to control for covariates that differed in our two groups despite r and omization . Long-term follow-up ( mean=72.6 months ) was available for 82 % ( 28/34 ) of the original study group . The objective cure rates for the Burch and sling groups were 84.6 % and 100 % , respectively ( P=0.17 ) . Mean uroflowmetry rates for the Burch and sling groups were 7.38 and 6.8 ml/s , respectively ( P=0.58 , 95%CI −2.5 , 4.4 ) . Mean postvoid residual volumes for both groups were 35 ml ( P=0.97 , 95 % CI −23.8 , 65.9 ) . Two sling patients ( 12 % ) required partial resection of their slings because of erosion . Both patients remained continent . In terms of voiding function and stress incontinence cure , there were no differences between groups undergoing modified Burch or sling procedures for treatment of urodynamic stress incontinence with low-pressure urethra OBJECTIVES To describe the methods and rationale for the first r and omized controlled trial conducted by the Urinary Incontinence Treatment Network . METHODS The primary objective of this clinical trial is to compare two commonly performed surgical procedures for stress urinary incontinence-the Burch colposuspension and the autologous rectus fascial sling-for overall treatment success for urinary incontinence and stress-type symptoms of incontinence at 24 months after surgery . Secondary aims include a comparison of complications , quality of life , sexual function , patient satisfaction , costs , and the need for additional treatments or surgery ; and an evaluation of the prognostic value of preoperative urodynamic studies . The Stress Incontinence Surgical Treatment Efficacy Trial is being conducted on 655 women with predominant stress urinary incontinence , as determined by history and physical examination , urinary stress test with witnessed leakage , and voiding diary . Administration of all question naires and performance of examinations , tests , and both surgical procedures are st and ardized within and across the clinical centers . Assessment s occur preoperatively and at 6 weeks and 3 , 6 , 12 , 18 , and 24 months postoperatively . A sample of 655 women ensures 80 % power to detect a 12 % difference ( 60 % versus 72 % ) at the 5 % significance level . The intent-to-treat analysis will use Fisher 's exact test and time-to-failure analyses . RESULTS Enrollment was completed in June 2004 with 24 months of follow-up to end in June 2006 . CONCLUSIONS This is the first large , multicenter r and omized clinical trial comparing these two st and ard-of-care procedures for stress incontinence OBJECTIVE : To estimate whether perioperative and postoperative outcomes after Burch colposuspension or pubovaginal sling for stress urinary incontinence ( SUI ) differed with age . METHODS : This study was a prospect i ve secondary analysis of the Stress Incontinence Surgical Treatment Efficacy Trial . Baseline characteristics , adverse events , and 2-year outcomes of women at least 65 years old were compared with those younger than 65 years using χ2 and t tests . Multivariable analyses were performed , including age and outcomes that differed between age groups on univariable analysis , adjusting for variables that differed by age group at baseline and by surgical treatment group . RESULTS : Six-hundred fifty-five women were included in analyses of perioperative events and 520 for 2-year outcomes . Mean age ( ±st and ard deviation ) was 69.7 ( ±3.7 ) years in the older group and 49.4 ( ±8.2 ) in the younger group . Older women had slightly longer time to normal activities ( 50 days compared with 42 days , P=.05 ) , but there was no difference in time to normal voiding ( 14 days compared with 11 days , P=.42 ) . Older women were more likely to have a positive stress test at follow-up ( odds ratio [ OR ] 3.7 , 95 % confidence interval [ CI ] 1.70–7.97 , P=.001 ) , less subjective improvement in stress ( 8 point lesser decrease , 95 % CI 1.5–14.1 , P=.02 ) , and urge incontinence ( 7 point lesser decrease , 95 % CI 1.5–12.2 , P=.01 ) by the Medical and Epidemiologic Social Aspects of Aging question naire , and were more likely to undergo surgical retreatment for SUI ( OR 3.9 , 95 % CI 1.30–11.48 ) . Perioperative adverse events and length of stay did not differ between groups . CONCLUSION : Older women undergoing surgery for stress incontinence can expect to do as well as younger women with respect to perioperative outcomes , but experience 2-year outcomes that are worse . CLINICAL TRIAL REGISTRATION : Clinical Trials.gov , www . clinical trials.gov , NCT00064662 LEVEL OF EVIDENCE : Various authors have reported that a pubovaginal sling is efficacious for correction of all types of female stress incontinence.7 Autologous , cadaver , and synthetic allografts have been utilized as supporting material s. Leach et al16 have suggested that autologous slings decay over time , result ing in recurrent stress incontinence . Badlani et al10 have reported that synthetic material s are more durable in maintaining stable cure rates than autologous slings . Infectious and erosive complications of synthetic material s are well known . Urethral erosion is the most feared complication of synthetic sling surgery , causing many urologie surgeons to shy away from using synthetic bio material s. However , not all synthetic material s result in equally unfavorable reaction to human host tissues . Various synthetic material s have differing inherent biochemical and surface characteristics that result in different biological outcomes . This chapter will review these characteristics OBJECTIVE The purpose of this study was to assess patient expectations of surgical outcome after preoperative counseling of surgical procedures in a r and omized trial of 655 women in a comparison of the rectus fascial sling and Burch colposuspension . STUDY DESIGN Women who selected surgery for treating stress incontinence and who consented to this r and omized , surgical trial completed a preoperative question naire to assess expectations for the postsurgical effects of surgery on urinary incontinence-related symptoms , limitations , and emotions . Associations of expectations with a range of preoperative urinary incontinence measures were explored . RESULTS The most frequent preoperative symptoms were urine leakage ( 98 % ) , embarrassment ( 88 % ) , frequency ( 74 % ) , physical activity ( 72 % ) , and urgency ( 70 % ) . Sexual and social limitations were less frequent ( < or = 44 % ) . Treatment expectations were higher for women who reported more symptom bother . As expected , most women ( 98 % ) had an expectation that urine leakage would be completely or almost completely eliminated . However , most women ( 92 % ) who reported urgency or frequency ( 83 % ) expected significant improvement of these symptoms after surgery . CONCLUSION Patients who undergo stress incontinence surgery have high expectations regarding the outcome of incontinence surgery , which include the resolution of urgency and frequency OBJECTIVES Stress urinary incontinence affects between 10 percent and 50 percent of women . Surgery is commonly recommended for troublesome incontinence that does not respond to nonsurgical management . Tension-free vaginal tape ( TVT ) is a newer , minimal access surgical sling procedure , which is being increasingly adopted worldwide . The cost-effectiveness of TVT in comparison with other surgical procedures , particularly open colposuspension , is assessed . METHODS Effectiveness estimates came from a systematic review of TVT compared with other surgical procedures ( open and laparoscopic colposuspension , traditional slings , and injectables ) . Deterministic and probabilistic analyses were used to assess the likelihood of TVT being cost-effective . Sensitivity analyses assessed the impact of changing assumptions about cure rates and costs for TVT , cure rates for retreatment open colposuspension , and proportions of women who choose retreatment . RESULTS Reliable estimates of relative effectiveness were difficult to derive because the few r and omized controlled comparisons had not been optimally analyzed or fully reported . Results of the economic model suggested that TVT dominates open colposuspension ( lower cost and same quality of life years [ QALYs ] ) within 5 years after surgery . Stochastic analysis indicated that the likelihood of TVT being cost-effective was 100 percent if decision-makers are unwilling to pay for additional QALYs . TVT 's dominance depended on the assumption fact that retreatment open colposuspension has lower cure rates than a first colposuspension . CONCLUSIONS Analysis based on current short-term data indicates dominance of TVT over open colposuspension from approximately 5 years . There is a need for longer-term follow-up data from method ologically rigorous r and omized trials to provide a sounder basis for estimating the relative benefits and cost implication This r and omised control trial compares full-length autologous slings ( Group A : 81 women ) with a modified “ sling-on-a-string ” ( Group B : 84 women ) technique for the treatment of stress urinary incontinence ( SUI ) . Primary outcomes are quality of life ( QoL ) scores ; Group A/Group B. The IIQ-7 scores decrease from 1.91/1.85 at baseline to 0.65/0.72 at 12 months and 0.85/0.92 at + 5 years . The UDI-6 scores decrease from 1.85/1.61 at baseline to 0.66/0.62 at 12 months and 1.22/1.08 at + 5 years . The incidence of SUI is 13 % at 3 months but averages 53 % at + 5 years . Both techniques offer similar improvements . The shorter sling is quicker , less painful and with less hospital readmissions . The ‘ sling-on-a-string ’ technique is as effective as the st and ard technique with better short-term sequelae . The incidence of SUI post-autologous slings rises over the long term Objective To determine the sensitivity and specificity of several urodynamic testing methods in the diagnosis of genuine stress urinary incontinence ( GSI ) . Methods One hundred eight consecutive patients were evaluated prospect ively by history and physical examination , cough stress test , and single and multichannel urodynamics . Sensitivities and specificities in detecting genuine stress incontinence were calculated for : a positive cough stress test with a negative cystometrogram , equalization throughout a cough urethral pressure profile , a positive stress leak-point pressure determination , observed urine loss with cough during multichannel urodynamics , and a pressure transmission ratio of less than 90 % for each third of the urethra . Results Sixty-five patients ( 60 % ) were found to have GSI . Observed urine loss with cough during multichannel studies was 91 % sensitive and 100 % specific . A positive stress leak-point pressure determination had a 78 % sensitivity and was 100 % specific . A positive cough stress test with a negative cystometrogram was 77 % sensitive and 100 % specific . Pressure equalization throughout the length of the urethra during a cough urethral pressure profile was 49 % sensitive and 98 % specific . A pressure transmission ratio of less than 90 % in the distal , middle , and proximal urethra had sensitivities and specificities of 54 and 79 % , 51 and 65 % , and 45 and 58 % , respectively . A pressure transmission ratio of less than 90 % along the entire length of the urethra was 22 % sensitive and 93 % specific . Conclusion Observed urine loss with cough during multichannel urodynamics was the best examination for diagnosing GSI in our population PURPOSE We determined the clinicodemographic factors associated with complications of continence procedures , the impact of concomitant surgery on the complication rate and the relationship between the incidence of cystitis and the method of postoperative bladder drainage . MATERIAL S AND METHODS We review ed serious adverse events and adverse events in the Stress Incontinence Surgical Efficacy Trial , a r and omized trial comparing Burch colposuspension to the autologous rectus fascial sling . Clinicodemographic variables were analyzed to determine those associated with adverse events using logistic regression analysis . Complications were stratified based on the presence or absence of concomitant surgery . Differences in complication rates ( controlling for concomitant surgery ) and cystitis rates ( controlling for the bladder emptying method ) were compared using Fisher 's exact test . RESULTS Blood loss ( p = 0.0002 ) and operative time ( p < 0.0001 ) were significantly associated with an adverse event . Patients who underwent concomitant surgery had a significantly higher serious adverse event rate ( 14.2 % vs 7.3 % , p = 0.01 ) and adverse event rate ( 60.5 % vs 48 % , p < 0.01 ) than patients who underwent continence surgery alone . Cystitis rates were higher in the sling vs the Burch group up to 6 weeks postoperatively regardless of concomitant surgery status ( p < 0.01 ) . Intermittent self-catheterization increased the cystitis rate by 17 % and 23 % in the Burch and sling groups , respectively . CONCLUSIONS Concomitant surgery at continence surgery increased the risk of complications . Sling surgery was associated with a higher risk of cystitis within the first 6 weeks postoperatively . Intermittent self-catheterization increased the risk of cystitis in each group . Complications were associated with surgical factors and not with patient related factors Abstract We compared morbidity and success rate of pubovaginal sling with Burch colposuspension operations in Type I/type II genuine stress urinary incontinence ( GSI ) . The study included patients who had no preoperative detrusor instability ( DI ) , no recurrent GSI , no severe pelvic prolapsus and whose Valsalva leak point pressure ( VLPP ) values were higher than 90 cm water . Twenty three of free-rectus fascial sling and 23 of Burch colposuspension operations were performed r and omly on the patients by a single surgeon . There was no statistical difference between patients in terms of age , BMI , parity , number of daily pads used and preoperative bladder neck mobility . Operation time , change in hematocrit , spontaneous voiding time , length of hospitalization and urinary infection were not different in 2 procedures . 17 patients from both groups could be compared after one year . The bladder neck mobility of both groups were similar . One surgical failure , 1 DI , 1 severe cystocele and 1 enterocele were found in the Burch group while only 1 DI was found in the pubovaginal sling group . When pubovaginal sling operation was performed as the primary surgery on the patients with type I/II GSI , the morbidity , complications and 1 year success rate are the same as Burch procedure Background : A wide variety of surgical procedures has been used to treat female stress urinary incontinence ( SUI ) . The purpose of this study was to compare cadaveric fascia lata ( CFL ) sling with intravaginal slingplasty ( IVS ) in the surgical treatment of SUI . Methods : One hundred and thirty-nine women with SUI were r and omly assigned to either CFL sling ( n = 67 ) or IVS ( n = 72 ) . Concomitant urinary urge incontinence was present in 49 patients ( 73 % ) in the CFL sling and 44 patients ( 61 % ) in the IVS group . Daily mean pad usage was 4.1 ± 3.5 in the CFL sling and 2.9 ± 1.7 in the IVS group . The objective cure rate was evaluated by the pad test , and patient satisfaction rate was assessed by a subjective question naire . Results : The surgical results of both procedures with a follow-up 12 months were documented . The overall success rate was 79 % in the CFL sling and 70.8 % in the IVS ( p = 0.261 ) . In contrast patient satisfaction rates were 82 and 87.5 % , respectively ( p = 0.210 ) . Comparison of the CFL sling with IVS showed persistent urinary urge incontinence in 67 and 25 % ( p = 0.0001 ) and de novo urinary urge incontinence in 22 and 6.9 % , respectively ( p = 0.009 ) . The groups did not differ significantly with respect to intraoperative and postoperative complications . Conclusions : There is no statistical difference in the overall success , satisfaction and complication rates in either group . In our series , both procedures were found to be effective , durable and significantly improved quality of life in patients with SUI but long-term results are awaited Introduction and hypothesisTo underst and the patient burden of study procedures / measures at completion of a r and omized controlled trial ( RCT ) requiring extensive testing and follow-up visits . Methods A survey sent after completing the 2-year visit of an RCT comparing Burch colposuspension and fascial retropubic sling to treat stress urinary incontinence assessed degree of bother for seven study procedures , eight study -related factors , and possible motivations to participate in the study . Results A total of 450 study participants ( 88 % ) returned the survey . Urodynamic testing was the most bothersome procedure , followed by 24-h pad test and Q-tip test . Self-administered question naires were the least bothersome . Main reasons to participate in the study were to help others , obtain better knowledge about the condition , and be guided by a committed team of investigators/ study coordinators . Conclusions At the end of a large multicenter RCT , we learned from a confidential patient survey that the most burdensome activities involved invasive procedures , frequent visits , and multiple forms to fill out OBJECTIVES To compare short-term functional outcomes , urodynamic parameters , and quality of life of transobturator and retropubic routes in the cure of urinary stress incontinence . POPULATION AND METHODS This prospect i ve , multicentre study involved 88 women undergoing suburethral sling procedure for stress urinary incontinence ( SUI ) . The retropubic route ( RPR ) and the transobturator route ( TOR ) were used in 42 and 46 women , respectively . No difference in epidemiologic and preoperative urinary functional status ( SUI stage , and pollakiuria , nocturia , and urgency rates ) was found between the groups . Functional results and quality of life were evaluated before surgery and at 1 , 3 , 6 , and 12 mo postoperatively . Urodynamic examinations were performed before and 3 mo after surgery . RESULTS The mean follow-up was 10 mo . No difference in the rate of de novo urge incontinence and immediate and late voiding dysfunction was noted between the groups . No difference in the cure rate was observed between the groups ( 89.3 % in the RPR group and 88.6 % in the TOR group ) . RPR was associated with a significant decrease in maximum urinary flow and an increase in residual urine volume . Quality of life was significantly improved after surgery without difference between the groups . CONCLUSIONS Retropubic and transobturator routes for treatment of female SUI have similar high cure rates and quality of life improvement . Because of advantages in the rate of complications and postoperative pain previously demonstrated on the same population , the transobturator route appears to be the best option for the treatment of urinary incontinence PURPOSE Urodynamic studies have been proposed as a means of identifying patients at risk for voiding dysfunction after surgery for stress urinary incontinence . We determined if preoperative urodynamic findings predict postoperative voiding dysfunction after pubovaginal sling or Burch colposuspension . MATERIAL S AND METHODS Data were analyzed from preoperative , st and ardized urodynamic studies performed on participants in the Stress Incontinence Treatment Efficacy Trial , in which women with stress urinary incontinence were r and omized to undergo pubovaginal sling surgery or Burch colposuspension . Voiding dysfunction was defined as use of any bladder catheter after 6 weeks , or reoperation for takedown of a pubovaginal sling or Burch colposuspension . Urodynamic study parameters examined were post-void residual urine , maximum flow during noninvasive flowmetry , maximum flow during pressure flow study , change in vesical pressure at maximum flow during pressure flow study , change in abdominal pressure at maximum flow during pressure flow study and change in detrusor pressure at maximum flow during pressure flow study . The study excluded women with a preoperative post-void residual urine volume of more than 150 ml or a maximum flow during noninvasive flowmetry of less than 12 ml per second unless advanced pelvic prolapse was also present . RESULTS Of the 655 women in whom data were analyzed voiding dysfunction developed in 57 including 8 in the Burch colposuspension and 49 in the pubovaginal sling groups . There were 9 patients who could not be categorized and , thus , were excluded from the remainder of the analysis ( 646 ) . A total of 38 women used a catheter beyond week 6 , 3 had a surgical takedown and 16 had both . All 19 women who had surgical takedown were in the pubovaginal sling group . The statistical analysis of urodynamic predictors is based on subsets of the entire cohort , including 579 women with preoperative uroflowmetry , 378 with change in vesical pressure , and 377 with change in abdominal and detrusor pressure values . No preoperative urodynamic study findings were associated with an increased risk of voiding dysfunction in any group . Mean maximum flow during noninvasive flowmetry values were similar among women with voiding dysfunction compared to those without voiding dysfunction in the entire group ( 23.4 vs 25.7 ml per second , p = 0.16 ) , in the Burch colposuspension group ( 25.8 vs 25.7 ml per second , p = 0.98 ) and in the pubovaginal sling group ( 23.1 vs 25.7 ml per second , p = 0.17 ) . Voiding pressures and degree of abdominal straining were not associated with postoperative voiding dysfunction . CONCLUSIONS In this carefully selected group preoperative urodynamic studies did not predict postoperative voiding dysfunction or the risk of surgical revision in the pubovaginal sling group . Our findings may be limited by the stringent exclusion criteria and study ing a group believed to be at greater risk for voiding dysfunction could alter these findings . Additional analysis using subjective measures to define voiding dysfunction is warranted to further determine the ability of urodynamic studies to stratify the risk of postoperative voiding dysfunction , which appears to be limited in the current study Objective To compare the pubovaginal sling and transurethral Macroplastique in the treatment of female stress urinary incontinence ( SUI ) and intrinsic sphincter deficiency ( ISD ) Objective To assess the effectiveness and late postoperative morbidity of the Burch procedure and the sling procedure for the treatment of recurrent urinary stress incontinence after vaginal hysterectomy and anterior repair . Methods Clinical , urodynamic , and sonographic examinations were done on 77 women suffering with recurrent urinary stress incontinence . The women were r and omized to two groups , modified Burch colposuspension and lyophilized dura mater sling surgery ; 72 women were reexamined 32–48 months after these procedures . Results The cure rate at 32–48 months ' follow-up was 86 % for the Burch procedure and 92 % for the sling . Women who had had the sling procedure demonstrated a clear decrease in maximal bladder capacity , from 330 to 240 mL ( P < .05 ) . In both groups , stress profiles demonstrated a shift of maximal pressure point toward the proximal urethra and a significant improvement in pressure transmission ( P < .05 ) . The post-operative patients who had persistent incontinence were found to have insufficient elevation of the bladder neck ( less than 10 mm ) . The uroflow examination showed an increase of urination time in both groups . The incidence of bladder problems was 10 % with the Burch procedure and 29 % with the sling procedure ; however , 13 % of the Burch group developed rectoceles . Conclusion Both procedures offer a high rate of success . We believe that the sling surgery should be used only in certain special cases because of its higher rate of complications , but that posterior vaginal repair should be considered after modified Burch colposuspension because of the possibility of rectocele and enterocele OBJECTIVE To determine the method ological quality of studies evaluating surgery for stress incontinence , the effectiveness of different procedures and the frequency of complications associated with each procedure . MATERIAL S AND METHODS Eleven r and omized controlled trials , 20 non-r and omized trials/ prospect i ve cohort studies and 45 retrospective cohort studies were review ed systematic ally . RESULTS The method ological quality of the 31 prospect i ve studies was generally poor . The considerable variation in inclusion criteria , surgical management and assessment of outcome precluded any statistical meta- analysis . Evidence as to the effectiveness of surgery for stress incontinence is weak ; therefore , any conclusions are speculative . It appears that colposuspension may be more effective and the effect more long-lasting than that following anterior colporrhaphy and needle suspension . There is little information on the value of sling procedures . Comparisons of different ways of performing each procedure show no significant differences in outcome but this may reflect the method ological weaknesses of the studies . Valid and reliable data on the frequency of complications following surgery are lacking so the safety of the procedures is unclear . Repeat operations to correct stress incontinence are less successful than first procedures but this finding may be subject to confounding . CONCLUSIONS There is an urgent need for some large , rigorous , prospect i ve studies of high quality . Until such studies have been completed , recommendations as to the best clinical practice can not be based on scientific evidence . Studies need to define cases according to widely accepted criteria , including st and ard measures of the severity of stress incontinence , and surgical terminology for the procedures performed needs to be st and ardized and outcomes need to be clearly defined , valid and reliable , not confined to short-term assessment and include patients ' views along with the surgeon 's assessment It is difficult to make a choice among the many surgical procedures design ed for the correction of stress urinary incontinence by the vaginal route because their results have not been correctly compared . The Bologna ( B ) operation uses two flaps from the anterior vaginal wall that are anchored to the abdominal wall ; the Ingelman-Sundberg ( IS ) operation is a suburethral sling made from two transplants from the pubococcygeus muscle . A prospect i ve r and omized study has been carried out in order to compare these two procedures . A selection of cases has been based upon the presence of genuine or potential stress incontinence , genital prolapse and available tissues ( anterior vaginal wall excess and palpable pubococcygeus muscles ) for both procedures . No significant difference was noted for clinical results ( 91.7 % and 93.7 % of patients cured by the B and IS operations , respectively ) or for transmission rate gain at 3 months and 1 year . Maximum urethral closing pressure was maintained in both treatment arms . No significant postoperative complication or persistent dysuria occurred . The Bologna procedure is best indicated in case of frank anterior vaginal excess , and the Ingelman-Sundberg procedure when strong anterior parts of pubococcygeus muscles are available . Both are excellent in the cure of stress incontinence associated with genital prolapse OBJECTIVE Our purpose was to evaluate and compare the long-term results of the Bologna and the Ingelman-Sundberg procedures for the treatment of stress urinary incontinence in women with genital prolapse . PATIENTS AND METHODS Forty-seven women underwent surgery at the gynecologic division at Dunkirk Hospital , France between January 1989 and August 1990 . All patients presented a genital prolapse with a cystocele of at least degree 2 associated with urinary stress incontinence . The subjects were r and omly allocated to one of the two procedures . In the clinical incontinence group ( 28 patients ) , 12 procedures were Bologna operations and 16 were Ingelman-Sundberg operations . In the potential incontinence group ( 19 patients ) , 11 procedures were Bologna operations and 8 were Ingelman-Sundberg operations . Physical examination and urodynamic explorations were performed preoperatively , and 3 months and 1 year postoperatively . A question naire was sent to all participating women during the tenth year of follow-up . We obtained 46 answers . RESULTS Mean follow-up was 9.7 years . The result of the 1-year postoperative evaluation has been previously published . At 1 year , complete cure was achieved in 91.7 % of the patients who underwent the Bologna procedure and 93.7 % in those who had the Ingelman-Sundberg procedure . At 10 years , the cure rate was 72.7 % and 56.2 % ( p<0.05 ) respectively . After the first year , the decline in cure rate was twice as fast with the Ingelman-Sundberg procedure than with the Bologna operation . CONCLUSION The longevity of the Bologna procedure is greater than that of the Ingelman-Sundberg procedure . Recovery rate declines by 20 % in 9 years . All results of urinary stress incontinence surgery were good after the first year . One has to wait 5 to 10 years before reliable informative results can be obtained . This fact should be taken into consideration before accepting to use of new procedures Introduction and objectives The resting urethral pressure profile ( UPP ) , used for the assessment of women with stress incontinence , is routine in many urodynamic units . It is time- and effort-consuming , and its diagnostic value is controversial , as well as its value in the prediction of outcome of anti-incontinence surgery . Herein , we assessed its value in the prediction of the outcome of surgery . Patients and methods Sixty women were r and omized to fascial sling or TVT . Urodynamics were performed preoperatively , 6 months and annually thereafter . After filling and voiding cystometry , resting UPP was performed while sitting . Automated catheter pulling , at a rate of 1 mm/s , was adopted . Averaged readings were obtained . Comparison of maximum urethral closure pressure ( MUCP ) in success and failure , as well as in sling and TVT , was performed , utilizing ANOVA . Results Preoperative MUCP and functional urethral length ( FUL ) were 72.9 ± 27.9 cmH2O and 2.4 ± 0.7 cm . At last follow-up , they were 71.1 ± 20.7 cmH2O and 2.7 ± 0.7 cm , respectively . The differences between sling and TVT as regards value of MUCP and FUL were not significant . The relationship of the outcome of surgery and UPP parameters showed no statistical difference . No significant effect was shown for the success of surgery , duration of follow-up , and interaction of outcome and time over MUCP ( P = 0.82 , 0.56 and 0.69 , respectively ) or FUL ( P = 0.82 , 0.11 and 0.67 , respectively ) . Conclusion The routine use of resting UPP has no added value in terms of the prediction of success of incontinence surgery . It does not help with follow-up and adds to the time and cost of the examination BACKGROUND Many surgical procedures are available for women with urinary stress incontinence , yet few r and omized clinical trials have been conducted to provide a basis for treatment recommendations . METHODS We performed a multicenter , r and omized clinical trial comparing two procedures --the pubovaginal sling , using autologous rectus fascia , and the Burch colposuspension -- among women with stress incontinence . Women were eligible for the study if they had predominant symptoms associated with the condition , a positive stress test , and urethral hypermobility . The primary outcomes were success in terms of overall urinary-incontinence measures , which required a negative pad test , no urinary incontinence ( as recorded in a 3-day diary ) , a negative cough and Valsalva stress test , no self-reported symptoms , and no retreatment for the condition , and success in terms of measures of stress incontinence specifically , which required only the latter three criteria . We also assessed postoperative urge incontinence , voiding dysfunction , and adverse events . RESULTS A total of 655 women were r and omly assigned to study groups : 326 to undergo the sling procedure and 329 to undergo the Burch procedure ; 520 women ( 79 % ) completed the outcome assessment . At 24 months , success rates were higher for women who underwent the sling procedure than for those who underwent the Burch procedure , for both the overall category of success ( 47 % vs. 38 % , P=0.01 ) and the category specific to stress incontinence ( 66 % vs. 49 % , P<0.001 ) . However , more women who underwent the sling procedure had urinary tract infections , difficulty voiding , and postoperative urge incontinence . CONCLUSIONS The autologous fascial sling results in a higher rate of successful treatment of stress incontinence but also greater morbidity than the Burch colposuspension . ( Clinical Trials.gov number , NCT00064662 [ Clinical Trials.gov ] . ) To evaluate the outcome of surgery for stress urinary incontinence ( SUI ) in patients presenting with a combination of stress and sensory urge UI PURPOSE We identified baseline demographic and clinical factors associated with treatment failure after surgical treatment of stress urinary incontinence . MATERIAL S AND METHODS Data were obtained from 655 women r and omized to Burch colposuspension or autologous rectus sling . Of those , 543 ( 83 % ) had stress failure status assessed at 24 months ( 269 Burch , 274 sling ) . Stress failure ( 261 ) was defined as self-report of stress urinary incontinence by the Medical , Epidemiological , and Social Aspects of Aging question naire , positive stress test or re-treatment for stress urinary incontinence . Nonstress failure ( 66 ) was defined as positive 24-hour pad test ( more than 15 ml ) or any incontinent episodes by 3-day voiding diary with none of the 3 criteria for stress failure . Subjects not meeting any failure criteria were considered a treatment success ( 185 ) . Adjusting for surgical treatment group and clinical site , logistic regression models were developed to predict the probability of treatment failure . RESULTS Severity of urge incontinence symptoms ( p = 0.041 ) , prolapse stage ( p = 0.013 ) , and being postmenopausal without hormone therapy ( p = 0.023 ) were significant predictors for stress failure . Odds of nonstress failure quadrupled for every 10-point increase in Medical , Epidemiological , and Social Aspects of Aging question naire urge score ( OR 3.93 CI 1.45 , 10.65 ) and decreased more than 2 times for every 10-point increase in stress score ( OR 0.36 , CI 0.16 , 0.84 ) . The associations of risk factors and failure remained similar regardless of surgical group . CONCLUSIONS Two years after surgery , risk factors for stress failure are similar after Burch and sling procedures and include greater baseline urge incontinence symptoms , more advanced prolapse , and menopausal not on hormone replacement therapy . Higher urge scores predicted failure by nonstress specific outcomes PURPOSE Video urodynamic changes were compared after the pubovaginal sling procedure using rectus fascia or polypropylene mesh in women with stress urinary incontinence . MATERIAL S AND METHODS A total of 50 women with various types of stress urinary incontinence were treated with the pubovaginal sling procedure using r and omly abdominal rectus fascia in 24 or polypropylene mesh in 26 . The sling was placed at the level of the bladder neck and tied with sufficient tension to prevent urinary leakage without obstructing the bladder outlet . Video urodynamics were performed preoperatively , and 7 to 14 days and 3 to 6 months postoperatively in all cases . Surgical results and urodynamic changes after the pubovaginal sling procedure were compared in the 2 groups . Long-term results were evaluated at a mean followup of 2 years . RESULTS Complete continence was achieved in 23 patients ( 95.8 % ) in the rectus fascia group and 26 ( 100 % ) in the polypropylene mesh group , including 1 initial failure with reoperation , at a median followup of 24 and 23 months , respectively . The subjective success rate was 91.6 % for rectus fascia and 92.3 % for polypropylene mesh . The main cause of dissatisfaction was persistent urge incontinence and dysuria in 2 cases each . In each group video urodynamics revealed a mild but nonsignificant decrease in maximum urinary flow and a significant increase in bladder neck opening time at 7 to 14 days versus baseline . However , these parameters returned to baseline within 3 to 6 months postoperatively . Voiding pressure , cystometric capacity and post-void residual urine also showed no significant change in either group after the pubovaginal sling procedure . Patients treated with a polypropylene mesh sling had a shorter operative time and hospital stay , a higher spontaneous voiding rate after catheter removal and a lower incidence of wound pain after surgery . One patient treated with polypropylene mesh had sling margin extrusion . The incidence of new onset detrusor instability and persistent dysuria was similar in the 2 groups . Transrectal sonography of the sling showed that it was located beneath the bladder neck and proximal urethra in all patients in each group . CONCLUSIONS The results of this study show that the pubovaginal sling procedure using rectus fascia or polypropylene mesh as the sling material had similar effectiveness for treating female stress incontinence but the polypropylene group had more rapid recovery . Postoperatively video urodynamics demonstrated that the pubovaginal sling using either sling material did not cause bladder outlet obstruction with proper surgical technique OBJECTIVE We sought to describe change in sexual function 2 years after surgery to treat stress urinary incontinence . STUDY DESIGN This analysis included 655 women r and omized to Burch colposuspension or sling surgery . Sexual activity was assessed by the Pelvic Organ Prolapse/Urinary Incontinence Sexual Question naire ( PISQ-12 ) among those sexually active at baseline and 2 years after surgery . RESULTS Mean PISQ-12 total score improved from baseline 32.23 + /- 6.85 to 36.85 + /- 5.89 . After surgery , fewer subjects reported incontinence ( 9 % vs 53 % ; P < .0001 ) , restriction of sexual activity as a result of fear of incontinence ( 10 % vs 52 % ; P < .0001 ) , avoidance of intercourse because of vaginal bulging ( 3 % vs 24 % ; P < .0001 ) , or negative emotional reactions during sex ( 9 % vs 35 % ; P < .0001 ) . Women with successful surgery had greater improvement PISQ-12 scores ( 5.77 vs 3.79 ; P < .006 ) . Sexually active women were younger , thinner , and had lower Medical , Epidemiological , and Social Aspects of Aging scores ( total and urge subscale ) than sexually inactive women . CONCLUSION Sexual function improves after successful surgery and does not differ between Burch and sling This prospect i ve r and omised study involved 52 female patients suffering from recurrent stress urinary incontinence , objective ly confirmed by means of clinical incontinence tests and urodynamic examinations . They alternatively underwent colposuspension according to Burch or suburethral sling procedure surgery . Urodynamic and sonographic examinations were carried out before and 2.5 years ( i.e. within a range of 2 - 3 ) after surgery according to Burch or suburethral sling procedure . There was no significant difference between the two methods with respect to subjective and objective rate of cure , which amounted to 85 % of the cases involving colposuspension and 88 % of cases involving the suburethral sling procedure . Both methods result ed in a significant improvement of the depression quotient and a significant elevation of the internal urethral meatus ( p < 0.05 ) . Apart from an aggravation of urge symptoms in both groups , the patients with surgery according to Burch tended towards enterocele and rectocele in the medium range , whereas urination disorders had to be accepted in the patients operated on according to the sling procedure in the long term The CONSORT statement is used worldwide to improve the reporting of r and omised controlled trials . Kenneth Schulz and colleagues describe the latest version , CONSORT 2010 , which up date s the reporting guideline based on new method ological evidence and accumulating OBJECTIVE The aim of this study was to identify factors associated with urinary incontinence severity at baseline in women undergoing surgery for stress incontinence . STUDY DESIGN Baseline data were obtained from 650 women ( age 28 to 81 years ) with stress incontinence participating in a r and omized surgical trial . Severity of incontinence was defined by the mean number of incontinence episodes per day recorded in a 3-day bladder diary . The relationships between severity and several baseline variables were examined , including demographics , medical , obstetric , and gynecologic history , body mass index , smoking status , Q-tip displacement , and Pelvic Organ Prolapse Quantification stage ( POP-Q ) . RESULTS In a multivariable model , severity of incontinence was positively associated with body mass index ( P = .0003 ) and current smoking ( P = .01 ) , and negatively associated with prolapse stage ( P < .0001 ) and Q-tip displacement ( P = .042 ) . CONCLUSION Incontinence severity in a surgical population was independently associated with 2 modifiable factors , obesity and tobacco use , as well as pelvic support PURPOSE The incidence of urinary incontinence in women of childbearing age is about 30 % . Around half have stress incontinence . Many treatment modalities have been eluci date d to treat stress incontinence , and among the most popular are rectus fascia sling and tension-free vaginal tape ( TVT ) . The introduction of TVT to the urological armamentarium put a multiplicity of synthetic material s into use in the correction of stress urinary incontinence . A comparison of the impact of these 2 commonly used techniques is needed . MATERIAL S AND METHODS A total of 53 female patients older than 21 years ( mean age 45.09 ) were r and omized , using closed envelopes , to undergo TVT or rectus fascia sling . R and omization was performed after patients received spinal anesthesia . One surgeon performed the 2 types of treatment . Associated grade 2 cystocele was simultaneously corrected . Patients with bladder or urethral pathology , as well as those with cystocele greater than grade 2 , were excluded from analysis . RESULTS All 53 patients completed 6 months of followup and all had stress urinary incontinence . There were 15 patients who underwent sling surgery and 17 who underwent TVT who had concomitant grade 1 or 2 cystocele . No statistically significant difference was found between the 2 groups at baseline . Cure was accomplished in 23 of 25 ( 92 % ) with sling and in 26 of 28 ( 92.9 % ) with TVT at first followup visit ( 1 week ) . There were 7 patients who needed at least 1 extra week of catheterization in the sling group and 3 in the TVT group . No significant difference was detected in terms of post-void residual urine , symptom score , and filling and voiding parameters . At 6 months 1 patient had de novo detrusor overactivity and 7 had wound pain . Compared to those with TVT , 2 cases of sling were considered treatment failures , none had de novo overactivity and 2 had wound pain . None of the patients had symptoms suggestive of urethral erosion . CONCLUSIONS Rectus fascia sling and TVT seem to be equally effective regarding primary outcome measure ( ie cure of stress incontinence ) . Symptom score related to incontinence surgery as well as simultaneous correction of cystocele are comparable in the 2 groups . Fascial sling is a longer treatment process yet it is more economical . Longer followup is vital before rigorous conclusions can be drawn OBJECTIVE To use data from a r and omized controlled trial and up date an earlier economic evaluation of surgery versus collagen injection for the treatment of female stress urinary incontinence ( SUI ) . MATERIAL S AND METHODS A decision tree model was developed using probabilities of success and complications from a r and omized controlled trial . Re source use and cost data were taken from the earlier economic evaluation . The primary outcome was treatment success , which was defined as a negative 24 hour PAD test given 1 year post-treatment . The evaluation was conducted from the ' healthcare system ' perspective and separate analyses were undertaken for Ontario and Québec . Sensitivity analyses were used to examine uncertainty in probabilities and costs . RESULTS Surgery was generally more costly and more successful than collagen injection . Incremental cost effectiveness ratios indicated that the healthcare system would incur an additional cost of $ 121.08 to $ 341.35 per additional patient that was successfully treated with surgery . Sensitivity analyses showed that surgery would be less costly and more successful than collagen injection if the postoperative length of hospital stay was reduced to 1 day . Surgery might also be more cost effective than collagen injection if the number of injections used to treat patients were to increase beyond two for treatment successes and four for treatment failures . CONCLUSIONS Collagen injection is an outpatient procedure without risk of significant morbidity or complications . However , this does not readily translate into a clear cost effective advantage relative to surgery . In some cases , surgery may be more cost effective than collagen injection in the treatment of female SUI PURPOSE We prospect ively compared transvaginal antimicrobial mesh ( MycroMesh * ) and anterior vaginal wall slings using an outcomes analysis . MATERIAL S AND METHODS Between August 1997 and November 1998 we implanted transvaginal slings in 40 consecutive women r and omized to a synthetic mesh ( 20 ) or vaginal wall ( 20 ) group . All patients had documented stress urinary incontinence on preoperative urodynamics . We prospect ively compared postoperative outcomes data obtained from pelvic examinations , cough stress test , cotton swab test and vali date d patient question naires using a visual analog scale . RESULTS Complete followup was available in all patients . Mean followup was 22 months ( range 12 to 27 ) . Stress incontinence was cured in 95 % of the mesh and 70 % of the vaginal wall group , and pelvic prolapse was cured in 100 % and 95 % , respectively . Transient de novo urge incontinence was noted in 12.5 % of the mesh and 14.3 % of the vaginal wall group . Mean postoperative cotton swab angle during Valsalva 's maneuver was 20 and 45 degrees for the mesh and vaginal wall groups , respectively . The incidence of urinary retention and tissue erosion was 0 % for both groups . The satisfaction rate was 100 % and 80 % for the mesh and vaginal wall groups , respectively . CONCLUSIONS The antimicrobial MycroMesh sling was superior to the vaginal wall sling for correction of stress incontinence and pelvic prolapse with comparatively low morbidity OBJECTIVE To analyze the use of the Gore-Tex in the treatment of exertion incontinence . METHODS During 1991 , two gynecology units used the Mouchel technique and a Goebell-Stoeckel type technique in 72 patients with exertion incontinence , alone in 36 and in combination with a cure for prolapsus in 36 others . Results were analyzed with the chi 2 squared test and the Student 's test for paired series . RESULTS The rate of incontinence was 65 % with a range from 60 to 66.7 % according to the type of technique used and whether a cure for prolapsus was also performed . Gore-Tex was not well tolerated in 23/72 cases . Rejection was seen in 20 to 37.5 % according to the type of vaginal suture and the type of protection . CONCLUSION The high rate of rejection suggests prudence in using Gore-Tex Objective : To compare the safety and efficacy of three types of suburethral slings for the treatment of urodynamic stress incontinence PURPOSE We compared 2 measures of urethral hypermobility , the Q-tip test and voiding cystourethrogram , preoperatively in women recruited in 1 center participating in a multicenter r and omized clinical trial comparing Burch colposuspension with autologous rectus fascia sling . MATERIAL S AND METHODS Following institutional review board approval , women with stress urinary incontinence and pelvic organ prolapse stage 2 or less underwent a st and ardized st and ing voiding cystourethrogram and a Q-tip test at a 45 degree angle reclining position preoperatively . Urethral angle at rest and straining were measured with a radiological ruler ( voiding cystourethrogram ) or goniometer ( Q-tip ) by 2 different investigators blinded to each other findings . RESULTS In 43 patients the mean urethral angle at rest and UAS were 20 degrees + /- 12 and 51 degrees + /- 20 , by voiding cystourethrogram compared to 16 degrees + /- 9 and 58 degrees + /- 10 by Q-tip test , respectively . The mean angle difference ( urethral angle with straining minus urethral angle at rest ) was greater for the Q-tip test ( 42 degrees + /- 9 ) than that for the voiding cystourethrogram test ( 32 degrees + /- 17 ; p < 0.05 ) . Fewer patients ( 14 % by Q-tip , 28 % by voiding cystourethrogram ) had urethral hypermobility using the definition of urethral angle at rest greater than 30 , while almost all patients ( 91 % by voiding cystourethrogram , 100 % by Q-tip ) had urethral hypermobility using the definition of urethral angle with straining greater than 30 . However , using the definition of urethral angle with straining minus urethral angle at rest greater than 30 , only 58 % of patients had urethral hypermobility by voiding cystourethrogram compared to 98 % by Q-tip . CONCLUSIONS The voiding cystourethrogram and the Q-tip test measure urethral hypermobility differently . This may affect which patients are classified as having urethral hypermobility , and the choice of anti-incontinence surgery OBJECTIVE To compare the cure rate and confirm the clinical efficacy of the 3 most frequently performed surgical procedures for stress urinary incontinence ( SUI ) . METHODS Between January 2001 and May 2003 , 92 women with SUI were r and omly assigned to undergo the Burch colposuspension ( n=33 ) , pubovaginal sling ( n=28 ) , or tension-free vaginal tape ( n=31 ) at the Department of Obstetrics and Gynecology , Yonsei Medical Center , Seoul , Korea . Patient characteristics , urodynamic study results , cure rates at 3 , 6 , and 12 months , and complication rates were compared using the chi2 test . RESULTS There were no statistically significant differences in the cure rates initially , but after 12 months the cure rate of the pubovaginal sling procedure was found to be significantly higher than those of the tension-free vaginal tape or Burch colposuspension procedures . CONCLUSION The cure rate of the pubovaginal sling procedure was significantly higher after 1 year , but no difference in efficacy was observed between the 2 other procedures . A r and omized prospect i ve study of a larger population should be conducted OBJECTIVE To evaluate the use of Goretex pubovaginal sling and compare the results with a typical indigenous material graft made of rectal fascia . METHODS We have prospect ively evaluated 48 consecutive patients in a r and omized fashion in whom a sling procedure was performed to treat their type III incontinence . Sixteen women had a vesicourethral suspension ( VUS ) by a Goretex sling and another group of 32 patients , comparable in age range and medium age with the previous group , had a similar VUS by a sling from the rectus abdominis fascia . Both groups were evaluated urodynamically 6 and 30 months later . RESULTS In the first group , cure of incontinence was observed in 87.5 % and in the remaining patients it was significantly improved . In 2 patients there was an erosion of the urethra and the Goretex sling had to be removed 3.5 years later . Three other women remained dry but complained of occasional irritative symptoms . In the remaining 11 there was no erosion and the excellent postoperative result was maintained . In the group with fascial slings there was no erosion observed and in general they had less irritative symptoms . Cure or improvement of incontinence was comparable with the first group when studied 6 months after surgery , but there was a significant difference in the 30 months postoperative evaluation . CONCLUSIONS Use of a Goretex sling provides better long-term results even though it is associated with somewhat increased morbidity Summary . Twenty women with urodynamically proven genuine stress incontinence were r and omly allocated to treatment by suburethral sling or Stamey endoscopic bladder neck suspension . Urodynamic assessment was performed before and 3 months after surgery ; clinical follow‐up is reported up to 2 years . Blood loss was greater , and there were significantly more postoperative complications associated with the sling procedures . The subjective and objective cure rates at 3 months and 2 years were not significantly different between the two procedures . No significant changes in the resting urethral pressure profile were evident , although with both procedures , cure was associated with an enhancement in pressure transmission ratios in the proximal urethra . Detrusor instability occurring for the first time after operation was associated with both procedures ; the sling , in addition , induced a significant degree of outflow obstruction , although this was not evident after the Stamey procedure Background and Purpose : The purpose of this study was to describe how clinical pelvic-floor muscle ( PFM ) strength ( force-generating capacity ) is related to patient characteristics , lower urinary tract symptoms , and fecal incontinence symptoms . Subjects : Data were obtained from 643 women who were participating in a r and omized surgical trial for treatment of stress urinary incontinence . Methods : Patient demographic variables , baseline urinary and fecal incontinence symptom question naires , urodynamic data and urinary diary data , pad test results , and st and ardized assessment of pelvic organ support were compared with PFM strength as described by the Brink scoring system . Bivariate analysis of factors associated with the Brink scale score was done using analysis of variance and linear regression . Multivariate analysis included patient variables that were significant on bivariate analysis . Results : The mean Brink scale score was 9 ( SD=2 ) and did not vary widely in this large , but highly select , patient sample . We found a weak , but statistically strong , relationship between age and Brink score . Brink scores were not related to diary and pad test measures of incontinence severity . Discussion and Conclusion : Overall , PFM strength was good in this sample of women with stress incontinence . Scores tended to be similar , and it is possible that the Brink scale does not reflect real clinical differences in PFM strength OBJECTIVE To identify urodynamic changes that correlate with successful outcomes after stress urinary incontinence ( SUI ) surgery . METHODS Six-hundred fifty-five women were r and omized to Burch colposuspension or autologous fascial sling as part of the multicenter Stress Incontinence Surgical Treatment Efficacy Trial . Preoperatively and 24 months after surgery , participants underwent st and ardized urodynamic testing that included noninvasive uroflowmetry , cystometrogram , and pressure flow studies . Changes in urodynamic parameters were correlated to a successful outcome , defined a priori as ( 1 ) negative pad test ; ( 2 ) no urinary incontinence on 3-day diary ; ( 3 ) negative cough and Valsalva stress test ; ( 4 ) no self-reported SUI symptoms on the Medical , Epidemiologic and Social Aspects of Aging Question naire ; and ( 5 ) no re-treatment for SUI . RESULTS Subjects who met criteria for surgical success showed a greater relative increase in mean Pdet@Qmax ( baseline vs 24 months ) than women who were considered surgical failures ( P = .008 ) . Although a trend suggested an association between greater increases in bladder outlet obstruction index and outcome success , this was not statistically significant . Other urodynamic variables , such as maximum uroflow , bladder compliance , and the presence of preoperative or de novo detrusor overactivity did not differ with respect to outcome status . CONCLUSIONS Successful outcomes in both surgical groups ( Burch and sling ) were associated with higher voiding pressures relative to preoperative baseline values . However , concomitant changes in other urodynamic voiding parameters were not significantly associated with outcome OBJECTIVES To compare , in a multicenter , r and omized clinical trial , collagen injections versus surgery with regard to efficacy , quality of life , satisfaction , and complications . METHODS Of 133 women with stress urinary incontinence , 66 were r and omized to collagen injection and 67 to surgery ( 6 needle bladder neck suspensions , 19 Burch , and 29 slings ) . After r and omization , 15 women refused their allocated treatment . " Intent-to-treat " and " per protocol " analyses were applied . Women assigned to collagen injection could receive up to three injections before it was considered a failure . A " top-up " injection was allowed within 3 months after cure . Success as the primary outcome at 12 months was defined as a dry 24-hour pad test ( 2.5 g or less of urine ) after having received only the allocated intervention . RESULTS The per protocol analysis showed that the success rate 12 months after collagen injections ( 53.1 % ) was much lower than that after surgery ( 72.2 % ) . The difference was 19.1 % ( 95 % confidence interval -36.2 % to -2 % ) . The general and disease-specific quality -of-life scores measured by the R and Medical Outcomes Study 36-item Health Survey and Incontinence Impact Question naire were similar in the two groups ( P = 0.306 ) . Women treated by surgery were , on average , more satisfied ( 79.6 % ) than those treated by collagen injection ( 67.2 % ) , but the difference was not significant ( P = 0.228 ) . Finally , complications were less frequent and severe with collagen injection : 36 events in 23 subjects for collagen injection versus 84 events in 34 subjects for surgery ( P = 0.03 ) . CONCLUSIONS One year after intervention , the success rate of collagen injection as a treatment for stress urinary incontinence was about 19 % lower than that after surgery . This has to be tempered by the similar changes in quality of life and satisfaction in both groups and that the number and severity of complications were much greater after surgery than after collagen injection . The results of this study indicate that collagen injections might be a worthwhile alternative to surgery for the treatment of stress urinary incontinence PURPOSE We determined the prognostic value of preoperative urodynamic results in patients with stress urinary incontinence . MATERIAL S AND METHODS In a 9-center surgical trial , women with stress urinary incontinence were r and omized to a Burch or pubovaginal sling procedure . Women were eligible for the study if they had predominant stress urinary incontinence symptoms , a positive cough stress test , a bladder capacity more than 200 ml and urethral hypermobility . Preoperative free uroflowmetry , filling cystometry and pressure flow studies were performed in all . Overall treatment success required a negative pad test , no urinary incontinence on a 3-day diary , a negative stress test , no self-reported stress urinary incontinence symptoms and no re-treatment for stress urinary incontinence . Stress specific success required all of the last 3 criteria . We examined urodynamic measures , and whether the presence of urodynamic stress incontinence , the presence of detrusor overactivity and Valsalva leak point pressure would predict surgical success . RESULTS Subjects with urodynamic stress incontinence had a 2-fold greater odds of overall success when compared with the No urodynamic stress incontinence group , but this trend did not quite reach statistical significance ( OR 2.26 ; 95 % C.I. 0.99 , 5.17 ) . Odds of stress specific success did not differ by urodynamic stress incontinence status . Subjects with detrusor overactivity did not have significantly worse success rates . Stratifying by treatment group , there was no difference in mean Valsalva leak point pressure values between surgical successes and failures . CONCLUSIONS We found a nearly statistically significant trend that women with urodynamic stress incontinence are twice as likely to have a successful overall outcome from surgical management of stress urinary incontinence as women without urodynamic stress incontinence . The level of Valsalva leak point pressure and the presence of detrusor overactivity do not predict the success outcomes after the Burch or autologous fascia sling procedures in women with pure or predominant stress urinary incontinence . The impact of urodynamic studies on surgical outcomes needs further investigation Objective To assess specific parturition and reproductive variables as potential risk factors for urinary incontinence in later life . Methods a mail survey was conducted with a r and om sample of 1922 women members of a large health maintenance organization . Multivariate analysis was used to estimate the independent association between parturition factors , husterectomy , hormone use , and incontinence . Results Completed surveys were returned by 939 women ( 49 % ) , 682 of whom reported at least one episode of incontinence in the past 12 months or ever having been treated for incontinence . On univariate analysis , women with incontinence were more likely to be white and heavier and to have had a hysterectomy before age 45 , at least one live birth , a post date ( at least 42 weeks ' gestation ) birth , alabor lasting longer than 24 hours , and exposure to oxytocin . The risk of incontinence increased significantly with the number of exposures to oxytocin . In a multivariate model including age , there was a significant association between incontinence and white race ( odds ratio [ OR ] 1.8 , 95 % confidence interval [ CI ] 1.2 , 2.8 ) , body mass ( OR for fourth quartile 3.0 , 95 % CI 1.8 , 5.0 ) , estrogen replacement ( OR 1.9 , 95 % CI 1.3 , 2.8 ) and oxytocin ( OR 1.9 , 95 % CI 1.0 , 3.6 ) . Parity was also associated with incontinence ( P < .05 ) . Conclusion This study supports previous findings of a positive association between urinary incontinence and body mass , parity , and use of estrogen . In addition , we found a significant independent association between exposure to oxytocin during labor and incontinence in later life AIMS To identify predictors and correlates of patient satisfaction 24 months after Burch colpopexy or autologous fascial sling for treatment of stress urinary incontinence ( SUI ) . METHODS Participants were the 655 r and omized subjects in the Stress Incontinence Surgical Treatment Efficacy Trial ( SISTEr ) . Variables potentially associated with satisfaction were tested in bivariate analysis , including demographics , baseline clinical characteristics of incontinence , and outcomes on vali date d subjective and objective measures . Satisfaction with treatment was defined as a response of " completely satisfied " or " mostly satisfied " on the Patient Satisfaction Question naire ( PSQ ) at 24 months . Variables significantly related to satisfaction were entered into multivariable regression models to test their independent association with satisfaction . RESULTS At 24 months post-surgery , 480 ( 73 % ) participants completed the PSQ . Mean ( ±SD ) age of the sample was 52 ( ±10 ) years and 77 % were white . Most ( 82 % ) were completely or mostly satisfied with their surgery related to urine leakage . In the final multivariable model , patient satisfaction was associated with greater reduction in SUI symptoms ( from baseline to 24 months ; OR = 1.17 , 95 % CI : 1.10 , 1.24 ) and greater reductions in symptom distress ( OR = 1.16 ; CI : 1.08 , 1.24 ) . Lower odds of satisfaction were associated with greater urge incontinence symptoms at baseline ( OR = 0.09 , CI : 0.04 , 0.22 ) , detrusor overactivity at 24 months ( OR = 0.29 , CI : 0.12 , 0.69 ) , and a positive stress test at 24 months ( OR = 0.45 , CI : 0.22 , 0.91 ) . CONCLUSIONS Stress incontinent women who also have urge incontinence symptoms may benefit from additional preoperative counseling to set realistic expectations about potential surgical outcomes or proactive treatment of urge incontinence symptoms to minimize their post-operative impact Objectives : To compare two different procedures , tension-free vaginal tape ( TVT ) and autologous rectus fascia sling , according to their medium-term subjective and objective outcomes and satisfaction rates in the treatment of urinary stress incontinence in women . Subjects and Methods : One hundred women with type II urinary stress incontinence were r and omized to be treated with either TVT or autologous rectus fascia sling . They were evaluated by means of a cough-induced stress test , 1-hour pad test , Incontinence Impact Question naire ( IIQ ) , and urodynamic study . They were reevaluated postoperatively every 6 months , and the collected data of more than 1 year ’s follow-up were compared with preoperative assessment s. Results : All patients completed the full 6-month postoperative assessment . However , of the 100 patients , only 61 ( 25 in the TVT and 36 in the sling group ) were followed for more than 1 year . Mean follow-up time was 38.5 and 40 months in the TVT and sling group , respectively . Objective cure was achieved in 22 ( 88 % ) of the TVT group and in 30 ( 83 % ) of the sling group ( p = 0.78 ) using a cough-induced stress test , and in 76 and 75 % of the women in the TVT versus sling group ( p = 0.83 ) , respectively , using a 1-hour pad test . Postoperative mean IIQ scores were 44.3 ( range 35.5–61.5 ) and 48.5 ( range 38.5–69.7 ) in the TVT versus sling group ( p = 0.46 ) . Five ( 20 % ) and 11 ( 30 % ) of the TVT and sling group , respectively , reported some changes in the voiding pattern or posture at more than 1 year ’s follow-up . Conclusion : There is no significant difference between the TVT and autologous rectus fascia sling procedures in the treatment of urinary stress incontinence at medium-term follow-up . There were changes in the voiding pattern for patients in both groups at more than 1 year postoperatively , which were not evident at early follow-up |
11,550 | 28,982,217 | The yoga group showed significant improvement in their quality of life according to the Satisfaction With Life Scale ( SWLS ) ( P < 0.05 ) , while the ACT group had significant improvement in the World Health Organization Quality of Life-BREF ( WHOQOL-BREF ) scale ( P < 0.01).Overall , we assessed the quality of evidence as low ; no reliable conclusions can be drawn at present regarding the efficacy of yoga as a treatment for epilepsy .
Results of the overall efficacy analysis show that yoga treatment was better when compared with no intervention or interventions other than yoga ( postural exercises mimicking yoga ) .
There was no difference between yoga and Acceptance and Commitment Therapy .
Physician blinding would normally be taken to be the person delivering the intervention , whereas we think the ' physician ' would in fact be the outcome assessor ( who could be blinded ) , so that would be a reduction in detection bias rather than performance bias . | BACKGROUND This is an up date d version of the original Cochrane Review published in the Cochrane Library , Issue 5 , 2015.Yoga may induce relaxation and stress reduction , and influence the electroencephalogram and the autonomic nervous system , thereby controlling seizures .
Yoga would be an attractive therapeutic option for epilepsy if proved effective .
OBJECTIVES To assess whether people with epilepsy treated with yoga:(a ) have a greater probability of becoming seizure free;(b ) have a significant reduction in the frequency or duration of seizures , or both ; and ( c ) have a better quality of life . | Fifty three patients with asthma underwent training for two weeks in an integrated set of yoga exercises , including breathing exercises , suryanamaskar , yogasana ( physical postures ) , pranayama ( breath slowing techniques ) , dhyana ( meditation ) , and a devotional session , and were told to practise these exercises for 65 minutes daily . They were then compared with a control group of 53 patients with asthma matched for age , sex , and type and severity of asthma , who continued to take their usual drugs . There was a significantly greater improvement in the group who practised yoga in the weekly number of attacks of asthma , scores for drug treatment , and peak flow rate . This study shows the efficacy of yoga in the long term management of bronchial asthma , but the physiological basis for this beneficial effect needs to be examined in more detail Objective To examine the prevalence of outcome reporting bias — the selection for publication of a subset of the original recorded outcome variables on the basis of the results — and its impact on Cochrane review s. Design A nine point classification system for missing outcome data in r and omised trials was developed and applied to the trials assessed in a large , unselected cohort of Cochrane systematic review s. Research ers who conducted the trials were contacted and the reason sought for the non-reporting of data . A sensitivity analysis was undertaken to assess the impact of outcome reporting bias on review s that included a single meta- analysis of the review primary outcome . Results More than half ( 157/283 ( 55 % ) ) the review s did not include full data for the review primary outcome of interest from all eligible trials . The median amount of review outcome data missing for any reason was 10 % , whereas 50 % or more of the potential data were missing in 70 ( 25 % ) review s. It was clear from the publications for 155 ( 6 % ) of the 2486 assessable trials that the research ers had measured and analysed the review primary outcome but did not report or only partially reported the results . For reports that did not mention the review primary outcome , our classification regarding the presence of outcome reporting bias was shown to have a sensitivity of 88 % ( 95 % CI 65 % to 100 % ) and specificity of 80 % ( 95 % CI 69 % to 90 % ) on the basis of responses from 62 trialists . A third of Cochrane review s ( 96/283 ( 34 % ) ) contained at least one trial with high suspicion of outcome reporting bias for the review primary outcome . In a sensitivity analysis undertaken for 81 review s with a single meta- analysis of the primary outcome of interest , the treatment effect estimate was reduced by 20 % or more in 19 ( 23 % ) . Of the 42 meta-analyses with a statistically significant result only , eight ( 19 % ) became non-significant after adjustment for outcome reporting bias and 11 ( 26 % ) would have overestimated the treatment effect by 20 % or more . Conclusions Outcome reporting bias is an under-recognised problem that affects the conclusions in a substantial proportion of Cochrane review s. Individuals conducting systematic review s need to address explicitly the issue of missing outcome data for their review to be considered a reliable source of evidence . Extra care is required during data extraction , review ers should identify when a trial reports that an outcome was measured but no results were reported or events observed , and contact with trialists should be encouraged PURPOSE Psychological interventions in the treatment of epilepsy have been developed and evaluated for many years but the amount of research has hardly made an impact on how epilepsy is treated . The purpose of this study was to develop and evaluate a psychological treatment program consisting of acceptance and commitment therapy ( ACT ) together with some behavioral seizure control technology shown to be successful in earlier research . METHODS The method consisted of a r and omized controlled trial group design with repeated measures ( n=27 ) . All participants had an EEG verified epilepsy diagnosis with drug refractory seizures . Participants were r and omized into one of two conditions , ACT or supportive therapy ( ST ) . Therapeutic effects were measured by examining changes in quality of life ( SWLS and WHOQOL ) and seizure index ( frequency x duration ) . Both treatment conditions consisted of only nine hours of professional therapy distributed in two individual and two group sessions during a four-week period . RESULTS The results showed significant effects over all of the dependent variables for the ACT group as compared to the ST group at six- and twelve-month follow-ups . CONCLUSIONS The results from this study suggest that a short-term psychotherapy program combined with anticonvulsant drugs may help to prevent the long-term disability that occurs from drug refractory seizures We determined the efficacy of progressive muscle relaxation in reducing seizure frequency . Subjects were 24 people with epilepsy attending an urban neurology clinic . The experimental design consisted of an 8-week baseline period , a treatment period of six sessions of progressive relaxation training ( PRT , n = 13 ) or quiet sitting ( QS , n = 11 ) and an 8-week follow up . In the PRT group , 11 subjects reported a decrease in seizure frequency ( p less than 0.01 ) , and in the QS group , 7 reported a decrease ( p greater than 0.05 ) . The mean decrease in seizure frequency was 29 % for the PRT group ( p less than 0.01 ) but only 3 % for the QS group ( p greater than 0.05 ) . This is the fifth recent report of a controlled study documenting the success of progressive relaxation therapy in seizure reduction . PRT is inexpensive and noninvasive and facilitates patient participation . Such a technique should be incorporated into clinical practice The effects of two pranayama yoga breathing exercises on airway reactivity , airway calibre , symptom scores , and medication use in patients with mild asthma were assessed in a r and omised , double-blind , placebo-controlled , crossover trial . After baseline assessment over 1 week , 18 patients with mild asthma practised slow deep breathing for 15 min twice a day for two consecutive 2-week periods . During the active period , subjects were asked to breathe through a Pink City lung ( PCL ) exerciser -- a device which imposes slowing of breathing and a 1:2 inspiration : expiration duration ratio equivalent to pranayama breathing methods ; during the control period , subjects breathed through a matched placebo device . Mean forced expiratory volume in 1 s ( FEV1 ) , peak expiratory flow rate , symptom score , and inhaler use over the last 3 days of each treatment period were assessed in comparison with the baseline assessment period ; all improved more with the PCL exerciser than with the placebo device , but the differences were not significant . There was a statistically significant increase in the dose of histamine needed to provoke a 20 % reduction in FEV1 ( PD20 ) during pranayama breathing but not with the placebo device . The usefulness of controlled ventilation exercises in the control of asthma should be further investigated Hatha-Yoga has become increasingly popular in western countries as a method for coping with stress . However , little is known about the physiological and psychological effects of yoga practice . We measured heart rate , blood pressure , the hormones cortisol , prolactin and growth hormone and certain psychological parameters in a yoga practicing group and a control group of young female volunteers reading in a comfortable position during the experimental period . There were no substantial differences between the groups concerning endocrine parameters and blood pressure . The course of heart rate was significantly different , the yoga group had a decrease during the yoga practice . Significant differences between both groups were found in psychological parameters . In the personality inventory the yoga group showed markedly higher scores in life satisfaction and lower scores in excitability , aggressiveness , openness , emotionality and somatic complaints . Significant differences could also be observed concerning coping with stress and the mood at the end of the experiment . The yoga group had significant higher scores in high spirits and extravertedness Three children with very frequent refractory epileptic seizures underwent a behavioral intervention consisting of symptom discrimination , counter measures , contingent relaxation , and positive reinforcement for correct responses in a systematic replication series . The studies involved a 6-h nonintervention base rate , a 6-h treatment phase , and a 6-h nonintervention follow-up under laboratory conditions for each child . Neurophysiologic and behavioral measures of the effects of treatment were made using electroencephalogram (EEG)-video equipment . Effects of treatment were assessed by using a r and om sample of EEG-video sequences in base rate and follow-up . Results showed that no significant reduction of either seizure behavior or paroxysmal EEG activity was found subsequent to training in discrimination of early paroxysmal activity and /or sensations preceding seizures . Both seizure behavior and paroxysmal activity were significantly reduced in all three cases following intervention with an adapted countermeasure technique . No additional effects could be noted subsequent to the application of either contingent relaxation or positive reinforcement for correct responses . Paroxysmal EEG changes and seizure behavior were highly correlated . Reduction of the clinical manifestation or seizure response by behavioral manipulation was accompanied by a reduction of the total amount of paroxysmal activity as measured by the EEG The effect of Sahaja yoga meditation on 32 patients with primary idiopathic epilepsy on regular and maintained antiepileptic medication was studied . The patients were r and omly divided into 3 groups : group I practice d Sahaja Yoga meditation twice daily for 6 months under proper guidance ; group II practice d postural exercises mimicking the meditation for the same duration ; and group III was the control group . Visual Contrast Sensitivity ( VCS ) , Auditory Evoked Potentials ( AEP ) , Brainstem Auditory Evoked Potentials ( BAEP ) , and Mid Latency Responses ( MLR ) were recorded initially ( 0 month ) and at 3 and 6 months for each group . There was a significant improvement in VCS following meditation practice in group I participants . Na , the first prominent negative peak of MLR and Pa , the positive peak following Na did not register changes in latency . The Na-Pa amplitude of MLR also showed a significant increase . There were no significant changes in the absolute and interpeak latencies of BAEP . The reduced level of stress following meditation practice may make patients more responsive to specific stimuli . Sahaja Yoga meditation appears to bring about changes in some of the electrophysiological responses studied in epileptic patients OBJECTIVE Yoga and relaxation techniques have traditionally been used by nonmedical practitioners to help alleviate musculoskeletal symptoms . The objective of this study was to collect controlled observations of the effect of yoga on the h and s of patients with osteoarthritis ( OA ) . METHODS Patients with OA of the h and s were r and omly assigned to receive either the yoga program or no therapy . Yoga techniques were supervised by one instructor once/week for 8 weeks . Variables assessed were pain , strength , motion , joint circumference , tenderness , and h and function using the Stanford H and Assessment question naire . RESULTS The yoga treated group improved significantly more than the control group in pain during activity , tenderness and finger range of motion . Other trends also favored the yoga program . CONCLUSION This yoga derived program was effective in providing relief in h and OA . Further studies are needed to compare this with other treatments and to examine longterm effects 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 More than 30 percent of patients with epilepsy have inadequate control of seizures with drug therapy , but why this happens and whether it can be predicted are unknown . We studied the response to antiepileptic drugs in patients with newly diagnosed epilepsy to identify factors associated with subsequent poor control of seizures . METHODS We prospect ively studied 525 patients ( age , 9 to 93 years ) who were given a diagnosis , treated , and followed up at a single center between 1984 and 1997 . Epilepsy was classified as idiopathic ( with a presumed genetic basis ) , symptomatic ( result ing from a structural abnormality ) , or cryptogenic ( result ing from an unknown underlying cause ) . Patients were considered to be seizure-free if they had not had any seizures for at least one year . RESULTS Among the 525 patients , 333 ( 63 percent ) remained seizure-free during antiepileptic-drug treatment or after treatment was stopped . The prevalence of persistent seizures was higher in patients with symptomatic or cryptogenic epilepsy than in those with idiopathic epilepsy ( 40 percent vs. 26 percent , P=0.004 ) and in patients who had had more than 20 seizures before starting treatment than in those who had had fewer ( 51 percent vs. 29 percent , P<0.001 ) . The seizure-free rate was similar in patients who were treated with a single established drug ( 67 percent ) and patients who were treated with a single new drug ( 69 percent ) . Among 470 previously untreated patients , 222 ( 47 percent ) became seizure-free during treatment with their first antiepileptic drug and 67 ( 14 percent ) became seizure-free during treatment with a second or third drug . In 12 patients ( 3 percent ) epilepsy was controlled by treatment with two drugs . Among patients who had no response to the first drug , the percentage who subsequently became seizure-free was smaller ( 11 percent ) when treatment failure was due to lack of efficacy than when it was due to intolerable side effects ( 41 percent ) or an idiosyncratic reaction ( 55 percent ) . CONCLUSIONS Patients who have many seizures before therapy or who have an inadequate response to initial treatment with antiepileptic drugs are likely to have refractory epilepsy An attempt was made to evaluate the effect of Sahaja yoga meditation in stress management in patients of epilepsy . The study was carried out on 32 patients of epilepsy who were rendomly divided into 3 groups : group I subjects practised Sahaja yoga meditation for 6 months , group II subjects practised postural exercises mimicking Sahaja yoga and group III served as the epileptic control group . Galvanic skin resistance ( GSR ) , blood lactate and urinary vinyl m and elic acid ( U-VMA ) were recorded at 0 , 3 and 6 months . There were significant changes at 3 & 6 months as compared to 0 month values in GSR , blood lactate and U-VMA levels in group I subjects , but not in group II and group III subjects . The results indicate that reduction in stress following Sahaja yoga practice may be responsible for clinical improvement which had been earlier reported in patients who practised Sahaja yoga |
11,551 | 28,336,286 | Robotic surgery is comparable with laparoscopic or open surgery for oncological outcomes and overall complications , and provides somewhat better functional outcome when compared with laparoscopic and open surgery | Robotic surgery represents a new horizon in minimally invasive urologic surgery .
This systematic review of the literature and meta- analysis examines the effectiveness of robotic surgery compared with laparoscopic or open surgery for major uro-oncological procedures . | INTRODUCTION Lack of r and omized controlled trials ( RCTs ) that compare pure laparoscopic radical prostatectomy ( LRP ) with robot-assisted laparoscopic radical prostatectomy ( RALRP ) is an important gap of the literature related to the surgical treatment of the clinical ly localized prostate cancer ( PCa ) . AIM To provide the first prospect i ve r and omized comparison on the functional and oncological outcomes of LRP and RALRP for the treatment of the clinical ly localized PCa . METHODS Between 2007 and 2008 , 128 consecutive male patients were r and omized in two groups and treated by a single experienced surgeon with traditional LRP ( Group I-64 patients ) or RALRP ( Group II-64 patients ) in all cases with intent of bilateral intrafascial nerve sparing . MAIN OUTCOME MEASURES Primary end point was to compare the 12 months erectile function ( EF ) outcomes . Complication rates , continence outcomes , and oncological results were also compared . The sample size of our study was able , with an adequate power ( 1-beta > 0.90 ) , to recognize as significant large differences ( above 0.30 ) between incidence proportions of considered outcomes . RESULTS No statistically significant differences were observed for operating time , estimated blood loss , transfusion rate , complications , rates of positive surgical margins , rates of biochemical recurrence , continence , and time to continence . However , the 12-month evaluation of capability for intercourse ( with or without phosphodiesterase type 5 inhibitors ) showed a clear and significant advantage of RALRP ( 32 % vs. 77 % , P < 0.0001 ) . Time to capability for intercourse was significantly shorter for RALRP . Rates of return to baseline International Index of Erectile Function ( IIEF-6 ) EF domain score question naires ( questions 1 - 5 and 15 ) ( 25 % vs. 58 % ) and to IIEF-6 > 17 ( 38 % vs. 63 % ) were also significantly higher for RALRP ( P = 0.0002 and P = 0.008 , respectively ) . CONCLUSIONS Our study offers the first high-level evidence that RALRP provides significantly better EF recovery than LRP without hindering the oncologic radicality of the procedure . Larger RCTs are needed to confirm if a new gold-st and ard treatment in the field of RP has risen PURPOSE Robotic assisted laparoscopic radical cystectomy for bladder cancer has been reported with potential for improvement in perioperative morbidity compared to the open approach . However , most studies are retrospective with significant selection bias . MATERIAL S AND METHODS A pilot prospect i ve r and omized trial evaluating perioperative outcomes and oncologic efficacy of open vs robotic assisted laparoscopic radical cystectomy for consecutive patients was performed from July 2009 to June 2011 . RESULTS To date 47 patients have been r and omized with data available on 40 patients for analysis . Each group was similar with regard to age , gender , race , body mass index and comorbidities , as well as previous surgeries , operative time , postoperative complications and final pathological stage . We observed no significant differences between oncologic outcomes of positive margins ( 5 % each , p = 0.50 ) or number of lymph nodes removed for open radical cystectomy ( 23 , IQR 15 - 28 ) vs robotic assisted laparoscopic radical cystectomy ( 11 , IQR 8.75 - 21.5 ) groups ( p = 0.135 ) . The robotic assisted laparoscopic radical cystectomy group ( 400 ml , IQR 300 - 762.5 ) was noted to have decreased estimated blood loss compared to the open radical cystectomy group ( 800 ml , IQR 400 - 1,100 ) and trended toward a decreased rate of excessive length of stay ( greater than 5 days ) ( 65 % vs 90 % , p = 0.11 ) compared to the open radical cystectomy group . The robotic group also trended toward fewer transfusions ( 40 % vs 50 % , p = 0.26 ) . CONCLUSIONS Our study vali date s the concept of r and omizing patients with bladder cancer undergoing radical cystectomy to an open or robotic approach . Our results suggest no significant differences in surrogates of oncologic efficacy . Robotic assisted laparoscopic radical cystectomy demonstrates potential benefits of decreased estimated blood loss and decreased hospital stay compared to open radical cystectomy . Our results need to be vali date d in a larger multicenter prospect i ve r and omized clinical trial BACKGROUND The absence of trial data comparing robot-assisted laparoscopic prostatectomy and open radical retropubic prostatectomy is a crucial knowledge gap in uro-oncology . We aim ed to compare these two approaches in terms of functional and oncological outcomes and report the early postoperative outcomes at 12 weeks . METHOD In this r and omised controlled phase 3 study , men who had newly diagnosed clinical ly localised prostate cancer and who had chosen surgery as their treatment approach , were able to read and speak English , had no previous history of head injury , dementia , or psychiatric illness or no other concurrent cancer , had an estimated life expectancy of 10 years or more , and were aged between 35 years and 70 years were eligible and recruited from the Royal Brisbane and Women 's Hospital ( Brisbane , QLD ) . Participants were r and omly assigned ( 1:1 ) to receive either robot-assisted laparoscopic prostatectomy or radical retropubic prostatectomy . R and omisation was computer generated and occurred in blocks of ten . This was an open trial ; however , study investigators involved in data analysis were masked to each patient 's condition . Further , a masked central pathologist review ed the biopsy and radical prostatectomy specimens . Primary outcomes were urinary function ( urinary domain of EPIC ) and sexual function ( sexual domain of EPIC and IIEF ) at 6 weeks , 12 weeks , and 24 months and oncological outcome ( positive surgical margin status and biochemical and imaging evidence of progression at 24 months ) . The trial was powered to assess health-related and domain-specific quality of life outcomes over 24 months . We report here the early outcomes at 6 weeks and 12 weeks . The per- protocol population s were included in the primary and safety analyses . This trial was registered with the Australian New Zeal and Clinical Trials Registry ( ANZCTR ) , number ACTRN12611000661976 . FINDINGS Between Aug 23 , 2010 , and Nov 25 , 2014 , 326 men were enrolled , of whom 163 were r and omly assigned to radical retropubic prostatectomy and 163 to robot-assisted laparoscopic prostatectomy . 18 withdrew ( 12 assigned to radical retropubic prostatectomy and six assigned to robot-assisted laparoscopic prostatectomy ) ; thus , 151 in the radical retropubic prostatectomy group proceeded to surgery and 157 in the robot-assisted laparoscopic prostatectomy group . 121 assigned to radical retropubic prostatectomy completed the 12 week question naire versus 131 assigned to robot-assisted laparoscopic prostatectomy . Urinary function scores did not differ significantly between the radical retropubic prostatectomy group and robot-assisted laparoscopic prostatectomy group at 6 weeks post-surgery ( 74·50 vs 71·10 ; p=0·09 ) or 12 weeks post-surgery ( 83·80 vs 82·50 ; p=0·48 ) . Sexual function scores did not differ significantly between the radical retropubic prostatectomy group and robot-assisted laparoscopic prostatectomy group at 6 weeks post-surgery ( 30·70 vs 32·70 ; p=0·45 ) or 12 weeks post-surgery ( 35·00 vs 38·90 ; p=0·18 ) . Equivalence testing on the difference between the proportion of positive surgical margins between the two groups ( 15 [ 10 % ] in the radical retropubic prostatectomy group vs 23 [ 15 % ] in the robot-assisted laparoscopic prostatectomy group ) showed that e quality between the two techniques could not be established based on a 90 % CI with a Δ of 10 % . However , a superiority test showed that the two proportions were not significantly different ( p=0·21 ) . 14 patients ( 9 % ) in the radical retropubic prostatectomy group versus six ( 4 % ) in the robot-assisted laparoscopic prostatectomy group had postoperative complications ( p=0·052 ) . 12 ( 8 % ) men receiving radical retropubic prostatectomy and three ( 2 % ) men receiving robot-assisted laparoscopic prostatectomy experienced intraoperative adverse events . INTERPRETATION These two techniques yield similar functional outcomes at 12 weeks . Longer term follow-up is needed . In the interim , we encourage patients to choose an experienced surgeon they trust and with whom they have rapport , rather than a specific surgical approach . FUNDING Cancer Council Queensl and To compare health‐related quality ‐of‐life ( HRQoL ) outcomes for robot‐assisted laparoscopic radical cystectomy ( RARC ) with those of traditional open radical cystectomy ( ORC ) in a prospect i ve r and omised fashion 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 284 Background : We reported our results on a prospect i ve , r and omized trial of open vs. robotic cystectomy in 2008 . Three years later , we report our findings with regard to overall ( OS ) and disease-specific survival ( DS ) , recurrence rates and long-term complications . METHODS A prospect i ve , r and omized study comparing open vs. robotic cystectomy for bladder cancer was initiated at our institution with IRB approval in 2008 . A target accrual of 40 patients was established to evaluate for non-inferiority based upon nodal yield . Peri-operative and pathologic results were reported in 2008 . We now report our median 36-month follow-up for this patient cohort . RESULTS Of the 41 patients , 21 were r and omized to robotic and 20 to open . On surgical pathology , in the robotic group 14 patients had < = pT2 , 3 pT3/T4 , and 4 N+ disease . In the open group , 9 had < = pT2 , 5 pT3/T4 , and 7 N+ disease . No positive margins were noted . With median follow-up of 35 and 36 months in the robotic and open arms , OS was 65 % ( 13/20 ) and 81 % ( 17/21 ) respectively ( p=0.3058 ) . DSS was 68 % in the open group ( 13/19 ) and 85 % in the robotic group ( 17/20 ) ( p=0.2733 ) . There were 7 recurrences ( 35 % ) in the open cohort compared to 3 patients ( 14 % ) undergoing the robotic procedure ( p=0.1589 ) . Examining overall complications , there were no differences between the open and robotic groups when evaluating 30-day complications and > = 90 day complications ( p=0.8651 ) . The open and robotic cohorts demonstrated 2 strictures in each cohort . Two parastomal hernias were noted in the open group compared to none in the robotic group . On multivariate analysis , controlling for age , BMI and pathologic stage , cystectomy type did not predict OS or DSS , recurrences , or complications . CONCLUSIONS Median 3-year follow-up evaluating open versus robotic cystectomy demonstrates no differences with regard to OS , DSS , cancer recurrence or long-term complications . Although this study was not powered to assess survival differences , this is the first r and omized study to report such data in a non-selected population with 3-year median follow-up BACKGROUND Open radical cystectomy ( ORC ) and urinary diversion in patients with bladder cancer ( BCa ) are associated with significant perioperative complication risk . OBJECTIVE To compare perioperative complications between robot-assisted radical cystectomy ( RARC ) and ORC techniques . DESIGN , SETTING , AND PARTICIPANTS A prospect i ve r and omized controlled trial was conducted during 2010 and 2013 in BCa patients scheduled for definitive treatment by radical cystectomy ( RC ) , pelvic lymph node dissection ( PLND ) , and urinary diversion . Patients were r and omized to ORC/PLND or RARC/PLND , both with open urinary diversion . Patients were followed for 90 d postoperatively . INTERVENTION St and ard ORC or RARC with PLND ; all urinary diversions were performed via an open approach . OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS Primary outcomes were overall 90-d grade 2 - 5 complications defined by a modified Clavien system . Secondary outcomes included comparison of high- grade complications , estimated blood loss , operative time , pathologic outcomes , 3- and 6-mo patient-reported quality -of-life ( QOL ) outcomes , and total operative room and inpatient costs . Differences in binary outcomes were assessed with the chi-square test , with differences in continuous outcomes assessed by analysis of covariance with r and omization group as covariate and , for QOL end points , baseline score . RESULTS AND LIMITATIONS The trial enrolled 124 patients , of whom 118 were r and omized and underwent RC/PLND . Sixty were r and omized to RARC and 58 to ORC . At 90 d , grade 2 - 5 complications were observed in 62 % and 66 % of RARC and ORC patients , respectively ( 95 % confidence interval for difference , -21 % to -13 % ; p=0.7 ) . The similar rates of grade 2 - 5 complications at our m and ated interim analysis met futility criteria ; thus , early closure of the trial occurred . The RARC group had lower mean intraoperative blood loss ( p=0.027 ) but significantly longer operative time than the ORC group ( p<0.001 ) . Pathologic variables including positive surgical margins and lymph node yields were similar . Mean hospital stay was 8 d in both arms ( st and ard deviation , 3 and 5 d , respectively ; p=0.5 ) . Three- and 6-mo QOL outcomes were similar between arms . Cost analysis demonstrated an advantage to ORC compared with RARC . A limitation is the setting at a single high-volume , referral center ; our findings may not be generalizable to all setting s. CONCLUSIONS This trial failed to identify a large advantage for robot-assisted techniques over st and ard open surgery for patients undergoing RC/PLND and urinary diversion . Similar 90-d complication rates , hospital stay , pathologic outcomes , and 3- and 6-mo QOL outcomes were observed regardless of surgical technique . PATIENT SUMMARY Of 118 patients with bladder cancer who underwent radical cystectomy , pelvic lymph node dissection , and urinary diversion , half were r and omized to open surgery and half to robot-assisted laparoscopic surgery . We compared the rate of complications within 90 d after surgery for the open group versus the robotic group and found no significant difference between the two groups . TRIAL REGISTRATION Clinical Trials.gov identifier NCT01076387 , www . clinical trials.gov BACKGROUND In recent years , surgeons have begun to report case series of minimally invasive approaches to radical cystectomy , including robotic-assisted techniques demonstrating the surgical feasibility of this procedure with the potential of lower blood loss and more rapid return of bowel function and hospital discharge . Despite these experiences and observations , at this point high levels of clinical evidence with regard to the benefits of robotic cystectomy are absent , and the current experiences represent case series with limited comparisons to historical controls at best . OBJECTIVE We report our results on a prospect i ve r and omized trial of open versus robotic-assisted laparoscopic radical cystectomy with regard to perioperative outcomes , complications , and short-term narcotic usage . DESIGN , SETTING , AND PARTICIPANTS A prospect i ve r and omized single-center noninferiority study comparing open versus robotic approaches to cystectomy in patients who are c and i date s for radical cystectomy for urothelial carcinoma of the bladder . Of the 41 patients who underwent surgery , 21 were r and omized to the robotic approach and 20 to the open technique . INTERVENTION Radical cystectomy , bilateral pelvic lymphadenectomy , and urinary diversion by either an open approach or by a robotic-assisted laparoscopic technique . MEASUREMENTS The primary end point was lymph node ( LN ) yield with a noninferiority margin of four LNs . Secondary end points included demographic characteristics , perioperative outcomes , pathologic results , and short-term narcotic use . RESULTS AND LIMITATIONS On univariate analysis , no significant differences were found between the two groups with regard to age , sex , body mass index , American Society of Anesthesiologists classification , anticoagulation regimen of aspirin , clinical stage , or diversion type . Significant differences were noted in operating room time , estimated blood loss , time to flatus , time to bowel movement , and use of inpatient morphine sulfate equivalents . There was no significant difference in regard to overall complication rate or hospital stay . On surgical pathology , in the robotic group 14 patients had pT2 disease or higher ; 3 patients had pT3/T4 disease ; and 4 patients had node-positive disease . In the open group , eight patients had pT2 disease or higher ; five patients had pT3/T4 disease ; and seven patients had node-positive disease . The mean number of LNs removed was 19 in the robotic group versus18 in the open group . Potential study limitations include the limited clinical and oncologic follow-up and the relatively small and single-institution nature of the study . CONCLUSIONS We present the results of a prospect i ve r and omized controlled noninferiority study with a primary end point of LN yield , demonstrating the robotic approach to be noninferior to the open approach . The robotic approach also compares favorably with the open approach in several perioperative parameters BACKGROUND The advantages of robot-assisted radical prostatectomy ( RARP ) over laparoscopic radical prostatectomy ( LRP ) have rarely been investigated in r and omised controlled trials . OBJECTIVE To compare RARP and LRP in terms of the functional , perioperative , and oncologic outcomes . The main end point of the study was changes in continence 3 mo after surgery . DESIGN , SETTING , AND PARTICIPANTS From January 2010 to January 2011 , 120 patients with organ-confined prostate cancer were enrolled and r and omly assigned ( using a r and omisation plan ) to one of two groups based on surgical approach : the RARP group and the LRP group . INTERVENTION All RARP and LRP interventions were performed with the same technique by the same single surgeon . OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS The demographic , perioperative , and pathologic results , such as the complications and prostate-specific antigen ( PSA ) measurements , were recorded and compared . Continence was evaluated at the time of catheter removal and 48 h later , and continence and potency were evaluated after 1 , 3 , 6 , and 12 mo . The student t test , Mann-Whitney test , χ(2 ) test , Pearson χ(2 ) test , and multiple regression analysis were used for statistics . RESULTS AND LIMITATIONS The two groups ( RARP : n=60 ; LRP : n=60 ) were comparable in terms of demographic data . No differences were recorded in terms of perioperative and pathologic results , complication rate , or PSA measurements . The continence rate was higher in the RARP group at every time point : Continence after 3 mo was 80 % in the RARP group and 61.6 % in the LRP group ( p=0.044 ) , and after 1 yr , the continence rate was 95.0 % and 83.3 % , respectively ( p=0.042 ) . Among preoperative potent patients treated with nerve-sparing techniques , the rate of erection recovery was 80.0 % and 54.2 % , respectively ( p=0.020 ) . The limitations included the small number of patients . CONCLUSIONS RARP provided better functional results in terms of the recovery of continence and potency . Further studies are needed to confirm our results 305 Background : In the past decade minimally invasive robotic assisted approaches have emerged as a viable option for the treatment of many urologic malignancies . Robotic-assisted radical cystectomy ( RARC ) for bladder cancer has been reported with the potential for lower blood loss , less transfusion requirement , and shorter hospital stay in prior studies . We present preliminary data from a single institution prospect i ve r and omized clinical trial of open radical cystectomy ( ORC ) versus RARC . METHODS Prospect i ve r and omized single institution series evaluating the feasibility of ORC versus RARC for consecutive patients was performed from July 2009 to June 2011 . Oncologic efficacy was assessed based on the surrogates of total number of lymph nodes removed and positive surgical margins . Perioperative morbidity was assessed evaluating for estimated blood loss , transfusion requirements , length of stay and perioperative morbidity . RESULTS To date 46 patients have been r and omized with data available on 39 patients for analysis . Each group was similar with regards to age , sex , race , BMI , comorbidities , and previous abdominal procedures , operative time , and final pathologic stage . We observed no significant difference between oncologic outcomes of positive surgical margins ( 5 % vs 5.263 % , p 0.48 ) or number of LN removed ( 11 vs 23 , p 0.40 ) for the RARC versus ORC groups respectively . The RARC group was noted to have decreased estimated blood loss ( 400 mL vs 800 mL , p 0.008 ) and a trend towards decreased rate of excessive length of stay ( > 5 days ) ( 65 % vs 84 % , p 0.17 ) for the RARC versus ORC groups . The robotic group had a trend towards decreased rate of transfusion however this was not statistically significant ( 40 % versus 53 % , p 0.26 ) . CONCLUSIONS Our preliminary findings from a single institution r and omized trial of RARC versus ORC indicates that RARC has equivalent oncologic outcomes as measured by positive surgical margins and total number of lymph node removed . RARC demonstrates Perioperative benefits of decreased blood loss , fewer excessive hospital stays , and a trend toward fewer transfusions that was not significant |
11,552 | 27,878,878 | No significant differences between conventional amphotericin B and any of the five formulations evaluated were observed , with regard to the efficacy analysis .
With respect to the adverse events of nephrotoxicity , fever , chills and vomiting , all lipid formulations presented better profiles than the conventional formulation .
The present systematic review and meta- analysis showed that conventional amphotericin B presents the same efficacy profile as lipid-based formulations , although the latter were associated with a safer profile | Invasive fungal infections , an important cause of mortality , are primarily treated using amphotericin B , which is available in different formulations , both conventional and lipid-based ( liposomal , lipid complex , colloidal dispersion and Intralipid ® infusion ) .
The aim of our study was to determine the efficacy and safety of conventional amphotericin B vs its lipid-based formulations . | OBJECTIVES --To compare the tolerance , efficacy , and pharmacokinetics of amphotericin deoxycholate ( Fungizone ) prepared in a parenteral fat emulsion ( Intralipid 20 % ) or glucose in HIV patients with c and idiasis . DESIGN --Non-blind r and omised controlled trial . SETTING --University hospital ; tertiary clinical care . PATIENTS --22 HIV positive patients with oral c and idiasis . INTERVENTIONS --Amphotericin 1 mg/kg/day given on four consecutive days as a one hour infusion dissolved in either 5 % glucose ( amphotericin-glucose ) or parenteral fat emulsion at a final concentration of 2 g/l fat emulsion ( amphotericin-fat emulsion ) . MAIN OUTCOME MEASURES -- Clinical tolerance ( fever , chills , sweats , nausea , arterial pressure , and pulse rate ) ; biological tolerance ( serum creatinine , electrolyte , and magnesium values ) ; clinical score of c and idiasis ; and serum concentrations of amphotericin . RESULTS --11 patients were enrolled in each group . All the amphotericin-fat emulsion infusions were given without serious problem whereas four amphotericin-glucose infusions were stopped because of renal impairment ( n = 3 ) or severe chills ( n = 2 ) , or both . For patients completing the amphotericin-glucose treatment creatine concentration increased by 42 mumol/l ; four of seven patients had at least one creatinine value > or = 133 mumol/l versus one of 11 receiving amphotericin-fat emulsion . Magnesium concentration fell significantly with amphotericin-glucose but not with amphotericin-fat emulsion . Clinical side effects were noted in 36/38 infusions with amphotericin-glucose but 10/44 with amphotericin-fat emulsion . Oral c and idiasis score was reduced similarly in both groups . Serum amphotericin concentrations were significantly lower and the volume of distribution of the drug higher after infusion of amphotericin-fat emulsion than after amphotericin-glucose . CONCLUSIONS -- Clinical and renal toxicity of amphotericin are reduced when the drug is prepared in fat emulsion . Preparation is simple and cost effective . Its efficacy is similar to that of conventional amphotericin ABSTRACT Amphotericin B deoxycholate ( AmBd ) is the recommended induction treatment for HIV-associated cryptococcal meningitis ( CM ) . Its use is hampered by toxicities that include electrolyte abnormalities , nephrotoxicity , and anemia . Protocol s to minimize toxicity are applied inconsistently . In a clinical trial cohort of AmBd-based CM induction treatment , a st and ardized protocol of preemptive hydration and electrolyte supplementation was applied . Changes in blood counts , electrolyte levels , and creatinine levels over 14 days were analyzed in relation to the AmBd dose , treatment duration ( short course of 5 to 7 days or st and ard course of 14 days ) , addition of flucytosine ( 5FC ) , and outcome . In the 368 patients studied , the hemoglobin levels dropped by a mean of 1.5 g/dl ( 95 % confidence interval [ CI ] , 1.0 to 1.9 g/dl ) following 7 days of AmBd and by a mean of 2.3 g/dl ( 95 % CI , 1.1 to 3.6 g/dl ) after 14 days . Serum creatinine levels increased by 37 μmol/liter ( 95 % CI , 30 to 45 μmol/liter ) by day 7 and by 49 μmol/liter ( 95 % CI , 35 to 64μmol/liter ) by day 14 of AmBd treatment . Overall , 33 % of patients developed grade III/IV anemia , 5.6 % developed grade III hypokalemia , 9.5 % had creatinine levels that exceeded 220 μmol , and 6 % discontinued AmBd prematurely . The addition of 5FC was associated with a slight increase in anemia but not neutropenia . Laboratory abnormalities stabilized or reversed during the second week in patients on short-course induction . Grade III/IV anemia ( adjusted odds ratio [ aOR ] , 2.2 ; 95 % CI , 1.1 to 4.3 ; P = 0.028 ) and nephrotoxicity ( aOR , 4.5 ; 95 % CI , 1.8 to 11 ; P = 0.001 ) were risk factors for 10-week mortality . In summary , routine intravenous saline hydration and preemptive electrolyte replacement during AmBd-based induction regimens for HIV-associated CM minimized the incidence of hypokalemia and nephrotoxicity . Anemia remained a concerning adverse effect . The addition of flucytosine was not associated with increased neutropenia . Shorter AmBd courses were less toxic , with rapid reversibility ABSTRACT A multicentric r and omized trial was undertaken to compare the toxicity of amphotericin B in 5 % dextrose with that of amphotericin B in a fat emulsion ( Intralipid ) in cancer patients . Group 1 ( n = 33 ) received amphotericin B diluted in 5 % dextrose with premedication consisting of promethazine plus an antipyretic . Group 2 ( n = 28 ) received amphotericin B diluted in 20 % Intralipid without premedication . Amphotericin B was infused daily at a dose of 1 mg/kg of body weight over a 1-h period to members of both groups for empirical antifungal therapy ( in neutropenic patients ) or for the treatment of documented fungal infections . The majority of patients ( 80 % ) received empirical amphotericin B treatment . The two groups were comparable with regard to age , gender , underlying disease , and the following baseline characteristics : use of other nephrotoxic drugs and serum levels of potassium and creatinine . The median cumulative doses of amphotericin B were 240 mg in group 1 and 245 mg in group 2 ( P = 0.73 ) . Acute adverse events occurred in 88 % of patients in group 1 and in 71 % of those in group 2 ( P = 0.11 ) . Forty percent of the infusions in group 1 were associated with fever , compared to 23 % in group 2 ( P < 0.0001 ) . In addition , patients in group 2 required less meperidine for the control of acute adverse events ( P = 0.008 ) , and fewer members of this group presented with hypokalemia ( P = 0.004 ) or rigors ( P < 0.0001 ) . There was no difference in the proportions of patients with nephrotoxicity ( P = 0.44 ) . The success rates of empirical antifungal treatment were similar in the two groups ( P = 0.9 ) . Amphotericin B diluted in a lipid emulsion seems to be associated with a smaller number of acute adverse events and fewer cases of hypokalemia than amphotericin B diluted in 5 % dextrose In this double-blind study to compare safety of 2 lipid formulations of amphotericin B , neutropenic patients with unresolved fever after 3 days of antibacterial therapy were r and omized ( 1:1:1 ) to receive amphotericin B lipid complex ( ABLC ) at a dose of 5 mg/kg/d ( n=78 ) , liposomal amphotericin B ( L Amph ) at a dose of 3 mg/kg/d ( n=85 ) , or L Amph at a dose of 5 mg/kg/d ( n=81 ) . L Amph ( 3 mg/kg/d and 5 mg/kg/d ) had lower rates of fever ( 23.5 % and 19.8 % vs. 57.7 % on day 1 ; P<.001 ) , chills/rigors ( 18.8 % and 23.5 % vs. 79.5 % on day 1 ; P<.001 ) , nephrotoxicity ( 14.1 % and 14.8 % vs. 42.3 % ; P<.01 ) , and toxicity-related discontinuations of therapy ( 12.9 % and 12.3 % vs. 32.1 % ; P=.004 ) . After day 1 , infusional reactions were less frequent with ABLC , but chills/rigors were still higher ( 21.0 % and 24.3 % vs. 50.7 % ; P<.001 ) . Therapeutic success was similar in all 3 groups ABSTRACT In a prospect i ve , r and omized clinical trial , the toxicity of 1 mg of amphotericin B ( AmB ) per kg of body weight per day infused in 5 % dextrose was compared with that of AmB infused in lipid emulsion in children with malignant disease . In an analysis of 82 children who received a full course of 6 days or more of AmB ( 117 courses ) , it was shown that there were significant increases in plasma urea and creatinine concentrations and in potassium requirement after 6 days of therapy with both AmB infused in dextrose and AmB infused in lipid emulsion , with there being no difference between the two methods of AmB administration . An intent-to-treat comparison of the numbers of courses affected by acute toxicity ( fever , rigors ) and chronic toxicity ( nephrotoxicity ) also indicated that there was no significant difference between AmB infused in dextrose ( 78 courses ) and AmB infused in lipid emulsion ( 84 courses ) . The pharmacokinetics of AmB were investigated in 20 children who received AmB in dextrose and 15 children who received AmB in lipid emulsion . Blood sample s were collected up to 24 h after administration of the first dose , and the concentration of AmB in plasma was analyzed by a high-performance liquid chromatography assay . The clearance ( CL ) of AmB in dextrose ( 0.039 ± 0.016 liter · h−1 · kg−1 ) was significantly lower ( P < 0.005 ) than the CL of AmB in lipid emulsion ( 0.062 ± 0.024 liter · h−1 · kg−1 ) . The steady-state volume of distribution for AmB in dextrose ( 0.83 ± 0.33 liter · kg−1 ) was also significantly lower ( P < 0.005 ) than that for AmB in lipid emulsion ( 1.47 ± 0.77 liter · kg−1 ) . Although AmB in lipid emulsion is apparently cleared faster and distributes more widely than AmB in dextrose , this study did not reveal any significant advantage with respect to safety and tolerance in the administration of AmB in lipid emulsion compared to its administration in dextrose in children with malignant disease The study objective was to obtain preliminary information regarding the safety and efficacy of amphotericin B ( AmB ) lipid complex ( ABLC ) in the treatment of AIDS-associated cryptococcal meningitis . Of 55 patients r and omly assigned to 6 weeks of therapy with ABLC ( 1.2 - 5.0 mg/[kg.d ] , with ascending doses for three sequential cohorts ) or AmB ( 0.7 - 1.2 mg/[kg.d ] ) , 46 received > or = 12 doses . Transfusion requirements , mean decreases in hemoglobin level , and mean increases in creatinine level were significantly greater with AmB than with ABLC . The total number of adverse events , infusion-related events , and occurrences of hypomagnesemia and hypokalemia associated with each form of therapy were similar . Among 21 recipients of ABLC at a dosage of 5 mg/kg ( daily for 2 weeks and then thrice weekly for 4 weeks ) , symptoms and signs resolved for 18 ( 86 % ) . Of those receiving > or = 12 doses of ABLC , cultures converted to negative for 8 ( 42 % ) , were undeterminable for 3 ( 16 % ) , and remained positive for 8 ( 42 % ) despite resolution of symptoms . Although preliminary , these data suggest ABLC has significant activity in patients with AIDS-associated cryptococcal meningitis . Because this formulation has less hematologic and renal toxicity than does AmB , further evaluation of ABLC is warranted In 2005 , several groups , including the European Group for Blood and Marrow Transplantation , the European Organization for Treatment and Research of Cancer , the European Leukemia Net and the Immunocompromised Host Society created the European Conference on Infections in Leukemia ( ECIL ) . The main goal of ECIL is to elaborate guidelines , or recommendations , for the management of infections in leukemia and stem cell transplant patients . The first sets of ECIL slides about the management of invasive fungal disease were made available on the web in 2006 and the papers were published in 2007 . The third meeting of the group ( ECIL 3 ) was held in September 2009 and the group up date d its previous recommendations . The goal of this paper is to summarize the new proposals from ECIL 3 , based on the results of studies published after the ECIL 2 meeting : ( 1 ) the prophylactic recommendations for hematopoietic stem cell transplant recipients were formulated differently , by splitting the neutropenic and the GVHD phases and taking into account recent data on voriconazole ; ( 2 ) micafungin was introduced as an alternative drug for empirical antifungal therapy ; ( 3 ) although several studies were published on preemptive antifungal approaches in neutropenic patients , the group decided not to propose any recommendation , as the only r and omized study comparing an empirical versus a preemptive approach showed a significant excess of fungal disease in the preemptive group BACKGROUND . It is generally acknowledged that amphotericin B is the most effective treatment for cryptococcal meningitis . However , administration of this drug is accompanied by substantial adverse effects . This double-blind study , performed before the routine availability of highly active antiretroviral therapy , was design ed to compare the efficacy and safety of liposomal amphotericin B to conventional amphotericin deoxycholate in patients with acquired immunodeficiency syndrome ( AIDS ) and acute cryptococcal meningitis . METHODS . Patients were r and omized ( ratio , 1:1:1 ) from multiple sites in the United States and Canada to receive either amphotericin B at 0.7 mg/kg/day ( n = 87 ) , liposomal amphotericin B at 3 mg/kg/day ( n = 86 ) , or liposomal amphotericin B at 6 mg/kg/day ( n = 94 ) . RESULTS . Efficacy was similar among all 3 treatment groups . The overall incidence of infusion-related reactions was significantly lower for both the 3 mg/kg/day and 6 mg/kg/day dosages of liposomal amphotericin B , compared with conventional amphotericin B ( P < .001 ) . Significantly fewer patients who received the 3 mg/kg/day dosage of liposomal amphotericin B developed nephrotoxicity , indicated by a doubling of the serum creatinine value , compared with recipients of conventional amphotericin B ( P = .004 ) . Overall mortality at 10 weeks was 11.6 % , with no significant differences among the treatment groups . CONCLUSIONS . Liposomal amphotericin B provides an equally efficacious alternative to conventional amphotericin B deoxycholate in patients with AIDS and acute cryptococcal meningitis . Liposomal amphotericin B at a dosage of 3 mg/kg/day is accompanied by significantly fewer adverse effects We report a r and omized , double-blind , multicenter trial in which amphotericin B colloidal dispersion ( ABCD [ Amphotec ] ; 6 mg/kg/day ) was compared with amphotericin B ( AmB ; 1.0 - 1.5 mg/kg/day ) for the treatment of invasive aspergillosis in 174 patients . For evaluable patients in the ABCD and AmB treatment groups , respective rates of therapeutic response ( 52 % vs. 51 % ; P=1.0 ) , mortality ( 36 % vs. 45 % ; P=.4 ) , and death due to fungal infection ( 32 % vs. 26 % ; P=.7 ) were similar . Renal toxicity was lower ( 25 % vs. 49 % ; P=.002 ) and the median time to onset of nephrotoxicity was longer ( 301 vs. 22 days ; P<.001 ) in patients treated with ABCD . Rates of drug-related toxicity in patients receiving ABCD and AmB , respectively , were 53 % versus 30 % ( chills ) , 27 % versus 16 % ( fever ) , 1 % versus 4 % ( hypoxia ) and 22 % versus 24 % ( toxicity requiring study drug discontinuation ) . ABCD appears to have equivalent efficacy and superior renal safety , compared with AmB , in the treatment of invasive aspergillosis . However , infusion-related chills and fever occurred more frequently in patients receiving ABCD than in those receiving Abstract Objective : To compare the feasibility of treatment , safety , and toxicity of intravenous amphotericin B deoxycholate prepared in either glucose or intralipid for empirical antimycotic treatment of neutropenic cancer patients . Design : Single centre stratified , r and omised non-blinded phase II study . Setting : University hospital providing tertiary clinical care . Subjects : 51 neutropenic patients ( leukaemia ( 35 ) , lymphoma ( 11 ) , solid tumours ( 5 ) ) with refractory fever of unknown origin ( 24 ) or pneumonia ( 27 ) . Interventions : Amphotericin B 0.75 mg/kg/day in 250 ml glucose 5 % solution or mixed with 250 ml intralipid 20 % , given on eight consecutive days then alternate days , as a 1 - 4 hour infusion . Main outcome measures : Feasibility of treatment , subjective tolerance ( question naire ) , and objective toxicity ( common toxicity criteria of the National Cancer Institute ) . Results : Study arms were balanced for age , sex , underlying malignancy , renal and liver function , and pre- and concomitant treatment with antibiotics and nephrotoxic agents . No statistically significant or clinical ly relevant differences were found between the treatment groups for : daily or cumulative dose and duration of treatment with amphotericin B ; incidence and time of dose modifications or infusion duration changes related to toxicity ; dose or duration of symptomatic support with opiates , antipyretics , or antihistamines ; renal function ; subjective tolerance ; most common toxicity scores ; course of infection ; and incidence of treatment failures . Patients treated with amphotericin B in intralipid were given fewer diuretics ( P<0.05 ) and therefore had more peripheral oedema ( P<0.01 ) and needed less potassium supplementation ( P<0.05 ) than patients given amphotericin in glucose . Acute respiratory events were more common in the intralipid arm ( P<0.05 ) . Conclusions : Amphotericin B 0.75 mg/kg/day in intralipid given on eight consecutive days then alternate days provides no benefit and is associated with potential pulmonary side effects possibly because of fat overload or an incompatibility of the two drugs We conducted a prospect i ve , r and omized , double-blind study comparing amphotericin B colloidal dispersion ( ABCD ) with amphotericin B in the empirical treatment of fever and neutropenia . Patients with neutropenia and unresolved fever after > or = 3 days of empirical antibiotic therapy were stratified by age and concomitant use of cyclosporine or tacrolimus . Patients were then r and omized to receive therapy with ABCD ( 4 mg/[kg.d ] ) or amphotericin B ( 0.8 mg/[kg.d ] ) for < or = 14 days . A total of 213 patients were enrolled , of whom 196 were evaluable for efficacy . Fifty percent of ABCD-treated patients and 43.2 % of amphotericin B-treated patients had a therapeutic response ( P = .31 ) . Renal dysfunction was less likely to develop and occurred later in ABCD recipients than in amphotericin B recipients ( P < .001 for both parameters ) . Infusion-related hypoxia and chills were more common in ABCD recipients than in amphotericin B recipients ( P = .013 and P = .018 , respectively ) . ABCD appeared comparable in efficacy with amphotericin B , and renal dysfunction associated with ABCD was significantly less than that associated with amphotericin B. However , infusion-related events were more common with ABCD treatment than with amphotericin B treatment The clinical use of amphotericin B is sometimes limited by nephrotoxicity . In a r and omized prospect i ve study , 32 patients treated for haematological malignancies received either amphotericin B in 5 % dextrose ( group A , 16 patients , 0.7 - 1 mg/kg/day ) , or amphotericin B mixed with Intralipid ( group B , 16 patients , 0.7 - 1 mg/kg/day ) during prolonged neutropenia . Renal dysfunction occurred in 9/16 patients in group A and 2/16 patients in group B ( P < 0.05 ) . Clinical tolerance was improved with a reduction of fever with chills in 12/16 patients in group A compared with 5/16 in group B ( P < 0.05 ) . Preparation of amphotericin B with Intralipid reduces nephrotoxicity , improves clinical tolerance , may allow an increase in the daily dose of amphotericin B , and be an alternative to liposomal-amphotericin B infusion Context Amphotericin B is the preferred initial treatment for moderate to severe disseminated histoplasmosis . Because amphotericin B has many serious side effects , alternative treatments are needed . Contribution This double-blind , multicenter trial compared liposomal amphotericin B with regular amphotericin B in patients with disseminated histoplasmosis and AIDS . Liposomal amphotericin B had a higher treatment response ( 88 % vs. 64 % ) and lower mortality rates ( 2 % vs. 13 % ) . It also had fewer infusion-related side effects ( 25 % vs. 63 % ) and less nephrotoxicity ( 9 % vs. 37 % ) . Implication s Although expensive , liposomal amphotericin B is better than regular amphotericin B for treating severe disseminated histoplasmosis . The Editors In endemic areas , 5 % to 20 % of HIV-infected persons develop disseminated histoplasmosis ( 1 - 3 ) . Amphotericin B is the therapeutic agent of choice for induction therapy of moderate to severe disseminated histoplasmosis ( 1 ) , whereas noncomparative studies show that itraconazole ( 4 ) and fluconazole ( 5 , 6 ) are effective for induction and consolidation treatment of milder disease . Treatment of severe disease with amphotericin B , however , has not produced optimal results ( 3 ) . Liposomal amphotericin B achieves high concentrations in the reticuloendothelial system ( 7 ) and is less nephrotoxic . It achieves higher blood concentrations and exhibits reduced clearance compared with deoxycholate amphotericin B and other lipid preparations ( 8) . In addition , it achieves the highest concentrations in the brains of rabbits ( 9 ) . Central nervous system involvement indicates poor outcome in patients with AIDS and disseminated histoplasmosis ( 2 , 10 ) . We compared the safety and efficacy of liposomal amphotericin B with deoxycholate amphotericin B for treatment of moderate to severe disseminated histoplasmosis in persons with AIDS . Methods Study Design After we obtained informed consent , patients with AIDS and moderate to severe disseminated histoplasmosis were r and omly assigned in a 2:1 ratio ( liposomal amphotericin Bamphotericin B ) in this multicenter double-blind trial . R and omization blocks of size 3 were used , and the research pharmacist at each site r and omly assigned patients using the closed-envelope ( security ) technique . Disseminated histoplasmosis was diagnosed by culture of Histoplasma capsulatum , by histopathologic examination , or by urine or serum antigen levels determined by enzyme immunoassay ( 11 , 12 ) . Patients were excluded from the trial if they had a serum creatinine level greater than twice the upper limit of normal ; had other uncontrolled opportunistic infections or malignant disease ; or had been treated for 3 or more days with ketoconazole , itraconazole , fluconazole , or amphotericin B. Medication Administration Patients received daily doses of liposomal amphotericin B ( AmBisome , Fujisawa Healthcare , Deerfield , Illinois ) , 3.0 mg/kg of body weight , or amphotericin B , 0.7 mg/kg , for 2 weeks . Medication was administered in a blinded fashion by intravenous infusion over 2 hours . Patients in whom induction therapy was successful received itraconazole for 10 weeks as consolidation therapy . Premedication was not allowed before the first dose . For later doses , premedication could be used and infusion times could be modified depending on side effects . Monitoring Before r and om assignment , a history and physical examination was performed and hematologic and serum chemistry values , serum and urine sample s for detecting H. capsulatum antigen levels , quantitative lysis centrifugation blood cultures , and a chest radiograph were obtained . Sample s were drawn for blood cultures and serum and urine antigen testing for H. capsulatum on days 4 , 7 , and 14 and at weeks 4 , 8 , and 12 ( or when a patient withdrew from the study ) . Sample s were analyzed at the Histoplasmosis Reference Laboratory in Indianapolis , Indiana . Response Criteria Clinical and mycologic successes were the primary efficacy end points . A successful clinical response to induction therapy was defined as a maximum daily temperature lower than 37.8 C for 72 hours ; no increase in severity of signs , symptoms , or laboratory abnormalities attributable to histoplasmosis ; and the resolution of at least one of the signs or symptoms of histoplasmosis that qualified the patient for enrollment in the trial . A clinical success could be declared after as few as 7 days of induction therapy , at which time itraconazole therapy could be started . A successful clinical outcome after consolidation therapy was defined as resolution or reduction in clinical severity of symptoms and signs attributed to histoplasmosis compared with baseline . Survival was compared for the two treatments . Early discontinuation of induction therapy due to drug toxicity was the primary end point for safety . Secondary end points were time to defervescence ; mycologic efficacy , defined as rate of blood culture conversion ; change in H. capsulatum antigen levels in urine and serum at week 2 ; and rates of acute infusion toxicities and nephrotoxicity ( increase in serum creatinine level to more than twice the baseline level ) . Statistical Analysis The accrual target was 75 patients . Positive baseline blood cultures were estimated at 80 % . The response rate for both therapies was expected to be 70 % . Outcome analysis was performed on an intention-to-treat basis . Treatment groups were compared by using the KruskalWallis test for ordered measurements ( 13 ) and the Fisher exact test for categorized measurements with corresponding exact 95 % CIs ( 14 ) . MantelHaenszel methods were used in a post hoc analysis to assess the impact of enrolling-site differences on clinical outcome ( 15 ) . The KaplanMeier method was used in survival and defervescence analyses , and the treatment groups were compared by using the log-rank test ( 16 ) . We used StatXact 4 for Windows ( Cytel Software , Cambridge , Massachusetts ) for efficacy comparisons that involved exact methods . We used SAS software , version 6.12 ( SAS Institute , Inc. , Cary , North Carolina ) for all other analyses . Role of the Funding Source This study was supported by a research grant from the National Institute of Allergy and Infectious Diseases ( NIAID ) and the National Center for Research Re sources , and by Gilead Sciences , Inc. The NIAID assisted in the collection , analysis , and interpretation of the data and in the decision to su bmi t the paper for publication . The National Center for Research Re sources assisted with data collection at sites with a General Clinical Research Center . Gilead Sciences , Inc. had no direct role in the conduct of this study . Results Eighty-one patients were enrolled by 21 sites . Flow of patients through the study is shown in Figure 1 . Of 55 patients r and omly assigned to receive liposomal amphotericin B , 2 withdrew consent before receiving the study medication and were ineligible for the efficacy and safety analyses and 2 were excluded from the efficacy analysis because they did not have disseminated histoplasmosis . Of 26 patients r and omly assigned to receive amphotericin B , 1 died and 1 withdrew consent before receiving any medication . These 2 patients were excluded from the efficacy and safety analyses . Another 2 patients did not have histoplasmosis and were excluded from the efficacy analysis . Overall , 73 patients were evaluated for efficacy and 77 patients were evaluated for safety in an intention-to-treat analysis . Figure 1 . Flow of patients through the study . The two treatment groups did not differ significantly in any baseline characteristics tested , including clinical features of severe disease ( Table ) . The median age of patients was 33 years ( range , 16 to 68 years ) , and approximately 88 % of the 73 patients were men . Fifty-two percent were African American , 32 % were white , 15 % were Hispanic , and 1 % were Asian . Baseline blood cultures were positive in 74 % of patients . Table . Characteristics of Patients with Progressive Disseminated Histoplasmosis and AIDS , according to Treatment Group The overall clinical efficacy of induction therapy differed between groups . Clinical success was achieved in 45 of 51 patients ( 88 % [ 95 % CI , 77 % to 96 % ] ) treated with liposomal amphotericin B compared with 14 of 22 patients in the other treatment group ( 64 % [ CI , 42 % to 83 % ] ) ( P = 0.014 ) . The difference between groups was 24 percentage points ( CI , 1 to 52 percentage points ) . Twenty-eight of 51 patients ( 55 % [ CI , 40 % to 69 % ] ) treated with liposomal amphotericin B and 7 of 22 patients ( 32 % [ CI , 14 % to 55 % ] ) treated with amphotericin B successfully completed therapy before 14 days ( difference , 23 percentage points [ CI , 2 to 48 percentage points ] ) . The median time to defervescence was 3 days for both therapies ( Figure 2 , top ) . By day 14 , however , patients receiving liposomal amphotericin B were less likely to have fever than those receiving amphotericin B ( 13 % vs. 36 % ; P = 0.09 [ log-rank test ] ) . Figure 2 . KaplanMeier analysis . Top P Bottom P Among the 57 patients receiving itraconazole for consolidation therapy , 89 % had a clinical response . Consolidation therapy was successful in 38 of 43 patients ( 88 % [ CI , 76 % to 96 % ] ) treated with liposomal amphotericin B and 13 of 14 patients ( 93 % [ CI , 66 % to 99 % ] ) treated with amphotericin B ( difference , 5 percentage points [ CI , 25 to 35 percentage points ] ) ( P > 0.2 ) . There was no significant difference in time to negative cultures ( P > 0.2 ) . After 2 weeks of therapy , 89 % of all patients had negative cultures , regardless of type of treatment . Of the 54 patients with a baseline blood culture positive for H. capsulatum , 74 % responded to induction therapy and received consolidation therapy . There was no statistically significant difference in negative cultures between the two groups at the end of consolidation therapy . Histoplasma capsulatum antigen clearance was also similar between the treatment groups . To control for potential investigator bias in outcome responses , data for 42 patients from eight sites were evaluated by using Fungal infections remain a major cause of treatment failure and death in acute leukemia . New liposomal preparations of amphotericin B are now available . While less toxic , their comparative efficacy and toxicity profiles are unknown . In this study the comparative efficacy and safety of ABLC vs. AmBisome was evaluated in seventy-five patients with leukemia who developed 82 episodes of suspected or documented mycosis , and were treated ( 1:1 ) with either ABLC ( n=43 ) or AmBisome ( n=39 ) . Both drugs were dosed accordingly from 3 to 5mg/kg/day . Using an intent-to-treat analysis , the overall response to therapy was 27/43 ( 63 % ) for ABLC and 15/39 ( 39 % ) for AmBisome ( p=0.03 ) . Median dose and duration of treatment was 10 days at 3mg/kg for ABLC and 15 days at 4 mg/kg for AmBisome . Acute , not dose-limiting infusion side effects were seen in 70 % vs. 36 % ( p=0.002 ) , ABLC vs. AmBisome . Increase of bilirubin > 1.5 times from baseline was 38 % vs. 59 % , ABLC vs. AmBisome ( p=0.05 ) . ABLC and AmBisome were equally effective for the treatment of suspected or documented fungal infections . While , acute infusion-toxicity was greater with ABLC , infusion toxicity requiring discontinuation was similar for both drugs . AmBisome was better tolerated than ABLC but was associated with mild abnormalities in liver function tests at the end of therapy PURPOSE To describe the experience with a new lipid-based amphotericin product ( amphotericin B colloidal dispersion or ABCD ) in children with fever and neutropenia who are at high risk for fungal infection . PATIENTS AND METHODS Forty-nine children with febrile neutropenia were treated in a prospect i ve , r and omized trial comparing ABCD with amphotericin B. An additional 70 children with presumed or proven fungal infection were treated with 5 different open-label studies of ABCD . Patients were registered into these studies for reasons of : 1 ) failure to respond to amphotericin B ; 2 ) development of nephrotoxicity or preexisting renal impairment ; or 3 ) willingness to participate in a dose-escalation study . Extensive data detailing response and toxicity were collected from each patient . RESULTS In the r and omized trial , there was significantly less renal toxicity in the children receiving ABCD than in those receiving amphotericin B ( 12.0 % vs. 52.4 % [ P = 0.003 ] ) . Other adverse symptoms were not significantly different . In the additional open-label studies , although 80 % of patients receiving ABCD reported some adverse symptom , the majority of these were infusion related , and nephrotoxicity was reported in only 12 % of these patients . CONCLUSIONS ABCD was well-tolerated at doses up to 5 times greater then those usually tolerated with amphotericin B. Renal toxicity was markedly less than expected , and there were no other unexpected severe toxicities . Further r and omized studies are needed to further define the role of this and other liposomal products in children It has been suggested that a better outcome of neutropenia‐associated invasive fungal infections can be achieved when high doses of lipid formulations of amphotericin B are used . We now report a r and omized multicentre study comparing liposomal amphotericin B ( AmBisome , 5 mg/kg/d ) to amphotericin B deoxycholate ( AmB , 1 mg/kg/d ) in the treatment of these infections . Of 106 possible patients , 66 were enrolled and analysed for efficacy : nine had documented fungaemia , 17 had other invasive mould infections and 40 had suspected pulmonary aspergillosis . After completion of the course medication , in the AmBisome group ( n = 32 ) 14 patients had achieved complete response , seven a partial response and 11 were failures as compared to 6 , 13 and 15 patients ( n = 34 ) treated with AmB ( P = 0.09 ) ; P = 0.03 for complete responders . A favourable trend for AmBisome was found at day 14 , in patients with documented infections and in patients with pulmonary aspergillosis ( P = 0.05 and P = 0.096 respectively ) . Mortality rates were lower in patients treated with AmBisome ( adjusted for malignancy status , P = 0.03 ) . More patients on AmB had a > 100 % increase of their baseline serum creatinine ( P < 0.001 ) Patients with haematological malignancies requiring an antifungal therapy were r and omly assigned to receive amphotericin B diluted in either 5 % dextrose or in fat emulsion ( Intralipid ) . Twenty-one patients were included in each group . Mean duration of amphotericin B therapy was 8.4 days in the dextrose group and 12.8 days in the Intralipid group . Amphotericin B infusion induced chills in 16 of 21 patients in the dextrose group and in 5 of 21 in the Intralipid group ( P = 0.0008 ) . Serum creatinine increased > 75 % from baseline in ten patients in the dextrose group compared with only two in the Intralipid group ( P = 0.007 ) . A > or = 50 % decrease of creatinine clearance was observed in 14 of 21 patients in the dextrose group compared with seven of 21 patients in the Intralipid group ( P = 0.025 ) . No difference was found between the two groups with regard to potassium and sodium requirement . Among patients who did not receive magnesium before antifungal therapy , magnesium supplementation was required more frequently in the dextrose group ( 8/12 vs 2/11 ; P = 0.02 ) . Concomitant amikacin dosage reduction was more frequent in the dextrose group due to nephrotoxicity ( 7/19 vs 2/20 ; P = 0.045 ) . A similar difference in vancomycin dosage reduction was observed between the two groups ( 12/20 vs 5/19 ; P = 0.03 ) Objective : To evaluate the usefulness of a 20 % lipid emulsion as a delivery system for amphotericin B ( 1 mg/mL ) administered over 1 hour to patients with neutropenia with hematologic malignancies compared with amphotericin B ( 0.1 mg/mL ) administered in dextrose 5 % solution over the same time . Design : A prospect i ve , comparative , r and omized , labeled study . Setting : Hematology unit , pharmacy service , university general hospital . Participants : Twenty patients with neutropenia with hematologic malignancies and proven or suspected fungal infections , 10 in the fat emulsion group ( group 1 ) and 10 in the dextrose 5 % group ( group 2 ) . Main Outcome Measures : Clinical tolerance ( i.e. , fever , shaking chills , nausea , blood pressure , pulse rate ) and biologic tolerance ( i.e. , urea , creatinine , sodium , potassium ) . Results : Clinical tolerance was comparable in both groups although amphotericin B in fat emulsion was better tolerated . Medication for symptoms related to the administration of amphotericin B was given in 6 cases in group 1 and in 8 cases in group 2 . There was a statistically significant difference in the urea concentrations between the 2 groups ( p = 0.023 ) ; there was an observed increase between the initial and the final serum urea ( 56.8 mg/d in group 1 , 79.8 mg/dL in group 2 ) . Statistically significant differences in creatinine serum concentrations ( 84.9 μmol/L in group 1 , 123.8 μmol/L in group 2 ) ( p = 0.047 ) were found . No differences were found in the antifungal efficacy of the treatment . However , as amphotericin B was started in the majority of cases ( 75 % ) as empiric treatment for fever unresponsive to antibiotic therapy , it is difficult to compare the efficacy of both preparations . Conclusions : The clinical tolerance of lipid-emulsion infusions is similar to that of conventionally administered amphotericin B therapy . Renal toxicity appears to be decreased when the drug is administered in a fat emulsion . This type of preparation permits the reduction of the volume and the time of administration for amphotericin B therapy OBJECTIVES To evaluate the differences in efficacy and in clinical and biochemical tolerance to amphotericin B administered in a lipid emulsion compared with amphotericin B administered in 5 % dextrose in water in the treatment of C and ida albicans infection in intensive care unit ( ICU ) patients . DESIGN Prospect i ve , controlled , r and omized study , conducted during a 2.5-yr period , comparing the two treatment protocol s. SETTING General ICU of a university-affiliated municipal hospital . PATIENTS Sixty consecutive critically ill patients with confirmed or suspected C and ida infection . INTERVENTIONS Patients received amphotericin B ( 1 mg/kg/24 hrs ) , administered r and omly in 5 % dextrose in water ( group A ) , or in lipid emulsion ( 20 % intralipid ) ( group B ) . MEASUREMENTS AND MAIN RESULTS Clinical tolerance ( fever , chills , hemodynamics ) , hepatorenal tolerance , and biological tolerance ( serum electrolytes and coagulation profile ) were evaluated . Patients receiving amphotericin B in lipid emulsion experienced a lower frequency rate of drug-associated fever ( 61.4 % vs. 5.8 % , p < .003 ) rigors ( 54 % vs. 8.5 % , p < .004 ) , hypotension ( 17 % vs. 0 % ) , and nephrotoxicity ( increase of serum creatinine concentration 66.7 % vs. 20 % , p < .0002 ) . Significant ( 264,500 + /- 71,460 to 163,570 + /- 34,450 mm3 , p < .01 ) thrombocytopenia , not associated with active bleeding , occurred in patients receiving amphotericin B lipid in emulsion but not in patients receiving the drug in dextrose . CONCLUSIONS Treatment with amphotericin B in a lipid emulsion when given to critically ill patients with C and ida sepsis seems to be safer and as effective as the conventional mode of administration Objective : Amphotericin B deoxycholate initial therapy and fluconazole maintenance therapy is the treatment of choice for AIDS-associated cryptococcal meningitis . However , the administration of amphotericin B is associated with considerable toxicity . A potential strategy for reducing the toxicity and increasing the therapeutic index of amphotericin B is the use of lipid formulations of this drug . Design and methods : HIV-infected patients with cryptococcal meningitis were r and omized to treatment with either liposomal amphotericin B ( AmBisome ) 4 mg/kg daily or st and ard amphotericin B 0.7 mg/kg daily for 3 weeks , each followed by fluconazole 400 mg daily for 7 weeks . During the first 3 weeks , clinical efficacy was assessed daily . Mycological response was primarily evaluated by cerebrospinal fluid ( CSF ) cultures at days 7 , 14 , 21 and 70 . Results : Of the 28 evaluable patients , 15 were assigned to receive AmBisome and 13 to receive amphotericin B. Baseline characteristics were comparable . The time to and the rate of clinical response were the same in both arms . AmBisome therapy result ed in a CSF culture conversion within 7 days in six out of 15 patients versus one out of 12 amphotericin B-treated patients ( P = 0.09 ) , within 14 days in 10 out of 15 AmBisome patients versus one out of nine amphotericin B patients ( P = 0.01 ) , and within 21 days in 11 out of 15 AmBisome patients versus three out of eight amphotericin B patients ( P = 0.19 ) . When Kaplan-Meier estimates were used to compare time to CSF culture conversion , AmBisome was effective more ( P < 0.05 ; median time between 7 and 14 days for AmBisome versus > 21 days for amphotericin B ) . AmBisome was significantly less nephrotoxic . Conclusions : A 3-week course of 4 mg/kg AmBisome result ed in a significantly earlier CSF culture conversion than 0.7 mg/kg amphotericin B , had equal clinical efficacy and was significantly less nephrotoxic when used for the treatment of primary episodes of AIDS-associated cryptococcal meningitis BACKGROUND Amphotericin B is the agent of choice for most invasive fungal infections in critically ill patients . It is associated with at least a 50 % incidence of nephrotoxicity , despite prophylactic measures such as sodium loading . Newer formulations of amphotericin B are available but are costly and have unknown bioavailability in critically ill patients . Previous trials in neutropenic and critically ill patients have demonstrated that mixing amphotericin B with 20 % lipid solution ( Intralipid ; Clintec Nutrition , Deerfield , III ) may decrease nephrotoxicity . METHODS In this r and omized , prospect i ve clinical trial , patients with positive fungal blood cultures , tracheal/sputum cultures or peritoneal cavity cultures were r and omized to receive either 0.5 mg/kg per day of amphotericin B dextrose or 1.0 mg/kg per day of amphotericin B lipid emulsion . Duration of therapy was determined by the primary care team . Weekly 24-hour creatinine clearance was measured until 2 weeks after amphotericin B therapy was completed . RESULTS The two groups were similar based on age , white blood cell count , serum creatinine , and creatinine clearance at the beginning of therapy . The group receiving amphotericin B lipid emulsion had significantly less decrease in creatinine clearance compared with controls , despite receiving significantly more amphotericin B. CONCLUSION Amphotericin B lipid emulsion can be given at a higher total cumulative dose than amphotericin B dextrose with less nephrotoxicity Background : Conventional amphotericin B ( c‐AmB ) remains the empirical antifungal treatment of choice for neutropenic patients with persistent fever of unknown origin ( FUO ) . Unfortunately , empirical treatment with c‐AmB is hampered by its safety profile , with frequent infusion‐related adverse events ( IRAEs ) and renal toxicity . Amphotericin B lipid complex ( ABLC ) has been investigated for this indication due to its low toxicity profile . The recommended dose of ABLC is 5 mg/kg/d , which is five to seven times higher than the recommended dose of The use of amphotericin B limited by dose-dependent nephrotoxicity . Elevated creatinine associated with amphotericin B is not only a marker for renal dysfunction , but is also linked to an increase in hospital costs and a substantial risk for the use of haemodialysis and a higher mortality rate . Therefore , amphotericin B nephrotoxicity is not a benign complication and its prevention is essential . Several manipulations have been proposed to minimize amphotericin B-induced nephrotoxicity . Mannitol and frusemide administration are reported to be protective based on anecdotal observational reports . Small prospect i ve and r and omized trials do not suggest a protective effect . Three new formulations have been developed in attempts to improve both efficacy and tolerability : amphotericin B in a lipid complex ( ABLC ; Abelcet ) ; amphotericin B colloidal dispersion ; and liposomal amphotericin B ( AmBisome ) . Three prospect i ve r and omized studies have clearly shown that AmBisome is less nephrotoxic than amphotericin B. In a double-blind r and omized trial significantly fewer patients receiving AmBisome had nephrotoxic effects . This significant reduction in azotaemia was also observed among subgroups of patients receiving concomitant therapy with nephrotoxic agents . Moreover , there were fewer patients with hypokalaemia in the group receiving AmBisome . A recent multicentre double-blind study has shown that AmBisome ( 3 or 5 mg/kg/day ) has a better safety profile than Abelcet ( 5 mg/kg ) . Patients in both AmBisome treatment groups experienced less chills/rigors , less nephrotoxicity based on a doubling of serum creatinine , and fewer toxic reactions result ing in discontinuation of therapy . In conclusion , amphotericin B nephrotoxicity is observed frequently . It clearly increases patient mortality . Nephrotoxicity must be recognized early , based on tubular abnormalities and a mild increase in serum creatinine . Its prevention relies on the detection and suppression of risk factors and the use of AmBisome BACKGROUND In patients with persistent fever and neutropenia , amphotericin B is administered empirically for the early treatment and prevention of clinical ly occult invasive fungal infections . However , breakthrough fungal infections can develop despite treatment , and amphotericin B has substantial toxicity . METHODS We conducted a r and omized , double-blind , multicenter trial comparing liposomal amphotericin B with conventional amphotericin B as empirical antifungal therapy . RESULTS The mean duration of therapy was 10.8 days for liposomal amphotericin B ( 343 patients ) and 10.3 days for conventional amphotericin B ( 344 patients ) . The composite rates of successful treatment were similar ( 50 percent for liposomal amphotericin B and 49 percent for conventional amphotericin B ) and were independent of the use of antifungal prophylaxis or colony-stimulating factors . The outcomes were similar with liposomal amphotericin B and conventional amphotericin B with respect to survival ( 93 percent and 90 percent , respectively ) , resolution of fever ( 58 percent and 58 percent ) , and discontinuation of the study drug because of toxic effects or lack of efficacy ( 14 percent and 19 percent ) . There were fewer proved breakthrough fungal infections among patients treated with liposomal amphotericin B ( 11 patients [ 3.2 percent ] ) than among those treated with conventional amphotericin B ( 27 patients [ 7.8 percent ] , P=0.009 ) . With the liposomal preparation significantly fewer patients had infusion-related fever ( 17 percent vs. 44 percent ) , chills or rigors ( 18 percent vs. 54 percent ) , and other reactions , including hypotension , hypertension , and hypoxia . Nephrotoxic effects ( defined by a serum creatinine level two times the upper limit of normal ) were significantly less frequent among patients treated with liposomal amphotericin B ( 19 percent ) than among those treated with conventional amphotericin B ( 34 percent , P<0.001 ) . CONCLUSIONS Liposomal amphotericin B is as effective as conventional amphotericin B for empirical antifungal therapy in patients with fever and neutropenia , and it is associated with fewer breakthrough fungal infections , less infusion-related toxicity , and less nephrotoxicity ABSTRACT The pharmacokinetics , excretion , and mass balance of liposomal amphotericin B ( AmBisome ) ( liposomal AMB ) and the conventional formulation , AMB deoxycholate ( AMB-DOC ) , were compared in a phase IV , open-label , parallel study in healthy volunteers . After a single 2-h infusion of 2 mg of liposomal AMB/kg of body weight or 0.6 mg of AMB-DOC/kg , plasma , urine , and feces were collected for 168 h. The concentrations of AMB were determined by liquid chromatography t and em mass spectrometry ( plasma , urine , feces ) or high-performance liquid chromatography ( HPLC ) ( plasma ) . Infusion-related side effects similar to those reported in patients , including nausea and back pain , were observed in both groups . Both formulations had triphasic plasma profiles with long terminal half-lives ( liposomal AMB , 152 ± 116 h ; AMB-DOC , 127 ± 30 h ) , but plasma concentrations were higher ( P < 0.01 ) after administration of liposomal AMB ( maximum concentration of drug in serum [ Cmax ] , 22.9 ± 10 μg/ml ) than those of AMB-DOC ( Cmax , 1.4 ± 0.2 μg/ml ) . Liposomal AMB had a central compartment volume close to that of plasma ( 50 ± 19 ml/kg ) and a volume of distribution at steady state ( Vss ) ( 774 ± 550 ml/kg ) smaller than the Vss of AMB-DOC ( 1,807 ± 239 ml/kg ) ( P < 0.01 ) . Total clearances were similar ( approximately 10 ml hr−1 kg−1 ) , but renal and fecal clearances of liposomal AMB were 10-fold lower than those of AMB-DOC ( P < 0.01 ) . Two-thirds of the AMB-DOC was excreted unchanged in the urine ( 20.6 % ) and feces ( 42.5 % ) with > 90 % accounted for in mass balance calculations at 1 week , suggesting that metabolism plays at most a minor role in AMB elimination . In contrast , < 10 % of the liposomal AMB was excreted unchanged . No metabolites were observed by HPLC or mass spectrometry . In comparison to AMB-DOC , liposomal AMB produced higher plasma exposures and lower volumes of distribution and markedly decreased the excretion of unchanged drug in urine and feces . Thus , liposomal AMB significantly alters the excretion and mass balance of AMB . The ability of liposomes to sequester drugs in circulating liposomes and within deep tissue compartments may account for these differences Infusion-related adverse events ( IRAEs ) such as nausea , vomiting , fever , chills , and thrombophlebitis that are associated with amphotericin B therapy often lead clinicians to prescribe a number of adjunctive pretreatment medications in an attempt to reduce the incidence and severity of these events . The purpose of this study was to determine the incidence of IRAEs during the first week of systemic amphotericin B therapy and to identify pretreatment regimens that are effective in preventing these IRAEs . Three hundred ninety-seven adult in patients receiving amphotericin B therapy were prospect ively monitored , and data regarding IRAEs and pretreatment regimens were collected . Of these patients , 282 ( 71 % ) developed at least one IRAE during the first 7 days of therapy . The IRAEs most commonly reported were fever ( 51 % of patients ) and chills ( 28 % ) , followed by nausea ( 18 % ) , headache ( 9 % ) , and thrombophlebitis ( 5 % ) . The most common regimens included diphenhydramine , a corticosteroid , acetaminophen , and heparin , administered alone or in combination with these or other drugs . Overall , common pretreatment regimens were similar in efficacy to no pretreatment in the prevention of IRAEs . Thus empirical premedication for IRAEs associated with amphotericin B can not be routinely advocated ; instead , patients should be treated when symptoms first arise and then premedicated for subsequent amphotericin B infusions One hundred and thirty‐four adults and 204 children were r and omized in two prospect i ve , parallel comparative multicentre trials to receive either conventional amphotericin B 1 mg/kg/d ( c‐AMB ) , liposomal amphotericin B 1 mg/kg/d ( L‐AMB1 ) or liposomal amphotericin B 3 mg/kg/d ( L‐AMB3 ) . Patients were entered if they had a pyrexia of unknown origin ( PUO ) defined as temperature of 38 ° C or more , not responding to 96 h of systemic broad‐spectrum antibiotic treatment , and neutropenia ( < 0.5 × 109/l ) . The safety and toxicity of liposomal amphotericin B was compared with that of conventional amphotericin B. Efficacy of treatment was assessed , with success defined as resolution of fever for 3 consecutive days ( < 38 ° C ) without the development of any new fungal infection . Clinical and laboratory parameters were collected for safety analysis . In both the paediatric and adult population s , L‐AMB treated patients had a 2–6‐fold decrease in the incidence ( P 0.01 ) of test‐drug‐related side‐effects , compared to c‐AMB . Severe trial‐drug‐related side‐effects were seen in 1 % of L‐AMB treated patients , in contrast to 12 % of patients on c‐AMB ( P < 0.01 ) . Nephrotoxicity , in the patient subset not receiving concomitant nephrotoxic agents , defined as a doubling from the patients baseline serum creatinine level , was not observed in the L‐AMB1 arm whereas the incidence was 3 % in patients on L‐AMB3 and 23 % in those on c‐AMB ( P < 0.01 ) . Moreover , time to develop nephrotoxicity was longer in both L‐AMB arms than c‐AMB ( P < 0.01 ) . Severe hypokalaemia was observed less frequently in both L‐AMB arms ( P < 0.01 ) BACKGROUND In patients with persistent fever and netropenia , amphotericin B is administered empirically for early treatment and prevention of systemic fungal infections . Despite this treatment , there are chances of breakthrough fungal infections and drug is also toxic . MATERIAL S AND METHODS A multicentric , r and omized , controlled clinical trial was conducted to compare liposomal amphotericin B two doses with conventional amphotericin B as empirical antifungal therapy . RESULTS The average body weight of patients was 26.4 ± 14.8 ( n=22 ) , 32.9 ± 19.4 ( n=23 ) and 37.9 ± 20.0 ( n=20 ) kg in 1 mg , 3 mg Fungisome ( liposomal amphotericin B ) and 1 mg/kg/day conventional amphotericin B group , respectively . The mean age was 16.2 ± 13.4 , 16.0 ± 10.9 and 22.7 ± 16.2 yrs in 1 and 3 mg/kg/day Fungisome and 1 mg/kg/day conventional AMP B group , respectively . The average duration of treatment with 1 mg and 3 mg/kg/day Fungisome and 1 mg/kg/day conventional amphotericin B was 17 ± 9.8 , 16.2 ± 8.3 , and 14.7 ± 10.7 days , respectively . The time to resolve fever was 13.3 ± 10.2 , 10.9 ± 7.1 , 10.1 ± 6.7 days , and for absolute neutrophil count ( ANC ) to be above 500 cells per microliter , it took 13.4 ± 9.6 , 10.6 ± 7.6 and 7.3 ± 3.4 days , respectively . Liposomal formulations were well-tolerated compared to conventional amphotericin B. CONCLUSIONS This small r and omized study showed that the indigenous liposomal formulation Fungisome appears to be equally efficacious and safer than conventional amphotericin B. Also , the lower dose Fungisome ( 1 mg/kg/day ) appears to be equally efficacious and was well-tolerated as compared to higher dose Fungisome ( 3 mg/kg/day ) . Treatment cost would be a major factor for limiting use of higher dose of Fungisome |
11,553 | 18,676,420 | Most alarm features had poor sensitivity and specificity for the diagnosis of colorectal carcinoma , whilst statistical models performed better in terms of sensitivity . | OBJECTIVE Colorectal cancer is the second most common cause of cancer death in Europe and North America .
Alarm features are used to prioritize access to urgent investigation , but there is little information concerning their utility in the diagnosis of colorectal cancer . | OBJECTIVES : It has been suggested that the variation in the prevalence of irritable bowel syndrome ( IBS ) may be due to the application of different diagnostic criteria . New criteria for IBS have been proposed ( Rome II ) . It is unknown whether persons meeting different criteria for IBS have similar psychological and symptom features . The aim of this study was to measure the prevalence of IBS according to Manning and Rome definitions of IBS and to evaluate the clinical and psychological differences between diagnostic categories . METHODS : A total of 4500 r and omly selected subjects , with equal numbers of male and female subjects aged ≥18 yr and representative of the Australian population , took part in this study . Subjects were mailed a question naire ( response rate , 72 % ) . Characteristics measured were gastrointestinal symptoms over the past 12 months , neuroticism and extroversion ( Eysenck Personality Question naire ) , anxiety and depression ( Delusions-Symptoms-States Inventory ) , mental and physical functioning ( SF-12 ) , and somatic distress ( Sphere ) . RESULTS : The prevalence for IBS according to Manning , Rome I , and Rome II was 4.4 % ( 95 % confidence interval [ CI ] = 3.5–5.1 % ) , 6.9 % ( CI 6.0–7.8 % ) , and 13.6 % ( CI 12.3–14.8 % ) , respectively . Only 12 persons with Rome I did not also meet Rome II criteria ; 196 persons with Manning criteria did not meet Rome II cut-offs . Having IBS regardless of which criteria were used was significantly associated with psychological morbidity , but psychological factors were not important in discriminating between diagnostic categories . However , pain and bowel habit severity independently discriminated between diagnostic groups . CONCLUSIONS : IBS is a relatively common disorder in the community . The new Rome II criteria may be unnecessarily restrictive in practice Over a 3‐year period , all patients referred for barium enema examination had a double‐contrast barium enema and flexible sigmoidoscopy performed on the same day . A total of 462 joint examinations were performed . Abnormalities were found in 193 patients by the use of barium enema , 164 patients by using sigmoidoscopy and 294 by the use of both methods of investigation . Sigmoidoscopy was superior to barium enema in the detection of polyps and inflammatory bowel disease but barium enema was more sensitive for diverticular disease . The presenting symptoms had no predictive value in distinguishing carcinoma , polyps and diverticular disease . Diverticular disease did not reduce the sensitivity of barium enema examination to polyps in the sigmoid colon . Fibreoptic sigmoidoscopy immediately before barium enema was well tolerated by patients . The investigations were complementary in the diagnosis of colonic polyps , inflammatory bowel disease and diverticular disease In a prospect i ve study involving 833 consecutive outpatient and open-access colonoscopies , attempts were made to characterize the benefit of colonoscopy in terms of both predicted and unpredicted findings and therapeutic procedures . The endoscopist therefore predicted the endoscopic findings before the endoscopy . The results were compared for the different indications for colonoscopy . The overall agreement between the predictions and the colonoscopic findings was 61 % . Clinical ly significant abnormalities were found in about half the examinations . The most frequent abnormal findings were benign polyps ( 24 % ) , inflammatory bowel disease ( 17 % ) , and malignancy ( 5 % ) . In about half the patients with a malignancy the indication for colonoscopy was rectal bleeding , and half of the malignancies were not predicted . The greatest benefit of colonoscopy was found in patients referred because of overt rectal bleeding or occult faecal blood , and abnormal barium enema or endoscopy findings . The importance of complete colonoscopy in connection with operation for colorectal carcinoma is emphasized Colonoscopy is an integral part of the clinician armamentarium in the diagnosis of colorectal cancer and its precursor , the adenoma . Polypoid lesions when identified can be excised at colonoscopy and in turn reduce the risk of colorectal cancer . We prospect ively evaluated the yield of colorectal cancer and adenomatous polyps by indication for colonoscopy over a one-year period . A total of 375 colonoscopies were carried out . The more common indications of colonoscopy were rectal bleeding , abdominal pain , surveillance of colorectal cancer and altered bowel habit . The highest yield for cancer was for rectal bleeding with 12.5 % while surveillance of patients with a history of polyps yielded the highest percentage of new polyps . We conclude that rectal bleeding as an indication for colonoscopy yielded the highest number of cancers OBJECTIVES To assess the clinical yield of colonoscoping in patients who present with rectal bleeding , persistent abdominal pain , or change in bowel habits in the absence of bleeding . DESIGN A prospect i ve study of colonoscopy patients . SETTING Three colonoscopy practice s in New York City between April 1986 and November 1989 . PATIENTS Eight hundred sixty-one patients with rectal bleeding , 113 patients with abdominal pain , 154 with change in bowel habits , and 44 patients with both abdominal pain and bowel change . MAIN RESULTS Of 861 patients with rectal bleeding , 293 ( 33.6 % ) had colonic neoplasia ( 8.6 % cancer and 25 % adenomatous polyps ) . In patients who had colonoscopy because of abdominal pain ( n = 113 ) , change in bowel habits ( n = 154 ) , or both abdominal pain and bowel change ( n = 44 ) , respectively 25 ( 22.1 % ) , 42 ( 27.3 % ) , and 10 ( 22.7 % ) had colonic neoplasms . If one looks at significant neoplasia ( cancer or adenomas > 1 cm ) , then the findings in rectal bleeders were 14.5 % , whereas the abdominal pain , change in bowel habits , and both groups had 7.1 % , 7.1 % , and 13.6 % , respectively . Patients with rectal bleeding were more likely to have multiple adenomas than those with nonbleeding symptoms ( p < 0.05 ) . CONCLUSIONS Patients with persistent nonbleeding GI symptoms , including abdominal pain and change in bowel habits , have almost as high a yield of colorectal neoplasia as those with rectal bleeding BACKGROUND AND STUDY AIMS Appropriateness of use of colonoscopy is an important issue in health care in the quest to improve quality of care while at the same time containing costs . This prospect i ve study examined whether detailed and explicit appropriateness criteria significantly improve the diagnostic yield of colonoscopy . PATIENTS AND METHODS Consecutive patients referred for diagnostic colonoscopy at five centers ( one university hospital and its outpatient department , two district hospitals , and two gastroenterology practice s ) were prospect ively studied over a 17-month period . The appropriateness of the indications for these colonoscopies was assessed using explicit Swiss criteria developed by the R and Corporation/University of California at Los Angeles ( R AND /UCLA ) panel method , and the relationship between appropriateness of use and the presence of clinical ly relevant endoscopic lesions was analysed . RESULTS 1188 patients were included in the study . Indications for 1144 ( 96.3 % ) of the colonoscopies could be evaluated using explicit criteria ; 64.1 % of the colonoscopies were judged appropriate , 13.3 % uncertain and 22.6 % inappropriate . Significant endoscopic lesions were found in 23.8 % of the colonoscopies . Colonoscopies judged appropriate or uncertain yielded significantly more relevant lesions than did those judged to be inappropriate ( 25.6 % vs. 17.4 % ; P = 0.007 ) . Of 51 colon cancers , all but one were found in colonoscopies judged to be appropriate or uncertain . In a multivariate analysis , the diagnostic yield of colonoscopy was significantly influenced by appropriateness , patient gender and treatment setting . CONCLUSIONS The use of detailed and explicit appropriateness criteria for colonoscopy significantly enhances the identification of relevant lesions and in particular of colon cancer . The use of such criteria could therefore improve patient selection for colonoscopy and thus contribute to efforts aim ed at enhancing the quality and efficiency of care Objective : Little data on rectal bleeding in the U.S. population are available . We therefore sought to assess the prevalence of different types of rectal bleeding , their association with potential risk factors including other colonic symptoms , and predictors of health care seeking in a U.S. community . Methods : We used a crossectional survey by mail , applying a previously vali date d self-report symptom question naire . Our population comprised an age- and gender-stratified r and om sample of Olmsted County , Minnesota residents aged 20–64 yr . Results : In total , 1643 responded ( 77 % ) . Rectal bleeding was reported by 235 subjects ( age- and gender-adjusted prevalence , 15.5 per 100 ; 95 % confidence interval [ CI ] , 13.6–17.4 ) ; 218 found blood on wiping , 74 noted blood coating the stools , and 46 reported dark blood mixed in the stools . The prevalence of rectal bleeding was significantly higher in younger persons ( 18.9 % , 20–40 yr vs 11.3 % > 40 yr ; p < 0.001 ) . By stepwise logistic regression analysis , constipation ( odds ratio [ OR ] = 3.03 ; 95 % CI , 2.09–4.41 ) and diarrhea ( OR = 1.90 ; 95 % CI , 1.25–2.84 ) were independent predictors of rectal bleeding . Among those with rectal bleeding , 13.9 % ( 95 % CI , 9.6–19.1 % ) had visited a physician for bowel problems in the prior yr ; only a history of abdominal surgery was an independent predictor of physician visits but this explained just 15.9 % of the deviance . Conclusions : In otherwise healthy young and middle-aged persons , approximately one in seven have a history of rectal bleeding and this is more frequent in younger people ; only a minority seek health care and this is not related to symptom status BACKGROUND Open-access endoscopy allows physicians to directly schedule endoscopic procedures for their patients without prior consultation . Evaluation of both appropriateness and diagnostic yield of endoscopic procedures is critical when assessing the costs and benefits of endoscopy in an open-access setting . The aim of this study was to assess the appropriate use of colonoscopy in an open-access system and to establish the yield of diagnostic information relevant to patient care . METHODS Overall , 1123 consecutive patients referred for open-access colonoscopy were prospect ively enrolled in the study . The American Society for Gastrointestinal Endoscopy ( ASGE ) guidelines were used to assess the relationship between the appropriate use of colonoscopy and the presence of relevant endoscopic findings . RESULTS The rate of colonoscopies " generally not indicated " according to ASGE guidelines was 29 % ( 39 % for primary care physicians and 23 % for specialists ; p < 0.0001 ) . A relevant endoscopic finding was detected in 338 examinations ( 35 % ) . The diagnostic yield was significantly higher for " generally indicated " colonoscopies ( 43 % ) compared with " generally not indicated " procedures ( 16 % ) ( p < 0.001 ) . CONCLUSIONS Although the rate of inappropriate use of colonoscopy was high , open-access colonoscopy was effective in detecting neoplastic lesions . Because most of these were detected during examinations performed for appropriate indications , the appropriateness of the indication emerges as crucial to the cost-effectiveness of an open-access system |
11,554 | 31,964,311 | Statin therapy was also associated with increased overall patency rates and lower incidence of MACCE .
In conclusion , statins are associated with decreased risk for amputation , mortality , and MACCE , as well as increased overall patency rates among patients with CLI . | High-intensity statins are recommended for patients with peripheral artery disease ( PAD ) .
Critical limb ischemia ( CLI ) is the most advanced presentation of PAD .
The benefit of statins in the CLI population is unclear based on the existent studies .
Our objective was to perform a systematic review and meta- analysis regarding the efficacy of statin therapy in patients with CLI . | Objective Secondary prevention in patients with critical limb ischemia ( CLI ) is crucial for the reduction of cardiovascular morbidity and mortality . Nonetheless , current recommendations are extrapolated from other high‐risk population s because of the lack of CLI‐dedicated trials . The aim of this explorative study was to evaluate the association of statin therapy with the outcomes of CLI patients . Methods The First‐Line Treatments in Patients With Critical Limb Ischemia ( CRITISCH ) registry is a prospect i ve multicenter registry analyzing the effectiveness of all available treatment strategies in 1200 CLI patients . For the purpose s of this analysis , patients were divided into two groups based on statin administration . Treatment crossovers and nonadherent patients were excluded from analysis . The primary composite end point of this study was the amputation‐free survival ( AFS ) . Major adverse cardiovascular and cerebral events ( MACCEs ) , time to death , and time to major amputation were also analyzed . Results Statin therapy was applied in 445 individuals ( 37 % ) , 371 ( 31 % ) patients received no statins , and 384 subjects were excluded from analysis ( treatment crossovers ) . Patients receiving statins were more likely to be younger ( P < .001 ) and to have a history of coronary heart disease ( P < .001 ) or previous intervention at index limb ( P < .001 ) . Patients receiving statin therapy had a lower hazard regarding AFS ( hazard ratio [ HR ] , 0.45 ; 95 % confidence interval [ CI ] , 0.34‐0.63 ; P < .001 ) and death ( HR , 0.40 ; 95 % CI , 0.24‐0.66 ; P < .001 ) as well as lower odds of MACCE ( odds ratio , 0.41 ; 95 % CI , 0.23‐0.69 ; P = .001 ) . However , statin therapy was not associated with reduced amputation rates ( HR , 1.02 ; 95 % CI , 0.67‐1.56 ; P = .922 ) . Statin effect on AFS was consistent among diabetics ( HR , 0.47 ; 95 % CI , 0.31‐0.70 ; P < .001 ) , patients with chronic kidney disease ( HR , 0.53 ; 95 % CI , 0.32‐0.87 ; P = .012 ) , and patients older than 75 years ( HR , 0.40 ; 95 % CI , 0.26‐0.60 ; P < .001 ) . Statin administration was also associated with an improved AFS in patients with antiplatelet medication ( HR , 0.64 ; 95 % CI , 0.41‐0.99 ; P = .049 ) and without antiplatelet medication ( HR , 0.26 ; 95 % CI , 0.12‐0.57 ; P = .001 ) and after both endovascular therapy ( HR , 0.51 ; 95 % CI , 0.34‐0.76 ; P = .001 ) and bypass revascularization ( HR , 0.38 ; 95 % CI , 0.21‐0.68 ; P = .001 ) . Conclusions Statin therapy in CLI patients is associated with an increased AFS and lower rates of mortality and MACCEs without improving , however , the salvage rates of the affected limb In patients with peripheral artery disease ( PAD ) , statins may improve the symptoms of claudication . The Intermittent Claudication Proof of Principle ( ICPOP ) study tested the hypothesis that the combination of extended release niacin plus lovastatin would improve exercise performance in patients with PAD and claudication compared with a diet intervention . A phase 3 double-blind , parallel-group , multi-center , 28-week multi-national study evaluated subjects with a history of claudication who had an ankle — brachial index ( ABI ) ≤ 0.90 , a reproducible peak treadmill walking time ( PWT ) of 1—20 minutes , and a low-density lipoprotein (LDL)-cholesterol level < 160 mg/dl ( < 4.1 mmol/l ) . Subjects were r and omly assigned to low-dose niacin 1000 mg plus lovastatin 40 mg ( low niacin — statin ) , high-dose niacin 2000 mg plus lovastatin 40 mg ( high niacin — statin ) , or diet intervention ( diet ) . The co- primary efficacy endpoint of percent change in PWT and claudication onset time ( COT ) at 28 weeks was assessed using a grade d treadmill protocol . At completion , 385 subjects were analyzed for safety and 370 subjects were analyzed for efficacy . The primary efficacy analysis showed no statistical significance for overall treatment effect at week 28 for the co- primary endpoint of PWT and COT . The PWT component of the primary endpoint increased 26.5 % on diet , 37.8 % on high niacin — statin ( p = 0.137 ) and 38.6 % on low niacin — statin ( p = 0.096 ) . Flushing as the most common event leading to discontinuation and treatment was associated with increases in liver enzymes , fasting blood glucose concentration and a decrease in platelet count OBJECTIVE A population -based point-prevalence study was conducted to determine the prevalence of peripheral arterial disease ( PAD ) in Sweden , with special attention to critical limb ischemia and sex differences . METHODS An age-st and ardized r and omly selected population sample of 8000 women and men , aged 60 to 90 years , from four different regions in Sweden was invited to participate . The sample had the same age and gender distribution as the Swedish population in this age group . Participating subjects completed question naires on medical history , present medication , and symptoms , and their ankle-brachial index ( ABI ) was measured . Subjects were analyzed for presence of PAD according to reported symptoms and an ABI<0.9 . RESULTS A total of 5080 subjects were included , giving a participation rate of 64 % . The prevalence of any PAD , asymptomatic PAD , intermittent claudication , and severe limb ischemia was , respectively , 18 % ( 95 % confidence interval [ CI ] , 16 % to 20 % ) 11 % ( 9 % to 13 % ) , 7 % ( 6.5 to 7 % ) and 1.2 % ( 1 % to 1.5 % ) . Women had a higher prevalence than men when PAD was diagnosed with ABI only ; that is , asymptomatic PAD ( 12.6 % vs 9.4 % , P=.03 ) and severe limb ischemia ( 1.5 % vs 0.8 % , P<.008 ) . The prevalence of any PAD was 7.9 % in the age group 60 to 65 years and increased to 47.2 % among the age group 85 to 90 years . Severe limb ischemia occurred in 0.3 % in the youngest age group , was highest in the age group 80 to 84 years at 3.3 % , and declined to 2.5 % among the oldest . The prevalence of PAD differed between regions ( P<.0001 ) . CONCLUSIONS PAD is common in Sweden , and almost a fifth of all elderly individuals have some stage of this disease . Women are more often afflicted than men . The prevalence of severe ischemia , as a measure of critical limb ischemia , is about 1 % the population Background —Cholesterol modification reduces cardiovascular events in patients with atherosclerosis , including those with peripheral arterial disease . The purpose of this study was to determine whether cholesterol lowering with atorvastatin improves walking performance in patients with intermittent claudication . Methods and Results —This r and omized , double-blind , parallel- design study included 354 persons with claudication attributable to peripheral arterial disease . Patients were treated with placebo , atorvastatin ( 10 mg per day ) , or atorvastatin ( 80 mg per day ) for 12 months . The outcome measures included change in treadmill exercise time and patient-reported measures of physical activity and quality of life based on question naires . Maximal walking time after 12 months of treatment with atorvastatin did not change significantly . However , there was improvement in pain-free walking time after 12 months of treatment for the 80-mg ( P = 0.025 ) group compared with placebo . A physical activity question naire demonstrated improvement in ambulatory ability for the 10- and 80-mg groups ( P = 0.011 ) , whereas 2 quality of life instruments , the Walking Impairment Question naire and Short Form 36 Question naire , did not show significant change . Conclusions —Atorvastatin improves pain-free walking distance and community-based physical activity in patients with intermittent claudication . When treated with atorvastatin , patients with peripheral arterial disease may experience improvement in symptoms to complement the anticipated reduction in cardiovascular events reported in other studies of statins Background : The PCSK9 ( proprotein convertase subtilisin/kexin type 9 ) inhibitor evolocumab reduced low-density lipoprotein cholesterol and cardiovascular events in the FOURIER trial ( Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk ) . We investigated the efficacy and safety of evolocumab in patients with peripheral artery disease ( PAD ) as well as the effect on major adverse limb events . Methods : FOURIER was a r and omized trial of evolocumab versus placebo in 27 564 patients with atherosclerotic disease on statin therapy followed for a median of 2.2 years . Patients were identified as having PAD at baseline if they had intermittent claudication and an ankle brachial index of < 0.85 , or if they had a prior peripheral vascular procedure . The primary end point was a composite of cardiovascular death , myocardial infa rct ion , stroke , hospital admission for unstable angina , or coronary revascularization . The key secondary end point was a composite of cardiovascular death , myocardial infa rct ion , or stroke . An additional outcome of interest was major adverse limb events defined as acute limb ischemia , major amputation , or urgent peripheral revascularization for ischemia . Results : Three thous and six hundred forty-two patients ( 13.2 % ) had PAD ( 1505 with no prior myocardial infa rct ion or stroke ) . Evolocumab significantly reduced the primary end point consistently in patients with PAD ( hazard ratio [ HR ] 0.79 ; 95 % confidence interval [ CI ] , 0.66–0.94 ; P=0.0098 ) and without PAD ( HR 0.86 ; 95 % CI , 0.80–0.93 ; P=0.0003 ; Pinteraction=0.40 ) . For the key secondary end point , the HRs were 0.73 ( 0.59–0.91 ; P=0.0040 ) for those with PAD and 0.81 ( 0.73–0.90 ; P<0.0001 ) for those without PAD ( Pinteraction=0.41 ) . Because of their higher risk , patients with PAD had larger absolute risk reductions for the primary end point ( 3.5 % with PAD , 1.6 % without PAD ) and the key secondary end point ( 3.5 % with PAD , 1.4 % without PAD ) . Evolocumab reduced the risk of major adverse limb events in all patients ( HR , 0.58 ; 95 % CI , 0.38–0.88 ; P=0.0093 ) with consistent effects in those with and without known PAD . There was a consistent relationship between lower achieved low-density lipoprotein cholesterol and lower risk of limb events ( P=0.026 for the beta coefficient ) that extended down to < 10 mg/dL. Conclusions : Patients with PAD are at high risk of cardiovascular events , and PCSK9 inhibition with evolocumab significantly reduced that risk with large absolute risk reductions . Moreover , lowering of low-density lipoprotein cholesterol with evolocumab reduced the risk of major adverse limb events . Clinical Trial Registration : URL : https://www . clinical trials.gov . Unique identifier : NCT01764633 Non-r and omised studies of the effects of interventions are critical to many areas of healthcare evaluation , but their results may be biased . It is therefore important to underst and and appraise their strengths and weaknesses . We developed ROBINS-I ( “ Risk Of Bias In Non-r and omised Studies - of Interventions ” ) , a new tool for evaluating risk of bias in estimates of the comparative effectiveness ( harm or benefit ) of interventions from studies that did not use r and omisation to allocate units ( individuals or clusters of individuals ) to comparison groups . The tool will be particularly useful to those undertaking systematic review s that include non-r and omised studies OBJECTIVES The Heart Protection Study ( HPS ) provides an opportunity to assess directly the effects of cholesterol-lowering therapy on major vascular events ( defined as myocardial infa rct ion , coronary death , stroke , or revascularization ) in patients with peripheral arterial disease ( PAD ) . In addition , the effects on peripheral vascular events ( ie , non-coronary revascularization , aneurysm repairs , major amputations or PAD deaths ) can be assessed . METHODS 6748 UK adults with PAD and 13,788 other high-risk participants were r and omly allocated to receive 40 mg simvastatin daily or matching placebo , yielding an average LDL cholesterol difference of 1.0 mmol/L ( 39 mg/dL ) during a mean of 5 years . RESULTS For participants with PAD , allocation to simvastatin was associated with a highly significant 22 % ( 95 % CI 15 - 29 ) relative reduction in the rate of first major vascular event following r and omisation ( 895 [ 26.4 % ] simvastatin-allocated vs 1101 [ 32.7 % ] placebo-allocated ; P < .0001 ) , which was similar to that seen among the other high-risk participants . The absolute reduction in first major vascular event was 63 ( SE 11 ) per 1000 patients with PAD and 50 ( SE 7 ) per 1000 without pre-existing PAD . Overall , among all participants , there was a 16 % ( 5 - 25 ) relative reduction in the rate of first peripheral vascular event following r and omisation ( 479 [ 4.7 % ] simvastatin vs 561 [ 5.5 % ] placebo ) , largely irrespective of baseline LDL cholesterol and other factors . This effect chiefly reflects a 20 % ( 8 - 31 ) relative reduction in non-coronary revascularization procedures ( 334 [ 3.3 % ] vs 415 [ 4.0 % ] ; P = .002 ) . CONCLUSION HPS demonstrates the benefits of cholesterol-lowering statin therapy in patients with PAD , regardless of their presenting cholesterol levels and other presenting features . Allocation to 40 mg simvastatin daily reduces the rate of first major vascular events by about one-quarter , and that of peripheral vascular events by about one-sixth , with large absolute benefits seen in participants with PAD because of their high vascular risk . Consequently , statin therapy should be considered routinely for all patients with PAD BACKGROUND Acute coronary , cerebrovascular , and peripheral vascular events have common underlying arterial pathology , risk factors , and preventive treatments , but they are rarely studied concurrently . In the Oxford Vascular Study , we determined the comparative epidemiology of different acute vascular syndromes , their current burdens , and the potential effect of the ageing population on future rates . METHODS We prospect ively assessed all individuals presenting with an acute vascular event of any type in any arterial territory irrespective of age in a population of 91 106 in Oxfordshire , UK , in 2002 - 05 . FINDINGS 2024 acute vascular events occurred in 1657 individuals : 918 ( 45 % ) cerebrovascular ( 618 stroke , 300 transient ischaemic attacks [ TIA ] ) ; 856 ( 42 % ) coronary vascular ( 159 ST-elevation myocardial infa rct ion , 316 non-ST-elevation myocardial infa rct ion , 218 unstable angina , 163 sudden cardiac death ) ; 188 ( 9 % ) peripheral vascular ( 43 aortic , 53 embolic visceral or limb ischaemia , 92 critical limb ischaemia ) ; and 62 unclassifiable deaths . Relative incidence of cerebrovascular events compared with coronary events was 1.19 ( 95 % CI 1.06 - 1.33 ) overall ; 1.40 ( 1.23 - 1.59 ) for non-fatal events ; and 1.21 ( 1.04 - 1.41 ) if TIA and unstable angina were further excluded . Event and incidence rates rose steeply with age in all arterial territories , with 735 ( 80 % ) cerebrovascular , 623 ( 73 % ) coronary , and 147 ( 78 % ) peripheral vascular events in 12 886 ( 14 % ) individuals aged 65 years or older ; and 503 ( 54 % ) , 402 ( 47 % ) , and 105 ( 56 % ) , respectively , in the 5919 ( 6 % ) aged 75 years or older . Although case-fatality rates increased with age , 736 ( 47 % ) of 1561 non-fatal events occurred at age 75 years or older . INTERPRETATION The high rates of acute vascular events outside the coronary arterial territory and the steep rise in event rates with age in all territories have implication s for prevention strategies , clinical trial design , and the targeting of funds for service provision and research OBJECTIVE Evidence suggesting a beneficial effect of cardioprotective medications in patients with lower extremity atherosclerosis derives largely from secondary prevention studies of heterogeneous population s. Patients with critical limb ischemia ( CLI ) have a large atherosclerotic burden with related high mortality . The effect of such therapies in this population is largely inferred and unproven . METHODS The Project of Ex-Vivo vein graft Engineering via Transfection III ( PREVENT III ) cohort comprised 1404 patients with CLI who underwent lower extremity bypass grafting in a multicenter , r and omized prospect i ve trial testing the efficacy of edifoligide for the prevention of graft failure . Propensity scores were used to evaluate the influence of statins , beta-blockers , and antiplatelet agents on outcomes while adjusting for demographics , comorbidities , medications , and surgical variables that may influence drug use . Primary outcomes were major adverse cardiovascular events < or = 30 days , vein graft patency , and 1-year survival assessed by Kaplan-Meier method . Potential determinants of 1-year survival were modeled using a multivariate Cox regression . RESULTS In this cohort , 636 patients ( 45 % ) were taking statins , 835 ( 59 % ) were taking beta-blockers , and 1121 ( 80 % ) were taking antiplatelet drugs . Perioperative major adverse cardiovascular events ( 7.8 % ) and early mortality ( 2.7 % ) were not measurably affected by the use of any drug class . Statin use was associated with a significant survival advantage at 1 year of 86 % vs 81 % ( hazard ratio [ HR ] , 0.71 ; 95 % confidence interval [ CI ] , 0.52 - 0.98 ; P = .03 ) by analysis of both unweighted and propensity score-weighted data . Use of beta-blockers and antiplatelet drugs had no appreciable impact on survival . None of the drug classes were associated with graft patency measures at 1 year . Significant predictors of 1-year mortality by Cox regression modeling were statin use ( HR , 0.67 ; 95 % CI , 0.51 - 0.90 ; P = .001 ) , age > 75 ( HR , 2.1 ; 95 % CI , 1.60 - 2.82 ; P = .001 ) , coronary artery disease ( HR , 1.5 ; 95 % CI , 1.15 - 2.01 ; P = .001 ) , chronic kidney disease stages 4 ( HR , 2.0 ; 95 % CI , 1.17 - 3.55 ; P = .001 ) and 5 ( HR , 3.4 ; 95 % CI , 2.39 - 4.73 ; P < .001 ) , and tissue loss ( HR , 1.9 ; 95 % CI , 1.23 - 2.80 ; P = .003 ) . CONCLUSIONS Statin use is associated with improved survival in CLI patients 1 year after surgical revascularization . Further studies are indicated to determine optimal dosing in this population and to definitively address the question of relationship to graft patency . These data add to the growing literature supporting statin use in patients with advanced peripheral arterial disease BACKGROUND Throughout the usual LDL cholesterol range in Western population s , lower blood concentrations are associated with lower cardiovascular disease risk . In such population s , therefore , reducing LDL cholesterol may reduce the development of vascular disease , largely irrespective of initial cholesterol concentrations . METHODS 20,536 UK adults ( aged 40 - 80 years ) with coronary disease , other occlusive arterial disease , or diabetes were r and omly allocated to receive 40 mg simvastatin daily ( average compliance : 85 % ) or matching placebo ( average non- study statin use : 17 % ) . Analyses are of the first occurrence of particular events , and compare all simvastatin-allocated versus all placebo-allocated participants . These " intention-to-treat " comparisons assess the effects of about two-thirds ( 85 % minus 17 % ) taking a statin during the scheduled 5-year treatment period , which yielded an average difference in LDL cholesterol of 1.0 mmol/L ( about two-thirds of the effect of actual use of 40 mg simvastatin daily ) . Primary outcomes were mortality ( 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 All-cause mortality was significantly reduced ( 1328 [ 12.9 % ] deaths among 10,269 allocated simvastatin versus 1507 [ 14.7 % ] among 10,267 allocated placebo ; p=0.0003 ) , due to a highly significant 18 % ( SE 5 ) proportional reduction in the coronary death rate ( 587 [ 5.7 % ] vs 707 [ 6.9 % ] ; p=0.0005 ) , a marginally significant reduction in other vascular deaths ( 194 [ 1.9 % ] vs 230 [ 2.2 % ] ; p=0.07 ) , and a non-significant reduction in non-vascular deaths ( 547 [ 5.3 % ] vs 570 [ 5.6 % ] ; p=0.4 ) . There were highly significant reductions of about one-quarter in the first event rate for non-fatal myocardial infa rct ion or coronary death ( 898 [ 8.7 % ] vs 1212 [ 11.8 % ] ; p<0.0001 ) , for non-fatal or fatal stroke ( 444 [ 4.3 % ] vs 585 [ 5.7 % ] ; p<0.0001 ) , and for coronary or non-coronary revascularisation ( 939 [ 9.1 % ] vs 1205 [ 11.7 % ] ; p<0.0001 ) . For the first occurrence of any of these major vascular events , there was a definite 24 % ( SE 3 ; 95 % CI 19 - 28 ) reduction in the event rate ( 2033 [ 19.8 % ] vs 2585 [ 25.2 % ] affected individuals ; p<0.0001 ) . During the first year the reduction in major vascular events was not significant , but subsequently it was highly significant during each separate year . The proportional reduction in the event rate was similar ( and significant ) in each subcategory of participant studied , including : those without diagnosed coronary disease who had cerebrovascular disease , or had peripheral artery disease , or had diabetes ; men and , separately , women ; those aged either under or over 70 years at entry ; and --most notably -- even those who presented with LDL cholesterol below 3.0 mmol/L ( 116 mg/dL ) , or total cholesterol below 5.0 mmol/L ( 193 mg/dL ) . The benefits of simvastatin were additional to those of other cardioprotective treatments . The annual excess risk of myopathy with this regimen was about 0.01 % . There were no significant adverse effects on cancer incidence or on hospitalisation for any other non-vascular cause . INTERPRETATION Adding simvastatin to existing treatments safely produces substantial additional benefits for a wide range of high-risk patients , irrespective of their initial cholesterol concentrations . Allocation to 40 mg simvastatin daily reduced the rates of myocardial infa rct ion , of stroke , and of revascularisation by about one-quarter . After making allowance for non-compliance , actual use of this regimen would probably reduce these rates by about one-third . Hence , among the many types of high-risk individual studied , 5 years of simvastatin would prevent about 70 - 100 people per 1000 from suffering at least one of these major vascular events ( and longer treatment should produce further benefit ) . The size of the 5-year benefit depends chiefly on such individuals ' overall risk of major vascular events , rather than on their blood lipid concentrations alone BACKGROUND Lower blood cholesterol concentrations have consistently been found to be strongly associated with lower risks of coronary disease but not with lower risks of stroke . Despite this observation , previous r and omised trials had indicated that cholesterol-lowering statin therapy reduces the risk of stroke , but large-scale prospect i ve confirmation has been needed . METHODS 3280 adults with cerebrovascular disease , and an additional 17256 with other occlusive arterial disease or diabetes , were r and omly allocated 40 mg simvastatin daily or matching placebo . Subgroup analyses were prespecified of first " major vascular event " ( ie , non-fatal myocardial infa rct ion or coronary death , stroke of any type , or any revascularisation procedure ) in prior disease subcategories . Subsidiary outcomes included any stroke , and stroke sub-type . Comparisons are of all simvastatin-allocated versus all placebo-allocated participants ( ie , " intention-to-treat " ) , which yielded an average difference in LDL cholesterol of 1.0 mmol/L ( 39 mg/dL ) during the 5-year treatment period . FINDINGS Overall , there was a highly significant 25 % ( 95 % CI 15 - 34 ) proportional reduction in the first event rate for stroke ( 444 [ 4.3 % ] simvastatin vs 585 [ 5.7 % ] placebo ; p<0.0001 ) , reflecting a definite 28 % ( 19 - 37 ) reduction in presumed ischaemic strokes ( p<0.0001 ) and no apparent difference in strokes attributed to haemorrhage ( 51 [ 0.5 % ] vs 53 [ 0.5 % ] ; rate ratio 0.95 [ 0.65 - 1.40 ] ; p=0.8 ) . In addition , simvastatin reduced the numbers having transient cerebral ischaemic attacks alone ( 2.0 % vs 2.4 % ; p=0.02 ) or requiring carotid endarterectomy or angioplasty ( 0.4 % vs 0.8 % ; p=0.0003 ) . The reduction in stroke was not significant during the first year , but was already significant ( p=0.0004 ) by the end of the second year . Among patients with pre-existing cerebrovascular disease there was no apparent reduction in the stroke rate , but there was a highly significant 20 % ( 8 - 29 ) reduction in the rate of any major vascular event ( 406 [ 24.7 % ] vs 488 [ 29.8 % ] ; p=0.001 ) . The proportional reductions in stroke were about one-quarter in each of the other subcategories of participant studied , including : those with coronary disease or diabetes ; those aged under or over 70 years at entry ; and those presenting with different levels of blood pressure or lipids ( even when the pretreatment LDL cholesterol was below 3.0 mmol/L [ 116 mg/dL ] ) . INTERPRETATION Much larger numbers of people in the present study suffered a stroke than in any previous cholesterol-lowering trial . The results demonstrate that statin therapy rapidly reduces the incidence not only of coronary events but also of ischaemic strokes , with no apparent effect on cerebral haemorrhage , even among individuals who do not have high cholesterol concentrations . Allocation to 40 mg simvastatin daily reduced the rate of ischaemic strokes by about one-quarter and so , after making allowance for non-compliance in the trial , actual use of this regimen would probably reduce the stroke rate by about a third . HPS also provides definitive evidence that statin therapy is beneficial for people with pre-existing cerebrovascular disease , even if they do not already have manifest coronary disease OBJECTIVES This study sought to investigate the 3-year follow-up results of OLIVE registry patients . BACKGROUND Although favorable 12-month clinical outcomes after endovascular therapy ( EVT ) in OLIVE registry patients with critical limb ischemia ( CLI ) from infrainguinal disease have been reported , long-term results after EVT remain unknown . METHODS This was a prospect i ve multicenter registry study that consecutively enrolled patients who received infrainguinal EVT for CLI . The primary outcome was 3-year amputation-free survival ( AFS ) , whereas secondary outcome measures were 3-year freedom from major adverse limb events ( MALE ) , wound-free survival , and wound recurrence rate . Prognostic predictors for each outcome were also eluci date d by Cox proportional hazard regression analysis or the log-rank test . RESULTS The completion rate of 3-year follow-up was 95 % . Three-year AFS , freedom from MALE , and wound-free survival rates were 55.2 % , 84.0 % , and 49.6 % , respectively . Wound recurrence out to 3 years was 43.9 % . After multivariable analysis , age ( hazard ratio [ HR ] : 1.43 , p = 0.001 ) , body mass index ≤18.5 ( HR : 2.17 , p = 0.001 ) , dialysis ( HR : 2.91 , p < 0.001 ) , and Rutherford 6 ( HR : 1.64 , p = 0.047 ) were identified as predictors of 3-year major amputation or death . Statin use ( HR : 0.28 , p = 0.02 ) , Rutherford 6 ( HR : 2.40 , p = 0.02 ) , straight-line flow to the foot ( HR : 0.27 , p = 0.001 ) , and heart failure ( HR : 1.96 , p = 0.04 ) were identified as 3-year MALE predictors . Finally , CLI due to isolated below-the-knee lesion was a wound recurrence predictor ( HR : 4.28 , p ≤ 0.001 ) . Three-year survival , freedom from major amputation , and reintervention rates were 63.0 % , 87.9 % , and 43.2 % . CONCLUSIONS In CLI patients with infrainguinal lesions , 3-year clinical results of EVT were reasonable despite high reintervention and moderate ulcer recurrence rate . ( A Prospect i ve , Multi-Center , Three-Year Follow-Up Study on Endovascular Treatment for Infra-Inguinal Vessel in Patients With Critical Limb Ischemia [ OLIVE 3-Year Follow-Up Study ] ; UMIN000014759 ) AIMS To investigate the effect of combined treatment with angiotensin-converting enzyme inhibitors ( ACE ) and statins on mortality in diabetic patients with critical limb ischemia ( CLI ) . METHODS Prospect i ve observational study of 553 consecutive diabetic patients admitted because of CLI followed for a mean of 2.2 years . All patients underwent peripheral revascularization and antithrombotic therapy was prescribed or continued and therapy with statin and ACE was recorded . Mortality from any cause was assessed and Kaplan-Meier analyses were performed to compare the relationship between survival and recorded variables . RESULTS One hundred thirty-nine patients did not have therapy with statin or an ACE , 78 had therapy with statin without ACE , 164 had therapy with ACE without statin and 172 patients had therapy with both statin and ACE . One hundred thirty-six patients died , 45/139 with neither statin nor ACE , 40/164 with ACE only , 26/78 with statin only , and 25/172 with both statin and ACE . Multivariate analysis confirmed the independent role of age , history of stroke , renal insufficiency and dialysis . Combined treatment with ACE and statin appeared to have a protective role . CONCLUSIONS In patients with diabetes and CLI mortality after two years is high . Life expectancy was better in patients receiving combined therapy with ACE and statin but not with therapy with only a statin or an ACE To investigate the efficacy of statin treatment after endovascular therapy ( EVT ) for isolated below-the-knee ( BTK ) lesions in patients with critical limb ischemia ( CLI ) . From March 2004 to June 2011 , 812 patients ( 984 limbs , 69.0 % male , 71.6 ± 10.0 years old ) with CLI underwent successful EVT for de novo isolated BTK lesions at 11 cardiovascular centers in Japan . Of these patients , 169 patients were treated with statins . Successful EVT was defined as direct-line flow to the pedal arch with < 30 % residual stenosis . The multicenter data were analyzed retrospectively for outcomes of overall survival , amputation-free survival ( AFS ) , cardiovascular death , limb salvage , freedom from repeat revascularization , and major adverse limb events [ MALE : repeat revascularization for the limb or major amputation ( defined as above-the-ankle amputation ) ] . The mean follow-up period was 19.4 ± 17.6 months . Overall survival , AFS and freedom from repeat revascularization at 4 years were significantly higher in patients treated with statins ( 64.5 vs. 45.9 % , P = 0.004 ; 64.1 vs. 43.0 % , P = 0.003 ; and 56.4 vs. 45.4 % , P = 0.03 , respectively ) . However , rates of cardiovascular death , limb salvage , and MALE at 4 years did not differ significantly between the two groups ( 86.0 vs. 75.2 % , P = 0.11 ; 87.2 vs. 87.7 % , P = 0.39 ; and 84.4 vs. 82.9 % , P = 0.64 , respectively ) . After adjusting all outcomes against differences in prespecified baseline variables , there was no significant difference in overall survival , AFS , cardiovascular death , limb salvage , repeat revascularization , and MALE between the groups . In a subgroup of 513 patients who were ambulatory at baseline , statin treatment significantly improved overall survival [ hazard ratio ( HR ) 0.54 , 95 % confidential interval ( CI ) 0.29–0.97 , adjusted P = 0.04 ] and numerically improved AFS ( HR 0.63 , 95 % CI 0.35–1.07 , adjusted P = 0.086 ) . In this subgroup analysis , there was no significant difference in the rates of repeat revascularization , cardiovascular death , limb salvage , and MALE between patients treated with and without statins . In this retrospective study , the statin treatment after successful EVT establishing one straight line for isolated BTK lesions with CLI do not influence overall survival , AFS , and the rates of cardiovascular death , limb salvage , and MALE . However , in ambulatory patients , the statins may improve overall survival and AFS after successful EVT establishing one straight line for isolated BTK lesions |
11,555 | 19,941,729 | Oxytocin ( 10 IU ) , administered intramuscularly , is the preferred medication and route for the prevention of PPH in low-risk vaginal deliveries .
For women delivering vaginally with 1 risk factor for PPH , carbetocin 100 microg IM decreases the need for uterine massage to prevent PPH when compared with continuous infusion of oxytocin .
There is no evidence that , in an uncomplicated delivery without bleeding , interventions to accelerate delivery of the placenta before the traditional 30 to 45 minutes will reduce the risk of PPH .
( II-2C ) 12 .
Placental cord drainage can not be recommended as a routine practice since the evidence for a reduction in the duration of the third stage of labour is limited to women who did not receive oxytocin as part of the management of the third stage .
There is no evidence that this intervention prevents PPH .
Evidence for the benefit of recombinant activated factor VII has been gathered from very few cases of massive PPH . | OBJECTIVE To review the clinical aspects of postpartum hemorrhage ( PPH ) and provide guidelines to assist clinicians in the prevention and management of PPH .
These guidelines are an up date from the previous Society of Obstetricians and Gynaecologists of Canada ( SOGC ) clinical practice guideline on PPH , published in April 2000 .
Active management of the third stage of labour ( AMTSL ) reduces the risk of PPH and should be offered and recommended to all women . (
Ergonovine can be used for prevention of PPH but may be considered second choice to oxytocin owing to the greater risk of maternal adverse effects and of the need for manual removal of a retained placenta . | 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 Postpartum haemorrhage is a leading cause of maternal morbidity and mortality . Active management of the third stage of labour , including use of a uterotonic agent , has been shown to reduce blood loss . Misoprostol ( a prostagl and in E1 analogue ) has been suggested for this purpose because it has strong uterotonic effects , can be given orally , is inexpensive , and does not need refrigeration for storage . We did a multicentre , double-blind , r and omised controlled trial to determine whether oral misoprostol is as effective as oxytocin during the third stage of labour . METHODS In hospitals in Argentina , China , Egypt , Irel and , Nigeria , South Africa , Switzerl and , Thail and , and Vietnam , we r and omly assigned women about to deliver vaginally to receive 600 microg misoprostol orally or 10 IU oxytocin intravenously or intramuscularly , according to routine practice , plus corresponding identical placebos . The medications were administered immediately after delivery as part of the active management of the third stage of labour . The primary outcomes were measured postpartum blood loss of 1000 mL or more , and the use of additional uterotonics without an unacceptable level of side-effects . We chose an upper limit of a 35 % increase in the risk of blood loss of 1000 mL or more as the margin of clinical equivalence , which was assessed by the confidence interval of the relative risk . Analysis was by intention to treat . FINDINGS 9264 women were assigned misoprostol and 9266 oxytocin . 37 women in the misoprostol group and 34 in the oxytocin group had emergency caesarean sections and were excluded . 366 ( 4 % ) of women on misoprostol had a measured blood loss of 1000 mL or more , compared with 263 ( 3 % ) of those on oxytocin ( relative risk 1.39 [ 95 % CI 1.19 - 1.63 ] , p<0.0001 ) . 1398 ( 15 % ) women in the misoprostol group and 1002 ( 11 % ) in the oxytocin group required additional uterotonics ( 1.40 [ 1.29 - 1.51 ] , p<0.0001 ) . Misoprostol use was also associated with a significantly higher incidence of shivering ( 3.48 [ 3.15 - 3.84 ] ) and raised body temperature ( 7.17 [ 5.67 - 9.07 ] ) in the first hour after delivery . INTERPRETATION 10 IU oxytocin ( intravenous or intramuscular ) is preferable to 600 microg oral misoprostol in the active management of the third stage of labour in hospital setting s where active management is the norm It has been recognised that , if the length of the third stage of labour exceeds 30 min , then there is an increased risk of a post‐partum haemorrhage . Recent information has suggested that 18 min is the optimal time for removal of the undelivered placenta to prevent a post‐partum haemorrhage . A r and omised trial comparing 20 vs. 30 min was stopped after an interim analysis because only eight of 1607 patients ’ placentas had not delivered by 20 min . A third stage of labour that exceeded 10 min was observed to be significantly correlated with an increased risk of post‐partum haemorrhage Abstract The distribution of the circulatingblood volume in the infant-placental circuit at birth and in the first minutes after birth was studied in 111 normal full-term deliveries . The blood-volume of the infants , divided in groups where umbilical cords were clamped at various times , was measured by the 125 I-serum-albumin dilution method , and the placental residual blood-volume was measured by drainage both when the placenta was still in utero and after its delivery . The distribution of the blood between the infant 's and placental circuits was about 67%/33 % at birth , 80%/20 % at 1 minute , and 87%/13 % at the termination of placental transfusion Methods We describe a prospect i ve study , done over a 2-year period in which a total of 958 women having a vaginal delivery were r and omised to the drainage method ( 478 women ) or controlled cord traction method ( 480 women ) for placental delivery . Results The mean age , parity , gestation and birth weight were similar in the two groups . The mean duration of third stage of labor was 3.24 min and 3.2 min in the placental drainage group in contrast to 8.57 min and 6.20 min in controlled cord traction method in primigravida and multigravida respectively . Conclusion Placental drainage significantly reduces the duration of third stage of labour in vaginal deliveries BACKGROUND The cardiovascular effects of oxytocin in animal models and women undergoing Caesarean section include tachycardia , hypotension and decrease in cardiac output . These can be sufficient to cause significant compromise in high-risk patients . We aim ed to find a simple way to decrease these risks whilst retaining the benefits of oxytocin in decreasing bleeding after delivery . Method . We recruited 30 women undergoing elective Caesarean section . They were r and omly allocated to receive 5 u of oxytocin either as a bolus injection ( bolus group ) or an infusion over 5 min ( infusion group ) . These women had their heart rate and intra-arterial blood pressure recorded every 5 s throughout the procedure . The haemodynamic data , along with the estimated blood loss , were compared between the groups . RESULTS Marked cardiovascular changes occurred in the bolus group ; the heart rate increased by 17 ( 10.7 ) beats min(-1 ) [ mean ( sd ) ] compared with 10 ( 9.7 ) beats min(-1 ) in the infusion group . The mean arterial pressure decreased by 27 ( 7.6 ) mm Hg in the bolus group compared with 8 ( 8.7 ) mm Hg in the infusion group . There were no differences in the estimated blood loss between the two groups . CONCLUSION We recommend that bolus doses should be used with caution , and further studies should ascertain if oxytocin is equally effective in reducing blood loss when given at a slower rate OBJECTIVE : To assess the effects of oxytocin bolus or infusion on maternal hemodynamics in the third stage of labor . METHODS : In a r and omized , double-blind , double-dummy fashion , 99 women received an intravenous oxytocin bolus ( 10 IU push ) and 102 women received an infusion ( 10 IU in 500 mL saline at 125 mL/h ) at delivery of the anterior shoulder . Mean arterial pressure and heart rate were measured every minute for 10 minutes , then every 5 minutes for the next 20 minutes . These serial measurements were analyzed using a 2-factor analysis of variance for repeated measures . RESULTS : Serial mean arterial pressure measures varied significantly between groups ( interaction effect , P = .002 ) . Mean arterial pressure ( ± st and ard deviation ) nadirs were reached after 10 minutes , 80.9 ( ± 11.0 ) mm Hg in the bolus group compared with 77.0 ( ± 12.1 ) mm Hg in the dilute infusion group . The mean difference ( 95 % confidence interval ) between groups was 4.0 ( 0.7–7.2 ) mm Hg . Serial heart rate measures also varied between groups ( interaction effect , P < .001 ) . Mean heart rate ( ± st and ard deviation ) peaked 1 minute after the oxytocin infusion , 115 ( ± 27 ) beats per minute ( bpm ) in the bolus group compared with 109 ( ± 21 ) bpm in the dilute infusion group . The mean difference ( 95 % confidence interval ) between groups was 6.6 bpm ( −0.1 to 13.3 ) . The dilute oxytocin infusion group experienced a greater mean estimated blood loss ( 423.7 mL compared with 358.1 mL , P = .029 , t test ) , increased use of additional oxytocics ( 35.3 % compared with 22.2 % , P = .044 , Fisher exact test ) and a greater drop in hemoglobin ( admission minus postpartum ) ( 17.4g/L compared with 11.4g/L , P = .002 , t test ) compared with the oxytocin bolus group . CONCLUSION : Bolus oxytocin of 10 IU is not associated with adverse hemodynamic responses and can safely be administered to women with intravenous access in the third stage of labor for postpartum hemorrhage prophylaxis . LEVEL OF EVIDENCE : 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 The goal of this study was to compare carbetocin , a long-acting oxytocin analog , with oxytocin in the prevention of uterine atony after cesarean section . STUDY DESIGN We enrolled 694 patients undergoing elective cesarean section in a Canadian multicenter , double-blind , r and omized clinical trial . We compared the effect of a single 100 microg dose of carbetocin with that of a st and ard 8-hour infusion of oxytocin . The primary outcome was the proportion of patients requiring additional oxytocic intervention for uterine atony . A variable sample size , sequential design was used . RESULTS The overall oxytocic intervention rate was 7.4 % . The odds of treatment failure requiring oxytocic intervention was 2.03 ( 95 % confidence interval 1.1 to 2.8 ) times higher in the oxytocin group compared with the carbetocin group , respectively , 32 of 318 ( 10.1 % ) versus 15 of 317 ( 4.7 % ) , P < .05 . CONCLUSIONS Carbetocin , a new drug for the prevention of uterine atony , appears to be more effective than a continuous infusion of oxytocin and has a similar safety profile Background . Manual removal of placenta is performed in 1–3 % of cases , and whilst a well established and relatively safe procedure , it is not without complications , which include infection , hemorrhage , uterine rupture , and occasional maternal death . Methods . A three‐arm r and omized controlled trial of 50 IU Syntocinon ( in 30 ml N saline ) versus 800 mcg misoprostol ( in 30 ml N saline ) versus 30 ml N saline alone ( control ) , injected into the placental bed via the umbilical vein using the Pipingas method . A group sequential research model ( triangular test : PEST4 ) was adopted to minimize the sample size , as retained placenta is a relatively uncommon condition . Results . No significant difference in the rate of manual removal was observed between the control and Syntocinon groups . On triggering the automatic stopping rule for this arm of the trial all subsequent cases recruited were allocated to receive either Syntocinon or misoprostol . After a total of 54 cases a significant reduction in manual removal of placenta was observed in the misoprostol group , triggering the automatic stopping rule and terminating the trial . Conclusion . Misoprostol ( 800 mcg ) dissolved in 30 ml N saline and administered by intraumbilical injection using the Pipingas technique significantly reduces the need for manual removal for retained adherent placenta , whereas Syntocinon has similar effectiveness to injection of N saline alone OBJECTIVES To compare the efficacy of a single 100 micro g intramuscular ( IM ) carbetocin injection , a long-acting oxytocin agonist , to a 2-hour 10 IU oxytocin intravenous ( IV ) infusion , in reducing the incidence and severity of postpartum hemorrhage ( PPH ) in women at risk for this condition . METHODS A r and omized , double-blind , placebo-controlled study was conducted at 2 hospital centres , including 160 women with at least 1 risk factor for PPH . Eighty-three women received 100 microg carbetocin IM and an IV placebo immediately after placental delivery , while 77 women received placebo IM and oxytocin IV infusion . Complete blood count was collected at entry and 24 hours postpartum . All outcome measures , including the need for additional uterotonic agents or uterine massage , blood loss , and drop in hemoglobin and hematocrit , were analyzed using chi-square , Fisher exact , and Student t tests . RESULTS Population profile and risk factors for PPH were similar for each group . No significant difference was observed in the number of women requiring additional uterotonic medication ( 12 in each group ) . However , in the carbetocin group , 36 of the 83 women ( 43.4 % ) required at least 1 uterine massage compared to 48 of the 77 women ( 62.3 % ) in the oxytocin group ( P < .02 ) . Overall , uterotonic intervention was clinical ly indicated in 37 of the women ( 44.6 % ) receiving carbetocin compared to 49 of the women ( 63.6 % ) given an IV oxytocin infusion ( P < .02 ) . There were no differences in laboratory PPH indicators between the 2 groups OBJECTIVES Our purpose was to record gestational age-specific data for third-stage duration of labor , frequencies of retained placentas ( undelivered at 30 minutes ) , manual removal of the placenta , and hemorrhage . STUDY DESIGN Included were 45,852 singleton deliveries > or = 20 weeks ' gestation from 1984 to 1992 . Odds ratios , 95 % confidence intervals , and actuarial life analysis with censoring of cases with manual placenta removal were performed . RESULTS The frequency of retained placentas ( 2.0 % overall ) was markedly increased among gestations < or = 26 weeks ( odds ratio 20.8 , 95 % confidence interval 17.1 to 25.4 ) and < 37 weeks ( odds ratio 3.0 , 95 % confidence interval 2.6 to 3.5 ) compared with term . The frequency of manual removal ( 3.0 % overall ) was increased among gestations < or = 26 weeks ( odds ratio 9.2 , 95 % confidence interval 7.5 to 11.4 ) and < 37 weeks ( odds ratio 2.8 , 95 % confidence interval 2.4 to 3.1 ) compared with term . Hemorrhage ( 3.5 % overall ) was increased among subjects with manual placenta removal ( odds ratio 10.4 , 95 % confidence interval 9.1 to 11.9 ) ; hemorrhage was also increased among gestations < or = 26 weeks ( odds ratio 3.0 , 95 % confidence interval 2.3 to 4.0 ) and < 37 weeks ( odds ratio 1.2 , 95 % confidence interval 1.01 to 1.3 ) compared with term . The frequency of hemorrhage peaked by 40 minutes regardless of gestational age . Life-table analysis predicted 90 % of placentas would spontaneously deliver by 180 minutes for gestations at 20 weeks , 21 minutes at 30 weeks , and 14 minutes at 40 weeks ; the predicted frequency of retained placentas was 42 % higher than the recorded incidence . CONCLUSIONS The duration of the third stage decreases and the frequencies of hemorrhage and manual removal decrease with increasing gestational age . Hemorrhage was associated with manual placental removal . Life-table analysis indicated that manual removal of placentas shortened the duration of the third stage of labor , especially among preterm deliveries . A prospect i ve trial is needed to determine whether manual placental removal can reduce hemorrhage among prolonged third stages OBJECTIVE : To investigate the clinical effects of early versus late cord clamping in preterm infants . STUDY DESIGN : A total of 32 premature infants were prospect ively r and omized . The following parameters were measured : Initial spun hematocrit ( Hct ) , hemoglobin ( Hgb ) , red blood cell ( RBC ) counts , frequency of blood transfusions , peak serum bilirubin , mean blood pressure ( MBP ) , oxygen index , intraventricular hemorrhage , and significant patent ductus arteriosus ( PDA ) . RESULTS : Over the 4-week study period , the delayed cord clamping ( DCC ) group exhibited a decrease in the frequency of blood transfusion ( p < 0.001 ) and also a decrease in albumin transfusions over the first 24 hours ( p < 0.03 ) . MBP in the first 4 hours was higher in the DCC group ( p < 0.01 ) , and there were statistically significant increases in Hct ( 21 % ) , Hgb ( 23 % ) , and RBC count ( 21 % ) compared with the early cord clamping group . The risks of patent ductus arteriosus , hyperbilirubinemia , or intraventricular hemorrhage were similar in both groups . Late clamping of the umbilical cord had little or no effect on the oxygen index . CONCLUSION : DCC significantly reduced the requirement for blood and albumin transfusion . It also increased the initial Hct , RBC count , Hgb levels , and MBP OBJECTIVE To determine if the timing of the administration of prophylactic oxytocin influences the incidence of postpartum hemorrhage caused by uterine atony , retained placenta , and third-stage duration . STUDY DESIGN Parturients who presented for vaginal delivery were r and omized in a double-blinded fashion to receive oxytocin , 20 units in a 500-mL crystalloid intravenous bolus , beginning upon delivery of either the fetal anterior shoulder or placenta . For all patients , the third stage of labor was managed with controlled cord traction until placental expulsion , followed by at least 15 seconds of fundal massage . Patients were excluded if they had a previous cesarean section , multiple gestation , antepartum hemorrhage , or bleeding disorder . RESULTS A total of 1486 patients were enrolled : 745 in the before-placenta group and 741 in the after-placenta group . The groups were similar with respect to gestational age , fetal weight , labor duration , maternal age , parity , and ethnicity . The incidence of postpartum hemorrhage did not differ significantly between the two groups ( 5.4 % vs 5.8 % ; crude OR , 0.92 ; 95 % CI , 0.59 to 1.43 ) . There were no significant differences between the two groups with respect to incidence of retained placenta ( 2.4 % vs 1.6 % ; OR , 1.49 ; 95 % CI , 0.72 to 3.08 ) , or third-stage duration ( 7.7 minutes vs 8.1 minutes ; P = .23 ) . CONCLUSIONS The administration of prophylactic oxytocin before placental delivery does not reduce the incidence of postpartum hemorrhage or third-stage duration , when compared with giving oxytocin after placental delivery . Early administration , however , does not increase the incidence of retained placenta OBJECTIVE To compare the effect of rectal misoprostol with intramuscular oxytocin in the routine management of the third stage in a rural developing country . METHODS A r and omized controlled trial was performed at two district hospitals in Ghana , West Africa . Four hundred fifty women in advanced labour were enrolled . The only exclusion criterion was a known medical contraindication to prostagl and in administration . Women were r and omized to receive rectal misoprostol 800 microg or intramuscular oxytocin 10 IU with delivery of the anterior shoulder . The main outcome measure was change in hemoglobin concentration from before to after delivery . Secondary outcomes included the need for additional uterotonics , estimated blood loss , transfusion , and medication side effects . RESULTS Demographic characteristics were similar in each treatment group . There was no significant difference between treatment groups in change in hemoglobin ( misoprostol 1.19 g/dL and oxytocin 1.16 g/dL ; relative difference 2.6 % ; 95 % confidence intervals [CI]-16.8 % to 19.4 % ; P = 0.80 ) . The only significant secondary outcome was shivering , which was more common in the misoprostol group ( misoprostol 7.5 % vs. oxytocin 0.9 % ; relative risk 8.0 ; 95 % CI 1.86 - 34.36 ; P = 0.001 ) . CONCLUSION Rectal misoprostol 800 microg is as effective as 10 IU intramuscular oxytocin in minimizing blood loss in the third stage of labour . Rectal misoprostol has a lower incidence of side effects than the equivalent oral dose . This confirms the utility of misoprostol as a safe and effective uterotonic for use in the rural and remote areas of developing nations where other pharmacologic agents may be less feasible |
11,556 | 26,607,412 | Five analyses on moderator variables indicated significant tDCS beneficial effects : ( a ) on both cognitive and motor task performances , ( b ) across a wide-range of cognitive tasks , ( c ) on specific brain areas , ( d ) stimulation offline ( before ) or online ( during ) the cognitive and motor tasks . | The use of transcranial direct current stimulation ( tDCS ) to enhance cognitive and motor functions has enjoyed a massive increase in popularity .
Modifying neuroplasticity via non-invasive cortical stimulation has enormous potential to slow or even reverse declines in functions associated with ageing .
The current meta- analysis evaluated the effects of tDCS on cognitive and motor performance in healthy older adults . | Transcranial direct current stimulation ( tDCS ) of the human motor cortex results in polarity-specific shifts of cortical excitability during and after stimulation . Anodal tDCS enhances and cathodal stimulation reduces excitability . Animal experiments have demonstrated that the effect of anodal tDCS is caused by neuronal depolarisation , while cathodal tDCS hyperpolarises cortical neurones . However , not much is known about the ion channels and receptors involved in these effects . Thus , the impact of the sodium channel blocker carbamazepine , the calcium channel blocker flunarizine and the NMDA receptor antagonist dextromethorphane on tDCS-elicited motor cortical excitability changes of healthy human subjects were tested . tDCS- protocol s inducing excitability alterations ( 1 ) only during tDCS and ( 2 ) eliciting long-lasting after-effects were applied after drug administration . Carbamazepine selectively eliminated the excitability enhancement induced by anodal stimulation during and after tDCS . Flunarizine result ed in similar changes . Antagonising NMDA receptors did not alter current-generated excitability changes during a short stimulation , which elicits no after-effects , but prevented the induction of long-lasting after-effects independent of their direction . These results suggest that , like in other animals , cortical excitability shifts induced during tDCS in humans also depend on membrane polarisation , thus modulating the conductance of sodium and calcium channels . Moreover , they suggest that the after-effects may be NMDA receptor dependent . Since NMDA receptors are involved in neuroplastic changes , the results suggest a possible application of tDCS in the modulation or induction of these processes in a clinical setting . The selective elimination of tDCS-driven excitability enhancements by carbamazepine proposes a role for this drug in focussing the effects of cathodal tDCS , which may have important future clinical applications OBJECTIVE Recent evidence suggests that fibromyalgia is a disorder characterized by dysfunctional brain activity . Because transcranial direct current stimulation ( tDCS ) can modulate brain activity noninvasively and can decrease pain in patients with refractory central pain , we hypothesized that tDCS treatment would result in pain relief in patients with fibromyalgia . METHODS Thirty-two patients were r and omized to receive sham stimulation or real tDCS with the anode centered over the primary motor cortex ( M1 ) or the dorsolateral prefrontal cortex ( DLPFC ) ( 2 mA for 20 minutes on 5 consecutive days ) . A blinded evaluator rated the patient 's pain , using the visual analog scale for pain , the clinician 's global impression , the patient 's global assessment , and the number of tender points . Other symptoms of fibromyalgia were evaluated using the Fibromyalgia Impact Question naire and the Short Form 36 Health Survey . Safety was assessed with a battery of neuropsychological tests . To assess potential confounders , we measured mood and anxiety changes throughout the trial . RESULTS Anodal tDCS of the primary motor cortex induced significantly greater pain improvement compared with sham stimulation and stimulation of the DLPFC ( P < 0.0001 ) . Although this effect decreased after treatment ended , it was still significant after 3 weeks of followup ( P = 0.004 ) . A small positive impact on quality of life was observed among patients who received anodal M1 stimulation . This treatment was associated with a few mild adverse events , but the frequency of these events in the active-treatment groups was similar to that in the sham group . Cognitive changes were similar in all 3 treatment groups . CONCLUSION Our findings provide initial evidence of a beneficial effect of tDCS in fibromyalgia , thus encouraging further trials Transcranial direct current stimulation ( tDCS ) can up- and down-regulate cortical excitability depending on current direction , however our abilities to measure brain-tissue effects of the stimulation and its after-effects have been limited so far . We used regional cerebral blood flow ( rCBF ) , a surrogate measure of brain activity , to examine regional brain-tissue and brain-network effects during and after tDCS . We varied the polarity ( anodal and cathodal ) as well as the current strength ( 0.8 to 2.0mA ) of the stimulation . Fourteen healthy subjects were r and omized into receiving either anodal or cathodal stimulation ( two subjects received both , one week apart ) while undergoing Arterial Spin Labeling ( ASL ) in the MRI scanner with an alternating off-on sampling paradigm . The stimulating , MRI-compatible electrode was placed over the right motor region and the reference electrode over the contralateral supra-orbital region . SPM5 was used to process and extract the rCBF data using a 10 mm spherical volume of interest ( VOI ) placed in the motor cortex directly underneath the stimulating scalp electrode . Anodal stimulation induced a large increase ( 17.1 % ) in rCBF during stimulation , which returned to baseline after the current was turned off , but exhibited an increase in rCBF again in the post-stimulation period . Cathodal stimulation induced a smaller increase ( 5.6 % ) during stimulation , a significant decrease compared to baseline ( -6.5 % ) after cessation , and a continued decrease in the post-stimulation period . These changes in rCBF were all significant when compared to the pre-stimulation baseline or to a control region . Furthermore , for anodal stimulation , there was a significant correlation between current strength and the increase in rCBF in the on-period relative to the pre-stimulation baseline . The differential rCBF after-effects of anodal ( increase in resting state rCBF ) and cathodal ( decrease in resting state rCBF ) tDCS support findings of behavioral and cognitive after-effects after cathodal and anodal tDCS . We also show that tDCS not only modulates activity in the brain region directly underlying the stimulating electrode but also in a network of brain regions that are functionally related to the stimulated area . Our results indicate that ASL may be an excellent tool to investigate the effects of tDCS and its stimulation parameters on brain activity OBJECTIVE To investigate in a r and omized , double-blind design , cumulative effects of anodal tDCS on EEG oscillations and neuropsychological tests among patients with traumatic brain injury ( TBI ) undergoing subacute neurorehabilitation . METHODS Twenty-six patients were r and omly assigned to active ( n=13 ) or sham ( n=13 ) tDCS groups . EEGs were recorded at 6 different time points , assessing both immediate and cumulative effects of tDCS on EEG oscillations . Twenty minute sessions of 1mA anodal stimulation to the left dorsolateral prefrontal cortex ( F3 , cathode placed at right supraorbital site , Fp2 ) , were provided on 10 consecutive days . Neuropsychological tests were administered before and after the series of tDCS sessions . RESULTS Theta was significantly reduced for active tDCS patients following the first tDCS session . Delta decreased and alpha increased , both significantly , for the active tDCS group after 10 consecutive tDCS sessions . No significant changes were seen for sham group . Decreases in delta were significantly correlated with improved performance on neuropsychological tests for the active tDCS group to far greater degree than for the sham group . Participants in the active tDCS group who had excess slow EEG activity in their initial recordings showed greater improvement on neuropsychological tests than other groups . CONCLUSION Results suggest that 10 anodal tDCS sessions may beneficially modulate regulation of cortical excitability for patients with TBI . SIGNIFICANCE EEG-guided tDCS warrants further investigation as a potential intervention for TBI during subacute neurorehabilitation BACKGROUND The brain-derived neurotrophic factor ( BDNF ) gene is involved in mechanisms of synaptic plasticity in the adult brain . It has been demonstrated that BDNF also plays a significant role in shaping externally induced human brain plasticity . Plasticity induced in the human motor cortex by intermittent theta-burst stimulation ( iTBS ) was impaired in individuals expressing the Val66Met polymorphism . METHODS To explore whether this polymorphism is also important for other neuroplasticity-inducing tools in humans with modes of action differing from that of iTBS , namely , transcranial direct current ( tDCS ) and r and om noise stimulation ( tRNS ) , we retrospectively analyzed the data of 64 subjects studied in our laboratory with regard to BDNF genotype . RESULTS Fifteen subjects with the Val66Met allele , 46 subjects with the Val66Val allele , and 3 Met66Met carriers were identified . The response of the Val66Met allele carriers to stimulation differed in two protocol s compared with the response of Val66Val individuals . For iTBS ( 15 subjects , 5 heterozygotes ) , plasticity could be only induced in the Val66Val allele carriers . However , for facilitatory tDCS ( 24 subjects , 10 heterozygotes ) , as well as for inhibitory tDCS , ( 19 subjects , 8 heterozygotes ) , carriers of the Val66Met allele displayed enhanced plasticity , whereas for transcranial r and om noise stimulation ( 29 subjects , 8 heterozygotes ) , the difference between groups was not so pronounced . CONCLUSIONS BDNF polymorphism has a definite impact on plasticity in humans , which might differ according to the mechanism of plasticity induction . This impact of BDNF on plasticity should be taken into account for future studies , as well as having wider ranging implication s for the treatment of neuropsychiatric disorders with transcranial stimulation tools , as it may predetermine their efficacy for the treatment of disease and rehabilitation Decline in cognitive functions , including impaired acquisition of novel skills , is a feature of older age that impacts activities of daily living , independence , and integration in modern societies The rising proportion of elderly people worldwide will yield an increased incidence of age-associated cognitive impairments , imposing major burdens on societies . Consequently , growing interest emerged to evaluate new strategies to delay or counteract cognitive decline in aging . Here , we assessed immediate effects of anodal transcranial direct current stimulation ( atDCS ) on cognition and previously described detrimental changes in brain activity attributable to aging . Twenty healthy elderly adults were assessed in a crossover sham-controlled design using functional magnetic resonance imaging ( fMRI ) and concurrent transcranial DCS administered to the left inferior frontal gyrus . Effects on performance and task-related brain activity were evaluated during overt semantic word generation , a task that is negatively affected by advanced age . Task-absent resting-state fMRI ( RS-fMRI ) assessed atDCS-induced changes at the network level independent of performance . Twenty matched younger adults served as controls . During sham stimulation , task-related fMRI demonstrated that enhanced bilateral prefrontal activity in older adults was associated with reduced performance . RS-fMRI revealed enhanced anterior and reduced posterior functional brain connectivity . atDCS significantly improved performance in older adults up to the level of younger controls ; significantly reduced task-related hyperactivity in bilateral prefrontal cortices , the anterior cingulate gyrus , and the precuneus ; and induced a more “ youth-like ” connectivity pattern during RS-fMRI . Our results provide converging evidence from behavioral analysis and two independent functional imaging paradigms that a single session of atDCS can temporarily reverse nonbeneficial effects of aging on cognition and brain activity and connectivity . These findings may translate into novel treatments to ameliorate cognitive decline in normal aging in the future Transcranial direct current stimulation ( tDCS ) over the primary motor cortex ( M1 ) has been shown to induce changes in motor performance and learning . Recent studies indicate that tDCS is capable of modulating widespread neural network properties within the brain . However the temporal evolution of online- and after-effects of tDCS on functional connectivity ( FC ) within and across the stimulated motor cortices ( M1 ) still remain elusive . In the present study , two different tDCS setups were investigated : ( i ) unilateral M1 tDCS ( anode over right M1 , cathode over the contralateral supraorbital region ) and ( ii ) bilateral M1 tDCS ( anode over right M1 , cathode over left M1 ) . In a r and omized single-blinded cross-over design , 12 healthy subjects underwent functional magnetic resonance imaging at rest before , during and after 20 min of either bi- , unilateral , or sham M1 tDCS . Seed-based FC analysis was used to investigate tDCS-induced changes across and within M1 . We found that bilateral M1 tDCS induced ( a ) a decrease in interhemispheric FC during stimulation and ( b ) an increase in intracortical FC within right M1 after termination of the intervention . While unilateral M1 tDCS also result ed in similar effects during stimulation , no such changes could be observed after termination of tDCS . Our results provide evidence that depending on the electrode montage , tDCS acts upon a modulation of either intracortical and /or interhemispheric processing of M1 Bihemispheric transcranial direct current stimulation ( tDCS ) is thought to upregulate excitability of the primary motor cortex ( M1 ) using anodal stimulation while concurrently downregulating contralateral M1 using cathodal stimulation . This “ dual ” tDCS method enhances motor learning in healthy subjects and facilitates motor recovery after stroke . However , its impact on motor system activity and connectivity remains unknown . Therefore , we assessed neural correlates of dual and unihemispheric anodal tDCS effects in 20 healthy older subjects in a r and omized , sham-controlled study using a cross-over design . Participants underwent tDCS and simultaneous functional magnetic resonance imaging during a choice reaction time task and at rest . Diffusion tensor imaging ( DTI ) allowed us to relate potential functional changes to structural parameters . The resting-state analysis demonstrated that , compared with sham , both dual and anodal tDCS decreased connectivity of right hippocampus and M1 ( contralateral to the anode position ) while increasing connectivity in the left prefrontal cortex . Notably , dual but not anodal tDCS enhanced connectivity of the left dorsal posterior cingulate cortex . Furthermore , dual tDCS yielded stronger activations in bilateral M1 compared with anodal tDCS when participants used either their left or right h and during the motor task . The corresponding tDCS-induced changes in laterality of activations were related to the microstructural status of transcallosal motor fibers . In conclusion , our results suggest that the impact of bihemispheric tDCS can not be explained by mere add-on effects of anodal and concurrent cathodal stimulation , but rather by complex network modulations involving interhemispheric interactions and areas associated with motor control in the dorsal posterior cingulate cortex Memory is the capacity to store , maintain , and retrieve events or information from the mind . Difficulties in verbal episodic memory commonly occur in healthy aging . In this paper , we assess the hypothesis that anodal transcranial direct current stimulation ( tDCS ) applied over the dorsolateral prefrontal cortex ( DLPFC ) or over the parietal cortex ( PARC ) could facilitate verbal episodic memory in a group of 32 healthy older adults and in a group of 32 young subjects relative to a sham stimulation using a single-blind r and omized controlled design . Each participant underwent two sessions of anodal tDCS ( left and right ) and one session of sham stimulation . Overall , our results demonstrated that , in young and in older subjects , anodal tDCS applied during the retrieval phase facilitates verbal episodic memory . In particular , we found that tDCS applied over the left and right regions ( DLPFC and PARC ) induced better performance in young participants ; only tDCS applied over the left regions ( DLPFC and PARC ) increased retrieval in older subjects . These results suggest that anodal tDCS can be a relevant tool to modulate the long-term episodic memory capacities of young and older subjects Background Progression of Parkinson 's disease ( PD ) is characterised by motor deficits which eventually respond less to dopaminergic therapy and thus pose a therapeutic challenge . Deep brain stimulation has proven efficacy but carries risks and is not possible in all patients . Non-invasive brain stimulation has shown promising results and may provide a therapeutic alternative . Objective To investigate the efficacy of transcranial direct current stimulation ( tDCS ) in the treatment of PD . Design R and omised , double blind , sham controlled study . Setting Research institution . Methods The efficacy of anodal tDCS applied to the motor and prefrontal cortices was investigated in eight sessions over 2.5 weeks . Assessment over a 3 month period included timed tests of gait ( primary outcome measure ) and bradykinesia in the upper extremities , Unified Parkinson 's Disease Rating Scale ( UPDRS ) , Serial Reaction Time Task , Beck Depression Inventory , Health Survey and self- assessment of mobility . Results Twenty-five PD patients were investigated , 13 receiving tDCS and 12 sham stimulation . tDCS improved gait by some measures for a short time and improved bradykinesia in both the on and off states for longer than 3 months . Changes in UPDRS , reaction time , physical and mental well being , and self-assessed mobility did not differ between the tDCS and sham interventions . Conclusion tDCS of the motor and prefrontal cortices may have therapeutic potential in PD but better stimulation parameters need to be established to make the technique clinical ly viable . This study was publicly registered ( clinical trials.org : NCT00082342 ) The primary motor cortex ( M1 ) area recruitment enlarges while learning a finger tapping sequence . Also M1 excitability increases during procedural consolidation . Our aim was to investigate whether increasing M1 excitability by anodal transcranial DC stimulation ( AtDCS ) when procedural consolidation occurs was able to induce an early consolidation improvement . Forty-seven right-h and ed healthy participants were trained in a nine-element serial finger tapping task ( SFTT ) executed with the left h and . R and om series blocks were interspersed with training series blocks . Anodal or sham tDCS was administered over the right M1 after the end of the training session . After stimulation , the motor skills of both trained and a new untrained sequential series blocks were tested again . For each block , performance was estimated as the median execution time of correct series . Early consolidation of the trained series , assessed by the performance difference between the first block after and the last block before stimulation normalized by the r and om , was enhanced by anodal and not by sham tDCS . Stimulation did not affect r and om series execution . No stimulation effect was found on the on-line learning of the trained and new untrained series . Our results suggest that AtDCS applied on M1 soon after training improves early consolidation of procedural learning . Our data highlight the importance of neuromodulation procedures for underst and ing learning processes and support their use in the motor rehabilitation setting , focusing on the timing of the application OBJECTIVES To determine the effects of cognitive training on cognitive abilities and everyday function over 10 years . DESIGN Ten-year follow-up of a r and omized , controlled single-blind trial ( Advanced Cognitive Training for Independent and Vital Elderly ( ACTIVE ) ) with three intervention groups and a no-contact control group . SETTING Six U.S. cities . PARTICIPANTS A volunteer sample of 2,832 persons ( mean baseline age 73.6 ; 26 % African American ) living independently . INTERVENTION Ten training sessions for memory , reasoning , or speed of processing ; four sessions of booster training 11 and 35 months after initial training . MEASUREMENTS Objective ly measured cognitive abilities and self-reported and performance-based measures of everyday function . RESULTS Participants in each intervention group reported less difficulty with instrumental activities of daily living ( IADLs ) ( memory : effect size = 0.48 , 99 % confidence interval ( CI ) = 0.12 - 0.84 ; reasoning : effect size = 0.38 , 99 % CI = 0.02 - 0.74 ; speed of processing : effect size = 0.36 , 99 % CI = 0.01 - 0.72 ) . At a mean age of 82 , approximately 60 % of trained participants , versus 50 % of controls ( P < .05 ) , were at or above their baseline level of self-reported IADL function at 10 years . The reasoning and speed-of-processing interventions maintained their effects on their targeted cognitive abilities at 10 years ( reasoning : effect size = 0.23 , 99 % CI = 0.09 - 0.38 ; speed of processing : effect size = 0.66 , 99 % CI = 0.43 - 0.88 ) . Memory training effects were no longer maintained for memory performance . Booster training produced additional and durable improvement for the reasoning intervention for reasoning performance ( effect size = 0.21 , 99 % CI = 0.01 - 0.41 ) and the speed-of-processing intervention for speed-of-processing performance ( effect size = 0.62 , 99 % CI = 0.31 - 0.93 ) . CONCLUSION Each Advanced Cognitive Training for Independent and Vital Elderly cognitive intervention result ed in less decline in self-reported IADL compared with the control group . Reasoning and speed , but not memory , training result ed in improved targeted cognitive abilities for 10 years Noninvasive brain stimulation has recently been used to augment motor training-induced plasticity . However , the exact time during which noninvasive brain stimulation can be combined with motor therapy to maximize neuroplasticity and behavioral changes is unknown . We conducted a r and omized sham-controlled crossover trial to examine when ( before , during , or after training ) transcranial direct current stimulation ( tDCS ) should be applied to best reinforce motor training-induced plasticity in 12 healthy right-h and ed participants ( mean age : 21.8±1.6 ) who underwent active or sham tDCS combined with motor training . Transcranial magnetic stimulation-elicited motor-evoked potentials from the right first dorsal interosseous muscle were recorded before ( baseline ) and immediately after each session . The training task comprised four practice trials – 3 min each ( 30 s pause between trials ) – of repetitive finger movements ( thumb abduction/adduction ) with the right h and . Anodal tDCS ( 1 mA , 13 min , on the motor primary cortex ) was applied before , during , and after the training . Compared with baseline motor-evoked potentials and the sham condition , tDCS that was applied before , but not during or after , the motor task enhanced corticospinal excitability . These data suggest that tDCS performed before – not during or after – promotes optimization of motor training-induced plasticity Remembering the location of objects , an integral part of everyday life , is known to decline with advancing age and early in the course of neurodegenerative dementia . Here , we aim ed to test if object-location learning and its retention could be modified by noninvasive brain stimulation . In a group of 20 elderly ( mean age 62.1 years ) right-h and ed individuals , we applied transcranial direct current stimulation ( tDCS ; 20 minutes , 1 mA ) over the right temporoparietal cortex , while subjects acquired the correct position of buildings on a street map using an associative learning paradigm . Each subject participated in a r and omized and balanced order in 1 session of anodal tDCS and 1 session of sham stimulation , in a double-blind design with 2 parallel versions of the task . Outcome measures were learning success at the end of each session , and immediate as well as delayed ( 1 week ) free recall . We found that subjects performed comparably in the learning task in the 2 conditions , but showed improved recall 1 week after learning with anodal tDCS compared with learning with sham stimulation . In conclusion , retention of object-location learning in the elderly may be modulated by noninvasive brain stimulation , a finding of potential relevance not only for normal aging but also for memory deficits in pathological aging Transcranial direct current stimulation ( tDCS ) has been proposed for experimental and therapeutic modulation of regional brain function . Specifically , anodal tDCS of the dorsolateral prefrontal cortex ( DLPFC ) together with cathodal tDCS of the supraorbital region have been associated with improvement of cognition and mood , and have been suggested for the treatment of several neurological and psychiatric disorders . Although modeled mathematically , the distribution , direction , and extent of tDCS-mediated effects on brain physiology are not well understood . The current study investigates whether tDCS of the human prefrontal cortex modulates resting-state network ( RSN ) connectivity measured by functional magnetic resonance imaging ( fMRI ) . Thirteen healthy subjects underwent real and sham tDCS in r and om order on separate days . tDCS was applied for 20 min at 2 mA with the anode positioned over the left DLPFC and the cathode over the right supraorbital region . Patterns of resting-state brain connectivity were assessed before and after tDCS with 3 T fMRI , and changes were analyzed for relevant networks related to the stimulation – electrode localizations . At baseline , four RSNs were detected , corresponding to the default mode network ( DMN ) , the left and right frontal-parietal networks ( FPNs ) and the self-referential network . After real tDCS and compared with sham tDCS , significant changes of regional brain connectivity were found for the DMN and the FPNs both close to the primary stimulation site and in connected brain regions . These findings show that prefrontal tDCS modulates resting-state functional connectivity in distinct functional networks of the human brain Adult age differences in cognitive plasticity have been studied less often in working memory than in episodic memory . The authors investigated the effects of extensive working memory practice on performance improvement , transfer , and short-term maintenance of practice gains and transfer effects . Adults age 20 - 30 years and 70 - 80 years practice d a spatial working memory task with 2 levels of processing dem and s across 45 days for about 15 min per day . In both age groups and relative to age-matched , no-contact control groups , we found ( a ) substantial performance gains on the practice d task , ( b ) near transfer to a more dem and ing spatial n-back task and to numerical n-back tasks , and ( c ) 3-month maintenance of practice gains and near transfer effects , with decrements relative to post practice performance among older but not younger adults . No evidence was found for far transfer to complex span tasks . The authors discuss neuronal mechanisms underlying adult age differences and similarities in patterns of plasticity and conclude that the potential of deliberate working memory practice as a tool for improving cognition in old age merits further exploration The brain-derived neurotrophic factor gene ( BDNF ) is one of many genes thought to influence synaptic plasticity in the adult brain and shows a common single nucleotide polymorphism ( BDNF Val66Met ) in the normal population that is associated with differences in hippocampal volume and episodic memory . It is also thought to influence possible synaptic changes in motor cortex following a simple motor learning task . Here we extend these studies by using new non-invasive transcranial magnetic stimulation ( TMS ) and transcranial direct current stimulation ( TDCS ) techniques that directly test the excitability and plasticity of neuronal circuits in human motor cortex in subjects at rest . We investigated whether the susceptibility to TMS probes of plasticity is significantly influenced by the BDNF polymorphism . Val66Met carriers were matched with Val66Val individuals and tested on the following protocol s : continuous and intermittent theta burst TMS ; median nerve paired associative stimulation ; and homeostatic plasticity in the TDCS/1 Hz rTMS model . The response of Met allele carriers differed significantly in all protocol s compared with the response of Val66Val individuals . We suggest that this is due to the effect of BNDF on the susceptibility of synapses to undergo LTP/LTD . The circuits tested here are implicated in the pathophysiology of movement disorders such as dystonia and are being assessed as potential new targets in the treatment of stroke . Thus the polymorphism may be one factor that influences the natural response of the brain to injury and disease The long pre clinical phase of Alzheimer 's disease provides opportunities for potential disease‐modifying interventions in prodromal stages such as mild cognitive impairment ( MCI ) . Anodal transcranial direct current stimulation ( anodal‐tDCS ) , with its potential to enhance neuroplasticity , may allow improving cognition in MCI BACKGROUND Recently we have shown that transcranial r and om noise ( tRNS ) and 140 Hz transcranial alternating current stimulations ( tACS ) , applied over the primary motor cortex ( M1 ) and using 10 min stimulation duration and 1 mA intensity , significantly increases cortical excitability as measured by motor evoked potentials at rest before and after stimulation . OBJECTIVE /HYPOTHESIS Here , by decreasing the stimulation intensity in 0.2 mA steps from 1.0 mA , we investigate to what extent intensity depends on the induced after-effects . METHODS All twenty-five subjects participated in two different experimental sessions each . They received tACS using 140 Hz frequency and full spectrum tRNS at five different intensities on separate days . Sham stimulation was used as a control . RESULTS Instead of receiving a simple threshold , unexpectedly , in these two independent data sets at threshold intensities of 0.4 mA we found a switch of the already known excitation achieved with an intensity of 1 mA to inhibition . The intermediate intensity ranges of 0.6 and 0.8 mA had no effect at all . Interestingly , the inhibition produced by 140 Hz tACS was stronger than that induced by tRNS . CONCLUSIONS In summary , we have shown here the possibility of selectively controlling the enhancement or reduction of M1 excitability by applying different intensities of high frequency transcranial electrical stimulation The aim of the present study was to analyze the long-term effects of transcranial direct current stimulation ( tDCS ) of the bilateral prefrontal cortex combined with computer-assisted cognitive training on working memory and cognitive function in healthy older adults aged at least 65 years . Forty healthy older adults were enrolled and r and omly assigned to two groups : anodal and sham tDCS . All participants completed 10 sessions of computer-assisted cognitive training , combined with tDCS of the bilateral prefrontal cortex . The accuracy of the verbal working memory task and performance of the digit span forward test were significantly improved after computer-assisted cognitive training combined with bifrontal anodal tDCS as compared with that after computer-assisted cognitive training combined with sham tDCS . Moreover , the effect lasts for 4 weeks in the verbal working memory task . We suggest that the tDCS-induced changes in the bilateral prefrontal excitability during computer-assisted cognitive training may have beneficial effects on age-related cognitive decrement in healthy older adults |
11,557 | 28,577,047 | The systematic review revealed that near misses motivate continued play , but have varying effects on the emotional state or betting behaviour of the player .
Near miss events were also shown to be associated with elevated skin conductance levels and diffuse activity across the brain , most consistently in areas processing reinforcement and reward . | Near misses and losses disguised as wins have been of interest to gambling research ers and policymakers for many years ( e.g. , Griffiths in J Gambl Stud 9(2):101–120 , 1993 ) .
This systematic literature review describes the behavioural , psychological , and psychobiological effects of near misses and losses disguised as wins ( LDWs ) in an effort to evaluate their precise influence on the player and to highlight areas requiring further investigation . | Near-miss events are situations in which an action yields a negative result but is very close to being successful . They are known to influence behavior , especially in gambling scenarios . Previous neuroimaging studies have described an ' anomalous ' activity of brain reward areas following these events . The goal of the present research was to study electrophysiological correlates of near-misses in the expectation and outcome phases . Electroencephalography was recorded while participants were playing a simplified version of a slot machine . Four possible outcomes ( gain , near-miss , loss and no-information ) were presented in a pseudor and om order to ensure fixed proportions . Results from the time-frequency analysis for the theta ( 4 - 8 Hz ) , alpha ( 9 - 13 Hz ) , low beta ( 15 - 22 Hz ) and beta-gamma ( 25 - 35 Hz ) frequency-b and s presented larger power increases for wins and near-misses compared with losses . In the anticipation phase , power changes were lower than in the resolution phase . The current results are in agreement with previous studies showing that near-miss events recruit brain areas of the reward network . Likewise , the oscillatory activity in near-misses is very similar to the one elicited in the gain condition . In addition , present findings suggest that oscillatory activity in the expectation phase does not play a crucial role in near-miss events This study was conducted to examine the effects of the " near miss , " when a player almost wins , and the " big win , " a large early monetary gain , on persistence at slot machine gambling . One hundred eighty male and female undergraduates played a 4-wheel computerized slot machine . A 2 x 3 r and omized factorial design and an acquisition-extinction procedure were used . The dependent variable , persistence , was defined by the number of trials in the extinction phase . As hypothesized , the near miss had a statistically significant effect on the number of trials in extinction . An inverted U-shaped effect of the near miss showed that the 30 % near miss condition led to the greatest persistence , as compared to 45 % and 15 % near miss conditions . There was no statistically significant effect of the big win . Both cognitive and behavioral theories are discussed as explanations for effects of the near miss Problematic gambling is thought to be influenced by neurobiological mechanisms . However , the neuroendocrine response to gambling is largely unknown . Therefore , the effect of casino gambling on the sympathoadrenal system , the HPA-axis , and pituitary hormones were analyzed . Fourteen male problem gamblers and 15 non-problem gamblers were examined in a balanced cross-over design . In the experimental session , participants played blackjack in a casino wagering their own money . During the control session , subjects played cards for accumulation of points . Heart rate and endocrine measures were recorded at baseline , at 30 , 60 and 90 min during gambling/card playing , and after the game . Heart rate and norepinephrine levels increased with the onset of blackjack in both groups , with problem gamblers showing significantly higher levels across the entire gambling session . In addition , dopamine levels were significantly higher in problem gamblers during casino gambling compared to non-problem gamblers . Cortisol levels were transiently increased with the onset of blackjack in both groups . Casino gambling as a " real life " situation induces activation of the HPA-axis and the sympathoadrenergic system , with significantly more pronounced changes in problem gamblers . These findings may contribute to a better underst and ing of neuroendocrine disturbances in problem gambling A particularly rapid onset of pathological gambling ( PG-onset ) through the use of gambling machines has been widely alluded to , but this is the first study to empirically examine the phenomenon . This study compared the latency of PG-onset in those who gambled primarily on machines , compared to those who gambled primarily on more “ traditional ” forms of gambling at PG-onset . Subjects were 44 adult pathological gamblers ( PGs ) seeking outpatient treatment in Rhode Isl and ( 17 females ; mean age = 46.9 ) . Subjects completed question naires and a diagnostic interview including a complete history of gambling activities and the course of PG . The “ latency ” of PG-onset was defined as the time ( in years ) elapsed between the age of regular involvement in the primary form of gambling and the age at which DSM-IV criteria were first met . “ Machine ” PGs ( n = 25 ) had a significantly shorter latency of onset than did “ traditional ” PGs ( 1.08 years vs. 3.58 years ) . Females and machine PGs had a significantly older age of onset , but gender was not associated with latency of PG-onset . Lifetime comorbidity of either substance use disorders ( SUDS ) or depressive disorders ( DDS ) was also not associated with the latency of PG-onset . The results of the current study suggest that intrapersonal variables such as gender and comorbid disorders do not generally affect the speed with which people develop PG . Rather , the social , environmental , and stimulus features of mechanized gambling are implicated . Prospect i ve longitudinal studies on the onset and course of PG are needed , as well as more basic research on the features of machine gambling that may contribute to rapid onset Near-miss outcomes during gambling are non-win outcomes that fall close to a pay-out . While objective ly equivalent to an outright miss , near-misses motivate ongoing play and may therefore be implicated in the development of disordered gambling . Given naturalistic data showing increases in heart rate ( HR ) and electrodermal activity ( EDA ) during periods of real gambling play , we sought to explore the phasic impact of win , near-miss and full-miss outcomes on physiological arousal in a controlled laboratory environment . EDA and HR were monitored as healthy , student participants ( n = 33 ) played a simulated slot-machine task involving unpredictable monetary wins . A second gambling distortion , perceived personal control , was manipulated within the same task by allowing the participant to select the play icon on some trials , and having the computer automatically select the play icon on other trials . Near-misses were rated as less pleasant than full-misses . However , on trials that involved personal choice , near-misses produced higher ratings of ‘ continue to play ’ than full-misses . Winning outcomes were associated with phasic EDA responses that did not vary with personal choice . Compared to full-misses , near-miss outcomes also elicited an EDA increase , which was greater on personal choice trials . Near-misses were also associated with greater HR acceleration than other outcomes . Near-miss outcomes are capable of eliciting phasic changes in physiological arousal consistent with a state of subjective excitement , despite their objective non-win status Significance Gambling games are associated with a distorted psychological processing of r and om sequences ( the gambler ’s fallacy ) and unrewarded outcomes that fall close to a jackpot ( near misses ) . Problem gamblers appear more susceptible to these effects . Here , we show that these two gambling distortions are disrupted in patients with brain injury affecting the insula compared with patients with damage to the ventromedial prefrontal cortex or amygdala . In a roulette task ( red/black predictions ) , comparison groups chose either color less after longer runs of that color outcome . On a slot machine task , comparison groups rated higher motivation following near misses relative to full misses . Our results generate a clinical hypothesis that , in disordered gambling , these cognitions may be underpinned by excessive recruitment of insula circuitry . Gambling is a naturalistic example of risky decision-making . During gambling , players typically display an array of cognitive biases that create a distorted expectancy of winning . This study investigated brain regions underpinning gambling-related cognitive distortions , contrasting patients with focal brain lesions to the ventromedial prefrontal cortex ( vmPFC ) , insula , or amygdala ( “ target patients ” ) against healthy comparison participants and lesion comparison patients ( i.e. , with lesions that spare the target regions ) . A slot machine task was used to deliver near-miss outcomes ( i.e. , nonwins that fall spatially close to a jackpot ) , and a roulette game was used to examine the gambler ’s fallacy ( color decisions following outcome runs ) . Comparison groups displayed a heightened motivation to play following near misses ( compared with full misses ) , and manifested a classic gambler ’s fallacy effect . Both effects were also observed in patients with vmPFC and amygdala damage , but were absent in patients with insula damage . Our findings indicate that the distorted cognitive processing of near-miss outcomes and event sequences may be ordinarily supported by the recruitment of the insula . Interventions to reduce insula reactivity could show promise in the treatment of disordered gambling Responses to fear- and sadness-inducing films were assessed using a broad range of cardiovascular ( heart rate , T-wave amplitude , low- and high-frequency heart rate variability , stroke volume , preejection period , left-ventricular ejection time , Heather index , blood pressure , pulse amplitude and transit time , and finger temperature ) , electrodermal ( level , response rate , and response amplitude ) , and respiratory ( rate , tidal volume and its variability , inspiratory flow rate , duty cycle , and end-tidal pCO(2 ) ) measures . Subjective emotional experience and facial behavior ( Corrugator Supercilii and Zygomaticus Major EMG ) served as control measures . Results indicated robust differential physiological response patterns for fear , sadness , and neutral ( mean classification accuracy 85 % ) . Findings are discussed in terms of the fight-flight and conservation-withdrawal responses and possible limitations of a valence-arousal categorization of emotion in affective space |
11,558 | 24,972,606 | The results expose a gap in the literature for well-developed measures that capture self-reported adherence to prescribed but unsupervised home-based rehabilitation exercises | BACKGROUND Adherence is an important factor contributing to the effectiveness of exercise-based rehabilitation .
However , there appears to be a lack of reliable , vali date d measures to assess self-reported adherence to prescribed but unsupervised home-based rehabilitation exercises .
OBJECTIVES A systematic review was conducted to establish what measures were available and to evaluate their psychometric properties . | PURPOSE The aims of this pilot study were the following : 1 ) to examine patterns of adherence to a brisk walking program in women receiving adjuvant chemotherapy or radiation therapy for newly diagnosed breast cancer using a prospect i ve , r and omized , controlled experimental design ; 2 ) to examine the influence of disease symptoms and treatment side effects on exercise levels ; and 3 ) to suggest methods that may improve future clinical trials of moderate-intensity exercise in similar population s. DESCRIPTION OF STUDY Fifty-two patients with newly diagnosed breast cancer were r and omly assigned to one of two treatment arms : usual care or usual care plus exercise . Those assigned to the exercise group received a st and ardized , self-administered , home-based brisk walking intervention in addition to usual care . Each day subjects completed self-report diary forms that elicited information about activity levels , and the occurrence of symptoms and side effects during cancer treatment . RESULTS Analyses of self-reported daily activity levels revealed a diffusion of treatment effect . Fifty percent of the usual-care group reported maintaining or increasing their physical activity to a moderate-intensity level , while 33 % of the exercise group did not exercise at the prescribed levels . Analyses of self-reported disease symptoms and treatment side effects did not reveal clinical ly meaningful differences between the two groups . CLINICAL IMPLICATION S The results of this study suggest that women who exercised regularly before receiving a breast cancer diagnosis attempted to maintain their exercise programs . Women who lead sedentary lifestyles may benefit from a structured exercise program that includes information and support related to exercise adherence strategies The primary aim of this study was to test the effect of a Protection Motivation Theory (PMT)-based patient education intervention on physiotherapy patients ' beliefs about their injury and physiotherapy , intentions to adhere , rehabilitation adherence , and ankle function . A secondary aim was to explore the relationships between the patients ' injury and physiotherapy beliefs , intentions , adherence behaviours , and ankle function . A r and omized controlled trial was undertaken in New Zeal and ; 71 people with ankle sprains were allocated to either PMT present video information or two control groups ( non-PMT information about ankle sprains and no formal information ) before commencing their course of physiotherapy . The two information groups watched a video about ankle sprains and physiotherapy before answering the Beliefs about Ankle Sprains and Physiotherapy Scale and behavioural intentions question naires that measured the PMT constructs . Adherence was assessed at each treatment and ankle function was measured before and after the physiotherapy program . After viewing the video , the PMT present information group 's beliefs about severity , vulnerability , and response efficacy were significantly higher than the other two groups . The groups did not differ significantly on their self-efficacy , intentions , rehabilitation adherence , and post-physiotherapy program ankle function . Significant correlations existed between the patients ' PMT-based beliefs and intentions , intentions and adherence , and adherence and post-physiotherapy ankle function . With the exception of self-efficacy , the findings indicate that persuasive information grounded in PMT does enhance physiotherapy patients ' beliefs about their injury and treatment The feasibility and efficacy of an additional progressive home-based strengthening exercise program ( PHSEP ) on subjects that already attended supervised institutional exercise therapy was investigated . Thirty-six hip patients with hip osteoarthritis ( OA ) and /or total hip replacement in at least one hip joint were r and omly assigned to an intervention group ( IG ) or a control group ( CG ) . IG ( 18 patients , mean age 64.9 , st and ard deviation ( SD ) 7.5 ) followed an 8-week PHSEP in addition to their weekly institutional exercise therapy , while CG ( 18 patients , mean age 64.7 , SD 9 ) solely continued the weekly institutional exercise sessions . Before and after the intervention period , strength of hip muscles was quantified applying isokinetic concentric and isometric measurements , and health-related quality of life was monitored using the SF36 question naire . Adherence to the exercise program was evaluated using exercise logs . The PHSEP was feasible for all subjects in IG with an adherence of 99 % . Exercise logs reported that pain result ing from the PHSEP was low . Increased strength in isokinetic concentric hip adduction ( 13 % ) and isometric hip abduction ( 9 % ) , adduction ( 12 % ) , and flexion ( 7 % ) was found in IG in comparison to CG . The results of the SF36 did not change during the intervention period . Consequently , supervised institutional exercise therapy supplemented by a PHSEP could increase hip muscle strength in patients with hip OA and /or total hip replacement . However , further research should evaluate the optimal frequency and duration of such supplementary sessions and their potential to increase physical function and reduce pain Background Despite emerging evidence that foot problems and inappropriate footwear increase the risk of falls , there is little evidence as to whether foot-related intervention strategies can be successfully implemented . The aim of this study was to evaluate adherence rates , barriers to adherence , and the predictors of adherence to a multifaceted podiatry intervention for the prevention of falls in older people . Methods The intervention group ( n = 153 , mean age 74.2 years ) of a r and omised trial that investigated the effectiveness of a multifaceted podiatry intervention to prevent falls was assessed for adherence to the three components of the intervention : ( i ) foot orthoses , ( ii ) footwear advice and footwear cost subsidy , and ( iii ) a home-based foot and ankle exercise program . Adherence to each component and the barriers to adherence were documented , and separate discriminant function analyses were undertaken to identify factors that were significantly and independently associated with adherence to the three intervention components . Results Adherence to the three components of the intervention was as follows : foot orthoses ( 69 % ) , footwear ( 54 % ) and home-based exercise ( 72 % ) . Discriminant function analyses identified that being younger was the best predictor of orthoses use , higher physical health status and lower fear of falling were independent predictors of footwear adherence , and higher physical health status was the best predictor of exercise adherence . The predictive accuracy of these models was only modest , with 62 to 71 % of participants correctly classified . Conclusions Adherence to a multifaceted podiatry intervention in this trial ranged from 54 to 72 % . People with better physical health , less fear of falling and a younger age exhibited greater adherence , suggesting that strategies need to be developed to enhance adherence in frailer older people who are most at risk of falling . Trial registration Australian New Zeal and Clinical Trials Registry ACTRN12608000065392 STUDY DESIGN A prospect i ve unblinded r and omized clinical trial . OBJECTIVES To compare the effectiveness of 2 types of home program instruction , videotape versus personal instruction by a physical therapist , on subjective outcomes and exercise compliance following arthroscopic repair of a full-thickness rotator cuff tear . BACKGROUND Advances in orthopedic surgery and rehabilitation have placed increased emphasis on home exercise programs . Therefore , assessing the effectiveness of different methods of home program instruction is important . METHODS AND MEASURES Patients who consented to undergo surgical repair were r and omly assigned to either a videotape or personal instruction group . A self-reported compliance log categorized subjects as fully compliant , partially compliant , or noncompliant . The Shoulder Pain and Disability Index and the University of Pennsylvania Shoulder Scale scores were obtained from subjects preoperatively and at 12 , 24 , and 52 weeks postoperatively . The null hypotheses that neither group would have better outcomes as measured by 2 shoulder outcome scales at any level of compliance over 4 levels of time , were assessed by 2 separate 2x3x4 multiple analyses of variances ( MANOVAs ) , 1 for each outcome measure ( alpha = 0.025 ) . RESULTS Neither MANOVA was significant and the null hypotheses were not rejected . The main effect of time ( number of weeks postsurgery ) was significant across all time intervals for both outcome measures ( P < 0.0005 ) . CONCLUSIONS With a therapist available for questions , patients who utilized the videotape method for their home program instruction had self-reported outcomes equal to patients instructed in their home program personally by a physical therapist . Self-reported compliance with the rehabilitation program had little effect on the outcomes OBJECTIVES The purpose s of this study were 1 ) to determine compliance with a pedometer and mobile phone- based physical activity diary , and 2 ) to assess concordance between self-reported daily steps recorded and transmitted by a mobile phone and pedometer-measured daily steps in sedentary women . METHODS In this 3-week pilot clinical study , 41 sedentary women who met all inclusion criteria were recruited from local communities . We asked the participants to wear a pedometer every day and to report their daily steps using a mobile phone diary each night before retiring . In the first week , women were asked to monitor their daily steps ( baseline steps ) . In the second and third weeks , they were asked to increase their steps by 20 % from the previous week . Although the pedometer can automatically store the most recent 41 days ' performance , the participants were not informed of this function of the pedometer . RESULTS Overall compliance was 93.8 % with pedometer use and 88.3 % with the mobile phone physical activity diary . Bl and Altman plots showed that the agreement between self-reported daily steps by mobile phone diary and pedometer-recorded daily steps from week 1 to week 3 was high . CONCLUSION The combination of a pedometer and a mobile phone diary may enhance the quality of self-reported data in clinical studies Despite the numerous benefits of physical activity for patients with diabetes , most healthcare providers in busy clinical setting s rarely find time to counsel their patients about it . A Web-based program for healthcare providers can be used as an effective counseling tool , when strategies are outlined for specific stages of readiness for physical activity . Seventy-three adults with type 2 diabetes were r and omly assigned to Web-based intervention , printed- material intervention , or usual care . After 12 weeks , the effects of the interventions on physical activity , fasting blood sugar , and glycosylated hemoglobin were evaluated . Both Web-based and printed material intervention , compared with usual care , were effective in increasing physical activity ( P < .001 ) and decreasing fasting blood sugar ( P<.01 ) and glycosylated hemoglobin ( P < .01 ) . Post hoc analysis for change scores indicated significant differences between Web-based intervention and usual care and between printed material intervention and usual care , but not between web-based and printed material intervention . The findings of this study support the value of Web-based and printed material interventions in healthcare counseling . With increasing Web access , the effectiveness of Web-based programs offered directly to patients needs to be tested OBJECTIVES /HYPOTHESES There are many documented barriers to successful adherence to voice therapy . However , methods for facilitating adherence are not well understood . The purpose of this study was to determine if patient adherence and motivation for practice could be improved by providing patients with practice support between sessions using mobile treatment videos . METHODS Thirteen voice therapy participants were provided with portable media players containing videos of voice exercises exemplified by their therapists and themselves . A r and omized crossover design of two conditions was used : ( 1 ) st and ard of care voice therapy where participants were provided with written homework descriptions ; and ( 2 ) video-enhanced voice therapy where participants received a portable digital media player with clinician and self-videos . The duration of each condition was 1 week . Self-report measures of practice frequency and aspects of motivation were obtained at the end of each session . RESULTS Practice of voice exercises was significantly greater in the video-enhanced voice therapy condition than in the st and ard of care " written " condition ( P<0.05 ) . Three aspects of participant motivation for practice -overall commitment to practice , importance of practice , and confidence in the ability to practice were also significantly greater after video-enhanced condition than after st and ard of care condition . CONCLUSION These results support the use of video examples and portable digital media players in voice therapy for individuals who are comfortable using such technology OBJECTIVE Great efforts have been made to find effective treatments for back pain . Nevertheless , the effectiveness of a particular treatment can depend on patient compliance . The objective of this study was to prospect ively investigate whether patients ' demographic factors , clinical factors , external barriers in following the treatment , and perceptions of disability , quality of life , depression , and control over health were predictive of compliance with a physical therapy program carried out with patients with low back pain . METHODS This was an exploratory prospect i ve cohort study that was carried out in New York City during 1999 . All study participants answered a question naire at the initial clinical evaluation by a physical therapist and were followed during the treatment . The study assessed compliance with the three treatment regimens that were prescribed for every patient : attending scheduled physical therapy sessions , following a program of home exercises , and watching back-education videotapes . Depending on the individual patient , the planned treatment program could last from 2 to 6 weeks . The study employed a battery of instruments to measure patient characteristics that included perceived functional limitations , perceived quality of life , depression , and their beliefs about their health . Student 's t tests and chi-square tests were used to determine if non- and low-compliant patients differed significantly from high-compliant patients . Logistic regression was used to estimate adjusted odds ratios expressing the association of selected variables with compliance . RESULTS We found that 51 % of the patients were either noncompliant or low-compliant overall with the low back pain treatment program . There were differences in compliance behavior among the three treatment regimens , with compliance being highest for watching the back-education videotapes and lowest for doing the home exercises . Poor compliance overall was positively associated with the expectation of barriers in following the proposed treatment , with comorbidity , and with longer duration of treatment in this program . CONCLUSIONS The findings of our study indicate that patient compliance with back pain treatment is a serious and complex problem . Nevertheless , while this study was only an exploratory one , we believe that the results of this study can be used by care providers to identify patients likely to become noncompliant and also by research ers to plan specific studies on the effectiveness of treatment programs for patients with low back pain Background Evidence suggests that to facilitate physical activity sedentary people may adhere to one component of exercise prescriptions ( intensity , duration or frequency ) without adhering to other components . Some experts have provided evidence for determinants of adherence to different components among healthy people . However , our underst and ing remains scarce in this area for patients with neck or low back pain . The aims of this study are to determine whether patients with neck or low back pain have different rates of adherence to exercise components of frequency per week and duration per session when prescribed with a home exercise program , and to identify if adherence to both exercise components have distinct predictive factors . Methods A cohort of one hundred eighty-four patients with chronic neck or low back pain who attended physiotherapy in eight primary care centers were studied prospect ively one month after intervention . The study had three measurement periods : at baseline ( measuring characteristics of patients and pain ) , at the end of physiotherapy intervention ( measuring characteristics of the home exercise program ) and a month later ( measuring professional behaviors during clinical encounters , environmental factors and self-efficacy , and adherence behavior ) . Results Adherence to duration per session ( 70.9 % ± 7.1 ) was more probable than adherence to frequency per week ( 60.7 % ± 7.0 ) . Self-efficacy was a relevant factor for both exercise components ( p < 0.05 ) . The total number of exercises prescribed was predictive of frequency adherence ( p < 0.05 ) . Professional behaviors have a distinct influence on exercise components . Frequency adherence is more probable if patients received clarification of their doubts ( adjusted OR : 4.1 ; p < 0.05 ) , and duration adherence is more probable if they are supervised during the learning of exercises ( adjusted OR : 3.3 ; p < 0.05 ) . Conclusion We have shown in a clinic-based study that adherence to exercise prescription frequency and duration components have distinct levels and predictive factors . We recommend additional study , and advise that differential attention be given in clinical practice to each exercise component for improving adherence Background Knee osteoarthritis ( OA ) is one of the most common and costly chronic musculoskeletal conditions world-wide and is associated with substantial pain and disability . Many people with knee OA also experience co-morbidities that further add to the OA burden . Uptake of and adherence to physical activity recommendations is suboptimal in this patient population , leading to poorer OA outcomes and greater impact of associated co-morbidities . This pragmatic r and omised controlled trial will investigate the clinical - and cost-effectiveness of adding telephone coaching to a physiotherapist-delivered physical activity intervention for people with knee OA . Methods / Design 168 people with clinical ly diagnosed knee OA will be recruited from the community in metropolitan and regional areas and r and omly allocated to physiotherapy only , or physiotherapy plus nurse-delivered telephone coaching . Physiotherapy involves five treatment sessions over 6 months , incorporating a home exercise program of 4–6 exercises ( targeting knee extensor and hip abductor strength ) and advice to increase daily physical activity . Telephone coaching comprises 6–12 telephone calls over 6 months by health practitioners trained in applying the Health Change Australia ( HCA ) Model of Health Change to provide behaviour change support . The telephone coaching intervention aims to maximise adherence to the physiotherapy program , as well as facilitate increased levels of participation in general physical activity . The primary outcomes are pain measured by an 11-point numeric rating scale and self-reported physical function measured by the Western Ontario and McMaster Universities Osteoarthritis Index subscale after 6 months . Secondary outcomes include physical activity levels , quality -of-life , and potential moderators and mediators of outcomes including self-efficacy , pain coping and depression . Relative cost-effectiveness will be determined from health service usage and outcome data . Follow-up assessment s will also occur at 12 and 18 months . Discussion The findings will help determine whether the addition of telephone coaching sessions can improve sustainability of outcomes from a physiotherapist-delivered physical activity intervention in people with knee OA.Trial Registration Australian New Zeal and Clinical Trials Registry reference : The aim of the present study was to examine an adapted integrated psycho-social model to predict sport injury rehabilitation adherence . A longitudinal prospect i ve design was used whereby 70 patients attending private physiotherapy clinics completed a battery of question naires both pre- and post-rehabilitation treatment based on the adapted framework . All participants were receiving treatment for tendonitis-related injuries . Adherence was monitored prospect ively over the entire rehabilitation program using an observational measure of clinic adherence , a self-report measure of home-based adherence , in addition to monitoring attendance at rehabilitation sessions . In the initial phase of rehabilitation learning goal orientation , attitudes and perceived severity were found to predict rehabilitation intention . Intentions were also found to mediate the relationship between the aforementioned variables and clinic rehabilitation . Self-efficacy and self-motivation were predictors of clinic rehabilitation and attendance but not home rehabilitation . During the maintenance phase of rehabilitation coping ability and social support were predictors regarding all three measures of adherence . Implication s for practitioners rehabilitating injured athletes are discussed Background Behavioral intervention outcomes for urinary incontinence ( UI ) depend on active patient participation . Objective The purpose of this study was to describe adherence to behavioral interventions ( pelvic-floor muscle [ PFM ] exercises , UI prevention strategies , and delayed voiding ) , patient-perceived exercise barriers , and predictors of exercise adherence in women with urge-predominant UI . Design This was a prospect ively planned secondary data analysis from a 2-stage , multicenter , r and omized clinical trial . Patients and Intervention Three hundred seven women with urge-predominant UI were r and omly assigned to receive either 10 weeks of drug therapy only or 10 weeks of drug therapy combined with a behavioral intervention for UI . One hundred fifty-four participants who received the combined intervention were included in this analysis . Measurements Pelvic-floor muscle exercise adherence and exercise barriers were assessed during the intervention phase and 1 year afterward . Adherence to UI prevention strategies and delayed voiding were assessed during the intervention only . Results During intervention , 81 % of women exercised at least 5 to 6 days per week , and 87 % performed at least 30 PFM contractions per day . Ninety-two percent of the women used the urge suppression strategy successfully . At the 12-month follow-up , only 32 % of the women exercised at least 5 to 6 days per week , and 56 % performed 15 or more PFM contractions on the days they exercised . The most persistent PFM exercise barriers were difficulty remembering to exercise and finding time to exercise . Similarly , difficulty finding time to exercise persisted as a predictor of PFM exercise adherence over time . Limitations Co-administration of medication for UI may have influenced adherence . Conclusions Most women adhered to exercise during supervised intervention ; however , adherence declined over the long term . Interventions to help women remember to exercise and to integrate PFM exercises and UI prevention strategies into daily life may be useful to promote long-term adherence OBJECTIVES To assess the effects of a home-based aerobic and resistance training program on the physical function of adults with New York Heart Association ( NYHA ) class II and III patients and systolic heart failure ( HF ) . DESIGN R and omized controlled trial . SETTING Home based . PARTICIPANTS Stable patients ( N=24 ; mean age , 60 ± 10 y ; left ventricular ejection fraction , 25 % ± 9 % ; 50 % white ; 50 % women ) with New York Heart Association ( NYHA ) classes II and III ( NYHA class III , 58 % ) systolic heart failure ( HF ) . INTERVENTION A 12-week progressive home-based program of moderate-intensity aerobic and resistance exercise . Attention control wait list participants performed light stretching and flexibility exercises . MAIN OUTCOME MEASURES A 10-item performance-based physical function measure , the Continuous Scale Physical Functional Performance test ( CS-PFP10 ) , was the major outcome variable and included specific physical activities measured in time to complete a task , weight carried during a task , and distance walked . Other measures included muscle strength , HRQOL ( Minnesota Living With Heart Failure Question naire , Epworth Sleepiness Scale ) , functional capacity ( Duke Activity Status Index ) , and disease severity ( brain natriuretic peptide ) levels . RESULTS After the exercise intervention , 9 of 10 specific task activities were performed more rapidly , with increased weight carried by exercise participants compared with the attention control wait list group . Exercise participants also showed significant improvements in CS-PFP10 total score ( P<.025 ) , upper and lower muscle strength , and HRQOL ( P<.001 ) compared with the attention control wait list group . Adherence rates were 83 % and 99 % for the aerobic and resistance training , respectively . CONCLUSIONS Patients with stable HF who participate in a moderate-intensity combined aerobic and resistance exercise program may improve performance of routine physical activities of daily living by using a home-based exercise approach . Performance-based measures such as the CS-PFP10 may provide additional insights into physical function in patients with HF that more commonly used exercise tests may not identify . Early detection of subtle changes that may signal declining physical function that are amenable to intervention potentially may slow further loss of function in this patient population Background : Self-monitoring is part of many weight-loss programs and is widely accepted as effective . However , there is a lack of research related to the efficacy of various self-monitoring instruments in meeting the needs of individuals with limited mobility or access to healthcare providers , especially those with limited education living in rural setting s. Purpose : This study examined the efficacy of using self-monitoring diaries in a weight loss program targeting chronically ill and obese rural-dwelling adults . Methods : A community-based intervention program using a pretest and posttest design examined the effect of using self-monitoring diaries on weight loss . Fifty participants were enrolled from the chronic disease clinic of a district health center with limited medical re sources in a remote village in southwestern Taiwan . All participants were diagnosed with diabetes and /or hypertension , had body mass indices between 27 and 32 kg/m2 , and had a minimum educational level of junior high school . Mean participant age was 43.7 years . Participants were r and omly assigned to the intervention or control group . All attended a m and atory 12-week weight loss program . The intervention group received instructions on how to record diet and exercise details in a structured , graphics-based diary provided by the research ers . Body weight and percentage of body fat were measured before and after the program , and data were analyzed by chi-square and ANCOVA . Results : The intervention group significantly lost more weight than the control group ( 5.7 kg vs. 2.1 kg ; p < .05 ) . The participants of 88 % in the intervention group lost 5 % or more of their baseline weight greater than the 23 % in the control group . Both groups achieved the mean of body fat reductions by comparing pretest and posttest . Conclusions / Implication s for Practice : Self-monitoring diaries can have a significant impact on weight loss in individuals living in rural communities . Healthcare providers and health promotion agencies can use the suggested checklist method to improve weight loss promotion programs in isolated rural communities with limited medical re sources Background Evidence exists demonstrating the benefits of exercise for people with osteoarthritis , but little is known about whether exercise programs are effective , that is , whether the benefits of exercise can be seen in “ real life ” programs for “ normal ” people under nonlaboratory conditions . Objective To identify characteristics of and outcomes for participants who adhere to a community-based aquatic exercise program . Method Two hundred and forty-nine adults with osteoarthritis were recruited from Washington State for r and omization to a 20-week Arthritis Foundation aquatic exercise program ( n = 125 ) or a wait-list control group ( n = 124 ) . Adherers were defined as those attending at least two classes per week for 16 of 20 weeks . Measures included : Quality of Well Being Scale , Health Assessment Question naire , Center for Epidemiological Studies -Depression Scale , and a single arthritis quality of life rating-item . Results Baseline to postintervention change scores revealed that treatment-group adherers ( N = 35 ) reported improved quality of well-being , physical function , and change in arthritis quality of life compared to controls ( N = 124 ) . When comparing treatment-group adherers ( N = 35 ) to treatment-group nonadherers ( N = 67 ) , quality of well-being and depressed mood improved for adherers , but not for nonadherers . Conclusion When analyzed for level of participation , exercise benefits adults with osteoarthritis . Consistent participation in exercise programs results in better outcomes . Improved methods are needed to enhance adherence , with increased attention to the role of intrinsic factors such as self-efficacy and belief systems OBJECTIVE To determine the effects of structured exercise programs on self-reported disability in older adults with knee osteoarthritis . SETTING AND DESIGN A r and omized , single-blind clinical trial lasting 18 months conducted at 2 academic medical centers . PARTICIPANTS A total of 439 community-dwelling adults , aged 60 years or older , with radiographically evident knee osteoarthritis , pain , and self-reported physical disability . INTERVENTIONS An aerobic exercise program , a resistance exercise program , and a health education program . MAIN OUTCOME MEASURES The primary outcome was self-reported disability score ( range , 1 - 5 ) . The secondary outcomes were knee pain score ( range , 1 - 6 ) , performance measures of physical function , x-ray score , aerobic capacity , and knee muscle strength . RESULTS A total of 365 ( 83 % ) participants completed the trial . Overall compliance with the exercise prescription was 68 % in the aerobic training group and 70 % in the resistance training group . Postr and omization , participants in the aerobic exercise group had a 10 % lower adjusted mean ( + /- SE ) score on the physical disability question naire ( 1.71 + /- 0.03 vs 1.90 + /- 0.04 units ; P<.001 ) , a 12 % lower score on the knee pain question naire ( 2.1 + /- 0.05 vs 2.4 + /- 0.05 units ; P=.001 ) , and performed better ( mean [ + /- SE ] ) on the 6-minute walk test ( 1507 + /- 16 vs 1349 + /- 16 ft ; P<.001 ) , mean ( + /-SE ) time to climb and descend stairs ( 12.7 + /- 0.4 vs 13.9 + /- 0.4 seconds ; P=.05 ) , time to lift and carry 10 pounds ( 9.1 + /- 0.2 vs 10.0 + /- 0.1 seconds ; P<.001 ) , and mean ( + /-SE ) time to get in and out of a car ( 8.7 + /- 0.3 vs 10.6 + /- 0.3 seconds ; P<.001 ) than the health education group . The resistance exercise group had an 8 % lower score on the physical disability question naire ( 1.74 + /- 0.04 vs 1.90 + /- 0.03 units ; P=.003 ) , 8 % lower pain score ( 2.2 + /- 0.06 vs 2.4 + /- 0.05 units ; P=.02 ) , greater distance on the 6-minute walk ( 1406 + /- 17 vs 1349 + /- 16 ft ; P=.02 ) , faster times on the lifting and carrying task ( 9.3 + /- 0.1 vs 10.0 + /- 0.16 seconds ; P=.001 ) , and the car task ( 9.0 + /- 0.3 vs 10.6 + /- 0.3 seconds ; P=.003 ) than the health education group . There were no differences in x-ray scores between either exercise group and the health education group . CONCLUSIONS Older disabled persons with osteoarthritis of the knee had modest improvements in measures of disability , physical performance , and pain from participating in either an aerobic or a resistance exercise program . These data suggest that exercise should be prescribed as part of the treatment for knee osteoarthritis Loss of function and low exercise adherence is common among older people after hospitalization . The aim of this r and omized-controlled trial was to evaluate the effects of a combined counseling- and exercise program on changes in health-related quality of life ( HRQL ) and physical function in patients attending a day hospital and continuing exercise at home . The exercise program consisted of counseling , balance- and progressive resistance training and support from the physical therapist at Geriatric Day-Hospital ( GDH ) and home for the Intervention-group . The Control-group received counseling , balance-training and support from the physical therapist . The sample was recruited from a GDH in Norway . 108 participants were r and omized into the Intervention group ( IT ) ( n=53 ) or the Control group ( CT ) ( n=55 ) . After 3 months 77 participants were tested . The intention to treat analysis showed that the program had significant benefits in terms of Health Related Quality of Life , measured by SF-36 , on the domains vitality and bodily pain , in favor of the IT-group who performed the combined resistance exercises and balance program . All participants increased their scores on physical function , measured by Berg Balance Scale , Timed Up and Go , 5 times Sit-to-St and , 6 Min Walk Test and Activities Balance Confidence Scale , no group differences . Both groups were adherent to the home exercise program The results show that it is possible to facilitate older people to increase their HRQL , physical function and level of physical activity through counseling , exercise and support from physical therapists BACKGROUND AND PURPOSE This correlational study describes factors that are related to patient compliance with exercise regimens during physical therapy . We investigated whether patient compliance was related to characteristics of the patient or the patient 's illness , to the patient 's attitude , or to the physical therapist 's behavior . SUBJECTS AND METHODS Of a r and om sample of 300 physical therapists in private practice in the Netherl and s , 222 therapists responded to a question naire survey . Eighty-four respondents also made audio recordings . Material s of the study were 1,931 registration forms , 1,837 audio-recorded sessions of physical therapy sessions , and 1,681 patient question naires . RESULTS The results show that the three main factors related to noncompliance were ( 1 ) the barriers patients perceive and encounter , ( 2 ) the lack of positive feedback , and ( 3 ) the degree of helplessness . The first factor , the barriers patients perceive and encounter , shows the strongest relation with noncompliance . The results also show that noncompliance is more strongly related to the characteristics of the illness than to the illness , a bad prognosis is negatively related to compliance , and much hindrance of the complaint is positively related to compliance . There was no difference between men and women with regard to patient compliance , but less educated patients were slightly more compliant than more highly educated patients . CONCLUSION AND DISCUSSION These correlational findings can be used to formulate hypotheses of cause and effect in future clinical research . Future research should take into account the type and efficacy of therapeutic exercise for different diseases . For physical therapy practice , it seems important that physical therapists carefully explore which problems patients encounter in their efforts to comply and that they seek solutions to those problems in mutual cooperation with their patients OBJECTIVE The optimum method for sustaining the benefits gained from pulmonary rehabilitation ( PR ) has not been determined . In this report the authors describe the 4-year referral and uptake patterns to a hospital-based outpatient PR programme , and the sustained benefits of PR in patients with COPD attending a community-based maintenance exercise programme . METHODS Entry and exit data were mapped for all patients referred to the PR service over the review period . All eligible patients were offered a community-based maintenance exercise programme upon completion of PR . A total of 21 patients underwent follow-up assessment of functional exercise capacity , quality of life ( QOL ) and health-care utilization . RESULTS Over a 4-year period , 467 patients ( 80 % with COPD ) were referred to the programme , of whom 230 entered PR . In total , 172 patients completed PR , with attrition ( 25 % ) being mostly due to medical problems . Of the 84 patients who elected for the community-based programme , 46 were still attending at follow up and 21 patients with moderate-to-severe COPD ( 44.9 + /- 12.6 ( mean + /- SD ) FEV(1)% predicted ) were reassessed at 18.4 + /- 11.9 months post PR . Significant improvements ( mean change ( 95 % confidence interval ) ) persisted in 6-min walk distance ( 41.1 m ( 15.7 - 66.5 ) ) , distance walked in 20 min ( 195.1 m ( 82.3 - 308 ) ) and in QOL ( Chronic Respiratory Disease Question naire ) ( 11.0 points ( 4.4 - 17.6 ) ) ( P < 0.01 ) . The QOL improvements exceeded the minimum clinical ly important difference . A trend towards a reduction in COPD -related hospital admissions , bed-days and emergency department presentations was observed in the 12 months following PR . Self-reported adherence with the home exercise programme indicated that 67 % of patients were exercising at least 3 - 5 days each week in addition to attending a class . CONCLUSION For patients with moderate-to-severe COPD , a weekly community-based maintenance exercise class , supervised by a physiotherapist , combined with a home exercise programme is an effective intervention for maintaining improvements following PR Exercise rehabilitation is one of the few evidence -based treatments for chronic non-specific low back pain ( cLBP ) , but individual success is notoriously variable and may depend on the patient ’s adherence to the prescribed exercise regime . This prospect i ve study examined factors associated with adherence and the relationship between adherence and outcome after a programme of physiotherapeutic spine stabilisation exercises . A total of 32/37 patients with cLBP completed the study ( mean age , 44.0 ( SD = 12.3 ) years ; 11/32 ( 34 % ) male ) . Adherence to the 9-week programme was documented as : percent attendance at therapy , percent adherence to daily home exercises ( patient diary ) and percent commitment to rehabilitation ( Sports Injury Rehabilitation Adherence Scale ( SIRAS ) ) . The average of these three measures formed a multidimensional adherence index ( MAI ) . Psychological disturbance , fear-avoidance beliefs , catastrophising , exercise self-efficacy and health locus of control were measured by question naire ; disability in everyday activities was scored with the Rol and –Morris disability scale and back pain intensity with a 0–10 graphic rating scale . Overall , adherence to therapy was very good ( average MAI score , 85 % ; median ( IQR ) , 89 (15)% ) . The only psychological/beliefs variable showing a unique significant association with MAI was exercise self-efficacy ( Rho = 0.36 , P = 0.045 ) . Pain intensity and self-rated disability decreased significantly after therapy ( each P < 0.01 ) . Adherence to home exercises showed a moderate , positive correlation with the reduction in average pain ( Rho = 0.54 , P = 0.003 ) and disability ( Rho = 0.38 , P = 0.036 ) ; higher MAI scores were associated with greater reductions in average pain ( Rho = 0.48 , P = 0.008 ) and a ( n.s . ) tendency for greater reductions in disability ( Rho = 0.32 , P = 0.07 ) Neither attendance at therapy nor SIRAS were significantly related to any of the outcomes . The benefits of rehabilitation depended to a large extent on the patient ’s exercise behaviour outside of the formal physiotherapy sessions . Hence , more effort should be invested in finding ways to improve patients ’ motivation to take responsibility for the success of their own therapy , perhaps by increasing exercise self-efficacy . Whether the “ adherence– outcome ” interaction was mediated by improvements in function related to the specific exercises , or by a more “ global ” effect of the programme , remains to be examined The purpose of this investigation was to test the effectiveness of an adherence facilitation intervention consisting of goal setting , graphic feedback , and provider guidance to support adherence to home exercise in a sample of patients with heart failure who had completed a supervised exercise program . The sample consisted of 13 patients with an ejection fraction of 40 % or less who were r and omly assigned to either the exercise only group ( n=6 ) or the exercise with adherence facilitation group ( n=7 ) . The format of the intervention was graphic depiction of each patient 's exercise goals in comparison to each patient 's exercise participation . Graphs were mailed at 3-week intervals for 12 weeks . Results indicate that patients who received the intervention demonstrated higher exercise adherence and greater confidence in continuing to exercise in the future . The adherence facilitation intervention may be helpful to heart failure patients in adapting to a program of home exercise . (c)2002 CHF , Patients with heart failure ( HF ) often have profound activity limitations and diminished quality of life ( QOL ) due to symptoms of dyspnea and fatigue . Although recent studies demonstrate positive physiologic and psychological benefits of low to moderate intensity , supervised , aerobic exercise training performed 3 to 5 days/ week for 20 to 40 minutes ' duration , in a monitored setting , the efficacy of a home-based exercise program combining endurance and resistance exercise on symptoms and QOL , are unknown . This r and omized controlled study examined the efficacy , safety , and adherence rates of a 3-month home-based combined walking and resistance exercise program on symptoms and QOL in 40 women and men aged 30 to 76 years with New York Heart Association class II to III HF . Baseline and 3-month evaluations consisted of a chronic HF question naire to assess symptoms and QOL and exercise capacity by symptom-limited treadmill exercise test with respiratory gas analysis . The exercise intervention improved fatigue ( p = 0.02 ) , emotional function ( p = 0.01 ) , and mastery ( p = 0.04 ) . Overall exercise adherence was excellent ( 90 % ) and there were no reported adverse events . A moderate intensity home-based combined walking and resistance program for patients with class II to III HF is safe and effective in reducing symptoms and improving QOL BACKGROUND We know little about long-term exercise behavior and adherence in patients with chronic obstructive pulmonary disease ( COPD ) . PURPOSE The study 's purpose was ( 1 ) to describe exercise behavior and adherence to a home-walking exercise prescription over 12 months in a sample of patients with COPD ; and ( 2 ) to vali date categories of exercise adherence over time in this population . DESIGN This was a secondary analysis of a r and omized controlled trial . SUBJECTS A total of 103 participants with COPD who were r and omly assigned to one of three versions of a dyspnea self-management program participated . MEASURES The components of exercise frequency , duration , and intensity were measured by exercise/dyspnea daily logs , and participants were classified into categories on the basis of their pattern of exercise adherence over the year . RESULTS Participants walked an average of 3 days per week initially , with a decline to 2.5 days per week over the year . On average , participants walked longer than the prescribed duration of 20 minutes per session . Dyspnea intensity at the end of the walk tended to remain stable at a mean level of 4 over the year . Classification by adherence category distinguished differences in 6-minute walk distance , endurance treadmill test time , Short Form-36 physical function , and Short Form-36 mental health , with endurance treadmill test time and physical function improvements mirroring increases in exercise adherence , and mental health highest among occasional lapse and lowest among relapser and recycle categories . CONCLUSIONS This investigation provides a description of long-term exercise behavior and adherence in a sample of patients with COPD . The categories suggest that physical benefits are related to consistent adherence , whereas mental health improvements are related to regular exercise with some flexibility in the schedule . Future research should test interventions to improve exercise adherence in patients with COPD and identify characteristics of patients who are most likely and least likely to adhere over time Computerized educational technology , in various forms , is permeating the health care setting , and clinicians and program managers are charged with evaluating its potential to improve patient health outcomes . The purpose of this r and omized controlled trial was to compare two alternative methods of therapeutic exercise instruction in a sample of orthopedic rehabilitation patients ( n = 40 ) . The traditional ( control ) group received routine inpatient rehabilitation exercise education from physical therapists ( using demonstrations , verbal feedback , and written material s ) , and the technology ( intervention ) group received routine care as described plus one additional therapeutic session in which a customized set of exercises was downloaded from a computerized data base to videotape by each patient 's therapist and given to the patient for continued use at home . Data on patient compliance and patient satisfaction were collected at patient discharge and at four-week follow-up using a question naire design ed specifically for this study . Analysis of results showed no significant differences in patient compliance or patient satisfaction between the two study groups . Results of this r and omized trial suggest that computerized patient education technology may not provide the benefits anticipated Background and Objectives : Few studies have examined the effectiveness of pelvic-floor muscle ( PFM ) exercises to reduce female stress urinary incontinence ( SUI ) over the long term . This study : ( 1 ) evaluated continence and quality -of-life outcomes of women 6 months following formalized therapy and ( 2 ) determined whether low- and high-frequency maintenance exercise programs were equivalent in sustaining outcomes . Subjects and Methods : Thirty-six women with SUI who completed an intensive PFM exercise intervention trial were r and omly assigned to perform a maintenance exercise program either 1 or 4 times per week . Urine leaks per week , volume of urine loss , quality of life ( Incontinence Impact Question naire [ IIQ ] score ) , PFM strength ( Brink score ) , and prevalence of urodynamic stress incontinence ( USI ) were measured at a 6-month follow-up for comparison with postintervention status . Parametric and nonparametric statistics were used to determine differences in outcome status over time and between exercise frequency groups . Results : Twenty-eight women provided follow-up data . Postintervention status was sustained at 6 months for all outcomes ( mean [ SD ] urine leaks per week=1.2±2.1 versus 1.4±3.1 ; mean [ SD ] urine loss=0.2±0.5 g versus 0.2±0.8 g ; mean [ SD ] IIQ score=17±20 versus 22±30 ; mean [ SD ] Brink score=11±1 versus 11±1 ; and prevalence of USI=48 % versus 35 % ) . Women assigned to perform exercises once or 4 times per week similarly sustained their postintervention status . Discussion and Conclusions : Benefits of an initial intensive intervention program for SUI were sustained over 6 months . However , only 15 of the 28 women provided documentation of their exercise adherence , limiting conclusions regarding the need for continued PFM exercise during follow-up intervals of ≤6 months Purpose : To evaluate whether long-term neck and upper body exercises conducted in economical community-based outpatient clinic and home-based setting s could improve health-related quality of life (HRQoL)for individuals affected by chronic neck pain . The effect of baseline HRQoL and neck pain values on training adherence was also studied . Methods : Subjects ( n = 101 , 91 women/10 men , mean age 41.0 ± 9.5 years ) with chronic non-specific neck pain were r and omized to a combined strength-training and stretching-exercise group ( CSSG , n = 49 ) or to a stretching exercise group ( SG , n = 52 ) . HRQoL was assessed at baseline and after 12 months using the R AND -36 question naire . Comparisons between groups were performed using bootstrap-type analysis of covariance . The impact of HRQoL and neck pain values on training adherence , determined using participants ’ exercise logs , was studied using generalized estimating equations . Results : CSSG showed significant improvements in five and SG in four of eight of the HRQoL dimensions . There were no significant differences between the groups . Adherence to long-term training was only slightly affected by baseline-assessed HRQoL and neck pain values . Conclusions : The two training protocol s were feasible and equally effective in improving HRQoL. Baseline HRQoL and pain values had only a minor effect on training adherence . Implication s for Rehabilitation Long-term strength training and stretching are effective in improving HRQoL in people with chronic neck pain . Baseline HRQoL and neck pain values have little effect on training adherence Although the health benefits of exercise for individuals with Persian Gulf War veterans illnesses ( GWVI ) are documented , many of these individuals do not exercise regularly enough to obtain benefits . The purpose of this study was to investigate factors predicting exercise compliance among individuals with GWVI in a multicenter , r and omized , clinical trial . Participants were 1,092 veterans who reported at least two of the following cardinal symptoms of GWVI : ( 1 ) fatigue , ( 2 ) musculoskeletal pain , and ( 3 ) cognitive problems . Participants received exercise alone or exercise and cognitive-behavioral therapy . The overall level of compliance was relatively low during the exercise treatment phase ( 46.2 % ) and decreased by one-half during the follow-up period ( 23.0 % ) . Predictors of compliance during treatment included less pain and greater age , motivation , and body mass index . Predictors of compliance during the follow-up period included less pain and greater age . The results highlight factors that affect adoption and maintenance of physical activity in a population with GWVI Pelvic floor muscle exercises are recommended as an initial treatment to women with stress urinary incontinence . This treatment is often unsuccessful because of patient noncompliance . A post-test , experimental control group design was used to examine Pender 's ( 1992 ) concept of an external cue to action , an audiocassette tape , to enhance patient compliance to pelvic floor exercises . Eighty-six women with urodynamically evaluated stress urinary incontinence participated through a Pelvic Floor Exercise Unit at a large teaching hospital . Patients received biofeedback training and written information to reinforce pelvic floor muscle exercises during a 45-min appointment with a nurse . Patients were instructed to perform the exercises for 10 min twice daily . Forty-three women r and omly assigned to an experimental group received an audiocassette tape . Four to 6 weeks later all patients completed a research er-developed question naire that was validity and reliability tested assessing pelvic floor exercise compliance . The 43 patients ( 100 % ) who received the audiocassette tape reported compliance with " routine " exercises . Twenty-two of 34 patients ( 65 % ) who did not receive the tape were compliant ( P = 0.0003 ) . Thirty-four of 41 patients ( 83 % ) who received the tape reported exercise compliance twice a day , while 4 of 34 patients ( 12 % ) in the control group were similarly compliant ( P = 0.0000 ) . The findings suggest adding an audiocassette tape to a pelvic floor exercise program enhances patient compliance for incontinent women compared to verbal and written instruction combined with biofeedback OBJECTIVE --To determine the effectiveness of group- vs home-based exercise training of higher and lower intensities among healthy , sedentary older adults . DESIGN --Year-long r and omized , controlled trial comparing ( 1 ) higher-intensity group-based exercise training ; ( 2 ) higher-intensity home-based exercise training ; ( 3 ) lower-intensity home-based exercise training ; or ( 4 ) assessment -only control . SETTING --General community located in northern California . PARTICIPANTS --One hundred sixty women and 197 men 50 to 65 years of age who were sedentary and free of cardiovascular disease . One out of nine persons contacted through a community r and om-digit-dial telephone survey and citywide promotion were r and omized . INTERVENTIONS --For higher-intensity exercise training , three 40-minute endurance training sessions per week were prescribed at 73 % to 88 % of peak treadmill heart rate . For lower-intensity exercise training , five 30-minute endurance training sessions per week were prescribed at 60 % to 73 % of peak treadmill heart rate . MAIN OUTCOME MEASURES --Treadmill exercise test performance , exercise participation rates , and heart disease risk factors . RESULTS --Compared with controls , subjects in all three exercise training conditions showed significant improvements in treadmill exercise test performance at 6 and 12 months ( P less than .03 ) . Lower-intensity exercise training achieved changes comparable with those of higher-intensity exercise training . Twelve-month exercise adherence rates were better for the two home-based exercise training conditions relative to the group-based exercise training condition ( P less than .0005 ) . There were no significant training-induced changes in lipid levels , weight , or blood pressure . CONCLUSIONS --We conclude that ( 1 ) this community-based exercise training program improved fitness but not heart disease risk factors among sedentary , healthy older adults ; ( 2 ) home-based exercise was as effective as group exercise in producing these changes ; ( 3 ) lower-intensity exercise training was as effective as higher-intensity exercise training in the home setting ; and ( 4 ) the exercise programs were relatively safe |
11,559 | 24,941,907 | Overall , vaginal prostagl and in E2 compared with placebo or no treatment probably reduces the likelihood of vaginal delivery not being achieved within 24 hours .
The overall effect on improving maternal and fetal outcomes ( across a variety of measures ) is uncertain .
PGE2 tablets , gels and pessaries ( including sustained release preparations ) appear to be as effective as each other , small differences are detected between some outcomes , but these maybe due to chance .
Prostagl and ins PGE2 probably increase the chance of vaginal delivery in 24 hours , they increase uterine hyperstimulation with fetal heart changes but do not effect or may reduce caesarean section rates .
They increase the likelihood of cervical change , with no increase in operative delivery rates . | BACKGROUND Prostagl and ins have been used for induction of labour since the 1960s .
This is one of a series of review s evaluating methods of induction of labour .
This review focuses on prostagl and ins given per vaginam , evaluating these in comparison with placebo ( or expectant management ) and with each other ; prostagl and ins ( PGE2 and PGF2a ) ; different formulations ( gels , tablets , pessaries ) and doses .
OBJECTIVES To determine the effects of vaginal prostagl and ins E2 and F2a for third trimester cervical ripening or induction of labour in comparison with placebo/no treatment or other vaginal prostagl and ins ( except misoprostol ) . | Summary We combined real-time B-mode ultrasonography with a 2 MHz pulsed Doppler technique to record blood flow in the fetal descending aorta and in the intra-abdominal part of the umbilical vein in 14 pregnant women at term . The blood flow was studied before and after instillation into the vagina of either 4 mg prostagl and in E2 ( PGE2 ) gel or placebo gel . The PGE2 gel was significantly more effective in cervical priming and labor induction than the placebo gel . After instillation of the gel neither group showed a change in the fetal volume blood flow or in the aortic blood velocity waveform . We conclude that the instillation of 4 mg of PGE2 gel does not affect fetal hemodynamics at term Induction of labour is a common obstetric intervention . When the cervix is unfavourable ripening agents are used , commonly prostagl and in E2 . There are several methods of administration of prostagl and in E2 and little comparative work has been performed as to their acceptability by patients . Patients undergoing induction of labour by prostagl and in E2 were r and omised to receive either intravaginal gel or an intravaginal slow-release pessary . Patient satisfaction with the method received was then assessed . Sixty-nine patients were r and omised , 34 to receive gel and 35 to receive a pessary . Median scores for satisfaction of the induction process were the same for both methods ; however , satisfaction with the labour was increased with those who had been r and omised to the pessary group ( median pessary=5 , gel=4 ) . There may be a marginal improvement in patient satisfaction when a slow-release intravaginal prostagl and in E2 pessary is used for the induction of labour This study represents the first of its kind in Kuwait . Two preparations of prostagl and in E2 ( PGE2 ) have been compared as agents for induction of labor . In a r and omized controlled study of 200 women of low parity and unfavorable cervical induction features induction of labor by means of a single vaginal tablets of PGE2 was compared with locally prepared PGE2 vaginal pessaries . The gradual increase of uterine contractions and the establishment of labor in a similar way to that observed during spontaneous labor was more apparent after PGE2 tablets . Labor induction was successful in 80 % of patients in PGE2 tablet group compared with 59 % in PGE2 pessaries group . The incidence of cesarean section was equal in both groups ( 4 % ) , but none was performed due to uterine hyperactivity . The data presented indicate that the PGE2 vaginal tablet is safe and effective in induction of labor in healthy women at term The unfavorable cervix remains a major obstacle to the successful induction of labor . Reported are results from an ongoing study of topical prostagl and in preparations used to effect preinduction cervical ripening . The current study compares the efficacy of 40 mg of prostagl and in ( PG ) F2 alpha versus 5 mg of PGE2 , applied to the cervix in a methyltylose gel the night before attempted induction of labor . A prospect i ve double-blind protocol was used similar to that which previously established the efficacy of the 5 mg of PGE2 preparation versus placebo at this institution . Results indicate the superiority of the PGE2 preparation as measured by change in Bishop score , Pitocin requirement , rate of cervical dilatation , and percentage of failed inductions . Cesarean section rates were similar in the two study groups , and no fetal or maternal morbidity was attributable to the preinduction ripening technique In 345 women with a favorable cervical score at due date , labor was either induced by means of intravaginal application of tablets containing 3 mg of prostagl and in E2 or spontaneous onset of labor was awaited until the 42nd week of pregnancy . Eighty percent of the nulliparae and 96.3 % of the multiparae of the induction group gave birth within 24 h of the administration of the first tablet . All pertinent delivery intervals were significantly shorter in this group compared to those women where spontaneous onset of labor was awaited . The rate of operative deliveries was lower in the induction group . With the exception of 1 fetal death 3 days after due date , fetal outcome was excellent in both groups . Elective induction was at least equivalent to awaiting the onset of spontaneous labor and was not associated with higher complication rates due to the method of induction Two hundred consecutive women with uncomplicated pregnancies , at or within 4 days of their expected date of confinement , were prospect ively r and omized into 2 groups . One group had expectant management , with twice weekly surveillance tests , while the other group had 3 mg of vaginal prostagl and in E2 as outpatient treatment . There were 104 women in the expectant group and 70 in the induction group ( 26 women allocated to induction preferred no treatment ) . The average number of days to delivery was 1.6 in the induction group and 5.2 in the expectant group ( p < 0.001 ) . While meconium was much less frequent in the induction group ( p < 0.002 ) , all other outcome measures , including cesarean section rates , incidence of macrosomia , and Apgar scores , were similar in the two groups OBJECTIVE To compare the efficacy and safety of a prostagl and in E2 ( PGE2 ) vaginal insert with PGE2 administered as a vaginal tablet . STUDY DESIGN A r and omized , observational study was performed . Women requiring induction of labor were r and omly assigned to receive either a 10-mg PGE2 vaginal insert ( group 1 , n = 100 ) or 3-mg PGE2 tablets twice at six-hour intervals ( group 2 , n = 100 ) . The primary efficacy outcome variable was vaginal delivery within 24 hours of insertion . The criteria for safety were the occurrence of uterine hyperstimulation , abnormal fetal heart rate patterns , use of beta 2-sympathomimetic drugs and fetal outcome . RESULTS No differences in terms of vaginal delivery or cesarean section within 24 hours of induction were found . The cesarean section rate was 21 % in group 1 and 22 % in group 2 . The interval from insertion of the induction agent to the onset of regular uterine contractions and the insertion-to-delivery interval were not different between the two cohorts . No difference in the frequency of uterine hyperstimulation , use of beta 2-sympathomimetic drugs , abnormal fetal heart rate patterns , fetal outcome , or oxytocin and analgesic requirements were found . In seven of eight patients in group 1 who experienced uterine hyperstimulation , removal of the insert was sufficient to stop it , whereas in group 2 , of nine cases , eight needed medical interventions to end hyperstimulation ( P = .003 ) . CONCLUSION The continuous release of PGE2 from the vaginal insert permits controlled induction of labor , and easy removal of the drug in cases of uterine hyperstimulation is possible Summary In a r and omized double-blind study we evaluated the effects on cervical ripening and labor induction of 0.5 mg PGE2 in gel given intracervically and 2.0 mg PGE2 given as a vaginal suppository . All patients were at term with unfavorable cervical scores . The indications for induction were toxemia , diabetes mellitus , Rh-immunization , or intrauterine growth retardation . Significantly better results for both cervical priming and labor induction were obtained after intracervical PGE2-gel application than after treatment with placebo or vaginal suppositories . Eleven out of 19 patients ( 58 % ) were delivered within 24 h after intracervical PGE2-gel compared to two out of 19 patients given placebo ( p < 0.01 ) . In patients not delivered 24 h after the start of treatment , the mean cervical score had changed from 3.7 to 6.0 ( p < 0.05 ) after PGE2-gel application compared to a change from 3.9 to 4.3 after placebo treatment ( n.s . ) . The outcome after treatment with PGE2 suppositories did not differ significantly from that with placebo treatment . In a subsequent study 25 patients were given 0.5 mg PGE2-gel intracervically . The results were consistent with those obtained in patients receiving PGE2-gel intracervically in the double-blind study .Few side effects were noted . No patient complained of gastro-intestinal discomfort but increased myometrial activity was observed in two patients ; one after placebo and the other after active intracervical PGE2-gel treatment . The hyperactivity was readily countered with the β2-agonist , terbutaline . All infants were born in good condition with Apgar scores of 7 or more within 5 min . At pediatric examinations at 1 week and at 6 months of age all children seemed healthy BACKGROUND As the interval between rupture of the fetal membranes at term and delivery increases , so may the risk of fetal and maternal infection . It is not known whether inducing labor will reduce this risk or whether one method of induction is better then another . METHODS We studied 5041 women with prelabor rupture of the membranes at term . The women were r and omly assigned to induction of labor with intravenous oxytocin ; induction of labor with vaginal prostagl and in E2 gel ; or expectant management for up to four days , with labor induced with either intravenous oxytocin or vaginal prostagl and in E2 gel if complications developed . The primary outcome was neonatal infection . Secondary outcomes were the need for cesarean section and women 's evaluations of their treatment . RESULTS The rates of neonatal infection and cesarean section were not significantly different among the study groups . The rates of neonatal infection were 2.0 percent for the induction-with-oxytocin group , 3.0 percent for the induction-with-prostagl and in group , 2.8 percent for the expectant-management ( oxytocin ) group , and 2.7 percent for the expectant-management ( prostagl and in ) group . The rates of cesarean section ranged from 9.6 to 10.9 percent . Clinical chorioamnionitis was less likely to develop in the women in the induction-with-oxytocin group than in those in the expectant-management ( oxytocin ) group ( 4.0 percent vs. 8.6 percent , P<0.001 ) , as was postpartum fever ( 1.9 percent vs. 3.6 percent , P=0.008 ) . Women in the induction groups were less likely to say they liked " nothing " about their treatment than those in the expectant-management groups . CONCLUSIONS In women with prelabor rupture of the membranes at term , induction of labor with oxytocin or prostagl and in E2 and expectant management result in similar rates of neonatal infection and cesarean section . Induction of labor with intravenous oxytocin results in a lower risk of maternal infection than does expectant management . Women view induction of labor more positively than expectant management OBJECTIVE The aim of our study was to evaluate the optimum dose of intravaginal prostagl and in E2 gel for induction for labor in nulliparous women with a relatively ripe cervix ( modified Bishop score 4 or 5 ) . METHOD One hundred and sixty-seven nulliparous women at term with indications for the induction of labor were treated r and omly with two doses of intravaginal 2.0 ( group A ) or 3.0 mg ( group B ) of prostagl and in PGE2 gel every 12 h. Data were analyzed by chi 2-test and Student 's t-test . RESULTS Of 87 patients 64 went into labor after gel application in group A , compared with 68/80 in group B ( 73.5 % vs. 85.0 % ) ( P = NS ) . A second gel administration was needed for 9 women in group A and 6 women in group B. More side effects ( both local and systemic ) were noted in group B than in group A ( 28.7 % vs. 14.9 % ) ( P = 0.03 ) . In particular , more local ( hyperstimulation or hypertonus ) side effects were noted in group B ( 13.7 % vs. 2.3 % ) ( P = 0.01 ) . CONCLUSION The vaginal administration of 2.0 mg of PGE2 gel seems to be equally effective as 3.0 mg in terms of labor success rate with a significant lower incidence of side effects The effect of low-dose prostagl and in E2 vaginal gel specially prepared from commercially available material s , on subsequent indicated oxytocin induction of labor , was investigated in a r and omized , double-blind , placebo-controlled clinical trial . The stability of the gel after preparation was documented by radioimmunoassay in vitro . No differences between the treated and placebo groups were noted in subsequent modified Bishop scores , length of labor , use of analgesia or anesthesia , success of induction , mode of delivery , or perinatal outcome . Comparisons of this clinical trial with those previously reported are offered OBJECTIVE To compare two dosage regimens for the administration of vaginal prostagl and in gel in triacetin base for induction of labor . METHODS Seventy subjects planned for elective induction of labor at term were r and omized to treatment with PGE2 vaginal gel every 6 or 12 hours . The 6-hourly group received an initial dose of 1 mg , followed by 2 mg at 6 hour intervals for a maximum of two additional doses if not in active labor . The 12-hourly group had an initial dose of 2 mg followed by two additional doses at 12 hour intervals if not in active labor . RESULTS Successful induction rate was higher in the 12-hourly as compared to 6-hourly gel regimen ( 100 % vs. 91 % , P > 0.05 ) . Twelve hours after the initial dose , delivery occurred in 34 % delivery had occurred in 57 % and 37 % respectively ( P < 0.01 ) . We found no difference in the induction-active labor interval ( P > 0.05 ) , and the induction-delivery interval ( P > 0.05 ) between the two groups . Active labor followed a single dose of gel in 66 % of the 12-hourly group compared to 40 % of the 6-hourly group ( P < 0.01 ) . Syntocinon augmentation was needed in 6 % of subjects in the 12-hourly group as compared to 26 % in the 6-hourly group ( P < 0.01 ) . The cesarean section rate was similar in both groups . Uterine hyperstimulation occurred less frequently in the 12-hourly group ( P < 0.05 ) . The perinatal outcome was similar in both groups . CONCLUSIONS The 12-hourly regimen was more effective than the 6-hourly regimen in initiating labor . The majority of the subjects in the 12 hourly group achieved labor following a single dose of gel . Induction delivery interval , however , was similar in both groups OBJECTIVE Our purpose was to determine whether a protocol for outpatient induction is safe and effective for initiating labor . STUDY DESIGN A r and omized , double-blind , placebo-controlled trial was performed with 100 low-risk patients having well- date d pregnancies . Women with a Bishop score < or = 6 at 38 to 40 weeks ' gestation were administered either 2 mg of intravaginal prostagl and in E2 gel or placebo for 5 consecutive days as out patients while undergoing fetal monitoring . RESULTS The median interval from r and omization to delivery was 4 days in the prostagl and in E2 group ( range 0 to 28 days ) versus 10 days in the placebo group ( range 0 to 26 days , p = 0.002 ) . Twenty-seven of 50 patients ( 54 % ) in the prostagl and in E2 group were admitted for labor during the dosing interval compared with 10 placebo-treated patients ( 20 % , p = 0.001 ) . The mean gestational age at delivery was significantly reduced in the treatment group ( 39.9 + /- 1.0 weeks vs 40.5 + /- 0.99 weeks , p = 0.003 ) as was the incidence of post date s pregnancy ( 40 % vs 66 % , p = 0.016 ) . Hyperstimulation was observed in one prostagl and in E2-treated patient , but no intervention was required . CONCLUSIONS Outpatient low-dose prostagl and in E2 gel administration is effective for initiating labor in patients with an unfavorable cervix and appears safe if performed with adequate monitoring AN ideal method of induction of labour should be simple , safe , effective and noninvasive thereby increasing the acceptance by the patient and reducing the risks associated with amniotomy . The unripe cervix has always been a problem but in recent years prostagl and in E2 has been shown to have a direct effect on this , possibly by modifying the glyco-amnio glycans in the cervical ground substance . Over the past few years prostagl and in has been used with varying success rates by differing routes , however its use intravenously and orally has been limited by the side-effects of gastro-intestinal disturbance and local cellulitis at the venopuncture site . Prostagl and in has been administered as a jel extra-amniotically and as a pessary with encouraging results reported in the recent medical literature . Work from Queen Charlotte 's Hospital by Shepherd et al. suggests that induction of labour using a 3 mg pessary can be a highly efficient and acceptable procedure . However , it was noted by these authors that a multiparous patient with a favourable cervix had vigorous uterine contractions upon insertion of the pessary . Uterine hypertonus had been noted by us in a higher percentage of cases while using a 3 mg pessary even when the cervix was not particularly favourable . Gordon-Wright and Elder have demonstrated that there is rapid systemic absorption of prostagl and in after administration of the drug in pessary form with a maximum effect in two hours and that the systemic level can remain high for up to six hours-this may explain the cases of hypertonus OBJECTIVE To investigate clinical reasonable dose of methyl carboprost suppository ( 15-methyl-PGF2 alpha ) for induction of labor . METHOD A total of 150 gravidas with singleton pregnancy and cephalic presentation , accepted for induction of labor , were r and omly allocated into 3 groups : group 1 , 15-methyl-PGF2 alpha 0.100 mg ( n = 50 ) ; group 2 , 0.125 mg ( n = 50 ) ; and group 3 , 0.200 mg ( n = 50 ) . RESULTS The success rates of induction were 90.0 % , 94.0 % and 100.0 % for group 1 , 2 and 3 , respectively . As cervical Bishop score < or = 5 , the cases needed oxytocin intravenous infusion during the active phase were 48.5 % , 40.7 % and 5.0 % , respectively ; cervical Bishop score > or = 6 , the cases were 11.8 % , 13.0 % and 0.0 % , respectively . There were 3 cases of precipitate delivery in group 2 and 3 . No uterine hyperstimulation occurred in group 1 and 2 , while 3 cases of uterine hyperstimulation in group 3 . CONCLUSION ( 1 ) A single maximum dose of 15 methyl-PGF2 alpha for term labor induction should be < 0.200 mg . ( 2 ) The different dose was chosen according to cervical Bishop score , i.e. 0.200 mg or 0.125 mg for Bishop score < or = 5 , and 0.100 mg for Bishop score > or = 6 Prostagl and in E2 ( PGE ) 4 mg administered as an intrarectal suppository failed to induce labour in 70 % of patients with a favourable cervical score . This may indicate that intravaginally administered PGE , which is effective in inducing labour in 70 % of patients , acts at least in part directly on the cervix BACKGROUND As the interval between rupture of the fetal membranes at term and delivery increases , so may the risk of fetal and maternal infection . Recently the TERMPROM ( Term Prelabor Rupture of the Membranes ) Study Group reported the results of a r and omized controlled trial comparing 4 management strategies : induction with oxytocin ( IwO ) , induction with prostagl and in ( IwP ) , and expectant management and induction with either oxytocin ( EM-O ) or prostagl and in ( EM-P ) if complications developed . The study found no statistically significant differences in neonatal infection and cesarean section rates between any of the 4 groups . OBJECTIVE To conduct an economic evaluation comparing the cost of ( a ) IwO and EM-O , ( b ) IwP and EM-P and ( c ) IwO and IwP. DESIGN An economic analysis , conducted alongside the clinical trial , using a third-party payer perspective . Analysis included all treatment costs incurred for both the mother and the baby . Information on health care utilization and outcomes was collected for all study participants . Three countries ( Canada , the United Kingdom and Australia ) , corresponding to the largest study recruitment , were chosen for calculation of unit costs . For each country , the base , low and high estimates of unit cost for each service item were generated . Intention-to-treat analysis . Extensive statistical and sensitivity analyses were performed . RESULTS The median cost of IwO per patient was significantly lower statistically than that of EM-O and IwP. This result held in all 3 countries compared -$114 and -$46 in Canada , -113 Pounds and -63 Pounds in the UK , and -A$30 and -A$49 in Australia ) and after an extensive sensitivity analysis . There was no statistically significant difference in median cost per patient between IwP and EM-P. CONCLUSION Although the clinical results of the TERMPROM study did not find IwO to be preferable to the other treatment alternatives , the economic evaluation found it to be less costly . However , these cost differences , even though statistically significant , are not likely to be important in many countries . When this is the case , the authors recommend that women be offered a choice between management strategies Objective : The aim of this study was to determine whether dinoprostone vaginal insert ( Cervidil ) can ripen the cervix and induce labor more effectively and safely than a hospital-prepared intravaginal gel . Methods : Three hundred thirty-six patients undergoing cervical ripening for induction of labor at term were r and omly assigned to receive either Cervidil insert or a hospital-formulated prostagl and in E(2 ) gel . Bishop scores were evaluated before and after administration of the ripening agent , and charts were subsequently review ed for labor characteristics , mode of delivery , and complications of labor and delivery . Results : Cervical ripening as measured by a change in Bishop score was significantly better in those patients receiving Cervidil than those receiving the gel ( 3.54 vs 2.29 , P < .0001 ) . Although duration of labor was similar between the two groups , those receiving Cervidil were less likely to require oxytocin stimulation ( RR 0.51 , 95 % CI 0.29 - 0.91 ) . Though the Cervidil group had a lower cesarean section rate than the gel group , the difference did not achieve statistical significance ( 25.4 % vs 33.8 % , P = .089 ) . Complication rates did not differ significantly between the two groups . Conclusions : Cervidil insert is superior to intravaginal gel in ripening the cervix and inducing labor , with no increase in morbidity . It has not been shown to have a significant effect on duration of labor or mode of delivery A double-blind , placebo-controlled , prospect i ve investigation was undertaken to determine whether the outpatient administration of prostagl and in E2 gel was helpful for ripening the cervix in post date pregnancies . One hundred eighteen women with an uncomplicated pregnancy at or beyond 42 weeks ' gestation with an unripe cervix ( Bishop score less than or equal to 5 ) were r and omly administered a single dose of gel containing either 2.5 mg prostagl and in E2 ( n = 55 ) or a placebo ( n = 63 ) before induction of labor with Pitocin . No side effects were detected in these healthy mothers and fetuses . A distinct change in Bishop score after 12 hours occurred more often in the prostagl and in E2 than in the placebo group ( 42 % versus 6 % , p less than 0.0001 ) . Forty-four women ( 80 % ) who had received prostagl and in E2 were admitted in early labor ; they required little or no oxytocin for augmentation . The duration of labor and maximum dose of oxytocin infused were significantly decreased in the prostagl and in E2 group , and forceps delivery or primary cesarean sections were performed less often when prostagl and in E2 was used ( 24 % versus 44 % , p less than 0.05 ) . The outpatient administration of a single dose of prostagl and in E2 gel is safe in the uncomplicated post date pregnancy and was found to significantly change the unripe cervix , enhance the onset of labor , minimize the need for oxytocin administration , and encourage a spontaneous vaginal delivery Objective To compare conservative management of pre-labor spontaneous rupture of membranes ( SROM ) with the use of prostagl and in ( PG ) E2 in healthy parous women at term ( gestational age at least 37 weeks ) . Methods An open r and omized study was conducted with 100 parous women ; 50 were treated conservatively for 24 hours , and 50 were managed actively using PGE2 gel ( 1 mg ) , administered at admission and repeated 6 hours later if labor was not established . Both groups received intravenous oxytocin if labor did not start within 24 hours after admission . Results The use of PGE2 gel led to a significant reduction in the mean interval ( ± st and ard error of the mean ) from SROM to onset of labor : 17.26 ± 1.51 hours in the conservative group versus 6.50 ± 1.23 in the PGE2 group . A significantly smaller proportion of subjects required oxytocin in the PGE2 group ( 12 versus 38 % , P < .02 ) . The two groups were comparable with respect to analgesic requirements . Within 24 hours of SROM , 80 % of the women in the PG group and 56 % in the conservative group had delivered ( P < .02 ) . Most women delivered vaginally , 96 % of those managed conservatively and 100 % of those managed actively with PGE2 . Conclusion Active management using PGE2 gel in parous women with pre-labor SROM significantly improves the time to delivery without influencing the cesarean rate or fetal-maternal infective morbidity Summary Fifty nine women with prelabour rupture of membranes , unfavourable cervix and no evidence of infection or fetal distress were r and omized formally to receive prostagl and in E2 ( 3 mg ) gel or sterile K‐Y Jelly intravaginally The purpose of this r and omized , double-blind study was to evaluate the efficacy and safety of a new controlled-release hydrogel pessary for ripening the cervix and initiating labor . Subjects had an entry Bishop score of 4 or less and gestational age of 37 or more weeks . One hundred fourteen women received a placebo pessary and 101 received the hydrogel pessary , containing 10 mg of prostagl and in ( PG ) E2 . Compared with the placebo group , those given the PGE2 pessary were more likely to have an increase in Bishop score of 3 or more ( 60 or 59 % versus 21 or 18 % ; P less than .0001 ) , change to a Bishop score of 6 or higher ( 59 or 58 % versus 18 or 16 % ; P less than .0001 ) , and active labor ( 68 or 67 % versus 15 or 13 % ; P less than .0001 ) . Including the crossover study , uterine hyperstimulation ( 28 of 182 , 15 % ) and fetal heart rate abnormalities ( 18 of 182 , 10 % ) in PGE2-treated subjects were reversed on removal of the pessary with no apparent harm to the mother or fetus . These temporary adverse effects appeared while the pessary was in place and after the onset of active labor . Oxytocin was unnecessary in 89 of 182 ( 49 % ) of the PGE2-treated cases and was used more often to augment than to induce labor . We conclude that the described controlled-release PGE2 vaginal pessary induces appreciable cervical ripening and frequently initiates active labor with little or no need for oxytocin . The pessary may cause uterine hyperstimulation or fetal heart rate abnormalities , but these would be expected to reverse on removal of the pessary Objective : To compare the relative cost efficacy of three commercially available prostagl and in analogues , misoprostol ( Cytotec(R ) , PGE(1 ) ) , dinoprostone gel ( Prepidil(R ) , PGE(2 ) ) , and dinoprostone pessary ( Cervidil(R ) , PGE(2 ) ) , as labor preinduction agents . Methods : The investigation was conducted as a prospect i ve r and omized , blinded phase III clinical trial . One hundred twelve gravid females undergoing induction of labor with an unfavorable cervix ( Bishop score < /=5 ) were enrolled and r and omized to receive either Cytotec(R ) 50 µg q6 hours x 2 doses , Prepidil(R ) 0.5 mg q6 hours x 2 doses , or Cervidil(R ) 10 mg x 1 intravaginally . Twelve hours after initial treatment , cervical Bishop score was reassigned by the same blinded initial examiner and oxytocin induction initiated per st and ardized protocol . Therapeutic efficacy and cost of the labor preinduction/induction with the study treatments were compared . Statistical comparisons between groups were made using ANOVA with Bonferroni post test , Wilcoxon rank sum test , and chi(2 ) test . Results : The three study groups did not differ significantly with respect to parity , gestational age , indication for induction , or initial cervical Bishop score . A significantly greater proportion of patients had a favorable cervix ( Bishop score > /=6 ) after the initial preinduction interval in the Cytotec(R ) ( 79.0 % ) and Cervidil(R ) groups ( 60.5 % ) as compared to Prepidil(R ) ( 40.0 % ) ( P < .05 ) . The average relative cost per patient for prostagl and in preinduction was significantly less with Cytotec(R ) ( $ 0.42 ) as compared to both Cervidil(R ) ( $ 168.00 ) and Prepidil(R ) ( $ 184.17 ) ( P < .0001 ) . A greater percentage of patients treated with Cytotec(R ) ( 42.1 % ) achieved active labor and delivered without the use of oxytocin when compared to Cervidil(R ) ( 15.8 % ) or Prepidil(R ) treatment groups ( 2.9 % ) ( P < .05 ) . Additionally , time to delivery ( + /-SD ) was significantly shorter in the Cytotec(R ) group ( 24.0 + /- 10.8 h ) as compared to the Cervidil(R ) ( 32.2 + /- 14.7 h ) or Prepidil(R ) groups ( 33.9 + /- 16.2 h ) ( P < .05 ) . This reduction in time result ed in a significantly lower overall mean cost per patient incurred by labor induction in the Cytotec(R ) group ( $ 723.66 ) as compared to the Cervidil(R ) ( $ 1058.90 ) or Prepidil(R ) treatment ( $ 1124.84 ) ( P < .01 ) . No significant differences were noted with respect to rate of cesarean delivery . Conclusion : Misoprostol is more cost-effective than the comparable commercial dinoprostone prostagl and in preparations as an adjuvant to labor induction in patients with an unfavorable cervix Objective To evaluate the safety and efficacy of serial frequent intravaginal prostagl and in ( PG ) E2 gel applications in shortening the time required to achieve an inducible cervix . Methods From May 1 , 1993 , through April 30 , 1994 , 101 pregnant women with medical indications for induction of labor and Bishop scores less than 7 were r and omized to receive intravaginal 2.5 mg of PGE2 gel every 6 hours or as often as every hour until the Bishop score was at least 7 or intervention was required . Results The mean total number of PGE2 gel applications was significantly different between the 1- and 6-hour groups , 6.5 and 4.4 PGE2 applications , respectively . The mean time from PGE2 application to delivery was similar , 42 and 45 hours , for the 1- and 6-hour groups , respectively . The intervention rate , occurrence of labor during ripening , and neonatal outcomes were also similar . Conclusion Intravaginal application of 2.5 mg PGE2 gel as frequently as every hour appears to be safe , but it does not decrease the time interval to induction or delivery , nor does it decrease the cesarean rate OBJECTIVE The purpose of this study was to determine if prostagl and in E2 in a controlled-release vaginal pessary can produce cervical ripening at term . STUDY DESIGN This was a double-blind , r and omized , placebo-controlled study conducted at a university center and involving 81 patients with 42 receiving active agent . Categoric data were analyzed by Pearson 's chi 2 or logistic regression . Continuous variables were analyzed by analysis of variance and the F test . RESULTS Prostagl and in E2 was significantly better than placebo at cervical ripening and at decreasing the time to rupture of membranes , the time to onset of labor , the need to give oxytocin , and the time to vaginal delivery . Multiparous women benefitted more than primiparous ones . The cesarean section rate decreased only for multiparous women . Uterine hyperstimulation occurred only with prostagl and in E2 and after the onset of labor . CONCLUSIONS Prostagl and in E2 , when administered in a controlled-release vaginal pessary , is affective in producing cervical ripening at term . This agent should be used on in patients who are under continuous monitoring and it should be removed at the onset of labor Objectives To compare the effectiveness , safety of immediate induction with PGE2 gel and expectant management in terms of maternal and fetal outcome in term PROM . Methods 100 women were r and omized to group A , immediate induction and group B expectant management . Results Spontaneous vaginal deliveries were more in group B. CS and operative vaginal deliveries were more in group A. Conclusion Expectant management followed by delayed induction with oxytocin is better than immediate induction with PGE2 gel in term PROM . A good number of women go into spontaneous labor and deliver vaginally with out increase in the Cesarean section rate and infectious morbidity for mother and fetus A r and omised double-blind trial was done to determine the effect on cervical ripening of 50 mg intravaginal prostagl and in F2 alpha ( P.G.F.2 alpha ) in a methyl cellulose gel given on the evening before surgical induction of labour . Patients were given either placebo or P.G.F.2 alpha and in both groups cervical stretching and sweeping of the fetal membranes was attempted . Of the 40 control patients , 3 had gone into labour and the mean improvement in the cervical score was 1.6 before surgical induction the next morning . However , 20 of the 40 patients receiving P.G.F.2 alpha went into labour before the proposed induction and the mean change in cervical score ( 5.1 ) was significantly greater than that in the placebo group . Of the 40 patients pretreated with P.G.F.2 alpha , 37 had improved cervical scores and significantly fewer required augmentation in labour with intravenous oxytocin than in the control group . No side-effects were experienced and the patients found the treatment acceptable Background Our objective was to determine the best treatment for parturients at term with an unfavorable cervix and premature rupture of membranes ( PROM ) . Methods In this prospect i ve study , 96 women with PROM and an unfavorable cervix were r and omized into one of three treatment groups : oxytocin induction , vaginal prostagl and in E2 gel followed by oxytocin , or expectant management Results Length of labor , cesarean section rate , and maternal/neonatal morbidity were not significantly different . In contrast , the interval from PROM until delivery and length of hospital stay were significantly longer in the expectantly managed group than in the other groups . Four of the patients who received expectant management required delivery because of nonreassuring fetal assessment s. Conclusions Expectant management of PROM at term significantly prolongs hospital stay without decreasing the incidence of abdominal delivery or infectious morbidity . There appears to be potential for cord compression in patients managed expectantly without continuous electronic fetal surveillance Background . Although there are many comparative studies concerning the local administration of prostagl and in E2 gel for cervical ripening and labor induction , the safety , efficacy and the appropriate route and dose of the gel are still debated Objective : To shorten post- date pregnancies in a safe , effective manner by outpatient acceleration of cervical ripening . Methods : Eighty patients with uncomplicated pregnancies at or beyond 41 weeks ' gestation and a cervical Bishop score less than 9 were r and omized to daily self-administered , 2-mg intravaginal prostagl and in E2 ( PGE2 ) or placebo suppositories . Each followed a st and ard post- date antepartum surveillance protocol . Patients were admitted for spontaneous labor or for induction if the Bishop score reached 9 , antepartum testing was nonreassuring , exclusion criteria were fulfilled , or if the gestational age reached 44 weeks . Results : Fewer suppositories were used in the PGE2 group ( four versus seven ; P=.006 ) , result ing in earlier gestational age on admission ( 295 versus 297 days ; P=.021 ) and lower antepartum testing charges ( $ 476.97 versus $ 647.29 ; P=.001 ) . Labor and delivery time was significantly decreased in nulliparas ( 10.7 ± 5.1 versus 15.3 ± 7.6 hours ; P=.035 ) . Conclusions : Daily low-dose , patient-administered PGE2 vaginal suppositories can decrease the gestational length and cost of uncomplicated post- date pregnancies by reducing the time to achieve a favorable cervix , the need for antepartum testing , and , potentially , post- date -related complications OBJECTIVE To evaluate patient satisfaction of cervical ripening using dinoprostone ( PGE2 ) by either intravaginal gel or pessary . STUDY DESIGN A group of 173 nulliparous women requiring cervical ripening were recruited in the study and r and omized to receive either intravaginal gel ( Prepidil , Upjohn , Milan , Italy [ group A ] ) or intravaginal pessary ( Propess , Ferring Pharmaceuticals , Malmö , Sweden [ group B ] ) . Before administration of PGE2 and after delivery , the patients answered a question naire investigating the anxiety and discomfort caused by cervical ripening . RESULTS Of the group , 22 women did not adequately complete the question naire ; therefore 151 women were included in the study . Before cervical ripening , anxiety and discomfort did not significantly differ between the two study groups ; more patients in group A than in group B declared they would have preferred the other form of application . The intensity of pain experienced during the application of PGE2 was higher in group B than in group A. For the future opportunity to choose the application necessary for cervical ripening , more patients in group B than in group A would change the form of application . CONCLUSION Patient satisfaction with the two forms of treatment appears to be equally good . The application of the intravaginal pessary causes more discomfort than the vaginal gel Objective To compare two prostagl and in ( PG ) E2 preparations for pre-induction cervical ripening in a r and omized clinical trial . Methods Two milligrams of vaginal PGE2 gel was compared with a vaginal PGE2 3-mg tablet in 200 nulliparous women . Outcomes assessed were induction failure , need for labor augmentation , pain relief requirements , fetal heart rate ( FHR ) abnormalities , operative delivery rate , induction-to-delivery interval , neonatal condition , and occurrence of uterine hyperstimulation . Results There was no statistical difference in pre- and post-dose cervical scores . Compared with the tablet group , women in the gel group were more likely to have significant FHR abnormalities in early labor ( odds ratio [ OR ] 4.77 , 95 % confidence interval [ CI ] 1.15–19.5 ) requiring cesarean delivery . Fetal heart rate tracings in the active phase of labor were also more likely to be abnormal in the gel group ( X2 = 4.31 , P < .05 ) . Compared with the gel group , women in the tablet group were significantly more likely to require operative delivery for poor progress in labor ( OR 2.83 , 95 % CI 1.20–7.24 ) . Other clinical outcomes were identical , with no significant differences in the overall rate of failed induction , cesarean delivery , rate of assisted delivery , requirement for oxytocin infusion , induction-to-delivery interval , pain relief requirements , or neonatal condition . Conclusions When compared with the PGE2 tablet , the use of PGE2 gel for cervical ripening and labor induction in nulliparous women did not result in significant improvements in labor outcome . Whereas the gel was associated with an increase in significant FHR abnormalities , the tablet was associated with an increase in the rate of operative delivery for poor progress in labor The outcome of labor induced by use of a glyceride-based vaginal suppository of prostagl and in E2 ( PGE2 ) inserted 3 hours before amniotomy , when the cervix is favorable , has been assessed . Using 5 mg PGE2 for primigravidas and 2.5 mg for multigravidas , 63 % of the former and 81 % of the latter established labor and were delivered of their infants without oxytocin augmentation , allowing ambulation during early labor . No maternal complications were detected as a result of the PGE2 treatment . Compared with patients undergoing conventional induction by amniotomy and immediate oxytocin titration there was no difference in the duration of labor , with a few patients establishing labor and giving birth quickly with both induction methods . Fetal distress was less common following PGE2 treatment than following conventional induction , with three patients in each group requiring delivery by cesarean section . Cephalopelvis disproportion in the second stage of labor requiring cesarean section to deliver occurred more frequently in the prostagl and in-treated group , possibly as a result of reduced upper segment contractility in the first stage of labor with subsequent poor fetal head molding . Epidural analgesia and postpartum hemorrhge were both reduced following PGE2-induced labor Two hundred women were studied in a r and omized controlled trial of induction of labor using high-dose ( 3 mg ) or low-dose ( 0.5 mg ) prostagl and in E2 vaginal pessaries . Induction using 3-mg pessaries was more successful , with a shorter overall induction – delivery interval and less requirement for analgesia , although uterine hyperstimulation occurred in two patients . In contrast , the low-dose regimen did not cause hypertonus and , though less successful in inducing labor , the total dose of prostagl and in E2 used was considerably less than in the 3-mg group . The cesarean section rate when the cervix was initially unfavorable was high in both groups ( high dose 18.2 % , low dose 16.7 % ) . The response to prostagl and in E2 did not relate closely to the initial cervical state OBJECTIVE To determine maternal and perinatal morbidity and the spontaneous labor rate beyond 41 weeks of gestation . METHOD Patients with uncomplicated pregnancy were recruited at 41 weeks and screened for fetal or maternal well-being . Following observation between 41 and 42 weeks , patients were r and omized to either serial monitoring by cardiotocography and measurement of amniotic fluid index , or to immediate induction . Comparisons were made using the chi(2 ) test . Results after 42 weeks were analyzed according to intention at r and omization . RESULTS Morbidity was not increased before 42 weeks . After 42 weeks , the cesarean section rate and incidence of meconium below the vocal cords were increased in monitored patients . The median gestational age in patients who were monitored was 298.5 ( 294 - 321 ) days . In patients observed from 41 weeks , 91.6 % labored spontaneously . CONCLUSION It is reasonable to observe uncomplicated pregnancy until 42 weeks with adequate monitoring . After 42 weeks , induction of labor is preferred Please cite this paper as : Taher S , Inder J , Soltan S , Eliahoo J , Edmonds D , Bennett P. Prostagl and in E2 vaginal gel or tablets for the induction of labour at term : a r and omised controlled trial . BJOG 2011;118:719–725 Previous reports with an 850 micrograms prostagl and in E2 film for cervical ripening before induction of labour in term pregnancy have been favourable . These studies however had no controls . The present study compares this PGE2 vaginal film with a nonmedicated similar vaginal film ( placebo ) for preinduction cervical ripening in primigravid women at term . A total of 69 women with modified Bishop 's cervical scores 1 - 5 were assigned r and omly to either the PGE2 group ( 33 women ) or placebo group ( 36 women ) . Cervical score assessment s were made at 12 and 24 hours after which labour was induced by amniotomy and oxytocin infusion . Although the cervical scores between placebo and PGE2 groups at 12 and 24 hours were not significantly different , the scores were marginally better with the prostagl and in film . Pregnancy outcome was satisfactory in both groups with no perinatal or maternal mortality and morbidity . The caesarean rate was 30.6 % in the placebo group and 24.2 % in the PGE2 group . This study emphasizes the need for a control group when study ing the success of agents used for ripening the pregnant cervix at term Objective To compare the impact upon maternity unit re sources and finances of two protocol s for induction of labour using prostagl and ins A r and omized blinded investigation was undertaken to determine the efficacy and safety of sequentially applied intravaginal prostagl and in E2 ( PGE2 ) gel for accelerating cervical ripening in an outpatient setting in low-risk prolonged pregnancies . Fifty women with uncomplicated pregnancies at or beyond 41 weeks ' gestation and Bishop scores below 9 received twice-weekly outpatient administration of gel containing 2.0 mg of PGE2 or placebo . Thirty nulliparas and 20 multiparas were enrolled . The PGE2 gel failed to improve cervical ripening over placebo , as judged by Bishop scores . There was no difference between the groups in gestational age on admission to the labor and delivery suite , number of gel applications , requirement for oxytocin , incidence of cesarean delivery , or neonatal outcome . Only two patients ( 4 % ) experienced regular uterine contractions after gel insertion ; these subsided spontaneously in both . None of the subjects experienced labor , tetanic contractions , evidence of fetal distress , or any other side effects related to gel insertion . We conclude that PGE2 gel in this dosage may be used safely in an outpatient setting , but more frequent application or earlier initiation may be required to produce a clinical A prospect i ve r and omized study of 267 pregnant women was undertaken to compare the efficacy of a pharmacy‐prepared 3‐mg prostagl and in E2 ( PGE2 ) vaginal suppository with a 3‐mg PGE2 vaginal tablet for induction of labor and cervical ripening . No statistically significant difference in success frequency was found between the two groups , either on the first day ( 72 % and 74 % , respectively ; p > 0.05 ) or on the second day ( 89 % in both groups ) . There was an equal proportion of women requiring oxytocin augmentation in the two groups , but the slower releasing properties of the vaginal tablet were reflected in a longer mean induction — delivery interval of about 4 h for this group . In both the pessary and the vaginal tablet groups , women who had not gone into labor on the First day showed a statistically significant increment in the Bishop score on the morning of the second day . The frequency of cesarean section was the same in both groups , but instrumental deliveries were more frequent in the vaginal tablet group . It is concluded that PGE , vaginal tablets — a chemically stable alternative to pharmacy prepared pessaries — appear to be effective as regards cervical ripening as well as for labor induction A r and omized controlled trial was carried out in order to establish the efficacy of a scoring system for calculating the dose of vaginal prostagl and in E2 tablets for the induction of labor . One hundred ten women were included in the study . The patients received a dose of prostagl and in E2 calculated according to a scoring system based on the Bishop 's score , or the st and ard dose of 3 mg repeated 6 h later if labor did not start . The percentage of inductions achieved was the same with both regimens ( 92.7 % ) . The mean total dose used in the scoring system-group ( 2.7 mg ) was significantly lower than that used in the 3-mg group ( 3.5 mg , P less than 0.025 ) . Thirty-seven of 55 women receiving the scoring dose delivered with amounts of 2.5 mg prostagl and in E2 or less . Three cases of uterine hyperstimulation were observed in the 3-mg group whereas no cases were observed in the scoring group . The scoring system is proposed as a method for calculating the dose of vaginal prostagl and in E2 for induction of labor and minimizing the risk of overdosage The purpose of this study is to proceed and estimate the effect of Propess for cervical ripening for induction of labor due to medical indications . Seventy pregnant women are included divided in two groups-36 of them with vaginally applicated Propess and the other 34 are at the control group . Changes in the cervix , induction of uterine activity , labor , status of the fetus and the side effects are proceeded . In the group with vaginally applicated Propess 9 of the patients gave birth till the twelfth hour from the application of the pessar . The Bishop score increased over 6 points in 7 of them and increased by 3 points in 11 of the cases within 12 hours . In the control group no delivery is registered till the twelfth hour , in two of the cases there is an increase of the Bishop score over 6 points and only in 5 of the cases is estimated an increase of the Bishop score with 3 points . There is one case of uterine hyperstimulation . There was no other side effects Objective . To compare 24‐hour controlled‐release vaginal dinoprostone pessary vs. gel for induction of labor at term in women with an unfavorable cervix . Design . R and omized controlled trial . Setting . University hospital . Population . A total of 133 women with singleton pregnancies , fetal cephalic presentation , Bishop score ≤ 4 , gestational age of 37–42 weeks , no previous cesarean section and intact membranes admitted for induction of labor . Methods . R and om allocation to either 24‐hour 10‐mg controlled‐release vaginal dinoprostone pessary or repeat doses of 2 mg vaginal dinoprostone gel . Main outcome measures . Rate of spontaneous vaginal , operative vaginal and cesarean delivery . Results . The rate of spontaneous vaginal delivery was significantly higher in the pessary group ( 72 % ) than in the gel group ( 54 % ) , paralleled by a lower rate of operative vaginal deliveries ( 3 vs. 15 % ) . The difference in cesarean section rate ( 25 vs. 31 % ) did not reach statistical significance . Both methods of induction of labor appeared to be safe , with no cases of 5‐minute Apgar scores < 7 or episodes of uterine hyperstimulation in either group . The medication cost was lower in the pessary group , with a median saving of 50.20 € compared to the gel group . Conclusions . Both the 24‐hour dinoprostone vaginal pessary and the vaginal gel appear to be safe for labor induction . In women induced at term with a Bishop score ≤ 4 the pessary achieved a significantly higher rate of spontaneous vaginal delivery The intravaginal application of prostagl and in E2 for preinduction cervical ripening has proved to be advantageous in the management of patients with an unfavorable cervix . The purpose of this double-blind r and omized investigation was to compare the efficacy and safety of two methods of prostagl and in E2 delivery . Patients who were to have preinduction cervical ripening because of an unfavorable cervix ( Bishop score less than or equal to 4 ) were r and omly assigned to be given a single dose of prostagl and in E2 as either 2.5 mg of gel or a 3.0 mg " chip " intravaginally in a placebo-controlled manner . Sixty-nine patients received the active prostagl and in E2 , 34 in the gel group and 35 in the " chip " group . The groups were similar in maternal age , race , parity , gestational age , and initial Bishop score . Both forms of prostagl and in E2 were easy to administer and helpful in priming an unfavorable cervix . The need for , duration of , and maximum dose of oxytocin were similar in both groups . Cesarean delivery because of failed induction occurred in 5 of 35 ( 14.3 % ) patients receiving a " chip " and 4 of 34 ( 11.8 % ) receiving the gel . However , patients receiving a " chip " experienced a 20 % ( 7/35 ) incidence of hyperstimulation , compared with 2.9 % ( 1/36 ) in those receiving the gel ( p less than 0.05 ) . The only case requiring immediate cesarean delivery because of intractable uterine hyperstimulation received a " chip . " We conclude that both methods were effective for cervical ripening , but the lower incidence of uterine hyperstimulation seen with the gel would suggest that it is preferable to the " chip . Eighty patients with a Bishop score of less than or equal to 4 were r and omly administered vaginal triacetin gel containing placebo or prostagl and in E2 in 1 , 2 , and 3 mg doses . Twelve to sixteen hours later , those not in labor underwent oxytocin induction . Increasing doses of prostagl and in were effective in ripening the cervix , and the higher doses were associated with significant success in inducing labor Vaginal application of tablets containing prostagl and in at term in pregnant women with a favorable cervical score is a very efficacious method of induction of labour . Due to the motility of the women they consider this method of induction as almost natural . We , therefore , aim ed at discussing the optimal procedure in low-risk pregnancies at due date , by means of a prospect i ve r and omised trial . In 345 women with a favourable cervical score , labour was either induced by means of intravaginal application of tablets containing PGE2 according to a precise plan , or spontaneous onset of labour was awaited while CTG-controls were performed on an outpatient basis every second day until the 42nd week of pregnancy was completed . 80 per cent of the nulliparas and 96.3 per cent of the multiparas of the induction group delivered within 24 hours of the first tablet application . All pertinent delivery intervals were significantly shorter in this group compared to those women where spontaneous onset of labour was awaited . The incidence of prolonged labour was low in both groups and not significantly different . Only 4.2 per cent of the women in the group where spontaneous labour was awaited , reached the completed 42nd week of pregnancy . Only one woman had to be induced because of a suspicious CTG . The rate of operative deliveries was lower in the induction group ( 1.1 % versus 3.8 % Caesarean sections ) . With the exception of one foetal death due to a cord complication three days after the due date the foetal outcome was excellent in both groups . The acceptance of the procedure was tested by means of a question naire during the post partum period . ( ABSTRACT TRUNCATED AT 250 WORDS Slow release prostagl and in pessary ( propess ) is compared with instant release prostagl and in gel ( prostin ) for the induction of labour in nulliparous women with a modified Bishop 's score of less than 6 . In this r and omised study 50 women received prostin gel and 45 received propess . More than one dose of prostagl and in was required to achieve amniotomy more often in the propess group ( 53 % ) compared with the prostin group ( 34 % ) ( P = 0·03 ) . Propess was unable to demonstrate any advantage over Prostin gel group . Propess was not cost-effective in this study The purpose of the study was to determine the safety and efficacy of outpatient intravaginal prostagl and in E2 ( PGE2 ) and membrane stripping in promoting labor in the uncomplicated post date pregnancy . In a double-blind placebo-controlled study , 150 enrollees were r and omized to one of four treatment groups ; group I , no membrane stripping and placebo gel ; group II , no membrane stripping and PGE2 gel ; group III , membrane stripping and placebo gel ; and group IV , membrane stripping and PGE2 gel . The treatments were administered at 287 days ( 41 weeks ) and 294 days ( 42 weeks ) of gestation , then every 3 - 4 days until 307 days ( 43 completed weeks ) of gestation . The patients in group IV had the shortest interval to delivery with a median of 1 day , P = .001 , and the fewest antenatal surveillance visits with only 21 % requiring more than one visit , P = .02 . Group I patients in comparison , had a 7-day median to delivery , and 61 % required more than one visit . The time spent in labor and delivery and the need for oxytocin augmentation was not significantly reduced in groups II , III , and IV . No adverse side effects to either mother or neonate could be directly attributed to this outpatient treatment combination . We conclude that intravaginal PGE2 gel combined with membrane stripping reduces postterm pregnancies and antenatal visits in our patients We describe a technique of administering prostagl and in E2 ( PGE2 ) in a viscous cellulose gel into the vagina to ripen the unfavourable cervix in patients requiring induction of labour . A total of 168 primigravidae were studied , of whom 102 received 2 mg PGE2 in 2 % gel and 66 received 5 mg PGE2 in 4 % gel . In the latter group , the state of the cervix was significantly improved in 58 patients ( 87.9 % ) , while 32 ( 48.5 % ) had started labour before planned induction . There were no maternal or fetal side effects or complications The purpose of this study was to determine if prostagl and in E2 ( PGE2 ) in a controlled-release vaginal insert with retrieval system can produce cervical ripening at term . This was a multicenter , double blind , r and omized , placebo-controlled study involving 206 patients with 102 receiving active agent . A successful outcome was defined as a change in Bishop score of > or = 3 , or a Bishop score of > or = 6 at 12 h or delivery within 12 h of the insert placement . Analysis was by Fisher 's exact test , Wilcoxon 's two- sample rank-sum test , and Student 's t-test where appropriate . One hundred ninety-three women completed the protocol . Initial Bishop scores were 2.6 + /- 1.2 and 2.5 + /- 1.4 in the PGE2 and placebo groups , respectively . The incidence of cesarean delivery was identical in the two groups . Uterine hyperstimulation lasted 2 - 13 min in 5 PGE2 patients ( 4.9 % ) with 1 patient requiring tocolysis . More patients in the PGE2 group had a change in Bishop score of > or = 3 ( 62 % vs. 40 % ; P = 0.002 ) , a Bishop score > or = 6 after 12 h ( 46 % vs. 34 % ; P = 0.11 ) , and vaginal delivery within 12 h ( 6.5 % vs. 1 % ; P = 0.055 ) . Sixty-five percent of PGE2 group patients had a successful outcome vs. 44 % of control patients ( P = 0.001 ) . In conclusion , when administered in a controlled-release vaginal insert with a retrieval system , PGE2 is effective in promoting cervical ripening at term Objective : To compare the efficacy and safety of a controlled release vaginal insert ( Cervidil ) with hospital compounded prostagl and in E(2 ) vaginal gel for cervical ripening before labor induction . Methods : A prospect i ve r and omized study was performed between July 1996 and August 1997 on 200 patients undergoing cervical ripening before induction of labor . The efficacy and safety of a 12-hour controlled release 10-mg vaginal insert ( Cervidil , Forest Pharmaceuticals ) was compared with two 4-mg doses of prostagl and in E(2 ) gel . Results : The study groups did not differ by parity , estimated gestational age , indications for induction , and initial Bishop scores . No differences were noted in Bishop score at 12 hours or change in Bishop score . No statistically significant differences were noted in the successful inductions , additional days of induction , and the number of patients discharged undelivered . There were no differences in mean time to active labor , cesarean section , meconium staining , 1 and 5 minute Apgar scores , cord pH values , NICU admissions , and incidence of hyperstimulation . Conclusions : Two 4-mg doses of prostagl and in vaginal gels are equally effective to a Cervidil vaginal insert for preinduction cervical ripening Summary The purpose of the trial was to determine whether a sustained release preparation of prostagl and in E2 ( Propess ) is better in inducing labour when compared with the more widely used short-acting ( instant-release ) preparation ( Prostin ) . A r and omised controlled clinical trial involving 100 pregnant women at term with an indication for induction of labour was conducted in a district general hospital in the UK over a 1-year period . Women were r and omised to receive one of the two preparations . The study revealed that there was no statistically significant difference in time to onset of labour , duration of labour , total time from induction to delivery , method of delivery , and analgesia requirements . The number of preparations required to induce labour were significantly less in the Propess group . Our data suggest that both Propess and Prostin are safe and effective in induction of labour , for either primips or multips . However , Prostin use is more cost-effective In a r and omized study , uterine activity patterns were characterized with a portable pressure-sensitive device in 40 nonlaboring women at term with an unfavorable cervix who were undergoing preinduction cervical ripening with prostagl and in E2 . The prostagl and in E2 was inserted into the posterior vaginal fornix as a single dose of either a 2.5 mg methylcellulose gel ( 20 cases ) or 10 mg controlled-release pessary ( 20 cases ) . Uterine activity monitoring began 1 hour before dosing and continued for 12 hours . For those treated with the gel , low-amplitude , high-frequency contractions began within the first hour , reached a peak within 4 hours , and initiated sustained high-amplitude contractions in 10 ( 50 % ) cases . With the controlled-release pessary , low-amplitude , high-frequency contractions had a slightly later onset , reached a peak between the fifth and eighth hours , and initiated sustained high-amplitude contractions in 18 ( 80 % ) cases . Uterine hyperstimulation occurred in two ( 10 % ) pessary cases , with no adverse effect after removal . We conclude that low-amplitude , high-frequency uterine contractions began with either method of intravaginal prostagl and in E2 delivery but led to sustained , high-amplitude contractions primarily with the pessary Prostagl and in E2 is effective for induction of labor but many preparations exist using a variety of vehicles from which the active ingredient may not be equally available . Plasma concentrations of bicyclic PGE2 metabolite ( PGEM ) and 13 , 14‐dihydro , 15‐keto PGF2α ( PGFM ) were measured following administration of a 3 mg PGE2 vaginal tablet or 1 mg PGE2 vaginal gel to twenty‐four parous women with favorable induction features , r and omly allocated to receive one or other preparation . PGEM increased rapidly following both administration of the 3 mg PGE2 vaginal tablet and the 1 mg PGE2 vaginal gel , reaching a peak within 40 minutes of PGE2 administration . The maximal rise in PGEM in the gel group correlated directly with the change in cervical score and inversely with the need for augmentation with oxytocin and the induction‐delivery interval . A secondary rise in PGFM was noted in both groups 3–4 hours following PGE2 administration . The magnitude of the increase in PGE2 may be important in the clinical response to PGE2 administration , while PGE2 absorption may switch‐on endogenous PGF2 , production , similar to what is seen in spontaneous labor Plasma levels of bicyclic PGE2 ( PGE2 M ) were measured after administration of a 5 mg , PGE2 slow release hydrogel pessary and a 3 mg vaginal tablet ( Upjohn ) . Twenty-four women of low parity with favourable induction features were r and omised to receive either the hydrogel pessary or the vaginal tablet . A single pessary was administered and amniotomy was performed after 4 hours . Augmentation with oxytocin was carried out after amniotomy if required . Both groups showed a rise in plasma PGE2 levels in keeping with the release profiles of the pessaries . Wide interindividual differences in absorption were found A study was conducted to compare the efficacy and safety of two methods of delivering prostagl and in E2 ( PGE2 ) as a low-dose gel delivered in up to two sequential , 2.5-mg doses and as a single-dose , controlled-release , 10-mg pessary . A cervical change was present in both groups , but a Bishop score > or = 8 occurred in more nulliparous patients in the pessary than in the gel group by 12 hours after dosing . Labor was initiated without oxytocin more frequently in the pessary than gel group for nulliparas and multiparas . Reversal of uterine hyperstimulation was possible by removal of the pessary without tocolytic therapy . The controlled-release PGE2 pessary was more effective in changing the cervix in nulliparas and in initiating labor and offered the advantage of removal when desired Methods of vaginal and extra-amniotic prostagl and in administration to achieve ripening of the cervix as a preliminary to induction of labour are described . Three groups of twenty patients with unfavourable induction features were studied , each receiving prostagl and in E2 the evening prior to planned induction . One group received PGE2 500 micrograms suspended in a viscous medium extra-amniotically . One group received PGE2 3 mg suspended in a viscous medium into the vaginal vault . A third group received a 3 mg PGE2 vaginal pessary to the posterior fornix . Improvement in cervical status at time of induction occurred in all groups but no single group had a significant advantage when regarding mean improvement , the induction-delivery interval or the number of patients in whom labour began before formal induction . However , with regard to relative cost , ease of preparation and storage , as well as patient and medical staff convenience , Prostagl and in E2 in pessary form is a superior form of administration PURPOSE To evaluate the efficacy and safety of the vaginal insertion of dinoprostone in terms of achieving cervical ripening , shortening the length of labor , and lowering the cesarean delivery rate for term pregnancies complicated with premature rupture of membranes . METHODS A prospect i ve , r and omized , controlled trial enrolled 100 women with term pregnancies complicated with premature rupture of membranes . Each had a normal non stress test , unscarred uterus , a singleton pregnancy with cephalic presentation , and a Bishop score of less than 4 . Patients were r and omized to receive a 10 mg dinoprostone vaginal insert single dose or no medication . After cervical ripening , oxytocin induction was performed during labor for both the study and control group . Cervical ripening in the 12th hour , total delivery time and delivery mode were compared between the two groups . RESULTS More often cervical ripening was obtained in the study group women who used dinoprostone vaginal inserts compared to the control group ( p : 0.001 ) . Latent phase of labor and total delivery time was shorter in the study group women than the control group ( p : 0.022 and p : 0.026 ) . There was no difference in terms of delivery mode and indication of section between study and control groups . CONCLUSION The use of dinoprostone vaginal inserts in patients with term pregnancy of premature rupture of membranes reduced both the latent phase of labor and total delivery time without increasing the rate of cesarean section Prostagl and in ( PG ) E2 has proven effective in many studies as a pie-induction agent for cervical ripening . The purpose of this study was to compare the efficacy of a 5-mg dose of PGE2 prepared gel with that of a quartered PGE2 20-mg suppository . Previous studies have documented uniform distribution of PGE2 in the suppository . After 90 patients entered the study , there appeared to be an unacceptable rate of hyperstimulation following the induction dose using the suppository . The study was discontinued , and data analysis revealed a 24 % hyperstimulation rate with the quartered suppository versus 0 % with the gel . The successful vaginal delivery rates were equivalent , at 75 % for the gel and 66 % for the suppository . The 5-mg quartered suppository appeared to initiate an unacceptable amount of uterine activity , much greater than with the 5-mg gel dose Objective To compare the outcome of induction of labour using a single versus two doses of prostagl and in E2 vaginal gel Cervical ripening prior to oxytocin stimulation is highly desirable to ensure a successful induction . Prostagl and in E2 has been administered by intracervical , intravaginal and extra-amniotic routes with successful ripening of the cervix . The dose of PGE2 administered is under investigation . Use of 3 or 4 mg of PGE2 , although effective , has been reported to be accompanied by uterine hypertonus or fetal heart changes . Lower dose of PGE2 at 0.2 mg and 0.4 mg do not have the above-mentioned side effects but necessitate multiple applications . This r and omized double-blinded study incorporated the use of 2 mg of PGE2 administered by intravaginal route in a hydroxyethyl cellulose gel medium . A significant increase in Bishop score ( 40 % higher ) was achieved in patients receiving PGE2 as compared to placebo patients . There were no adverse side effects , indicating application of 2 mg of PGE2 as a safe method of cervical ripening prior to induction of labor Summary : A r and omised double‐blind trial involving 90 patients was set up to compare the efficacy of 25 mg PG F2α , 50 mg PG F2α and a placebo on cervical ripening when given in a vaginal tylose gel on the evening before surgical induction of labour . Preliminary stretching of the cervix and sweeping of the fetal membranes was not undertaken . In the 30 control patients , labour was not initiated and the mean improvement in the cervical score before surgical induction the next morning was 0.86 . In the group of 30 patients receiving 25 mg PG F2α , labour commenced during the night in 9 patients and the mean improvement in the cervical score was 3.76 ( P < 0.0005 ) ; the corresponding figures for the 30 patients receiving 50 mg of PG F2α were 10 patients coming into labour and cervical score improvement of 4.63 ( P < 0.0005 ) . he difference in the mean improvement of the cervical score between the 2 prostagl and in groups was not significant . Significantly fewer prostagl and in‐treated patients needed augmentation during labour with intravenous oxytocin ( P < 0.025 ) and there was a significant increase in the spontaneous delivery rate in the combined prostagl and in‐treated group ( P < 0.025 ) . There was no statistical difference in the outcome of labour between the 2 prostagl and in groups . It was not possible to predict the patients whose cervices would not respond to PG F2α pretreatment ( 15 % ) or those in whom labour would be initiated ( 30 % ) . No side effects were experienced OBJECTIVE To compare the effectiveness and safety of 2.5 vs. 5.0 mg of prostagl and in E2 ( PGE2 ) gel for preinduction cervical ripening . STUDY DESIGN Patients presenting for induction of labor with an unfavorable Bishop score ( < or 4 ) were assigned r and omly , in a double-blind manner , to receive either 2.5 or 5.0 mg of PGE2 gel intravaginally . A repeat Bishop score was determined in four to six hours , and if the score was still unfavorable , the same dose of gel was administered a second time . All patients returned within 12 hours for induction of labor . RESULTS A total of 119 patients received PGE2 gel , 55 in the 2.5-mg group and 64 in the 5.0-mg group . Both groups were similar with respect to age , parity , race , indication for induction and preinduction Bishop score . Both doses of PGE2 gel were safe and effective . The need for additional doses of gel , the need for and duration of oxytocin use , and the duration of labor were similar in both groups . More infants whose mothers received the 5.0-mg dose had one-minute Apgar scores < 7 ( P = .027 ) . No significant difference in five-minute Apgar scores was noted . Cesarean delivery for failed induction was uncommon , occurring in 3.6 % of patients who received 2.5 mg and in 4.7 % of patients who received 5.0 mg of PGE2 gel ( P = NS ) . Finally , the incidence of hyperstimulation was 3.6 % in the 2.5-mg group and 1.6 % in the 5.0-mg group ( P = NS ) . CONCLUSION A 5-mg dose of PGE2 gel was neither more effective nor associated with more side effects than the more commonly used 2.5-mg dose A group of 84 women at 39 - 43 weeks of pregnancy were r and omly allocated to a blind trial of induction of labor with vaginal suppositories containing inert material or either 0.2 mg or 0.4 mg of prostagl and in E2 . The suppositories were self-administered every two hours during waking hours on two successive days until labor started or 15 had been used . Side-effects were absent . Labor was established within 48 hr of insertion of the first suppository in 9.3 % of control patients , 65.4 % of those treated with 0.2 mg PGE2 and 85.7 % of those treated with 0.4 mg PGE2 . The mean Apgar scores in the three groups were the same . The mean total dose of PGE2 were 2.0 mg ( 0.2 mg group ) and 2.3 mg ( 0.4 mg group ) . It is concluded that vaginal PGE2 is an effective and acceptable method of inducing labor at term Ripening of the cervix by intravaginal application of a prostagl and in-containing gel is evaluated . Thirty patients with an unfavorable cervix needing labor induction were studied in a double-blind , prospect i ve fashion . The prostagl and in gel proved superior to placebo in ripening the cervix ( P<.05 ) , reducing induction failures ( P<.025 ) , diminishing the oxytocin dosage necessary for induction ( P<.05 ) , and lowering the rate of cesarean section ( .05<P<.1 ) . One hundred fifty additional patients with varying Bishop scores and differing clinical situations were also studied . There were 35 cesarean sections ( 23.3 % ) , nine failed inductions ( 6 % ) , a spontaneous labor rate of 46 % , and an average Bishop score change of 2.5 . Twenty patients with premature rupture of the membranes and an unfavorable cervix received a modified gel containing 2.5 mg of prostagl and in E2 . Average Bishop score change was 2.9 , and there was a 55 % incidence of spontaneous labor Prostagl and in E2 tablets administered vaginally succesfully induced labour in 64 % of patients . There were no maternal or fetal complications . Comparison of the Bishop score failed to identify any factors which significantly influenced the success rate A single , endocervical application of a new commercial preparation of prostagl and in E2 ( PGE2 ) gel , 0.5 mg of PGE2 in 2.5 ml ( 3 g ) , was evaluated for preinduction cervical softening . Safety and efficacy were assessed in a comparison with a 2.0 mg PGE2 vaginal tablet and placebo in normal nulliparous women at term , with low Bishop scores . Treatment was administered in r and omized , double blind fashion . Overall success , defined as a progression in Bishop score of at least 3 points within 12 hours , was achieved in 22/40 ( 55 % ) of the gel group , 15/41 ( 37 % ) in the tablet treated women , and 8/40 ( 20 % ) in those receiving placebo . Of interest was the observation that of women with very unfavorable induction features ( Bishop score 0 - 2 ) , the cervical gel treatment result ed in a 6/8 ( 75 % ) success rate compared with 2/13 ( 15 % ) success for the vaginal tablet and 0/17 ( 0 % ) for placebo . In as much as a very low incidence of side effects accompanied this treatment scheme , exp and ed multi-center testing is recommended Objective . To compare pain associated with vaginal dinoprostone pessary vs. gel for induction of labor in women with an unfavorable cervix . Study design . A r and omized controlled trial in a large academic public general hospital . A total of 52 nulliparous women of gestational age ≥38 weeks , with Bishop score ≤4 and intact membranes were allocated either to a controlled-release vaginal dinoprostone pessary or repeat doses of vaginal dinoprostone gel . Pain was recorded hourly from early induction until the onset of labor . Results . Mean pain experienced by women belonging to the two groups differed significantly ( p < 0.01 ) . Women in the controlled-release device group were also significantly more often severe pain-free than women receiving gel ( p < 0.05 ) . Both methods had similar rates of oxytocin infusion and vaginal deliveries . Conclusions . The two induction procedures should be considered equivalent as far as ripening the cervix and initiating labor . In view of this finding , the low Bishop score should be considered an indication to prefer the controlled-release device , since it reduces pain thereby improving the physical and emotional wellbeing of the parturient Fifty-four patients were r and omized in a double blind fashion into either a placebo group or a group treated with a 3 mg dose of an intravaginal prostagl and in E2 gel . The group receiving the prostagl and in E2 gel had a mean change in cervical score of 2.7 while the patients in the placebo group had no significant change . Even though a significantly higher number of patients in the prostagl and in group went into spontaneous labor , the incidence of cesarean section was not different between the two groups . Upon comparing the conflicting reports of various studies on the subject , it is concluded that the method of product preparation , particularly the source of prostagl and in E2 utilized and the choice of drug vehicle , may be important variables in determining treatment success , as measured in terms of decreased cesarean section rate A prospect i ve trial was conducted to compare the effects of conservative management of prolonged pregnancy ( conservative group ) with routine induction of labour at 42 weeks ' gestation ( active group ) in otherwise uncomplicated pregnancies . Of the 402 pregnancies studied , 207 ( 51 % ) were allocated to conservative management and 195 ( 49 % ) were allocated to have labour induced . The groups were well matched for age , parity , and smoking habits . One hundred and sixty six ( 80 % ) of the patients in the conservative group went into spontaneous labour . Of the remainder , two underwent elective caesarean section , 19 had labour induced because of clinical concern , and the remaining 20 had labour induced at the patient 's own request . One hundred and twenty five ( 64 % ) of the patients in the planned active group underwent induction of labour . Of the remaining 70 , 49 went into spontaneous labour and 21 ( 11 % ) asked that they should not have labour induced . Comparison of the two groups showed no difference in the length of the first stage of labour but a trend towards an increased need for intervention for fetal distress ( p less than 0.06 ) in the active group . There were no differences in the length of the second stage , the need for intervention , or the mode of delivery . In terms of Apgar scores the neonatal outcome was not significantly different between the two groups , but a greater proportion of the babies ( 15 % v 8 % ) in the active group required intubation . Umbilical cord venous pH estimated in the last 183 consecutive deliveries in the study showed a significantly lower mean value in the active group ( p less than 0.05 ) . There was no difference in birth weight between the two groups . Two deaths occurred in the study . There was a stillbirth in the conservative group at 292 days after massive abruption , and one neonatal death in the active group owing to multiple congenital abnormalities . The outcome for mother and baby in patients from both groups who went into spontaneous labour was generally good . The outcome for patients for whom conservative management was planned but induction became necessary was no different from that of patients who underwent planned induction at term . Thus from our results we can find no evidence to support the view that women with normal prolonged pregnancy should undergo routine induction of labour at 42 weeks ' gestation Objective : To evaluate the effects of prostagl and in ( PG ) E2 , given for induction of labor at term , on fetal breathing and body movements . Methods : Eighteen women with term pregnancies , mild gestational hypertension , intact membranes , and unripe cervices who were not in labor participated in this study . After a 60-minute baseline ultrasound examination of fetal chest and body movements , recorded on videotape , the patients were r and omly assigned to either 3 mg intravaginal PGE2 tablets or controls ( placebo intravaginal tablets ) . Following tablet insertion and a 3-hour observation time , a second 60-minute ultrasound recording of fetal movements was taped . The videotape recordings were interpreted according to the total amount of time occupied by fetal body movements and fetal breathing movements . Results : There was a total of 2180 minutes of ultrasound tape recordings , with 136.2 minutes of fetal body movements ( 6.2 % ) and 207.8 minutes of fetal breathing movements ( 9.5 % ) . Mean ( ± st and ard deviation ) observation times per patient before and after tablet insertion were 60.3 ± 1.2 and 56.4 ± 1.2 minutes for the PGE2 group and 60.1 ± 1.3 and 60.4 ± 1.1 minutes for the control group . Three hours after PGE2 insertion , there were significant decreases in the percentage of time occupied by body movements ( 7.8 ± 3.1 versus 3.4 ± 2.0 % ; P<.003 ) and breathing movements ( 10.6 ± 8.6 versus 3.9 ± 2.3 % ; P<.007 ) . Three hours after tablet insertion , there were statistically significant decreases in the percentage of time occupied by body movements ( P<.025 ) and breathing movements ( P<.01 ) between the control and study groups . Conclusion : Induction of labor with intravaginal PGE2 tablets inhibits fetal body and breathing movements . The effects could be due to direct action on the fetus or indirect effects of PGE2 ( through uterine contraction and /or endogenous PG ) A prospect i ve , r and omized , double-blind , placebo-controlled study was undertaken to evaluate the safety and efficacy of a 3-mg prostagl and in E2 ( PGE2 ) vaginal suppository for the initiation of cervical ripening before the induction of labor . All patients were required to have an initial Bishop score of 4 or less . The 3-mg PGE2 vaginal suppository was found to be an effective method of both cervical ripening and labor induction . Its use result ed in a highly significant improvement in the mean Bishop score compared with the placebo group ( 2.67 versus 0.55 points , P<.00005 ) . Its use also result ed in a significant reduction in the number of failed inductions ( 5 versus 23 % , P<.0005 ) . Moreover , 68 % of the patients treated with PGE2 labored after initial suppository placement , and 42 % of these patients never required oxytocin augmentation of labor . However , there were three instances of uterine hyperstimulation/ hypertonus following placement of the 3-mg PGE2 suppository , suggesting that perhaps a lower dose of PGE2 would improve its safety as a ripening agent without affecting its efficacy Objective To compare the efficacy within 24 hours of a three‐times‐a‐day intensive dosing regimen with a st and ard once daily dosing regimen using dinoprostone vaginal pessary in preinduction cervical priming Objective To determine whether the use of a prostagl and in ( PG ) E2 3-mg pessary followed by a delay of 12 hours before stimulation of labor with oxytocin improves obstetric outcome compared with the use of a placebo pessary . Methods One hundred fifty-five nulliparas at term with poor cervical scores ( modified Bishop score below 6 of 10 ) and premature rupture of membranes ( PROM ) were recruited for this double-blind , placebo-controlled r and omized trial . On admission to the study , either a PGE2 pessary or an identical-appearing placebo pessary was inserted into the posterior fornix . If labor did not start in the next 12 hours or if symptoms and signs of infection were evident , labor was induced with oxytocin infusion . Assignment was unblinded at the end of the study , and details of the labor and maternal and neonatal outcome in women who received a PG pessary were compared with those who received a placebo pessary . Results Women receiving a PG pessary were significantly less likely to require stimulation of labor at the end of 12 hours than were those given a placebo pessary ( 37 versus 58 % , P = .002 ) . The mean time between admission to study and delivery was significantly shorter in the PG group compared with the placebo group ( 15 versus 19 hours , P = .01 ) . The rate of cesarean delivery was not statistically different in the two groups ( 13.9 % with PG versus 15.8 % with placebo ) . Conclusion In nulliparas with poor cervical scores who present with PROM at term and no evidence of infection or obstetric complications , use of a PGE2 pessary result ed in more women establishing labor earlier , with a result ant reduction in the admission-to-delivery interval , compared with the use of a placebo pessary . The cesarean delivery rates in the two groups were similar , and there were no significant differences in neonatal outcome Abstract . A study was planned to evaluate the effect of Prostagl and in E2 pessaries in three different dosages in ripening the unfavourable cervix prior to the induction of labor Summary A r and omised controlled trial was conducted to compare the clinical efficacy and cost-effectiveness of Dinoprostone Slow Release Pessary ( Propess ) with Gel ( Prostin ) for induction of labour ( IOL ) at term . A total of 120 women requiring IOL at term with no previous uterine surgery and no contraindication to prostagl and ins were included . The main outcome measures were efficacy of drug preparations , patient satisfaction and the cost-effectiveness . The secondary outcome measures noted were maternal complications during the labour , type of delivery , the neonate 's Apgar scores at birth and 5 min and incidence of significant morbidities . There were insignificant differences between the two groups in induction-to-delivery interval , mode of delivery , number of women delivering within 24 h and neonatal outcomes . However , the number of vaginal examinations was significantly lower in the Propess group . Propess was found to be more cost effective compared with Prostin in view of single dose and less midwifery hours |
11,560 | 28,329,831 | Research ers reported racial/ethnic minorities were more likely to refuse vaccinations and less likely to have vaccinations offered and their vaccination status tracked compared to Whites . | This systematic review analyzes research examining racial/ethnic disparities in influenza and pneumococcal vaccination coverage between White and racial/ethnic minority ( Black and Hispanic ) nursing home residents . | OBJECTIVES Known disparities in pneumococcal vaccination in the community raise the question of whether disparities also exist in the nursing home setting , which is better controlled . This study used nationally representative nursing home data to compare black and white nursing home residents with respect to receiving , not receiving , or having an unknown PPV vaccination status , and to examine the interaction of race with various facility characteristics . DESIGN Multinomial logistic regression was used to analyze a 2-year merged file ( 1997 and 1999 ) of the National Nursing Home Survey , a cross-sectional national probability sample of nursing homes and residents . SETTING AND PARTICIPANTS Residents 65 years or older ( n = 14,782 ) residing in nursing homes between July and December of 1997 or 1999 . MEASUREMENTS Record-based staff report of whether residents ever had a pneumococcal immunization ( yes/no/unknown ) ; race measured as black or white . RESULTS Pneumococcal vaccination rates are lower for black nursing home residents than for white residents , as shown using a merged file of the 1997 and 1999 National Nursing Home Surveys . Participants include 14,303 r and omly sample d residents 65 years or older . In this sample , 31 % of black residents compared with 24 % of white residents 65 years or older had never received pneumococcal vaccination ( P < .01 ) . Multivariate logistic regression confirmed that blacks were more likely to be unimmunized than whites ( 95 % CIs ) , specifically in Medicaid-only facilities and dually certified Medicare and Medicaid facilities . Blacks also had higher odds of unknown vaccination status than whites in Medicaid-only facilities and lower odds of unknown status in government-owned facilities . CONCLUSIONS Results suggest that the racial difference in pneumococcal vaccination exists predominantly in certain facility types . In addition , facility-based interventions such as having an organized PPV immunization program or improving documentation of vaccination status can be effective in increasing vaccination rates for all races OBJECTIVE To examine the effects of the racial composition of residents on nursing homes ' financial and quality performance . The study examined Medicare and Medicaid-certified nursing homes across the United States that su bmi tted Medicare cost reports between the years 1999 and 2004 ( 11,472 average per year ) . DATA SOURCE Data were obtained from the Minimum Data Set , the On-Line Survey Certification and Reporting , Medicare Cost Reports , and the Area Re source File . STUDY DESIGN Panel data regression with r and om intercepts and negative binomial regression were conducted with state and year fixed effects . PRINCIPAL FINDINGS Financial and quality performance differed between nursing homes with high proportions of black residents and nursing homes with no or medium proportions of black residents . Nursing homes with no black residents had higher revenues and higher operating margins and total profit margins and they exhibited better processes and outcomes than nursing homes with high proportions of black residents . CONCLUSION Nursing homes ' financial viability and quality of care are influenced by the racial composition of residents . Policy makers should consider initiatives to improve both the financial and quality performance of nursing homes serving predominantly black residents 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 Influenza vaccination coverage among nursing home residents has consistently been reported well below the Healthy People goals . We sought to determine if st and ing order programs ( SOPs ) in long-term care facilities are associated with greater influenza vaccination coverage among residents . METHODS The National Nursing Home Survey ( 2004 ) is cross-sectional . A total of 1152 US long-term care facilities were systematic ally sample d with probability proportional to number of beds . A total of 11,939 people aged 65 years or older residing in sample d long-term care facilities between August and December 2004 were r and omly sample d. Influenza vaccination coverage of residents was obtained from facility records . Facility 's immunization program included st and ing orders versus other ( preprinted admission order , advance physician order , personal physician order , and no program ) . Multinomial logistic regression was used to examine the relationship between type of influenza immunization program and receipt of vaccination , adjusted for resident and facility confounders . RESULTS The proportion of residents aged 65 years or older who received influenza vaccination was 64 % ; 41 % of residents lived in a facility with an SOP . Influenza vaccination coverage among residents residing in facilities with st and ing orders was 68 % compared with 59 % to 63 % of residents in facilities with other program types . Logistic regression showed that st and ing order programs were independently associated with greater influenza vaccination coverage ( 66.7 % versus 62.0 % , P < .01 ) . CONCLUSION This study indicates that residents in long-term care facilities having st and ing order programs for influenza were more likely to be immunized . More research needs to be done to underst and how to facilitate adoption of these programs OBJECTIVE To evaluate collaborative efforts and intervention strategies by peer- review organizations ( PROs ) and long-term-care facilities ( LTCFs ) for improving pneumococcal vaccination rates among residents of LTCFs . DESIGN Prospect i ve , before-after quality improvement project . SETTING 133 LTCFs in Alaska , Idaho , Montana , and Wyoming . PATIENTS All residents of participating LTCFs . METHODS Baseline pneumococcal vaccination rates were determined by medical-record review , self-reporting by patient or family members , and review of Medicare cl aims information . Remeasurement of vaccination rates was accomplished from documentation of vaccination of eligible residents by each LTCF . RESULTS 133 LTCFs with 7,623 residents from Alaska , Idaho , Montana , and Wyoming participated in this quality -improvement project . This accounted for 41 % ( 133/321 ) of the potential nursing homes and resident population in the participating states . Baseline overall vaccination rates were 40 % ( 3,050/7,589 ) . The overall vaccination rate improved to 75 % ( 5,720/7,623 , P<.001 ) . The number of facilities meeting the Healthy People 2000 vaccination goal of 80 % improved from 18 % ( 24/133 ) to 62 % ( 83/133 , P<.001 ) . Initial use of chart stickers and implementation of st and ing orders led to similar increases in vaccination rates , but the st and ing-order strategy required commitment of fewer PRO re sources at a statewide level . Remeasurement of vaccination rates in a subset of participating Idaho LTCFs 1 year after initial vaccination efforts demonstrated a sustained vaccination rate of 70 % in facilities enforcing a st and ing-order policy . CONCLUSIONS Simple and straightforward vaccination strategies implemented in LTCFs over a short period of time can have a significant impact on vaccination rates . Collaborative efforts between state PROs and LTCFs enhance implementation of these strategies and can result in the achievement of national vaccination objectives . St and ing orders appear to be one intervention effective in sustaining successful vaccination efforts . Regardless of the specific interventions employed , PROs played a significant role in facilitating vaccination program development and intervention implementation OBJECTIVES To assess Advisory Committee for Immunization Practice s recommendations for the pneumococcal vaccine in nursing home residents using national surveys to examine factors associated with vaccination . DESIGN Cross-sectional national sample surveys of nursing homes and nursing home residents with a two-stage probability design , stratified on size and Medicare and Medicaid certification status . SETTING U.S. nursing homes during 1995 , 1997 , and 1999 . PARTICIPANTS Six current residents were r and omly selected from each facility ( n = approximately 8,000 each year ) . MEASUREMENTS Residents ' pneumococcal vaccination status was obtained by asking the facility respondent for each resident : " Has [ the resident ] EVER had a pneumococcal vaccine , that is a pneumonia vaccination ? " Vaccination status was coded as yes , no , and unknown . RESULTS The proportion of residents aged 65 and older that received pneumococcal vaccination increased significantly , from 23.6 % in 1995 to 28.2 % in 1997 to 37.4 % in 1999 ( P<.001 ) . The proportion of residents in homes with pneumococcal immunization programs increased significantly , from 65.2 % in 1995 to 88.9 % in 1999 . CONCLUSION The proportion of nursing home residents aged 65 and older receiving the pneumococcal vaccine increased significantly from 1995 to 1999 . Residents living in nursing homes with programs for pneumococcal immunizations were significantly more likely to be vaccinated OBJECTIVE To identify nursing home resident and facility characteristics associated with patients not receiving influenza immunization and having unknown immunization status . DESIGN Secondary data analysis using multinomial logistic regression of data from the National Nursing Home Survey , a nationally representative establishment-based survey . SETTING A total of 1,423 nursing facilities of all ownerships and certifications systematic ally sample d with probability proportional to number of beds . PATIENTS A total of 7,350 r and omly sample d people aged 65 years or older residing in nursing homes between July and December 1999 ( approximately 6 per facility ) . MAIN OUTCOME MEASURE Immunization status of residents . RESULTS Fifteen percent of residents were not immunized and 19 % had unknown immunization status . In multivariate analysis , lack of immunization and unknown immunization status were each separately associated with being newly admitted , with no or unknown pneumococcal immunization , and with facility failures to screen for immunization and to record inoculation in the medical record . High-risk status and staff immunization requirements had no effect . Separate analyses showed that residents with unknown immunization status are statistically significantly different from both those vaccinated and those not vaccinated . CONCLUSION This study indicates that both resident and facility characteristics are associated with failure to be immunized for influenza . Facilities should consider targeting younger , newly admitted , and residential care residents for influenza immunization , since they are more likely to be missed . Further research into the barriers to immunization specific to nursing home resident choice or opportunity may be warranted OBJECTIVES To determine whether the racial inequity between African Americans and Caucasians in receipt of influenza vaccine is narrower in residents of nursing homes with facility-wide vaccination strategies than in residents of facilities without vaccination strategies . DESIGN Secondary data analysis using the National Nursing Home Survey 2004 , a nationally representative survey . SETTING One thous and one hundred seventy-four participating nursing homes sample d systematic ally with probability proportional to bed size . PARTICIPANTS Thirteen thous and five hundred seven r and omly sample d residents of nursing homes between August and December 2004 . MEASUREMENTS Receipt of influenza vaccine within the last year . Logistic regression was used to examine the relationship between facility-level influenza immunization strategy and racial inequity in receipt of vaccination , adjusted for characteristics at the resident , facility , state , and regional levels . RESULTS Overall in the United States , vaccination coverage was higher for Caucasian and African-American residents ; the racial vaccination gaps were smaller ( < 6 percentage points ) and nonsignificant in residents of homes with st and ing orders for influenza vaccinations ( P=.14 ) , verbal consent allowed for vaccinations(P=.39 ) , and routine review of facility-wide vaccination rates ( P=.61 ) than for residents of homes without these strategies . The racial vaccination gap in residents of homes without these strategies were two to three times as high ( P=.009 , P=.002 , and P=.002 , respectively ) . CONCLUSION The presence of several immunization strategies in nursing homes is associated with higher vaccination coverage for Caucasian and African-American residents , narrowing the national vaccination racial gap The US Center for Medicare and Medicaid Services ( CMS ) requires nursing homes and long-term-care facilities to document residents ' vaccination status on the Resident Assessment Instrument ( RAI ) . Vaccinating residents can prevent costly hospital admissions and deaths . CMS and public health officials use RAI data to measure vaccination rates in long-term-care residents and assess the quality of care in nursing homes . We assessed the accuracy of RAI data against medical records in 39 nursing homes in Florida , Georgia , and Wisconsin . We r and omly sample d residents in each home during the 2010 - 2011 and 2011 - 2012 influenza seasons . We collected data on receipt of influenza vaccination from charts and RAI data . Our final sample included 840 medical charts with matched RAI records . The agreement rate was 0·86 . Using the chart as a gold st and ard , the sensitivity of the RAI with respect to influenza vaccination was 85 % and the specificity was 77 % . Agreement rates varied within facilities from 55 % to 100 % . Monitoring vaccination rates in the population is important for gauging the impact of programmes and policies to promote adherence to vaccination recommendations . Use of data from RAIs is a reasonable approach for gauging influenza vaccination rates in nursing-home residents |
11,561 | 16,437,473 | Compared with placebo , a St and ard Chinese herbal formula , individualised Chinese herbal medicine , STW 5 and STW 5-II , Tibetan herbal medicine Padma Lax , traditional Chinese formula Tongxie Yaofang , and Ayurvedic preparation showed significantly improvement of global symptoms .
Some herbal medicines may improve the symptoms of irritable bowel syndrome . | BACKGROUND Traditional herbal therapies have been used for a long time to treat gastrointestinal disorders including irritable bowel syndrome , and their effectiveness from clinical research evidence needs to be systematic ally review ed .
OBJECTIVES To assess the effectiveness and safety of herbal medicines in patients with irritable bowel syndrome . | CONTEXT Irritable bowel syndrome ( IBS ) is a common functional bowel disorder for which there is no reliable medical treatment . OBJECTIVE To determine whether Chinese herbal medicine ( CHM ) is of any benefit in the treatment of IBS . DESIGN R and omized , double-blind , placebo-controlled trial conducted during 1996 through 1997 . SETTING Patients were recruited through 2 teaching hospitals and 5 private practice s of gastroenterologists , and received CHM in 3 Chinese herbal clinics . PATIENTS A total of 116 patients who fulfilled the Rome criteria , an established st and ard for diagnosis of IBS . INTERVENTION Patients were r and omly allocated to 1 of 3 treatment groups : individualized Chinese herbal formulations ( n = 38 ) , a st and ard Chinese herbal formulation ( n = 43 ) , or placebo ( n = 35 ) . Patients received 5 capsules 3 times daily for 16 weeks and were evaluated regularly by a traditional Chinese herbalist and by a gastroenterologist . Patients , gastroenterologists , and herbalists were all blinded to treatment group . MAIN OUTCOME MEASURES Change in total bowel symptom scale scores and global improvement assessed by patients and gastroenterologists and change in the degree of interference in life caused by IBS symptoms assessed by patients . RESULTS Compared with patients in the placebo group , patients in the active treatment groups ( st and ard and individualized CHM ) had significant improvement in bowel symptom scores as rated by patients ( P=.03 ) and by gastroenterologists ( P=.001 ) , and significant global improvement as rated by patients ( P=.007 ) and by gastroenterologists ( P=.002 ) . Patients reported that treatment significantly reduced the degree of interference with life caused by IBS symptoms ( P=.03 ) . Chinese herbal formulations individually tailored to the patient proved no more effective than st and ard CHM treatment . On follow-up 14 weeks after completion of treatment , only the individualized CHM treatment group maintained improvement . CONCLUSION Chinese herbal formulations appear to offer improvement in symptoms for some patients with IBS CONTEXT A prior national survey documented the high prevalence and costs of alternative medicine use in the United States in 1990 . OBJECTIVE To document trends in alternative medicine use in the United States between 1990 and 1997 . DESIGN Nationally representative r and om household telephone surveys using comparable key questions were conducted in 1991 and 1997 measuring utilization in 1990 and 1997 , respectively . PARTICIPANTS A total of 1539 adults in 1991 and 2055 in 1997 . MAIN OUTCOMES MEASURES Prevalence , estimated costs , and disclosure of alternative therapies to physicians . RESULTS Use of at least 1 of 16 alternative therapies during the previous year increased from 33.8 % in 1990 to 42.1 % in 1997 ( P < or = .001 ) . The therapies increasing the most included herbal medicine , massage , megavitamins , self-help groups , folk remedies , energy healing , and homeopathy . The probability of users visiting an alternative medicine practitioner increased from 36.3 % to 46.3 % ( P = .002 ) . In both surveys alternative therapies were used most frequently for chronic conditions , including back problems , anxiety , depression , and headaches . There was no significant change in disclosure rates between the 2 survey years ; 39.8 % of alternative therapies were disclosed to physicians in 1990 vs 38.5 % in 1997 . The percentage of users paying entirely out-of-pocket for services provided by alternative medicine practitioners did not change significantly between 1990 ( 64.0 % ) and 1997 ( 58.3 % ) ( P=.36 ) . Extrapolations to the US population suggest a 47.3 % increase in total visits to alternative medicine practitioners , from 427 million in 1990 to 629 million in 1997 , thereby exceeding total visits to all US primary care physicians . An estimated 15 million adults in 1997 took prescription medications concurrently with herbal remedies and /or high-dose vitamins ( 18.4 % of all prescription users ) . Estimated expenditures for alternative medicine professional services increased 45.2 % between 1990 and 1997 and were conservatively estimated at $ 21.2 billion in 1997 , with at least $ 12.2 billion paid out-of-pocket . This exceeds the 1997 out-of-pocket expenditures for all US hospitalizations . Total 1997 out-of-pocket expenditures relating to alternative therapies were conservatively estimated at $ 27.0 billion , which is comparable with the projected 1997 out-of-pocket expenditures for all US physician services . CONCLUSIONS Alternative medicine use and expenditures increased substantially between 1990 and 1997 , attributable primarily to an increase in the proportion of the population seeking alternative therapies , rather than increased visits per patient OBJECTIVE To determine whether clinical trials originating in certain countries always have positive results . DATA SOURCES Abstract s of trials from Medline ( January 1966-June 1995 ) . STUDY SELECTION Two separate studies were conducted . The first included trials in which the clinical outcome of a group of subjects receiving acupuncture was compared to that of a group receiving placebo , no treatment , or a nonacupuncture intervention . In the second study , r and omized or controlled trials of interventions other than acupuncture that were published in China , Japan , Russia/USSR , or Taiwan were compared to those published in Engl and . DATA EXTRACTION Blinded review ers determined inclusion and outcome and separately classified each trial by country of origin . DATA SYNTHESIS In the study of acupuncture trials , 252 of 1085 abstract s met the inclusion criteria . Research conducted in certain countries was uniformly favorable to acupuncture ; all trials originating in China , Japan , Hong Kong , and Taiwan were positive , as were 10 out of 11 of those published in Russia/USSR . In studies that examined interventions other than acupuncture , 405 of 1100 abstract s met the inclusion criteria . Of trials published in Engl and , 75 % gave the test treatment as superior to control . The results for China , Japan , Russia/USSR , and Taiwan were 99 % , 89 % , 97 % , and 95 % , respectively . No trial published in China or Russia/USSR found a test treatment to be ineffective . CONCLUSIONS Some countries publish unusually high proportions of positive results . Publication bias is a possible explanation . Research ers undertaking systematic review s should consider carefully how to manage data from these countries The effects of prokinetic treatment with cisapride in patients with constipation-predominant irritable bowel syndrome ( IBS ) were evaluated in a r and omized , double-blind , placebo-controlled study . Sixty-nine IBS patients were assigned to a 12-week treatment with either 5 mg cisapride or placebo t.i.d . ; this dosage could be changed if necessary . The mean weekly number of days on which a stool was passed in the cisapride and placebo group increased to 5.3 and 4.4 ( p less than 0.05 ) during weeks 8 - 12 of treatment , and the number of days with stools of normal consistency increased to 3.5 and 1.9 ( p less than 0.05 ) , respectively . At week 12 , the reduction in severity and frequency scores for abdominal pain was significantly greater ( p less than or equal to 0.05 ) in the cisapride group ( 60 and 61 % ) than in the placebo group ( 40 and 32 % ) , as it was for abdominal distension ( p less than 0.05 ) . Cisapride tended to be better than placebo in diminishing flatulence . In 71 % versus 39 % of the patients the overall rating for the response to treatment was good or excellent at week 12 . Cisapride was well tolerated . These results suggest that the drug will be useful for the management of constipation-predominant IBS BACKGROUND Irritable bowel syndrome is a common cause of abdominal pain and discomfort and may be related to disordered gastrointestinal motility . Our aim was to assess the effects of long-term treatment with a prokinetic agent , cisapride , on postpr and ial jejunal motility and symptoms in the irritable bowel syndrome ( IBS ) . METHODS Thirty-eight patients with IBS ( constipation-predominant , n = 17 ; diarrhoea-predominant , n = 21 ) underwent 24-h ambulatory jejunal manometry before and after 12 week 's treatment [ cisapride , 5 mg three times daily ( n = 19 ) or placebo ( n = 19 ) ] . RESULTS In diarrhoea-predominant patients significant differences in contraction characteristics were observed between the cisapride and placebo groups . In cisapride-treated diarrhoea-predominant patients the mean contraction amplitude was higher ( 29.3 + /- 3.2 versus 24.9 + /- 2.6 mm Hg , cisapride versus placebo ( P < 0.001 ) ; pretreatment , 25.7 + /- 6.0 mm Hg ) , the mean contraction duration longer ( 3.4 + /- 0.2 versus 3.0 + /- 0.2 sec , cisapride versus placebo ( P < 0.001 ) ; pretreatment , 3.1 + /- 0.5 sec ) , and the mean contraction frequency lower ( 2.0 + /- 0.2 versus 2.5 + /- 0.4 cont./min , cisapride versus placebo ( P < 0.001 ) ; pretreatment , 2.5 + /- 1.1 cont./min ] than patients treated with placebo . No significant differences in jejunal motility were found in the constipation-predominant IBS group . Symptoms were assessed by using a visual analogue scale before and after treatment . Symptom scores relating to the severity of constipation were lower in cisapride-treated constipation-predominant IBS patients [ score , 54 + /- 5 versus 67 + /- 14 mm , cisapride versus placebo ( P < 0.05 ) ; pretreatment , 62 + /- 19 mm ] . Diarrhoea-predominant IBS patients had a higher pain score after cisapride therapy [ score , 55 + /- 15 versus 34 + /- 12 mm , cisapride versus placebo ( P < 0.05 ) ; pretreatment , 67 + /- 19 mm ] . CONCLUSION Cisapride affects jejunal contraction characteristics and some symptoms in IBS OBJECTIVE To observe the clinical efficacy of the combination of traditional Chinese medicine and western medicine in treating irritable bowel syndrome ( IBS ) and the result of intestinal flora regulation . METHODS Sixty IBS patients , 36 males and 24 females , were divided into two groups , with 30 patients in each group . Herbal formula of TongxieYaofang and clostridium butyricum ( Cb ) were used in the first group for four weeks , while only Cb was used for four weeks in the second group . We observed the changes of coliform group , enterococcus , lactobacillus , bifidobacterium after treatment . RESULTS The effective rate of the Tongxie Yaofang and Cb treated group was significantly higher than that of the Cb treated group ( P < 0.05 ) . The numbers of bifidobacterium and lactobacillus increased , while the numbers of coliform group and enterococcus decreased after the treatment , and the changes of intestinal flora in the integrative medicine treated group were significantly greater than those in the Cb treated group . CONCLUSION After treatment with the combination of traditional Chinese medicine and western medicine , the intestinal flora can be regulated to equilibrium state Background and Aims : Padma Lax , a complex Tibetan herbal formula for constipation was evaluated for safety and effectiveness in treating constipation-predominant irritable bowel syndrome in a 3-month double-blind r and omised pilot study . Methods : Patients were recruited from Hadassah Hospital ’s Gastroenterology clinic , using the Rome I Criteria for irritable bowel syndrome , and the international consensus criteria for constipation . Symptom severity was evaluated monthly by patients and gastroenterologist , using categorical and numerical rating scales . A patient diary recorded daily stool habit and trial medication . Results : In 61 patients , ( 34 Padma Lax , 27 placebo ) , significant improvement was demonstrated after 3 months in the Padma Lax group compared to placebo in constipation , severity of abdominal pain , and its effect on daily activities , incomplete evacuation , abdominal distension and flatus/flatulence . A global assessment indicated that significantly more Padma Lax patients , compared to placebo , rated the current treatment superior to previous therapies tried for irritable bowel . Laboratory parameters displayed no clinical ly significant changes . Side effects , primarily loose stools in 7 Padma Lax patients responded well to lowering treatment dosage from 2 to 1 capsule/day . Conclusions : Padma Lax is a safe and effective treatment for constipation-predominant irritable bowel syndrome and may offer an alternative to the current multi drug approach Background : Herbal medications have been used in many countries for the treatment of patients with irritable bowel syndrome . Controlled data supporting the efficacy of these treatments in patients with irritable bowel syndrome are lacking OBJECTIVE To verify the clinical efficacy and safety of the proven Chinese Compound Changjitai ( CJT ) , in treating the diarrheic irritable bowel syndrome ( DIBS ) . METHODS R and omized controlled open clinical trial design was adopted , 45 patients were r and omly divided into two groups , CJT and pinaverium bromide ( PVB ) were given as treated and control agent respectively . IBS scoring system ( BSS ) , defecation state question naire ( DSQ ) were used to record the changes of the patients ' main symptoms before and after treatment . RESULTS The total effective rate of CJT group was 83.3 % , while that of PVB was 73.3 % . CJT was superior in efficacy to that of PVB in improving stool quality , reducing defecation episodes of diarrheic patients , alleviating tenesmus symptoms , decreasing bellyache days and ameliorating abdominal distention . Any drug-related adverse reaction was not seen . CONCLUSION The efficacy of CJT in treating DIBS is definite and without any toxic and adverse effects BACKGROUND Cisapride improves symptoms in patients with idiopathic constipation . This trial compares the effect of cisapride with that of placebo in patients with irritable bowel syndrome ( IBS ) and constipation . METHODS Seventy patients were r and omized to 12 weeks ' treatment with 5 mg cisapride three times daily or placebo in a double-blind trial . The dose could be doubled after 4 weeks in patients without satisfactory improvement . The patients scored their symptoms on a 100-mm visual analogue scale ( VAS ) ( 0 = best , 100 = worst ) , and the investigators evaluated the symptomatic effect . RESULTS The dose was doubled in 17 and 23 patients in the cisapride and placebo groups , respectively , after 4 weeks . The patients ' mean VAS score for global evaluation of IBS symptoms in the cisapride and placebo groups was 73 and 71 mm , respectively , at the start of treatment and 47 and 41 mm at the end . The difference between cisapride and placebo at the end was 6 mm in favour of placebo ( 95 % confidence interval ( CI ) , -6 , 18 ) ( NS ) . The investigators evaluated the effect as good or excellent in 39.2 % and 58.8 % in the cisapride and placebo groups , respectively . The difference in favour of placebo was 19.5 % ( 95 % CI , -5 , 44 ) ( NS ) . Nor were any statistically significant differences seen between cisapride and placebo in the other effect factors . CONCLUSIONS The trial seems to exclude a clinical ly significant effect of 15 - 30 mg cisapride daily in patients with IBS and constipation during a 12-week treatment period |
11,562 | 28,182,249 | This review presents moderate- quality evidence that fixed dose LMWH reduced the incidence of recurrent thrombotic complications and occurrence of major haemorrhage during initial treatment ; and low- quality evidence that fixed dose LMWH reduced thrombus size when compared to UFH for the initial treatment of VTE .
There was no difference in overall mortality between participants treated with LMWH and those treated with UFH ( moderate- quality evidence ) . | BACKGROUND Low molecular weight heparins ( LMWHs ) have been shown to be effective and safe in preventing venous thromboembolism ( VTE ) .
They may also be effective for the initial treatment of VTE .
This is the third up date of the Cochrane Review first published in 1999 .
OBJECTIVES To evaluate the efficacy and safety of fixed dose subcutaneous low molecular weight heparin compared to adjusted dose unfractionated heparin ( intravenous or subcutaneous ) for the initial treatment of people with venous thromboembolism ( acute deep venous thrombosis or pulmonary embolism ) . | BACKGROUND Patients with acute proximal deep-vein thrombosis are usually treated first in the hospital with intravenous st and ard ( unfractionated ) heparin . However , the longer plasma half-life , better bioavailability after subcutaneous administration , and more predictable anticoagulant response of low-molecular-weight heparins make them attractive for possible home use . We compared these two approaches . METHODS Patients with acute proximal deep-vein thrombosis were r and omly assigned to receive either intravenous st and ard heparin in the hospital ( 253 patients ) or low-molecular-weight heparin ( 1 mg of enoxaparin per kilogram of body weight subcutaneously twice daily ) administered primarily at home ( 247 patients ) . The study design allowed out patients taking low-molecular-weight heparin to go home immediately and hospitalized patients taking low-molecular-weight heparin to be discharged early . All the patients received warfarin starting on the second day . RESULTS Thirteen of the 247 patients receiving low-molecular-weight heparin ( 5.3 percent ) had recurrent thromboembolism , as compared with 17 of the 253 patients receiving st and ard heparin ( 6.7 percent ; P=0.57 ; absolute difference , 1.4 percentage points ; 95 percent confidence interval , -3.0 to 5.7 ) . Five patients receiving low-molecular-weight heparin had major bleeding , as compared with three patients receiving st and ard heparin . After r and omization , the patients who received low-molecular-weight heparin spent a mean of 1.1 days in the hospital , as compared with 6.5 days for the st and ard-heparin group ; 120 patients in the low-molecular-weight- heparin group did not need to be hospitalized at all . CONCLUSIONS Low-molecular-weight heparin can be used safely and effectively to treat patients with proximal deep-vein thrombosis at home Subcutaneous body weight-adjusted low molecular weight heparin ( LMWH ) has been proven as effective and safe as intravenous aPTT-adjusted unfractionated heparin ( UFH ) for the treatment of patients with acute deep venous thrombosis ( DVT ) . In this study we evaluate the efficacy of the initial treatment of proximal DVT with a fixed-dose , body weight-independent application of the LMWH Certoparin with a six month follow-up . In a prospect i ve , multicentre , r and omized , active-controlled study 1220 patients with objective ly diagnosed proximal DVT were r and omly assigned to subcutaneous 8000 U anti-factor Xa of Certoparin twice daily for 10 to 14 days or intravenous aPTT-adjusted UFH for 5 to 8 days . Both regimen were followed by oral anticoagulation for 6 months . The primary end point was the rate of symptomatic and objective ly confirmed thromboembolic events within 6 months . The aim of the study was to demonstrate the non-inferiority of the Certoparin regimen as compared to UFH . The per- protocol analysis revealed 22 ( 3.8 % ) thromboembolic events in the Certoparin group and 24 ( 4.3 % ) in patients assigned to UFH within 6 months , thereby proving the non-inferiority ( p<0.01 ) , confirmed by intent-to-treat analysis ( p<0.001 ) . Major bleeding occurred in 6 and 7 patients started on Certoparin or UFH during the treatment period . Thromboembolic events were equally distributed in body weight categories with < 50 , 50 - 80 and > 80 kg as followed : 0 , 3.6 % and 4.1 % of patients for the Certoparin group and 0 , 4.6 % and 4.2 % of patients for the UFH group . The same was true for major bleeding complications with 0 , 2.9 % and 1.5 % for Certoparin and 0 , 3.5 % and 4.2 % for UFH . Overall mortality was 1.9 % in the Certoparin group and 2.7 % in the UFH group . Fixed-dose body weight-independent subcutaneous LMWH Certoparin is at least as efficacious and safe as intravenous aPTT-adjusted UFH for the initial treatment of acute proximal DVT . This effect is maintained during a 6-months follow-up of treatment with oral anticoagulation INTRODUCTION Trials comparing the use of full dose unfractionated heparin ( UFH ) or low molecular weight heparins ( LMWHs ) in very elderly patients with impaired renal function are lacking . IRIS aim ed to assess whether LMWH is at least as safe as UFH in this population . MATERIAL S AND METHODS The study included renally impaired patients ≥70 years with acute symptomatic lower limb deep vein thrombosis ( DVT ) . Patients were r and omized to initial treatment with either tinzaparin 175 IU/kg once daily ( n=269 ) or activated partial thromboplastin time-adjusted UFH twice daily ( n=270 ) . After acute management both groups received vitamin K antagonist to day 90 . RESULTS The trial was stopped prematurely due to a difference in mortality favoring the UFH group ( 11.5 vs. 6.3 % ; p=0.035 ) . Rates of clinical ly relevant bleedings by day 90 were similar in the tinzaparin ( 11.9 % ) and UFH ( 11.9 % ) groups , as were rates of confirmed recurrent venous thromboembolism ( VTE ) ( 2.6 vs. 1.1 % ; p=0.34 ) . As the mortality difference could not be explained by bleedings or recurrent VTE , a post-hoc analysis was performed . This identified six baseline characteristics significantly correlated with mortality , of which five were over-represented in the tinzaparin group . CONCLUSION The IRIS study was a challenging study involving patients ( mean age 83 years ) usually excluded from clinical studies , but its early termination has left questions unanswered . The mortality difference observed with tinzaparin vs. UFH in elderly , renally-impaired patients with DVT can not be explained on the basis of bleedings or recurrent VTE , and may reflect an imbalance of mortality risk factors at baseline Intravenous heparin followed by oral anticoagulant therapy ( e. g. with coumarin ) is still the most widely used treatment for deep venous thromboembolism . Self-administered subcutaneous injections of heparin have been thought of as a promising alternative to coumarin , but the high doses required for ongoing prophylaxis have raised concerns about the possible development of bone disease . Certainly , long-term heparin therapy has been reported to cause osteoporosis in both laboratory animals and humans . This study aim ed to compare the efficacy and safety of unfractionated ( UF ) heparin with that of a low molecular weight heparin ( Fragmin , Kabi Pharmacia ) in the prevention of recurrent deep venous thrombosis ( DVT ) and pulmonary embolism ( PE ) in a consecutive series of patients with contraindications to coumarin therapy . The patients comprised 40 men and 40 women , aged between 19 and 92 years ( mean age , 68 years ) . They had all previously been diagnosed as having acute DVT and had been treated with conventional doses of heparin while in hospital . All patients had at least one of the following conditions : recent blood loss ( either spontaneous or during admission while receiving heparin therapy ) ; active gastroduodenal ulcer disease ; psychological or physical inability or unwillingness to underst and and accept the need for regular laboratory monitoring during coumarin treatment ; chronic alcoholism ; dementia ; pregnancy ; recent neurosurgery , and pericardial effusion ; or were over 80 years of age . They were r and omly allocated to receive either UF heparin , 10,000 IU s.c . b.d . , or Fragmin , 5000 IU anti-Factor Xa s.c . b.d . , for a period of 3 - 6 months . ( ABSTRACT TRUNCATED AT 250 WORDS BACKGROUND Body weight-adjusted subcutaneous low-molecular-weight heparin ( LMWH ) has been proven to be at least as effective and safe as dose-adjusted intravenous unfractionated heparin ( UFH ) for the treatment of patients with venous thromboembolism . However , body weight-adjusted dosage of low-molecular-weight heparin may be cumbersome and could lead possibly to incorrect dosing . Therefore a fixed LMWH dose , independent of body-weight , might rationalize initial treatment for venous thromboembolism . METHODS Patients with proven proximal deep-vein thrombosis were r and omly assigned to fixed dose subcutaneous LMWH Certoparin ( 8,000 anti-factor Xa U b.i.d . ; 265 patients ) or to adjusted dose i.v . UFH ( 273 patients ) for 12 days . Vitamin K antagonists were started between day 3 and 7 and continued for up to 6 months . The primary outcome measure was a 30 percent or greater improvement in the Marder Score , as revealed by repeated venography on day 12 ( end of the initial treatment ) . The secondary composite outcome measure included death , recurrent venous thromboembolism and major bleeding and was assessed at day 12 and after 6 months by a blinded adjunction committee . RESULTS The Marder score improved by 30 % or more in 30.3 % and 25.0 % of patients assigned to LMWH ( 198 paired venograms ) and UFH ( 192 paired venograms ) , respectively ( 2p = 0.26 ) . At the end of the initial treatment , the composite outcome was observed in 4 of the 265 patients ( 1.5 % ) r and omized to LMWH , as compared with 14 of the 273 patients ( 5.1 % ) r and omized to UFH ( 2p = 0.03 ) . At 6 months these figures were 6.8 % and 12.8 % , respectively ( risk reduction 0.53 , confidence interval 0.31 - 0.90 , 2p = 0.02 ) . CONCLUSION Fixed dose subcutaneous LMWH certoparin is at least as efficacious as UFH in resolving proximal vein thrombosis We performed a prospect i ve , r and omized , double-blind trial in 194 unselected patients to determine the safety and efficacy of low molecular weight heparin ( Fragmin ) compared with st and ard heparin as the initial treatment of acute venous thromboembolism . Ninety-eight patients received continuous intravenous heparin , and 96 patients received Fragmin for 5 - 10 days . Doses were adjusted to maintain anti-Xa levels between 0.3 and 0.6 unit/ml for patients with a high risk for a bleeding complication and between 0.4 and 0.9 unit/ml for patients with a low risk for bleeding . Treatment was stopped when a therapeutic level of anticoagulation ( International Normalized Ratio greater than 3.5 ) was reached with coumarins . Thirteen patients in the heparin group and 10 patients in the Fragmin group had a major bleeding complication . The incidence of major and minor bleeding complications combined decreased from 48.9 % to 38.5 % ( 95 % confidence interval for the difference , -3.5 % to + 24.2 % ) , corresponding with a relative bleeding risk reduction of 21.2 % . There were no significant differences in efficacy as defined by new high-probability defects on repeat ventilation-perfusion scintigraphy of the lung in 80 patients : six of 46 patients in the heparin group and 3 of 34 patients in the Fragmin group had new defects ( 95 % confidence interval for the difference , -9.4 % to + 17.8 % ) . We conclude that low molecular weight heparin ( Fragmin ) given in adjusted , continuous , and intravenous doses is safe and effective as initial treatment of acute venous thromboembolism compared with heparin . There is a trend in risk reduction for bleeding in favor of low molecular weight heparin , a trend , however , that is smaller than expected compared with animal studies BACKGROUND An intravenous course of st and ard ( unfractionated ) heparin with the dose adjusted to prolong the activated partial-thromboplastin time to a desired length is the st and ard initial in-hospital treatment for patients with deep-vein thrombosis , but fixed-dose subcutaneous low-molecular-weight heparin appears to be as effective and safe . Because the latter treatment can be given on an outpatient basis , we compared the two treatments in symptomatic out patients with proximal-vein thrombosis but no signs of pulmonary embolism . METHODS We r and omly assigned patients to adjusted-dose intravenous st and ard heparin administered in the hospital ( 198 patients ) or fixed-dose subcutaneous low-molecular-weight heparin administered at home , when feasible ( 202 patients ) . We compared the treatments with respect to recurrent venous thromboembolism , major bleeding , quality of life , and costs . RESULTS Seventeen of the 198 patients who received st and ard heparin ( 8.6 percent ) and 14 of the 202 patients who received low-molecular-weight heparin ( 6.9 percent ) had recurrent thromboembolism ( difference , 1.7 percentage points ; 95 percent confidence interval , -3.6 to 6.9 ) . Major bleeding occurred in four patients assigned to st and ard heparin ( 2.0 percent ) and one patient assigned to low-molecular-weight heparin ( 0.5 percent ; difference , 1.5 percentage points ; 95 percent confidence interval , -0.7 to 2.7 ) . Quality of life improved in both groups . Physical activity and social functioning were better in the patients assigned to low-molecular-weight heparin . Among the patients in that group , 35 percent were never admitted to the hospital at all , and 40 percent were discharged early . This treatment was associated with a mean reduction in hospital days of 67 percent , ranging from 29 percent to 86 percent in the various study centers . CONCLUSIONS In patients with proximal-vein thrombosis , treatment with low-molecular-weight heparin at home is feasible , effective , and safe BACKGROUND Enoxaparin , a low-molecular-weight heparin administered to hospitalized patients once or twice daily , has shown efficacy and safety equivalent to unfractionated heparin in the treatment of acute venous thromboembolic disease . Although the cost of either enoxaparin regimen is greater than that of unfractionated heparin , the overall cost of care for each of these 3 treatment strategies is unknown . METHODS A cost minimization analysis of a 3-month , partially blinded , r and omized , controlled efficacy and safety trial of anticoagulant therapy for deep vein thrombosis . Three hundred thirty-nine hospitalized patients with symptomatic lower extremity deep vein thrombosis were r and omly assigned to initial therapy with subcutaneous enoxaparin either once ( n = 112 ) or twice ( n = 123 ) daily , or with dose-adjusted intravenous unfractionated heparin ( n = 104 ) , followed by long-term oral anticoagulant therapy . Estimated 1997 total cost from a third-party payer perspective for the 3-month episode of care was calculated by assigning st and ard unit costs to counts of medical re sources used by each patient in the clinical trial . RESULTS Average total cost for the 3-month episode of care was similar across all 3 treatment regimens : once-daily dose of enoxaparin , $ 12,166 ( 95 % confidence interval [ CI ] , $ 10,744-$13,588 ) ; twice-daily dose of enoxaparin , $ 11,558 ( 95 % CI , $ 10,201-$12,915 ) ; and unfractionated heparin , $ 12,146 ( 95 % CI , $ 10,670-$12,622 ) . Bootstrapped estimates and sensitivity analyses did not significantly change findings . CONCLUSIONS There was no significant difference in the overall cost for the 3-month episode of care for patients treated with either enoxaparin or unfractionated heparin . Additional acquisition costs for anticoagulant medication among patients treated with enoxaparin were offset by savings associated with lower incidence of hospital readmission and shorter duration of venous thromboembolism-related readmissions In view of the potential of low-molecular-weight heparins ( LMWH ) to simplify initial therapy and allow outpatient treatment of proximal deep-vein thrombosis , we undertook a r and omised comparison of fixed-dose subcutaneous LMWH with adjusted-dose intravenous st and ard heparin in the initial treatment of this disorder . Our main objectives were to compare the efficacy of these regimens for 6 months of follow-up and to assess the risk of clinical ly important bleeding . Of 170 consecutive symptomatic patients with venographically proven proximal deep-venous thrombosis , 85 received st and ard heparin ( to achieve an activated partial thromboplastin time of 1.5 to 2.0 times the pretreatment value ) and 85 LMWH ( adjusted only for body weight ) for 10 days . Oral coumarin was started on day 7 and continued for at least 3 months . The frequency of recurrent venous thromboembolism diagnosed objective ly did not differ significantly between the st and ard-heparin and LMWH groups ( 12 [ 14 % ] vs 6 [ 7 % ] ; difference 7 % [ 95 % confidence interval -3 % to 15 % ] ; p = 0.13 ) . Clinical ly important bleeding was infrequent in both groups ( 3.5 % for st and ard heparin vs 1.1 % for LMWH ; p greater than 0.2 ) . We conclude that fixed-dose subcutaneous LMWH is at least as effective and safe as intravenous adjusted-dose heparin in the initial treatment of symptomatic proximal-vein thrombosis . Since there is no need for laboratory monitoring with the LMWH regimen , patients with venous thrombosis can be treated at home Summary Two studies have been done to establish recommendations for dosage and dose adjustment in the treatment of deep vein thrombosis ( DVT ) with low molecular weight heparin ( LMWH ) . In the first , 56 patients were r and omized in a double blind study to be treated either with unfractionated heparin ( UFH ) or LMWH s. c. every 12 h. Initial doses were given according to age and sex , disregarding bodyweight , and the dose was then adjusted when the peak plasma heparin concentration fell outside the desired range of 0.5–0.8 anti-FXa U/ml . There were fewer dose adjustments in the LMWH group . The correlation between injected dose ( U/kg bodyweight ) and the heparin concentration was higher in the LMWH group ( r=0.59 ) than in the UFH group ( r=0.38 ) . The results suggest that , in order to obtain the desired heparin concentration , the initial dose of LMWH should be about 100 U/kg bodyweight every 12 h . In the second , open study , this dosage plan was followed in 15 patients . The peak heparin concentration on Day 2 ranged from 0.40 to 0.75 anti-FXa U/ml and adjustment was only required in 3 patients . Day to day variation in peak heparin activity in the individual patient varied little ( CV 11–22 % ) , and there was no accumulation . The results indicate that plasma heparin concentration is more predictable using LMWH than UFH , and they point to definite advantages in the use of LMWH in a bodyweight adjusted dosage BACKGROUND The efficacy and safety of vena caval filters in the prevention of pulmonary embolism in patients with proximal deep-vein thrombosis is still a matter of debate . METHODS Using a two-by-two factorial design , we r and omly assigned 400 patients with proximal deep-vein thrombosis who were at risk for pulmonary embolism to receive a vena caval filter ( 200 patients ) or no filter ( 200 patients ) , and to receive low-molecular-weight heparin ( enoxaparin , 195 patients ) or unfractionated heparin ( 205 patients ) . The rates of recurrent venous thromboembolism , death , and major bleeding were analyzed at day 12 and at two years . RESULTS At day 12 , two patients assigned to receive filters ( 1.1 percent ) , as compared with nine patients assigned to receive no filters ( 4.8 percent ) , had had symptomatic or asymptomatic pulmonary embolism ( odds ratio , 0.22 ; 95 percent confidence interval , 0.05 to 0.90 ) . At two years , 37 patients assigned to the filter group ( 20.8 percent ) , as compared with 21 patients assigned to the no-filter group ( 11.6 percent ) , had had recurrent deep-vein thrombosis ( odds ratio , 1.87 ; 95 percent confidence interval , 1.10 to 3.20 ) . There were no significant differences in mortality or the other outcomes . At day 12 , three patients assigned to low-molecular-weight heparin ( 1.6 percent ) , as compared with eight patients assigned to unfractionated heparin ( 4.2 percent ) , had had symptomatic or asymptomatic pulmonary embolism ( odds ratio , 0.38 ; 95 percent confidence interval , 0.10 to 1.38 ) . CONCLUSIONS In high-risk patients with proximal deep-vein thrombosis , the initial beneficial effect of vena caval filters for the prevention of pulmonary embolism was counterbalanced by an excess of recurrent deep-vein thrombosis , without any difference in mortality . Our data also confirmed that low-molecular-weight heparin was as effective and safe as unfractionated heparin for the prevention of pulmonary embolism BACKGROUND Few reports have addressed the value of unfractionated heparin ( UFH ) or low-molecular-weight heparin in treating the full spectrum of patients with venous thromboembolism ( VTE ) , including recurrent VTE and pulmonary embolism . METHODS In an open , multicenter clinical trial , 720 consecutive patients with acute symptomatic VTE , including 119 noncritically ill patients ( 16.5 % ) with pulmonary embolism and 102 ( 14.2 % ) with recurrent VTE , were r and omly assigned to treatment with subcutaneous UFH with dose adjusted by activated partial thromboplastin time by means of a weight-based algorithm ( preceded by an intravenous loading dose ) , or fixed-dose ( adjusted only to body weight ) subcutaneous nadroparin calcium . Oral anticoagulant therapy was started concomitantly and continued for at least 3 months . We recorded the incidence of major bleeding during the initial heparin treatment and that of recurrent VTE and death during 3 months of follow-up . RESULTS Fifteen ( 4.2 % ) of the 360 patients assigned to UFH had recurrent thromboembolic events , as compared with 14 ( 3.9 % ) of the 360 patients assigned to nadroparin ( absolute difference between rates , 0.3 % ; 95 % confidence interval , -2.5 % to 3.1 % ) . Four patients assigned to UFH ( 1.1 % ) and 3 patients assigned to nadroparin ( 0.8 % ) had episodes of major bleeding ( absolute difference between rates , 0.3 % ; 95 % confidence interval , -1.2 % to 1.7 % ) . Overall mortality was 3.3 % in each group . CONCLUSIONS Subcutaneous UFH with dose adjusted by activated partial thromboplastin time by means of a weight-based algorithm is as effective and safe as fixed-dose nadroparin for the initial treatment of patients with VTE , including those with pulmonary embolism and recurrent VTE Low molecular weight heparin ( LMWH ) is effective in the treatment of acute deep vein thrombosis ( DVT ) in adults . This has not been demonstrated for one LMWH alone . The relationship between venographic changes due to LMWH therapy and clinical outcome in the initial treatment period has not been reported . A pooled analysis of two clinical trials was performed . The trials compared a fixed-dose , body weight-independent , subcutaneous LMWH , certoparin ( 8000 antifactor Xa [ aXa ] U twice a day [ b.i.d . ] ) , with an adjusted-dose intravenous unfractionated heparin ( UFH ) with respect to venographic changes expressed as Marder score and occurrence of recurrent venous thromboembolism , major bleeding , and mortality . The Marder score was 23.2 + /- 8.4 in patients r and omized to LMWH ( n = 299 paired phlebograms ) and 23.9 + /- 8.9 in patients allocated to UFH ( n = 297 paired phlebograms ) at entry ( 2p = 0.23 ) and 18.9 + /- 9.7 and 20.5 + /- 9.9 at the end of the initial therapy ( 2p = 0.04 ) , respectively . The composite outcome of recurrent venous thromboembolism , major bleeding , and mortality occurred less frequently during treatment with LMWH ( n = 393 ) than it did with UFH ( n = 404 , 1.3 % versus 5.0 % , risk reduction [ RR ] 0.26 , 95 % confidence interval [ CI ] 0.11 to 0.63 , 2p = 0.004 ) . Single events of recurrent thromboembolism ( 2p = 0.12 ) , major bleeding ( 2p = 0.03 ) , and mortality ( 2p = 0.12 ) were observed less frequently with LMWH . A trend toward a lack of regression of thrombus size was observed in recurrent venous thromboembolism ( 2p = 0.08 ) . Body weight-independent LMWH significantly reduces thrombus size and the incidence of composite outcome during the initial treatment of acute proximal venous thrombosis compared with adjusted dose intravenous UFH . The data indicate a relation between an unimproved Marder score and a recurrent venous thromboembolism BACKGROUND A low-molecular-weight heparin , enoxaparin sodium , has been shown to be effective and safe in preventing deep vein thrombosis both in general surgery and in high-risk orthopedic surgery . We conducted a controlled , r and omized trial with enoxaparin in the treatment of established deep vein thrombosis . METHODS In a multicenter trial , we compared fixed-dose subcutaneous enoxaparin , given twice daily , with adjusted-dose intravenous unfractionated heparin ( UFH ) given by continuous intravenous infusion for the initial 10 days of treatment of patients with proximal vein thrombosis . The primary efficacy outcome was the change of the size of the thrombus assessed by repeated venograms between day 0 and day 10 . The primary analysis of safety was based on the incidence of major bleeding during 10 days of treatment . RESULTS There were 67 patients in each group . Venographic assessment of clot size evolution between day 0 and day 10 showed a statistically significant superiority ( P < .002 ) of enoxaparin over the reference treatment with UFH . Moreover , the incidence of overall recurrent thromboembolic events during 10 days of treatment was significantly higher ( P < .002 ) in the UFH group ( seven of 67 ) than in the enoxaparin group ( one of 67 ) . There were no serious bleeding complications in either group . CONCLUSIONS Enoxaparin is at least as effective and safe as UFH under the conditions of this study . Moreover , it is more comfortable for patients and less time-consuming for nurses and laboratories . Thus , our study confirmed , with the use of enoxaparin , other observations that low-molecular-weight heparin provides a real therapeutic advance in the treatment of deep vein thrombosis BACKGROUND Low-molecular-weight heparin appears to be at least as effective and safe as st and ard , unfractionated heparin for the treatment of deep-vein thrombosis , but only limited data are available on the use of low-molecular-weight heparin to treat acute symptomatic pulmonary embolism . METHODS We r and omly assigned 612 patients with symptomatic pulmonary embolism who did not require thrombolytic therapy or embolectomy to either subcutaneous low-molecular-weight heparin ( tinzaparin ) given once daily in a fixed dose or adjusted-dose , intravenous unfractionated heparin . Oral anticoagulant therapy was begun between the first and the third day and was given for at least three months . We compared the treatments at day 8 and day 90 with respect to a combined end point of recurrent thromboembolism , major bleeding , and death . RESULTS In the first eight days of treatment , 9 of 308 patients assigned to receive unfractionated heparin ( 2.9 percent ) reached at least one of the end points , as compared , with 9 of 304 patients assigned to low-molecular-weight heparin ( 3.0 percent ; absolute difference , 0.1 percentage point ; 95 percent confidence interval , -2.7 to 2.6 ) . By day 90 , 22 patients assigned to unfractionated heparin ( 7.1 percent ) and 18 patients assigned to low-molecular-weight heparin ( 5.9 percent ) had reached at least one end point ( P=0.54 ; absolute difference , 1.2 percentage points ; 95 percent confidence interval , -2.7 to 5.1 ) . The risk of major bleeding was similar in the two treatment groups throughout the study . CONCLUSIONS Under the conditions of this study , initial subcutaneous therapy with the low-molecular-weight heparin tinzaparin appeared to be as effective and safe as intravenous unfractionated heparin in patients with acute pulmonary embolism Background We compared the efficacy and safety of different dosages of a low-molecular-weight heparin , CY 216 D ( Fraxiparine ) , in the treatment of submassive pulmonary embolism with unfractionated heparin in a prospect i ve , r and omized , dose-finding study . Methods and Results The primary outcome was the evolution of pulmonary vascular obstruction . We enrolled 101 patients . Four patient groups were formed : st and ard heparin by continuous intravenous infusion ( group 1 ) and Fraxiparine subcutaneously 400 , 600 , and 900 anti-Xa Institute Choay units/kg , respectively ( groups 2 , 3 , and 4 ) . Inclusion s were stopped prematurely in groups 3 and 4 because of the incidence of major bleedings . At day 8 , the improvement of the pulmonary vascular obstruction and the major bleedings were similar in groups 1 and 2 . Conclusions The Fraxiparine dosage of 400 anti-Xa Institute Choay units/kg is as effective and safe as unfractionated heparin in the treatment of submassive pulmonary embolism UNLABELLED A total of 164 patients were recruited from a r and omized trial comparing a low molecular weight heparin , dalteparin , given subcutaneously once daily with a continuous intravenous infusion of unfractionated heparin in the initial treatment of acute deep vein thrombosis . The primary objective of this follow-up study was to investigate whether there were any differences between the two treatment groups with respect to Marder score changes 6 months after the initial diagnosis using repeated venography . The secondary objectives were to analyse whether certain haemostatic and acute phase parameters or patient characteristics influenced the venographic outcome . RESULTS Complete lysis of the thrombus was observed in 38.4 % of the patients and a partial lysis in another 54.3 % assessed by venography 6 months after the acute event . Extension of the thrombus was seen in 7.3 % of the patients . There were no significant differences in the change in mean Marder score before treatment and at the 6 month follow-up between the two treatment groups , irrespective of thrombus localisation . In a regression model , male gender , low levels of orosomucoid and increased levels of d-dimer in plasma on day 5 were independently associated ( p < 0.05 ) with an enhanced absolute resolution of the thrombus at 6 months . No differences in symptoms and signs in the thrombotic leg at follow-up , comparing the treatment given , or thrombus extension at diagnosis and 6 months later , were demonstrated . CONCLUSION Dalteparin given once daily subcutaneously was as effective as continuous intravenous infusion of unfractionated heparin in the initial treatment of deep vein thrombosis assessed by Marder score evaluation 6 months after the acute event BACKGROUND Low-molecular-weight heparins are frequently used to treat venous thromboembolism , but optimal dosing regimens and clinical outcomes need further definition . METHODS In this multicenter , open-label study with blinded adjudication of end points , we r and omly assigned patients with acute deep-vein thrombosis to one of three treatment regimens : intravenous administration of unfractionated heparin ; subcutaneous administration of a low-molecular-weight heparin , reviparin , twice a day for one week ; or subcutaneous administration of reviparin once a day for four weeks . The primary end point was evidence of regression of the thrombus on venography on day 21 ; secondary end points were recurrent venous thromboembolism , major bleeding within 90 days after enrollment , and death . RESULTS Of the patients receiving unfractionated heparin , 40.2 percent ( 129 of 321 ) had thrombus regression , as compared with 53.4 percent ( 175 of 328 ) of patients receiving reviparin twice daily and 53.5 percent ( 167 of 312 ) of the patients receiving reviparin once daily . With regard to thrombus regression , reviparin administered twice daily was significantly more effective than unfractionated heparin ( relative likelihood of thrombus regression , 1.28 ; 97.5 percent confidence interval , 1.08 to 1.52 ) , as was reviparin administered once daily ( relative likelihood , 1.29 ; 97.5 percent confidence interval , 1.08 to 1.53 ) . Mortality and the frequency of episodes of major bleeding were similar in the three groups . CONCLUSIONS In acute deep-vein thrombosis , reviparin regimens are more effective than unfractionated heparin in reducing the size of the thrombus . Reviparin is also more effective than unfractionated heparin for the prevention of recurrent thromboembolism and equally safe Two hundred and four consecutive patients with venographically confirmed deep vein thrombosis ( DVT ) were r and omised either to a low molecular weight heparin , Fragmin , administered subcutaneously ( s.c . ) once daily as a fixed dose of 200 IU anti-factor Xa/kg or to continuous intravenous infusion of unfractionated heparin ( UFH ) . The UFH dose was adjusted to maintain the activated partial thromboplastin time between 1.5 and 3.0 times the upper limit of the reference value at each centre . Fragmin or UFH was given for a minimum of 5 days until anticoagulation with warfarin , given from day 1 , was established ( i.e. an Internation Normalised Ratio , of 2.0 - 3.0 ) . A second venogram was obtained after Fragmin or UFH treatment . There were no significant differences in the change in mean Marder score before and after treatment between the two treatment groups , irrespective of thrombus localisation . No major bleeding events , symptomatic pulmonary embolism , symptomatic thrombosis progression or death occurred during hospitalisation . Eight documented venous thromboembolic events occurred before the follow-up visit 6 months after r and omisation : 5 in patients treated with Fragmin and 3 in those treated with UFH . Six of these events occurred after cessation of warfarin treatment . In conclusion Fragmin given s.c . once daily in a fixed dose adjusted for body weight , is no less effective or safe than a continuous infusion of UFH in the initial treatment of acute DVT This open , r and omised multicenter trial compares the efficacy and safety of Fragmin administered subcutaneously twice daily with st and ard heparin administered by continuous infusion in the treatment of deep vein thrombosis ( DVT ) . The initial dose of Fragmin is 100 U anti-Xa/kg/12 h and the further doses are adjusted according to the anti-Xa activity between 0.5 and 0.8 U/ml , 3 hours after the morning injection . The initial dose of st and ard heparin is 240 UI/kg/12 h. The dose adjustments are based on the daily results of APTT ( 1.5 - 3 times the control ) . Treatments efficacy are appreciated when comparing the venography performed before and after 10 days of treatment . The safety is evaluated on clinical parameters and iterative biological tests . Sixty-six patients have been included in this study . Efficacy of the two treatments is equivalent with a phlebographic improvement in respectively 79.3 p. 100 ( Heparin Group ) and 71.0 p. 100 ( Fragmin Group ) of the cases and an aggravation in 3.4 p. 100 and 6.4 p. 100 ( NS ) respectively . The frequency of dosage adjustments is lower and the stability of biological tests is better in the Fragmin group . In conclusion , the administration of Fragmin twice daily by subcutaneous route seems to be equivalent at least to st and ard heparin continuous infusion in the treatment of recent DVT . The better convenience and safety of Fragmin have to be verified on a larger panel of patients In order to avoid selective biases and to minimize r and om errors , inference about the effects of treatment on serious endpoints needs to be based not on one , or a few , of the available trial results , but on a systematic overview of the totality of the evidence from all the relevant unconfounded r and omized trials . But , only where coverage of all , or nearly all , r and omized patients in all relevant trials ( or a reasonably unbiased sample of such trials ) can be assured , is a systematic overview of trials reasonably trustworthy , for then any selective biases are likely to be small in comparison with any moderate effects of treatment . Checks for the existence of such biases can best be conducted if reasonably detailed data are available from each trial . Future trials should take into account the results of any relevant overviews in their design , and should plan to obtain sufficient numbers of events to contribute substantially to such overviews . In many cases , this implies the need for r and omized trials that are much larger than is currently st and ard BACKGROUND Multiple clinical trials have been performed to compare st and ard heparin with low molecular weight heparin in the therapy of deep vein thrombosis , but little is known about the time course of the markers of hemostatic system during the treatment with these two heparin regimens . METHODS Twenty patients with proximal deep vein thrombosis confirmed by duplex ultrasound and phlebography were r and omly assigned to either unfractionated heparin ( UH ) given as an intravenous bolus of 80 U/kg followed by a constant infusion of 18 U/kg/h , or nadroparin 185 AXa IU/kg once daily subcutaneously . Oral anticoagulants were started at day 4 . Markers of hemostatic activation ( F1 + 2 , FPA , TAT , D-dimer ) were measured daily for 4 days . Primary endpoints were the time course of these markers ; secondary endpoints consisted in the evaluation of thromboembolic and hemorrhagic complications by clinical outcome and Marder score . RESULTS Treatment with UH result ed in a rapid achievement of therapeutic heparin levels . UH reduced markers of fibrin formation and fibrinolysis more rapidly than nadroparin ( p < 0.05 ) . Within the nadroparin group activation of prothrombotic markers four hours after the subcutaneous injection ( peak level ) was significantly lower when compared with the time prior to injection ( trough level ) . Secondary endpoints showed no significant difference between the two groups . CONCLUSION Continuous intravenous perfusion of UH administered on a basis of a weight-adjusted nomogram controlled markers of the hemostatic system more rapidly than once-daily subcutaneously administered weight-adjusted nadroparin Danaparoid ( Org 10172 ; Organon Scientific Development Group , Oss , the Netherl and s ) , a heparinoid with a mean molecular weight of 5500 d , is obtained from the intestinal mucosa of the pig after removal of heparin . It is a mixture of sulfated glycosaminoglycans with low molecular weight : heparan sulfate ( 84 % ) , dermatan sulfate ( 12 % ) , and chondroitin sulfate ( 4 % ) [ 1 , 2 ] . Only a subfraction ( 4 % ) of heparan sulfate contains the pentasaccharide sequence , common to heparin and to low-molecular-weight heparins , that has a high affinity to antithrombin III . This subfraction acts through the selective inhibition of factor Xa through antithrombin III , which leads to the inhibition of thrombin generation . The fraction of heparan sulfate with a low affinity for antithrombin III does not affect coagulation factors Xa and IIa but contributes substantially to antithrombotic activity , probably through an endothelial cellular mechanism [ 3 ] . The dermatan sulfate component of danaparoid activates heparin cofactor II , which acts at the level of factor IIa . The synergistic activity of these three components determines the antithrombotic profile . As reflected in its anti-factor Xa : anti-factor IIa inhibitory ratio of more than 28:1 , danaparoid is a more selective inhibitor of factor Xa than heparin or the low-molecular-weight heparins . The dose-related response to danaparoid remains gradual and linear over a wide dosing range , which may contribute to its safety as an antithrombotic drug . Compared with heparin and low-molecular-weight heparins , danaparoid has almost no effect on physiologic platelet function and has low cross-reactivity with heparin-induced antibodies against platelets . The wide therapeutic range of danaparoid and its minimal effect on platelets may render it a safer anticoagulant than heparin or low-molecular-weight heparins . Treatment with unfractionated heparin is limited by the drug 's pharmacokinetic , biophysical , and antihemostatic ( nonanticoagulant ) properties . Heparin must be given in sufficient quantities under frequent monitoring , its dose-response curve is nonlinear and unpredictable in individual persons , and the risk for bleeding increases with increasing doses and duration of treatment . Danaparoid has been shown in animal studies to be more effective than st and ard heparin or two different low-molecular-weight heparin preparations in preventing the extension of experimentally induced venous thrombi [ 4 ] . It has been both safe and effective in the prophylaxis of deep venous thrombosis in patients having cancer surgery [ 5 ] , hip-fracture surgery [ 6 ] , or hip-replacement surgery [ 7 ] and in patients with nonhemorrhagic stroke [ 8 ] . It has been used as an anticoagulant during hemodialysis [ 9 , 10 ] and in patients with heparin-induced thrombocytopenia [ 11 , 12 ] or disseminated intravascular coagulation [ 13 ] . Data from studies of the treatment of deep venous thrombosis in patients with hemorrhagic stroke indicate that treatment with danaparoid can prevent the extension of venous thromboembolism without aggravating cerebral bleeding [ 14 ] . No study has yet assessed the efficacy and safety of danaparoid in the treatment of patients presenting with acute deep venous thrombosis or pulmonary embolism . Danaparoid has a bioavailability of 100 % after subcutaneous administration ; the bioavailability of unfractionated heparin after subcutaneous injection is only 20 % to 30 % . Therefore , danaparoid is particularly suitable for subcutaneous administration , much like the low-molecular-weight heparin preparations [ 15 - 19 ] , which have a bioavailablity of approximately 90 % . Our study was design ed to assess the efficacy and safety of two doses of subcutaneously administered danaparoid and of continuous intravenous administration of unfractionated heparin as initial treatment in patients presenting with acute proximal deep venous thrombosis of the leg , pulmonary embolism , or both . Methods Study Design Our study was a r and omized , open , parallel-group clinical trial done in one university hospital and two university-affiliated hospitals in the Netherl and s. The study protocol and forms giving informed consent were approved by the institutional review board at each hospital . Patients All patients gave witnessed informed consent before being entered into the study . Men and women 18 years of age or older who presented with clinical symptoms of acute proximal deep venous thrombosis of the leg or pulmonary embolism of no more than 7 days duration were eligible . Patients were excluded if they had had intracranial bleeding within 2 months or resuscitation by external chest compression within 48 hours ; if they were allergic to heparin ; if they were pregnant ; if they were receiving treatment with coumarin derivatives ; if they had been treated with thrombolytic drugs within 7 days ; or if they were receiving ongoing treatment with aspirin , nonsteroidal anti-inflammatory drugs , dextran , or fibrinolytic drugs . The provisional diagnosis of venous thrombosis or pulmonary embolism had to be confirmed within 48 hours after the start of study treatment by compression ultrasonography or contrast venography ( whichever could be done soonest ) or by ventilation-perfusion lung scan . Treatment was discontinued and the patient was excluded from the study if the clinical diagnosis was not confirmed . Enrollment began in March 1991 and continued through August 1992 . Dosing Schedule The efficacy and safety of two dosing schedules of danaparoid were compared with the efficacy and safety of continuous intravenous unfractionated heparin . The schedule for low-dose danaparoid was 1250 anti-factor Xa units given as an intravenous bolus , followed by subcutaneous doses of 1250 anti-factor Xa units every 12 hours . The schedule for high-dose danaparoid was 2000 anti-factor Xa units given as an intravenous bolus , followed by subcutaneous doses of 2000 anti-factor Xa units every 12 hours . The first subcutaneous injection was simultaneous with the intravenous bolus injection . The second subcutaneous injection was given at the time of the first of the routine twice-daily injections , unless this was within 6 hours of the first injection . Unfractionated heparin was given intravenously as a loading dose of 2500 U and was followed by an initial maintenance dose of 30 000 U every 24 hours . This maintenance dose was adjusted to reach activated partial thromboplastin 2.5 to 3.5 times the control values ; these times were equivalent to a heparin level of 0.25 to 0.40 U/mL. This was measured daily and 4 hours after any dose adjustment . Study treatment was given for at least 5 days and was continued until an international normalized ratio of at least 3.0 was achieved with oral anticoagulation therapy , which was started 48 hours after the initiation of study treatment . The oral anticoagulant dose was calculated daily using the Thrombotest ( Nyegaard and Co. , Oslo , Norway ; international sensitivity index , 0.94 ) ; this was done each morning using plasma sample s taken before the morning dose had been given . If the international normalized ratio was below the target level after 8 days of study treatment , the attending physician decided whether to continue heparin therapy , continue danaparoid therapy , or switch patients being treated with danaparoid to intravenous heparin . Study treatment was r and omized as follows . Consecutively numbered , identical boxes were kept in each hospital pharmacy ; each box contained one of the three treatments , r and omized per hospital . After giving informed consent , a patient was treated with medication from the next consecutive box . The investigators were blinded to the r and omization schedule . Only when the study medication for one individual patient was delivered did the treatment become known . After being assigned to treatment , patients were excluded from the efficacy analysis only if diagnosis of deep venous thrombosis or pulmonary embolism could not be confirmed within 48 hours of admission . Evaluations and Scheduling The primary method of assessment for recurrence or extension was repeated ultrasonography of the leg , contrast venography , ventilation-perfusion scanning , or both contrast venography and ventilation-perfusion scanning . Assessment was done after at least 5 days and at most 8 days of study treatment , within 24 hours after stopping treatment , or if clinical ly indicated . Institutional physicians , who were blinded to treatment assignments , interpreted venograms , ultrasonograms , and lung scans . Clinical evidence of recurrence or extension was defined as documented clinical circumstances suggestive of venous thromboembolic disease leading to the discontinuation of study treatment . A daily physical examination ( including tests for hemoglobin level , platelet count , and leukocyte count ) and a urinalysis to test for erythrocyte count were done . Liver function tests were done and creatinine levels were measured before and at the end of study treatment . Plasma used to measure amidolytic anti-factor Xa activity was collected at the time of screening and at treatment days 2 and 4 ( before and 2.5 hours after the morning injection on both days ) . This plasma was frozen at 20C and stored until assay . Plasma sample s were collected at the time of screening for determination of activated partial thromboplastin times before study treatment . Follow-up assessment was done 2 months after the initiation of study treatment to gather information on state of health , recurrence or extension of venous thromboembolism , and bleeding complications . Compression Ultrasonography To establish the extent of thrombosis using ultrasonography [ 20 ] , the deep venous system was divided into six segments : lower popliteal , upper popliteal , inferior femoral , mid-femoral , upper femoral , and common femoral veins . Each patient was first examined in the supine position so that the superficial femoral , common femoral , and iliac vein segments could be assessed . Patients were then examined in the prone position In a prospect i ve , r and omized , open study 119 consecutive patients with phlebographically verified deep venous thrombosis ( DVT ) of the leg ( 36 % distal and 64 % proximal ) were treated either with a low molecular weight heparin ( Fragmin , Kabi-Vitrum ) subcutaneously ( 120 anti-FXa U/kg ) twice daily or st and ard heparin ( SH ) as continuous intravenous infusion ( 480 IU kg-1 day-1 ) . The Fragmin doses were adjusted to achieve an anti-FXa activity of 0.2 - 0.4 U/ml before injection and not greater than 1.5 U/ml 4 h after the morning injection . The SH dose was modified to prolong the APTT 2 - 3 times . Repeat phlebography after 5 - 7 days showed improvement in 34/45 patients ( 76 % ) in the Fragmin group and in 30/49 patients ( 61 % ) in the SH group and progress in 2/45 ( 4 % ) and 3/49 ( 6 % ) , respectively . The mean Marder scores decreased from 18.7 + /- 12.1 to 15.7 + /- 12.7 in the Fragmin group and from 16.9 + /- 12.0 to 14.4 + /- 11.8 in the SH group ( ns ) . Two patients in the SH group and none in the Fragmin group had major bleedings . After 22 + /- 7 months follow up 6 rethromboses had occurred in the SH group and 4 in the Fragmin group . Postthrombotic signs and symptoms were similar in both groups . We conclude that two daily sc Fragmin doses seem as effective and safe as continuous SH in the treatment of DVT of the leg BACKGROUND In patients with venous thromboembolism ( VTE ) , identifying clinical risk factors for recurrence during the initial 3 months of anticoagulant therapy and knowledge of the time course of recurrence may help clinicians decide about the frequency of clinical surveillance and the appropriateness of outpatient treatment . METHODS Analysis of a r and omized controlled trial data base involving 1021 patients with VTE ( 750 with deep vein thrombosis [ DVT ] and 271 with pulmonary embolism [ PE ] ) who were followed up for 3 months after the start of anticoagulant therapy . All patients received initial treatment with unfractionated heparin or a low-molecular-weight heparin ( reviparin ) and a coumarin derivative starting the first or second day of treatment , with a target international normalized ratio of 2.0 to 3.0 . RESULTS Four independent clinical risk factors for recurrent VTE were identified : ( 1 ) cancer ( odds ratio [ OR ] , 2.72 ; 95 % confidence interval [ CI ] , 1 . 39 - 5.32 ) , ( 2 ) chronic cardiovascular disease ( OR , 2.27 ; 95 % CI , 1 . 08 - 4.97 ) , ( 3 ) chronic respiratory disease ( OR , 1.91 ; 95 % CI , 0.85 - 4 . 26 ) , and ( 4 ) other clinical ly significant medical disease ( OR , 1.79 ; 95 % CI , 1.00 - 3.21 ) . Older age was associated with a decreased risk for recurrent VTE ( OR , 0.76 ; 95 % CI , 0.64 - 0.92 ) . Previous VTE , sex , and idiopathic VTE were not risk factors for recurrence . In patients with DVT or PE , there was no significant difference in the rates of recurrent nonfatal VTE ( 4.8 % vs 4.1 % ; P = .62 ) , major bleeding ( 2.9 % vs 2.2 % ; P = .53 ) , and non-VTE death ( 6.4 % vs 7.8 % ; P = .45 ) , but recurrent fatal PE was more frequent in patients with PE than DVT ( 2 . 2 % vs 0 % ; P<.01 ) . There was a clustering of recurrent VTE episodes during the initial 2 to 3 weeks after the start of treatment . CONCLUSIONS During the initial 3 months of anticoagulant therapy , recurrent VTE is more likely to occur in patients with cancer , chronic cardiovascular disease , chronic respiratory disease , or other clinical ly significant medical disease . Patients with PE are as likely to develop recurrent VTE as those with DVT ; however , recurrence is more likely to be fatal in patients who initially present with PE . Arch Intern Med . 2000;160:3431 - 3436 BACKGROUND Ardeparin sodium has recently received approval by the Food and Drug Administration for prophylaxis against venous thromboembolism in patients undergoing elective total knee replacement . However , this low-molecular-weight heparin has not been previously evaluated in a r and omized controlled trial for treatment of established acute deep venous thrombosis . METHODS The study included patients with ultrasound-documented acute symptomatic deep venous thrombosis of the legs . They had to be deemed appropriate for discharge home to receive subcutaneous low-molecular-weight heparin . Patients were r and omized to receive ardeparin with a 2-day hospitalization or unfractionated heparin sodium with a 5-day hospitalization . Both groups received warfarin sodium . Follow-up ultrasound examinations were undertaken at 6 weeks . RESULTS Of the 80 patients enrolled , 75 had follow-up ultrasonography . Evaluation of baseline vs 6-week venous scans demonstrated that , overall , 31 of the 39 ardeparin-treated patients improved , compared with 21 of the 36 patients assigned to receive unfractionated heparin ( P=.05 ) . The 95 % confidence interval for the difference in improvement was 0.6 % to 42 % in favor of ardeparin . Median charges for ardeparin and unfractionated heparin were $ 2815 and $ 6500 , respectively ( P<.001 ) . There were no differences in bleeding or patient satisfaction between the 2 groups . CONCLUSIONS The results of this small preliminary trial suggest that ardeparin can be administered effectively and safely to selected patients with acute deep venous thrombosis and that , with proper nursing and home services , it can help decrease the duration of hospitalization In this study , 294 patients with acute proximal DVT ( deep venous thrombosis ) were r and omly assigned to receive intravenous st and ard heparin in the hospital ( 98 patients ) or low-molecular-weight heparin ( LMWH ) ( nadroparin 0.1 mL [ equivalent to 100 AXa IU ] per kg of body weight subcutaneously twice daily ) administered primarily at home ( out patients ) or alternatively in hospital ( 97 patients ) or subcutaneous calcium heparin ( SCHep ) ( 99 patients , 0.5 mL bid ) administered directly at home . The study design allowed out patients taking LMWH heparin to go home immediately and hospitalized patients taking LMWH to be discharged early . Patients treated with st and ard heparin or LMWH received the oral anticoagulant starting on the second day , and heparin was discontinued when the therapeutic range ( INR 2 - 3 ) had been reached . Anticoagulant treatment was maintained for 3 months . Patients treated with SCHep were injected twice daily for 3 months without oral anticoagulants . Patients were evaluated for inclusion and follow-up with color duplex scanning . Venography was not used . In case of suspected pulmonary embolism ( PE ) a ventilatory-perfusional lung scan was performed . Endpoints of the study were recurrent or extension of DVT , bleeding , the number of days spent in hospital , and costs of treatments . Of the 325 patients included , 294 completed the study . Dropouts totaled 31 ( 10.5 % ) ; six of the 325 included patients ( 1.8 % ) died from the related , neoplastic illness . Recurrence or extension of DVT was observed in 6.1 % of patients in the LMWH group , in 6.2 % in the st and ard heparin group , and in 7.1 % in the SCHep group . Most recurrences ( 11/17 ) were in the first month in all groups . Bleedings were all minor , mostly during hospital stay . Hospital stay in patients treated with LMWH was 1.2 ± 1.4 days in comparison with 5.4 ± 1.2 in those treated with st and ard heparin . There was no hospital stay in the SCHep group . Average treatment costs in 3 months in the st and ard heparin group ( US $ 2,760 ) were considered to be 100 % ; in comparison costs in the LMWH group was 28 % of the st and ard heparin and 8 % in the SCHep group . This study indicated that LMWH and SCHep can be used safely and effectively to treat patients with proximal DVT at home at a lower cost The st and ard treatment of deep vein thrombosis is given by continuous intravenous infusion of unfractionated heparin . This entails hospitalisation , nursing care , immobility and repeated laboratory tests ( e.g. activated partial thromboplastin time [ APTT ] , platelet count ) . In addition approximately 10 % of patients suffer major haemorrhages . The potential advantages of a low molecular weight heparin ( CY 216 ) given subcutaneously were explored in a r and omised trial with blind quantitative evaluation of venograms . The study included 166 patients and both " therapeutic efficacy " and " intention to-treat " analyses showed that subcutaneous CY 216 in fixed doses based only on body weight was more effective on the Arnesen and Marder phlebographic scores than continuous i.v . st and ard heparin with daily dose adjustment according to results of coagulation tests . There was no increase in the risks of pulmonary embolism , haemorrhage or clot extension In order to study whether a low molecular weight heparin ( LMWH ) of mw 4000 D is effective in the treatment of deep venous thrombosis ( DVT ) , patients with DVT verified by phlebography were r and omized to treatment by continuous intravenous infusion of either unfractionated heparin ( UFH ) or LMWH . The initial dose was 240 U ( anti F Xa)/kg/12 h. This study ( study I ) was stopped because of major bleeding in 2 newly operated patients in the LMWH group after 27 patients had been treated . The heparin activity measured as F Xa inhibition assayed in retrospect , was found to be much higher in the LMWH group ( mean 1.6 - 2.0 anti F Xa U/ml ) than in the UFH group ( mean 0.5 - 0.8 anti F Xa U/ml ) . A second study was therefore initiated in which the DVT patients were r and omly given UFH ( 240 U/kg/12 h ) or LMWH only 120 U ( anti F Xa)/kg/12 h , as initial doses ( study II ) . In this study 27 patients could be evaluated , the mean heparin activity still being higher in the LMWH group ( 0.9 - 1.2 anti F Xa U/ml ) than in the UFH group ( 0.5 - 0.7 anti F Xa U/ml ) . A second phlebographic investigation showed progression of thrombus size in 3 ( 11 % ) of the UFH patients of studies I and II ( n = 29 ) and improvement in 14 ( 48 % ) . There was no progression in any LMWH patient , 6 ( 50 % ) had improved in study I and 10 ( 77 % ) in study II . The mean decrease of thrombus size score ( according to Marder ) during treatment did not differ between the 3 groups . ( ABSTRACT TRUNCATED AT 250 WORDS Two clinical trials in patients with acute deep venous thrombosis have indicated that the outpatient management with fixed-dose , subcutaneous low-molecular-weight heparin is at least as effective and safe as inpatient treatment with unfractionated intravenous heparin with respect to recurrent venous thromboembolism and major bleeding . We performed an economic evaluation alongside one of these trials to assess the cost consequences of the outpatient management strategy . Data were collected through case record forms , complemented by a prospect i ve question naire in 78 consecutive patients , interviews with health care providers , and hospital data bases . Our study demonstrated that seventy-five percent of patients allocated to low-molecular-weight heparin received treatment either entirely at home or after a brief hospital stay . Fifteen percent of these patients required professional domiciliary care . Within-centre comparisons of re source utilisation in terms of natural units showed that outpatient management with low-molecular-weight heparin reduced the average number of hospital days in the initial treatment period in nine centres by 59 percent ( 95 % CI : 43 to 71 percent ) accompanied by a limited increase in outpatient and professional domiciliary care . The average reduction in hospital days at the end of follow up was 40 percent ( 95 % CI : 25 to 54 percent ) . A cost-minimisation analysis , focusing on re source utilisation directly related to the treatment of deep venous thrombosis and associated costs in one centre demonstrated a cost reduction of 64 percent ( 95 % CI : 56 to 72 percent ) with the outpatient management with low-molecular-weight heparin . These data suggest that outpatient management of patients with proximal venous thrombosis using low-molecular-weight heparin reduces re source utilisation and total treatment cost . Implementation should be preceded by a cautious evaluation of a potential cost shifting and organisational prerequisites In a prospect i ve multicenter trial , 149 consecutive patients with phlebographically proven proximal and /or distal deep vein thrombosis of the leg were r and omly allocated to receive subcutaneously for 10 days either low molecular weight heparin CY 216 ( Fraxiparine ) in a fixed dose or unfractionated heparin ( UFH ) in doses adjusted according to the activated partial thromboplastin time . Pre- and post-treatment phlebograms were assessed blindly using the Arnesen 's score system in 134 patients available for analysis of the treatment efficacy . The mean phlebographic score after 10 days of treatment was significantly decreased in both groups ( p less than 0.001 ) in comparison with the baseline score but the difference in score changes between the two groups was not statistically significant . There was an improvement in 45/68 patients ( 66 % ) in the Fraxiparine group and in 32/66 patients ( 48 % ) in the UFH group , and an increase in the thrombus size in 10/68 ( 15 % ) and 12/66 ( 18 % ) , respectively . One symptomatic non-fatal pulmonary embolism and one major bleeding episode were observed in the UFH group . During a follow-up period of 3 months , two rethromboses had occurred in the UFH group and none in the Fraxiparine group . It is concluded that subcutaneous fixed dose Fraxiparine is safe and at least as effective as subcutaneous adjusted UFH in the treatment of deep vein thrombosis Venous thromboembolic disease causes significant morbidity and mortality in both hospitalized and nonhospitalized patients . The mean annual incidence in the United States is 48 per 100 000 for deep venous thrombosis and 23 per 100 000 for pulmonary embolism , according to an epidemiologic study conducted in Massachusetts ( 1 ) . A similar study in Sweden showed an annual incidence of 160 new cases of deep venous thrombosis per 100 000 inhabitants ( 2 ) . Five to 10 days of unfractionated heparin is a common recommended initial treatment for deep venous thrombosis . This treatment maintains the activated partial thromboplastin time above 1.5 times its control value ( 3 , 4 ) , as calibrated by protamine titration or an antifactor Xa assay . Another recommended initial treatment is 5 to 10 days of weight-adjusted low-molecular-weight heparin followed by at least 3 months of oral anticoagulant therapy ( 3 - 7 ) . Low-molecular-weight heparins are now frequently being used in place of unfractionated heparin for both prevention and treatment of venous thromboembolism ( 3 , 8) . R and omized trials and meta-analyses have shown subcutaneously administered low-molecular-weight heparins to have antithrombotic efficacy equal to ( 9 - 12 ) or greater than ( 13 - 16 ) that of continuously infused unfractionated heparin in the initial treatment of deep venous thrombosis and equal to that of unfractionated heparin in the treatment of pulmonary embolism ( 17 , 18 ) . However , many of these studies enrolled small numbers of patients ( 9 - 13 , 15 , 16 ) , used primarily venographic plethysmographic or scintigraphic end points ( 9 - 11 , 13 , 16 ) , and sometimes excluded patients with pulmonary embolism ( 11 , 15 ) . Most trials of twice-daily low-molecular-weight heparin adjusted treatment regimens according to patient weight without laboratory monitoring . However , several studies suggest that once-daily weight-adjusted dosage of a low-molecular-weight heparin is as effective in the treatment of proximal deep venous thrombosis as adjusted dosages of intravenous unfractionated heparin ( 14 , 19 ) or twice-daily low-molecular-weight heparin ( 20 ) . Since low-molecular-weight heparins differ in their physicochemical and pharmacologic characteristics , study results that apply to one can not be extended to another ( 21 , 22 ) . We conducted the present study to determine whether enoxaparin administered subcutaneously once or twice per day is as effective as continuously infused unfractionated heparin in the treatment of patients with acute , symptomatic venous thromboembolic disease . Methods Study Description This parallel-group , r and omized , partially blinded , international , multicenter clinical trial compared continuously infused unfractionated heparin ( adjusted to maintain activated partial thromboplastin time within a defined range ) with two weight-adjusted dosages of enoxaparin administered subcutaneously once or twice daily . The study was conducted in 74 hospitals in 16 countries , including the United States , several European countries , Australia , and Israel , and was approved by the institutional review board or ethics committees at each location . Written informed consent was obtained from each patient . Four committees participated in this study : an Advisory Committee ; an Outcome Adjudication Committee , which provided blinded outcome assignments for incidence of recurrent venous thromboembolic disease , major or minor hemorrhage , immune thrombocytopenia , and cause of death ; an independent Safety Committee ; and a Vascular Imaging Committee , which review ed all baseline venograms and all vascular imaging studies in a blinded manner to determine whether deep venous thrombosis was present at baseline and whether objective evidence of recurrence existed . Patient Characteristics Patients were required to be at least 18 years of age and willing to remain hospitalized during r and omized therapy . The primary inclusion criteria were symptomatic lower-extremity deep venous thrombosis confirmed by venography or ultrasonography ( if venography was inconclusive ) , symptomatic pulmonary embolism confirmed by high-probability ventilationperfusion scanning , or positive pulmonary angiography with confirmation of lower-extremity deep venous thrombosis . All eligible patients underwent baseline lung scanning or angiography . Exclusion criteria were more than 24 hours of previous treatment with heparin or warfarin ; need for thrombolytic therapy ; known hemorrhagic risk , including active hemorrhage , active intestinal ulcerative disease , known angiodysplasia , or eye , spinal , or central nervous system surgery within the previous month ; renal insufficiency ( serum creatinine concentration>180 mol/L [ 2.03 mg/dL ] ) ; severe hepatic insufficiency ; allergy to heparin , protamine , porcine products ( both heparin and enoxaparin are derived from pork intestinal mucosa ) , iodine , or contrast media ; history of heparin-associated thrombocytopenia or heparin- or warfarin-associated skin necrosis ; treatment with other investigational therapeutic agents within the previous 4 weeks ; inferior vena cava interruption ; or known pregnancy or lactation . Treatments Within each center , consecutive eligible patients were r and omly assigned sequentially to one of three treatment groups . R and omization was done without stratification in blocks of six , according to ascending r and omization number . The numbers were affixed to sealed treatment kits that contained study medication and were provided by the study sponsor . Patients assigned to enoxaparin received a weight-adjusted subcutaneous dose . Two blinded regimens were tested : 1.0 mg/kg of body weight twice daily or 1.5 mg/kg once daily . Several clinical trials have shown the twice-daily regimen to be effective and safe ( 16 , 23 , 24 ) . The once-daily dosage was chosen on the basis of results of pharmacokinetic studies that showed it to have a suitable pharmacokinetic profile in healthy volunteers and to be well tolerated in the treatment of patients with venous thromboembolism ( 25 , 26 ) . In these previous studies , therapeutic antifactor Xa levels were present for up to 18 hours in both volunteers and patients , and measurable levels were present for up to 24 hours . A total of three injections , study drug and placebo , were given each day to maintain blinding for volume of solutions and frequency of administration . Patients assigned to the nonblinded unfractionated heparin group received an intravenous bolus dose and infusion on the basis of an approved institution-specific nomogram . In most cases , administration was as follows : Six hours after the initial bolus , the activated partial thromboplastin time was measured and the dose was adjusted to maintain the specified value , which was between 55 and 80 seconds in most centers ( 4 - 7 ) . Activated partial thromboplastin time was measured at least daily during unfractionated heparin treatment . Enoxaparin and heparin treatments were continued for at least 5 days , and warfarin was started within 72 hours of initial study drug administration . Forty-three patients received phenprocoumon in place of warfarin sodium . Prothrombin time was measured daily , and patients could be discharged from the hospital after the international normalized ratio was found to be between 2.0 and 3.0 on 2 consecutive days . Oral anticoagulation was continued for at least 3 months . Study Assessment s Observers who were aware of treatment assignment assessed patients daily and monthly during the 3-month follow-up for worsening or recurrence of deep venous thrombosis or pulmonary embolism , hemorrhage , adverse events , changes in concomitant medications and adequacy of warfarin use , and warfarin adherence . For patients receiving unfractionated heparin , adherence was defined as an activated partial thromboplastin time within or above the therapeutic range on the second day of treatment . For patients receiving enoxaparin , adherence was defined as at least 10 doses of study medication given with no dosing errors . Adherence to warfarin therapy was defined as having at least one international normalized ratio value greater than or equal to 2.0 between day 4 and the last dose of study treatment during the initial treatment period . These definitions of treatment adherence were established before the analysis of the study outcomes . Efficacy Analysis The efficacy analysis was performed on two study sample s : all treated patients , who received at least one dose of study medication , and evaluable patients , which excluded all patients who met at least one of the criteria for nonevaluability . These criteria were no confirmed deep venous thrombosis at baseline , insufficient study therapy , placement of an inferior vena cava filter , two r and om assignments , and no 3-month follow-up . Insufficient study therapy was defined as one or more missed enoxaparin doses among at least eight consecutive enoxaparin doses or less than 4 consecutive days of heparin infusion . The definition of insufficient study therapy was established before analysis of study outcomes . These two study sample s were analyzed to strengthen the conclusion of equivalence among the treatment groups . The homogeneity of the results of the two analyses is considered to be more supportive of the conclusion of equivalence than the results of either analysis alone . Primary clinical end points were recurrent deep venous thrombosis or pulmonary embolism within 3 months of r and omization . Patients with symptoms of recurrent thrombosis underwent confirmatory testing with venography , ultrasonography , or both . Patients presenting with signs or symptoms of pulmonary embolism underwent lung perfusion scanning , pulmonary angiography , or both . Clinical symptoms and supportive findings on objective tests ; extension of existing thrombi or new thrombi for venography , angiography , or ultrasonography ; or high-probability defect patterns on perfusion scans were required to confirm recurrent thrombosis . Prespecified subgroup analyses were performed on the basis of patient BACKGROUND The main objective of the study presented was to test if thrombus regression can be improved by treatment with an intravenously or subcutaneously administered low molecular weight heparin ( LMWH ) . Patients with acute deep vein thrombosis were r and omly assigned to receive either intravenous UFH ( 131 patients ) , intravenous ( i.v . ) LMWH ( 128 patients ) , or 8000 IU of the same LMWH bid subcutaneously ( s.c . ) ( 128 patients ) . All patients were treated with heparin for 14 to 16 days . Vitamin-K-antagonist prophylaxis was started between Day 12 and Day 14 after enrollment into the study . METHODS Phlebographies and perfusion/ventilation lung scans were performed at baseline and on Days 12 to 16 . Primary endpoint of the study was a reduction of the phlebographic Marder score . Secondary endpoints were recurrent thrombosis and pulmonary embolism ( PE ) , major and minor bleedings and the rate of PE at inclusion and at the end of the study assessed by ventilation/perfusion scans . RESULTS The Marder score improved by at least 30 % in 32.4 % ( 95 % CI : 22.6 ... 42.2 ) of the patients receiving UFH , in 34.0 % ( 95 % CI : 24.9 ... 44.0 ) receiving LMWH i.v . and in 42.6 % ( 95 % CI : 32.8 ... 52.8 ) treated with the low molecular weight heparin s.c . The difference between LMWH s.c . and UFH was 10.2 % ( 95 % CI : -3.7 % ... + 24.5 % ) ( p = 0.11 ) . PE with clinical signs confirmed by objective methods occurred in three patients of the UFH group , one of whom died and was not observed in patients of the i.v . or s.c . LMWH-groups . During the first 15 days no patient receiving UFH or i.v . LMWH , and one patient on s.c . LMWH had a recurrent thrombosis . Major bleedings were observed in four patients receiving i.v . UFH compared to nine patients on i.v . LMWH ( one of these patients died ) and one patient on s.c . LMWH . Perfusion ventilation lung scans were obtained from 287 patients at baseline and from 246 patients on Days 12 - 16 . PE , defined according to PIOPED- criteria as intermediate or high probability scans , was observed in 38.0 % of the patients entering the study and in 18.3 % on Days 12 to 16 . New asymptomatic PE occurred less frequently in the groups on LMWH ( 7.1 % , 7.5 % , respectively ) than in the UFH-group ( 12.6 % ) ( not significant ) . CONCLUSIONS S.c . treatment with a LMWH ( certoparin ) ( b.i.d . ) is at least as effective as UFH i.v . The hypothesis of increased efficacy of subcutaneous LMWH in resolving venous thrombi will have to be confirmed by an independent study comparing s.c . LMWH with UFH . The i.v . continuous infusion of the LMWH for 12 to 16 days does not result in a higher venous re-opening rate than intravenous st and ard heparin Inherent contradictions in current diagnostic recommendations for pulmonary embolism have created considerable confusion and controversy . To resolve these contradictions , we did a prospect i ve study of ventilation-perfusion scanning , pulmonary angiography , and venography in consecutive patients with clinical ly suspected pulmonary embolism and abnormal perfusion scans . Ventilation scanning increased the probability of pulmonary embolism in patients with large perfusion defects and ventilation mismatch , but a ventilation-perfusion match was not helpful in ruling out pulmonary embolism . Small perfusion defects with mismatch had neither sufficiently high nor low probability to be of diagnostic value . The observed frequency of proximal vein thrombosis ( 19 % to 51 % ) and its association with the range of ventilation-perfusion defects have important implication s for management of pulmonary embolism . Pulmonary angiography is required in combination with venography in most patients with perfusion abnormalities because the probability of pulmonary embolism is neither sufficiently high nor low to confirm or exclude pulmonary embolism Sixty-eight patients with acute deep vein thrombosis were allocated at r and om to two treatment groups . One group ( n = 33 ) received a fixed dose of 750 anti-Xa units of a low molecular weight heparin ( CY 222 Choay Institute ) ; the other group ( n = 35 ) received st and ard heparin in doses of 500 IU/kg/24 h. Both treatments were given for 10 days in two daily subcutaneous injections . A second phlebography was performed on the last day of treatment . No haemorrhagic complication was observed in the group treated with CY 222 , as opposed to three cases of haemorrhage in the group treated with st and ard heparin . The initial phlebographic score and the location of deep vein thrombotic lesions were the same in both groups . Angiographic improvement , with more than 30 % thrombolysis , was obtained at the end of treatment in 64 % of patients in the CY 222 group and in 65 % of patients in the st and ard heparin group ( NS ) . In 2 patients treated with st and ard heparin the second phlebography showed extension of the thrombosis . The initial score remained unchanged in 1/3 of patients in both groups . The activated partial thromboplastin time was prolonged ( 2 or 3 fold the normal value ) in the st and ard heparin group and unchanged in the CY 222 group . Anti-Xa activity was significantly higher in the CY 222 group than in the st and ard heparin group . It is concluded that CY 222 and st and ard heparin were equally effective in patients with deep vein thrombosis . However , haemorrhagic complications were more frequent with st and ard heparin that with CY 222 Background : Low-molecular-weight heparin ( LMWH ) appears to be as effective as unfractionated heparin ( UFH ) for both treatment and prophylaxis of deep vein thrombosis ( DVT ) , but limited data are available for its use in acute pulmonary thromboembolism ( PTE ) . Objective : To determine whether enoxaparin , a LMWH , was clinical ly as efficient and safe as UFH in patients with a diagnosis of acute PTE . Material and Methods : After exclusion of those with massive forms , 59 patients with acute PTE were r and omly assigned to either subcutaneous enoxaparin given twice daily ( 1 mg/kg/dose ) or adjusted dose intravenous UFH . Oral anticoagulant treatment was begun on the second day and was given for at least 6 months . We compared the treatment regimens at day 8 and day 90 with respect to a combined end point of major bleeding , recurrent venous thromboembolism ( VTE ) , and death . Results : In the first 8 days of treatment , 1 of 30 patients assigned to receive UFH ( 3.3 % ) reached one of the end points ( recurrence ) , as compared with none of 29 patients assigned to enoxaparin . Statistically this difference was not significant ( p = 0.508 ) . By day 90 , 3 patients assigned to UFH ( 10 % ) had symptomatic recurrent VTE , as compared with 1 patient assigned to enoxaparin ( 3.4 % ) . There was neither major bleeding nor death in the study groups . There was an absolute difference of 6.4 percentage points between the two treatment groups , but the difference was statistically not significant ( p = 0.318 ) . Conclusion : Initial subcutaneous treatment with enoxaparin appeared to be as effective and safe as UFH in acute PTE The aim of the study was to compare the efficacy and safety of once-daily subcutaneous injection of dalteparin , a low molecular weight heparin , with that of intravenous unfractionated heparin in the treatment of deep venous thrombosis ( DVT ) . Patients were included if they had deep venous thrombosis distal to inguinal ligament and were r and omised either before , if it was considered necessary , or after phlebographic verification of the diagnosis . There was no pre- inclusion treatment with unfractionated heparin . One hundred and twenty patients received dalteparin , administered subcutaneously once-daily at a fixed dose of 200 IU anti-factor Xa/kg , and 133 patients received a continuous intravenous infusion of unfractionated heparin ( UFH ) . Oral anticoagulation was started on the first or second day , and initial treatment with dalteparin or UFH discontinued when the prothrombin time was in the therapeutic range ( 2 < INR < 3 ) on two consecutive days . Control phlebograms were taken within 4 days , thereafter . There were no significant differences between the two initial treatment groups in improvements in Marder score . Two major bleeding events occurred in the UFH group versus none in the dalteparin group . One patient in each group experienced clinical ly significant pulmonary embolism . During a mean follow-up period of 6.9 + /- 1.5 months , recurrent DVT occurred in four patients in the dalteparin group and in two of the UFH group . These results confirm those of a previous study on dalteparin in the initial treatment of DVT , and suggest that dalteparin administered once-daily at a fixed dose of 200 UI/kg is as effective and well-tolerated as UFH in patients with DVT below the inguinal ligament . The present study also demonstrates that dalteparin can be started as soon as the diagnosis of DVT is suspected and without pre-treatment with UFH . Given that the administration of once-daily subcutaneous injections needs not require a patient to be hospitalised , studies to investigate the possibility of using dalteparin for the initial treatment of DVT in the outpatient setting are warranted BACKGROUND Low-molecular-weight heparin is known to be safe and effective for the initial treatment of patients with proximal deep-vein thrombosis . However , its application to pulmonary embolism or previous episodes of thromboembolism has not been studied . METHODS We r and omly assigned 1021 patients with symptomatic venous thromboembolism to fixed-dose , subcutaneous low-molecular-weight heparin ( reviparin sodium ) or adjusted-dose , intravenous unfractionated heparin . Oral anticoagulant therapy with a coumarin derivative was started concomitantly and continued for 12 weeks . Approximately one third of the patients had associated pulmonary embolism . The outcome events studied over the 12 weeks were symptomatic recurrent venous thromboembolism , major bleeding , and death . We sought to determine whether low-molecular-weight heparin is at least equivalent to unfractionated heparin in patients with venous thromboembolism . RESULTS Twenty-seven of the 510 patients assigned to low-molecular-weight heparin ( 5.3 percent ) had recurrent thromboembolic events , as compared with 25 of the 511 patients assigned to unfractionated heparin ( 4.9 percent ) . The difference of 0.4 percentage point indicates that the two therapies have equivalent value according to our predetermined definition of equivalence . Sixteen patients assigned to low-molecular-weight heparin ( 3.1 percent ) and 12 patients assigned to unfractionated heparin ( 2.3 percent ) had episodes of major bleeding ( P= 0.63 ) , and the mortality rates in the two groups were 7.1 percent and 7.6 percent , respectively ( P=0.89 ) . CONCLUSIONS Fixed-dose , subcutaneous low-molecular-weight heparin is as effective and safe as adjusted-dose , intravenous unfractionated heparin for the initial management of venous thromboembolism , regardless of whether the patient has pulmonary embolism or a history of venous thromboembolism Low-molecular-weight heparins have been extensively investigated in the treatment of deep venous thrombosis but limited data are available concerning their use in pulmonary embolism . In an open , pilot , r and omized study , we compare the safety and efficacy of Fragmin , a low-molecular-weight heparin with those of unfractionated heparin in 60 patients with non massive pulmonary embolism ( Miller Index < 20 ) . Thirty one patients received unfractionated heparin intravenously and 29 received a fixed dose of 120 Anti-Xa IU/kg of Fragmin administered subcutaneously twice a day for 10 days . There was no pulmonary embolism recurrence nor major bleeding in either group during the treatment period . The decrease in pulmonary vascular obstruction on perfusion lung scan between day 0 and day 10 was 17 + /- 13 % in the Fragmin group and 16 + /- 13 % in the heparin group ( NS ) . These results indicate that Fragmin may be a safe and effective treatment of submassive pulmonary embolism Abstract Purpose Current guidelines recommend the use of low molecular weight heparin ( LMWH ) for most haemodynamically stable patients with pulmonary thromboembolism ( PTE ) , however , it is not clear whether LMWH is preferable to unfractionated heparin ( UFH ) for the treatment of massive PTE . We aim ed to compare the use of LMWH versus UFH after thrombolytic treatment in the management of acute massive PTE for hemorrhage and hospital mortality . Methods The study , a r and omized , single center , parallel design trial , included the patients who had confirmed the diagnosis of massive PTE according to clinical findings and computerized thorax angiography and no contraindication to the treatment between January 2011 and October 2013 . After thrombolytic treatment , the patients assigned to therapy with LMWH or UFH . Any hemorrhage , major hemorrhage , and hospital mortality were assessed . Results A total of 121 patients , 71 female ( 58.7 % ) and 50 male ( 41.3 % ) , who had massive PTE with an average age 62.6 ± 15.7 ( ranges 22–87 ) were included for analyses in the study . They were allocated to either LMWH ( n = 60 ) or UFH ( n = 61 ) group . Although the occurrence of any adverse event ( 21.7 vs 27.9 % ) and each individual type of adverse event were all lower in the LMWH group compared to UFH group ( 6.7 vs 11.5 % , 3.3 vs 9.8 % , and 15.0 vs 19.7 % for death , major hemorrhage , and any hemorrhage , respectively ) , the differences were not statistically significant . Conclusions Our findings suggest that LMWH might be a better option in the management of the patients with massive PTE . Multi-center larger r and omized controlled trials are required to confirm our results We have performed a prospect i ve , r and omized , controlled trial comparing continuous intravenous unfractionated heparin with twice-daily subcutaneous ( s.c . ) high-dose low-molecular-weight ( LMW ) heparin in the initial treatment of 50 patients with acute proximal deep vein thrombosis . In this article we analyze the relationship between the dosage of the heparins , the anticoagulant effects on aPTT , and thrombin and factor Xa inhibition to the improvement of the Marder score after a 10-day treatment period . Improvement of the Marder score was observed in about 70 % of patients without regard to administration of unfractionated or LMW heparin . Patients in both treatment categories were divided into two groups , namely , those who showed an improvement of the Marder score and those who did not . In the group of patients with unfractionated heparin and regression of thrombus size the mean dosage was 33,000 U/day , whereas the mean dosage was 37,000 U/day in the patients with status idem of the Marder score after the 10-day treatment period . Thrombin clotting time values were in contrast to the dosage . Patients with regression of thrombosis showed higher thrombin clotting time values compared with those with status idem . These results were also seen with aPTT and the Heptest coagulation assay , but the differences between the two groups were less pronounced . No differences between these two groups of patients were seen or detected with the S2222 chromogenic anti-factor Xa method . Patients receiving 2 x 12,000 IU s.c./day LMW heparin did not show these differences , the dosage being adjusted by the anti-Xa levels , ranging from 0.6 to 1.0 U/mL 4 hours after the s.c . injection . The groups of patients categorized as to improvement or not of the Marder score did not show differences in the daily dose . The anti-Xa activity was higher in patients with regression of thrombosis compared with patients without regression . The other coagulation parameters did not show any relation to the clinical outcome of thrombus regression . The relationship between the change of the Marder score at day 10 and the anticoagulant effect on the different coagulation systems correlated weakly for patients receiving unfractionated heparin . The highest correlation was found for the improvement of Marder score and thrombin inhibition in the heparin group with r = 0.42 . For LMW heparin no correlation could be detected . Heptest coagulation values were in the same range for patients receiving unfractionated and LMW heparin . In contrast to the chromogenic anti-Xa assay , aPTT , thrombin clotting time , and prothrombin time values differed substantially in the two treatment regimens . Treatment of recent deep vein thrombosis with unfractionated heparin profits from laboratory monitoring , whereas monitoring of the anticoagulant effect during the treatment with s.c . LMW heparin does not influence the outcome on thrombus regression Low molecular weight heparins ( LMWHs ) are frequently used during acute treatment of deep vein thrombosis , but their utility for long-term treatment needs to be defined . In this multi-centre trial , 378 patients with acute deep vein thrombosis were r and omised to intravenous unfractionated heparin ( group A ) , once daily subcutaneous LMWH ( bemiparin ) for one week ( group B ) or once daily bemiparin in a therapeutic dose for one week followed by a maintenance dose for 12 weeks ( group C ) . Fifty-two per cent of patients in group A , 72 % of group B and 72 % of group C showed venographic reduction in thrombus size assessed objective ly on day 14 ; 20 % greater improvement in group B and C indicates not only non-inferiority of bemiparin ( p = 0.00003 ) but also superiority ( p = 0.004 ) compared to UFH . Day 84 venographic or Doppler sonographic recanalisation of the affected veins was demonstrated in 75.3 % , 79.8 % and 81.5 % in groups A , B and C respectively . Mortality , recurrent thromboembolic events and bleeding were similar in the three groups . Both bemiparin regimens were more effective than UFH in reducing thrombus size during the acute phase of treatment . The efficacy in terms of recurrence of venous thromboembolism and safety of Bemiparin is similar to UFH . Bemiparin is also an effective alternative to warfarin for long-term treatment OBJECTIVES To compare the efficacy and safety of the low molecular weight heparin ( LMWH ) dalteparin with unfractionated heparin ( UFH ) in the acute treatment of DVT patients who had not previously received UFH . DESIGN An open r and omized multicentre trial with blinded analysis of venograms . SETTING Seven hospitals in Sweden , Finl and and the USA . SUBJECTS A total of 330 patients , of 20 years or older , with suspected DVT , verified using venography . INTERVENTIONS Fixed-dose dalteparin ( 200 IU kg-1 ) given as a once-daily subcutaneous injection , or aPTT adjusted i.v . UFH infusion for 6 to 10 days . MAIN OUTCOME MEASURES Change in Marder score in patients with confirmed DVT and two evaluable venograms ; PE , bleeding events and follow-up . RESULTS Marder scores improved in 51 % ( 95 % CI 42 - 60 % ) of 92 patients treated with dalteparin and in 62 % ( 95 % CI 53 - 70 % ) of 98 patients treated with UFH ( P = 0.152 ) . One dalteparin-treated patient had a PE confirmed by V/Q scan ; another had progressive thrombosis with swelling in the affected limb . Bleeding complications occurred in six patients in each group . One patient treated with dalteparin and five treated with UFH died during the 6-month follow-up period as a result of underlying malignancy or heart disease . The 6-month recurrence rate was low with both treatments ( dalteparin , 3/97 ; UFH , 2/103 ) . CONCLUSIONS Fixed-dose subcutaneous dalteparin given once daily from the start of treatment is of equivalent efficacy and safety to conventional UFH therapy in the routine management of DVT |
11,563 | 9,474,831 | Consistent findings showed that bed rest is not an effective treatment for acute low back pain but may delay recovery .
Advice to stay active and to continue ordinary activities results in a faster return to work , less chronic disability , and fewer recurrent problems .
CONCLUSION A simple but fundamental change from the traditional prescription of bed rest to positive advice about staying active could improve clinical outcomes and reduce the personal and social impact of back pain | BACKGROUND In the United Kingdom ( UK ) , 9 % of adults consult their doctor annually with back pain .
The treatment recommendations are based on orthopaedic teaching , but the current management is causing increasing dissatisfaction .
Many general practitioners ( GPs ) are confused about what constitutes effective advice .
AIM To review all r and omized controlled trials of bed rest and of medical advice to stay active for acute back pain . | RésuméLe repos au lit est habituellement considéré comme un traitement efficace de la lombalgie aiguë . Cependant la durée optimale de cette mise au repos au lit est encore discutée , variant selon les écoles de 2 jours à 2 semaines . C'est un paramètre imporant à considérer , compte tenu des préjudices économiques et fonctionnels d'une inactivité prolongée . Le but de ce travail est de faire une évaluation objective de l'efficacité de deux durées de repos différentes , à l'aide d'une mesure dynamométrique de la fonction musculaire du tronc pratiquée à la suite d'une mise au repos plus ou moins longue . Cinquante et un patients , étudiants ou travaillant à leur propre compte , consultant pour des lombalgies aiguës , ont été r and omisés en deux groupes . Au groupe I a été prescrit un repos au lit de 3 jours et au groupe II un repos de 7 jours . Nous avons utilisé un appareil dynamométrique ( Isostation B200 , Isotechnologies , USA ) pour l'évaluation isoinertielle de la fonction musculaire du tronc dans les différents plans . Les patients ont été évalués au ler et au 5e jour dans le groupe I ; la seconde évaluation a été reportée au 9e jour dans le groupe II . Les variables mesurées dans le plan sagittal ont été les forces isometriques en flexion et extension , l'amplitude des mouvements sans résistance , la valeur moyenne des forces développées dans les mouvements de flexion et d'extension ainsi que les vitesses moyennes . On a également dem and é aux patients de situer sur une échelle graphique l'intensité de la douleur ressentie le jour de l'évaluation . L'amélioration de tous les paramètres mesurées a été importante et hautement significative ( P<0,001 ) dans les deux groupes . Les résultats du testing fonctionnel et de l'échelle des douleurs n'ont pas montré de différences significatives entre ces deux groupes . Chez ces patients relativement jeunes et motivés , un repos au lit de trois jours a abouti à la même amélioration de la fonction et de la douleur que le repos de sept jours . Compte tenu des résultats objectifs identiques et aussi des avantages physiologiques et économiques indiscutables , il est préférable de prescrire une mise au repos plus brève . Summary Bed rest is usually considered an efficient treatment for acute low back pain . However , the optimal duration of bed rest is still being discussed . The recommended periods vary from 2 days to 2 weeks . The duration of optimum length is an important topic given the economical and physiological drawbacks of prolonged inactivity . The purpose of this work is to measure objective ly the efficacy of two different duration s of bed rest through a dynamometric measure of trunk function . Some 51 male patients , students or self-employed , being treated for acute low back pain were r and omized into two groups . Group I was prescribed a bed rest period of 3 days and group II , a period of 7 days . We used a multiaxis isoinertial trunk testing dynamometric device ( Isostation B200 , Isotechnologies , USA ) . Patients were all assessed on day 1 and also on day 5 for group I or on day 9 for group II . The variables measured in the sagittal plane were isometric torques in flexion and extension , unresisted range of motion , average dynamic torques and average velocities . Patients were also asked to fill in a visual analogue pain scale on both assessment days . The improvement of all performance measures were important and highly significant ( P<0.001 ) in both groups . The results of the functional testing and the visual analogue pain scale showed no significant differences between the groups . In these relatively young and motivated patients , a duration of bed rest of 3 days result ed in the same objective functional improvement of trunk function and pain rating as a period of 7 days . This shorter duration should be considered as preferable , given the same objective results but important physiological and economical advantages The roles of bedrest , antiinflammatory medication , and analgesic medication in the treatment of acute back strain were objective ly analyzed to determine whether they have a measurable effect on the return of patients to full daily activities as well as on the relief of pain . Two hundred patients were studied prospect ively . Each patient had the diagnosis of acute back strain , which was defined as nonradiating low-back pain . The results of the patient 's neurologic examination , straight leg raising test , and lumbosacral spine roentgenograms had to be within normal limits for the patient to be included in the study . The results showed that bedrest , as compared with ambulation , will decrease the amount of time lost from work by 50 % . Bedrest will also decrease the amount of discomfort by 60 % . Analgesic medication , when combined with bedrest , will further decrease the amount of pain incurred , particularly when used in the first three days of the healing process . However , analgesic medication will not allow a more prompt return to work . Antiinflammatory medication , when added to bedrest in the treatment of lumbago , does not provide an advantage over bedrest alone The aim of this study was to determine whether grade d activity restored occupational function in industrial blue-collar workers who were sick-listed for 8 weeks because of subacute , nonspecific , mechanical low back pain ( LBP ) . Patients with LBP , who had been examined by an orthopedic surgeon and a social worker , were r and omly assigned to either an activity group ( n = 51 ) or a control group ( n = 52 ) . Patients with defined orthopedic , medical , or psychiatric diagnoses were excluded before r and omization . The grade d activity program consisted of four parts : ( 1 ) measurements of functional capacity ; ( 2 ) a work-place visit ; ( 3 ) back school education ; and ( 4 ) an individual , submaximal , gradually increased exercise program , with an operant-conditioning behavioral approach , based on the results of the tests and the dem and s of the patient 's work . Records of the amount of sick leave taken over a 3-year period ( ie , the 1-year periods before , during , and after intervention ) were obtained from each patient 's Social Insurance Office . The patients in the activity group returned to work significantly earlier than did the patients in the control group . The median number of physical therapist appointments before return to work was 5 , and the average number of appointments was 10.7 ( SD = 12.3 ) . The average duration of sick leave attributable to LBP during the second follow-up year was 12.1 weeks ( SD = 18.4 ) in the activity group and 19.6 weeks ( SD = 20.7 ) in the control group . Four patients in the control group and 1 patient in the activity group received permanent disability pensions . The grade d activity program made the patients occupationally functional again , as measured by return to work and significantly reduced long-term sick leave A controlled trial of continuous lumbar traction in the treatment of back pain and sciatica showed similar improvements in both the treated group ( weighted traction ) and the control group ( simulated traction ) . The findings of this study question the justification of admitting patients with back pain into hospitals for purpose s of traction alone The results of a multicentered r and omised clinical trial are reported of bed rest and of a physiotherapy and education programme for patients who presented in family practice with an acute episode of low back pain . No beneficial effect of either treatment was observed on several clinical outcome measures , including straight leg raising , lumbar flexion , activities of daily living , and pain . In fact the results favoured early mobilisation over bed rest and suggested that the physiotherapy and education programme was doing more harm than good . Moreover , additional analyses , which focused on clinical ly interesting patient subgroups , discovered no subset of patients who benefited from either of the treatments under study . Having failed to identify any clinical ly important benefits , or other explanations for these negative results , we can only conclude that family doctors have little reason to prescribe either bed rest or isometric exercises to patients who suffer from low back pain Because back pain is a widespread and costly condition that tends to recur , treatment must focus on both the amelioration of acute symptoms and prevention over the long term . This paper reports a longitudinal evaluation of a program from a community hospital that emphasizes both these aspects . One hundred twenty patients routinely admitted to this program were r and omly assigned to treatment and control groups . These groups were assessed for differences in demonstrated physical strength , mobility , body mechanics , and self-care knowledge , and in levels of self-reported exercise , anxiety , and pain . There were significant immediate gains on physical measures of fitness and in observed body mechanics ; patients also reported significant gains in physical capabilities at home and in leisure activities . Self-care knowledge also improved . When assessed one year later , original gains in physical strength and mobility were being maintained , and self-reported physical capabilities also remained high . Although demonstrated knowledge of correct body mechanics declined over this period , it was still significantly greater than before the program . In light of these results , we believe that outpatient programs like the one reported here merit careful consideration in an era of concern about rising costs for primary health care & NA ; The current investigation studied the effectiveness of a secondary prevention program for nurses with back pain who were deemed at risk for developing a chronic problem . A 2 × 3 repeated measures design was employed with 2 groups and 3 assessment periods . The treatment group received an intervention design ed to reduce current problems , but above all to prevent reinjury and minor pains from becoming chronic medical problems , and it included a physical and behavioral therapy package . The control group was placed on a waiting‐list . Results indicated that the treatment group had significantly greater improvements than the control group for pain intensity , anxiety , sleep quality and fatigue ratings , observed pain behavior , activities , mood , and helplessness . These differences were generally maintained at the 6 month follow‐up . In addition , the treatment group broke a trend for increasing amounts of pain‐related absenteeism , while the control group did not . Taken as a whole , the results suggest that a secondary prevention program aim ed at altering life style factors may represent an effective method for dealing with musculoskeletal pain problems Patients with nonspecific mechanical low back pain ( n = 103 ) , examined by an orthopaedic surgeon and a social worker , were r and omized to an activity group ( n = 51 ) and a control group ( n = 52 ) . Patients with defined orthopaedic , medical , or psychiatirc diagnoses were excluded before r and omization . No patients were excluded due to place of birth or difficulties in speaking or underst and ing the Swedish language . The purpose of the study was to compare mobility , strength and fitness after traditional care and after traditional care plus a grade d activity program with a behavioral therapy approach . A grade d activity program , with a behavioral therapy approach was given under the guidance of a physical therapist . The endpoint of the grade d activity program was return to work . This program significantly increased mobility , strength , and fitness more than could be explained by only a time recovery effect , especially in males . The patients in the activity group returned to work earlier than did the patients in the control group . Spinal rotation , abdominal muscle endurance time and lifting capacity were significantly correlated to rate of return to work . Traditional care plus a grade d activity program were superior to only traditional care , evaluated in terms of mobility , strength and fitness . The grade d activity program proved to be a successful method of restoring occupational function and facilitating return to work in subacute low back pain patients . The patients in the grade d activity program learned that it is safe to move , while regaining function Objective . This r and omized clinical trial was design ed to determine the effect of treating low back pain as a benign , self limiting condition by light normal activity . Methods . Patients on sickness leave from work for more than 8 weeks were r and omized into two groups : intervention ( n = 463 ) and control ( n = 512 ) . Those in the intervention group were examined , provided information , and given instruction . Outcome was measured by return or failure to return to work ( still on sickness leave ) . Results . Survival analysis showed a highly significant ( P = 0.000 ) reduction in sickness leave in the intervention group as compared with the control group . At 200 days 60 % were still on sickness leave in the control group vs. 30 % in the intervention group . A multivariate analysis with age , sex , and treatment as cofactors showed that sex had no effect on length of sickness leave and that treatment retained its effect when adjusting for differences in age composition . Conclusion . This study indicates that low back pain treated as a benign , self limiting condition recommended to light mobilization gives superior results as compared to treatment within a conventional medical system & NA ; Current conceptions of chronic pain clearly suggest that proper care at the acute stage should prevent the development of chronic problems . Patients ( 198 ) seeking help for acute musculoskeletal pain ( MSP ) , e.g. , back and neck pain participated in two studies of the effects of an Early Active intervention which underscored ‘ well ’ behavior and function compared to a Treatment as Usual control group . The quantity of the Early Active treatment was a median of 1 doctor 's appointment and 3 meetings with a physical therapist . Study I concerned patients with a prior history of sick‐listing for MSP , while study II involved patients with no prior history of MSP . Treatment satisfaction , pain experience , activities and sickness absenteeism were assessed before , after and at a 12‐month follow‐up . In study I ( patients with a history of MSP ) , the results showed significant improvements for both groups , but virtually no differences between the groups . Similarly , in study II ( no history of MSP ) both groups demonstrated significant improvements e.g. , for pain intensity and activity levels . However , the Early Active treatment result ed in significantly less sick‐listing relative to the control group . Moreover , the risk of developing chronic ( > 200 sick days ) pain was 8 times lower for the Early Activation group . This investigation shows that relatively simple changes in treatment result in reduced sickness absenteeism for ‘ first‐time ’ sufferers only . Consequently , the content and timing of treatment for pain appear to be crucial . Properly administered early intervention may therefore decrease sick leave and prevent chronic problems , thus saving considerable re sources BACKGROUND Bed rest and back-extension exercises are often prescribed for patients with acute low back pain , but the effectiveness of these two competing treatments remains controversial . METHODS We conducted a controlled trial among employees of the city of Helsinki , Finl and , who presented to an occupational health care center with acute , nonspecific low back pain . The patients were r and omly assigned to one of three treatments : bed rest for two days ( 67 patients ) , back-mobilizing exercises ( 52 patients ) , or the continuation of ordinary activities as tolerated ( the control group ; 67 patients ) . Outcomes and costs were assessed after 3 and 12 weeks . RESULTS After 3 and 12 weeks , the patients in the control group had better recovery than those prescribed either bed rest or exercises . There were statistically significant differences favoring the control group in the duration of pain , pain intensity , lumbar flexion , ability to work as measured subjectively , the Oswestry back-disability index , and number of days absent from work . Recovery was slowest among the patients assigned to bed rest . The overall costs of care did not differ significantly among the three groups . CONCLUSIONS Among patients with acute low back pain , continuing ordinary activities within the limits permitted by the pain leads to more rapid recovery than either bed rest or back-mobilizing exercises A preliminary investigation was undertaken on 117 acute back pain cases , to assess the utility of counseling at the acute stage upon the course of recovery over the subsequent 6 months . In addition , the extent to which psychological reactions to acute injury would allow the ' tagging ' of individuals at risk for chronic pain problems , was studied . The minimal rehabilitation counseling proved inadequate to effect the course of recovery , but remarkably accurate predictions were possible at the sub-chronic point ( 3 months ) as to who would make complete recoveries BACKGROUND Bed rest is a traditional treatment for back pain , yet only in recent years has the therapeutic benefit of this been question ed . AIM The aim of this pilot study was to ascertain whether or not 48 hours ' bed rest had an effect on the outcome of acute low back pain . METHOD The study was conducted as a r and omized controlled trial to compare a prescription of 48 hours ' strict bed rest with controls ; the control subjects were encouraged to remain mobile and to have no daytime rest . Nine general practitioners from practice s in the West Midl and s recruited patients in the age range 16 - 60 years who presented with low back pain of less than seven days ' duration , with or without pain radiation . The outcome measures assessed were : change in straight leg raise and lumbar flexion after seven days , Oswestry and Rol and -Morris disability scores after seven days and 28 days , and time taken from work . RESULTS Forty two patients were recruited : 20 were allocated to bed rest and 22 as controls . Compared with the bed rest group the control group had statistically better Rol and -Morris scores at day seven ( P < 0.05 ) but not at day 28 . At day seven , there were no statistically significant differences between groups in straight leg raise or lumbar flexion measurements although the control group had a better mean lumbar flexion than the bed rest group . The improvement in disability scores at day seven compared with day one was similar for the two groups but more of the control group had fully recovered ( defined as scores of one or zero on the Rol and -Morris disability scale and five or less on the Oswestry disability scale ) by day seven . Remaining mobile did not appear to cause any adverse effects . The number of days lost from work in both groups was equal . A large number of self-remedies and physical therapies were recorded by subjects from both groups . CONCLUSION The results of this pilot study did not indicate whether bed rest or remaining mobile was superior for the treatment of acute low back pain ; however , the study sample was small . Subjects in the control group possibly fared better as they appeared to have better lumbar flexion at day seven . It appears that 48 hours ' bed rest can not be recommended for the treatment of acute low back pain on the basis of this small study . Large-scale definitive trials are required to detect clinical ly significant differences A population -based survey of approximately 4000 adults in Belgium , a bi-cultural country with a uniform health care system , explored the relationships of socio-cultural and employment factors to the reported experience of low back pain ( LBP ) . Predictors of 1 ) history of LBP , 2 ) first LBP , and 3 ) daily LBP were examined by multiple logistic regression analysis . Thirty-three percent of the population had current LBP , including 5 % experiencing their first episode ; 26 % had past but not current LBP , and 41 % had never had LBP . Increasing age ( OR > 2.0 , P = .000 ) and female gender ( OR 2.16 , P = .000 ) were associated with history of LBP ; only gender ( OR 1.40 , P = .02 ) was associated with first episode ; neither was associated with daily LBP . Language was associated with history ( OR 1.80 , P = .000 ) and first occurrence ( OR 1.77 , P = .000 ) but not daily LBP . Among those employed , work dissatisfaction was associated with history of LBP ( OR > 2.4 , P = .02 ) and daily LBP ( OR 3.85 , P = .02 ) , but not with first episode . The results suggest that sociocultural factors influence the expression of LBP , but not the risk of chronicity once LBP is reported , and that work satisfaction may not be causally related to LBP , but may intervene along with type of occupation in the possibility of continuing employment once LBP is present . Prospect i ve studies are needed to confirm these results and eluci date causal relationships |
11,564 | 21,678,358 | The primary -care model was found to provide slightly better results than the comparator for some outcomes such as resident well-being or behaviour .
Therefore , these studies should be regarded with caution and there is little clear evidence for the effective use of any specific model of care in residential aged care to benefit either residents or care staff . | BACKGROUND A key concern for managers and nurse administrators of healthcare setting s is staffing .
Determining and maintaining an appropriate level and mix of staff is especially problematic for those working in the long-term aged-care sector , where resident needs are complex and recruitment and retention of staff is challenging .
OBJECTIVES To identify which staffing models are associated with the best patient and staff outcomes . | The purpose of this study was to evaluate primary and team nursing on two 45-bed geriatric units . A 2 year longitudinal study with a quasi-experimental ABA cross-over design and a staff survey , permitted comparisons of the two nursing systems on indices of patient well-being , nursing practice , staff morale and costs . Differences in nursing practice , in selected measures of patient well-being and in responses to the staff survey were positively associated with primary nursing . No differences emerged in relation to staff morale or costs . The benefits of primary nursing and implication s for further research are discussed This study is part of a project that aim ed to increase the participation of informal caregivers in the hospital care for elderly patients . The staff who worked in the wards that were studied created activity programmes for caregivers and changed their ward policies to encourage the participation of the caregivers . In addition , quality assurance programmes were developed and primary nursing was introduced to ensure individualized , need-based and family centered care . In order to explore the changes in perceived quality of care , and to test the differences in care quality between the study and the control wards ( i.e. two wards in a university hospital , two wards in a geriatric unit and two wards of a nursing home ) , the interrupted time series with a non-equivalent control group time series design was used . During periods of 2 months in 1991 , 1992 and 1993 the data were collected from elderly patients ( n = 97 ) and their informal caregivers ( n = 369 ) using a structured question naire based on need theories . The results indicated that the quality of care was improved , especially in the study wards of the university hospital and of the nursing home . This care quality measure was found to be a useful tool for getting feedback from patients and their caregivers concerning care given . Aspects of nursing practice that needed to be improved were identified ( i.e. poor communication between the patient , their caregiver and staff , and lack of support to the patient and caregiver by staff ) 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 CONTEXT Death is common in nursing homes , but access to palliative care is limited . OBJECTIVE To test whether a quality improvement ( QI ) intervention in nursing homes increases hospice , pain management , and advance care planning . DESIGN AND SETTING The QI intervention was tested in seven nursing homes using a prepost study design . Two additional nursing homes served as control sites . PARTICIPANTS Nine nursing homes serving 1169 residents . INTERVENTION The intervention included recruitment and training of Palliative Care Leadership Teams in each facility , followed by six technical assistance meetings for team members . Hospice providers delivered six educational sessions for all nursing home staff using a structured curriculum . Teams received feedback of performance data on hospice enrollment , pain management , and advance care planning at 0 , 3 , and 6 months . MAIN OUTCOME MEASURES Percentage of residents receiving hospice or palliative services , pain assessment , pain treatment among residents in pain , and documented advance care planning discussion s. RESULTS Intervention facilities increased hospice enrollment from 4.0 % of residents at baseline to 6.8 % postintervention ( p = .01 ) and increased pain assessment s from 18 % to 60 % ( p < .001 ) . Among resident in pain , orders for nonpharmacologic pain treatments increased from 15 % to 35 % ( p < .001 ) , but pain medication use did not change . Residents with in-depth discussion s about end-of-life care increased from 4 % to 17 % ( p < .001 ) . There were no significant changes in control sites . CONCLUSIONS A quality improvement intervention was effective in increasing hospice enrollment , pain assessment , nonpharmacologic pain treatment , and advance care planning discussion BACKGROUND In nursing homes there is a gradual move from traditional care to integrated care . Integrated care means a dem and -oriented , small-scale , co-operated and coordinated provision of services by different caregivers . This integration has direct effect on the work of these separate disciplines . With the introduction of integrated care the quality of work of these caregivers should be assured or even be improved . OBJECTIVES The purpose of this study was to examine the implementation of integrated care in the nursing home sector and its effects on the quality of work of the caregivers ( work content , communication and co-operation and worker 's outcomes ) . DESIGN A non-equivalent pre-test/post-test control group design was used in this study . SETTING S AND PARTICIPANTS Two nursing homes in the Netherl and s participated in the study . One nursing home provided the five experimental nursing wards and the other nursing home provided four control wards . METHOD Data were selected by means of written question naires . RESULTS The results showed that the intervention appeared to be only successful on the somatic wards . The caregivers of these wards were more able to create a home-like environment for their residents , to use a dem and -oriented working method and to integrate the provision of care and services . Regarding the effects of the intervention on quality of work factors , the results included an increase of social support by the supervisor , an increase of the degree of collaboration and a decrease in job dem and s. No changes were found for the worker 's outcomes such as job satisfaction . CONCLUSIONS The intervention on the psycho-somatic wards was unsuccessful . Although the introduction of integrated care on the somatic wards was successful , the effects on quality of work were limited . Next to quantitative research , more qualitative in-depth research is needed to examine models of integrated care and their effects on the work of caregivers within health care organisations , with special attention for specific characteristics of different types of nursing home care ( somatic vs. psycho-geriatric ) Several studies have examined the effectiveness of geriatric assessment teams in outpatient and acute care setting s. This project compared medical records of 69 consecutive nursing home patients r and omly assigned on arrival to team ( n = 33 ) and nonteam ( st and ard care , n = 36 ) conditions . Quality -of-care indices and healthcare service utilization were compared over a 12-month postadmission period . Team patients had a significantly greater number of diagnoses and ancillary services combined with nonsignificant trends toward decreased mortality , fewer emergency department visits , and fewer drugs prescribed . The team approach improves quality of care . Additional clinical studies evaluating the effectiveness of geriatric assessment teams should be made in other nursing homes OBJECTIVES To examine the effect of integrated emotion-oriented care on nursing home residents with dementia and nursing assistants . DESIGN A multi-site r and omized clinical trial with matched groups , and measurements at baseline and after seven months . SETTING Sixteen psychogeriatric wards in fourteen nursing homes in the Netherl and s. PARTICIPANTS One hundred and forty-six elderly residents with the diagnosis dementia of the Alzheimer ( DAT ) type , mixed DAT and vascular dementia , and dementia syndrome ( NAO ) and 99 nursing assistants . INTERVENTIONS Integrated emotion-oriented care and usual care . MESUREMENTS : Demented elderly : Behaviour and mood related to adaptation to the illness and the institutionalization . Nursing assistants : General health as measured by feelings of stress , stress reactions , feeling of competence and illness . RESULTS Positive effects in favour of the integrated emotion-oriented care were found in mild to moderately demented residents on two adaptive tasks : maintaining an emotional balance ( less anxiety ) and preserving a positive self-image ( less dissatisfaction ) . In the trained group of nursing assistants fewer stress reactions were found only in those who perceived improvement in their emotion-oriented care skills after training . CONCLUSION Emotion-oriented care is more effective with regard to the emotional adaptation in nursing homes of persons with a mild to moderate dementia . For the severely demented elderly we did not find this surplus value . This outcome is of clinical importance for elderly persons with dementia who are cared for in nursing homes . With respect to the nursing assistants it is concluded that emotion-oriented care has a positive influence on stress reactions in some of them OBJECTIVES --To assess the effect of preventive home visits by public health nurses on the state of health of and use of services by elderly people living at home . DESIGN --R and omised controlled trial . SETTING --General population of elderly people in one of the southern regions of the Netherl and s. SUBJECTS--580 subjects aged between 75 and 84 years r and omly allocated to intervention ( 292 ) or control ( 288 ) group . INTERVENTIONS --Four visits a year over three years in intervention group . Control group received no home visits . MAIN OUTCOME MEASURES --Self rated health , functional state , well being , loneliness , aspects of the mental state ( depressive complaints , memory disturbances ) , and mortality . Use of services and costs . RESULTS --Visits had no effect on the health of the subjects . In the group visited no higher scores were seen on health related measures , fewer died ( 42 ( 14 % ) v 50 ( 17 % ) ) , and community care increased slightly . In the control group more were referred to outpatient clinics ( 166 ( 66 % ) v 132 ( 55 % ) ) , and they had a 40 % increased risk of admission ( incidence rate ratio 1.4 ; 90 % confidence interval 1.2 to 1.6 ) . No differences were found in long term institutional care , and overall expenditure per person in the intervention group exceeded that in the control group by 4 % . Additional analyses showed that visits were effective for subjects who initially rated their health as poor . CONCLUSIONS --Preventive home visits are not beneficial for the general population of elderly people living at home but might be effective when restricted to subjects with poor health PURPOSE The purpose of this study was to describe the processes of care , organizational attributes , cost of care , staffing level , and staff mix in a sample of Missouri homes with good , average , and poor resident outcomes . DESIGN AND METHODS A three-group exploratory study design was used , with 92 nursing homes r and omly selected from all nursing homes in Missouri and classified into resident outcome groups . Resident outcomes were measured by use of quality indicators derived from nursing home Minimum Data Set resident assessment data . Cost and staffing information were derived from Medicaid cost reports . Participant observation methods were used to describe the care delivery processes . RESULTS In facilities with good resident outcomes , there are basics of care and processes surrounding each that staff consistently do : helping residents with ambulation , nutrition and hydration , and toileting and bowel regularity ; preventing skin breakdown ; and managing pain . The analysis revealed necessary organizational attributes that must be in place in order for those basics of care to be accomplished : consistent nursing and administrative leadership , the use of team and group processes , and an active quality improvement program . The only facility characteristic across the outcome groups that was significantly different was the number of licensed beds , with smaller facilities having better outcomes . No significant differences in costs , staffing , or staff mix were detected across the groups . A trend in higher total costs of 13.58 dollars per resident per day was detected in the poor- outcome group compared with the good- outcome group . IMPLICATION S For nursing homes to achieve good resident outcomes , they must have leadership that is willing to embrace quality improvement and group process and see that the basics of care delivery are done for residents . Good quality care may not cost more than poor quality care ; there is some evidence that good quality care may cost less . Small facilities of 60 beds were more likely to have good resident outcomes . Strategies have to be considered so larger facilities can be organized into smaller clusters of units that could function as small nursing homes within the larger whole Recently the Centers for Medicare and Medicaid Services ( CMS ) , citing increasing resident acuity , staffing shortages , and high turnover rates that make it difficult for nursing homes to provide adequate feeding assistance to residents who need minimal help at mealtimes , began allowing nursing facilities to use single-task workers to provide assistance during mealtimes . This article describes the use of single-task workers to provide feeding assistance to nutritionally at-risk residents during a 6-month clinical study design ed to evaluate the effectiveness and feasibility of implementing a buffet-dining program in an academic long-term care facility A 6-month clinical trial was conducted to evaluate two models of restorative nursing care design ed to improve mobility in nursing home residents . The models were compared on number of residents enrolled , documentation of nursing assistant ( NA ) compliance , and nursing staff satisfaction . The design ated model , which relied on one specially trained NA to perform restorative activities on the unit , result ed in higher rates of enrollment , compliance , and staff satisfaction compared with the integrated model , which relied on regular staff NAs who were trained to incorporate restorative activities into their daily routines |
11,565 | 27,051,991 | DISCUSSION The difference in risk of VTE based on the choice of progestin in COCs is , at worst , very small in absolute terms and should not be the sole factor considered when choosing the ' right ' COC for each woman | BACKGROUND Much scientific , media and patient interest surrounds the risk of venous thromboembolism ( VTE ) in women taking combined oral contraceptives ( COCs ) .
OBJECTIVE We conducted a systematic review and meta- analysis to assess VTE risk in women taking COCs , focusing on drospirenone . | Objective To examine the risk of non-fatal idiopathic venous thromboembolism in current users of a combined oral contraceptive containing drospirenone , relative to current users of preparations containing levonorgestrel . Design Nested case-control study . Setting UK General Practice Research Data base . Participants Women aged 15 - 44 years without major risk factors for venous thromboembolism who started a new episode of use of an oral contraceptive containing 30 µg oestrogen in combination with either drospirenone or levonorgestrel between May 2002 and September 2009 . Cases were women with a first diagnosis of venous thromboembolism ; up to four controls , matched by age , duration of recorded information , and general practice , were r and omly selected for each case . Main outcome measures Odds ratios and 95 % confidence intervals estimated with conditional logistic regression ; age adjusted incidence rate ratio estimated with Poisson regression . Results 61 cases of idiopathic venous thromboembolism and 215 matched controls were identified . In the case-control analysis , current use of the drospirenone contraceptive was associated with a threefold higher risk of non-fatal idiopathic venous thromboembolism compared with levonorgestrel use ; the odds ratio adjusted for body mass index was 3.3 ( 95 % confidence interval 1.4 to 7.6 ) . Subanalyses suggested that referral , diagnostic , first time user , duration of use , and switching biases were unlikely explanations for this finding . The crude incidence rate was 23.0 ( 95 % confidence interval 13.4 to 36.9 ) per 100 000 woman years in current users of drospirenone and 9.1 ( 6.6 to 12.2 ) per 100 000 woman years in current users of levonorgestrel oral contraceptives . The age adjusted incidence rate ratio was 2.7 ( 1.5 to 4.7 ) . Conclusions These findings contribute to emerging evidence that the combined oral contraceptive containing drospirenone carries a higher risk of venous thromboembolism than do formulations containing levonorgestrel OBJECTIVE To determine the incidence of venous thromboembolism ( VTE ) , comprising deep vein thrombosis ( DVT ) and pulmonary embolism ( PE ) , in a well defined urban community broadly representative of the Australian population in terms of age , sex and ethnic distribution . DESIGN , SETTING AND PARTICIPANTS A prospect i ve , community-based study conducted over a 13-month period from 1 October 2003 to 31 October 2004 . People in a population of 151 923 permanent residents of north-eastern metropolitan Perth , Western Australia , who developed VTE during the study period were identified prospect ively and retrospectively through multiple overlapping sources . MAIN OUTCOME MEASURE Number of cases of symptomatic , objective ly verified DVT and PE . RESULTS 137 patients had 140 VTE events ( 87 DVT and 53 PE ) . The crude annual incidence per 1000 residents was 0.83 ( 95 % CI , 0.69 - 0.97 ) for VTE , 0.52 ( 95 % CI , 0.41 - 0.63 ) for DVT , and 0.31 ( 95 % CI , 0.22 - 0.40 ) for PE . The annual incidence per 1000 residents after age adjustment to the World Health Organization World St and ard Population was 0.57 ( 95 % CI , 0.47 - 0.67 ) for VTE , 0.35 ( 95 % CI , 0.26 - 0.44 ) for DVT , and 0.21 ( 95 % CI , 0.14 - 0.28 ) for PE . CONCLUSION If the crude annual incidence of VTE in this area of metropolitan Perth is externally valid , then VTE affects about 17 000 Australians annually . Future studies of trends in VTE incidence will be needed to measure the effectiveness of VTE prevention strategies OBJECTIVES The study was conducted to compare risks of adverse cardiovascular and other events associated with the use of drospirenone (DRSP)-containing oral contraceptives ( OCs ) and other OCs . METHODS AND MATERIAL S The European Active Surveillance study ( EURAS ) was a multinational , prospect i ve , noninterventional cohort study of new users of DRSP , levonorgestrel ( LNG ) and other progestin-containing OCs . Semiannual follow-up was based on mailed question naires , with additional follow-up procedures when needed . RESULTS Overall , 58,674 women were followed for 142,475 women-years of observation . Loss to follow-up was 2.4 % . Serious adverse and fatal events were rare , and rate ratios were close to unity ( 1.0 ) . Cox regression analysis of cardiovascular outcomes yielded hazard ratios for DRSP-containing vs. LNG-containing and other OCs of 1.0 and 0.8 ( upper 95 % confidence limits , 1.8 and 1.3 ) for venous , and 0.3 and 0.3 ( upper 95 % confidence limits , 1.2 and 1.5 ) for arterial thromboembolism , respectively . CONCLUSIONS Risks of adverse cardiovascular and other serious events in users of a DRSP-containing OC are similar to those associated with the use of other OCs OBJECTIVE To determine current contraceptive management by general practitioners in Australia . DESIGN , SETTING AND PARTICIPANTS Analysis of data from a r and om sample of 3910 Australian GPs who participated in the Bettering the Evaluation and Care of Health ( BEACH ) survey , a continuous cross-sectional survey of GP activity , between April 2007 and March 2011 . Consultations with female patients aged 12 - 54 years that involved all forms of contraception were analysed . MAIN OUTCOME MEASURES GP and patient characteristics associated with the management of contraception ; types of contraception used ; rates of encounters involving emergency contraception . RESULTS Increased age , ethnicity , Indigenous status and holding a Commonwealth Health Care Card were significantly associated with low rates of encounters involving management of contraception . The combined oral contraceptive pill was the most frequently prescribed method of contraception , with moderate prescription of long-acting reversible contraception ( LARC ) , especially among women aged 34 - 54 years . Rates of consultations concerned with emergency contraception were low , but involved high rates of counselling , advice or education ( 48 % ) compared with encounters for general contraception ( > 20 % ) . CONCLUSION A shift towards prescribing LARC , as recommended in clinical guidelines , has yet to occur in Australian general practice . Better underst and ing of patient and GP perspectives on contraceptive choices could lead to more effective contraceptive use OBJECTIVES The " International Active Surveillance Study of Women Taking Oral Contraceptives " investigated the risks of short- and long-term use of an extended 24-day regimen of drospirenone and ethinylestradiol ( DRSP24d ) compared to established oral contraceptives ( OCs ) in a routine clinical setting . STUDY DESIGN Prospect i ve , controlled , noninterventional cohort study conducted in the United States and six European countries with three main cohorts : new users of DRSP24d , DRSP21d ( 21-day regimens of DRSP-containing OCs ) , and non-DRSP ( OCs without DRSP ) . All self-reported clinical outcomes of interest ( OoI ) were vali date d via attending physicians and relevant source documents . Main OoI were serious clinical outcomes , in particular venous thromboembolism ( VTE ) . Comprehensive follow-up procedures were implemented . Statistical analyses were based on Cox regression models . Primary statistical variable was the VTE hazard ratio ( HR ) for DRSP24d vs. non-DRSP . RESULTS A total of 2285 study centers enrolled 85,109 women . Study participants were followed for 2 to 6 years , which generated 206,296 woman-years ( WY ) of observation . A low loss to follow-up of 3.3 % was achieved . DRSP24d , DRSP21d , non-DRSP and levonorgestrel-containing OCs ( LNG ) showed similar incidence rates of venous and arterial thromboembolism , fatal outcomes , cancer , severe depression and other serious adverse events . VTE incidence rates for DRSP24d , DRSP21d , non-DRSP and LNG were 7.2 , 9.4 , 9.6 and 9.8 VTE/10,000 WY , respectively . Adjusted HRs for DRSP24d vs. non-DRSP and DRSP24d vs. LNG were 0.8 [ 95 % confidence interval ( CI ) , 0.5 - 1.3 ] and 0.8 ( 95 % CI , 0.4 - 1.5 ) . CONCLUSION DRSP24d , DRSP21d , non-DRSP and LNG use was associated with similar risks of serious adverse events , and particularly VTE , during routine clinical use . IMPLICATION STATEMENT The 24-day regimen of drospirenone-containing combined OCs is associated with similar risks of venous and arterial thromboembolism , fatal outcomes , cancer , severe depression and other serious adverse events compared to 21-day regimens of drospirenone-containing combined OCs , OCs without drospirenone and LNGs |
11,566 | 15,920,083 | It has been suggested that patients with type 2 diabetes who are not using insulin might also benefit from SMBG ( 13 ) .
These patients might cope more independently with their disease when using SMBG , and they might achieve a better underst and ing about the factors that affect their disease and potentially a better perceived quality of life .
SMBG might also improve adherence to pharmacological treatment and motivate patients to make appropriate lifestyle changes ( 10,14 ) .
Other outcome measures like quality of life | A strict glycemic control reduces the risk of the development of micro- and macrovascular complications ( 1–3 ) .
In the U.K. Prospect i ve Diabetes Study , each 1 % reduction in HbA1c was associated with a 37 % decrease in risk for microvascular complications and a 21 % decrease in risk for any end point or death related to diabetes ( 3 ) .
In clinical practice , a 3-monthly visit to the general practitioner is recommended for the assessment of glycemic control ( 4 ) .
There is now much debate on the effectiveness of self-monitoring of blood glucose ( SMBG ) as a tool in the self-management of diabetic patients ( 1,5,6 ) .
SMBG aims at collecting information on blood glucose levels at different time points during the day and allows for the timely identification of high levels .
SMBG has proven effective for patients with type 1 diabetes ( 7–9 ) and patients with type 2 diabetes who are using insulin ( 10–12 ) because the information about a patient ’s glucose level is useful to refine and adjust insulin dosages , result ing in an improved glycemic control . | A cross-sectional study to assess home glucose monitoring practice s was conducted in 200 non-insulin-treated diabetic patients consecutively attending our hospital clinic . Of the 200 , 97 ( 48 % ) patients ( Group 1 ) regularly monitored urine ( n = 74 ) , blood ( n = 19 ) or both ( n = 4 ) ; 103 ( 52 % ) patients ( Group 2 ) performed no home monitoring . The two groups were similar in terms of age , sex , duration of diabetes and type of treatment . The prevalence of diabetic complications was also closely comparable and only peripheral neuropathy differed between the groups , being more common in Group 1 ( n = 12 ) than Group 2 ( n = 4 ) ; p < 0.05 . There was also no significant difference between the HbA1 concentration ( mean + /- SD ) in Group 1 ( 9.7 + /- 2.2 % ) and Group 2 ( 9.4 + /- 2.0 % ) . The mean frequency of home monitoring was four tests weekly , but only 21 ( 22 % ) kept a written record and 60 ( 62 % ) would never alter their treatment on the basis of their results . Almost a third of patients could not interpret the results of monitoring or give the normal range of values . Home glucose monitoring , particularly of urine , is widely practised in Type 2 diabetes , at considerable overall expense . However , convincing evidence of its value in helping patients improve their blood glucose control or preventing the complications of the disease is lacking The goal of this study was to compare the relative efficacy and cost of self-monitoring of blood glucose ( SMBG ) with routine urine testing in the management of patients with type II ( non-insulin-dependent ) diabetes mellitus not treated with insulin . Fifty-four patients with type II diabetes mellitus , not treated with insulin , who had inadequate glucose control on diet aloneor diet and oral hypoglycemic agents were studied . Patients performed SMBG or urine glucose testing as part of a st and ardized treatment program that also included diet and exercise counseling . During the 6-mo study , both the urine-testing and SMBG groups showed similar improvement in glycemic control ; within each group , there were significant improvements in fasting plasma glucose ( reduction of 1.4 ± 3.2 mM , P < 0.03 ) and glycosylated hemoglobin ( reduction of 2.0 ± 3.4 % , P < 0.01 ) levels . Seventeen ( 31 % ) of54 patients actually normalized their glycosylated hemoglobin values , 9 in the urine-testing group and 8 in the SMBG group . Comparisons between the urine-testing and SMBG groups showed no significant differences in mean fasting plasma glucose ( P > 0.86 ) , glycosylated hemoglobin ( P > 0.95 ) , or weight ( P < 0.19 ) . In patients with type II diabetes mellitus not treated with insulin , SMBG is no more effective , but is 8–12 times more expensive , thanurine testing in facilitating improved glycemic control . Our results do not support widespread use of SMBG in diabetic patients not treated with insulin BACKGROUND Long-term microvascular and neurologic complications cause major morbidity and mortality in patients with insulin-dependent diabetes mellitus ( IDDM ) . We examined whether intensive treatment with the goal of maintaining blood glucose concentrations close to the normal range could decrease the frequency and severity of these complications . METHODS A total of 1441 patients with IDDM--726 with no retinopathy at base line ( the primary -prevention cohort ) and 715 with mild retinopathy ( the secondary -intervention cohort ) were r and omly assigned to intensive therapy administered either with an external insulin pump or by three or more daily insulin injections and guided by frequent blood glucose monitoring or to conventional therapy with one or two daily insulin injections . The patients were followed for a mean of 6.5 years , and the appearance and progression of retinopathy and other complications were assessed regularly . RESULTS In the primary -prevention cohort , intensive therapy reduced the adjusted mean risk for the development of retinopathy by 76 percent ( 95 percent confidence interval , 62 to 85 percent ) , as compared with conventional therapy . In the secondary -intervention cohort , intensive therapy slowed the progression of retinopathy by 54 percent ( 95 percent confidence interval , 39 to 66 percent ) and reduced the development of proliferative or severe nonproliferative retinopathy by 47 percent ( 95 percent confidence interval , 14 to 67 percent ) . In the two cohorts combined , intensive therapy reduced the occurrence of microalbuminuria ( urinary albumin excretion of > or = 40 mg per 24 hours ) by 39 percent ( 95 percent confidence interval , 21 to 52 percent ) , that of albuminuria ( urinary albumin excretion of > or = 300 mg per 24 hours ) by 54 percent ( 95 percent confidence interval 19 to 74 percent ) , and that of clinical neuropathy by 60 percent ( 95 percent confidence interval , 38 to 74 percent ) . The chief adverse event associated with intensive therapy was a two-to-threefold increase in severe hypoglycemia . CONCLUSIONS Intensive therapy effectively delays the onset and slows the progression of diabetic retinopathy , nephropathy , and neuropathy in patients with IDDM Most systematic review s rely substantially on the assessment of the method ological quality of the individual trials . The aim of this study was to obtain consensus among experts about a set of generic core items for quality assessment of r and omized clinical trials ( RCTs ) . The invited participants were experts in the field of quality assessment of RCTs . The initial item pool contained all items from existing criteria lists . Subsequently , we reduced the number of items by using the Delphi consensus technique . Each Delphi round comprised a question naire , an analysis , and a feedback report . The feedback report included staff team decisions made on the basis of the analysis and their justification . A total of 33 international experts agreed to participate , of whom 21 completed all question naires . The initial item pool of 206 items was reduced to 9 items in three Delphi rounds . The final criteria list ( the Delphi list ) was satisfactory to all participants . It is a starting point on the way to a minimum reference st and ard for RCTs on many different research topics . This list is not intended to replace , but rather to be used alongside , existing criteria lists Abstract Objective : To determine the relation between exposure to glycaemia over time and the risk of macrovascular or microvascular complications in patients with type 2 diabetes . Design : Prospect i ve observational study . Setting : 23 hospital based clinics in Engl and , Scotl and , and Northern Irel and . Participants : 4585 white , Asian Indian , and Afro-Caribbean UKPDS patients , whether r and omised or not to treatment , were included in analyses of incidence ; of these , 3642 were included in analyses of relative risk . Outcome measures : Primary predefined aggregate clinical outcomes : any end point or deaths related to diabetes and all cause mortality . Secondary aggregate outcomes : myocardial infa rct ion , stroke , amputation ( including death from peripheral vascular disease ) , and microvascular disease ( predominantly retinal photo-coagulation ) . Single end points : non-fatal heart failure and cataract extraction . Risk reduction associated with a 1 % reduction in up date d mean HbA1c adjusted for possible confounders at diagnosis of diabetes . Results : The incidence of clinical complications was significantly associated with glycaemia . Each 1 % reduction in up date d mean HbA1c was associated with reductions in risk of 21 % for any end point related to diabetes ( 95 % confidence interval 17 % to 24 % , P<0.0001 ) , 21 % for deaths related to diabetes ( 15 % to 27 % , P<0.0001 ) , 14 % for myocardial infa rct ion ( 8 % to 21 % , P<0.0001 ) , and 37 % for microvascular complications ( 33 % to 41 % , P<0.0001 ) . No threshold of risk was observed for any end point . Conclusions : In patients with type 2 diabetes the risk of diabetic complications was strongly associated with previous hyperglycaemia . Any reduction in HbA1c is likely to reduce the risk of complications , with the lowest risk being in those with HbA1c values in the normal range ( < 6.0 % ) To study if self-monitoring of glucose , urinary or capillary , could help them to improve their metabolic control through better compliance to diet and /or hypoglycaemic agents , 208 non-insulin-treated poorly controlled diabetic patients were r and omized to : group A -- regular HbA1c determinations but no self-monitoring , group B -- self-urine glucose monitoring , twice every other day , group C -- self blood glucose monitoring , twice every other day , and followed six months . At the end of the study period , the decrease of HbA1c over six months -- main endpoint -- was not significantly different between the three groups ( mean + /- SEM ; group A : -0.5 + /- 0.2 % ; group B : -0.1 + /- 0.3 % ; group C : -0.4 + /- 0.3 % ) . However , the degree of compliance to blood glucose self-monitoring in group C appeared to relate to the outcome : a significant correlation was found between the number of blood glucose strips used and the decrease of HbA1c ( r = .36 , p less than .02 ) . We conclude that regular self-monitoring has no definite advantage over the usual management for improving metabolic control in non-insulin-treated diabetic patients , though it may possibly help patients ready to comply with its use The Diabetes Control and Complications Trial ( DCCT ) provided much information towards settling the long-running controversy about the effectiveness of improving control of diabetes on the risk of its major complications . With the appearance or the advance of clinical ly significant retinopathy as its major outcome variable , DCCT r and omised 1,441 insulin-dependent diabetic patients to conventional or intensified control groups . In both primary prevention and secondary intervention arms of the trial , intensified control reduced retinopathy risk by half or more , and also reduced nephropathy and neuropathy risks -- however , risk of severe hypoglycaemic episodes was increased about three-fold . By contrast , there were no differences in quality of life , neurocognitive or emotional assessment s between the two groups . The application of trial findings to ' real life ' care is considered The purpose of the study was to determine whether blood glucose monitoring strips influence the management of patients with non-insulin dependent diabetes ( NIDDM ) in the primary care setting . The medical records of 115 patients with NIDDM taking a sulfonylurea drug ( oral hypoglycemic agent ) during the review period were r and omly selected for review . Patients were divided into two groups : those who did not receive a prescription for blood glucose monitoring strips during 1995 and 1996 and those who did for the same 2 years . The main outcome measures were hemoglobin A1c , blood sugar , number of laboratory tests ordered , and number and type of treatment interventions . No statistically significant differences between groups were noted for any measured parameter . Glucose control was independent of number of strips dispensed . Home glucose monitoring strips did not affect the management of patients with NIDDM taking a sulfonylurea agent in the primary care setting |
11,567 | 25,608,571 | Conclusion DWI has high sensitivity and specificity for detecting deep myometrial invasion and more importantly can reliably rule out deep myometrial invasion .
Therefore , it would be worthwhile to add a DWI sequence to the st and ard MRI protocol s in preoperative evaluation of endometrial cancer in order to detect deep myometrial invasion , which along with other poor prognostic factors like age , tumor grade , and LVSI would be useful in stratifying high risk groups thereby helping in the tailoring of surgical approach in patient with low risk of endometrial carcinoma | Background The objective of this study was to perform a systematic review and a meta- analysis in order to estimate the diagnostic accuracy of diffusion weighted imaging ( DWI ) in the preoperative assessment of deep myometrial invasion in patients with endometrial carcinoma . | PURPOSE To assess the diagnostic accuracy of fused T2-weighted and high-b-value diffusion-weighted ( DW ) magnetic resonance ( MR ) images at 3 T for evaluation of myometrial invasion in patients with endometrial cancer . MATERIAL S AND METHODS Institutional review board approval and informed consent were obtained . From May 2006 to October 2007 , 48 consecutive patients aged 25 - 80 years ( mean age , 57 years ) who had endometrial cancer were prospect ively enrolled for preoperative evaluation by using a 3-T MR unit . Two radiologists interpreted the depth of myometrial invasion on T2-weighted images , dynamic contrast material -enhanced MR images , and fused T2-weighted and DW MR images ( b = 1000 sec/mm(2 ) ) . Statistical methods included kappa statistics for reader agreement , Pearson analysis for pathologic correlation , accuracy assessment , and receiver operating characteristic analysis for diagnostic performance comparison . Surgical pathologic findings were the reference st and ard . RESULTS Reader agreement was excellent for fused T2-weighted and DW images ( weighted kappa , 0.79 ) , with a significant pathologic correlation regarding the depth of myometrial invasion ( r = 0.94 , P < .0001 ) . For assessing any myometrial involvement , addition of fused T2-weighted and DW imaging to dynamic contrast-enhanced or dynamic contrast-enhanced and T2-weighted imaging was significantly better compared with dynamic contrast-enhanced imaging alone ( P < .001 ) or dynamic contrast-enhanced and T2-weighted ( P = .001 ) imaging ; T2-weighted imaging combined with fused T2-weighted and DW imaging also was better than dynamic contrast-enhanced and T2-weighted imaging ( P = .001 ) . Tumor apparent diffusion coefficients were 0.60 - 1.32 x 10(-3 ) mm(2)/sec ( median , 0.75 x 10(-3 ) mm(2)/sec ) , with no significant correlation with the depth of myometrial invasion ( P = .31 , r = -0.15 ) . CONCLUSION Fused T2-weighted and high-b-value DW images at 3 T can provide accurate information for preoperative evaluation of myometrial invasion Abstract Objectives To prospect ively assess the efficacy of 3-T magnetic resonance ( MR ) imaging using the three-dimensional turbo spin-echo T2-weighted and diffusion-weighted technique ( 3D-TSE/DW ) compared with that of conventional imaging using the two-dimensional turbo spin-echo T2-weighted and dynamic contrast-enhanced technique ( 2D-TSE/DCE ) for the preoperative staging of endometrial cancer , with pathological analysis as the reference st and ard . Methods Seventy-one women with endometrial cancer underwent MR imaging using 3D-TSE/DW ( b = 1,000 s/mm2 ) and 2D-TSE/DCE . Two radiologists independently assessed the two imaging sets . Accuracy , sensitivity , and specificity for staging were analysed with the McNemar test ; the areas under the receiver operating characteristic curve ( Az ) were compared with a univariate z-score test . Results The results for assessing deep myometrial invasion , accuracy , sensitivity , specificity and Az , respectively , were as follows : 3D-TSE/DW — observer 1 , 87 % , 95 % , 85 % and 0.96 ; observer 2 , 92 % , 84 % , 94 % and 0.95 ; 2D-TSE/DCE — observer 1 , 80 % , 79 % , 81 % and 0.89 ; observer 2 , 86 % , 84 % , 87 % and 0.86 . Most of the values were higher with 3D-TSE/DW without significant differences ( P > 0.12 ) . For assessing cervical stromal invasion , there were no significant differences in those values for both observers ( P > 0.6 ) . Conclusions Accuracy of 3D-TSE/DW was at least equivalent to that of the conventional technique for the preoperative assessment of endometrial cancer . Key Points• New techniques in MR imaging help assess patients with endometrial cancer . • A 3D T2-weighted TSE sequence seems equally as accurate as conventional techniques . • Three-dimensional TSE/DW imaging does not require intravenous contrast material and is relatively quick . • Tumour extent of endometrial cancer can be clearly shown on diffusion-weighted images . • Junctional zone can be visualised well on 3D-TSE T2-weighted images Objective To determine the diagnostic accuracy of diffusion-weighted ( DW ) magnetic resonance ( MR ) imaging in the preoperative assessment of myometrial invasion by endometrial cancer . Material s and methods In this prospect i ve study , 47 patients with histologically confirmed endometrial cancer underwent preoperative MR imaging and total hysterectomy . The MR protocol included spin-echo multishot T2-weighted , dynamic T1-weighted and DW images acquired with b-values of 0 and 500 s/mm2 . Myometrial tumour spread was classified as superficial ( < 50 % ) or deep ( ≥50 % myometrial thickness ) . Postoperative histopathological findings served as a reference st and ard . Indices of diagnostic performance were assessed for each sequence . Results At histopathological examination , superficial myometrial invasion was found in 34 patients and deep myometrial invasion in 13 . In the assessment of tumour invasion , sensitivity , specificity , positive and negative predictive values of T2-weighted images were 92.3 % , 76.5 % , 60.0 % and 96.3 % , respectively . The corresponding values for dynamic images were 69.2 % , 61.8 % , 40.9 % and 84.0 % , and for DW images 84.6 % , 70.6 % , 52.4 % and 92.3 % . T2-weighted and DW imaging proved to be the most accurate techniques for tumour spread determination . Conclusion DW imaging proved to be accurate in assessing myometrial invasion , and it could replace dynamic imaging as an adjunct to routine T2-weighted imaging for preoperative evaluation of endometrial cancer PURPOSE To prospect ively assess the usefulness of diffusion-weighted magnetic resonance imaging ( MRI ) with background body signal suppression ( DWIBS ) at 3 T for the preoperative evaluation of endometrial cancer . MATERIAL S AND METHODS Fifty-two consecutive patients with biopsy-proven endometrial cancer were examined with a 3 T MR scanner , followed by a hysterectomy . MR examinations included T2-weighted ( T2WI ) , DWIBS , and dynamic contrast-enhanced T1-weighted imaging ( DCEI ) . The apparent diffusion coefficient ( ADC ) was calculated in the tumor and normal myometrium . According to tumor grade , the mean ADC of the tumor was analyzed . The depth of myometrial invasion was independently assessed by two radiologists for three MRI data sets on a five-point scale . RESULTS The mean ADC of the tumors was significantly lower than that of normal myometrium ( P < 0.001 ) . The mean ADC of grade s 2 or 3 was significantly lower than grade 1 ( P < 0.01 ) . For predicting myometrial invasion , the specificity , accuracy , and area under the curve of combined T2WI and DWIBS in both readers were similar to DCEI ( P > 0.05 ) . Interreader agreement in all MRI data sets was excellent . CONCLUSION DWIBS at 3 T has potential for being an effective method for the preoperative evaluation of endometrial cancer A prospect i ve study was undertaken to assess the value of both T2-weighted spin-echo ( SE ) and contrast-enhanced dynamic gradient-echo ( GRE ) sequences using MR imaging in differentiating the deep myometrial invasion from lower stages produced by endometrial carcinoma . For the correlation of MR findings with the histopathologic findings , patients who had no myometrial invasion ( stage 1 a ) and patients in whom tumors were confined to the superficial myometrium ( stage 1 b ) at pathologic examination were combined as lower stages . Twenty patients with endometrial carcinoma were studied using both techniques . The absence of any detectable tumor ( stage 1 a ) or the presence of a tumor confined to inner half of myometrium ( stage 1 b ) and extention of tumor to the outer half of myometrium ( stage 1 c ) were used as the diagnostic criteria . In pathologic examination of excised specimens , deep myometrial invasion was detected in 9 of 20 patients . The sensitivity , specificity , accuracy , positive predictive values ( PPV ) and negative predictive values ( NPV ) of T2-weighted SE in differentiating deep myometrial invasion from combined lower stages were 88 , 91 , 90 , 88 , and 91 % , respectively , whereas corresponding values for contrast-enhanced dynamic GRE sequences were 78 , 100 , 90 , 100 , and 85 % . Statistical difference between two sequences did not reach a significant level . We conclude that in cases of absence of visible junctional zone with SE sequence , contrast-enhanced dynamic GRE MR imaging may be helpful BACKGROUND Despite their low risk for recurrence , many women with endometrial adenocarcinoma receive postoperative radiation therapy ( RT ) . This study was developed to determine if adjunctive external beam irradiation lowers the risk of recurrence and death in women with endometrial cancer International Federation of Gynaecology and Obstetrics ( FIGO ) stages IB , IC , and II ( occult disease ) . METHODS Four hundred forty-eight consenting patients with " intermediate risk " endometrial adenocarcinoma were r and omized after surgery to either no additional therapy ( NAT ) or whole pelvic radiation therapy ( RT ) . They were followed to determine toxicity , date and location of recurrence , and overall survival . A high intermediate risk ( HIR ) subgroup of patients was defined as those with ( 1 ) moderate to poorly differentiated tumor , presence of lymphovascular invasion , and outer third myometrial invasion ; ( 2 ) age 50 or greater with any two risk factors listed above ; or ( 3 ) age of at least 70 with any risk factor listed above . All other eligible participants were considered to be in a low intermediate risk ( LIR ) subgroup . RESULTS Three hundred ninety-two women met all eligibility requirements ( 202 NAT , 190 RT ) . Median follow-up was 69 months . In the entire study population , there were 44 recurrences and 66 deaths ( 32 disease or treatment-related deaths ) , and the estimated 2-year cumulative incidence of recurrence ( CIR ) was 12 % in the NAT arm and 3 % in the RT arm ( relative hazard ( RH ) : 0.42 ; P=0.007 ) . The treatment difference was particularly evident among the HIR subgroup ( 2-year CIR in NAT versus RT : 26 % versus 6 % ; RH=0.42 ) . Overall , radiation had a substantial impact on pelvic and vaginal recurrences ( 18 in NAT and 3 in RT ) . The estimated 4-year survival was 86 % in the NAT arm and 92 % for the RT arm , not significantly different ( RH : 0.86 ; P=0.557 ) . CONCLUSIONS Adjunctive RT in early stage intermediate risk endometrial carcinoma decreases the risk of recurrence , but should be limited to patients whose risk factors fit a high intermediate risk definition BACKGROUND Pelvic lymph nodes are the most common site of extrauterine tumor spread in early-stage endometrial cancer , but the clinical impact of lymphadenectomy has not been addressed in r and omized studies . We conducted a r and omized clinical trial to determine whether the addition of pelvic systematic lymphadenectomy to st and ard hysterectomy with bilateral salpingo-oophorectomy improves overall and disease-free survival . METHODS From October 1 , 1996 , through March 31 , 2006 , 514 eligible patients with preoperative International Federation of Gynecology and Obstetrics stage I endometrial carcinoma were r and omly assigned to undergo pelvic systematic lymphadenectomy ( n = 264 ) or no lymphadenectomy ( n = 250 ) . Patients ' clinical data , pathological tumor characteristics , and operative and early postoperative data were recorded at discharge from hospital . Late postoperative complications , adjuvant therapy , and follow-up data were collected 6 months after surgery . Survival was analyzed by use of the log-rank test and a Cox multivariable regression analysis . All statistical tests were two-sided . RESULTS The median number of lymph nodes removed was 30 ( interquartile range = 22 - 42 ) in the pelvic systematic lymphadenectomy arm and 0 ( interquartile range = 0 - 0 ) in the no-lymphadenectomy arm ( P < .001 ) . Both early and late postoperative complications occurred statistically significantly more frequently in patients who had received pelvic systematic lymphadenectomy ( 81 patients in the lymphadenectomy arm and 34 patients in the no-lymphadenectomy arm , P = .001 ) . Pelvic systematic lymphadenectomy improved surgical staging as statistically significantly more patients with lymph node metastases were found in the lymphadenectomy arm than in the no-lymphadenectomy arm ( 13.3 % vs 3.2 % , difference = 10.1 % , 95 % confidence interval [ CI ] = 5.3 % to 14.9 % , P < .001 ) . At a median follow-up of 49 months , 78 events ( ie , recurrence or death ) had been observed and 53 patients had died . The unadjusted risks for first event and death were similar between the two arms ( hazard ratio [ HR ] for first event = 1.10 , 95 % CI = 0.70 to 1.71 , P = .68 , and HR for death = 1.20 , 95 % CI = 0.70 to 2.07 , P = .50 ) . The 5-year disease-free and overall survival rates in an intention-to-treat analysis were similar between arms ( 81.0 % and 85.9 % in the lymphadenectomy arm and 81.7 % and 90.0 % in the no-lymphadenectomy arm , respectively ) . CONCLUSION Although systematic pelvic lymphadenectomy statistically significantly improved surgical staging , it did not improve disease-free or overall survival AIM To evaluate the usefulness of dynamic magnetic resonance ( MR ) imaging in assessing the depth of myometrial invasion , compared with conventional T2-weighted and contrast-enhanced T1-weighted imaging . PATIENTS AND METHODS Forty patients with endometrial carcinoma were examined with T2-weighted images , dynamic studies and contrast-enhanced T1-weighted images , preoperatively . We evaluated enhancement patterns of myometrium and tumour , and compared MR findings with histological results concerning the depth of myometrial invasion . RESULTS In assessing the depth of myometrial invasion , the accuracy of T2-weighted images , dynamic studies and contrast-enhanced T1-weighted images was 58 % , 85 % and 68 % , respectively . The tumour-myometrial contrast of dynamic studies was higher than that of other images . In addition , subendometrial enhancement ( SEE ) was frequently observed in dynamic studies in post-menopausal women , which was an important l and mark in detecting myometrial invasion . CONCLUSION We consider that dynamic MR imaging has greater advantage in assessing myometrial invasion than T2-weighted or contrast-enhanced T1-weighted imaging Objective To compare the diagnostic accuracy of diffusion-weighted magnetic resonance imaging ( DWI ) and frozen-section analysis in assessing myometrial invasion in endometrial cancer to guide surgery . Methods In this prospect i ve study , 51 women with diagnosed endometrial cancer were examined using magnetic resonance imaging ( MRI ) and subsequently underwent hysterectomy with intraoperative frozen-section assessment . The MRI protocol included T2-weighted images ( T2WI ) , a dynamic T1-weighted post-gadolinium series , and DWI sequences acquired with b values of 0 , 150 , and 800 s/mm2 . Apparent diffusion coefficient ( ADC ) maps were obtained in all the studies . Deep myometrial invasion was defined as involvement of ≥50 % of the thickness of the myometrium . The final postoperative pathological evaluation was considered as the reference st and ard . Results The accuracy , sensitivity , specificity , positive predictive value , and negative predictive value of DWI for detecting deep invasion of the myometrium were 90.2 % , 77.8 % , 97 % , 93.3 % , and 88.9 % , respectively . For the intraoperative frozen section , these figures were 90.2 % , 73.7 % , 100 % , 100 % , and 86.5 % . The precision for both tests was the same using McNemar ’s test ( p = 1 ) . Conclusion In assessing the depth of myometrial invasion , ADC maps show the same accuracy as intraoperative histological studies in endometrial cancers . They also allow for a more precise assessment than conventional MRI sequences . Frozen-section analysis can be avoided if the preoperative MRI study includes DWI sequences and ADC maps A prospect i ve study was design ed to determine the sensitivity and specificity of nonenhanced T2-weighted and contrast material -enhanced T1-weighted magnetic resonance ( MR ) imaging in assessing the depth of myometrial invasion in patients with proved endometrial cancer . In 56 consecutive patients with clinical ly determined early-stage disease , findings of the two MR imaging techniques were compared with results of histologic examination of surgical specimens . Myometrial invasion was classified as absent ( stage IA ) , superficial ( stage IB ) , or deep ( stage IC ) . In the assessment of each tumor stage , the sensitivity and specificity of contrast-enhanced T1-weighted MR imaging were higher than those of non-enhanced T2-weighted MR imaging . In determining the degree of myometrial tumor invasion , the overall sensitivity of enhanced T1-weighted MR imaging was 87.5 % , whereas that of nonenhanced T2-weighted MR imaging was 71.4 % ( P less than .05 ) . The use of contrast material may improve the ability to assess , with MR imaging , the depth of myometrial invasion by endometrial cancer Abstract . The purpose of this study was to evaluate diffusion-weighted MR imaging in neuroblastomas . We prospect ively examined seven children ( age range 1–3 years ) with seven solid body neuroblastomas . Diagnosis was established histologically . Diffusion-weighted echo-planar imaging ( EPI ) sequence was performed in all patients , with a repetition time of 5400 ms and an echo time of 103 ms , and with a b-value of 1000 s/mm2 . The contrast of tumour tissue depicted with T2-weighted images and diffusion-weighted images were evaluated by means of region-of-interest measurements and a calculation of the apparent diffusion coefficient ( ADC ) was done . The ADC calculation showed a mean ADC of 1.1 × 10–3 ( SD 0.14 × 10–3 , range 0.9–1.2 × 10–3 ) mm2/s of all tumours . Diffusion-weighted images showed an increased tumour signal . Water proton diffusion within the tumour matrix of neuroblastomas is especially restricted by the molecular and macromolecular barriers due to the very dense structure of this tumour tissue . We hypothesize that high nuclear-to-cytoplasm ratio of neuroblastoma cells limits intracellular motion . Furthermore , the very densely packed tumour cells inhibit effective motion of extracellular water protons . Restricted proton motion leads to a reduction in the rate of apparent diffusion and to a marked increase in signal on diffusion-weighted EPI MR images PURPOSE To assess magnetic resonance ( MR ) imaging in depicting the depth of myometrial infiltration , cervical invasion , and presence of enlarged lymph nodes in patients with endometrial adenocarcinoma compared with surgicopathologic findings . MATERIAL S AND METHODS Thirty-seven consecutive patients with endometrial carcinoma were included in this prospect i ve study . All patients underwent MR imaging and surgery . Qualitative image analysis included the depth of myometrial infiltration , infiltration of the uterine cervix , and presence of enlarged lymph nodes . Quantitative image analysis included tumor and myometrium contrast-to-noise ratios during different phases of dynamic imaging . MR imaging findings were compared with surgicopathologic findings . Sensitivity , specificity , diagnostic accuracy , and positive and negative predictive values of MR imaging in depicting myometrial and cervical infiltration and in lymph node assessment were calculated . RESULTS Respective sensitivity , specificity , diagnostic accuracy , and positive and negative predictive values in assessing myometrial infiltration were 87 % , 91 % , 89 % , 87 % , and 91 % ; those for cervical infiltration , 80 % , 96 % , 92 % , 89 % , and 93 % ; and those for lymph node assessment , 50 % , 95 % , 90 % , 50 % , and 95 % . There was significant agreement between MR imaging and surgicopathologic findings in assessment of myometrial invasion ( P < .001 ) . Myometrial and cervical invasion and lymph node enlargement were correctly assessed with MR imaging in 28 ( 76 % ) of 37 patients . Quantitative analysis showed a significant improvement in tumor and myometrium contrast-to-noise ratios during the equilibrium phase compared with the arterial and precontrast phases ( P < .001 ) . CONCLUSION MR imaging coupled with contrast material -enhanced dynamic MR imaging is highly accurate in local-regional staging of endometrial carcinoma ; more challenging is the assessment of pelvic and lumboaortic lymph nodes OBJECTIVE The purpose of this study was to examine the feasibility of sentinel lymph node ( SLN ) detection in patients with endometrial cancer using preoperative lymphoscintigraphy and an intraoperative gamma probe . PATIENTS AND METHODS Between June 2001 and January 2003 , 28 consecutive patients with endometrial cancer who were scheduled for total abdominal hysterectomy , bilateral salpingo-oophorectomy , total pelvic lymphadenectomy , and paraaortic lymphadenectomy at Tohoku University School of Medicine underwent sentinel lymph node detection . On the day before surgery , preoperative lymphoscintigraphy was performed by injection of 99m-Technetium ( (99m)Tc)-labeled phytate into the endometrium during hysteroscopy . At the time of surgery , a gamma-detecting probe was used to locate radioactive lymph nodes . RESULTS At least one sentinel node was detected in each of 23 of the 28 patients ( 82 % ) . The mean number of sentinel nodes detected was 3.1 ( range , 1 - 9 ) . Sentinel nodes could be identified in 21 of 22 patients ( 95 % ) whose tumor did not invade more than halfway into the myometrium . Eighteen patients had radioactive nodes in the paraaortic area . Most patients had a sentinel node in one of the following three sites : paraaortic , external iliac , and obturator . The sensitivity and specificity for detecting lymph node metastases were both 100 % . CONCLUSION The combination of preoperative lymphoscintigraphy with intraoperative gamma probe detection may be useful in identifying sentinel nodes in early-stage endometrial cancer The aim of this retrospective study was to assess the predictive value of different clinicopathological variables ( patient age , tumour size , FIGO grade , myometrial invasion , lymph-vascular space involvement [ LVSI ] , invasion margins , peri-tumour phlogistic infiltrate and mitotic activity ) for the risk of distant haematogenous recurrences in patients with endometrioid-type stage Ib-II endometrial cancer . Between August 1990 and April 2005 , 259 patients had undergone laparotomy , peritoneal washing , total abdominal hysterectomy and bilateral salpingo-oophorectomy , with or without pelvic + /- para-aortic lymphadenectomy for endometrioid-type endometrial cancer . Thirty-six ( 13.9 % ) patients had developed recurrent disease after a median time of 17 months ( range , 2 - 128 months ) . The relapse had been locoregional in 9 , distant in 21 and both locoregional plus distant in 6 cases . This study assessed 12 patients with FIGO stage Ib-II disease who had developed distant haematogenous recurrences and 20 r and omly chosen control patients with FIGO stage Ib-II disease who had remained recurrence-free after a median follow-up of 52 months ( range , 37 - 66 months ) . Adjuvant therapy had been : no further treatment in 15 patients , external pelvic irradiation in 14 patients , adjuvant external pelvic irradiation plus brachytherapy in 2 patients and platinum-based chemotherapy followed by external pelvic irradiation in 1 patient . The site of distant failure had been the lung in 9 patients , liver in 2 patients and lung plus liver in 1 patient . A concomitant locoregional relapse ( vagina or lymph nodes ) had occurred in 3 patients . The median interval between surgery and the development of distant failure had been 16.5 months ( range , 5 - 113 months ) . On univariate analysis , a higher incidence of FIGO grade 3 ( 50 % versus 10 % , p=0.0114 ) , outer one-third myometrial invasion ( 91.7 % versus 35.0 % , p=0.0051 ) and LVSI ( 75.0.% versus 20.0 % , p=0.0022 ) was found in the patients who had developed distant haematogeneous metastases compared to the recurrence-free women . Multivariate analysis showed that LVSI ( p=0.0264 ) and deep myometrial invasion ( p=0.0345 ) were independent predictive variables for the risk of distant haematogeneous failure . Patients with these pathological findings should be enrolled in r and omised trials design ed to assess the role of adjuvant chemotherapy alone or combined with sequential and /or concomitant external pelvic irradiation A prospect i ve study to assess the usefulness of magnetic resonance ( MR ) imaging in the evaluation of endometrial carcinoma was undertaken by five institutions under the auspices of the National Cancer Institute . Six different MR imagers were used , ranging in magnetic field strength from 0.15 T to 1.5 T. For each unit , appropriate T1- and T2-weighted sequences in the transverse plane and T2-weighted sequences in the sagittal plane were used . Initially , 107 patients were entered in the study , but only 88 fulfilled all the criteria and provide the basis for this study . The abnormality within the endometrial cavity was demonstrated with MR imaging in 81 % of the patients . The overall accuracy with MR imaging for staging endometrial carcinoma was 85 % . In the evaluation of depth of myometrial invasion for stage I disease , overall accuracy with MR imaging was 74 % . The accuracy of MR imaging in assessing tumors confined to endometrium or tumor with superficial myometrial invasion was 89 % and decreased to 54 % in assessing deep myometrial invasion . The results of this prospect i ve study performed by multiple examiners with vastly different equipment demonstrate the inherent value of MR imaging in the evaluation of this neoplasm BACKGROUND AND OBJECTIVE Publication bias and other sample size effects are issues for meta-analyses of test accuracy , as for r and omized trials . We investigate limitations of st and ard funnel plots and tests when applied to meta-analyses of test accuracy and look for improved methods . METHODS Type I and type II error rates for existing and alternative tests of sample size effects were estimated and compared in simulated meta-analyses of test accuracy . RESULTS Type I error rates for the Begg , Egger , and Macaskill tests are inflated for typical diagnostic odds ratios ( DOR ) , when disease prevalence differs from 50 % and when thresholds favor sensitivity over specificity or vice versa . Regression and correlation tests based on functions of effective sample size are valid , if occasionally conservative , tests for sample size effects . Empirical evidence suggests that they have adequate power to be useful tests . When DORs are heterogeneous , however , all tests of funnel plot asymmetry have low power . CONCLUSION Existing tests that use st and ard errors of odds ratios are likely to be seriously misleading if applied to meta-analyses of test accuracy . The effective sample size funnel plot and associated regression test of asymmetry should be used to detect publication bias and other sample size related effects The pathologic features of a prospect i ve study of FIGO stage I endometrial cancer is presented . The uterus , tubes , ovaries , and pelvic lymph nodes of 222 cases and aortic nodes of 157 cases have been analyzed . The surgical – pathologic specimen would suggest a negligible risk for lymph node metastasis if : cancer is confined to the endometrium irrespective of grade , invasion is superficial for grade s 1 and 2 tumor , the intermediate third of the myometrium is invaded for grade 1 tumor only , and occult disease is not present in the cervix and /or adnexa . Conversely , a substantial risk for lymph node metastasis exists if the surgical-pathologic study identifies superficial myometrial invasion by grade 3 cancer , intermediate myometrial invasion by grade 2 or 3 cancer , deep myometrial invasion by cancer of any grade , vascular space involvement , and extension of tumor to the cervix and /or adnexa Purpose To evaluate the diagnostic accuracy of 3 T MRI in preoperative staging of myometrial invasion . Methods Twenty-eight women with histological diagnosis of endometrial carcinoma were included in this prospect i ve study . After T2-W SS-TSE and DWI , dynamic series of T1-W THRIVE images were obtained ( 0–180 s ) followed by a T1-W THRIVE sequence in the late phase ( 5th min ) . For detection of deep myometrial infiltration : sensitivity , specificity , PPV , NPV , and accuracy were calculated on T2-W , postcontrast early arterial and late phase T1-W , and DWI . For the quantitative analysis of DWI , ADC values of the tumor were calculated and correlated with histologic grade . For the quantitative evaluation of dynamic series , SI-time curves were obtained and the maximum relative enhancement , wash-in rate , time-to-peak , and wash-out rate of masses and myometrium were compared . Results T2-W and early phase contrast-enhanced sequences obtained sensitivity 100 % , specificity 76 % , PPV 58 % , NPV 100 % , and accuracy 82 % ; late-phase contrast-enhanced images obtained sensitivity 100 % , specificity 81 % , PPV 64 % , NPV 100 % , and accuracy 86 % ; DWI obtained lower accuracy [ sensitivity 71 % , specificity 62 % , PPV 38 % , NPV 87 % , and accuary 57 % ] than T2-W and postcontrast images . The MRE of carcinomas were significantly lower than those of the myometrium . This analysis showed a significant improvement in tumor versus myometrium contrast during the late phase . On DWI , the mean ADC value of tumor was 1.02 ± 0.48 × 10−3 . There was no statistically significant correlation between tumor grade s and ADCs . Conclusions As the 3 T MRI scanner allows high-resolution images , accurate assessment of myometrial infiltration can be done especially with postcontrast late phase images BACKGROUND In response to findings that pelvic lymphadenectomy does not have any therapeutic benefit for endometrial cancer , we aim ed to establish whether complete , systematic lymphadenectomy , including the para-aortic lymph nodes , should be part of surgical therapy for patients at intermediate and high risk of recurrence . METHODS We selected 671 patients with endometrial carcinoma who had been treated with complete , systematic pelvic lymphadenectomy ( n=325 patients ) or combined pelvic and para-aortic lymphadenectomy ( n=346 ) at two tertiary centres in Japan ( January , 1986-June , 2004 ) . Patients at intermediate or high risk of recurrence were offered adjuvant radiotherapy or chemotherapy . The primary outcome measure was overall survival . FINDINGS Overall survival was significantly longer in the pelvic and para-aortic lymphadenectomy group than in the pelvic lymphadenectomy group ( HR 0.53 , 95 % CI 0.38 - 0.76 ; p=0.0005 ) . This association was also recorded in 407 patients at intermediate or high risk ( p=0.0009 ) , but overall survival was not related to lymphadenectomy type in low-risk patients . Multivariate analysis of prognostic factors showed that in patients with intermediate or high risk of recurrence , pelvic and para-aortic lymphadenectomy reduced the risk of death compared with pelvic lymphadenectomy ( 0.44 , 0.30 - 0.64 ; p<0.0001 ) . Analysis of 328 patients with intermediate or high risk who were treated with adjuvant radiotherapy or chemotherapy showed that patient survival improved with pelvic and para-aortic lymphadenectomy ( 0.48 , 0.29 - 0.83 ; p=0.0049 ) and with adjuvant chemotherapy ( 0.59 , 0.37 - 1.00 ; p=0.0465 ) independently of one another . INTERPRETATION Combined pelvic and para-aortic lymphadenectomy is recommended as treatment for patients with endometrial carcinoma of intermediate or high risk of recurrence . If a prospect i ve r and omised or comparative cohort study is planned to vali date the therapeutic effect of lymphadenectomy , it should include both pelvic and para-aortic lymphadenectomy in patients of intermediate or high risk of recurrence . FUNDING Japanese Foundation for Multidisciplinary Treatment of Cancer , and the Japan Society for the Promotion of Science PURPOSE To prospect ively compare magnetic resonance imaging ( MRI ) at 3.0 T and 1.5 T in the same patients for preoperative evaluation of endometrial carcinoma . MATERIAL S AND METHODS Thirty consecutive patients with endometrial carcinoma underwent MRI at both 3.0 T and 1.5 T as well as surgery . Quantitative and qualitative analyses were performed . Two radiologists independently evaluated images . MR findings were compared with surgicopathologic findings . RESULTS Image homogeneity of T2-weighted images at 3.0 T was significantly inferior to that at 1.5 T ( P = 0.007 ) . The scores of image homogeneity and susceptibility artifacts were not significantly different between 3.0 T gadolinium-enhanced imaging and 1.5 T imaging ( P = 0.09 and 0.36 ) . Kappa statistics showed good interobserver agreement between the two radiologists for local-regional staging on T2-weighted images ( kappa>0.6 ) . The area under the receiver operating characteristic curve ( Az ) values for T2-weighted imaging in terms of myometrial invasion , cervical invasion , and lymph node metastases were 0.88 ( 3.0 T ) versus 0.91 ( 1.5 T ) , 0.84 versus 0.83 , and 0.94 versus 0.95 for reader 1 , respectively . There were no significant differences between imaging at 3.0 T and at 1.5 T in Az values for either reader ( P > 0.35 ) . CONCLUSION 3.0 T MRI is an equivalent imaging modality to 1.5 T imaging for presurgical evaluation of endometrial carcinoma , although not significantly superior to 1.5 T imaging |
11,568 | 19,000,592 | Low- quality evidence from inconsistent studies with limited protection against bias shows that autogenous access for chronic hemodialysis is superior to prosthetic access | OBJECTIVES The autogenous arteriovenous access for chronic hemodialysis is recommended over the prosthetic access because of its longer lifespan .
However , more than half of the United States dialysis patients receive a prosthetic access .
We conducted a systematic review to summarize the best available evidence comparing the two accesses types in terms of patient-important outcomes . | OBJECTIVE The construction of an autogenous radial-cephalic direct wrist arteriovenous fistula ( RCAVF ) is the primary and best option for vascular access for hemodialysis . However , 10%-24 % of RCAVFs thrombose directly after operation or do not function adequately due to failure of maturation . In case of poor arterial and /or poor venous vessels for anastomosis , the outcome of RCAVFs may be worse and an alternative vascular access is probably indicated . A prosthetic graft implant may be a second best option . Therefore , a r and omized multicenter study comparing RCAVF with prosthetic ( polytetrafluoroethylene [ PTFE ] ) graft implantation in patients with poor vessels was performed . METHODS A total of 383 consecutive new patients needing primary vascular access were screened for enrollment in a prospect i ve r and omized study . According to defined vessel criteria from the preoperative duplex scanning , 140 patients were allocated to primary placement of an RCAVF and 61 patients to primary prosthetic graft implantation . The remaining 182 patients were r and omized to receive either an RCAVF ( n = 92 ) or prosthetic graft implant ( n = 90 ) . Patency rate was defined as the percentage of AVFs that functioned well after implantation . RESULTS Primary and assisted primary 1-year patencies were 33 % + /- 5.3 % vs 44 % + /- 6.2 % ( P = .03 ) and 48 % + /- 5.5 % vs 63 % + /- 5.9 % ( P = .035 ) for the RCAVF and prosthetic AVF , respectively . Secondary patencies were 52 % + /- 5.5 % vs 79 % + /- 5.1 % ( P = .0001 ) for the RCAVF and prosthetic AVF , respectively . Patients with RCAVFs developed a total of 102 ( 1.19/patient-year [ py ] ) vs 122 ( 1.45/py ; P = .739 ) complications in the prosthetic AVFs . A total of 43 ( 0.50/py ) interventions in the RCAVF group and 79 ( 0.94/py ) in the prosthetic graft group were needed for access salvage ( P = .077 ) . CONCLUSIONS Although there were more interventions needed for access salvage in the patients with prosthetic graft implants , we may conclude that patients with poor forearm vessels do benefit from implantation of a prosthetic graft for vascular access OBJECTIVE To compare the patency of autologous and graft-bridging ( prosthetic ) arteriovenous ( AV ) fistulas in patients 70 years of age or more . DESIGN Non-r and omised comparative study . SETTING University hospital , Greece . PATIENTS 114 patients aged 70 years or more ( mean 78 ) who required 135 consecutive angioaccess procedures during the 8-year period January 1990-December 1997 . INTERVENTIONS 68 autologous and 67 prosthetic procedures , 64 of the prosthetic procedures being proximal brachioaxillary AV arm grafts . MAIN OUTCOME MEASURES Primary and secondary cumulative patency rates and cumulative survival . RESULTS Life table analysis showed that the 3-year secondary patency ( medium term patency ) was significantly superior in the prosthetic group ( 58 % compared with 44 % , p = 0.04 ) . Cumulative survival at 3-years was 21 % . CONCLUSIONS A proximal brachioaxillary prosthetic AV graft is a good alternative as initial primary access in elderly patients who are not suitable for an autologous proximal AV fistula . At this age long term patency and conservation of proximal access sites are of minimum importance because of their limited life expectancy BACKGROUND Vascular access is a necessity for patients with end-stage renal disease who need chronic intermittent hemodialysis . According to Kidney Disease Outcomes Quality Initiative ( KDOQI ) guidelines , radial-cephalic ( RC ) and brachial-cephalic ( BC ) arteriovenous fistulas ( AVF ) are the first and second choice for vascular access , respectively . If these options are not possible , an autogenous brachial-basilic fistula in the upper arm ( BBAVF ) or a prosthetic brachial-antecubital forearm loop ( PTFE loop ) may be considered . Until now , it was not clear which access type was preferable . We have performed a r and omized study comparing BBAVF and prosthetic implantation in patients without the possibility for RCAVF or BCAVF . METHODS Patients with failed primary / secondary access or inadequate arterial and /or venous vessels were r and omized for either BBAVF or PTFE loop creation . The numbers of complications and interventions were recorded . Kaplan-Meier method was used to calculate primary , assisted- primary and secondary patency rates . The patency rates were compared with the log-rank test . Complication and intervention rates were compared with the Mann-Whitney test . RESULTS A total of 105 patients were r and omized for a BBAVF or PTFE loop ( 52 vs 53 , respectively ) . Primary and assisted- primary 1-year patency rates were significantly higher in the BBAVF group : 46 % + /- 7.4 % vs 22 % + /- 6.1 % ( P = .005 ) and 87 % + /- 5.0 % vs 71 % + /- 6.7 % ( P = .045 ) for the BBAVF and PTFE group , respectively . Secondary patencies were comparable for both groups ; 89 % + /- 4.6 % vs 85 % + /- 5.2 % for the BBAVF and PTFE group , respectively . The incidence rate of complications was 1.6 per patient-year in the BBAVF group vs 2.7 per patient-year in the PTFE group . Patients in the BBAVF group needed a total of 1.7 interventions per patient-year vs 2.7 per patient-year for the PTFE group . CONCLUSION These data show a significantly better primary and assisted- primary patency in the BBAVF group compared with the PTFE group . Furthermore , in the BBAVF group , fewer interventions were needed . Therefore , we conclude that BBAVF is the preferred choice for vascular access if RCAVF or BCAVF creation is impossible , or when these types of access have already failed The increased incidence of vascular access thrombosis ( VAT ) associated with recombinant human erythropoietin ( r-HuEPO ) therapy is multifactorial and controversial . Sixty-three hemodialysis patients who received > or = 12 weeks of r-HuEPO therapy were prospect ively followed for the incidence of VAT . Those who experienced VAT ( Group 1 ) were compared with those who did not ( Group 2 ) . The patients initially received r-HuEPO 50 U/kg intravenously three times a week . The dose was adjusted for a target hematocrit ( t-Hct ) of 30 - 33 % . Twenty-five of the 63 patients ( 40 % ) experienced VAT ( Group 1 ) . These patients were older ( mean , 54.0 + /- 14.0 years versus 47.3 + /- 15.0 years , p = 0.08 ) . There was no difference between Groups 1 and 2 with respect to the baseline Hct level ( 21.5 + /- 2.9 % versus 21.4 + /- 4.3 % ) , the number of patients who achieved t-Hct ( 20 versus 28 ) , and the mean time to reach t-Hct ( 18.6 + /- 15.1 weeks versus 16.9 + /- 16.2 weeks ) . However , 20 of 25 Group 1 patients ( 80 % ) were diabetic compared with only 18 of 38 Group 2 patients ( 47 % , p = 0.0169 , by Fisher 's exact test ) . In addition , the types of vascular access differed markedly between the two groups : arteriovenous ( AV ) grafts/AV fistulae/Permcaths , Group 1 : 21/3/1 versus Group 2 : 15/21/2 , p = 0.0018 . It was concluded that the occurrence of VAT in r-HuEPO treated patients was not related to the patient 's hematologic response to the drug , but rather , it depended upon the integrity of the patient 's vasculature and the type of vascular access used The native arteriovenous fistula ( AVF ) is the preferred vascular access because of its longevity and its lower rates of infection and intervention . Recent studies suggest that the AVF may offer a survival advantage . Because these data were derived from observational studies , they are prone to potential bias . The use of propensity scores offers an additional method to reduce bias result ing from nonr and omized treatment assignment . Adult ( age 18 yr or more ) patients who commenced hemodialysis in Australia and New Zeal and on April 1 , 1999 , until March 31 , 2002 , were studied by using the Australian and New Zeal and Dialysis and Transplant Association ( ANZ DATA ) Registry . Cox regression was used to determine the effect of access type on total mortality . Propensity scores were calculated and used both as a controlling variable in the multivariable model and to construct matched cohorts . The catheter analysis was stratified by dialysis duration at entry to ANZ DATA to satisfy the proportional-hazard assumption . There were 612 deaths in 3749 patients ( median follow-up , 1.07 yr ) . After adjustment for confounding factors and propensity scores , catheter use was predictive of mortality . Patients with arteriovenous grafts ( AVG ) also had a significantly increased risk of death . Effect estimates were also consistent in the smaller propensity score-matched cohorts . Both AVG and catheter use in incident hemodialysis patients are associated with significant excess of total mortality . Reducing catheter use and increasing the proportion of patients commencing hemodialysis with a mature AVF remain important clinical objectives BACKGROUND H and ischemia result ing from arterial steal is a serious complication in patients undergoing hemodialysis access , but specific risk factors for steal remain in dispute . The purpose of this study was to determine whether plethysmographically derived finger pressures ( FPs ) or digital-brachial indices ( DBIs ) are predictive of symptomatic arterial steal . METHODS We prospect ively studied 72 patients ( 37 men , 35 women ; mean age , 57 + /- 10 years ) who were undergoing brachial artery-based hemodialysis access . All patients had complete pre- and postoperative h and examinations and FP determinations . Surgeons were blinded to preoperative FP results . RESULTS Prosthetic graft was used in 60 patients ( 6-mm polytetrafluoroethylene [ PTFE ] in 50 , tapered PTFE in 10 ) , and brachial-based arteriovenous fistulas were created in 12 . Fourteen ( 19 % ) patients developed arterial steal symptoms . The mean preoperative FP was significantly lower in steal patients than in those without steal ( 131 + /- 27 vs 151 + /- 31 mm Hg , P < .03 ) . Nine ( 64 % ) of the patients with steal had DBIs < 1.0 , compared to 18 ( 31 % ) of the patients without steal ( P = .02 ) . However , there was no absolute FP or DBI threshold below which steal was inevitable . The occurrence of steal was attributed to proximal arterial stenoses in seven , to distal arterial disease in five , and was unknown in two . When comparing the 14 patients who developed steal to the 58 who did not , we noted that a higher proportion of steal patients had coronary artery disease ( 57 % vs 17 % , P = .005 ) . Steal was more likely to develop in patients with arteriovenous fistulas than in patients with prosthetic grafts ( 43 % vs 14 % , P = .009 ) . There were no significant differences in demographic factors , atherosclerotic risks ( diabetes , smoking , hypertension , dyslipidemia ) , prevalence of peripheral vascular disease , cerebrovascular disease , shunt location , tapered vs straight graft , or number of prior grafts placed . CONCLUSIONS These data indicate that preoperative FPs are lower in patients who develop steal syndrome after hemodialysis access . Patients with preoperative DBIs < 1.0 are more likely to develop steal , but there is no DBI threshold below which steal is inevitable . Steal is more likely in patients undergoing brachial-based arteriovenous fistulas than in those receiving prosthetic grafts OBJECTIVES To compare patency and complication rates of polytetrafluoroethylene ( PTFE ) grafts and denatured homologous vein ( DHV ) grafts for long-term haemodialysis . DESIGN A prospect i ve r and omised multicentre trial . MATERIAL S One hundred and thirty-one patients were enrolled between September 1994 and April 1997 . Sixty-three DHV grafts and 68 PTFE grafts were implanted in 60 meals and 71 females . Complications and interventions were monitored . Patency rates , complication rates , and intervention rates of PTFE and DHV were compared . RESULTS The mean follow-up was 313 days for DHV ( range 1 - 771 ) and 339 ( 3 - 909 ) days for PTFE . The total follow-up was 54.1 patient-years for DHV and 63.1 for PTFE . The 1-year primary patency rates were 30 % and 40 % for DHV and PTFE respectively . Secondary patency rate was 63 % for both DHV and PTFE . Most frequent complication was thrombosis . A total of 75 thrombotic events ( 1.39 per patient-year ) occurred in 35 ( 56 % ) DHV grafts and 78 ( 1.24 per py ) in 36 ( 53 % ) PTFE grafts . A total of nine infections were seen in nine ( 14 % ) DHV grafts , whereas 21 infections in 20 ( 29 % ) PTFE grafts were seen ( p = 0.08 ) . All but one infected DHV graft could be salvaged with systemic antibiotics . In contrast , surgical intervention was necessary in nine PTFE grafts ( p = 0.02 ) . For aneurysms , eight DHV and two PTFE grafts needed revision ( p = 0.03 ) . CONCLUSION Patency rates between DHV and PTFE were not different . More infections were seen in PTFE grafts , and significantly more PTFE grafts needed surgical revision or removal because of infection . Significantly more DHV grafts were surgically revised or removed because of aneurysms This study identifies factors that are associated with the risk of access thrombosis in 267 new hemodialysis patients . There are few longitudinal studies evaluating the risk of access thrombosis despite the need for long-term use of the access for maintenance hemodialysis . We used a prospect i ve design following patients from 26 providers in Renal Network Council # 12 ( Iowa , Missouri , Kansas , and Nebraska ) for 1 year who were starting hemodialysis . There were significant increases in access thrombosis relative risk ( RR ) associated with the placement of a polytetrafluoroethylene graft compared with patients with the arteriovenous fistula ( RR 1.98 ; 95 % confidence interval [ CI ] = 1.3 , 3,01 ) . The probability of remaining thrombosis free 90 days after first use was 90.1 % ( 95 % CI = 82.9 , 94.4 ) for arteriovenous fistula patients , but only 71.6 % ( 95 % CI = 63.5 , 78.2 ) for polytetrafluoroethylene graft patients . In arteriovenous fistula patients with more than 30 days maturity time the risk of thrombosis was significantly lower than in those with less maturity time ( RR 0.40 ; 95 % CI = 0.14 , 0.84 ) ; however , there was no significant difference for maturity time among patients with a polytetrafluoroethylene graft . Reduced thrombosis risk also was observed in patients with dialyzer blood flow rates greater than 300 mL/min ( RR 0.66 ; 95 % CI = 0.44 , 0.99 ) . Total heparin dose and erythropoietin therapy were not associated with the risk of thrombosis . No differences in risk were found for age , renal diagnosis , or type of dialyzer The objective of this study was to determine the probabilities of specific morbid events or death among patients with end-stage renal disease ( ESRD ) treated by hemodialysis . A prospect i ve cohort study was performed between March 1988 and September 1989 in 18 hemodialysis centers in 13 Canadian cities , representing about one third of the hemodialysis population in Canada . The inception cohort consisted of 496 patients entering hemodialysis who had survived 1 month . The few new hemodialysis patients who received erythropoietin ( EPO ) in the last 3 months of the study were excluded . Survival curves were compared using the Cox proportional hazards regression model . Older age and history of cardiovascular disease were independently associated with a greater probability of death . Age and history of cardiovascular disease were also associated with a greater probability of nonfatal circulatory events ( myocardial infa rct ion , angina requiring hospitalization , or stroke ) , while a serum albumin level less than or equal to 30 g/L ( 3.0 g dL ) was associated with an increased probability of pulmonary edema . The probability of surviving 12 months without receiving a blood transfusion was 47.2 % for males and 27.5 % for females . The incidence of non-A , non-B hepatitis , as estimated by unexplained elevations in serum aspartate aminotransferase ( AST ) values , was not different between patients receiving and not receiving blood transfusions . The probability of hospitalization for any cause was greater for patients with grafts for vascular access than for those with fistulae , for those with a history of cardiovascular disease , for those with a serum albumin level less than or equal to 30 g/L , and for those with renal disease due to diabetes or vascular disease . Hospitalization due to circulatory disease was more likely among those with a history of cardiovascular disease and among those with a lower serum albumin level . Hospitalization for infectious disease was more likely among those with a lower serum albumin level and less likely among those with a fistula for vascular access . Among all patients receiving hemodialysis treatment for more than 6 months , there were 14.8 hospital days per year . ( ABSTRACT TRUNCATED AT 400 WORDS PURPOSE The aim of this study was to compare patency and complication rates between basilic vein and polytetrafluoroethylene ( PTFE ) for brachial arteriovenous fistulas ( AVF ) for long-term hemodialysis . METHODS All basilic vein and PTFE brachial AVF constructed between March 1988 and April 1993 were retrospectively review ed . After construction of life-tables , log-rank testing was used to compare the primary patency rate of basilic vein AVF ( n = 59 ) with the primary and secondary patency rates of PTFE AVF ( n = 47 ) . Complication rates were calculated for each type of fistula and compared by use of chi-squared testing . RESULTS The primary patency rate for basilic vein AVF ( 90 % ) was superior to that of PTFE AVF ( 70 % ) at 1 year ( p < 0.01 ) , and at 2 years ( 86 % vs 49 % , p < 0.001 ) . Complications occurred two and a half times more frequently in the PTFE group than in the basilic vein group ( p < 0.05 ) . CONCLUSIONS Basilic vein AVF provided superior patency rates and lower complication rates compared with PTFE AVF . Prospect i ve r and omized trials comparing the two fistula types is required to firmly establish the basilic vein AVF as the alternative access procedure of choice after a failed or unconstructable radiocephalic fistula BACKGROUND Vascular access ( VA ) complications account for 16 to 25 % of hospital admissions . This study tested the hypothesis that the type of VA in use is correlated with overall mortality and cause-specific mortality . METHODS Data were analyzed from the U.S. Renal Data System Dialysis Morbidity and Mortality Study Wave 1 , a r and om sample of 5507 patients , prevalent on hemodialysis as of December 31 , 1993 . The relative mortality risk during a two-year observation was analyzed by Cox-regression methods with adjustments for demographic and comorbid conditions . Using similar methods , cause-specific analyses also were performed for death caused by infection and cardiac causes . RESULTS In diabetic mellitus ( DM ) patients with end-stage renal disease , the associated relative mortality risk was higher for those with arteriovenous graft ( AVG ; RR = 1.41 , P < 0.003 ) and central venous catheter ( CVC ; RR = 1.54 , P < 0.002 ) as compared with arteriovenous fistula ( AVF ) . In non-DM patients , those with CVC had a higher associated mortality ( RR = 1.70 , P < 0.001 ) , as did to a lesser degree those with AVG ( RR = 1.08 , P = 0.35 ) when compared with AVF . Cause-specific analyses found higher infection-related deaths for CVC ( RR = 2.30 , P < 0.06 ) and AVG ( RR = 2.47 , P < 0.02 ) compared with AVF in DM ; in non-DM , risk was higher also for CVC ( RR = 1.83 , P < 0.04 ) and AVG ( RR = 1.27 , P < 0.33 ) . In contrast to our hypothesis that AV shunting increases cardiac risk , deaths caused by cardiac causes were higher in CVC than AVF for both DM ( RR = 1.47 , P < 0.05 ) and non-DM ( RR = 1.34 , P < 0.05 ) patients . CONCLUSION This case-mix adjusted analysis suggests that CVC and AVG are correlated with increased mortality risk when compared with AVF , both overall and by major causes of death Despite the importance of hemodialysis vascular access , the cost of vascular access care has not been studied in detail . A prospect i ve cost analysis was performed among incident hemodialysis patients to determine the cost of vascular access care overall and on the basis of access type . Detailed clinical and demographic information , as well as data on access type , was collected for all local incident hemodialysis patients between July 1 , 1999 , and November 1 , 2001 . A comprehensive measure of total vascular access costs , including surgery , radiology , hospitalization for access complications , physician costs , costs for management of outpatient bacteremia , and vascular access monitoring costs , was obtained . Costs are reported in 2002 Canadian dollars ( 1 CAN dollar = 0.69 US dollar ) . A total of 239 consecutive incident hemodialysis patients were identified , 49 , 157 , and 33 of whom were dialyzed exclusively with a catheter or had a native arteriovenous fistula or synthetic graft attempted , respectively . In year 1 , 18.4 % of all hospital admissions were for vascular access-related complications . The mean cost of all vascular access care in year 1 was 6890 CAN dollars(median 4020 dollars ; interquartile range [ IQR ] 2440 dollars to 7540 dollars ) . The mean cost of access care per patient-year at risk for maintaining a catheter exclusively , attempting an arteriovenous fistula , or attempting a graft was 9180 dollars ( median 3812 dollars ; IQR 2250 dollars to 7762 dollars ) , 7989 dollars ( median 4641 dollars ; IQR 3035 dollars to 8832 dollars ) , and 11,685 dollars ( median 8152 dollars ; IQR 3395 dollars to 12,908 dollars ) , respectively ( P = 0.01 ) . Vascular access care is responsible for a significant proportion of health care costs in the first year of hemodialysis . These results support clinical practice guidelines that recommend preferential placement of a native fistula In this first clinical trial femoral vein transposition ( FVT ) was prospect ively compared with its " graft " counterpart . Patients requiring vascular access due to occluded central veins were divided into two groups : group I ( n = 17 ) underwent femoral loop grafts and group II ( n = 15 ) , FVT . Complications were recorded prospect ively and patency rates were compared by the Kaplan Meier method with statistical comparisons by Mann Whitney U and chi-square tests as appropriate . Between 1999 and 2003 30 patients underwent 32 operations . Mean follow-up was 8.9 months in group I and 6.8 months in group II ( P > .05 ) . Three group I patients developed a steal , requiring closure of the fistula in one . Five group II patients developed a steal , requiring closure of the fistula in one . The incidence of steal was similar in both groups ( P > .05 ) . The infection rates were similar : 35.3 % and 26.7 % in group I versus group II ( P > .05 ) , respectively . Among the six infections in group I , four patients required excision of the graft due to infection , whereas only one arteriovenous fistula ( AVF ) was closed in group II for infection . The 1-year primary patency rate in group I was 37.5 % versus 86.7 % in group II ( P < .05 ) . In conclusion , Femoral AVF grafts have been condemned because of the unacceptable high rate of septic complications . FVT obviates the need for a graft and has fewer infectious problems and better patency rates Achieving Dialysis Outcomes Quality Initiative guidelines for native arteriovenous fistulae using the radiocephalic forearm fistula ( lower-arm fistula [ LAF ] ) is difficult . This study reports results using the upper-arm native arteriovenous fistula ( UAF ) . From a prospect i ve access data base ( 1992 to 1998 ) , this study was based on 204 patients ( 322 accesses ) . Average patient age was 56 + /- 1 years , 63 % were men , and 47 % had diabetes . A native fistula was the first access in 73 % of patients ( 36 % , LAFs ; 37 % , UAFs ) and accounted for 48 % of subsequent accesses ( 13 % , LAFs ; 35 % , UAFs ) . Younger men were more likely to receive an LAF , but there was no demographic difference between patients receiving a UAF or arteriovenous graft ( AVG ) . Both primary unassisted and cumulative access patencies were significantly better for UAFs than either LAFs or AVGs . For first accesses , cumulative access patency rates at 1 , 3 , and 5 years were 71 % , 57 % , and 57 % for UAFs ; 54 % , 46 % , and 36 % for LAFs ; and 54 % , 28 % , and 0 % for AVGs ( P < 0.01 ) . Despite shorter access survival , AVGs required more total access procedures than either UAFs or LAFs ( procedures per access : 2.5 , 1.0 , and 0.6 for AVGs , UAFs , and LAFs , respectively ) . When used , catheters were required for dialysis for a longer time for UAFs ( median catheter days , 36 , 53 , and 56 for AVGs , LAFs , and UAFs , respectively ; P < 0.05 ) . Access flow rates were greater in UAFs ( 1,247 mL/min ; n = 48 ; P < 0.01 ) than AVGs ( 851 mL/min ; n = 30 ) or LAFs ( 938 mL/min ; n = 31 ) . There was no evidence that UAFs were b and ed or ligated for steal syndromes or heart failure more often than AVGs or LAFs . These results show that the UAF is a good alternative to an AVG for achieving Dialysis Outcomes Quality Initiative guidelines PURPOSE Wrist fistulas are increasingly difficult to establish in the aging hemodialysis population . We assessed fistula patency and occlusion rate in elbow fistulas compared with wrist and graft fistulas . METHODS We analyzed all 104 fistulas created in all 68 patients who underwent hemodialysis during October 1993 at the St. Joseph General Teaching Hospital , Veldhoven , The Netherl and s. Life-table patency and complications were analyzed for 31 elbow fistulas , 56 wrist fistulas , and 17 polytetrafluoroethylene or saphenous vein graft fistulas . RESULTS The patency rate for elbow fistulas was 93 % at 1 year and 80 % at 3 years . Wrist fistulas had a patency rate of 76 % at 1 year and 65 % at 3 years . Graft fistulas had a poorer patency rate : 69 % at 1 year and 62 % at 3 years . There were significantly more failures in the wrist fistulas ( p < 0.02 ) . Thrombosis accounted for most fistula failures . Venous stenosis was the most frequent indication for revision . The high incidence of concomitant diseases was not related to fistula outcome . CONCLUSIONS The elbow fistula performed better than the wrist fistula . Liberal use of the elbow fistula is justified , especially when the epifascial veins or the radial artery at the wrist is in poor condition . Graft fistulas should be reserved for tertiary procedures This paper assessed the efficacy of arterio-venous fistulae , vein grafts , and synthetic grafts for long-term haemodialysis . Over a selected 10 year period , 486 primary access sites were established and 182 revisions were necessary . Access procedures were assessed for primary survival , the success or otherwise of revision surgery , and long-term efficacy for haemodialysis . Significant differences were shown for long-term survival of fistulae over vein grafts and synthetic grafts . Successful revision surgery favoured fistulae over synthetic grafts . Arterio-venous fistulae offered the best prospect for effective long-term dialysis . Revision surgery with continued dialysis using the primary -access site was largely unsuccessful , secondary access reconstruction being required in 78.2 % of all failures OBJECTIVE The study 's aim was to evaluate access patency and incidence of revisions in patients initiating hemodialysis and to determine differences in access performance by type of access among patient subgroups . METHODS The study used data from the United States Renal Data System Dialysis Morbidity and Mortality Study Wave 2 , which contained a r and om sample of dialysis patients initiating dialysis in 1996 and early 1997 . Failures and revisions were evaluated among 2247 newly placed hemodialysis accesses by using Cox proportional hazards regression model and Poisson regression . Primary and secondary patency rates were estimated using the Kaplan-Meier method . RESULTS Fifteen hundred seventy-four prosthetic grafts , 492 simple autogenous fistulas , and 181 venous transposition fistulas were available for evaluation . Prosthetic grafts had a 41 % greater risk of primary failure compared with simple fistulas ( relative risk , 1.41 ; 95 % CI , 1.22 - 1.64 ; P < .001 ) and a 91 % higher incidence of revision ( relative risk , 1.91 ; 95 % CI , 1.60 - 2.28 ; P < .001 ) . At 2 years , autogenous fistulas demonstrated superior primary patency ( 39.8 % versus 24.6 % , P < .001 ) and equivalent secondary patency ( 64.3 % versus 59.5 % , P = .24 ) compared with prosthetic grafts . When compared with simple fistulas , vein transpositions demonstrated equivalent secondary patency at 2 years ( 61.5 % versus 64.3 % , P = .43 ) but inferior primary patency ( 27.7 % versus 39.8 % , P = .008 ) and had a 32 % increased incidence of revision ( P = .04 ) . Autogenous fistulas had superior primary patency compared with prosthetic grafts in all patient subgroups except for patients with previously failed access . Vein transpositions showed the greatest benefit in terms of patency and incidence of revision in women and in patients with previously failed access . CONCLUSIONS The preferential placement of autogenous fistulas may increase primary patency and decrease the incidence of revisions . Vein transpositions had similar secondary patency compared with simple fistulas , but required more revisions . The greatest benefit of a vein transposition fistula was seen in women and in patients with a history of access failure PURPOSE Initiation of hemodialysis frequently requires temporary central venous catheterization , which leads to subsequent venous stenosis in 50 % of patients . These lesions severely limit upper extremity dialysis fistula creation . The present study was undertaken to determine whether early cannulation ( EC ) allowed omission of temporary venous catheterization without affecting perioperative morbidity and long-term graft patency . METHODS Seventy-nine prosthetic grafts for hemodialysis were placed in 76 patients over a 40-month period . Patients who required hemodialysis between 24 and 72 hours after surgery were assigned to EC . The remaining grafts underwent late cannulation ( LC ) after postoperative day 14 . All grafts were constructed with a 6 mm stretch-exp and ed polytetrafluoroethylene conduit in the brachial artery-to-axillary vein position . Statistical analysis of cumulative primary patency estimates and patient survival data were determined by Kaplan-Meier analysis and log-rank test , patient variables were compared using chi 2 and Fisher 's exact test , and multivariate analysis was performed using Cox 's proportional hazard model . RESULTS Forty-eight patients underwent EC and 31 underwent LC . There were no significant differences regarding age ( mean , 61.5 years ) , history of diabetes , congestive heart failure , hematocrit level ( mean , 30 % ) , or presence of peripheral vascular disease . Thrombosis occurred before cannulation in one of 48 ECs ( 2.0 % ) and one of 31 LCs ( 3.2 % ) . There were no episodes of cannulation hemorrhage or wound infection in either group . Cumulative primary patency estimates for EC were 0.89 , 0.82 , and 0.70 at 3 , 6 , and 12 months , respectively . These were not significantly different from the LC estimates of 0.86 , 0.78 , and 0.74 at 3 , 6 , and 12 months , respectively . Overall , patients who had a history of peripheral vascular disease had a significantly decreased 12-month patency rate ( 60 % vs 74 % ; p = 0.05 ) . Central venous catheters were omitted in 47 of 48 EC patients . CONCLUSION EC of prosthetic dialysis grafts does not increase perioperative morbidity rates or decrease 12-month cumulative primary patency rates Complications associated with vascular accesses account for approximately 30 % of hospital admissions for chronic hemodialysis patients . Long-term patency of access was evaluated in 76 patients , without diabetes mellitus , who had been on dialysis for at least 3 years and 41 patients , with diabetes mellitus , who had been on dialysis for over 2 years . Fistulas functioned longer than grafts ( 58 vs. 22 months , p < 0.01 , in nondiabetics and 70 vs 22 months , p < 0.01 , in patients with diabetes ) . Declotting or revision of restored graft function for short periods of time ( < 6 - 10 months ) and subsequent declotting was ineffective . Infections were uncommon in grafts ( 1 per 13.5 years of dialysis ) and in fistulas ( 1 in 200 years of dialysis ) |
11,569 | 28,639,319 | No subgroup effects were shown for any of the subgroups on any of the outcomes .
Multi-component behaviour-changing interventions that incorporate diet , physical activity and behaviour change may be beneficial in achieving small , short-term reductions in BMI , BMI z score and weight in children aged 6 to 11 years .
The evidence suggests a very low occurrence of adverse events . | BACKGROUND Child and adolescent overweight and obesity has increased globally , and can be associated with significant short- and long-term health consequences .
This is an up date of a Cochrane review published first in 2003 , and up date d previously in 2009 .
However , the up date has now been split into six review s addressing different childhood obesity treatments at different ages .
OBJECTIVES To assess the effects of diet , physical activity and behavioural interventions ( behaviour-changing interventions ) for the treatment of overweight or obese children aged 6 to 11 years . | Objective : This study examined the role of demographic characteristics , psychological factors , and family functioning on attendance in a r and omized controlled trial of a family-based pediatric obesity program . Method : Participants included 155 children between the ages of 4 and 7 years ( M age = 5.77 , 57.4 % female , 73.6 % black , M body mass index = 25.5 ) and their primary caregivers who were r and omized to the treatment group . Three groups of participants were created based on their patterns of attendance during the program : ( 1 ) noncompleters , ( 2 ) partial completers , and ( 3 ) completers . Results : Results indicated no differences among the attendance groups in child gender , child body mass index , or child psychological functioning . Significant group differences were found with respect to race/ethnicity , parent marital status , and family income , such that noncompleters were more likely to be racial/ethnic minorities , to living in single parent households , and to have lower incomes than partial completers and completers . After controlling for the effects of these sociodemographic risk factors , noncompleters , and partial completers reported more family dysfunction characterized by high levels of disengagement than completers . Conclusion : Adapting existing weight management programs to include a focus on family engagement in the early stages of treatment may help to improve participation in family-based obesity interventions targeting high risk , socioeconomically disadvantaged youth OBJECTIVE To assess height growth over 10 years in children treated for obesity . DESIGN Longitudinal , prospect i ve follow-up of a series of r and omized , controlled weight control trials . SETTING Specialized pediatric weight control clinic . PARTICIPANTS One hundred fifty-eight 6- to 12-year-old obese children who were followed up for 10 years after treatment . INTERVENTIONS Family-based behavioral weight control . MEASUREMENTS /MAIN RESULTS At entry the height percentiles of the obese children were significantly higher ( 71.6 percentile ) than same-sex parent ( 52.0 percentile ) or midparent ( 51.5 percentile ) height ( an estimate of parental contribution to height ) . After an average growth of 22.7 cm , children were 2.2 cm taller than their same-sex parent and decreased to an average height percentile of 57.8 . Multiple regression analysis showed that child sex , age , baseline height and percent overweight , midparent height , and height change of the child from baseline to 5 years accounted for 94 % of the variance in growth . Child percent overweight change made no contribution to predicting height change . Comparison between children obese and nonobese at 10 years showed no differences in growth . CONCLUSIONS Moderate energy restriction with dietary guidance by overweight children did not negatively influence long-term growth Background Recruitment to trials evaluating the effectiveness of childhood obesity management interventions is challenging . We report our experience of recruitment to the Families for Health study , a r and omised controlled trial evaluating the effectiveness of a family-based community programme for children aged 6–11 years , versus usual care . We evaluated the effectiveness of active recruitment ( contacting eligible families directly ) versus passive recruitment ( informing the community through flyers , public events , media ) . Methods Initial approaches included passive recruitment via the media ( newspapers and radio ) and two active recruitment methods : National Child Measurement Programme ( letters to families with overweight children ) and referrals from health-care professionals . With slow initial recruitment , further strategies were employed , including active ( e.g. targeted letters from general practice s ) and passive ( e.g. flyers , posters and public events ) methods . At first enquiry from a potential participant , families were asked where they heard about the study . Further quantitative ( question naire ) and qualitative data ( one-to-one interviews with parents/carers ) , were collected from recruited families at baseline and 3-month follow-up and included questions about recruitment . Results In total , 194 families enquired about Families for Health , and 115 ( 59.3 % ) were recruited and r and omised . Active recruitment yielded 85 enquiries , with 43 families recruited ( 50.6 % ) ; passive recruitment yielded 99 enquiries with 72 families recruited ( 72.7 % ) . Information seen at schools or GP surgeries accounted for over a quarter of enquiries ( 28.4 % ) and over a third ( 37.4 % ) of final recruitment . Eight out of ten families who enquired this way were recruited . Media-led enquiries were low ( 5 % ) , but all were recruited . Children of families recruited actively were more likely to be Asian or mixed race . Despite extensive recruitment methods , the trial did not recruit as planned , and was awarded a no-cost extension to complete the 12-month follow-up . Conclusions The higher number of participants recruited through passive methods may be due to the large number of potential participants these methods reached and because participants may see the information more than once . Recruiting to a child obesity treatment study is complex and it is advisable to use multiple recruitment strategies , some aim ing at blanket coverage and some targeted at families with children who are overweight . Trial registration Current Controlled Trials IS RCT N45032201 ( Date : 18 August 2011 INTRODUCTION The present study describes a r and omised controlled trial ( RCT ) based on a novel , generalisable intervention for childhood obesity , comparing the intervention with a no-treatment control group . METHOD The Malaysian Childhood Obesity Treatment Trial ( MASCOT ) was a single-blind RCT of a dietetic treatment for childhood obesity in children of primary school age ( 7 to 11 years old ) in Kuala Lumpur , Malaysia . The MASCOT comprising eight sessions , of an 8-hour family-centred group treatment programme is described , based on behavioural change techniques . The study sample was characterised by BMI z-score , health related quality of life reported by participants and their parents ( PedsQL question naire ) , objective ly measured habitual physical activity and sedentary behaviour ( Actigraph accelerometry ) RESULTS The MASCOT sample of 107 children was characterised by a low quality of life , mean total score on PedsQL 67.7 ( 4.5 ) as reported by the children , and 66.0 ( 16.4 ) as reported by their parents . The children spent , on average , 89 % of their waking day on sedentary activity , and 1 % of the day in moderate-vigorous intensity physical activity , equivalent to only around 8 minutes/day . CONCLUSION Obese children in the MASCOT study had an impaired quality of life , high levels of sedentary behaviour and very low levels of physical activity OBJECTIVE The objective was to compare targeting increased eating of healthy foods vs. reducing intake of high energy-dense foods within the context of a family-based behavioral weight control program . METHODS AND PROCEDURES Forty-one 8 - 12 year-old children > 85th BMI percentile were r and omly assigned to a 24-month family-based behavioral treatment that targeted increasing fruits and vegetables and low-fat dairy vs. reducing intake of high energy-dense foods . RESULTS Children in the increase healthy food group showed greater reduction in z BMI compared to children in the reduce high energy-dense food group at 12- ( -0.30 z BMI units vs. -0.15 z BMI units , P = 0.01 ) and 24- ( -0.36 z BMI units vs -0.13 z BMI units , P = 0.04 ) month follow-up . Parents in the increase healthy food group showed greater reductions in concern about child weight ( P = 0.007 ) , and these changes were associated with child z BMI change ( P = 0.008 ) . Children in the reduce high energy-dense group showed larger sustained reductions in high energy-dense foods ( P < 0.05 ) . Baseline levels of high energy-dense foods ( P < 0.05 ) , parent food restraint ( P = 0.01 ) , parent concern over parent weight ( P = 0.01 ) and parent acceptance of the child ( P < 0.05 ) moderated child z BMI change , with greater sustained reductions in z BMI for children in the increase healthy food group for each measure . Parent z BMI change followed the same pattern as child changes , and parent and child z BMI changes were correlated ( P < 0.001 ) . DISCUSSION Focusing on healthy food choices within an energy restricted diet may be useful in family-based weight control programs Background Child obesity internationally has been identified as one of the major threats to future population health . Indigenous people and those from lower socio-economic background s are over-represented in obesity statistics . There is a need for evidence of effect of interventions for child obesity with long-term follow-up . Whether engaging with those that are more motivated to make lifestyle changes is a useful strategy has not been fully explored . We hypothesise that in obese/overweight children , assessed as psychologically “ ready for change ” , delivery of a 12-month multi-disciplinary intervention programme results in a significant reduction in body mass index st and ard deviation score . Methods / Design Whanau Pakari is an unblinded r and omised controlled clinical trial comparing a 12 month intervention programme with st and ard practice , with 6 monthly assessment s for 2 years , conducted in Taranaki , New Zeal and ( a region where 15.8 % of the population are indigenous ) . It specifically targets indigenous people and those in more deprived households . Obese/overweight children and adolescents aged 5–16 years are eligible . Exclusion criteria are medical/psychological conditions leading to inability to undertake physical activity/participate in group sessions ; those not “ ready ” to make lifestyle changes ; and those without a committed family member . Assessment s of health parameters , dietary history , physical activity and overall health-related quality of life/psychological functioning are completed in the participant ’s home . Fasting blood tests are obtained at baseline , 12 and 24 months . The primary outcome is body mass index st and ard deviation score . Secondary outcomes include quality of life , dietary behaviour and physical activity , cardiovascular and metabolic profile ( blood pressure , resting heart rate , waist circumference ) , glycaemic control ( fasting glucose and glycated Haemoglobin ) , fasting insulin , and lipids . A general linear mixed model will be used to assess change from baseline using the 6 , 12 , 18 and 24 month measures , adjusting for age , gender , socioeconomic status and ethnicity , and whether at the contemplative or preparation/action stages of readiness for change . Discussion This trial will inform the development of management programmes for obese children and adolescents that are appropriate for indigenous population s. It will investigate whether those at the preparation/action stage of “ readiness ” to make lifestyle changes are more successful in making changes than those who are contemplative . Trial registration Australian New Zeal and Clinical Trials Registry (ANZCTR):12611000862943 . ( Date registered 15/08/2011 ) The objective of the present study was to evaluate the effectiveness of a one-year multi-component immersive day-camp weight-loss intervention for children with overweight and obesity . The study design was a parallel-group r and omized controlled trial . One hundred fifteen 11 - 13-year-old children with overweight and obesity were r and omized into either : A six-week day-camp intervention arm focusing on increased physical activity , and healthy diet followed by a subsequent one-year family-based intervention , or a st and ard intervention arm consisting of one weekly exercise session for six weeks . Body mass index ( BMI ) was the primary outcome . BMI z-score , clustered cardiovascular risk z-score , and body composition were secondary outcomes . All outcomes were measured at baseline , six week- , and 52 week follow-up . After six weeks , children from the day-camp intervention arm had improved their BMI ( -2.2 kg/m2 ( 95 % CI -2.6 to -1.7 , P<0.001 ) ) and all secondary outcomes when compared to the children from the st and ard intervention arm . After 52 weeks , the day-camp intervention arm had a lower BMI ( -1.2 kg/m2 ( 95 % CI -1.8 to -0.5 , P = 0.001 ) ) , and BMI z-score ( -0.20 ( 95 % CI -0.35 to -0.05 , P = 0.008 ) ) , and clustered cardiovascular risk z-score ( -0.23 ( 95 % CI -0.37 to -0.08 , P = 0.002 ) ) compared to the st and ard intervention arm . No group differences were detected in body composition after 52 weeks . This study shows that the day-camp intervention arm is effective in reducing BMI and improving the metabolic health of children with overweight and obesity . However , the effects seem to be diminishing over time OBJECTIVE To evaluate the feasibility , acceptability , and efficacy of an after-school team sports program for reducing weight gain in low-income overweight children . DESIGN Six-month , 2-arm , parallel-group , pilot r and omized controlled trial . SETTING Low-income , racial/ethnic minority community . PARTICIPANTS Twenty-one children in grade s 4 and 5 with a body mass index at or above the 85th percentile . INTERVENTIONS The treatment intervention consisted of an after-school soccer program . The " active placebo " control intervention consisted of an after-school health education program . MAIN OUTCOME MEASURES Implementation , acceptability , body mass index , physical activity measured using accelerometers , reported television and other screen time , self-esteem , depressive symptoms , and weight concerns . RESULTS All 21 children completed the study . Compared with children receiving health education , children in the soccer group had significant decreases in body mass index z scores at 3 and 6 months and significant increases in total daily , moderate , and vigorous physical activity at 3 months . CONCLUSION An after-school team soccer program for overweight children can be a feasible , acceptable , and efficacious intervention for weight control OBJECTIVE . The objective of this study was to determine whether a generalizable best- practice individualized behavioral intervention reduced BMI z score relative to st and ard dietetic care among overweight children . METHODS . The design consisted of an assessor-blinded , r and omized , controlled trial involving 134 overweight children ( 59 boys , 75 girls ; BMI ≥ 98th centile relative to United Kingdom 1990 reference data for children aged 5–11 years ) who were r and omly assigned to a best- practice behavioral program ( intervention ) or st and ard care ( control ) . The intervention used family-centered counseling and behavioral strategies to modify diet , physical activity , and sedentary behavior . BMI z score , weight , objective ly measured physical activity and sedentary behavior , fat distribution , quality of life , and height z score were recorded at baseline and at 6 and 12 months . RESULTS . The intervention had no significant effect relative to st and ard care on BMI z score from baseline to 6 months and 12 months . BMI z score decreased significantly in both groups from baseline to 6 and 12 months . For those who complied with treatment , there was a significantly smaller weight increase in those in the intervention group compared with control subjects from baseline to 6 months . There were significant between-group differences in favor of the intervention for changes in total physical activity , percentage of time spent in sedentary behavior , and light-intensity physical activity . CONCLUSIONS . A generalizable , best- practice individualized behavioral intervention had modest benefits on objective ly measured physical activity and sedentary behavior but no significant effect on BMI z score compared with st and ard care among overweight children . The modest magnitude of the benefits observed perhaps argues for a longer-term and more intense intervention , although such treatments may not be realistic for many health care systems OBJECTIVE . The study tested whether a combined environmental and educational intervention solely promoting water consumption was effective in preventing overweight among children in elementary school . METHODS . The participants in this r and omized , controlled cluster trial were second- and third- grade rs from 32 elementary schools in socially deprived areas of 2 German cities . Water fountains were installed and teachers presented 4 prepared classroom lessons in the intervention group schools ( N = 17 ) to promote water consumption . Control group schools ( N = 15 ) did not receive any intervention . The prevalence of overweight ( defined according to the International Obesity Task Force criteria ) , BMI SD scores , and beverage consumption ( in glasses per day ; 1 glass was defined as 200 mL ) self-reported in 24-hour recall question naires , were determined before ( baseline ) and after the intervention . In addition , the water flow of the fountains was measured during the intervention period of 1 school year ( August 2006 to June 2007 ) . RESULTS . Data on 2950 children ( intervention group : N = 1641 ; control group : N = 1309 ; age , mean ± SD : 8.3 ± 0.7 years ) were analyzed . After the intervention , the risk of overweight was reduced by 31 % in the intervention group , compared with the control group , with adjustment for baseline prevalence of overweight and clustering according to school . Changes in BMI SD scores did not differ between the intervention group and the control group . Water consumption after the intervention was 1.1 glasses per day greater in the intervention group . No intervention effect on juice and soft drink consumption was found . Daily water flow of the fountains indicated lasting use during the entire intervention period , but to varying extent . CONCLUSION . Our environmental and educational , school-based intervention proved to be effective in the prevention of overweight among children in elementary school , even in a population from socially deprived areas This study was conducted to assess the changes in body composition , such as body fat mass ( F ) and lean body mass ( LBM ) , after the treatment of obesity with a low calorie balanced diet ( LCBD ) in out patient clinics . Body composition was measured by a bioelectrical impedance analysis ( RJL Systems , Detroit , Michigan , USA ) . 67 patients with over 30 % of obesity index ( OI ) , 36 males and 31 females , aged 3 - 15 years old were studied . 41 % of the males and 13 % of the females showed an increasing trend of OI after a temporary improvement of obesity ( P < 0.001 ) during a one year treatment period . F and LBM , however , did not change significantly , irrespective of the OI increment ( P < 0.001 ) , which was due to the increase of LBM . These observations indicated that the effects of treatment with LCBD for obesity should be assessed by the changes in F and LBM BACKGROUND In view of the growing trend of obesity around the world , including in our country , and the effect of reduced physical activity in increasing the incidence of obesity and overweight in children and adolescents and limitations of families in providing transport for their children to attend exercise classes , as well as time limitations of students in taking part in these classes , accessing appropriate methods for presenting physical activity training seems essential . METHODS This non-pharmacological clinical trial was performed during six months from May to November 2007 on 105 children and adolescents aged 6 - 18 years with obesity , r and omly assigned to 3 groups of thirty-five . Nutrition and treatment behavior were the same in all groups , but physical activity training in the first group was taking part in physical activity training classes twice a week , in the second group by providing a training CD , and in the third group via face-to-face training . Before and after the intervention , anthropometric indicators were measured and recorded . RESULTS Mean body mass index ( BMI ) of participants in group attended physical activity training classes , and in the group undergone training with CD , after the interventions was significantly lower than that before the intervention . CONCLUSION Our findings demonstrated that training using CDs can also be effective in reducing BMI in overweight and obese children and adolescents as much as face-to-face education and participation in physical training classes . Extending such interventions can be effective at the community level Background Fetal conditions are known to be partly responsible for the child ’s risk for obesity . Our pilot study aim ed to determine the effect of gestational lifestyle counseling on the offspring weight gain until 4 years of age and to estimate power for future studies . Design and methods First-time pregnant mothers participated in a controlled trial conducted in maternity health clinics during 2004 – 2006 . The intervention included individual counseling on physical activity and diet , and an option to attend supervised group exercise sessions . The participant mothers ( N = 109 ) received a follow-up question naire concerning 13 repeated growth measurements of their offspring . Response rate to the follow-up question naire was 66.1 % ( N = 72/109 ) . Results The increase of BMI z-score between 24–48 months was not significantly slower among the intervention group offspring ( 95 % CI −0.025 to 0.009 , p = 0.34 ) compared to control group . Z-scores for weight-for-length/height did not differ between groups when the period 0–48 months was analyzed ( 95 % CI −0.010 to 0.014 , p = 0.75 ) . Conclusions In this pilot study gestational lifestyle counseling did not significantly slow the weight gain of the offspring . Gestational intervention studies with at least 300 mothers per group are needed to confirm the possible effect on offspring ’s risk for obesity . Trial registration Current Controlled Trials IS RCT N21512277 Obesity is highly prevalent in asthmatic children and associated with worse clinical outcomes . Energy restriction to induce weight loss in asthmatic children has not been investigated in a r and omized controlled trial ( RCT ) Background —The prevalence of obesity in both adults and children is increasing rapidly . Obesity in children is independently associated with arterial endothelial dysfunction and wall thickening , key early events in atherogenesis that precede plaque formation . Methods and Results —To evaluate the reversibility of obesity-related arterial dysfunction and carotid intima-media thickening by dietary and /or exercise intervention programs , 82 overweight children ( body mass index , 25±3 ) , 9 to 12 years of age , were r and omly assigned to dietary modification only or diet plus a supervised structured exercise program for 6 weeks and subsequently for 1 year . The prospect ively defined primary end points were ultrasound-derived arterial endothelial function ( endothelium-dependent dilation ) of the brachial artery and intima-media thickness of common carotid artery . At 6 weeks , both interventions were associated with decreased waist-hip ratio ( P < 0.02 ) and cholesterol level ( P < 0.05 ) as well as improved arterial endothelial function . Diet and exercise together were associated with a significantly greater improvement in endothelial function than diet alone ( P = 0.01 ) . At 1 year , there was significantly less thickening of the carotid wall ( P < 0.001 ) as well as persistent improvements in body fat content and lipid profiles in the group continuing an exercise program . Vascular function was significantly better in those children continuing exercise ( n=22 ) compared with children who withdrew from the exercise program ( n=19 ) ( P < 0.05 ) . Conclusions —Obesity-related vascular dysfunction in otherwise healthy young children is partially reversible with diet alone or particularly diet combined with exercise training at 6 weeks , with sustained improvements at 1 year in those persisting with diet plus regular exercise OBJECTIVE The objective of the current study was to examine the effectiveness of a multidisciplinary weekly family-based behavioral group delivered via telemedicine to rural areas , compared with a st and ard physician visit intervention . METHODS A r and omized controlled trial was conducted with 58 rural children and their families comparing a family-based behavioral intervention delivered via telemedicine to a structured physician visit condition . Outcome measures included child body mass index z-score ( BMI z ) , 24-hr dietary recalls , accelerometer data , Child Behavior Checklist , Behavioral Pediatrics Feeding Assessment Scale , and feasibility and fidelity . RESULTS Child BMI z outcomes were not statistically different between the 2 groups ( F = 0.023 , p = .881 ) . Improvements in BMI z , nutrition , and physical activity were seen for both groups . CONCLUSIONS Both telemedicine and structured physician visit may be feasible and acceptable methods of delivering pediatric obesity treatment to rural children OBJECTIVE To compare two strategies for childhood obesity management : ambulatory assistance ( individual ) and educational program ( in group ) . METHOD Children and adolescents from 7 to 13 years of age were selected at r and om . They were divided into two groups : individually assisted or assisted in groups . An educational program about childhood obesity was created , with monthly meetings that consisted of lectures with parents ' participation and group work . Simultaneously , children and teenagers of the other group received individual ambulatory assistance . The program took place for six months . Body composition , eating habits and physical activities were assessed before and after interventions . RESULTS The sample comprised 38 children and adolescents whose mean age was 9.9 years . The program was more effective in increasing physical activity ( p = 0.003 ) , specially walking ( p = 0.003 ) , as well as in reducing total cholesterol ( p = 0.038 ) . Reduction of body mass index , obesity index and caloric intake was similar in both groups . As for food habits , ambulatory assistance increased the intake of fruits ( p = 0.033 ) and vegetables ( p = 0.002 ) and reduced the amount of French fries and crisps ( p = 0.041 ) , while children participating in the program reduced the intake of soft drinks ( p = 0.022 ) , s and wiches , pizza and fast food ( p = 0.006 ) . CONCLUSIONS Both strategies for h and ling childhood obesity were favorable to changes in food and physical activity habits . Group assistance was as effective as individual assistance , consolidating it as an alternative for obesity treatment Background Childhood obesity has reached epidemic proportions in developed countries . Sedentary screen-based activities such as video gaming are thought to displace active behaviors and are independently associated with obesity . Active video games , where players physically interact with images onscreen , may have utility as a novel intervention to increase physical activity and improve body composition in children . The aim of the Electronic Games to Aid Motivation to Exercise ( eGAME ) study is to determine the effects of an active video game intervention over 6 months on : body mass index ( BMI ) , percent body fat , waist circumference , cardio-respiratory fitness , and physical activity levels in overweight children . Methods / Design Three hundred and thirty participants aged 10–14 years will be r and omized to receive either an active video game up grade package or to a control group ( no intervention ) . Discussion An overview of the eGAME study is presented , providing an example of a large , pragmatic r and omized controlled trial in a community setting . Reflection is offered on key issues encountered during the course of the study . In particular , investigation into the feasibility of the proposed intervention , as well as robust testing of proposed study procedures is a critical step prior to implementation of a large-scale trial . Trial registration Australian New Zeal and Clinical Trials Registry Objective To examine the prevalence of outcome reporting bias — the selection for publication of a subset of the original recorded outcome variables on the basis of the results — and its impact on Cochrane review s. Design A nine point classification system for missing outcome data in r and omised trials was developed and applied to the trials assessed in a large , unselected cohort of Cochrane systematic review s. Research ers who conducted the trials were contacted and the reason sought for the non-reporting of data . A sensitivity analysis was undertaken to assess the impact of outcome reporting bias on review s that included a single meta- analysis of the review primary outcome . Results More than half ( 157/283 ( 55 % ) ) the review s did not include full data for the review primary outcome of interest from all eligible trials . The median amount of review outcome data missing for any reason was 10 % , whereas 50 % or more of the potential data were missing in 70 ( 25 % ) review s. It was clear from the publications for 155 ( 6 % ) of the 2486 assessable trials that the research ers had measured and analysed the review primary outcome but did not report or only partially reported the results . For reports that did not mention the review primary outcome , our classification regarding the presence of outcome reporting bias was shown to have a sensitivity of 88 % ( 95 % CI 65 % to 100 % ) and specificity of 80 % ( 95 % CI 69 % to 90 % ) on the basis of responses from 62 trialists . A third of Cochrane review s ( 96/283 ( 34 % ) ) contained at least one trial with high suspicion of outcome reporting bias for the review primary outcome . In a sensitivity analysis undertaken for 81 review s with a single meta- analysis of the primary outcome of interest , the treatment effect estimate was reduced by 20 % or more in 19 ( 23 % ) . Of the 42 meta-analyses with a statistically significant result only , eight ( 19 % ) became non-significant after adjustment for outcome reporting bias and 11 ( 26 % ) would have overestimated the treatment effect by 20 % or more . Conclusions Outcome reporting bias is an under-recognised problem that affects the conclusions in a substantial proportion of Cochrane review s. Individuals conducting systematic review s need to address explicitly the issue of missing outcome data for their review to be considered a reliable source of evidence . Extra care is required during data extraction , review ers should identify when a trial reports that an outcome was measured but no results were reported or events observed , and contact with trialists should be encouraged Background : The program The combined DAK therapy for obesity in children and adolescents ’ funded and conducted by the Deutsche Angestellten-Krankenkasse ( DAK ) , a German health insurance company , commenced in 2003 . The treatment program lasts for 1 year and comprises of 2 phases : an initial inpatient therapy for 6 weeks followed by a home-based outpatient treatment of the overweight children , adolescents , and their families for 10.5 months . The therapy complies with the guidelines of the German Working Group of Obesity in Childhood and Adolescence ( AGA ) . Participants and Methods : In this study , 162 obese children and adolescents were compared with a control group of 75 obese subjects recruited from the waiting list for the program . The aim was to analyze whether the changes in weight , eating behavior , and physical fitness during the therapy period are a result of the therapy itself or whether they are attributable to external effects . Body weight , height , and physical fitness were assessed through direct measurements while behavior and quality of life were assessed using self-report question naires . The development of body weight was evaluated using the BMI -SDS which is a measure of how many st and ard deviations an individual BMI is above or below the age- and gender-specific mean . Results : Within the observation period the BMI SDS decreased significantly by 0.36 ± 0.34 in the intervention group , whereas no changes of BMI -SDS were observed in the control group ( 0.04 ± 0.17 ) . The study revealed significant , positive treatment effects in exploratory analyses with regard to weight loss , behavior changes , physical fitness , and development of quality of life as a result of the therapy . These effects were not seen in the control group . Conclusion : We conclude that these positive developments are a result of the treatment program Obese children ( 8 - 13 years old ) and at least one of their parents participated in a behaviorally oriented treatment program . Participants in a st and ard treatment condition experienced a multicomponent intervention in which parents were given primary responsibility for following program prescriptions . An enhanced child involvement condition provided the same basic intervention but with greater emphasis on , and training in , child self-regulation . Children in both conditions achieved a significant reduction in percentage overweight and triceps skin-fold during the 6-month treatment period . Overall , the follow-up period of 3 years was characterized by increases above posttreatment levels . There was , however , some suggestion in the 3-year follow-up results and the long-term patterns over a 6 1/2-year period of the benefits of the enhanced child involvement approach . Findings are discussed in terms of suggestions for reconsideration of treatment goals , improved interventions , and refinements in the assessment of self-regulatory behavior Background The prevalence of childhood obesity has increased worldwide , which is a serious concern as obesity is associated with many negative immediate and long-term health consequences . Therefore , the treatment of overweight and obesity in children and adolescents is strongly recommended . Inpatient weight-loss programs have shown to be effective particularly regarding short-term weight-loss , whilst little is known both on the long-term effects of this treatment and the determinants of successful weight-loss and subsequent weight maintenance . The purpose of this study is to evaluate the short , middle and long-term effects of an inpatient weight-loss program for children and adolescents and to investigate the likely determinants of weight changes , whereby the primary focus lies on the potential role of differences in polymorphisms of adiposity-relevant genes . Methods / Design The study involves overweight and obese children and adolescents aged 6 to 19 years , who participate in an inpatient weight-loss program for 4 to 6 weeks . It started in 2006 and it is planned to include 1,500 participants by 2013 . The intervention focuses on diet , physical activity and behavior therapy . Measurements are taken at the start and the end of the intervention and comprise blood analyses ( DNA , lipid and glucose metabolism , adipokines and inflammatory markers ) , anthropometry ( body weight , height and waist circumference ) , blood pressure , pubertal stage , and exercise capacity . Physical activity , dietary habits , quality of life , and family background are assessed by question naires . Follow-up assessment s are performed 6 months , 1 , 2 , 5 and 10 years after the intervention : Children will complete the same question naires at all time points and visit their general practitioner for examination of anthropometric parameters , blood pressure and assessment of pubertal stage . At the 5 and 10 year follow-ups , blood parameters and exercise capacity will be additionally measured . Discussion Apart from illustrating the short , middle and long-term effects of an inpatient weight-loss program , this study will contribute to a better underst and ing of inter-individual differences in the regulation of body weight , taking into account the role of genetic predisposition and lifestyle factors . Trial Registration NCT01067157 Introduction The successful recruitment and retention of participants is integral to the translation of research findings . We examined the recruitment and retention rates of racial/ethnic minority adolescents at a center involved in the National Institutes of Health Obesity Research for Behavioral Intervention Trials ( ORBIT ) initiative by the 3 recruitment strategies used : clinic , informatics , and community . Methods During the 9-month study , 186 family dyads , each composed of an obese African American adolescent and a caregiver , enrolled in a 6-month weight-loss intervention , a sequential multiple assignment r and omized trial . We compared recruitment and retention rates by recruitment strategy and examined whether recruitment strategy was related to dyad baseline characteristics . Results Of the 186 enrolled families , 110 ( 59.1 % ) were recruited through clinics , 53 ( 28.5 % ) through informatics , and 23 ( 12.4 % ) through community . Of those recruited through community , 40.4 % enrolled in the study , compared with 32.7 % through clinics and 8.2 % through informatics . Active refusal rate was 3 % . Of the 1,036 families identified for the study , 402 passively refused to participate : 290 ( 45.1 % ) identified through informatics , 17 ( 29.8 % ) through community , and 95 ( 28.3 % ) through clinics . Recruitment strategy was not related to the age of the adolescent , adolescent comorbidities , body mass index of the adolescent or caregiver , income or education of the caregiver , or retention rates at 3 months , 7 months , or 9 months . Study retention rate was 87.8 % . Conclusion Using multiple recruitment strategies is beneficial when working with racial/ethnic minority adolescents , and each strategy can yield good retention . Research affiliated with health care systems would benefit from the continued specification , refinement , and dissemination of these strategies BACKGROUND The purpose of this study was to examine the impact of the Pathways intervention on pychosocial variables related to physical activity and diet in American Indian children . METHODS Schools serving American Indian children were r and omized to a multicomponent intervention or control condition . At baseline ( fall of third grade ) and in the spring semester of third , fourth , and fifth grade s 755 boys and 692 girls completed a classroom-administered question naire . The question naire assessed self-efficacy , knowledge , and behavioral intentions related to diet and physical activity , as well as weight loss behaviors and body image . RESULTS Knowledge of nutrition and physical activity messages increased in both boys and girls in the intervention group compared to controls ; however , knowledge of which foods contained more fat did not increase consistently . Compared to controls , self-efficacy to be physically active increased among girls in intervention schools , but not among boys , whereas self-efficacy to make more healthy food choices did not increase more than in controls in either gender . In the intervention group , compared to controls , healthy food intentions and participation in physically active behaviors increased in both boys and girls . Perception of healthy body size and weight loss attempts did not differ in the intervention and control groups . CONCLUSION The Pathways intervention program had a positive impact on several aspects of obesity-related knowledge , attitudes , and behaviors BACKGROUND Health-related quality of life ( HRQoL ) has been recognized as an important target and health outcome in obesity research . The current study aim ed to examine HRQoL in overweight or obese children after a 10-week primary -care-based weight management program , Parent-Led Activity and Nutrition for Healthy Living , in southern Appalachia . METHODS Sixty-seven children ( ages 5 - 12 years ) and their caregivers were recruited from four primary care clinics , two of which were r and omized to receive the intervention . Caregivers in the intervention groups received two brief motivational interviewing visits and four group sessions led by providers as well as four phone follow-ups with research staff . Caregivers completed the PedsQL and demographic question naires at baseline and at 3 , 6 , and 12 months postintervention . Child height and weight were collected to determine st and ardized BMI . RESULTS Caregivers of children receiving the weight control intervention reported no statistically significant improvements in child total HRQoL , as compared to the control group , across the course of treatment ( β=0.178 ; 95 % confidence interval , -0.681 , 1.037 ; p=0.687 ) . Additionally , no statistically significant improvements were found across other HRQoL domains . CONCLUSIONS Future studies examining HRQoL outcomes in primary care may consider treatment dose as well as method ological factors , such as utilization of multiple informants and different measures , when design ing studies and interpreting outcomes Increasing fruits and vegetables ( FVs ) , a dietary recommendation for pediatric weight management , is theorized to reduce energy intake by reducing intake of more energy-dense foods , such as snack foods ( SFs ) . This study examined the relationship between changes in FV , SF , and energy intake in children enrolled in a 6-month , family-based behavioral pediatric weight management trial . Secondary data analyses examined dietary intake in 80 overweight ( ≥85th to < 95th percentile for body mass index [ BMI ] ) and obese ( ≥95th percentile for BMI ) children ( 7.2 ± 1.7 years ) with complete dietary records at 0 and 6 months . Participants were r and omized to one of three treatment conditions : ( 1 ) increased growth monitoring with feedback ; ( 2 ) decrease SFs and sugar sweetened beverages ; or ( 3 ) increase FVs and low-fat dairy . With treatment condition controlled in all analyses , FV intake significantly increased , while SF and energy intake decreased , but not significantly , from 0 to 6 months . Change in FV intake was not significantly associated with change in SF consumption . Additionally , change in FV intake was not significantly related to change in energy intake . However , reduction in SF intake was significantly related to reduction in energy intake . Changing only FVs , as compared to changing other dietary behaviors , during a pediatric obesity intervention may not assist with reducing energy intake OBJECTIVE To determine the changes in percentage of body fat , cardiovascular fitness , and insulin levels during the 3-month summer break in overweight children enrolled in a school-based fitness program . STUDY DESIGN Overweight middle-school children were r and omized to a lifestyle-focused physical education class ( treatment ) or st and ard physical education class ( control ) for 1 school year ( 9 months ; previously reported ) . This analysis reports changes during the 3-month summer break in children who participated in the fitness intervention group and who remained at this school the following year and repeated a fitness class . At the beginning and end of the school year , children underwent evaluation of ( 1 ) fasting levels of insulin and glucose , ( 2 ) body composition by means of dual x-ray absorptiometry , and ( 3 ) maximum oxygen consumption as determined by treadmill use . SETTING Rural middle school and an academic children 's hospital . PARTICIPANTS Overweight middle-school children . INTERVENTION School-based fitness curriculum , followed by summer break , and an additional year of school-based fitness intervention . MAIN OUTCOME MEASURES Cardiovascular fitness test results ( maximum oxygen consumption ) , body composition , and fasting insulin levels . RESULTS Improvements seen during the 9-month school-year intervention in cardiovascular fitness , fasting insulin levels , and body composition were lost during the 3-month summer break . During this summer break , mean + /- SD fitness level decreased ( maximum oxygen consumption , -3.2 + /- 1.9 mL/kg per minute ; P = .007 ) , fasting insulin level increased ( + 44 + /- 69 pmol/L [ + 6.1 + /- 9.7 mIU/mL ] ; P = .056 ) , and percentage of body fat increased ( + 1.3 % + /- 1.3 % ; P = .02 ) to levels that were similar to those seen before the school intervention . CONCLUSION In obese middle-school children , school-based fitness interventions are an important vehicle for health promotion , but without sustained intervention , these benefits may be lost during the extended summer break Background The bias toward immediate gratification is associated with maladaptive eating behaviors and has been cross-sectionally and prospect ively related to obesity . Engaging in episodic future thinking , which involves mental self-projection to pre-experience future events , reduces this bias and energy intake in overweight/obese adults and children . To examine how episodic future thinking can be incorporated into clinical interventions , a Web-based system was created to provide training for adults and children in their everyday lives . Objective Our study examined the technical feasibility , usability , and acceptability of a Web-based system that is accessible by mobile devices and adapts episodic future thinking for delivery in family-based obesity interventions . Methods We recruited 20 parent-child dyads ( N=40 ) from the surrounding community and r and omized to episodic future thinking versus a nutritional information thinking control to test the feasibility of a 4-week Web-based intervention . Parents were 44.1 ( SD 7.8 ) years of age with BMI of 34.2 ( SD 6.8 ) kg/m2 . Children were 11.0 ( SD 1.3 ) years of age with BMI percentile of 96.0 ( SD 1.8 ) . Families met weekly with a case manager for 4 weeks and used the system daily . Adherence was collected through the Web-based system , and perceived acceptance of the Web-based system was assessed postintervention . Measurements of body composition and dietary intake were collected at baseline and after the 4 weeks of intervention . Results All 20 families completed the intervention and attended all sessions . Results showed parents and children had high adherence to the Web-based system and perceived it to be easy to use , useful , and helpful . No differences between conditions were found in adherence for parents ( P=.65 ) or children ( P=.27 ) . In addition , results suggest that basic nutrition information along with episodic future thinking delivered through our Web-based system may reduce energy intake and weight . Conclusions We showed that our Web-based system is an accepted technology and a feasible utility . Furthermore , results provide initial evidence that our system can be incorporated into family-based treatments targeting behaviors related to weight control . These results show promising utility in using our Web-based system in interventions Background Obesity is significant problem involving eating behavior and peripheral metabolic conditions . The effect of carbohydrate and fat restriction on appetite regulation , fibroblast growth factor 21 ( FGF21 ) and leptin in children has not been defined . Our objective was to compare the effect of both diets . Methods One hundred and twenty children with body mass index ( BMI ) higher than the equivalent of 30 kg/m2 for an adult , as corrected for gender and age were r and omly assigned to ( n = 60 ) a low-carbohydrate ( L-CHO ) diet or ( n = 60 ) a low-fat ( L-F ) diet for 2 months . Fifty-three ( 88.3 % ) subjects on the low-carbohydrate-diet and 45 ( 75 % ) on the low-fat diet completed the study . Anthropometric measures , leptin and FGF21 levels were measured before and after the intervention . Comparison of the data for both of the diet groups was carried out using the t-test for independent variables . Intragroup comparisons before and after of each of the dietary treatments were performed using ANOVA for repeated measures . Factors associated with FGF21 , leptin levels and satiety , were analyzed by multiple regression . Results After both of the diets , weight , leptin , food responsiveness , and enjoyment of food significantly decreased and high density lipoprotein cholesterol ( HDL ) increased , but FGF21 decreased . Before and after both of the interventions FGF21 was associated with triglycerides . Before the diet , satiety was associated with lower screen time ( p < 0.04 ) and insulin levels ( p < 0.05 ) . Conclusions Both dietary restrictions improved the metabolic and hormonal parameters of obese children . FGF21 is an indicator of a beneficial metabolic response in younger children . After 2 months an adaptation of the eating behavior to food restriction was observed Objective : This study sought to document self-reported binge eating in a large sample of severely obese children and to examine the impact of binge eating on changes in percent overweight among children r and omized to family-based behavioral treatment ( intervention ) versus control ( usual care ) . Participants and methods : As part of a larger r and omized controlled trial , 192 children aged 8–12 years ( M=10.2 , s.d.=1.2 ) with a mean body mass index ( BMI ) percentile of 99.2 ( s.d.=0.7 ) completed assessment s at baseline and 6- , 12- , and 18 months post-r and omization . A parent or guardian also participated . Child psychological symptoms , including binge eating , were measured before r and omization using self-report question naires . Child height and weight were measured at baseline , 6- , 12- , and 18 months . The primary study outcome was percent overweight ( that is , percent over median BMI for age and sex ) . Results : Twenty-two children ( 11.5 % ) endorsed binge eating at baseline ( Binge Eating Group ) . Children in the Binge Eating Group were younger and had more depressive , anxiety , and eating disorder symptoms , and lower self-esteem than children in the rest of the sample ( No Binge Eating Group ) . There also were differences between the Binge Eating and No Binge Eating groups with respect to the short-term effects of treatment group assignment on change in percent overweight during the study . Specifically , improvements in percent overweight in the intervention condition relative to usual care were documented in the No Binge Eating Group only . Among children in the Binge Eating Group , those assigned to intervention showed a 2.6 % increase in percent overweight , on average , at the completion of acute treatment as compared to an 8.5 % decrease among children without binge eating . However , these effects were not maintained during follow-up . Conclusion : Results of this study suggest the importance of considering binge eating in the development of weight management programs for severely obese youth OBJECTIVE : To determine whether a 2-year family-based intervention using frequent contact and limited expert involvement was effective in reducing excessive weight compared with usual care . METHODS : Two hundred and six overweight and obese ( BMI ≥85th percentile ) children aged 4 to 8 years were r and omized to usual care ( UC ) or tailored package ( TP ) sessions at university research rooms . UC families received personalized feedback and generalized advice regarding healthy lifestyles at baseline and 6 months . TP families attended a single multidisciplinary session to develop specific goals suitable for each family , then met with a mentor each month for 12 months , and every third month for another 12 months to discuss progress and provide support . Outcome measurements ( anthropometry , question naires , dietary intake , accelerometry ) were obtained at 0 , 12 , and 24 months . RESULTS : BMI at 24 months was significantly lower in TP compared with UC children ( difference , 95 % confidence interval : –0.34 , –0.65 to –0.02 ) , as was BMI z score ( –0.12 , –0.20 to –0.04 ) and waist circumference ( –1.5 , –2.5 to –0.5 cm ) . TP children consumed more fruit and vegetables ( P = .038 ) and fewer noncore foods ( P = .020 ) than UC children , and fewer noncore foods were available in the home ( P = .002 ) . TP children were also more physically active ( P = .035 ) . No differences in parental feeding practice s , parenting , quality of life , child sleep , or behavior were observed . CONCLUSIONS : Frequent , low-dose support was effective for reducing excessive weight in predominantly mild to moderately overweight children over a 2-year period . Such initiatives could feasibly be incorporated into primary care Background Young children who are overweight are at increased risk of becoming obese and developing type 2 diabetes and cardiovascular disease later in life . Therefore , early intervention is critical . This paper describes the rationale , design , methodology , and sample characteristics of a 5-year cluster r and omized controlled trial being conducted in eight elementary schools in rural North Carolina , United States . Methods / Design The first aim of the trial is to examine the effects of a two-phased intervention on weight status , adiposity , nutrition and exercise health behaviors , and self-efficacy in overweight or obese 2nd , 3 rd , and 4th grade children and their overweight or obese parents . The primary outcome in children is stabilization of BMI percentile trajectory from baseline to 18 months . The primary outcome in parents is a decrease in BMI from baseline to 18 months . Secondary outcomes for both children and parents include adiposity , nutrition and exercise health behaviors , and self-efficacy from baseline to 18 months . A secondary aim of the trial is to examine in the experimental group , the relationships between parents and children 's changes in weight status , adiposity , nutrition and exercise health behaviors , and self-efficacy . An exploratory aim is to determine whether African American , Hispanic , and non-Hispanic white children and parents in the experimental group benefit differently from the intervention in weight status , adiposity , health behaviors , and self-efficacy . A total of 358 African American , non-Hispanic white , and bilingual Hispanic children with a BMI ≥ 85th percentile and 358 parents with a BMI ≥ 25 kg/m2 have been inducted over 3 1/2 years and r and omized by cohort to either an experimental or a wait-listed control group . The experimental group receives a 12-week intensive intervention of nutrition and exercise education , coping skills training and exercise ( Phase I ) , 9 months of continued monthly contact ( Phase II ) and then 6 months ( follow-up ) on their own . Safety endpoints include adverse event reporting . Intention-to-treat analysis will be applied to all data . Discussion Findings from this trial may lead to an effective intervention to assist children and parents to work together to improve nutrition and exercise patterns by making small lifestyle pattern changes . Trial registration NCT01378806 PURPOSE We aim ed to assess the impact of spin ( ie , reporting to convince readers that the beneficial effect of the experimental treatment is greater than shown by the results ) on the interpretation of results of abstract s of r and omized controlled trials ( RCTs ) in the field of cancer . METHODS We performed a two-arm , parallel-group RCT . We selected a sample of published RCTs with statistically nonsignificant primary outcome and with spin in the abstract conclusion . Two versions of these abstract s were used-the original with spin and a rewritten version without spin . Participants were clinician corresponding authors of articles reporting RCTs , investigators of trials , and review ers of French national grants . The primary outcome was clinicians ' interpretation of the beneficial effect of the experimental treatment ( 0 to 10 scale ) . Participants were blinded to study hypothesis . RESULTS Three hundred clinicians were r and omly assigned using a Web-based system ; 150 clinicians assessed an abstract with spin and 150 assessed an abstract without spin . For abstract s with spin , the experimental treatment was rated as being more beneficial ( mean difference , 0.71 ; 95 % CI , 0.07 to 1.35 ; P = .030 ) , the trial was rated as being less rigorous ( mean difference , -0.59 ; 95 % CI , -1.13 to 0.05 ; P = .034 ) , and clinicians were more interested in reading the full-text article ( mean difference , 0.77 ; 95 % CI , 0.08 to 1.47 ; P = .029 ) . There was no statistically significant difference in the clinicians ' rating of the importance of the study or the need to run another trial . CONCLUSION Spin in abstract s can have an impact on clinicians ' interpretation of the trial results Background : Treatment of childhood obesity is difficult , and successful management may differ in various areas with different cultural background s. The present study was conducted to assess the effect of lifestyle modification family-based intervention in young Iranian children . Methods : This field trial study was conducted in 2011 among 156 obese children in Tehran , Iran . They were r and omly assigned to intervention and control groups . At baseline , anthropometric measurements and biochemical analysis were performed . The second and third phases consisted of training sessions for parents of the intervention group . At the fourth phase , there was no training program . In all four phases , question naires on demographic characteristics , lifestyle and food frequency were completed by interviewing with mothers , and biochemical analysis was repeated at the end of the study . Results : During the second and third phases of the study , weight and height increased significantly in both groups , although weight increased more slowly , and waist and hip circumferences was decreased in the intervention group . Serum triglycerides and cholesterol decreased significantly in the intervention group ( P < 0.05 ) . Analysis of food group consumption showed that in the intervention group , not only consumption of milk , dairy and nuts group increased significantly but also the corresponding figure decreased for bread and cereals , sugar and confectionery ingredients ; moreover , the family 's oil and fat consumption decreased significantly ( P < 0.05 ) . Watching TV and playing on the computer decreased significantly in the intervention group ; however , walking time increased significantly in both groups ( P < 0.05 ) . Conclusions : The family-based lifestyle program had limited but desirable effects on anthropometric and metabolic outcomes of the obese children . We suggest that a longer period of intervention may have more favorable results Background Research suggests the neighborhood built environment is related to child physical activity and eating . Purpose The purpose of this study was to determine if characteristics of the neighborhood environment moderate the relationship between obesity treatment and weight loss , and if outcomes of particular treatments are moderated by built environment characteristics . Method The relationship between the built environment and st and ardized BMI ( z BMI ) changes for 191 8–12-year-old children who participated in one of four r and omized , controlled trials of pediatric weight management was assessed using mixed models analysis of covariance . Results At 2-year follow-up , greater parkl and , fewer convenience stores , and fewer supermarkets were associated with greater z BMI reduction across all interventions . No treatments interacted with characteristics of the built environment . Conclusions Activity- and eating-related built neighborhood characteristics are associated with child success in behavioral obesity treatments . Efficacy may be improved by individualizing treatments based on built environment characteristics Background : One of the basic principles of behavioral economics interventions is identification of alternative behaviors to compete with the reinforcing value of a highly rewarding commodity . Purpose : Two experiments that attempt to increase alternatives to eating in obese youth are presented . Methods : A r and omized , controlled trial was used in Study 1 to compare a comprehensive family-based behavioral treatment program or an experimental treatment that incorporated reinforcing children for engaging in alternative behaviors to eating for 41 overweight 8-to 12-year-old children . Study 2 used a within-subject design with baseline , enriched environment and a second baseline phase to determine the influence of providing activities that compete with eating for 13 overweight 8-to 12-year-old children . Measurements included body mass index ( BMI ) change , alternatives to eating , eating , and physical activity . Results : In Study I both treatments were associated with significant ( p < .05 ) and maintained reductions in z- BMI over the 24 months of observation . The experimental group showed a significantly ( p < .05 ) greater increase in alternatives to eating , and both groups showed significant ( p < .05 ) increases in physical activity . In Study 2 alternative behaviors to eating were increased by almost I hr/day ( p < .001 ) but were not associated with significant changes in energy intake or physical activity . Conclusion : These results suggest that using the methods studied , increasing behaviors that could compete with eating did not influence relative weight in a clinical outcome study or energy intake in a controlled field study BACKGROUND Sedentary activities such as video gaming are independently associated with obesity . Active video games , in which players physically interact with images on screen , may help increase physical activity and improve body composition . OBJECTIVE The aim of this study was to evaluate the effect of active video games over a 6-mo period on weight , body composition , physical activity , and physical fitness . DESIGN We conducted a 2-arm , parallel , r and omized controlled trial in Auckl and , New Zeal and . A total of 322 overweight and obese children aged 10 - 14 y , who were current users of sedentary video games , were r and omly assigned at a 1:1 ratio to receive either an active video game up grade package ( intervention , n = 160 ) or to have no change ( control group , n = 162 ) . The primary outcome was the change from baseline in body mass index ( BMI ; in kg/m(2 ) ) . Secondary outcomes were changes in percentage body fat , physical activity , cardiorespiratory fitness , video game play , and food snacking . RESULTS At 24 wk , the treatment effect on BMI ( -0.24 ; 95 % CI : -0.44 , -0.05 ; P = 0.02 ) favored the intervention group . The change ( ±SE ) in BMI from baseline increased in the control group ( 0.34 ± 0.08 ) but remained the same in the intervention group ( 0.09 ± 0.08 ) . There was also evidence of a reduction in body fat in the intervention group ( -0.83 % ; 95 % CI : -1.54 % , -0.12 % ; P = 0.02 ) . The change in daily time spent playing active video games at 24 wk increased ( 10.03 min ; 95 % CI : 6.26 , 13.81 min ; P < 0.0001 ) with the intervention accompanied by a reduction in the change in daily time spent playing nonactive video games ( -9.39 min ; 95 % CI : -19.38 , 0.59 min ; P = 0.06 ) . CONCLUSION An active video game intervention has a small but definite effect on BMI and body composition in overweight and obese children . This trial was registered in the Australian New Zeal and Clinical Trials Registry at http://www.anzctr.org.au/ as ACTRN12607000632493 Objective The objective of the current study was to examine the feasibility of telemedicine vs. telephone for the delivery of a multidisciplinary weekly family-based behavioural group intervention to treat paediatric obesity delivered to families living in rural areas using a r and omized controlled trial methodology . Methods 103 rural children and their families were recruited . Feasibility measures included participant satisfaction , session attendance and retention . Treatment outcome measures included child Body Mass Index z-score ( BMI z ) , parent BMI , 24-hour dietary recalls , accelerometer data , the child behavior checklist and the behavioral pediatrics feeding assessment scale . Results Participants were highly satisfied with the intervention both via telemedicine and via telephone . Completion rates were much higher than for other paediatric obesity intervention programmes , and both method ologies were highly feasible . There were no differences in telemedicine and telephone groups on primary outcomes . Conclusion Both telemedicine and telephone intervention appear to be feasible and acceptable methods of delivering paediatric obesity treatment to rural children BACKGROUND During the nutrition transition in Chile , dietary changes were marked by increased consumption of high-energy , nutrient-poor products , including sugar-sweetened beverages ( SSBs ) . Obesity is now the primary nutritional problem in posttransitional Chile . OBJECTIVE We conducted a r and omized controlled trial to examine the effects on body composition of delivering milk beverages to the homes of overweight and obese children to displace SSBs . DESIGN We r and omly assigned 98 children aged 8 - 10 y who regularly consumed SSBs to intervention and control groups . During a 16-wk intervention , children were instructed to drink 3 servings/d ( approximately 200 g per serving ) of the milk delivered to their homes and to not consume SSBs . Body composition was measured by dual-energy X-ray absorptiometry . Data were analyzed by multiple regression analysis according to the intention-to-treat principle . RESULTS For the intervention group , milk consumption increased by a mean ( + /- SEM ) of 452.5 + /- 37.7 g/d ( P < 0.0001 ) , and consumption of SSBs decreased by -711.0 + /- 33.7 g/d ( P < 0.0001 ) . For the control group , milk consumption did not change , and consumption of SSBs increased by 71.9 + /- 33.6 g/d ( P = 0.04 ) . Changes in percentage body fat , the primary endpoint , did not differ between groups . Nevertheless , the mean ( + /- SE ) accretion of lean body mass was greater ( P = 0.04 ) in the intervention ( 0.92 + /- 0.10 kg ) than in the control ( 0.62 + /- 0.11 kg ) group . The increase in height was also greater ( P = 0.01 ) in the intervention group ( 2.50 + /- 0.21 cm ) than in the control group ( 1.77 + /- 0.20 cm ) for boys but not for girls . CONCLUSION Replacing habitual consumption of SSBs with milk may have beneficial effects on lean body mass and growth in children , despite no changes in percentage body fat . This trial was registered at clinical trials.gov as NCT00149695 BACKGROUND Little is known about the effects of physical training on plasma leptin concentrations in children . OBJECTIVE We sought to determine the effects of 4-mo periods with and without physical training on leptin in obese children and to explore the determinants of leptin at baseline and in response to physical training . DESIGN Participants were 34 obese 7 - 11-y-old children r and omly assigned to engage in physical training during either the first or second 4 mo of the 8-mo study . RESULTS Total body composition , visceral adiposity , and insulin were all positively correlated with leptin at baseline ( P < or = 0.05 ) ; however , only fat mass was retained in the final stepwise regression ( P = 0.0001 , R2 = 0.57 ) . Leptin decreased during the 4-mo periods of physical training and increased in the 4 mo after cessation of physical training ( P < 0.001 for the time by group interaction ) . Decreases in leptin were greatest in children with higher pretraining leptin concentrations , those whose total mass increased least , and those whose insulin concentrations decreased most ( P < or = 0.05 ) ; only pretraining leptin concentration ( P = 0.009 ) and change in total mass ( P = 0.0002 ) were retained in the final regression ( R2 = 0.53 ) . CONCLUSIONS In obese children , leptin concentration decreased during 4 mo of physical training and increased during a subsequent 4-mo period without physical training , fat mass was highly correlated with baseline leptin , and greater reductions in leptin during 4 mo of physical training were seen in children with higher pretraining leptin and in those whose total mass increased least Exercise has been found to be effective for prevention of weight gain and maintenance of a stable weight in adults . The objective of this study was to evaluate the effect of a school-based aerobic exercise program on the obesity indexes of preschool children . Subjects were 292 second-year elementary school pupils from 2 kindergartens in Hat Yai municipality , Songkhla province , southern Thail and . A specially design ed exercise program , including a 15-min walk before beginning the morning class and a 20-min aerobic dance session after the afternoon nap , 3 times a week , was conducted for 29.6 wk . Weight , height , and triceps skinfold thickness were measured 4 times . At the end of the study , the prevalence of obesity , using 95th percentile National Center for Health Statistics triceps-skinfold-thickness cutoffs , of both the exercise and control groups decreased . That of the exercise group decreased from 12.2 % at baseline to 8.8 % ( Wilcoxon signed-rank test , P = 0.058 ) , whereas that of the control group decreased from 11.7 % to 9.7 % ( Wilcoxon signed-rank test , P = 0.179 ) . A sex difference in the response of body mass index ( BMI ) to exercise was observed . Girls in the exercise group had a lower likelihood of having an increasing BMI slope than the control girls did ( odds ratio : 0.32 ; 95 % CI : 0.18 , 0.56 ) . In conclusion , our study suggests that a 29.6-wk school-based exercise program can prevent BMI gain in girls and may induce a remission of obesity in preschool-age children BACKGROUND Childhood obesity is a major public health problem in the United States , particularly among American Indian communities . OBJECTIVE The objective was to evaluate the effectiveness of a school-based , multicomponent intervention for reducing percentage body fat in American Indian schoolchildren . DESIGN This study was a r and omized , controlled , school-based trial involving 1704 children in 41 schools and was conducted over 3 consecutive years , from 3rd to 5th grade s , in schools serving American Indian communities in Arizona , New Mexico , and South Dakota . The intervention had 4 components : 1 ) change in dietary intake , 2 ) increase in physical activity , 3 ) a classroom curriculum focused on healthy eating and lifestyle , and 4 ) a family-involvement program . The main outcome was percentage body fat ; other outcomes included dietary intake , physical activity , and knowledge , attitudes , and behaviors . RESULTS The intervention result ed in no significant reduction in percentage body fat . However , a significant reduction in the percentage of energy from fat was observed in the intervention schools . Total energy intake ( by 24-h dietary recall ) was significantly reduced in the intervention schools but energy intake ( by direct observation ) was not . Motion sensor data showed similar activity levels in both the intervention and control schools . Several components of knowledge , attitudes , and behaviors were also positively and significantly changed by the intervention . CONCLUSIONS These results document the feasibility of implementing a multicomponent program for obesity prevention in elementary schools serving American Indian communities . The program produced significant positive changes in fat intake and in food- and health-related knowledge and behaviors . More intense or longer interventions may be needed to significantly reduce adiposity in this population BACKGROUND Nationwide data on obesity prevalence in American Indian communities are limited . OBJECTIVE We describe the body composition and anthropometric characteristics of schoolchildren from 7 American Indian communities enrolled in the Pathways study , a r and omized field trial evaluating a program for the primary prevention of obesity . DESIGN A total of 1704 children in 41 schools were enrolled in the study . Basic anthropometric measurements included weight , height , and triceps and subscapular skinfold thicknesses . Percentage body fat was estimated from bioelectrical impedance and anthropometric variables with the use of an equation developed and vali date d for this population . RESULTS The children 's mean ( + /- SD ) age was 7.6 + /- 0.6 y , and their mean weight and height were 32.1 + /- 8.9 kg and 129.8 + /- 6.3 cm , respectively . Mean body mass index ( BMI ; in kg/m(2 ) ) was 18.8 + /- 3.9 , and mean percentage body fat was 32.6 + /- 6.8 % . With the use of current Centers for Disease Control and Prevention reference values , 30.5 % of girls and 26.8 % of boys were above the 95th percentiles for BMI -for-age , and 21 % of girls and 19.6 % of boys were between the 85th and 95th percentiles . Although there was a wide range in BMI across study sites and for both sexes , the percentage of children with a BMI above the 95th percentile was consistently higher than the national averages in all communities studied and in both girls and boys . CONCLUSIONS Overweight can be documented in a substantial number of American Indian children by the time they reach elementary school . Despite differences in the prevalence of overweight observed among communities , rates are uniformly high relative to national all-race averages OBJECTIVE : To evaluate the effectiveness of active parental involvement in a lifestyle intervention for the management of childhood obesity . DESIGN : Forty-two overweight children ( 32 girls and 10 boys ) , aged 9.2±0.2 years and with percent overweight 39.8±2.7 % , were r and omly allocated either to a child- and -parent group ( N = 23 ) or a child-alone group ( N = 19 ) . Both groups attended a 3-month multidisciplinary program extended by booster sessions during follow-up , which involved many cognitive behavioral therapy principles and assigned high self-regulation to the children , but differed in parental involvement . Percent overweight was evaluated at baseline , and at 3 , 6 , and 18 months thereafter . RESULTS : There was no significant interaction between time and group or a significant difference between groups . Percent overweight decreased by 4.9±1.4 at 18 months ( p < 0.001 ) ; the reduction occurred during the active phase of the treatment ( 0 - 3 months ) and was maintained thereafter . CONCLUSION : In the setting of the present study , the active parental involvement did not significantly modify the results of lifestyle interventions for children ’s overweight management BACKGROUND While overweight and obese children are more likely to have overweight or obese parents , less is known about the effect of parental weight status on children 's success in weight management programmes . OBJECTIVES This study was a secondary data analysis of a r and omized controlled trial and investigated the impact of having zero , one or two obese parents on children 's success in a school-based weight management programme . METHODS Sixty-one Mexican-American children participated in a 24-week school-based weight management intervention which took place in 2005 - 2006 . Children 's heights and weights were measured at baseline , 3 , 6 and 12 months . Parental weight status was assessed at baseline . Repeated measures anova and ancova were conducted to compare changes in children 's weight within and between groups , respectively . RESULTS Within-group comparisons revealed that the intervention led to significant decreases in st and ardized body mass index ( z BMI ) for children with zero ( F = 23.16 , P < .001 ) or one obese ( F = 4.99 , P < .05 ) parent . Between-group comparisons indicated that children with zero and one obese parents demonstrated greater decreases in z BMI compared to children with two obese parents at every time point . CONCLUSIONS The school-based weight management programme appears to be most efficacious for children with one or no obese parents compared to children with two obese parents . These results demonstrate the need to consider parental weight status when engaging in childhood weight management efforts Background Obesity is mainly attributed to environmental factors . In developed countries , the time spent on physical activity tasks is decreasing , whereas sedentary behaviour patterns are increasing . The purpose of the intervention is to evaluate the effectiveness of an intensive family-based behavioural multi-component intervention ( Nereu programme ) and compared it to counselling intervention such as a health centre intervention programme for the management of children ’s obesity . Methods / Design The study design is a r and omized controlled multicenter clinical trial using two types of interventions : Nereu and Counselling . The Nereu programme is an 8-month intensive family-based multi-component behavioural intervention . This programme is based on a multidisciplinary intervention consisting of 4 components : physical activity sessions for children , family theoretical and practical sessions for parents , behaviour strategy sessions involving both , parents and children , and lastly , weekend extra activities for all . Counselling is offered to the family in the form of a monthly physical health and eating habits session . Participants will be recruited according the following criteria : 6 to 12 year-old-children , referred from their paediatricians due to overweight or obesity according the International Obesity Task Force criteria and with a sedentary profile ( less than 2 hours per week of physical activity ) , they must live in or near the municipality of Lleida ( Spain ) and their healthcare paediatric unit must have previously accepted to cooperate with this study . The following variables will be evaluated : a ) cardiovascular risk factors ( anthropometric parameters , blood test and blood pressure ) , b ) sedentary and physical activity behaviour and dietary intake , c ) psychological aspects d ) health related quality of life ( HRQOL ) , e ) cost-effectiveness of the intervention in relation to HRQOL . These variables will be then be evaluated 4 times longitudinally : at baseline , at the end of the intervention ( 8 months later ) , 6 and 12 months after the intervention . We have considered necessary to recruit 100 children and divide them in 2 groups of 50 to detect the differences between the groups . Discussion This trial will provide new evidence for the long-term effects of childhood obesity management , as well as help to know the impact of the present intervention as a health intervention tool for healthcare centres . Trial registration Clinical Trials.gov , BACKGROUND Conjugated linoleic acid ( CLA ) is a supplemental dietary fatty acid that decreases fat mass accretion in young animals . OBJECTIVE The aim of this study was to determine CLA 's efficacy with regard to change in fat and body mass index ( BMI ; in kg/m(2 ) ) in children . DESIGN We conducted a 7 + /- 0.5-mo r and omized , double-blind , placebo-controlled trial of CLA in 62 prepubertal children aged 6 - 10 y who were overweight or obese but otherwise healthy . The subjects were r and omly assigned to receive 3 g/d of 80 % CLA ( 50:50 cis-9,trans-11 and trans-10,cis-12 isomers ) or placebo in chocolate milk . RESULTS Fifty-three subjects completed the trial ( n = 28 in the CLA group , n = 25 in the placebo group ) . CLA attenuated the increase in BMI ( 0.5 + /- 0.8 ) compared with placebo ( 1.1 + /- 1.1 ) ( P = 0.05 ) . The percentage change in body fat measured by dual-energy X-ray absorptiometry was smaller ( P = 0.001 ) in the CLA group ( -0.5 + /- 2.1 % ) than in the placebo group ( 1.3 + /- 1.8 % ) . The change in abdominal body fat as a percentage of total body weight was smaller ( P = 0.02 ) in the CLA group ( -0.09 + /- 0.9 % ) than in the placebo group ( 0.43 + /- 0.6 % ) . There were no significant changes in plasma glucose , insulin , or LDL cholesterol between groups . Plasma HDL cholesterol decreased significantly more ( P = 0.05 ) in the CLA group ( -5.1 + /- 7.3 mg/dL ) than in the placebo group ( -0.7 + /- 8 mg/dL ) . Bone mineral accretion was lower ( P = 0.04 ) in the CLA group ( 0.05 + /- 0.03 kg ) than in the placebo group ( 0.07 + /- 0.03 kg ) . Reported gastrointestinal symptoms did not differ significantly between groups . CONCLUSIONS CLA supplementation for 7 + /- 0.5 mo decreased body fatness in 6 - 10-y-old children who were overweight or obese but did not improve plasma lipids or glucose and decreased HDL more than in the placebo group . Long-term investigation of the safety and efficacy of CLA supplementation in children is recommended OBJECTIVE Our purpose in this study was to examine 2 treatments targeted at reducing eating in the absence of hunger in overweight and obese children . METHOD Thirty-six overweight and obese 8- to 12-year-old children ( 58 % female ; mean age = 10.3 years , SD = 1.3 ) , with high scores on eating in the absence of hunger , and their parents were r and omly assigned to an 8-week children 's appetite awareness training or cue exposure treatment-food . Children completed an eating in the absence of hunger ( EAH ) paradigm , an Eating Disorder Examination interview for children , and three 24-hr dietary recalls , and their height and weight were measured . Parents completed the EAH Question naire and the Binge Eating Scale , and their height and weight were measured . Assessment s were conducted at baseline , posttreatment , and 6 and 12 months posttreatment . RESULTS Results showed that both treatments result ed in significant decreases in binge eating in children over time . Additionally , children in the food cue exposure treatment showed significant decreases in EAH posttreatment and 6 months posttreatment , but children in the appetite awareness training showed no change in EAH . Neither treatment produced significant effects on caloric intake in children or on any of the parent outcomes . CONCLUSIONS This study demonstrates that training in food cue responsitivity and appetite awareness has the potential to be efficacious for reducing EAH and binge eating in children . Because these data are preliminary , further treatment development and r and omized controlled studies are needed Background Screen-based activities , such as watching television ( TV ) , playing video games , and using computers , are common sedentary behaviors among young people and have been linked with increased energy intake and overweight . Previous home-based sedentary behaviour interventions have been limited by focusing primarily on the child , small sample sizes , and short follow-up periods . The SWITCH ( Screen-Time Weight-loss Intervention Targeting Children at Home ) study aim ed to determine the effect of a home-based , family-delivered intervention to reduce screen-based sedentary behaviour on body composition , sedentary behaviour , physical activity , and diet over 24 weeks in overweight and obese children . Methods A two-arm , parallel , r and omized controlled trial was conducted . Children and their primary caregiver living in Auckl and , New Zeal and were recruited via schools , community centres , and word of mouth . The intervention , delivered over 20 weeks , consisted of a face-to-face meeting with the parent/caregiver and the child to deliver intervention content , which focused on training and educating them to use a wide range of strategies design ed to reduce their child ’s screen time . Families were given Time Machine TV monitoring devices to assist with allocating screen time , activity packages to promote alternative activities , online support via a website , and monthly newsletters . Control participants were given the intervention material on completion of follow-up . The primary outcome was change in children ’s BMI z-score from baseline to 24 weeks . Results Children ( n = 251 ) aged 9 - 12 years and their primary caregiver were r and omized to receive the SWITCH intervention ( n = 127 ) or no intervention ( controls ; n = 124 ) . There was no significant difference in change of z BMI between the intervention and control groups , although a favorable trend was observed ( -0.016 ; 95 % CI : -0.084 , 0.051 ; p = 0.64 ) . There were also no significant differences on secondary outcomes , except for a trend towards increased children ’s moderate intensity physical activity in the intervention group ( 24.3 min/d ; 95 % CI : -0.94 , 49.51 ; p = 0.06 ) . Conclusions A home-based , family-delivered intervention to reduce all leisure-time screen use had no significant effect on screen-time or on BMI at 24 weeks in overweight and obese children aged 9 - 12 years . Trial registration Australian New Zeal and Clinical Trials RegistryWebsite : http://www.anzctr.org.auTrial registration number : Background : The WATCH IT programme was developed to address the needs of obese children from disadvantaged communities in Leeds and has been running since January 2004 . Results of the pilot phase , prior to a r and omised controlled trial , are presented . Methods : A process evaluation to assess success of implementation was conducted in December 2004 . User views ( parent and child ) were obtained by semi-structured interviews and focus groups . Change in BMI SD score was calculated for children attending between January 2004 and November 2005 . Results : A total of 94 children ( 49 girls , 45 boys ) , mean age ( SD ) 12.2 ( 2.0 ) years attended . They were moderately to severely obese ( mean BMI SDS 3.09 ( 0.45 ) , with low quality of life and self-image scores . There was a significant reduction in overweight at 6 months ( Δ BMI SD −0.07 ) , especially for teenagers ( Δ BMI SD −0.13 ) and girls ( Δ BMI SD −0.07 ) . The programme was successfully implemented . By December 2004 mean attendance was 2.1 ( 0.7 ) clinics per month , and sports sessions 3.3 ( 1.7 ) sessions per month . Fourteen children dropped out and non-attendance was low ( only 7.5 % sessions missed in 12 months ) . Qualitative research indicated significant appreciation of the service , with reported increase in self-confidence and friendships , and reduction in self-harm . Conclusion : WATCH IT offers a model for a community based service for obese children . The programme suggests that effective care can be delivered by health trainers supervised by health professionals , and so potentially provides a cost effective programme within children ’s communities . These findings are encouraging , and need to be substantiated by extension to other locations and evaluation by r and omised controlled trial Abstract This study tested the association between aerobic fitness and executive function and the impact of enhanced , cognitively challenging physical activity on executive function in overweight and lean children . Seventy children aged 9–10 years were assigned to either a 6-month enhanced physical education programme including cognitively dem and ing ( open skill ) activities or curricular physical education only . Pre- and post-intervention tests assessed aerobic capacity ( Leger test ) and two components of executive function : inhibition and working memory updating ( r and om number generation task ) . Indices of inhibition and memory updating were compared in higher- and lower-fit children and intervention effects were evaluated as a function of physical activity programme ( enhanced vs. curricular ) and weight status ( lean vs. overweight ) . Results showed better inhibition in higher- than lower-fit children , extending the existing evidence of the association between aerobic fitness and executive function to new aspects of children ’s inhibitory ability . Overweight children had more pronounced pre- to post-intervention improvements in inhibition than lean children only if involved in enhanced physical education . Such intervention effects were not mediated by aerobic fitness gains . Therefore , the cognitive and social interaction challenges inherent in open skill tasks , even though embedded in a low-dose physical activity programme , may represent an effective means to promote cognitive efficiency , especially in overweight children Background Motor skills are impaired in overweight children whose levels of physical activity are low and these children are more likely to sustain lower extremity injuries . The purpose of this study was to analyze prospect ively in overweight children the influence of ball games and nutrition counseling on postural control . Methods In all , 46 overweight children ( age : 6–12 years , BMI : female : 25.2 ± 3.6 kg/m2 , male : 26.2 ± 2.8 kg/m2 ( mean value ± st and ard deviation ) were examined prospect ively in four r and omized groups ( ball games , nutrition counseling , ball games and nutrition counseling , and group without intervention ) for six months . A one-legged st and ing test was performed . Results The children demonstrated improved postural control after six months of intervention : mean difference M1-M2 ± st and ard deviation : 5 ± 6 error points ( p < 0.001 , T = 4.906 ) , whereas the control group without intervention did not show any significant improvement : 2 ± 8 error points ( p = 0.357 , T = 0.972 ) . Conclusions Ball games and nutrition counseling have a positive influence on postural control and therefore could help prevent injury . Trial registration Clinical Trials.gov Identifier : NCT01825174.Registered April 2 , Objective : The purpose of this study was to test a two-phased nutrition and exercise education , coping skills training , and exercise intervention program for overweight or obese low-income ethnic minority 2nd to 4th grade children and their parents in rural North Carolina , USA . Methods : A cluster r and omized controlled trial was carried out with 358 children ( 7–10 years ) and a parent for each child ( n=358 ) . General linear mixed models were used to determine the effects of the intervention on weight , adiposity , health behaviors , and eating and exercise self-efficacy by examining changes in children and parents from baseline to completion of the study ( 18 months ) . Results : At 18 months , children in the experimental group did not have a significantly decreased body mass index ( BMI ) percentile ( P=0.470 ) ; however , they showed a reduction in the growth rate of their triceps ( P=0.001 ) and subscapular skinfolds ( P<0.001 ) and an improvement in dietary knowledge ( P=0.018 ) and drank less than one glass of soda per day ( P=0.052 ) compared with the control group . Parents in the experimental group had decreased BMI ( P=0.001 ) , triceps ( P<0.001 ) and subscapular skinfolds ( P<0.001 ) and increased nutrition ( P=0.003 ) and exercise ( P<0.001 ) knowledge and more often drank water or unsweetened drinks ( P=0.029 ) . At 18 months , children in the experimental group did not show significant improvement in eating ( P=0.956 ) or exercise self-efficacy ( P=0.976 ) . Experimental parents demonstrated improved socially acceptable eating self-efficacy ( P=0.013 ) ; however , they did not show significant improvement in self-efficacy pertaining to emotional eating ( P=0.155 ) and exercise ( P=0.680 ) . Conclusion : The results suggest that inclusion of children and parents in the same intervention program is an effective way to decrease adiposity and improve nutrition behaviors in both children and parents and improve weight and eating self-efficacy in parents BACKGROUND AND OBJECTIVE : Clinic-based programs for childhood obesity are not available to a large proportion of the population . The purpose of this study was to evaluate the efficacy of a guided self-help treatment of pediatric obesity ( GSH-PO ) compared with a delayed treatment control and to evaluate the impact of GSH-PO 6-months posttreatment . METHODS : Fifty overweight or obese 8- to 12-year-old children and their parents were r and omly assigned to immediate treatment or to delayed treatment . The GSH-PO includes 12 visits over 5 months and addresses key components included in more intensive clinic-based programs . Children and parents in the immediate treatment arm were assessed at time 1 ( T1 ) , participated in GSH-PO between T1 and T2 , and completed their 6-month posttreatment assessment at T3 . Children and parents in the delayed treatment arm were assessed at T1 , participated in GSH-PO between T2 and T3 , and completed their 6-month posttreatment assessment at T4 . The main outcome measures were BMI , BMI z score , and percentage overweight ( % OW ) . RESULTS : Children in the immediate treatment GSH-PO arm decreased their BMI significantly more than did the delayed treatment arm ( BMI group × time = −1.39 ; P < .001 ) . Similar results were found for BMI z score and % OW . At the 6-month posttreatment assessment , changes result ing from GSH-PO were maintained for BMI z score and % OW but not BMI ( BMI time effect = −0.06 , not significant ; BMI z score time effect = −0.10 , P < .001 ; % OW time effect = −4.86 , P < .05 ) . CONCLUSIONS : The GSH-PO showed initial efficacy in decreasing BMI for children in this study . Additional efficacy and translational studies are needed to additionally evaluate GSH-PO PURPOSE The purpose of the study was to evaluate a parent involvement intervention for childhood obesity intended to increase parents ' skills in managing children 's weight-related behavior and to improve child-parent relationships . Many studies reported on parental influence on childhood obesity , emphasizing parent involvement in prevention and management of childhood obesity . METHODS A r and omized controlled trial was conducted . Forty-two parents of overweight/obese children were recruited from four cities and r and omized to the experimental group or control group . The parental intervention was provided only to parents in the experimental group and consisted of weekly newsletters and text messages for a period of 5 weeks . Exercise classes and nutrition education were provided to all children . Lifestyle Behaviour Checklist and the Child-Parent Relationship Scale ( CPRS ) were used for measurement of parent outcome . For the child outcome , dietary self-efficacy , exercise frequency , and body mass index were measured . A mixed- design analysis of variance was performed with city location entered as a r and om effect . RESULTS After the intervention , CPRS of parents and dietary self-efficacy of children showed an increase in the experimental group ( p < .05 ) . Intervention effects differed significantly according to the city location regarding the control efficacy of parents and dietary self-efficacy of children ( p < .05 ) . CONCLUSIONS The results support the effectiveness of the parent involvement intervention in promoting child-parent relationship and dietary self-efficacy of children . However , a 5-week parent involvement intervention was not sufficient to produce significant changes in children 's body mass index . Further research is needed to investigate effects of parent involvement intervention with long-term evaluation Background : Appetite lowering characteristics of dairy have attracted scientists to look for its effect on energy intake particularly among children . In the present study , we tried to assess the effect of low-fat milk on total and short-term energy intake among obese boys in a r and omized three-way cross-over clinical trial . Methods : A total of 34 obese 10 - 12-year-old boys were r and omized to consume three beverages ( low-fat milk , apple juice , or water ) with a fixed energy breakfast for two consecutive days , 1 week apart . Ad libitum lunch was provided for subjects 5 h later . The energy intake from breakfast till lunch and total energy intake on intervention days , and 2 days after intervention were compared . Generalized linear model repeated measures procedure in which test beverages were considered as repeated factors . Results : Energy intake from breakfast till lunch was lower when low-fat milk consumption was included in the breakfast compared with water and apple juice ( adjusted mean ± st and ard error : Low-fat milk = 1484.33 ± 15.30 Kcal , apple juice = 1543.39 ± 20.70 Kcal , water = 1606.6 ± 19.94 Kcal ; P < 0.05 ) . The energy intake on a day before interventions , total energy intake on intervention days , and 2 days after intervention was not statistically different between intervention periods ( P > 0.05 ) . Conclusions : One serving of low-fat milk might affect the energy intake in a short-term period . The possible effect of frequent consumption of dairy products on long-term energy intake among children is needed to be examined Objective : To assess the efficacy of a school-based intervention programme to reduce the prevalence of overweight in 6 to 10-year-old children . Design : Cluster-r and omized , controlled study .Subjects : A total of 3135 boys and girls in grade s 1–4 were included in the study . Methods : Ten schools were selected in Stockholm county area and r and omized to intervention ( n=5 ) and control ( n=5 ) schools . Low-fat dairy products and whole-grain bread were promoted and all sweets and sweetened drinks were eliminated in intervention schools . Physical activity ( PA ) was aim ed to increase by 30 min day−1 during school time and sedentary behaviour restricted during after school care time . PA was measured by accelerometry . Eating habits at home were assessed by parental report . Eating disorders were evaluated by self-report . Results : The prevalence of overweight and obesity decreased by 3.2 % ( from 20.3 to 17.1 ) in intervention schools compared with an increase of 2.8 % ( from 16.1 to 18.9 ) in control schools ( P<0.05 ) . The results showed no difference between intervention and controls , after cluster adjustment , in the longitudinal analysis of BMI sds changes . However , a larger proportion of the children who were initially overweight reached normal weight in the intervention group ( 14 % ) compared with the control group ( 7.5 % ) , P=0.017 . PA did not differ between intervention and control schools after cluster adjustment . Eating habits at home were found to be healthier among families with children in intervention schools at the end of the intervention . There was no difference between children in intervention and control schools in self-reported eating disorders . Conclusions : A school-based intervention can reduce the prevalence of overweight and obesity in 6 to 10-year-old children and may affect eating habits at home . The effect of the intervention was possibly due to its effect on healthy eating habits at school and at home rather than on increased levels of PA OBJECTIVE To evaluate the effect of a 3-year after-school physical activity ( PA ) intervention on aerobic fitness and percent body fat ( % BF ) . METHODS In total , 18 schools were r and omized into intervention or control arms . Measurements were made at the beginning and end of the third , fourth and fifth grade s. Fitness was measured with heart rate response to a bench-stepping task.%BF and bone density were measured with dual-energy x-ray absorptiometry . The intervention included 40 min of academic enrichment activities , during which healthy snacks were provided , and 80 min of moderate-to-vigorous PA ( MVPA ) . RESULTS Data analyses were performed on 206 youths who remained in the same schools for the 3-year period , who were measured at all six time points and , for the intervention group , who attended at least 40 % of the sessions in each of the 3 years . The group by time interactions were significant for fitness ( p < 0.01 ) and % BF ( p < 0.05 ) . Children in intervention schools improved in fitness and % BF during the school years and returned to levels similar to those in control schools during the summers . Over the six measurement points , the intervention group increased more than the control group in bone density ( p < 0.01 ) , fat-free soft tissue ( p < 0.01 ) , weight ( p < 0.01 ) , height ( p < 0.01 ) , and body mass index ( p < 0.05 ) . CONCLUSIONS An after-school program focusing on MVPA had a beneficial effect on fitness and body composition . During the summers , the beneficial effect of the previous year 's participation on fitness and % BF was lost . This highlights the importance of year-round programs to promote healthy growth in youths We report 10-year treatment outcomes for obese children in 4 r and omized treatment studies . At 10 years , 34 % decreased percentage overweight by 20 % or more , and 30 % were not obese . Significant effects were observed when parents and children were targeted and reinforced for weight loss in comparison with nontargeted controls and for children given lifestyle or aerobic exercise in comparison with a calisthenics control . Thirty-four percent of the variance in change in percentage overweight was predicted from sex , baseline percentage overweight , self-monitoring weight , meals eaten at home , and family and friends ' support for eating and exercise . Results show long-term changes in children depend on the treatment , and evidence converges on the importance of the family and other sources of support for eating and activity change BACKGROUND Few successful treatment modalities exist to address childhood obesity . Given Latinos ' strong identity with family , a family-focused intervention may be able to control Latino childhood obesity . PURPOSE To assess the feasibility and effectiveness of a family-centered , primary care-based approach to control childhood obesity through lifestyle choices . DESIGN R and omized waitlist controlled trial in which control participants received the intervention 6 months after the intervention group . SETTING / PARTICIPANTS Forty-one Latino children with BMI > 85 % , aged 9 - 12 years , and their caregivers were recruited from an urban community health center located in a predominantly low-income community . INTERVENTION Children and their caregivers received 6 weeks of interactive group classes followed by 6 months of culturally sensitive monthly in-person or phone coaching to empower families to incorporate learned lifestyles and to address both family and social barriers to making changes . MAIN OUTCOMES MEASURES Caregiver report on child and child self-reported health-related quality of life ( HRQoL ) ; metabolic markers of obesity ; BMI ; and accelerometer-based physical activity were measured July 2010-November 2011 and compared with post-intervention assessment s conducted at 6 months and as a function of condition assignment . Data were analyzed in 2012 . RESULTS Average attendance rate to each group class was 79 % . Socio-environmental and family factors , along with knowledge , were cited as barriers to changing lifestyles to control obesity . Caregiver proxy and child self-reported HRQoL improved for both groups with a larger but not nonsignificant difference among intervention vs control group children ( p=0.33 ) . No differences were found between intervention and control children for metabolic markers of obesity , BMI , or physical activity . CONCLUSIONS Latino families are willing to participate in group classes and health coaching to control childhood obesity . It may be necessary for primary care to partner with community initiatives to address childhood obesity in a more intense manner . TRIAL REGISTRATION This study is registered at Clinical trials.partners.org 2009P001721 Background : The best outcomes for treating childhood obesity have come from comprehensive family-based programmes . However there are questions over their generalizability . Objective : To examine the acceptability and effectiveness of ‘ family-based behavioural treatment ’ ( FBBT ) for childhood obesity in an ethnically and socially diverse sample of families in a UK National Health Service ( NHS ) setting . Methods : In this parallel group , r and omized controlled trial , 72 obese children were r and omized to FBBT or a waiting-list control . Primary outcomes were body mass index ( BMI ) and BMI s.d . scores ( SDSs ) . Secondary outcomes were weight , weight SDSs , height , height SDSs , waist , waist SDSs , FM index , FFM index , blood pressure ( BP ) and psychosocial measures . The outcomes were assessed at baseline and after treatment , with analyses of 6-month data performed on an intent-to-treat ( ITT ) basis . Follow-up anthropometric data were collected at 12 months for the treatment group . Results : ITT analyses included all children with baseline data ( n=60 ) . There were significant BMI SDS changes ( P<0.01 ) for the treatment and control groups of −0.11 ( 0.16 ) and −0.10 ( 1.6 ) . The treatment group showed a significant reduction in systolic BP ( −0.24 ( 0.7 ) , P<0.05 ) and improvements in quality of life and eating attitudes ( P<0.05 ) , with no significant changes for the control group . However the between-group treatment effects for BMI , body composition , BP and psychosocial outcomes were not significant . There was no overall change in BMI or BMI SDSs from 0–12 months for the treatment group . No adverse effects were reported . Conclusions : Both treatment and control groups experienced significant reductions in the level of overweight , but with no significant difference between them . There were no significant group differences for any of the secondary outcomes . This trial was registered at http://www.controlled-trials.com/ under IS RCT N 51382628 Objectives To develop a school-based obesity prevention programme and evaluate the feasibility and acceptability of the intervention and the planned definitive cluster r and omised trial . Design This was a three stage pilot involving six schools ( 398 children ) in South West Engl and , including an exploratory r and omised controlled trial and qualitative interviews and focus groups with teachers , parents and children . Intervention The Healthy Lifestyle Programme uses a range of school-based activities including lessons , assemblies , parents ' evenings , interactive drama workshops and goal setting to engage schools , children and their families . Results Of the 398 eligible children in the three pilot phases , only four opted out and a further three withdrew from the exploratory trial . In the exploratory trial , baseline measurements ( anthropometric and behavioural ) were obtained for 202/204 eligible children in four schools and both 18- and 24-month outcome measurements for 193/204 and 187/204 participants , respectively . Qualitative data show that delivery of the intervention is feasible within schools and acceptable to teachers , children and families . In the exploratory trial , 18/80 children ( 24 % ) in the intervention schools and 31/122 ( 26 % ) in the control schools were overweight or obese at baseline , increasing , at 18-month follow-up , to 38/119 ( 32 % ) in the control schools compared with 18/74 ( 24 % ) in the intervention schools . At 24 months the proportion of overweight and obese children in the control schools remained at 32 % ( 36/114 ) , whereas the proportion in the intervention schools decreased slightly to 22 % ( 16/73 ) . Conclusion The Healthy Lifestyle Programme is feasible to deliver and acceptable to schools , children and their families . We recruited , retained and obtained outcome measurements from 92 % of eligible children in the exploratory trial , including measurements taken after transition to secondary school , suggesting that a definitive trial is likely to be deliverable The one-year outcome of the r and omized controlled T.A.F.F. ( Telephone based Adiposity prevention For Families ) study is presented . Screening of overweight ( BMI -SDS > 90th centile ) children 3.5–17.4 years was performed via the German CrescNet data base , and c and i date s were r and omized to an intervention group ( IG ) and control group ( CG ) . The intervention consisted of computer-aided telephone counselling for one year , supported by mailed newsletters . The primary endpoint was change in BMI -SDS ; secondary endpoints were eating behavior , physical activity , media consumption , quality of life . Data from 289 families ( 145 IG ( 51 % females ) ; 144 CG ( 50 % females ) ) were analyzed ( Full Analysis Set : FAS ; Per Protocol Set : PPS ) . Successful intervention was defined as decrease in BMI -SDS ≥ 0.2 . In the FAS , 21 % of the IG was successful as compared to 16 % from the CG ( 95 % CI for this difference : ( −4 , 14 ) , p = 0.3 , mean change in BMI -SDS : −0.02 for IG vs. 0.02 for CG ; p = 0.4 ) . According to the PPS , however , the success rate was 35 % in the IG compared to 19 % in the CG ( mean change in BMI -SDS : −0.09 for IG vs. 0.02 for CG ; p = 0.03 ) . Scores for eating patterns ( p = 0.01 ) , media consumption ( p = 0.007 ) , physical activity ( p = 9 × 10−9 ) , quality of life ( p = 5 × 10−8 ) decreased with age , independent of group or change in BMI -SDS . We conclude that a telephone-based obesity prevention program suffers from well-known high attrition rates so that its effectiveness could only be shown in those who adhered to completion . The connection between lifestyle and weight status is not simple and requires further research to better underst and CONTEXT Some observational studies have found an association between television viewing and child and adolescent adiposity . OBJECTIVE To assess the effects of reducing television , videotape , and video game use on changes in adiposity , physical activity , and dietary intake . DESIGN R and omized controlled school-based trial conducted from September 1996 to April 1997 . SETTING Two sociodemographically and scholastically matched public elementary schools in San Jose , Calif. PARTICIPANTS Of 198 third- and fourth- grade students , who were given parental consent to participate , 192 students ( mean age , 8.9 years ) completed the study . INTERVENTION Children in 1 elementary school received an 18-lesson , 6-month classroom curriculum to reduce television , videotape , and video game use . MAIN OUTCOME MEASURES Changes in measures of height , weight , triceps skinfold thickness , waist and hip circumferences , and cardiorespiratory fitness ; self-reported media use , physical activity , and dietary behaviors ; and parental report of child and family behaviors . The primary outcome measure was body mass index , calculated as weight in kilograms divided by the square of height in meters . RESULTS Compared with controls , children in the intervention group had statistically significant relative decreases in body mass index ( intervention vs control change : 18.38 to 18.67 kg/m2 vs 18.10 to 18.81 kg/m2 , respectively ; adjusted difference -0.45 kg/m2 [ 95 % confidence interval [ CI ] , -0.73 to -0.17 ] ; P = .002 ) , triceps skinfold thickness ( intervention vs control change : 14.55 to 15.47 mm vs 13.97 to 16.46 mm , respectively ; adjusted difference , -1.47 mm [ 95 % CI , -2.41 to -0.54 ] ; P=.002 ) , waist circumference ( intervention vs control change : 60.48 to 63.57 cm vs 59.51 to 64.73 cm , respectively ; adjusted difference , -2.30 cm [ 95 % CI , -3.27 to -1.33 ] ; P<.001 ) , and waist-to-hip ratio ( intervention vs control change : 0.83 to 0.83 vs 0.82 to 0.84 , respectively ; adjusted difference , -0.02 [ 95 % CI , -0.03 to -0.01 ] ; P<.001 ) . Relative to controls , intervention group changes were accompanied by statistically significant decreases in children 's reported television viewing and meals eaten in front of the television . There were no statistically significant differences between groups for changes in high-fat food intake , moderate-to-vigorous physical activity , and cardiorespiratory fitness . CONCLUSIONS Reducing television , videotape , and video game use may be a promising , population -based approach to prevent childhood obesity BACKGROUND Fatty liver is highly prevalent among obese children and represents a major risk factor for chronic liver diseases and severe metabolic complications . METHODS We r and omly assigned 17 obese children 8 - 17 years of age with fatty liver to either an experimental low-glycemic-load or conventional low-fat diet for 6 months . Participants in both groups received nutrition education and behavioral counseling of equal intensity . The primary outcome was hepatic lipid content measured by proton magnetic resonance spectroscopy . Secondary outcomes included change in visceral fat , BMI , anthropometrics , alanine aminotransferase ( ALT ) , and insulin resistance . RESULTS A total of 16 participants completed the study . Reported glycemic load decreased in the low-glycemic-load group and reported dietary fat decreased in the low-fat group . At baseline , liver fat was 23.8 % [ st and ard deviation ( SD ) 12.2 ] in the low-glycemic-load group and 29.3 % ( 14.1 ) in the low-fat group . Liver fat decreased substantially in both groups at 6 months expressed as absolute percentage change , with no between-group differences [ -8.8 ( st and ard error ( SE ) 4.1 ) vs. -10.5 (3.7)% , respectively , p=0.76 for group × time interaction ] . Secondary outcomes also improved on both diets , with no between-group differences . Baseline and change in ALT were strongly associated with hepatic fat content . CONCLUSIONS Weight-reducing diets focused either on glycemic load or dietary fat improved hepatic steatosis over 6 months . Additional research is needed to determine whether these diets differ in effectiveness over the long term . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00480922 This study aim ed to evaluate the weight loss and hunger motivation effects of an energy-restricted high-protein ( HP ) diet in overweight and obese children . In total , 95 overweight and obese children attended an 8-week ( maximum ) program of physical activity , reduced-energy intake , and behavior change education . Children were r and omly assigned to one of two isoenergetic diets ( st and ard ( SP ) : 15 % protein ; HP : 25 % protein ) , based on individually estimated energy requirements . Anthropometry and body composition were assessed at the start and end of the program and appetite and mood ratings completed on the first 3 consecutive weekdays of each week children attended camp . The HP diet had no greater effect on weight loss , body composition , or changes in appetite or mood when compared to the SP diet . Overall , campers lost 5.2 + /- 3.0 kg in body weight and reduced their BMI st and ard deviation score ( sds ) by 0.25 . Ratings of desire to eat increased significantly over the duration of the intervention , irrespective of diet . This is the third time we have reported an increase in hunger motivation in weight-loss campers and replicates our previous failure to block this with a higher protein diet . Further work is warranted into the management of hunger motivation as a result of negative energy balance IMPORTANCE Active video games may offer an effective strategy to increase physical activity in overweight and obese children . However , the specific effects of active gaming when delivered within the context of a pediatric weight management program are unknown . OBJECTIVE To evaluate the effects of active video gaming on physical activity and weight loss in children participating in an evidence -based weight management program delivered in the community . DESIGN , SETTING , AND PARTICIPANTS Group-r and omized clinical trial conducted during a 16-week period in YMCAs and schools located in Massachusetts , Rhode Isl and , and Texas . Seventy-five overweight or obese children ( 41 girls [ 55 % ] , 34 whites [ 45 % ] , 20 Hispanics [ 27 % ] , and 17 blacks [ 23 % ] ) enrolled in a community-based pediatric weight management program . Mean ( SD ) age of the participants was 10.0 ( 1.7 ) years ; body mass index ( BMI ) z score , 2.15 ( 0.40 ) ; and percentage overweight from the median BMI for age and sex , 64.3 % ( 19.9 % ) . INTERVENTIONS All participants received a comprehensive family-based pediatric weight management program ( JOIN for ME ) . Participants in the program and active gaming group received hardware consisting of a game console and motion capture device and 1 active game at their second treatment session and a second game in week 9 of the program . Participants in the program-only group were given the hardware and 2 games at the completion of the 16-week program . MAIN OUTCOMES AND MEASURES Objective ly measured daily moderate-to-vigorous and vigorous physical activity , percentage overweight , and BMI z score . RESULTS Participants in the program and active gaming group exhibited significant increases in moderate-to-vigorous ( mean [ SD ] , 7.4 [ 2.7 ] min/d ) and vigorous ( 2.8 [ 0.9 ] min/d ) physical activity at week 16 ( P < .05 ) . In the program-only group , a decline or no change was observed in the moderate-to-vigorous ( mean [ SD ] net difference , 8.0 [ 3.8 ] min/d ; P = .04 ) and vigorous ( 3.1 [ 1.3 ] min/d ; P = .02 ) physical activity . Participants in both groups exhibited significant reductions in percentage overweight and BMI z scores at week 16 . However , the program and active gaming group exhibited significantly greater reductions in percentage overweight ( mean [ SD ] , -10.9%[1.6 % ] vs -5.5%[1.5 % ] ; P = .02 ) and BMI z score ( -0.25 [ 0.03 ] vs -0.11 [ 0.03 ] ; P < .001 ) . CONCLUSIONS AND RELEVANCE Incorporating active video gaming into an evidence -based pediatric weight management program has positive effects on physical activity and relative weight . TRIAL REGISTRATION clinical trials.gov Identifier : NCT01757925 Background Intensive combined lifestyle interventions are the recommended treatment for severely obese children and adolescents , but there is a lack of studies and their cost-effectiveness . The objective of this study is to compare the cost-effectiveness of two intensive one-year inpatient treatments and usual care for severely obese children and adolescents . Methods / Design Participants are 40 children aged 8 - 13 and 40 adolescents aged 13 - 18 with severe obesity ( SDS- BMI ≥ 3.0 or SDS- BMI ≥ 2.3 with obesity related co-morbidity ) . They will be r and omized into two groups that will receive a comprehensive treatment program of 12 months that focuses on nutrition , physical activity and behavior change of the participant and their parents . The two programs are the same in total duration ( 12 months ) , but differ in inpatient treatment duration . Group A will participate in a 6 month intensive inpatient treatment program during weekdays , followed by six monthly return visits of 2 days . Group B will participate in a 2 month intensive inpatient treatment program during weekdays , followed by biweekly return visits of 2 days during the next four months , followed by six monthly return visits of 2 days . Several different health care professionals are involved , such as pediatricians , dieticians , psychologists , social workers , nurses and physiotherapists . Results will also be compared to a control group that receives usual care . The primary outcome is SDS- BMI . Secondary outcomes include quality of life using the EQ-5D and cardiovascular risk factors . Data will be collected at baseline and after 6 , 12 and 24 months . An economic evaluation will be conducted alongside this study . Healthcare consumption will be based on actual re source use , using prospect i ve data collection during 2 years through cost diaries . Quality Adjusted Life Years ( QALYs ) will be calculated using the EQ-5D . Discussion This study will provide useful information on the effectiveness and cost-effectiveness of inpatient treatment in severely obese children and adolescents . Valuable information on long term effects , after 2 years , is also included . Trial registration Netherl and s Trial Register ( NTR ) : AIM Childhood obesity is remarkably spreading worldwide , involving both industrialized and low-income countries . Its prevalence , outcome and socioeconomic impact call for the attention of medical community . We conducted a monocentric , open , two-arm , parallel-group study to evaluate the efficacy at reducing appetite and increasing dietary compliance of obese children of Tuberil ® , a weight-loss supplement derived from potato and devoid of side effects . METHODS We recruited participants , children with BMI ≥ 85th , through direct referrals in pediatrician 's surgeries . Children were r and omized to receive Tuberil ® ( group A ) or nothing ( group B ) , following a chronological order ( A-B-A-B ) . Every child received a nutritionally balanced diet and had to record their appetite and to describe their meals in a diary . RESULTS Even if we found a significant reduction in BMI , weight and waist circumference in both groups , no statistically significant differences between groups were noted . We did not found any significant differences in appetite between group A and B. CONCLUSION Our data show that Tuberil ® has no efficacy neither in reducing appetite in children nor in increasing dietary compliance . We believe that only a nutritionally balanced diet and our attention in verifying their compliance led to the reduction in BMI , weight and waist circumferences noted in our series Background / Aims : The increasing rate of overweight and obesity is alarming . The complications of overweight and obesity at a young age are largely unknown . We aim ed to assess the prevalence of insulin resistance ( IR ) and cardiovascular risk factors among overweight and obese children aged 3 - 5 years . Methods : The study population consisted of 75 children ( 29 overweight , 46 obese ) . We performed anthropometry and bioelectrical impedance analysis as an indicator of body composition . IR was determined by the up date d Homeostasis Model Assessment of Insulin Resistance ( HOMA2-IR ) . Cardiovascular risk factors were defined by the presence of increased serum triglycerides , blood pressure , and HOMA2-IR and by a decreased serum HDL cholesterol . Results : An elevated HOMA2-IR was found in 7.7 % of the children . HOMA2-IR was correlated with body mass index ( r = 0.63 ) , waist circumference ( r = 0.62 ) and percentage body fat ( r = 0.58 ) ( all p < 0.001 ) . Cardiovascular risk factors were present in 6.9 % ( triglycerides ) to 74.3 % ( hypertension ) of the children . Conclusion : IR and cardiovascular risk factors are already evident in many 3- to 5-year-old overweight and obese children . IR is strongly related to body composition BACKGROUND The Care Of Childhood Obesity ( COCO ) clinic at the Bristol Royal Hospital for Children ( BRHC ) uses a multidisciplinary approach comprising a consultant , dietitian , and exercise specialist . The clinic has demonstrated efficacy in managing children 's weight but similar clinics are scarce in the UK . AIM This pilot r and omised controlled trial ( RCT ) aim ed to examine the feasibility of undertaking a fully powered RCT and to gauge whether the COCO model could be effective as a nurse-led clinic in primary care setting s. DESIGN AND SETTING Patients were r and omised to a hospital-based childhood obesity clinic or a nurse-led clinic in a primary care setting in south-west Engl and . METHOD Children aged 5 - 16 years with a body mass index ( BMI ) ≥98th centile were referred by GPs to the consultant in charge of the COCO clinic at BRHC . Referred children were clinical ly screened for suitability and invited into the study . Consenting families were r and omised to BRHC or a primary care clinic ( PCC ) and offered five appointments over 12 months . Clinical effectiveness was measured by change in body mass index st and ard deviation score ( BMI SDS ) at 12 months . Other measures included : treatment adherence , quality of life ( QOL ) , and satisfaction . Feasibility was examined by assessing referral , screening , and recruitment data . RESULTS A total 152 patients were referred by GPs : 31 ( 20 % ) were screened out ; 45 ( 30 % ) declined to participate . Seventy-six ( 50 % ) patients were r and omised and 68 provided baseline data ( PCC = 42 ; BRHC = 26 ) ; 52 provided outcome data ( PCC = 29 ; BRHC = 23 ) . Mean change in BMI SDS was PCC -0.17 ( 95 % confidence interval [ CI ] = -0.27 to -0.07 ) ; BRHC -0.15 ( 95 % CI = -0.26 to -0.05 ) . QOL , adherence , and satisfaction data indicated similar positive patterns in both trial arms . CONCLUSION Screening and recruitment data indicate that primary care is a clinical ly appropriate setting and acceptable to families . The primary clinical outcome measure ( reduction in BMI SDS ) , along with secondary outcome measures , indicate that primary care has the potential to be effective in providing weight management for children , using the COCO model Background Objective ly measured physical activity is low in British children , and declines as childhood progresses . Observational studies suggest that dog-walking might be a useful approach to physical activity promotion in children and adults , but there are no published public health interventions based on dog-walking with children . The Children , Parents , and Pets Exercising Together Study aims to develop and evaluate a theory driven , generalisable , family-based , dog walking intervention for 9 - 11 year olds . Methods / design The Children , Parents , and Pets Exercising Together Study is an exploratory , assessor-blinded , r and omised controlled trial as defined in the UK MRC Framework on the development and evaluation of complex interventions in public health . The trial will follow CONSORT guidance . Approximately 40 dog-owning families will be allocated r and omly in a ratio of 1.5:1 to receive a simple behavioural intervention lasting for 10 weeks or to a ' waiting list ' control group . The primary outcome is change in objective ly measured child physical activity using Actigraph accelerometry . Secondary outcomes in the child , included in part to shape a future more definitive r and omised controlled trial , are : total time spent sedentary and patterning of sedentary behaviour ( Actigraph accelerometry ) ; body composition and bone health from dual energy x-ray absorptiometry ; body weight , height and BMI ; and finally , health-related quality of life using the PedsQL . Secondary outcomes in parents and dogs are : changes in body weight ; changes in Actigraph accelerometry measured physical activity and sedentary behaviour . Process evaluation will consist of assessment of simultaneous child , parent , and dog accelerometry data and brief interviews with participating families . Discussion The Children , Parents , and Pets Exercising Together trial should be the first r and omised controlled study to establish and evaluate an intervention aim ed at dog-based physical activity promotion in families . It should advance our underst and ing of whether and how to use pet dogs to promote physical activity and /or to reduce sedentary behaviour in children and adults . The trial is intended to lead to a subsequent more definitive r and omised controlled trial , and the work should inform future dog-based public health interventions such as secondary prevention interventions in children or adults . Trial registration numberIS RCT Background Obesity amongst children is a growing problem worldwide . In contrast to adults , little is known on the effects of controlled weight loss on components of the metabolic syndrome in children . The primary aim of the study was to evaluate the effects of a 20-week exercise and diet guidance intervention on body mass index ( BMI ) in a group of overweight children . Our hypothesis was an observed reduction in BMI and secondarily in body fat content , insulin insensitivity , and other components of the metabolic syndrome in the intervention group . Methods School children from Copenhagen were r and omly allocated to an intervention group ( n = 19 ) or a control group ( n = 19 ) . Anthropometric assessment , whole body dual-energy X-ray absorptiometry scan , two hours oral glucose tolerance test , steps measured by pedometer , and fitness tests were measured at baseline and at 20 weeks . Results Thirty-seven children ( 30 girls ) participated at baseline , aged 8.7 ± 0.9 years with a BMI of 21.8 ± 3.7 kg/m2 ( mean ± SD ) , and 36 children completed the study . The intervention group decreased their BMI ( the intervention effect is the difference in change between the groups adjusted for the respective baseline values ( DELTA ) = -2.0 kg/m2 , 95 % CI : -2.5 ; -1.5 , P < 0.001 ) , total body mass ( DELTA = -4.0 kg , 95 % CI : -4.9 ; -3.0 , P < 0.001 ) , and fat mass ( DELTA = -3.3 kg , 95 % CI : -4.2 ; -2.7 , P < 0.001 ) compared to the control group after the intervention . The intervention group displayed decreased waist , hip and waist-to-height ratio ( WHtR ) ( all three variables ; P < 0.001 ) , area under curve for plasma insulin ( P < 0.05 ) , and increased mean and minimum steps/day ( P < 0.05 and P < 0.01 , respectively ) . Conclusions The multicomponent intervention had significant favorable effects on BMI , weight , WHtR , mean and minimum steps/day , and fat mass . In addition , similar beneficial metabolic effects were found in the children as shown in adults , e.g. increase in peripheral insulin sensitivity . Trial registration Clinical trials.gov Identifier number NCT01660789 Objective . To evaluate the effect of two intervention modalities concerning overweight and obesity among children in general practice . Design . Prospect i ve r and omized controlled trial . Setting . A total of 60 general practice s in the former County of Funen , Denmark . Subjects . Overweight children , identified by International Obesity Task Force criteria , aged 5–9 years . Intervention . Model 1 with health consultations in general practice during a two-year period or Model 2 , an educational programme for the children and their families in addition to the health consultations . Main outcome measures . Change in body mass index ( BMI ) z-score in order to compare the results , independent of gender- and age-related changes over time . Results . A total of 80 children were recruited with 35 and 45 children allocated to Model 1 and Model 2 , respectively . No significant differences were found in the change in BMI z-score ( SDS ) between the two groups . A decrease in the mean BMI z-score from baseline to study end of −0.20 ( 95%CI −0.38 to −0.01 ) in Model 1 and −0.26 ( 95%CI −0.44 to −0.09 ) in Model 2 , respectively , was detected . The majority of the participants ( 2/3 ) continued in the study for more than one year in both models , with a mean of 12 consultations in general practice . Conclusion . In this particular setting the two intervention strategies against overweight and obesity did not differ significantly with regard to change in BMI z-scores OBJECTIVES To evaluate the relationship between changes in physical activity ( PA ) , sedentary behavior , and physical self-perceptions and global self-worth in 30 , 8 - 12 years old , overweight/obese children ( 13 boys , 17 girls ) . METHODS Secondary analyses from a r and omized controlled trial design ed to increase PA and reduce sedentary behavior . PA was measured by accelerometers worn by participants every day for 8 weeks . Sedentary behavior , defined as minutes per day spent in television viewing , was assessed by self-report . RESULTS Increases in PA were associated with increases in perceived physical conditioning ( r = .54 , p < .01 ) , body satisfaction ( r = .55 , p < .01 ) , and overall physical self-worth ( r = .44 , p < .05 ) independent of changes in body mass index ( BMI ) . Reductions in TV viewing were also related to increased physical and global self-worth . CONCLUSIONS Increases in PA are associated with improvements in physical self-perceptions but not global self-worth , while reductions in TV viewing are associated with increased physical and global self-worth , and these psychosocial benefits appear to be independent of changes in adiposity Iron and zinc may interact in micronutrient supplements and thereby decrease efficacy . We investigated interactive effects of combined zinc and iron supplementation in a r and omized controlled trial conducted in 459 Guatemalan women . Four groups were supplemented for 12 weeks : ( 1 ) weekly iron and folic acid ( IFA ) ; ( 2 ) weekly IFA and 30 mg zinc ; ( 3 ) daily IFA ; ( 4 ) daily IFA and 15 mg zinc . Effects were assessed by generalized linear regression . Baseline hemoglobin ( Hb ) concentration was 137.4 ± 15.5 g/L , 13 % were anemic and 54 % had zinc deficiency . Hb cconcentrations were similar by supplement type , but Hb concentrations improved significantly in anemic women at baseline ( increase of 21.8 g/L ) . Mean percentage changes in serum ferritin were significantly higher in daily compared to weekly supplemented groups ( 86 % versus 32 % ) . The addition of zinc to IFA supplements had no significant impact on iron or zinc status . In conclusion , adding zinc to IFA supplements did not modify efficacy on iron status or improve zinc status , but daily supplementation was more efficacious than weekly in improving iron stores OBJECTIVE The purpose of this pilot novel chiropractic health education intervention was to gather preliminary evidence regarding possible benefits from recreational youth soccer and nutrition education in overweight women . A secondary purpose was to determine whether some nutrition knowledge is an independent predictor of changes in body mass index ( BMI ) . METHODS A quiz developed and vali date d on separate age and sex appropriate blinded cohorts was used on study participants -22 volunteers of 57 eligible fourth- grade , overweight female Mississippi public school students . At the beginning of a 5-month study period , a 15-minute baseline nutrition intervention , grounded in Social Cognitive Theory and based on the United States Department of Agriculture 's " My Tips for Families " information , was applied in a chiropractic clinic . Subjects were then r and omized to 2 months of recreational soccer ( n = 14 ) or waiting list control ( n = 8) . RESULTS No preintervention differences were found in height , weight , BMI , or age . Higher follow-up BMI scores were found in both groups , and no significant differences between groups were found , possibly because of the small sample sizes and the short 8-week soccer intervention period . Gains in nutrition knowledge were sustained ( P < .002 ) ; however , there was no association between nutrition knowledge and follow-up BMI ( r = -.185 ; P < .462 ) . CONCLUSIONS Minimal nutrition education alone may be an ineffective intervention for overweight children . The study provides an example of how youth soccer may benefit overweight children Background Childhood obesity is the result of a long lasting imbalance between energy intake and energy expenditure . A major contributing factor is physical inactivity which is closely linked to bone health , cardiovascular disease risk , fitness and psychological factors . The school seems to provide an excellent setting to enhance levels of physical activity ( PA ) . However , there is insufficient data from previous school-based intervention trials on how to enhance overall PA . It is also unknown whether an intervention aim ed at increasing PA is effective in improving the children 's health . The purpose of this paper is to outline the design of a school-based r and omized , controlled trial ( RCT ) aim ing to increase overall PA and to improve fitness and health in 6- to 13-year-old children . Methods / Design 15 schools were r and omized to the intervention ( n = 9 ) or the control ( n = 6 ) group , stratified by geographic region ( urban vs. rural ) and by age ( 1st and 5th grade ) . Participation was given for all children in the intervention group since in this group the intervention was part of the normal school curriculum . The intervention during one academic year consisted of : 1 . two additional physical education classes per week given by trained physical education teachers adding up to a total of five PA classes per week , 2 . short PA breaks ( 2–5 min each ) during academic lessons , 3 . PA home work , and 4 . adaptation of recreational areas around the school . All children underwent anthropometric measurements , blood pressure assessment , fitness testing , measurement of PA and they filled out question naires . At least 70 % of all children agreed to blood sampling and measurements of body composition and bone mineral measurements by dual energy x-ray absorptiometry . The primary endpoints of the study after one year were an increase in total PA by accelerometry , an increase in aerobic fitness measured by the 20 m shuttle run , a decrease in percent body fat derived from skinfold measurements and an increase in quality of life as assessed by the child health question naire in the intervention group compared to the control group . Secondary outcomes were overall fitness , differences in body composition including body fat distribution , cardiovascular risk factors , psychosocial health , bone mineral content and density of femur , lumbar spine and total body and food intake . Discussion Our preliminary data suggest that the children were representative of Swiss children with respect to sex , socio-demographic status , and body mass index . Short-term results can be expected by the beginning of 2007 . We hypothesized that our intervention will lead to an increase in PA , fitness and overall health . Based on our data , we aim to provide important information regarding the influence of such an intervention on these outcome measures in school-aged children and to provide nationwide guidelines to improve PA in children This study tested the efficacy of two school-based programs for prevention of body weight/fat gain in comparison to a control group , in all participants and in overweight children . The Louisiana ( LA ) Health study utilized a longitudinal , cluster r and omized 3-arm controlled design , with 28 months of follow-up . Children ( N=2060 ; M age = 10.5 years , SD = 1.2 ) from rural communities in Grade s 4 to 6 participated in the study . 17 school clusters ( M = 123 children/cluster ) were r and omly assigned to one of three prevention arms : 1 ) Primary Prevention ( PP ) , an environmental modification program , 2 ) Primary + Secondary Prevention ( PP+SP ) , the environmental program with an added classroom and internet education component , or 3 ) Control ( C ) . Primary outcomes were changes in percent body fat and body mass index z scores . Secondary outcomes were changes in behaviors related to energy balance . Comparisons of PP , PP+SP , and C on changes in body fat and BMI z scores found no differences . PP and PP+SP study arms were combined to create an environmental modification arm ( EM ) . Relative to C , EM decreased body fat for boys ( −1.7 % ± 0.38 % versus −0.14 % ± 0.69 % ) and attenuated fat gain for girls ( 2.9 % ± 0.22 % versus 3.93 % ± 0.37 % ) , but st and ardized effect sizes were relatively small ( < 0.30 ) . In conclusion , this school-based environmental modification programs had modest beneficial effects on changes in percent body fat . Addition of a classroom/internet program to the environmental program did not enhance weight/fat gain prevention , but did impact physical activity and social support in overweight children OBJECTIVES The aim of this study was to determine the effects of physical activity on systemic blood pressure ( BP ) and early markers of atherosclerosis in pre-pubertal obese children . BACKGROUND Hypertension and endothelial dysfunction are premature complications of obesity . METHODS We performed a 3-month r and omized controlled trial with a modified crossover design : 44 pre-pubertal obese children ( age 8.9 + or - 1.5 years ) were r and omly assigned ( 1:1 ) to an exercise ( n = 22 ) or a control group ( n = 22 ) . We recruited 22 lean children ( age 8.5 + or - 1.5 years ) for baseline comparison . The exercise group trained 60 min 3 times/week during 3 months , whereas control subjects remained relatively inactive . Then , both groups trained twice/week during 3 months . We assessed changes at 3 and 6 months in office and 24-h BP , arterial intima-media thickness ( IMT ) and stiffness , endothelial function ( flow-mediated dilation ) , body mass index ( BMI ) , body fat , cardiorespiratory fitness ( maximal oxygen consumption [ VO(2)max ] ) , physical activity , and biological markers . RESULTS Obese children had higher BP , arterial stiffness , body weight , BMI , abdominal fat , insulin resistance indexes , and C-reactive protein levels , and lower flow-mediated dilation , VO(2)max , physical activity , and high-density lipoprotein cholesterol levels than lean subjects . At 3 months , we observed significant changes in 24-h systolic BP ( exercise -6.9 + or - 13.5 mm Hg vs. control 3.8 + or - 7.9 mm Hg , -0.8 + or - 1.5 st and ard deviation score [ SDS ] vs. 0.4 + or - 0.8 SDS ) , diastolic BP ( -0.5 + or - 1.0 SDS vs. 0 + or - 1.4 SDS ) , hypertension rate ( -12 % vs. -1 % ) , office BP , BMI z-score , abdominal fat , and VO(2)max . At 6 months , change differences in arterial stiffness and IMT were significant . CONCLUSIONS A regular physical activity program reduces BP , arterial stiffness , and abdominal fat ; increases cardiorespiratory fitness ; and delays arterial wall remodeling in pre-pubertal obese children . ( Effects of Aerobic Exercise Training on Arterial Function and Insulin Resistance Syndrome in Obese Children : A R and omized Controlled Trial ; NCT00801645 ) Background Childhood obesity is one of the most critical public health problems in the world . It is associated with low neuromuscular function and postural deformities . Whether weight loss can improve postural stability and neuromuscular control , benefit daily activities , or prevent injury is unknown . Therefore , this study attempts to investigate the effect of a 6 month weight management program on postural stability and neuromuscular control among obese children . Methods / design We will conduct a prospect i ve , single-blind , r and omized controlled trial with 120 prepubescent obese children . Participants will be r and omly assigned to a weight management group or a control group . The weight management group will participate in a dietary and exercise program . The control group will receive health education . After the intervention , participants will be followed for 6 months with no active intervention . The primary and secondary outcomes will be assessed at the baseline , and after 6 months and 12 months . Primary outcome measures will include body weight , body height , body mass index , waist circumference , hip circumference , and body fat percentage . Secondary outcome measures will include three-dimensional functional biomechanics in different tasks , proprioception tests of the knee and ankle , neuromuscular response of the leg muscles , and muscle strength tests of the knee and ankle . Furthermore , adverse events will be recorded and analyzed . An intention-to-treat analysis will be performed if any participants withdraw from the trial . Discussion The important features of this trial include the r and omization procedures and large sample size . This study attempts to estimate the effect of weight loss intervention on outcomes , including daily life function , postural stability , and neuromuscular control in prepubescent obese children . Therefore , our results can be useful for obese children , medical staff , and healthcare decision makers . Trial registration Chinese Clinical Trial Registry ChiCTR-IOB-15005874 Background The prevalence of childhood obesity increased worldwide in recent decades and is associated with risk factors for the development of chronic diseases in adulthood . Strategies for health promotion directed at an early age , with recommendation for healthy habits , can achieve good results . The objective of this study is to evaluate the effectiveness of an innovative , simple and cost effective educational program to improve eating habits , physical activity and the knowledge about healthy habits in children , as well as in their families , as compared to routine outpatient care . Methods / Design The study is design ed as a r and omized clinical trial . Sample size is estimated to include 37 children , aged between 7 and 11 years , and their guardians , r and omized for an intervention or a control group . The intervention will consist of 11-weekly group meetings of nutritional education and distribution of explanatory material , with orientation about healthy food and family habits and physical activity . Recreational , simple and low cost re sources , carefully design ed for the presentation of contents to the children and parents , will be used in all meetings . The control group will receive st and ard outpatient care based in individual clinical practice guidelines . The primary outcomes will be changes in dietary habits , knowledge and physical activity of children and adults . The secondary outcomes will be changes of body mass index , waist circumference , systolic and diastolic blood pressure and laboratory tests , in children and adults . Discussion The Happy Heart Study offers a playful and low-cost approach for the prevention and control of obesity and cardiovascular disease in children . Although this program is being planned for implementation in Brazil , the method can be adapted to many other countries . Registry of protocol Protocol registered on the site ensaiosclinicos.gov.br : RBR-8ttw64 OBJECTIVE We examined the effect of a 12-week family-based cognitive behavioural weight management programme developed for use in primary care setting s. METHODS The sample consisted of 49 children with obesity ( aged 7 - 13 years ; mean ± SD : 10.68 ± 1.24 ) . Families were r and omly assigned to immediate start-up of treatment or to a 12-week waiting list condition . Outcome measures were body mass index st and ard deviation score ( BMI SDS ) , self-esteem , symptoms of depression and blood parameters indicative of cardio-metabolic risk . Assessment s were conducted at baseline , post-treatment , post-waiting list and 12 months after treatment termination . RESULTS The mean reduction for the treatment group was -0.16 BMI SDS units compared with an increase of 0.04 units for the waiting list group ( p = .001 ) . For the entire sample , there was a significant post-treatment improvement on BMI SDS ( p = .001 ) , all self-esteem measures ( p = .001-.041 ) and symptoms of depression ( p = .004 ) . The mean BMI SDS reduction was -0.18 units post-treatment , and it was maintained at 12-month follow-up . Significant reductions were found in blood lipid levels of total cholesterol ( p = .03 ) , LDL-cholesterol ( p = .005 ) and HDL-cholesterol ( p = .01 ) at 12-month follow-up . The favourable effect on most of the psychological measures waned from post-treatment to follow-up , but not approaching baseline levels . Boys demonstrated significantly greater reductions in BMI SDS than girls ( p = .001 ) , while baseline psychiatric co-morbidity did not influence BMI SDS outcome . CONCLUSIONS The treatment shows significant and favourable effects on BMI SDS , self-esteem and symptoms of depression compared with a waiting list condition 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 dose-response effects of an exercise program on depressive symptoms and self-worth in children . METHOD Overweight , sedentary children ( N = 207 , 7 - 11 years , 58 % male , 59 % Black ) were r and omly assigned to low or high dose ( 20 or 40 min/day ) aerobic exercise programs ( 13 + /- 1.6 weeks ) , or control group . Children completed the Reynolds Child Depression Scale and Self-Perception Profile for Children at baseline and posttest . RESULTS A dose-response benefit of exercise was detected for depressive symptoms . A race x group interaction showed only White children 's global self-worth ( GSW ) improved . There was some evidence that increased self-worth mediated the effect on depressive symptoms . CONCLUSIONS This study shows dose-response benefits of exercise on depressive symptoms and self-worth in children . However , Blacks did not show increased GSW in response to the intervention . Results provide some support for mediation of the effect of exercise on depressive symptoms via self-worth To decrease BMI in overweight and obese children , improved dietary intake and increased physical activity are key elements . Our objective was to evaluate the impact of a 1-y food and physical activity intervention on energy and macronutrient intake in overweight and obese children . A r and omized open trial was conducted with 92 overweight or obese 10.4 ± 1.08-y-old children . The intervention included 14 group sessions with different themes regarding food and physical activity . Dietary intake was assessed with diet history interviews covering 14 d at baseline and 4-d food records after 1 y and was evaluated according to national dietary recommendations . The control group participated in the same measurements as the intervention group but did not take part in group sessions . After 1 y , both groups had decreased their energy intake ( EI ) relative to total energy expenditure , but the effect was more pronounced for the intervention group than for the control group . At 1 y follow-up , a larger proportion of children in the intervention group compared with the control group met the recommended intake of refined sugar ( P = 0.019 ) . However , the groups did not differ in the proportion children who met the recommended intake of dietary fiber . Further , SFA intake relative to total EI did not differ between the groups at 1 y follow-up . In conclusion , despite a rather comprehensive intervention , only modest effects were achieved with respect to reduced EI and improved macronutrient intake Background / Objectives : To determine if a multi-component family focused education package is more effective than a waiting list control group in treating overweight and obese children . Subjects/ Methods : A 2-year r and omised controlled trial ; 65 overweight and obese children aged 6–14 years were allocated to active intervention in either the first or second year , with body composition monitoring alone in the control period . Anthropometric measurements were undertaken at six monthly intervals and a 7-day food and activity diary were issued . Results : Over the 2 years of the study body mass index ( BMI ) SDS ( z score ) fell significantly in the intervention/control ( I/C ) group , but not in the control/intervention ( C/I ) group . The difference between groups was 0.3 , which was borderline significant ( 95 % confidence interval ( 95 % CI ) −0.62 to 0.02 , P=0.06 ) before adjusting for potential confounding factors . Thirty-three percent of the I/C group and 12 % of the C/I group achieved the target reduction of 0.5 BMI SDS . The I/C group had a significantly greater reduction in the percentage with a BMI above the 99.6th centile at 24 months ( P=0.04 ) and gained 5.7 kg less over the time of the study . There were no significant differences between groups for mean percentage attendance at physical activity sessions ( I/C group=24.1 % , 95 % CI , 15.4–32.9 ; C/I group=31.7 % , 95 % CI , 22.4–41.1 , P=0.229 ) . Conclusions : Children given active intervention followed by body composition monitoring alone reduced their BMI SDS , and fewer children were classified as grossly overweight by the end of the study . If these findings are true , there are important implication s for the provision of services managing overweight in the community Children who are ethnic minorities , low income and live in urban neighborhoods are at higher risk for obesity . This study examined the feasibility and efficacy of a primary care-based and community partnered obesity intervention in Chinese American children . An experimental design with a historical comparison group was used to explore the feasibility of an obesity intervention for overweight Chinese American children , ages 7–12 . Data were collected on weight , height , blood pressure , waist circumference , physical activity , food intake , knowledge , and self-efficacy about diet and physical activity at baseline , 2 months , and 6 months post-baseline . Significant improvements in BMI , blood pressure , and nutrition knowledge and self-efficacy were found in the intervention group . Intervention group reduced their BMI compared to the comparison group ( F = 8.65 , p = .004 ) . An obesity intervention in primary care setting is feasible and demonstrates a short-term effect on weight loss in Chinese American children OBJECTIVE Maintaining weight loss results in childhood obesity treatment is difficult to achieve . Self-management techniques such as self-monitoring are associated with increased weight loss and maintenance . This study analyzes whether self-monitoring of lifestyle behaviours through a short message service maintenance treatment ( SMSMT ) via mobile phones with personalized feedback positively effects weight , lifestyle behaviours and psychological well-being in obese children . METHODS After 3 months of behavioural lifestyle treatment , 141 overweight and obese children ( 7 - 12 years ) were r and omly assigned to an intervention group receiving SMSMT for 9 months ( n = 73 ) or to the control group ( n = 68 ) . The intervention group sent weekly self-monitoring data on exercise and eating behaviour and their mood via mobile phones . In return , they received tailored feedback messages . Primary treatment outcomes were weight , eating behaviour and psychological well-being , i.e. competence , self-esteem and quality of life . Secondary outcome was adherence to the SMSMT . Data were analyzed with mixed modelling . RESULTS SMSMT did not improve treatment outcomes . Controls gained temporarily in physical health scores ( P = 0.01 ) . SMSMT completers sent on average every 2 weeks an SMS . Children who had greater weight loss during the first 3 months of lifestyle treatment sent more SMSs ( P = 0.04 ) . CONCLUSIONS We did not find a positive effect of SMSMT on weight , eating behaviour or psychological well-being in obese children . SMSMT seems to be a feasible method of treatment delivery . Future research should study variations of SMSMT to investigate how SMSMT can be more effective BACKGROUND During consultations on weight management in childhood obesity clinics , the additional costs incurred by healthy eating are often cited , as an economic barrier to achieving a better nutritional balance . AIM To examine whether adopting an improved theoretical , balanced diet compared to current dietary habits in children incurs additional cost . DESIGN AND SETTING Children aged 5 - 16 years ( body mass index [ BMI ] ≥98th percentile ) recruited to a r and omised trial comparing a hospital-based and primary care childhood obesity clinics provided data for this study . METHOD Three-day dietary diaries collected at baseline were analysed for energy and fat intake and then compared to a theoretical , adjusted healthy-eating diet based on the Food St and ards Agency , ' Eatwell plate ' . Both were priced contemporaneously using the appropriate portion size , at a neighbourhood , mid-range supermarket , at a budget supermarket , and on the local high street . RESULTS The existing diet purchased at a budget supermarket was cheapest ( £ 2.48/day ) . The healthier , alternative menu at the same shop cost an additional 33 pence/day ( £ 2.81 ) . The same exercise in a mid-range supermarket , incurred an additional cost of 4 pence per day ( £ 3.40 versus £ 3.44 ) . Switching from an unhealthy mid-range supermarket menu to the healthier , budget-outlet alternative saved 59 pence per day . The healthier , alternative menu was cheaper than the existing diet if purchased on the high street ( £ 3.58 versus £ 3.75 ) , although for both menus this was most expensive . CONCLUSION For many obese children , eating healthily would not necessarily incur prohibitive , additional financial cost , although a poor diet at a budget supermarket remains the cheapest of all options . Cost is a possible barrier to healthy eating for the most economically disadvantaged Background Substituting sugar-free for sugar-sweetened beverages reduces weight gain . A possible explanation is that sugar-containing and sugar-free beverages cause the same degree of satiety . However , this has not been tested in long-term trials . Methods We r and omized 203 children aged 7 - 11 years to receive 250 mL per day of an artificially sweetened sugar-free beverage or a similarly looking and tasting sugar-sweetened beverage . We measured satiety on a 5-point scale by question naire at 0 , 6 , 12 and 18 months . We calculated the change in satiety from before intake to 1 minute after intake and 15 minutes after intake . We then calculated the odds ratio that satiety increased by 1 point in the sugar-group versus the sugar-free group . We also investigated how much the children liked and wanted the beverages . Results 146 children or 72 % completed the study . We found no statistically significant difference in satiety between the sugar-free and sugar-sweetened group ; the adjusted odds ratio for a 1 point increase in satiety in the sugar group versus the sugar-free group was 0.77 at 1 minute ( 95 % confidence interval , 0.46 to 1.29 ) , and 1.44 at 15 minutes after intake ( 95 % CI , 0.86 to 2.40 ) . The sugar-group liked and wanted their beverage slightly more than the sugar-free group , adjusted odds ratio 1.63 ( 95 % CI 1.05 to 2.54 ) and 1.65 ( 95 % CI 1.07 to 2.55 ) , respectively . Conclusions Sugar-sweetened and sugar-free beverages produced similar satiety . Therefore when children are given sugar-free instead of sugar-containing drinks they might not make up the missing calories from other sources . This may explain our previous observation that children in the sugar-free group accumulated less body fat than those in the sugar group . Trial Registration Clinical Trials.gov NCT00893529 http:// clinical Background Reversing the obesity epidemic requires the development and evaluation of childhood obesity intervention programs . Lifestyle Triple P is a parent-focused group program that addresses three topics : nutrition , physical activity , and positive parenting . Australian research has established the efficacy of Lifestyle Triple P , which aims to prevent excessive weight gain in overweight and obese children . The aim of the current r and omized controlled trial is to assess the effectiveness of the Lifestyle Triple P intervention when applied to Dutch parents of overweight and obese children aged 4–8 years . This effectiveness study is called GO4fit . Methods / Design Parents of overweight and obese children are being r and omized to either the intervention or the control group . Those assigned to the intervention condition receive the 14-week Lifestyle Triple P intervention , in which they learn a range of nutritional , physical activity and positive parenting strategies . Parents in the control group receive two brochures , web-based tailored advice , and suggestions for exercises to increase active playing at home . Measurements are taken at baseline , directly after the intervention , and at one year follow-up . Primary outcome measure is the children ’s body composition , operationalized as BMI z-score , waist circumference , and fat mass ( biceps and triceps skinfolds ) . Secondary outcome measures are children ’s dietary behavior and physical activity level , parenting practice s , parental feeding style , parenting style , parental self-efficacy , and body composition of family members ( parents and siblings ) . Discussion Our intervention is characterized by a focus on changing general parenting styles , in addition to focusing on changing specific parenting practice s , as obesity interventions typically do . Strengths of the current study are the r and omized design , the long-term follow-up , and the broad range of both self-reported and objective ly measured outcomes .Trial Registration Current Controlled Trials NTR 2555MEC AzM/UMNL 31988.068.10 / MEC 10 - 3 - Background The prevalence of childhood obesity has increased rapidly during the last three decades in the Netherl and s. It is assumed that mainly environmental factors have contributed to this trend . Parental overweight and low social economic status are risk factors for childhood obesity . Childhood obesity affects self-esteem and has negative consequences on cognitive and social development . Obese children tend to become obese adults , which increases the risk for developing cardiovascular complications , type 2 diabetes mellitus , and psychosocial problems . Additionally , the secretion of several gastrointestinal hormones , responsible for appetite and food intake , is impaired in obese subjects . Weight reduction through lifestyle changes in order to change health risks is , until now , suggested as the preferred treatment for childhood obesity . The objective of this study is the effect evaluation of a family-based cognitive behavioral multidisciplinary lifestyle treatment . The intervention aims to establish long-term weight reduction and stabilization , reduction of obesity-related health consequences and improvement of self-image by change of lifestyle and learning cognitive behavioral techniques . Study design / Methods In this r and omized clinical trial newly presented children with obesity ( 8 - 17 years old ) are divided , by r and omization , in an intervention and control group , both consisting of 40 obese children . The intervention is carried out in groups of 8 - 11 children , and consists of respectively 7 and 5 separate group meetings for the children and their parents and 1 joint group meeting of 2 ½ hours . Main topics are education on nutrition , self-control techniques , social skills , physical activity and improvement of self-esteem . The control group is given advice on physical activity and nutrition . For normal data comparison , data were collected of 40 normal-weight children , 8 - 17 years old . Discussion Because of the increasing prevalence of childhood obesity and the impact on the individual as well as on society , prevention and treatment of obesity in children is of great importance . For evaluation of short- and long-term effects of the treatment , measurements are taken before and after 3 months of treatment , and after 12 and 24 months follow-up . During these visits clinical and biochemical data are determined , cardiovascular fitness tests are performed and quality of life question naires are completed . Trial registration International St and ard R and omised Controlled Trial Number Register IS RCT Objectives As parents of young children are often unaware their child is overweight , screening provides the opportunity to inform parents and provide the impetus for behaviour change . We aim ed to determine if parents could recall and underst and the information they received about their overweight child after weight screening . Design R and omised controlled trial of different methods of feedback . Setting Participants were recruited through primary and secondary care but appointments took place at a University research clinic . Participants and intervention 1093 children aged 4–8 years were screened . Only overweight children ( n=271 , 24.7 % ) are included in this study . Parents of overweight children were r and omised to receive feedback regarding their child 's weight using best practice care ( BPC ) or motivational interviewing ( MI ) at face-to-face interviews typically lasting 20–40 min . 244 ( 90 % ) parents participated in a follow-up interview 2 weeks later to assess recall and underst and ing of information from the feedback session . Primary and secondary outcome measures Interviews were audio-taped and transcribed verbatim before coding for amount and accuracy of recall . Scores were calculated for total recall and sub-categories of interest . Results Overall , 39 % of the information was recalled ( mean score 6.3 from possible score of 16 ) . Parents given feedback via BPC recalled more than those in the MI group ( difference in total score 0.48 ; 95 % CI 0.05 to 0.92 ) . Although 94 % of parents were able to correctly recall their child 's weight status , fewer than 10 parents could accurately describe what the measurements meant . Maternal education ( 0.81 ; 0.25 to 1.37 ) and parental ratings of how useful they found the information ( 0.19 ; 0.04 to 0.35 ) were significant predictors of recall score in multivariate analyses . Conclusions While parents remember that their child 's body mass index is higher than recommended , they are unable to remember much of the information and advice provided about the result . Trial registration number Australian New Zeal and Clinical Trials Registry ACTRN12609000749202 The objective of this study was to examine whether a protein-sparing modified fast diet and a hypocaloric balanced diet are effective in a clinic-based dietary intervention implemented in a school setting high-risk weight loss program for superobese ( > or = 140 % of their ideal body weight for height [ IBW ] children . A group of children from two suburban public schools in New Orleans , Louisiana were r and omized to either dietary-intervention group and control group . Children were followed for 6 months . In the dietary-intervention-group , 12 of 44 superobese children [ ages 8.8 to 13.4 years , weight 144 % to 212 % of IBW ] volunteered to participate . In the control group , 7 of 19 superobese children [ ages 9.4 to 12.9 years , weight 140 % to 195 % of IBW ] volunteered to participate . During the first 9 weeks , 12 superobese children were placed on a 2520 to 3360 J ( 600 to 800 Cal ) protein-sparing modified fast diet . Subsequently , the diets of all children were increased in a 3-month period 420 J ( 100 Cal ) every 2 weeks until a 5040 J ( 1200 Cal ) per day balanced diet was attained . In both groups , height and weight were obtained at baseline , 10 weeks , and 6 months ; and biochemical measurements were performed at baseline and 6 months . At 6 months the 12 superobese children on protein-sparing modified fast diet had a significant weight loss from baseline ( -5.6 + /- 7.1 kg , ANOVA p < 0.02 ) ; a significant decrease in percentage IBW ( -24.3 + /- 20 % , ANOVA p < 0.002 ) ; and had positive growth velocity Z-score ( 1.3 + /- 1.6 , ANOVA p < 0.05 ) . Six children were not superobese at 6 months . At 6 months eight of 12 children were active participants and 11 of 12 children were followed . Decrease in blood pressure , as well as , downward trends in serum lipids were observed at 6 months . No clinical complications were observed . At 6 months , the 7 control superobese children , when compared with baseline had gained weight ( 2.8 + /- 3.1 kg , ANOVA p < 0.008 ) ; but had no significant change in percentage IBW ( -0.3 + /- 5.9 % , ANOVA p = 0.61 ) ; and had no changes in growth velocity Z-score ( 0.1 + /- 1.3 , ANOVA p = 0.83 ) . These children did not have any change in blood pressure and an upward trend in serum lipids were observed at 6 months . Protein-sparing modified fast diet and a hypocaloric balanced diet appear to be effective in a group of superobese-school-age children in a medically supervised clinic-based program implemented in a school setting over a 6-month period . The efforts of committed clinic staffs , school officials , peers , and family involvement were crucial to the success of this intervention program in promoting and maintaining weight loss over a 6-month period . Further research with a specific comparison of the hypocaloric diets with longer follow-up periods in the school setting is necessary . In the meantime , these diets should be used only with close medical supervision OBJECTIVE The objective was to test the hypothesis that a community-based environmental change intervention could prevent weight gain in young children ( 7.6 + /- 1.0 years ) . RESEARCH METHODS AND PROCEDURES A non-r and omized controlled trial was conducted in three culturally diverse urban cities in Massachusetts . Somerville was the intervention community ; two socio-demographically-matched cities were control communities . Children ( n = 1178 ) in grade s 1 to 3 attending public elementary schools participated in an intervention design ed to bring the energy equation into balance by increasing physical activity options and availability of healthful foods within the before- , during- , after-school , home , and community environments . Many groups and individuals within the community ( including children , parents , teachers , school food service providers , city departments , policy makers , healthcare providers , before- and after-school programs , restaurants , and the media ) were engaged in the intervention . The main outcome measure was change in BMI z-score . RESULTS At baseline , 44 % ( n = 385 ) , 36 % ( n = 561 ) , and 43 % ( n = 232 ) of children were above the 85th percentile for BMI z-score in the intervention and the two control communities , respectively . In the intervention community , BMI z-score decreased by -0.1005 ( p = 0.001 , 95 % confidence interval , -0.1151 to -0.0859 ) compared with children in the control communities after controlling for baseline covariates . DISCUSSION A community-based environmental change intervention decreased BMI z-score in children at high risk for obesity . These results are significant given the obesigenic environmental backdrop against which the intervention occurred . This model demonstrates promise for communities throughout the country confronted with escalating childhood obesity rates Background Obesity is the most common chronic pediatric disease in westernized , especially low socioeconomic societies . We previously demonstrated the beneficial effects of a r and omized prospect i ve school-based health education program for low socioeconomic status Arab-Israeli kindergarten children . Methods To examine whether the effects of our program on nutrition and physical activity knowledge and preferences , anthropometric measures , and fitness persisted one year after the end of intervention . We were able to perform the one year follow-up in 203 kindergarten children ( 59 % of our 342 original cohort ; 85 control , 118 intervention ) . Results At one year following the intervention BMI and BMI percentiles approached baseline level in both the intervention ( 16.4±0.2 kg/m2 and 61.5±2.4 % , respectively ) and control group participants ( 16.5±0.2 kg/m2 and 58.5±3.3 % , respectively ) . Yet , a year after the end of the intervention , the decrease in BMI % ile from baseline was significantly greater in the intervention group ( -7.8±1.5 vs. -1.9±1.9 , p<0.012 ) . Nutritional and physical activity knowledge and preferences , and physical fitness remained significantly elevated in the intervention compared to the control group participants . Conclusions The beneficial effects of a kindergarten dietary-physical activity intervention applied by the kindergarten teachers , on nutrition and physical activity knowledge and preferences , fitness , and BMI percentile were evident one year after the end of intervention . This promising program may play a role in health promotion , prevention and treatment of childhood obesity Objective To evaluate the acceptability and feasibility of a scalable obesity treatment program integrated with pediatric primary care and delivered using interactive voice technology ( IVR ) to families from underserved population s. Design and Methods Fifty parent-child dyads ( child 9–12 yrs , BMI > 95th percentile ) were recruited from a pediatric primary care clinic and r and omized to either an IVR or a wait-list control ( WLC ) group . The majority were lower-income , African-American ( 72 % ) families . Dyads received IVR calls for 12 weeks . Call content was informed by two evidence d-based interventions . Anthropometric and behavioral variables were assessed at baseline and 3 mo follow-up . Results Forty-three dyads completed the study . IVR parents ate 1 cup more fruit than WLC ( p < .05 ) . No other groups differences were found . Children classified as high users of the IVR decreased weight , BMI and BMI z-score compared to low users ( p<.05 ) . Mean number of calls for parents and children were 9.1 ( 5.2 SD ) and 9.0 ( 5.7 SD ) , respectively . Of those who made calls , > 75 % agreed that the calls were useful , made for people like them , credible , and helped them eat healthy foods . Conclusion An obesity treatment program delivered via IVR may be an acceptable and feasible re source for families from underserved population Background The prevention and treatment of childhood obesity is a key public health challenge . However , certain groups within population s have markedly different risk profiles for obesity and related health behaviours . Well- design ed subgroup analysis can identify potential differential effects of obesity interventions , which may be important for reducing health inequalities . The study aim was to evaluate the consistency of the effects of active video games across important subgroups in a r and omised controlled trial ( RCT ) . Findings A two-arm , parallel RCT was conducted in overweight or obese children ( n = 322 ; aged 10–14 years ) to determine the effect of active video games on body composition . Statistically significant overall treatment effects favouring the intervention group were found for body mass index , body mass index z-score and percentage body fat at 24 weeks . For these outcomes , pre-specified subgroup analyses were conducted among important baseline demographic ( ethnicity , sex ) and prognostic ( cardiovascular fitness ) groups . No statistically significant interaction effects were found between the treatment and subgroup terms in the main regression model ( p = 0.36 to 0.93 ) , indicating a consistent treatment effect across these groups . Conclusions Preliminary evidence suggests an active video games intervention had a consistent positive effect on body composition among important subgroups . This may support the use of these games as a pragmatic public health intervention to displace sedentary behaviour with physical activity in young people Background This study evaluates the effects of an intervention performed by youth health care professionals on child health behaviors . The intervention consisted of offering healthy lifestyle counseling to parents of overweight ( not obese ) 5-year-old children . Effects of the intervention on the child having breakfast , drinking sweet beverages , watching television and playing outside were evaluated . Methods Data were collected with the ' Be active , eat right ’ study , a cluster r and omized controlled trial among nine youth health care centers in the Netherl and s. Parents of overweight children received lifestyle counseling according to the intervention protocol in the intervention condition ( n = 349 ) and usual care in the control condition ( n = 288 ) . Parents completed question naires regarding demographic characteristics , health behaviors and the home environment at baseline and at 2-year follow-up . Cluster adjusted regression models were applied ; interaction terms were explored . Results The population for analysis consisted of 38.1 % boys ; mean age 5.8 [ sd 0.4 ] years ; mean BMI SDS 1.9 [ sd 0.4 ] . There were no significant differences in the number of minutes of outside play or television viewing a day between children in the intervention and the control condition . Also , the odds ratio for having breakfast daily or drinking two or less glasses of sweet beverages a day showed no significant differences between the two conditions . Additional analyses showed that the odds ratio for drinking less than two glasses of sweet beverages at follow-up compared with baseline was significantly higher for children in both the intervention ( p < 0.001 ) and the control condition ( p = 0.029 ) . Conclusions Comparison of the children in the two conditions showed that the intervention does not contribute to a change in health behaviors . Further studies are needed to investigate opportunities to adjust the intervention protocol , such as integration of elements in the regular well-child visit . The intervention protocol for youth health care may become part of a broader approach to tackle childhood overweight and obesity . Trial registration Current Controlled Trials IS RCT Background In Lebanon , childhood obesity doubled during the past decade . Preventive measures should start early in life and Schools are considered an important environment to promote energy balance health behaviours . School-based programmes promoting healthy lifestyles are lacking . The purpose of this study was to evaluate the feasibility and effectiveness of a multicomponent school-based intervention to promote healthy eating and physical activity ( and prevent obesity ) with school children aged 9–11 years in Lebanon . Methods The intervention was developed based on the constructs of the Social Cognitive Theory and adapted to the culture of Lebanese and Arab population s. It consisted of three components : class curriculum , family involvement and food service . Eight schools were purposively selected from two communities of different socioeconomic status ( SES ) in Beirut and , within each school type , were matched on SES , religious sect profile , and then r and omly assigned to either the intervention or control group . Anthropometric measurements and question naires on determinants of behavioural change , eating and physical activity habits were completed by the students in both groups at baseline and post intervention . Focus group interviews were conducted in intervention schools at the end of the study . Challenges encountered during the programme implementation were also identified , since Lebanon is considered a country with political unrest and no similar research projects were conducted in the area . Results Students in the intervention group reported purchasing and consuming less chips and sweetened drinks post-intervention compared with controls ( 86 % & 88 % less respectively p < 0.001 ) . Knowledge and self-efficacy scores increased for the intervention ( + 2.8 & + 1.7 points respectively p < 0.001 ) but not for the control group . There was no difference in physical activity and screen time habits and no changes in BMI between groups at post intervention . Interview data from focus groups showed that the programme was generally well accepted . Limitations for better outcomes include the length of the programme and the school environment . Conclusion “ Health-E-PALS ” intervention is a promising innovative , theory-based , culturally sensitive intervention to promote healthy eating habits and physical activity in Lebanese school children with a potential to be scaled up , replicated and sustained BACKGROUND Staged clinical treatment of pediatric obesity is recommended , but untested . Underst and ing the lowest intensity stage 's effectiveness is necessary for future research . METHODS This was a r and omized controlled trial of children ages 4 to < 9 years . Participants were recruited after routine evaluations at a primary care pediatric clinic revealed a BMI ≥85th percentile . The intervention was patterned after the " Prevention plus , Stage 1 " treatment recommended by an expert committee . Groups were compared for changes , over a 3-month time period , in BMI z-score and parental reports of behavioral issues related to childhood obesity using intent-to-treat ( ITT ) analysis . RESULTS Seventy-two ( 30 % of eligible ) children were enrolled and 64 were remeasured at 3-month follow-up . ITT analysis revealed that both groups improved mean BMI z-score [ adjusted change -0.07 , control , and -0.04 , intervention ; 95 % confidence interval ( CI ) of difference=-0.14 - 0.20 ] . Over half of the children in each group improved their BMI z-score ( adjusted proportion decreasing=55 % in control vs. 72 % in intervention ; 95 % CI of difference=-0.07 - 0.42 ) . The intervention group improved comparatively to the control group on numerous behavioral indicators . CONCLUSIONS Implementation of the lowest intensity stage of current recommendations is feasible and possibly of benefit toward lifestyle changes . Results of this study can be used by future clinical research ers design ing protocol s to test the full multi-staged approach for the treatment of pediatric overweight and obesity in primary care clinical setting Aims . To evaluate 3 strategies to reduce weight in obese families . Research design and methods . 142 obese parents and 119 obese children kept a fat-calorie restriction diet . On top of this diet , the families were r and omized in a three-factorial design to one or more of three weight-loss strategies : ( 1 ) an additional diet preferring carbohydrates having a low glycemic index ( dual diet ) , ( 2 ) financial incentive , and ( 3 ) telemonitoring of weight and physical activity . Results . All children improved their BMI -SDS by 0.18 ± 0.25 ( P < .001 ) independently of the weight-loss strategy . In parents , relative losses of weight ( kg ) were −6.4 % versus −4.0 % for dual diet versus calorie restriction ( P = .029 ) , −6.9 % versus −3.4 % for with or without financial incentive ( P = .002 ) , and −8.0 % versus −4.8 % for with or without telemonitoring ( P = .033 ) . The weight loss after financial incentive plus dual diet plus telemonitoring was −14.4 % . Conclusions . All strategies were effective in adults , in particular when combined . Children improved their BMI -SDS regardless of the strategy OBJECTIVES . Television viewing and physical inactivity increase the risk of obesity in youth . Thus , identifying new interventions that increase physical activity and reduce television viewing would be helpful in the prevention and treatment of pediatric obesity . This study evaluated the effects of open-loop feedback plus reinforcement versus open-loop feedback alone on physical activity , targeted sedentary behavior , body composition , and energy intake in youth . METHODS . Thirty overweight or obese 8- to 12-year-old children were r and omly assigned to an intervention ( n = 14 ) or control group ( n = 16 ) . Participants wore accelerometers every day for 8 weeks and attended biweekly meetings to download the activity monitors . For children in the open-loop feedback plus reinforcement ( intervention ) group , accumulating 400 counts of physical activity on pedometers earned 1 hour of television/VCR/DVD time , which was controlled by a Token TV electronic device . Open-loop feedback control subjects wore activity monitors but had free access to targeted sedentary behavior . RESULTS . Compared with controls , the open-loop feedback plus reinforcement group demonstrated significantly greater increases in daily physical activity counts ( + 65 % vs + 16 % ) and minutes per day of moderate-to-vigorous physical activity ( + 9.4 vs + 0.3 ) and greater reductions in minutes per day spent in television viewing ( −116.1 vs + 14.3 ) . The intervention group also showed more favorable changes in body composition , dietary fat intake , and energy intake from snacks compared with controls . Reductions in sedentary behavior were directly related to reductions in BMI , fat intake , snack intake , and snack intake while watching television . CONCLUSIONS . Providing feedback of physical activity in combination with reinforcing physical activity with sedentary behavior is a simple method of modifying the home environment that may play an important role in treating and preventing child obesity Background Weight loss improves cardiovascular risk factors and “ quality of life ” . Most therapeutic approaches fail to induce a sustained weight loss and most individuals undergo weight regain . In this paper the comprehensive design of the “ MAINTAIN ” study , all assessment s as well as the one year lifestyle intervention will be outlined in detail . Methods / Design One-center r and omized controlled trial with seven assessment time points conducted 2009 - 2015 . For the r and omization eight groups were distinguished in a list to allocate intervention or control group : Females and males either pre-pubertal or pubertal and with a BMI -SDS under or over 2.5 . Setting : Weight loss at a residential weight reduction programme Berlin/Br and enburg and intervention at a paediatric outpatient clinic ; Participants : 137 children and adolescents ( 10 to 17 years ) . Intervention : Participants were r and omized after an initial weight loss at a residential weight reduction programme and allocated to intervention ( n=65 ) and control ( n=72 ) conditions . The intervention group received an one-year group multi-professional lifestyle intervention with monthly meetings at the paediatric outpatient obesity clinic . The control group had a free living phase for one year and both groups 48 months follow up . Main outcome measures : Participants who are engaged in monthly intervention meetings will benefit in terms of a sustained weight maintenance . The primary aim is to describe the dynamic of hormonal and metabolic mechanisms counter-balancing sustained weight loss during puberty and adolescence . The secondary aim is to investigate the effect of an intensive family based lifestyle intervention during the weight maintenance period on the endogenous counter-regulation as well as on health related quality of life . The third aim is to establish predictors for successful weight maintenance and risk factors for weight regain in obese children and adolescents . Discussion Weight maintenance after induced weight loss is one of the most important therapeutic challenges as long as most patients fail to maintain their weight loss . MAINTAIN is the first paediatric RCT addressing in parallel to a RCT in obese adults the course of weight regain after induced weight loss and is embedded in an experimental research consortium in order to also address several molecular mechanisms of weight regain . Trial registration Clinical Trials NCT00850629 , first registration 17 February 2009 , verified January 2012 , Paediatric part of the interventional study . Ethic proposal approved at BACKGROUND Comparative effectiveness research ( CER ) evidence on childhood obesity provides the basis for effective screening and management strategies in pediatric primary care . The uses of health information technology including decision support tools in the electronic health records ( EHRs ) , as well as remote and mobile support to families , offer the potential to accelerate the adoption of childhood obesity CER evidence . METHODS / DESIGN The Study of Technology to Accelerate Research ( STAR ) is a three-arm , cluster-r and omized controlled trial being conducted in 14 pediatric offices in Massachusetts design ed to enroll 800 , 6 to 12 year old children with a body mass index ( BMI ) ≥ 95th percentile seen in primary care at those practice s. We will examine the extent to which computerized decision support tools in the EHR delivered to primary care providers at the point of care , with or without direct-to-parent support and coaching , will increase adoption of CER evidence for management of obese children . Direct-to-parent intervention components include telephone coaching and twice-weekly text messages . Point-of-care outcomes include obesity diagnosis , nutrition and physical activity counseling , and referral to weight management . One-year child-level outcomes include changes in BMI and improvements in diet , physical activity , screen time , and sleep behaviors , as well as cost and cost-effectiveness . CONCLUSIONS STAR will determine the extent to which decision support tools in EHRs with or without direct-to-parent support will increase adoption of evidence -based obesity management strategies in pediatric practice and improve childhood obesity-related outcomes OBJECTIVE : Family-based , behavioral treatment has been shown to be an effective intervention for the management of pediatric obesity . The goal of this study was to compare the cost-effectiveness of two protocol s for the delivery of family-based behavioral treatment . REA SEARCH METHODS AND PROCEDURES : Thirty-one families with obese children were r and omized to groups in which families were provided mixed treatment incorporating both group and individualized treatment vs group treatment only . Cost-effectiveness of treatment was defined as the magnitude of reduction in st and ardized BMI and percentage overweight per dollar spent for recruitment and treatment . Anthropometric data were assessed at baseline , 6 months and 12 months post-r and omization . RESULTS : Results for the 24 families with complete data showed the group intervention was significantly more cost-effective than the mixed treatment . This was due to the similarity between the two groups in Z- BMI or percentage overweight change for children and their parents , while the mixed treatment was significantly more expensive to deliver than the group treatment . DISCUSSION : These findings suggest that a family-based , behavioral intervention employing group treatment alone is a more cost-effective approach to treating pediatric obesity than a mixed group plus individual format Objectives This study examined the relation of multiple aspects of the home food environment to dietary intake and body weight among overweight and obese children in southern Appalachia . Methods The study used baseline data from a cluster-r and omized controlled trial , Parent-Led Activity and Nutrition for Healthy Living , evaluating a parent-mediated approach to treating child overweight and obesity in the primary care setting in southern Appalachia . Sixty-seven children ages 5 to 11 years were recruited from four primary care clinics . Multiple linear regression was used to estimate the relation between multiple aspects of the home food environment to dietary intake ( fruit and vegetable intake , fat and sweets intake ) , and st and ardized body mass index ( z BMI ) , adjusted for baseline family characteristics ( education , smoking status during the past month , BMI ) and child characteristics ( sex , age , Medicaid/TennCare ) . Results Findings showed greater parental restriction and pressure in feeding were associated with greater fruit and vegetable intake in children ( & bgr ; = 0.33 , & bgr ; = 0.30 , respectively ; both P < 0.05 ) . The availability of chips and sweets in a child ’s home and parental inappropriate modeling of eating were associated with an increased risk for consumption of fats and sweets by children ( & bgr ; = 0.47 , & bgr ; = 0.54 , respectively ; both P < 0.01 ) . Parental monitoring of the child ’s eating was associated with a reduced risk for fat and sweets intake ( & bgr ; = −0.24 ; P < 0.01 ) . Finally , parental responsibility for feeding the child was associated with lower z BMI ( & bgr ; = −0.20 ; P < 0.05 ) . Conclusions The home food environment , including food availability and parenting behaviors , was associated with overweight and obese children ’s dietary intake and weight . This study adds to evidence suggesting that programs aim ed at improving overweight and obese children ’s eating patterns may target both aspects of the physical home environment and parental behaviors surrounding eating Children with low aerobic fitness have altered brain function compared to higher-fit children . This study examined the effect of an 8-month exercise intervention on resting state synchrony . Twenty-two sedentary , overweight ( body mass index ≥85th percentile ) children 8 - 11 years old were r and omly assigned to one of two after-school programs : aerobic exercise ( n=13 ) or sedentary attention control ( n=9 ) . Before and after the 8-month programs , all subjects participated in resting state functional magnetic resonance imaging scans . Independent components analysis identified several networks , with four chosen for between-group analysis : salience , default mode , cognitive control , and motor networks . The default mode , cognitive control , and motor networks showed more spatial refinement over time in the exercise group compared to controls . The motor network showed increased synchrony in the exercise group with the right medial frontal gyrus compared to controls . Exercise behavior may enhance brain development in children The present study aim ed at analyzing the efficacy of a 6-month football training program compared with a st and ard exercise program on health and fitness parameters in overweight children . The study design was a 6-month , two-arm , parallel-group r and omized trial . Twenty-two overweight children were r and omly assigned to two groups ( age=10.8+/-1.2 years , height=1.56+/-0.08 m , weight= 65.1+/-11.4 kg ) . One group conducted a football training program , and the other group an established st and ard sports program . Both interventions took place three times per week from mid-May to mid-November . Before , after 3 months and after the training period , comprehensive testing was conducted : anthropometric characteristics , cycling ergometry , psychometric monitoring as well as several motor ability tests . Maximal performance capacity increased and submaximal heart rate during cycling ergometry decreased significantly . Several motor skills as well as self-esteem also improved considerably . Body composition and other psychometric variables remained nearly unchanged . No relevant differences were observed between both exercise programs . It can be concluded that a 6-month football training is as efficacious in improving the physical capacity , health-related fitness parameters and self-esteem of overweight children as a st and ard exercise program . These results provide further evidence that playing football has significant health effects OBJECTIVE To assess the effect of a weight-loss program on improving iron status in overweight and obese school-aged children . STUDY DESIGN The data were analyzed in overweight and obese children ( 7 - 11 years of age ; 114 girls and 212 boys ) with body mass index-for-age z-scores ( BAZ ) > 1 from a weight-loss program . Schools were r and omly divided into 2 groups : intervention and control . Children in the intervention group underwent a 1-year , nutrition-based comprehensive intervention weight-loss program . Anthropometric , dietary intake , and physical activity data were collected at baseline and follow-up ( 1 year ) . Iron status and inflammatory markers were assessed within a month . RESULTS In the intervention group , BAZ decreased more than that in the control group ( -0.4 ± 0.7 vs -0.1 ± 0.6 , P < .0001 ) ; and iron profiles and inflammation status were improved at follow-up . In multivariable linear regression models , a greater decrease of BAZ and inflammation factors predicted a better improvement of iron status . After adjustment of ΔBAZ , ΔC-reactive protein was significantly associated with Δserum ferritin ( β : 1.89 ; 95 % CI , 0.70 - 3.09 ; P = .002 ) and Δsoluble transferrin receptor ( β : 0.88 ; 95 % CI , 0.16 - 0.59 ; P = .017 ) ; Δinterleukin-6 was significantly associated with Δserum ferritin ( β : 1.22 ; 95 % CI , 0.64 - 1.79 ; P < .0001 ) . CONCLUSIONS Iron status and inflammation were improved by weight reduction . The improvement in inflammatory markers during weight reduction was independently associated with improvements of iron status Background Childhood obesity is one of the most critical and accelerating health challenges throughout the world . It is a major risk factor for developing varus/valgus misalignments of the knee joint . The combination of misalignment at the knee and excess body mass may result in increased joint stresses and damage to articular cartilage . A training programme , which aims at developing a more neutral alignment of the trunk and lower limbs during movement tasks may be able to reduce knee loading during locomotion . Despite the large number of guidelines for muscle strength training and neuromuscular exercises that exist , most are not specifically design ed to target the obese children and adolescent demographic . Therefore , the aim of this study is to evaluate a training programme which combines strength and neuromuscular exercises specifically design ed to the needs and limitations of obese children and adolescents and analyse the effects of the training programme from a biomechanical and clinical point of view . Methods / Design A single assessor-blinded , pre-test and post-test r and omised controlled trial , with one control and one intervention group will be conducted with 48 boys and girls aged between 10 and 18 years . Intervention group participants will receive a 12-week neuromuscular and quadriceps/hip strength training programme . Three-dimensional ( 3D ) gait analyses during level walking and stair climbing will be performed at baseline and follow-up sessions . The primary outcome parameters for this study will be the overall peak external frontal knee moment and impulse during walking . Secondary outcomes include the subscales of the Knee injury and Osteoarthritis Outcome Score ( KOOS ) , frontal and sagittal kinematics and kinetics for the lower extremities during walking and stair climbing , ratings of change in knee-related well-being , pain and function and adherence to the training programme . In addition , the training programme will be evaulated from a clinical and health status perspective by including the following analyses : cardiopulmonary testing to quantify aerobic fitness effects , anthropometric measures , nutritional status and psychological status to characterise the study sample . Discussion The findings will help to determine whether a neuromuscular and strength training exercise programme for the obese children population can reduce joint loading during locomotion , and thereby decrease the possible risk of developing degenerative joint diseases later in adulthood . Trial registration Clinical Trials NCT02545764 , Date of registration : 24 September 2015 Objective : The aim of the study was to compare the efficacy of group treatment stressing a health-promoting lifestyle with routine counseling in the treatment of childhood obesity . Design and subjects : Seventy obese children ( weight for height 115–182 % ) aged 7–9 years were r and omized either to routine counseling ( two appointments for children ) or to family-based group treatment ( 15 separate sessions for parents and children ) . These sessions included nutrition education , physical activity education and behavioral therapy . Outcome measures : Children 's weights and heights were measured at baseline , after the 6-month intervention and after the 6-month follow-up . The change of weight for height based on Finnish growth charts was used as the primary , and changes in body mass index ( BMI ) and BMI st and ard deviation scores ( BMI -SDS ) as secondary outcome measures . Results : Children attending the group treatment lost more weight for height ( 6.8 % ) than children receiving routine counseling ( 1.8 % ) ( P=0.001 ) . The difference was significant when the data were analyzed in four groups by the cut-off limits of 0 , −5 and −10 % for the change in weight for height . The respective decreases in BMI were 0.8 vs 0.0 ( P=0.003 ) and in BMI -SDS 0.3 vs 0.2 ( P=0.022 ) . The results remained similar in adjusted analyses . Both group and routine programs were feasible with a high , 87–99 % , participation rate in sessions and appointments and very low , 3 % or less , attrition rate from the programs . Six months after the intervention , beneficial effects were partly lost , but for changes in weight for height and BMI , the differences between the two treatment programs still were significant , and for BMI -SDS , there was a trend . Conclusions : Family-based group treatment that stresses a health-promoting lifestyle and is given separately for parents and children , offers an effective mode of therapy to treat obese school-aged children Background . Obesity has become the most common pediatric chronic disease in the modern era . Early prevention and treatment of childhood and adolescent obesity is m and ated . Surprisingly , however , only a minor fraction of obese children participate in weight reduction interventions , and the longer-term effects of these weight-reduction interventions among children have not been eluci date d. Objective . To examine prospect ively the short- and long-term effects of a 3-month , combined dietary-behavioral-physical activity intervention on anthropometric measures , body composition , dietary and leisure-time habits , fitness , and lipid profiles among obese children . Methods . In this r and omized prospect i ve study , 24 obese subjects completed the 3-month intervention and were compared with 22 obese , age- and gender-matched , control subjects . Results . At 3 months , there were significant differences in changes in body weight ( −2.8 ± 2.3 kg vs 1.2 ± 2.2 kg ) , BMI ( −1.7 ± 1.1 kg/m2 vs −0.2 ± 1.0 kg/m2 ) , body fat percentage ( from skinfold tests ; −3.3 ± 2.6 % vs 1.4 ± 4.7 % ) , serum total cholesterol level ( −24.6 ± 15.1 mg/dL vs 0.8 ± 18.7 mg/dL ) , low-density lipoprotein cholesterol level ( −23.3 ± 15.2 mg/dL vs −3.7 ± 17.3 mg/dL ) , and fitness ( 215 ± 107 seconds vs 50 ± 116 seconds ) in the intervention group versus the control group . After a 1-year follow-up period , there were significant differences between the intervention group ( n = 20 ) and the control group ( n = 20 ) in body weight ( 0.6 ± 6.0 kg vs 5.3 ± 2.7 kg ) , BMI ( −1.7 ± 2.3 kg/m2 vs 0.6 ± 0.9 kg/m2 ) , and body fat percentage . There was a significant increase in leisure-time physical activity among the intervention participants , compared with a decrease among the control subjects . Conclusions . Our data demonstrate the short- and longer-term beneficial effects of a combined dietary-behavioral-physical activity intervention among obese children . These results highlight the importance of multidisciplinary programs for the treatment of childhood obesity and emphasize their encouraging long-term effects PURPOSE Childhood obesity is a matter of great concern because of its negative health and social consequences . We examined the effect of a weight control program focusing on maternal education on childhood obesity , given that the incidence of obesity is greatly affected by parents . METHODS A two-group pre-test/post-test design was used . Participants consisted of 65 obese children and their mothers . The children were fourth- to sixth- grade elementary students who did not currently receive any therapy for weight loss . The children and their mothers were r and omly assigned to either an experimental ( n = 32 ) or a control group ( n = 33 ) . The 8-week intervention for mothers included one-time group education , three-time phone counseling , and four-time fliers regarding obesity management . Four outcomes ( self-control , obesity index , abdominal circumference , and body fat percentage ) were measured before and after the intervention . Chi-squared test or t test was used to test homogeneity between the two groups . Analysis of covariance was used to test the intervention effects . RESULTS After the intervention was completed , the level of self-control was significantly heightened and obesity levels in the other three outcomes were greatly lowered in the experimental group when compared with the control group . CONCLUSION Due to strong maternal effects on children 's weight control , mothers ' active participation must be encouraged in order to resolve childhood obesity CONTEXT As of 2005 , the International Committee of Medical Journal Editors required investigators to register their trials prior to participant enrollment as a precondition for publishing the trial 's findings in member journals . OBJECTIVE To assess the proportion of registered trials with results recently published in journals with high impact factors ; to compare the primary outcomes specified in trial registries with those reported in the published articles ; and to determine whether primary outcome reporting bias favored significant outcomes . DATA SOURCES AND STUDY SELECTION MEDLINE via PubMed was search ed for reports of r and omized controlled trials ( RCTs ) in 3 medical areas ( cardiology , rheumatology , and gastroenterology ) indexed in 2008 in the 10 general medical journals and specialty journals with the highest impact factors . DATA EXTRACTION For each included article , we obtained the trial registration information using a st and ardized data extraction form . RESULTS Of the 323 included trials , 147 ( 45.5 % ) were adequately registered ( ie , registered before the end of the trial , with the primary outcome clearly specified ) . Trial registration was lacking for 89 published reports ( 27.6 % ) , 45 trials ( 13.9 % ) were registered after the completion of the study , 39 ( 12 % ) were registered with no or an unclear description of the primary outcome , and 3 ( 0.9 % ) were registered after the completion of the study and had an unclear description of the primary outcome . Among articles with trials adequately registered , 31 % ( 46 of 147 ) showed some evidence of discrepancies between the outcomes registered and the outcomes published . The influence of these discrepancies could be assessed in only half of them and in these statistically significant results were favored in 82.6 % ( 19 of 23 ) . CONCLUSION Comparison of the primary outcomes of RCTs registered with their subsequent publication indicated that selective outcome reporting is prevalent Background The prevalence of childhood obesity among adolescents has been rapidly rising in Mainl and China in recent decades , especially in urban and rich areas . There is an urgent need to develop effective interventions to prevent childhood obesity . Limited data regarding adolescent overweight prevention in China are available . Thus , we developed a school-based intervention with the aim of reducing excess body weight in children . This report described the study design . Methods / design We design ed a cluster r and omized controlled trial in 8 r and omly selected urban primary schools between May 2010 and December 2013 . Each school was r and omly assigned to either the intervention or control group ( four schools in each group ) . Participants were the 4th grade rs in each participating school . The multi-component program was implemented within the intervention group , while students in the control group followed their usual health and physical education curriculum with no additional intervention program . The intervention consisted of four components : a ) classroom curriculum , ( including physical education and healthy diet education ) , b ) school environment support , c ) family involvement , and d ) fun programs/events . The primary study outcome was body composition , and secondary outcomes were behaviour and behavioural determinants . Discussion The intervention was design ed with due consideration of Chinese cultural and familial tradition , social convention , and current primary education and exam system in Mainl and China . We did our best to gain good support from educational authorities , school administrators , teachers and parents , and to integrate intervention components into schools ’ regular academic programs . The results of and lesson learned from this study will help guide future school-based childhood obesity prevention programs in Mainl and China . Trial registration Registration number : CONTEXT No trials for childhood overweight have examined maintenance interventions to augment the effects of initial weight loss programs . OBJECTIVES To determine the short-term and long-term efficacy of 2 distinct weight maintenance approaches vs no continued treatment control following st and ard family-based behavioral weight loss treatment for childhood overweight , and to examine children 's social functioning as a moderator of outcome . DESIGN , SETTING , AND PARTICIPANTS A parallel-group , r and omized controlled trial conducted between October 1999 and July 2004 in a university-based weight control clinic . Participants were 204 healthy 7- to 12-year-olds , 20 % to 100 % above median body mass index ( BMI ) for age and sex , with at least 1 overweight parent . Children enrolled in 5 months of weight loss treatment and 150 were r and omized to 1 of 3 maintenance conditions . Follow-up assessment s occurred immediately following maintenance treatments and 1 and 2 years following r and omization . INTERVENTIONS Maintenance conditions included the control group or 4 months of behavioral skills maintenance ( BSM ) or social facilitation maintenance ( SFM ) treatment . MAIN OUTCOME MEASURES BMI z score and percentage overweight . RESULTS Children receiving either BSM or SFM maintained relative weight significantly better than children assigned to the control group from r and omization to postweight maintenance ( P < or = .01 for all ; effect sizes d = 0.72 - 0.96 ; mean changes in BMI z scores = -0.04 , -0.04 , -0.05 , and 0.05 for BSM alone , SFM alone , BSM and SFM together , and the control group , respectively ) . Active maintenance treatment efficacy relative to the control group declined during follow-up , but the effects of SFM alone ( P = .03 ; d = 0.45 ; mean change in BMI z score = -0.24 ) and when analyzed together with BSM ( P = .04 ; d = 0.38 ; mean change in BMI z score = -0.22 ) were significantly better than the control group ( mean change in BMI z score = -0.06 ) when examining BMI z score outcomes from baseline to 2-year follow-up . Baseline child social problem scores moderated child relative weight change from baseline to 2-year follow-up , with low social problem children in SFM vs the control group having the best outcomes . CONCLUSIONS The addition of maintenance-targeted treatment improves short-term efficacy of weight loss treatment for children relative to no maintenance treatment . However , the waning of effects over follow-up , although moderated by child initial social problems , suggests the need for the bolstering of future maintenance treatments to sustain effects . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00301197 IMPACT ( Ideas Moving Parents and Adolescents to Change Together ) is a 3-group r and omized , multi-level trial comparing the efficacy of two distinct behavioral interventions and a control condition on body mass index ( BMI ) in middle school urban youth who are overweight/obese . Interventions include : ( 1 ) SystemCHANGE ( SC ) , a promising new behavior change approach that focuses on system re design of the family environment and daily routines ; ( 2 ) HealthyCHANGE ( HC ) , a cognitive-behavioral and Motivational Interviewing (MI)-consistent approach to behavior change that focuses on increasing intrinsic motivation , self-monitoring , goal setting , and problem solving ; and ( 3 ) diet and physical education counseling ( attention control ) . In addition , about half of the participants are enrolled in a K-8 public school that offers an innovative community-sponsored fitness program , augmented by study -supported navigators . In addition to the primary interventions effects , the study assesses the moderating effect of the school environment on BMI , blood pressure , cardiovascular risk factors , and quality of life . The sample consists of 360 children entering 6th grade from a large urban school district in the Midwest , identified through an existing BMI screening program . The intervention period is 36 months , and measures are obtained at baseline , 12 , 24 , and 36 months . Using intent-to-treat analyses across the 36-month intervention window , we hypothesize that both SC and HC will have a greater impact on BMI and other health outcomes compared to health education alone , and that the enriched school environment will enhance these effects . This manuscript describes IMPACT 's study design and methods A strategy is needed on how to treat the growing number of obese children with the limited re sources available . We compared the long-term ( 24 months ) effectiveness of therapist-led groups ( TLG ) v. self-help groups ( SHG ) for parents on changes in children 's adiposity and dietary intake . The study included ninety-nine children ( forty-eight girls ) who were referred to obesity treatment ( 7–12 years , BMI z-scores ≥ 2 , attendance of at least one parent ) . Parents ( ninety-one mothers , fifty-four fathers ) were r and omised to TLG aim ed at increasing parents ' competence to accomplish lifestyle changes ( n 47 ) , or SHG ( n 52 ) , both with fifteen sessions . All children participated in children 's groups , and all families attended individual counselling by a clinical dietitian and physiotherapist . Percentage of body fat ( BF ) was measured by dual-energy X-ray absorptiometry , BMI z-score was calculated by international reference values and dietary intake was calculated from 4 d estimated food records at baseline and after 6 and 24 months . No significant between-group differences were detected in the children 's changes in adiposity or dietary intake after 6 and 24 months . BF , BMI z-scores and energy intake were significantly decreased after 6 months ( P < 0·05 ) in both intervention groups , and this persisted throughout 24 months without compromising the diet macronutrient composition . In conclusion , the TLG and SHG intervention groups appear to be equally effective in improving long-term adiposity and dietary intake in obese children . Further research should be performed to clarify whether the SHG should be preferred to parental group treatment for similar children with obesity Milk consumption has decreased in children over the past years . This may play a role in the prevalence of pediatric obesity , because clinical studies have found a beneficial effect of milk consumption for weight management . The objectives of this study were to test whether high-milk consumption leads to greater weight loss and improvements in metabolic risk factors than low milk consumption during a 16-wk healthy eating diet . Overweight children aged 8 - 10 y were r and omized to either high ( 4 x 236 mL/d ) or low ( 1 x 236 mL/d ) milk consumption . Children were provided dietary counseling on healthy eating at baseline and at wk 1 , 2 , 4 , 6 , 8 , and 12 . Serum glucose , insulin , and lipids were measured in fasting children at baseline and wk 8 and 16 . An oral glucose tolerance test and body composition assessment by magnetic resonance imaging were conducted at baseline and endpoint . Body weight changes during the 16-wk study not differ between the high-milk ( 1.3 + /- 0.3 kg ) and low-milk ( 1.1 + /- 0.3 kg ) groups . There was no beverage x week interaction on any of the body composition and metabolic variables studied ( blood pressure , serum lipids , glucose , and insulin ) . There was a beverage x week interaction ( P = 0.044 ) on insulin area under the curve showing a trend toward reduced insulin output with a glucose challenge after high-milk consumption ( P = 0.062 ) . These data suggest that in overweight children , high-milk consumption in conjunction with a healthy diet does not lead to greater weight loss but may ameliorate insulin action compared with low-milk consumption BACKGROUND & AIMS Little is known on the long-term effects of obesity intervention programs in preschool-aged children . We compared the long-term effects of a multidisciplinary treatment program with a usual-care program in seventy-five 3- to 5-year-old overweight or obese children who had participated in a r and omized controlled clinical trial . METHODS A follow-up study collecting data at 18 and 36 months after starting both programs . The multidisciplinary program consisted of diet counseling , exercise sessions teaching motor skills and focusing on an active lifestyle , and psychoeducation for parents . Outcome measures were changes in anthropometry and body composition , determined by bioelectrical impedance analysis and ultrasound . RESULTS At the end of the 16-week treatment program , the multidisciplinary intervention showed a greater decrease in body mass index z score ( BMI -z ) ( mean ( SD ) 0.2 ( 0.1 ) ) and waist circumference z score ( WC-z ) ( mean ( SD ) 0.3 ( 0.1 ) ) , than usual-care . During the 36-month follow-up , a significant overall treatment effect of the multidisciplinary intervention program was demonstrated on BMI -z ( 0.28 , 95 % CI 0.03 - 0.54 ) and abdominal subcutaneous fat ( SCF ) ( 0.23 , 95 % CI 0.01 - 0.45 ) , compared with the usual-care program . CONCLUSIONS A multidisciplinary intervention program in 3- to 5-year-old overweight and obese children shows greater long-term effects on reductions in BMI -z and SCF , compared with a usual-care program Background This paper describes a methodology for comparing the effects of an eduentertainment strategy involving a music concert , and a participatory class experience involving the description and making of a healthy breakfast , as educational vehicles for delivering obesity-preventing/cardiovascular health messages to children aged 7–8 years . Methods / design This study will involve a cluster-r and omised trial with blinded assessment . The study subjects will be children aged 7–8 years of both sexes attending public primary schools in the Madrid Region . The participating schools ( n=30 ) will be r and omly assigned to one of two groups : 1 ) Group MC , in which the children will attend a music concert that delivers obesity-preventing/cardiovascular health messages , or 2 ) Group HB , in which the children will attend a participatory class providing the same information but involving the description and making of a healthy breakfast . The main outcome measured will be the increase in the number of correct answers scored on a knowledge question naire and in an attitudes test administered before and after the above interventions . The secondary outcome recorded will be the reduction in BMI percentile among children deemed overweight/obese prior to the interventions . The required sample size ( number of children ) was calculated for a comparison of proportions with an α of 0.05 and a β of 0.20 , assuming that the Group MC subjects would show values for the measured variables at least 10 % higher than those recorded for the subjects of Group HB . Corrections were made for the design effect and assuming a loss to follow-up of 10 % . The maximum sample size required will be 2107 children . Data will be analysed using summary measurements for each cluster , both for making estimates and for hypothesis testing . All analyses will be made on an intention-to-treat basis . Discussion The intervention providing the best results could be recommended as part of health education for young schoolchildren . Trial registration Clinical trials.gov : UNLABELLED The CAPO Kids trial was a 9-mo , controlled , school-based intervention to examine the effects of a novel , brief , high intensity exercise regime on indices of musculoskeletal and metabolic health in pre- and early-pubertal girls . METHODS A total of 151 pre- and early-pubertal girls ( 10.6±0.6years ) , recruited from two different schools consented to participate ; 76 in the exercise group ( EX ) and 75 in the control group ( CON ) . EX performed 10min bouts of thrice-weekly jumping plus capoeira ( a Brazilian sport that combines martial art with dance ) , along with usual physical education ( PE ) activities . CON continued usual PE alone . Maturity , weight , height , waist circumference , resting heart rate and blood pressure , maximal vertical jump , and aerobic capacity were determined using st and ard clinical and field measures . Calcaneal broadb and ultrasound attenuation ( BUA ) and stiffness index ( SI ) were determined from quantitative ultrasonometry . A sub sample of children also underwent DXA and pQCT measures . Prior physical activity participation and daily calcium consumption were determined from vali date d instruments . RESULTS EX girls improved BUA more than CON ( + 4.5 % vs. + 1.4 % , p=0.019 ) . Resting heart rate ( -7.2 % vs. -1.8 % , p<0.01 ) , maximal vertical jump ( + 13.4 % vs. -1.2 % , p<0.001 ) , estimated maximal oxygen consumption ( + 10.6 % vs. + 1.0 % , p<0.001 ) , and waist circumference ( + 2.7 % vs. + 5.6 % , p<0.001 ) also improved more for EX than CON . CONCLUSION Ten minutes of high intensity exercise ( capoeira and jumping ) three times a week in the primary school setting enhances musculoskeletal and metabolic outcomes in pre- and early-pubertal girls without disrupting the academic schedule . The programme , amenable to broad-scale school implementation , would confer meaningful public health benefits Background : Treatment studies about childhood obesity in primary care are lacking . We hypothesized that providing a paid family membership to the YMCA would be effective in reducing weight . Methods : Patients 5 to17 years old in at least the 85th body mass index ( BMI ) percentile were eligible . All participants were scheduled to attend 4 nutrition classes and to return for evaluation at 2 , 4 , 6 , 9 , and 12 months . Participants were r and omized to nutrition classes only ( n = 39 ) or nutrition classes and family YMCA membership ( n = 44 ) . The primary outcome measure was year change in BMI -for-age percentile . Results : Median BMI percentile at baseline was 99 . Only 27 of 36 evaluable participants in the treatment group visited the YMCA . Four participants in the control group and one in the treatment group achieved the target reduction of 2 BMI percentile points ( Fisher 's exact , P = .17 ) . Within the treatment group , YMCA attendees had a mean increase of 0.30 BMI points compared with an increase of 0.60 BMI points in nonattendees ( P = .28 ) . Conclusion : In very obese children , eliminating financial barriers to YMCA membership is insufficient to induce more weight loss during 1 year compared with nutrition classes alone . Improvements in nutrition intake were reported by both groups Objective To compare a new comprehensive lifestyle programme performed in groups of families with overweight ( included obese ) children with a more conventional single-family programme . The study design and interim anthropometrical results after 12 months are presented . Design Altogether 97 overweight and obese children aged 6–12 years with body mass index ( BMI ) corresponding to cut-off point ≥27.5 in adults were included . Study participants were r and omised to multiple-family intervention ( MUFI ) or single-family intervention ( SIFI ) in a parallel design . MUFI comprised a 3-day inpatient programme at the hospital with other families and a multidisciplinary team , follow-up visits in their hometown individually and in groups , organised physical activity twice weekly and a 4-day family camp after 6 months . SIFI comprised individual counselling by paediatric nurse , paediatric consultant and nutritionist at the hospital and follow-up by public health nurse in the community . Solution focused approach was applied in both interventions . Primary outcome measures were change in BMI kg/m2 and BMI SD score ( BMI SDS ) . Results BMI increased by 0.37 units in the MUFI compared to 0.77 units in the SIFI ( p=0.18 ) . BMI SDS decreased by 0.16 units in the MUFI group compared to 0.07 units in the SIFI group ( p=0.07 ) . Secondary endpoint waist circumference decreased 0.94 cm in the multiple-family group and increased 0.95 cm in the single-family group , p=0.04 . Conclusions Interim analysis after 12 months showed no between-group difference in terms of BMI or BMI SDS . The MUFI group had a significant decrease in waist circumference compared to the SIFI group . The trial is registered at http://www . clinical trials.gov ( NCT00872807 Background Despite record rates of childhood obesity , effective evidence -based treatments remain elusive . While prolonged tertiary specialist clinical input has some individual impact , these services are only available to very few children . Effective treatments that are easily accessible for all overweight and obese children in the community are urgently required . General practitioners are logical care providers for obese children but high- quality trials indicate that , even with substantial training and support , general practitioner care alone will not suffice to improve body mass index ( BMI ) trajectories . HopSCOTCH ( the Shared Care Obesity Trial in Children ) will determine whether a shared-care model , in which paediatric obesity specialists co-manage obesity with general practitioners , can improve adiposity in obese children . Design R and omised controlled trial nested within a cross-sectional BMI survey conducted across 22 general practice s in Melbourne , Australia . Participants Children aged 3–10 years identified as obese by Centers for Disease Control criteria at their family practice , and r and omised to either a shared-care intervention or usual care . InterventionA single multidisciplinary obesity clinic appointment at Melbourne ’s Royal Children ’s Hospital , followed by regular appointments with the child ’s general practitioner over a 12 month period . To support both specialist and general practice consultations , web-based shared-care software was developed to record assessment , set goals and actions , provide information to caregivers , facilitate communication between the two professional groups , and jointly track progress . Outcomes Primary - change in BMI z-score . Secondary - change in percentage fat and waist circumference ; health status , body satisfaction and global self-worth . Discussion This will be the first efficacy trial of a general-practitioner based , shared-care model of childhood obesity management . If effective , it could greatly improve access to care for obese children . Trial Registration Australian New Zeal and Clinical Trials Registry OBJECTIVE : We evaluated the efficacy of family-based , behavioral weight control in the management of severe pediatric obesity . METHODS : Participants were 192 children 8.0 to 12.0 years of age ( mean ± SD : 10.2 ± 1.2 years ) . The average BMI percentile for age and gender was 99.18 ( SD : 0.72 ) . Families were assigned r and omly to the intervention or usual care . Assessment s were conducted at baseline , 6 months , 12 months , and 18 months . The primary outcome was percent overweight ( percent over the median BMI for age and gender ) . Changes in blood pressure , body composition , waist circumference , and health-related quality of life also were evaluated . Finally , we examined factors associated with changes in child percent overweight , particularly session attendance . RESULTS : Intervention was associated with significant decreases in child percent overweight , relative to usual care , at 6 months . Intent-to-treat analyses documented that intervention was associated with a 7.58 % decrease in child percent overweight at 6 months , compared with a 0.66 % decrease with usual care , but differences were not significant at 12 or 18 months . Small significant improvements in medical outcomes were observed at 6 and 12 months . Children who attended ≥75 % of intervention sessions maintained decreases in percent overweight through 18 months . Lower baseline percent overweight , better attendance , higher income , and greater parent BMI reduction were associated with significantly greater reductions in child percent overweight at 6 months among intervention participants . CONCLUSIONS : Intervention was associated with significant short-term reductions in obesity and improvements in medical parameters and conferred longer-term weight change benefits for children who attended ≥75 % of sessions More knowledge about improving dietary intake in secondary preventive actions against childhood overweight and obesity is needed . The objective was to evaluate the impact of a 2-year intervention on energy , macronutrient and food intake of overweight and obese children participating in a r and omised controlled trial . Children ( 8–12 years old ) living in Sweden were recruited to participate for 2 years between 2006 and 2009 . The children were r and omised into either an intervention group ( n 58 ) , participating in an intervention concerning food habits , physical activity and behavioural change , or a control group ( n 47 ) . Dietary intake at baseline and the 2-year measurement were assessed with a diet history interview covering 14 d. Energy intake ( EI ) of the intervention and control groups was underestimated by 28 and 21 % , respectively , after 2 years , but with no difference between the groups ( P = 0·51 ) . After 2 years of intervention , the intervention group , compared with the control group , had a lower intake of sugar-sweetened beverages ( P = 0·015 ) as well as a higher intake of foods high in fibre , low in saturated fat , sugar and salt ( P = 0·031 ) . Further , a lower EI in relation to BMR , lower total fat , MUFA and cholesterol was seen in the intervention group compared with the control group . In conclusion , the food and nutrient intake of overweight and obese children was improved after participating in a 2-year intervention programme . Dietary counselling should be included in secondary preventive actions against childhood overweight and obesity to promote healthy food habits Background Childhood obesity gives rise to health complications including impaired musculoskeletal development that associates with increased risk of fractures . Prevention and treatment programs should focus on nutrition education , increasing physical activity ( PA ) , reducing sedentary behaviours , and should monitor bone mass as a component of body composition . To ensure lifestyle changes are sustained in the home environment , programs need to be family-centered . To date , no study has reported on a family-centered lifestyle intervention for obese children that aims to not only ameliorate adiposity , but also support increases in bone and lean muscle mass . Furthermore , it is unknown if programs of such nature can also favorably change eating and activity behaviors . The aim of this study is to determine the effects of a 1 y family-centered lifestyle intervention , focused on both nutrient dense foods including increased intakes of milk and alternatives , plus total and weight-bearing PA , on body composition and bone mass in overweight or obese children . Methods / design The study design is a r and omized controlled trial for overweight or obese children ( 6–8 y ) . Participants are r and omized to control , st and ard treatment ( StTx ) or modified treatment ( ModTx ) . This study is family-centred and includes individualized counselling sessions on nutrition , PA and sedentary behaviors occurring 4 weeks after baseline for 5 months , then at the end of month 8 . The control group receives counselling at the end of the study . All groups are measured at baseline and every 3 months for the primary outcome of changes in body mass index Z-scores . At each visit blood is drawn and children complete a research er-administered behavior question naire and muscle function testing . Changes from baseline to 12 months in body fat ( % and mass ) , waist circumference , lean body mass , bone ( mineral content , mineral density , size and volumetric density ) , dietary intake , self-reported PA and sedentary behaviour are examined . Discussion This family-centered theory-based study permits for biochemical and physiological assessment s. This trial will assess the effectiveness of the intervention at changing lifestyle behaviours by decreasing adiposity while enhancing lean and bone mass . If successful , the intervention proposed offers new insights for the management or treatment of childhood obesity . Trial registration Clinical Trials.gov , NCT01290016 Background Increased underst and ing of why and how physical activity impacts on health outcomes is needed to increase the effectiveness of physical activity interventions . A recent r and omized controlled trial of an active video game ( PlayStation EyeToy ™ ) intervention showed a statistically significant treatment effect on the primary outcome , change from baseline in body mass index ( BMI ) , which favored the intervention group at 24 weeks . In this short paper we evaluate the mediating effects of the secondary outcomes . Objective To identify mediators of the effect of an active video games intervention on body composition . Methods Data from a two-arm parallel r and omized controlled trial of an active video game intervention ( n = 322 ) were analyzed . The primary outcome was change from baseline in BMI . A priori secondary outcomes were considered as potential mediators of the intervention on BMI , including aerobic fitness ( VO2Max ) , time spent in moderate-to-vigorous physical activity ( MVPA ) , and food snacking at 24 weeks . Results Only aerobic fitness at 24 weeks met the conditions for mediation , and was a significant mediator of BMI . Conclusion Playing active video games can have a positive effect on body composition in overweight or obese children and this effect is most likely mediated through improved aerobic fitness . Future trials should examine other potential mediators related to this type of intervention . Trial registration Australian New Zeal and Clinical Trials RegistryWebsite : http://www.anzctr.org.au Study ID number : Background In the evaluation of childhood obesity interventions , few research ers undertake a rigorous feasibility stage in which the design and procedures of the evaluation process are examined . Consequently , phase III studies often demonstrate method ological weaknesses . Purpose Our aim was to conduct a feasibility trial of the evaluation of WATCH IT , a community obesity intervention for children and adolescents . We sought to determine an achievable recruitment rate ; acceptability of r and omisation , assessment procedures , and dropout rate ; optimal outcome measures for the definitive trial ; and a robust sample size calculation . Method Our goal was to recruit 70 participants over 6 months , r and omise them to intervention or control group , and retain participation for 12 months . Assessment s were taken prior to r and omisation and after 6 and 12 months . Procedures mirrored those intended for a full-scale trial , but multiple measures of similar outcomes were included as a means to determine those most appropriate for future research . Acceptability of the research and impact of the research on the programme were ascertained through interviewing participants and staff . Results We recruited 70 participants and found that r and omisation and data collection procedures were acceptable . Self-referral ( via media promotion ) was more effective than professional referral . Blinding of assessors was sustained to a reasonable degree , and optimal outcome measures for a full-scale trial were identified . Estimated sample size was significantly greater than sample sized reported in published trials . There was some negative impact on the existing programme as a result of the research , a lesson for design ers of future trials . Limitations We successfully recruited socially disadvantaged families , but the majority of families were of White British nationality . The composition of the participants was an added valuable lesson , suggesting that recruitment strategies to obtain a more heterogeneous ethnic sample warrant consideration in future research . Conclusions This study provided us with confidence that we can run a phase III multi-centre trial to test the effectiveness of WATCH IT . Importantly , it was invaluable in informing the design not only of that trial but also of future evaluations of childhood obesity treatment interventions Interventions to promote physical activity are important in preventing children from becoming overweight . Many projects have been developed but only a few showed ( moderate ) effects . JUMP-in is a systematic ally developed primary -school-based intervention that focuses on the use of theory , environmental changes , parental influences and cooperation with multi-level parties in intervention development . The effects of JUMP-in were evaluated with a quasi-experimental pre-test/post-test research design . In total , 510 children from Grade s 4 , 5 and 6 of four intervention schools and two control schools in Amsterdam were followed for an intervention period of one school year . Changes in physical activity as well as in the social cognitive determinants were assessed using self-reports . In addition , a process evaluation has been executed . The results show that JUMP-in was effective in influencing physical activity , especially among children from Grade 6 . Children in the control group decreased their level of physical activity considerably , while activity levels in intervention children from Grade 6 remained stable . The intervention effects could not be explained by changes in the measured social cognitive determinants . In contrast , process information illuminated differences in intervention effects between the participating schools . The results from the JUMP-in study show the importance of intervention design s that focus on a theory-based mix of relevant environmental and social cognitive factors Background Effective programs to help children manage their weight are required . Families for Health focuses on a parenting approach , design ed to help parents develop their parenting skills to support lifestyle change within the family . Families for Health V1 showed sustained reductions in overweight after 2 years in a pilot evaluation , but lacks a r and omized controlled trial ( RCT ) evidence base . Methods / design This is a multi-center , investigator-blind RCT , with parallel economic evaluation , with a 12-month follow-up . The trial will recruit 120 families with at least one child aged 6 to 11 years who is overweight ( ≥91st centile BMI ) or obese ( ≥98th centile BMI ) from three localities and assigned r and omly to Families for Health V2 ( 60 families ) or the usual care control ( 60 families ) groups . R and omization will be stratified by locality ( Coventry , Warwickshire , Wolverhampton).Families for Health V2 is a family-based intervention run in a community venue . Parents/carers and children attend parallel groups for 2.5 hours weekly for 10 weeks . The usual care arm will be the usual support provided within each NHS locality . A mixed- methods evaluation will be carried out . Child and parent participants will be assessed at home visits at baseline , 3-month ( post-treatment ) and 12-month follow-up . The primary outcome measure is the change in the children ’s BMI z-scores at 12 months from the baseline . Secondary outcome measures include changes in the children ’s waist circumference , percentage body fat , physical activity , fruit/vegetable consumption and quality of life . The parents ’ BMI and mental well-being , family eating/activity , parent – child relationships and parenting style will also be assessed . Economic components will encompass the measurement and valuation of service utilization , including the costs of running Families for Health and usual care , and the EuroQol EQ-5D health outcomes . Cost-effectiveness will be expressed in terms of incremental cost per quality -adjusted life year gained . A de novo decision-analytic model will estimate the lifetime cost-effectiveness of the Families for Health program . Process evaluation will document recruitment , attendance and drop-out rates , and the fidelity of Families for Health delivery . Interviews with up to 24 parents and children from each arm will investigate perceptions and changes made . Discussion This paper describes our protocol to assess the effectiveness and cost-effectiveness of a parenting approach for managing childhood obesity and presents challenges to implementation . Trial registration Current Controlled Trials http://www.controlled-trials.com/IS RCT Background Because parental recognition of overweight in young children is poor , we need to determine how best to inform parents that their child is overweight in a way that enhances their acceptance and supports motivation for positive change . This study will assess 1 ) whether weight feedback delivered using motivational interviewing increases parental acceptance of their child 's weight status and enhances motivation for behaviour change , and 2 ) whether a family-based individualised lifestyle intervention , delivered primarily by a MInT mentor with limited support from " expert " consultants in psychology , nutrition and physical activity , can improve weight outcomes after 12 and 24 months in young overweight children , compared with usual care . Methods / Design 1500 children aged 4 - 8 years will be screened for overweight ( height , weight , waist , blood pressure , body composition ) . Parents will complete question naires on feeding practice s , physical activity , diet , parenting , motivation for healthy lifestyles , and demographics . Parents of children classified as overweight ( BMI ≥ CDC 85th ) will receive feedback about the results using Motivational interviewing or Usual care . Parental responses to feedback will be assessed two weeks later and participants will be invited into the intervention . Additional baseline measurements ( accelerometry , diet , quality of life , child behaviour ) will be collected and families will be r and omised to Tailored package or Usual care . Parents in the Usual care condition will meet once with an advisor who will offer general advice regarding healthy eating and activity . Parents in the Tailored package condition will attend a single session with an " expert team " ( MInT mentor , dietitian , physical activity advisor , clinical psychologist ) to identify current challenges for the family , develop tailored goals for change , and plan behavioural strategies that best suit each family . The mentor will continue to provide support to the family via telephone and in-person consultations , decreasing in frequency over the two-year intervention . Outcome measures will be obtained at baseline , 12 and 24 months . Discussion This trial offers a unique opportunity to identify effective ways of providing feedback to parents about their child 's weight status and to assess the efficacy of a supportive , individualised early intervention to improve weight outcomes in young children . Trial registration Australian New Zeal and Clinical Trials Registry OBJECTIVES The aim of this study was to use magnetic resonance imaging ( MRI ) together with proton magnetic resonance spectroscopy ( (1)H-MRS ) to study the influence of acupuncture therapy on abdominal fat and hepatic fat content in obese children . DESIGN The design was a longitudinal , clinical intervention study of acupuncture therapy . SUBJECTS SUBJECTS were 10 healthy , obese children ( age : 11.4 ± 1.65 years , body-mass index [ BMI ] : 29.03 ± 4.81 kg/m(2 ) ) . MEASUREMENTS Measurements included various anthropometric parameters , abdominal fat ( assessed by MRI ) and hepatic fat content ( assessed by (1)H-MRS ) at baseline and after 1 month of acupuncture therapy . RESULTS One ( 1 ) month of acupuncture therapy significantly reduced the subjects ' BMI by 3.5 % ( p = 0.005 ) , abdominal visceral adipose tissue ( VAT ) volume by 16.04 % ( p < 0.0001 ) , abdominal total adipose tissue volume by 10.45 % ( p = 0.001 ) , and abdominal visceral to subcutaneous fat ratio by 10.59 % ( p = 0.007 ) . Decreases in body weight ( -2.13 % ) , waist circumference ( -1.44 % ) , hip circumference ( -0.33 % ) , waist-to-hip ratio ( WHR ) ( -0.99 % ) , abdominal subcutaneous adipose tissue ( SAT ) volume ( -5.63 % ) , and intrahepatic triglyceride ( IHTG ) content ( -9.03 % ) were also observed , although these were not significant ( p > 0.05 ) . There was a significant correlation between the level of abdominal fat ( SAT , VAT ) and anthropometric parameters ( weight , BMI , waist circumferences , hip circumferences ) . There was no statistically significant correlation between IHTG and anthropometric parameters or abdominal fat content . CONCLUSIONS The first direct experimental evidence is provided demonstrating that acupuncture therapy significantly reduces BMI and abdominal adipose tissue by reducing abdominal VAT content without significant changes in body weight , waist circumference , hip circumference , WHR , abdominal SAT , or IHTG content . Thus , the use of acupuncture therapy to selectively target a reduction in abdominal VAT content should become more important and more popular in the future In childhood , excess adiposity and low fitness are linked to poor academic performance , lower cognitive function , and differences in brain structure . Identifying ways to mitigate obesity-related alterations is of current clinical importance . This study examined the effects of an 8-month exercise intervention on the uncinate fasciculus , a white matter fiber tract connecting frontal and temporal lobes . Participants consisted of 18 unfit , overweight 8- to 11-year-old children ( 94 % Black ) who were r and omly assigned to either an aerobic exercise ( n = 10 ) or a sedentary control group ( n = 8) . Before and after the intervention , all subjects participated in a diffusion tensor MRI scan . Tractography was conducted to isolate the uncinate fasciculus . The exercise group showed improved white matter integrity as compared to the control group . These findings are consistent with an emerging literature suggesting beneficial effects of exercise on white matter integrity OBJECTIVE This experiment tested the hypothesis that exercise would improve executive function . DESIGN Sedentary , overweight 7- to 11-year-old children ( N = 171 , 56 % girls , 61 % Black , M ± SD age = 9.3 ± 1.0 years , body mass index [ BMI ] = 26 ± 4.6 kg/m² , BMI z-score = 2.1 ± 0.4 ) were r and omized to 13 ± 1.6 weeks of an exercise program ( 20 or 40 min/day ) , or a control condition . MAIN OUTCOME MEASURES Blinded , st and ardized psychological evaluations ( Cognitive Assessment System and Woodcock-Johnson Tests of Achievement III ) assessed cognition and academic achievement . Functional MRI measured brain activity during executive function tasks . RESULTS Intent to treat analysis revealed dose-response benefits of exercise on executive function and mathematics achievement . Preliminary evidence of increased bilateral prefrontal cortex activity and reduced bilateral posterior parietal cortex activity attributable to exercise was also observed . CONCLUSION Consistent with results obtained in older adults , a specific improvement on executive function and brain activation changes attributable to exercise were observed . The cognitive and achievement results add evidence of dose-response and extend experimental evidence into childhood . This study provides information on an educational outcome . Besides its importance for maintaining weight and reducing health risks during a childhood obesity epidemic , physical activity may prove to be a simple , important method of enhancing aspects of children 's mental functioning that are central to cognitive development . This information may persuade educators to implement vigorous physical activity Dietary intake among Danish children , in general , does not comply with the official recommendations . The objectives of the present study were to evaluate the 3-year effect of a multi-component school-based intervention on nutrient intake in children , and to examine whether an intervention effect depended on maternal education level . A total of 307 children ( intervention group : n 184 ; comparison group : n 123 ) were included in the present study . All had information on dietary intake pre- and post-intervention ( mean age 6·8 and 9·5 years for intervention and comparison groups , respectively ) assessed by a 7-d food record . Analyses were conducted based on the daily intake of macronutrients ( energy percentage ( E% ) ) , fatty acids ( E% ) , added sugar ( E% ) and dietary fibre ( g/d and g/MJ ) . Analyses were stratified by maternal education level into three categories . Changes in nutrient intake were observed in the intervention group , mainly among children of mothers with a short education ( < 10 years ) . Here , intake of dietary fibre increased ( β = 2·1 g/d , 95 % CI 0·5 , 3·6 , P= 0·01 ) . Intake of protein tended to increase ( β = 0·6 E% , 95 % CI -0·01 , 1·2 , P= 0·05 ) , while intake of fat ( β = -1·7 E% , 95 % CI -3·8 , 0·3 , P= 0·09 ) and SFA ( β = -0·9 , 95 % CI -2·0 , 0·2 , P= 0·10 ) tended to decrease . Also , a significant intervention effect was observed on the intake of SFA among children of mothers with a long education ( β = -0·8 , 95 % CI -1·5 , -0·03 , P= 0·04 ) . This multi-component school-based intervention result ed in changes in the dietary intake , particularly among children of mothers with a short education . As the dietary intake of this subgroup generally differs most from the recommendations , the results of the present study are particularly encouraging OBJECTIVE To describe baseline characteristics of participants in a pediatric obesity intervention tailored specifically to rural families delivered via telemedicine . METHODS R and omized-control trial comparing a family-based behavioral intervention to a usual care condition . Participants Fifty-eight first through fifth grade rs and their parents from the rural Midwest . Measures Demographic , body mass index ( BMI ) , Actigraph activity monitor information , 24-h dietary recalls , Child Behavior Checklist , Behavioral Pediatrics Feeding Assessment Scale . RESULTS Child mean BMI was in the 94th percentile for weight . Average daily dietary intake exceeded 2,000 kcal and children consumed over eight servings of high-calorie , low-nutrient-dense foods . Children are engaged in approximately 65 min of moderate , 12 min of vigorous and over 300 min of sedentary physical activity daily . CONCLUSIONS Baseline data suggest children in rural areas may engage in adequate physical activity but eat many daily servings of energy-dense foods . Rural families may benefit from a comprehensive , rurally tailored obesity-related health behavior intervention Background Childhood overweight has noticeable psychological and social consequences for the child and leads to an increased risk of mortality and morbidity later in life . With the high prevalence of overweight in children and adolescents , it is important to identify effective approaches for the prevention and treatment of overweight in children and young individuals . The primary aim of the study is to assess the effect of an intensive day-camp intervention on body mass index ( BMI ) in overweight children . Methods The Odense Overweight Intervention Study is a semi-blinded r and omized controlled trial . Overweight children from the Municipality of Odense , Denmark , were invited to participate in the trial . Based on power calculations 98 participants were found to be sufficient to r and omize in order to find an effect of minimum 1.5 BMI points . Gender-stratified concealed block r and omization with a ratio of 1:1 and r and om block sizes of two , four , and six ensured balance between study arms . The intervention consisted of a six-week multi-component day camp including increased physical activity , healthy diet and health education followed by 46 weeks of family-based habitual intervention . The st and ard care arm was offered two weekly hours of physical activity training for six weeks . The outcomes were measured at baseline and at six-week and 52-week follow-ups . Furthermore , BMI will be assessed again at 48-month follow-up . Test personnel were kept blinded . The intervention effect will be evaluated using mixed model analyses . During 2012 and 2013 , 115 children were enrolled in the study . Fifty-nine children were r and omized to the day-camp intervention arm and 56 to the st and ard intervention arm . Discussion This study will provide novel information about the long-term health effects of an intense day-camp intervention program on overweight children , due to the design and the follow-up period . Moreover , it will add to the knowledge on design ing and implementing feasible camp setting s for preventing overweight in children . Trial registration NCT01574352 at http:// clinical trials.gov on the 8th of March 2012 Background There is an urgent need to develop and evaluate weight management interventions to address childhood obesity . Recent research suggests that interventions design ed for parents exclusively , which have been named parents as agents of change ( PAC ) approaches , have yielded positive outcomes for managing pediatric obesity . To date , no research has combined a PAC intervention approach with cognitive behavioural therapy ( CBT ) to examine whether these combined elements enhance intervention effectiveness . This paper describes the protocol our team is using to examine two PAC-based interventions for pediatric weight management . We hypothesize that children with obesity whose parents complete a CBT-based PAC intervention will achieve greater reductions in adiposity and improvements in cardiometabolic risk factors , lifestyle behaviours , and psychosocial outcomes than children whose parents complete a psycho-education-based PAC intervention ( PEP ) . Methods / Design This study is a pragmatic , two-armed , parallel , single-blinded , superiority , r and omized clinical trial . The primary objective is to examine the differential effects of a CBT-based PAC vs PEP-based PAC intervention on children ’s BMI z-score ( primary outcome ) . Secondary objectives are to assess intervention-mediated changes in cardiometabolic , lifestyle , and psychosocial variables in children and parents . Both interventions are similar in frequency of contact , session duration , group facilitation , lifestyle behaviour goals , and educational content . However , the interventions differ insofar as the CBT-based intervention incorporates theory-based concepts to help parents link their thoughts , feelings , and behaviours ; these cognitive activities are enabled by group leaders who possess formal training in CBT . Mothers and fathers of children ( 8–12 years of age ; BMI ≥85th percentile ) are eligible to participate if they are proficient in English ( written and spoken ) and agree for at least one parent to attend group-based sessions on a weekly basis . Anthropometry , cardiometabolic risk factors , lifestyle behaviours , and psychosocial health of children and parents are assessed at pre-intervention , post-intervention , 6- , and 12-months follow-up . Discussion This study is design ed to extend findings from earlier efficacy studies and provide data on the effect of a CBT-based PAC intervention for managing pediatric obesity in a real-world , outpatient clinical setting .Trial Registration Clinical Trials.gov identifier : OBJECTIVE This intervention sought to promote healthy eating with the ultimate goal of reducing childhood obesity risk . MATERIAL S AND METHODS Three hundred and sixty-one Latino families living on the US-Mexico border with at least one child between 7 - 13 years of age were eligible to participate . Families r and omly assigned to the four-month intervention received 14 contacts with a promotora ( community health worker ) , consisting of 11 home visits and three telephone calls ; the control condition was a delayed treatment intervention . Children reported on their dietary intake at baseline , immediately post-intervention and at the six month follow-up visit . RESULTS The intervention reduced weekly consumption of fast food ( p<0.05 ) . A dose-response relationship was observed such that for every seven hours of promotora contact , monthly variety of fruits ( p<0.01 ) and vegetables ( p<0.01 ) increased by one . No other intervention effects were observed . CONCLUSIONS Family-based interventions can improve children 's eating habits , with the amount of contact with the promotora being key to success Objective To assess the effectiveness of a school based physical activity programme during one school year on physical and psychological health in young schoolchildren . Design Cluster r and omised controlled trial . Setting 28 classes from 15 elementary schools in Switzerl and r and omly selected and assigned in a 4:3 ratio to an intervention ( n=16 ) or control arm ( n=12 ) after stratification for grade ( first and fifth grade ) , from August 2005 to June 2006 . Participants 540 children , of whom 502 consented and presented at baseline . Intervention Children in the intervention arm ( n=297 ) received a multi-component physical activity programme that included structuring the three existing physical education lessons each week and adding two additional lessons a week , daily short activity breaks , and physical activity homework . Children ( n=205 ) and parents in the control group were not informed of an intervention group . For most outcome measures , the assessors were blinded . Main outcome measures Primary outcome measures included body fat ( sum of four skinfolds ) , aerobic fitness ( shuttle run test ) , physical activity ( accelerometry ) , and quality of life ( question naires ) . Secondary outcome measures included body mass index and cardiovascular risk score ( average z score of waist circumference , mean blood pressure , blood glucose , inverted high density lipoprotein cholesterol , and triglycerides ) . Results 498 children completed the baseline and follow-up assessment s ( mean age 6.9 ( SD 0.3 ) years for first grade , 11.1 ( 0.5 ) years for fifth grade ) . After adjustment for grade , sex , baseline values , and clustering within classes , children in the intervention arm compared with controls showed more negative changes in the z score of the sum of four skinfolds ( −0.12 , 95 % confidence interval −0.21 to −0.03 ; P=0.009 ) . Likewise , their z scores for aerobic fitness increased more favourably ( 0.17 , 0.01 to 0.32 ; P=0.04 ) , as did those for moderate-vigorous physical activity in school ( 1.19 , 0.78 to 1.60 ; P<0.001 ) , all day moderate-vigorous physical activity ( 0.44 , 0.05 to 0.82 ; P=0.03 ) , and total physical activity in school ( 0.92 , 0.35 to 1.50 ; P=0.003 ) . Z scores for overall daily physical activity ( 0.21 , −0.21 to 0.63 ) and physical quality of life ( 0.42 , −1.23 to 2.06 ) as well as psychological quality of life ( 0.59 , −0.85 to 2.03 ) did not change significantly . Conclusions A school based multi-component physical activity intervention including compulsory elements improved physical activity and fitness and reduced adiposity in children . Trial registration Current Controlled Trials IS RCT N15360785 Introduction The prevalence of paediatric obesity is increasing , and with it , lifestyle-related diseases in children and adolescents . High-intensity interval training ( HIIT ) has recently been explored as an alternate to traditional moderate-intensity continuous training ( MICT ) in adults with chronic disease and has been shown to induce a rapid reversal of sub clinical disease markers in obese children and adolescents . The primary aim of this study is to compare the effects of HIIT with MICT on myocardial function in obese children and adolescents . Methods and analysis Multicentre r and omised controlled trial of 100 obese children and adolescents in the cities of Trondheim ( Norway ) and Brisbane ( Australia ) . The trial will examine the efficacy of HIIT to improve cardiometabolic outcomes in obese children and adolescents . Participants will be r and omised to ( 1 ) HIIT and nutrition advice , ( 2 ) MICT and nutrition advice or ( 3 ) nutrition advice . Participants will partake in supervised exercise training and /or nutrition sessions for 3 months . Measurements for study end points will occur at baseline , 3 months ( postintervention ) and 12 months ( follow-up ) . The primary end point is myocardial function ( peak systolic tissue velocity ) . Secondary end points include vascular function ( flow-mediated dilation assessment ) , quantity of visceral and subcutaneous adipose tissue , myocardial structure and function , body composition , cardiorespiratory fitness , autonomic function , blood biochemistry , physical activity and nutrition . Lean , healthy children and adolescents will complete measurements for all study end points at one time point for comparative cross-sectional analyses . Ethics and dissemination This r and omised controlled trial will generate substantial information regarding the effects of exercise intensity on paediatric obesity , specifically the cardiometabolic health of this at-risk population . It is expected that communication of results will allow for the development of more effective evidence -based exercise prescription guidelines in this population while investigating the benefits of HIIT on sub clinical markers of disease . Trial registration number NCT01991106 Background The grading of recommendation , assessment , development and evaluation ( GRADE ) approach is widely implemented in health technology assessment and guideline development organisations throughout the world . GRADE provides a transparent approach to reaching judgements about the quality of evidence on the effects of a health care intervention , but is complex and therefore challenging to apply in a consistent manner . Methods We developed a checklist to guide the research er to extract the data required to make a GRADE assessment . We applied the checklist to 29 meta-analyses of r and omised controlled trials on the effectiveness of health care interventions . Two review ers used the checklist for each paper and used these data to rate the quality of evidence for a particular outcome . Results For most ( 70 % ) checklist items , there was good agreement between review ers . The main problems were for items relating to indirectness where considerable judgement is required . Conclusions There was consistent agreement between review ers on most items in the checklist . The use of this checklist may be an aid to improving the consistency and reproducibility of GRADE assessment s , particularly for inexperienced users or in rapid review s without the re sources to conduct assessment s by two research ers independently Background : There is empirical evidence that the presence of a companion animal can have a positive impact on performance . The available evidence can be viewed in terms of differing hypotheses that attempt to explain the mechanisms behind the positive effects . Little attention has been given to motivation as a potential mode of action with regards to human-animal interactions . First we give an overview of evidence that animals might promote motivation . Second we present a study to examine the effect of a therapy dog on exercise performance in children with obesity . Methods : Twelve children , aged 8–12 years old , were r and omly assigned to two groups in a crossover design : dog-group and human confederate group . Several types of physical activities via accelerometer and subjective ratings of wellbeing , satisfaction , and motivation were assessed . Data were analyzed using analysis of variance for repeated measures on one factor . Results : The main effect of condition was significant for all performance variables . There was less passive behavior and more physical activity for all performance variables in the presence of the dog than in that of the human confederate . Between dog- and human- condition there was no difference in the subjective rating of motivation , wellbeing , or satisfaction . Discussion : The results demonstrate that the presence of a therapy dog has the potential to increase physical activity in obese children . Task performance as a declarative measure was increased by the presence of the dog in comparison to a human confederate , but self-report measures of motivation , satisfaction or wellbeing did not differ between the two conditions . Therefore , it st and s to reason that a dog could trigger implicit motives which enhance motivation for activity . The results of our study indicate the potentially beneficial effect of incorporating dogs into outpatient training for obese children Aerobic fitness is associated with white matter integrity ( WMI ) in adults as measured by diffusion tensor imaging ( DTI ) . This study examined the effect of an 8-month exercise intervention on WMI in children . Participants were 18 sedentary , overweight ( BMI ≥85th percentile ) 8- to 11-year-old children ( 94 % Black ) , r and omly assigned to either an aerobic exercise ( n = 10 ) or sedentary attention control group ( n = 8) . Each group was offered an instructor-led after-school program every school day for approximately 8 months . Before and after the program , all subjects participated in DTI scans . Tractography was conducted to isolate the superior longitudinal fasciculus and investigate whether the exercise intervention affected WMI in this region . There was no group by time interaction for WMI in the superior longitudinal fasciculus . There was a group by time by attendance interaction , however , such that higher attendance at the exercise intervention , but not the control intervention , was associated with increased WMI . Heart rate and the total dose of exercise correlated with WMI changes in the exercise group . In the overall sample , increased WMI was associated with improved scores on a measure of attention and improved teacher ratings of executive function . This study indicates that participating in an exercise intervention improves WMI in children as compared to a sedentary after-school program Background Primary prevention of childhood overweight is an international priority . In Australia 20 - 25 % of 2 - 8 year olds are already overweight . These children are at substantially increased the risk of becoming overweight adults , with attendant increased risk of morbidity and mortality . Early feeding practice s determine infant exposure to food ( type , amount , frequency ) and include responses ( eg coercion ) to infant feeding behaviour ( eg . food refusal ) . There is correlational evidence linking parenting style and early feeding practice s to child eating behaviour and weight status . A focus on early feeding is consistent with the national focus on early childhood as the foundation for life-long health and well being . The NOURISH trial aims to implement and evaluate a community-based intervention to promote early feeding practice s that will foster healthy food preferences and intake and preserve the innate capacity to self-regulate food intake in young children . Methods / Design This r and omised controlled trial ( RCT ) aims to recruit 820 first-time mothers and their healthy term infants . A consecutive sample of eligible mothers will be approached postnatally at major maternity hospitals in Brisbane and Adelaide . Initial consent will be for re-contact for full enrolment when the infants are 4 - 7 months old . Individual mother- infant dyads will be r and omised to usual care or the intervention . The intervention will provide anticipatory guidance via two modules of six fortnightly parent education and peer support group sessions , each followed by six months of regular maintenance contact . The modules will commence when the infants are aged 4 - 7 and 13 - 16 months to coincide with establishment of solid feeding , and autonomy and independence , respectively . Outcome measures will be assessed at baseline , with follow up at nine and 18 months . These will include infant intake ( type and amount of foods ) , food preferences , feeding behaviour and growth and self-reported maternal feeding practice s and parenting practice s and efficacy . Covariates will include sociodemographics , infant feeding mode and temperament , maternal weight status and weight concern and child care exposure . Discussion Despite the strong rationale to focus on parents ' early feeding practice s as a key determinant of child food preferences , intake and self-regulatory capacity , prospect i ve longitudinal and intervention studies are rare . This trial will be amongst to provide Level II evidence regarding the impact of an intervention ( commencing prior to age 12 months ) on children 's eating patterns and behaviours . Trial Registration Nutritional counseling for children with obesity is an important component of management . This r and omized controlled trial was conducted to compare change in body mass index ( BMI ) z score after 6 months . Children 8 to 16 years with a BMI greater than the 85th percentile were r and omized to st and ard of care nutrition counseling versus intervention with st and ard nutrition counseling including portion control tool training for the family . Measures were completed at baseline , 3 months , and 6 months . Fifty-one children were r and omized to control and 48 to intervention . Mean age was 11 years ( SD = 2.2 ) . Mean BMI z score was 2.7 ( SD = 0.4 ) . Forty-five percent were male ( n = 45 ) . Follow-up at 6 months was 73.7 % ( 73/99 ) . Although no differences were seen between the groups , there was a significant decrease in BMI z score between baseline and 6 months within each group OBJECTIVE : The aim of this study was to evaluate the effect of family pediatrician – led motivational interviews ( MIs ) on BMI of overweight ( 85th ≥ BMI percentile ≥95th ) children aged 4 to 7 years . METHODS : All the family pediatricians working in Reggio Emilia Province ( Italy ) were invited to participate in the study ; 95 % accepted . Specific training was provided . Parents were asked to participate in the trial if they recognized their child as overweight . Children were individually r and omly assigned to MIs or usual care . All children were invited for a baseline and a 12-month visit to assess BMI and lifestyle behaviors . The usual care group received an information leaflet , and the intervention group received 5 MI family meetings . The primary outcome was the individual variation of BMI , assessed by pediatricians unblinded to treatment groups . RESULTS : Of 419 eligible families , 372 ( 89 % ) participated ; 187 children were r and omized to MIs and 185 to the usual care group . Ninety-five percent of the children attended the 12-month visit . The average BMI increased by 0.49 and 0.79 during the intervention in the MI and control groups , respectively ( difference : –0.30 ; P = .007 ) . MI had no effect in boys or in children whose mothers had a low educational level . Positive changes in parent-reported lifestyle behaviors occurred more frequently in the MI group than in the control group . CONCLUSIONS : The pediatrician-led MI was overall effective in controlling BMI in these overweight children aged 4 to 7 years , even though no effect was observed in male children or when the mother ’s education level was low Background Childhood obesity and its related metabolic and psychological abnormalities are becoming serious health problems in China . Effective , feasible and practical interventions should be developed in order to prevent the childhood obesity and its related early onset of clinical cardiovascular diseases . The objective of this paper is to describe the design of a multi-centred r and om controlled school-based clinical intervention for childhood obesity in China . The secondary objective is to compare the cost-effectiveness of the comprehensive intervention strategy with two other interventions , one only focuses on nutrition education , the other only focuses on physical activity . Methods / Design The study is design ed as a multi-centred r and omised controlled trial , which included 6 centres located in Beijing , Shanghai , Chongqing , Sh and ong province , Heilongjiang province and Guangdong province . Both nutrition education ( special developed carton style nutrition education h and book ) and physical activity intervention ( Happy 10 program ) will be applied in all intervention schools of 5 cities except Beijing . In Beijing , nutrition education intervention will be applied in 3 schools and physical activity intervention among another 3 schools . A total of 9750 primary students ( grade 1 to grade 5 , aged 7 - 13 years ) will participate in baseline and intervention measurements , including weight , height , waist circumference , body composition ( bioelectrical impendence device ) , physical fitness , 3 days dietary record , physical activity question naire , blood pressure , plasma glucose and plasma lipid profiles . Data concerning investments will be collected in our study , including costs in staff training , intervention material s , teachers and school input and supervising related expenditure . Discussion Present study is the first and biggest multi-center comprehensive childhood obesity intervention study in China . Should the study produce comprehensive results , the intervention strategies would justify a national school-based program to prevent childhood obesity in China . Trial Registration Chinese clinical trial registry ( Primary registry in the WHO registry network ) Identifier : IMPORTANCE Working memory training may help children with attention and learning difficulties , but robust evidence from population -level r and omized controlled clinical trials is lacking . OBJECTIVE To test whether a computerized adaptive working memory intervention program improves long-term academic outcomes of children 6 to 7 years of age with low working memory compared with usual classroom teaching . DESIGN , SETTING , AND PARTICIPANTS Population -based r and omized controlled clinical trial of first grade rs from 44 schools in Melbourne , Australia , who underwent a verbal and visuospatial working memory screening . Children were classified as having low working memory if their scores were below the 15th percentile on either the Backward Digit Recall or Mister X subtest from the Automated Working Memory Assessment , or if their scores were below the 25th percentile on both . These children were r and omly assigned by an independent statistician to either an intervention or a control arm using a concealed computerized r and om number sequence . Research ers were blinded to group assignment at time of screening . We conducted our trial from March 1 , 2012 , to February 1 , 2015 ; our final analysis was on October 30 , 2015 . We used intention-to-treat analyses . INTERVENTION Cogmed working memory training , comprising 20 to 25 training sessions of 45 minutes ' duration at school . MAIN OUTCOMES AND MEASURES Directly assessed ( at 12 and 24 months ) academic outcomes ( reading , math , and spelling scores as primary outcomes ) and working memory ( also assessed at 6 months ) ; parent- , teacher- , and child-reported behavioral and social-emotional functioning and quality of life ; and intervention costs . RESULTS Of 1723 children screened ( mean [ SD ] age , 6.9 [ 0.4 ] years ) , 226 were r and omized to each arm ( 452 total ) , with 90 % retention at 1 year and 88 % retention at 2 years ; 90.3 % of children in the intervention arm completed at least 20 sessions . Of the 4 short-term and working memory outcomes , 1 outcome ( visuospatial short-term memory ) benefited the children at 6 months ( effect size , 0.43 [ 95 % CI , 0.25 - 0.62 ] ) and 12 months ( effect size , 0.49 [ 95 % CI , 0.28 - 0.70 ] ) , but not at 24 months . There were no benefits to any other outcomes ; in fact , the math scores of the children in the intervention arm were worse at 2 years ( mean difference , -3.0 [ 95 % CI , -5.4 to -0.7 ] ; P = .01 ) . Intervention costs were A$ 1035 per child . CONCLUSIONS AND RELEVANCE Working memory screening of children 6 to 7 years of age is feasible , and an adaptive working memory training program may temporarily improve visuospatial short-term memory . Given the loss of classroom time , cost , and lack of lasting benefit , we can not recommend population -based delivery of Cogmed within a screening paradigm . TRIAL REGISTRATION anzctr.org.au Identifier : ACTRN12610000486022 We report the design , rationale , and statistical procedures used in Pathways , a r and omized , school-based intervention for the primary prevention of obesity in American Indian children . The intervention , which is now being implemented in 7 American Indian communities around the country , includes a health-promotion curriculum , a physical education program , a school meal program , and a family involvement component . Forty-one schools serving American Indian children were r and omly assigned to be either intervention or control groups . The intervention will begin in the third grade and continue through the end of the fifth grade . Efficacy of intervention will be assessed by differences in mean percentage body fat , calculated by a prediction equation , between intervention and control schools at the end of the fifth grade . Power computations indicate that the study has power to detect a mean difference of 2.8 % in body fat . Data analysis will use intention-to-treat concepts and the mixed linear model . The study will be completed in 2000 Objective . To determine the immediate effects of two types of elementary school-based interventions on children with multiple cardiovascular disease ( CVD ) risk factors . Design . R and omized , controlled field trial . Setting . Conducted in 18 r and omly selected elementary schools across North Carolina . Study Participants . Four hundred twenty-two children age 9 ± 0.8 years with at least two risk factors at baseline : low aerobic power and either high serum cholesterol or obesity . Intervention . Both 8-week interventions consisted of a knowledge and attitude program and an adaptation of physical education . The classroom-based intervention was given by regular teachers to all children in the 3rd and 4th grade s. The risk-based intervention was given in small groups only to children with identified risk factors . Children in the control group received usual teaching and physical education . Outcome Measures . The primary outcome measure was cholesterol ; additional measures were blood pressure , body mass index , body fat , eating and activity habits , and health knowledge . Results . Both interventions produced large reductions in cholesterol ( −10.1 mg/dL and −11.7 mg/dL ) compared with a small drop ( −2.3 mg/dL ) in the controls . There was a trend for systolic blood pressure to increase less in both intervention groups than in the controls . Both intervention groups had a small reduction in body fat and higher health knowledge than the control group . Conclusions . Both brief interventions can improve the CVD risk profile of children with multiple risk factors . The classroom-based approach was easier to implement and used fewer re sources . This population approach should be considered as one means of early primary prevention of CVD BACKGROUND The Connect for Health study is design ed to assess whether a novel approach to care delivery that leverages clinical and community re sources and addresses socio- context ual factors will improve body mass index ( BMI ) and family-centered , obesity-related outcomes of interest to parents and children . The intervention is informed by clinical , community , parent , and youth stakeholders and incorporates successful strategies and best practice s learned from ' positive outlier ' families , i.e. , those who have succeeded in changing their health behaviors and improve their BMI in the context of adverse built and social environments . DESIGN Two-arm , r and omized controlled trial with measures at baseline and 12 months after r and omization . PARTICIPANTS 2 - 12 year old children with overweight or obesity ( BMI ≥ 85th percentile ) and their parents/guardians recruited from 6 pediatric practice s in eastern Massachusetts . INTERVENTION Children r and omized to the intervention arm receive a context ually-tailored intervention delivered by trained health coaches who use advanced geographic information system tools to characterize children 's environments and neighborhood re sources . Health coaches link families to community-level re sources and use multiple support modalities including text messages and virtual visits to support families over a one-year intervention period . The control group receives enhanced pediatric care plus non-tailored health coaching . MAIN OUTCOME MEASURES Lower age-associated increase in BMI over a 1-year period . The main parent- and child-reported outcome is improved health-related quality of life . CONCLUSIONS The Connect for Health study seeks to support families in leveraging clinical and community re sources to improve obesity-related outcomes that are most important to parents and children The effects of weight change on serum lipid changes were assessed in a sample of 56 obese children r and omly assigned to family-based behavioral obesity treatment vs controls given no treatment . Fasting serum lipid levels , height , weight , and fitness were measured at program entry and after 6 months of treatment . Children assigned to treatment showed significantly greater relative weight and weight changes than children in the control group , and the weight changes were significantly related to reductions in fasting serum triglyceride and total serum cholesterol levels and increases in high-density lipoprotein serum cholesterol . Results after 5 years of follow-up available for a small sample of treated children showed that a change in relative weight and fitness from 6 months to 5 years was also associated with changes in the high-density lipoprotein level . These results suggest that weight control in obese preadolescent children may be associated with improvement in lipoprotein profiles Introduction This study assessed the short- and long-term effects of a 3-month family-based group treatment in the management of childhood obesity versus individual treatment . Material s and methods Eighty obese children , aged between 6 and 14 years , and their parents were included in this prospect i ve controlled clinical study . Forty participants were r and omly assigned for group treatment and the other 40 for individual treatment . A 3-month intervention program was focused on implementing healthy eating behaviors . The weight and height of the children were measured initially and at each treatment session and at follow-up visits . Body mass index was calculated and expressed as st and ard deviation score . Results and discussion At the end of 3-month treatment program , there was a significant decline in BMI SDS in both groups ( p < 0.001 ) . After 1 year of follow-up period , there was still a significant decrease in BMI SDS in the study group ( p < 0.001 ) , whereas the decrease in BMI SDS was not maintained over the follow-up period in the st and ard group . There was a significantly increased consumption of vegetable and fruit and reduced consumption of carbonated drinks and fruit juice in both groups ( p < 0.001 ) . Conclusion These findings demonstrate that the group treatment is more successful than the individual treatment in the management of childhood obesity Objective : To determine the long-term effect of a r and omized controlled trial of a dairy-rich diet on generalized and abdominal obesity , as well as on the components of the metabolic syndrome , among obese prepubescent children . Methods : This trial was conducted among a population -based sample of 120 obese prepubescent children who were r and omly assigned to 3 groups of equal number . In addition to attending 6 consecutive monthly family-centered education sessions about healthy lifestyle , an isocaloric dairy-rich diet ( > 800 mg ca/d ) was recommended to the children of one group ( DR : dairy-rich diet ) , the second group was placed on a caloric-restricted regimen ( ER : energy-restricted ) , and the third group received no additional recommendation ( C : controls ) . The groups were then followed-up twice a year for 3 years . Results : The mean age of the children was 5.6 ± 0.5 years . Of 120 participants , 95 ( 75 % ) completed the study ; the DR group had the highest retention rate . In all groups , body mass index-st and ard deviation score ( BMI -SDS ) and waist circumference decreased significantly after the 6-month trial , but had a sustained significant rise during the follow-up period to the end of the study ; however , in the DR group , this rise was significantly lower than in the 2 other groups . After the 6-month trial , in all groups , serum triglycerides ( TG ) and insulin levels decreased , and serum high-density lipoprotein cholesterol ( HDL-C ) level and homeostasis model assessment of insulin resistance ( HOMA-R ) increased . In the DR group , the TG , insulin and HOMA-R levels remained significantly lower than baseline until the 12-month follow-up . Conclusions : We suggest that in addition to lifestyle changes , an isocaloric diet rich in dairy products may be a well-accepted regimen and can be a safe and practical strategy for weight control in young , overweight children For obese children behavioral treatment results in only small changes in relative weight and frequent relapse . The current study investigated the effects of an Executive Functioning ( EF ) training with game-elements on weight loss maintenance in obese children , over and above the care as usual in an inpatient treatment program . Forty-four children ( aged 8 - 14 years ) who were in the final months of a 10-months inpatient treatment program in a medical paediatric centre were r and omized to either the 6 week EF-training condition or to a care as usual only control group . The EF-training consisted of a 25-session training of inhibition and working memory . Treatment outcomes were child performances on cognitive tasks of inhibition and working memory and childcare worker ratings on EF-symptoms as well as weight loss maintenance after leaving the clinic . Children in the EF-training condition showed significantly more improvement than the children in the care as usual only group on the working memory task as well as on the childcare worker reports of working memory and meta-cognition . They were also more capable to maintain their weight loss until 8 weeks post-training . This study shows promising evidence for the efficacy of an EF-training as weight stabilization intervention in obese children The Biochemical Evaluation of a Health Intervention Programme ( B.E. H.I.P. ) investigated the impact of progressive exercise intensity in overweight and obese children . A 5-month prospect i ve r and omized crossover design ( X(A ) , immediate intervention ; O(B ) , control group ; X(B ) , delayed intervention , O(A ) , postintervention follow-up ) with a 10-week health intervention programme was employed . The intervention utilized a progressive increase in high-intensity exercise ( ≥ 75 % maximum heart rate ) and included 3 nutrition and 2 parent education sessions . Primary analysis was completed with ( i ) X(A ) versus O(B ) and ( ii ) all intervention participants ( collapsed X(A ) and X(B ) = X(A)X(B ) ) . Prepubertal overweight and obese male and female children ( n = 27 ) between 5 and 10 years of age were r and omly allocated to X(A ) ( n = 16 ; 11 females ; waist circumference = 80.0 ± 10.6 cm ) or O(B ) ( n = 11 ; 3 females ; waist circumference = 76.6 ± 7.5 cm ) . The primary variables were heart rate and percent fat mass . All variables , including body composition , habitual activity , and serum lipids , were repeatedly measured for up to a maximum of 7 time points . Energy expenditure was quantitatively measured throughout each exercise class ( n = 20 ) . A significantly longer time in the exercise sessions was spent in high-intensity ( 35.1%-60.0 % ) versus low- to moderate-intensity ( 64.9%-40.0 % ) exercise as the intervention progressed from the first to the last attended exercise class ( Fisher exact test , p < 0.0001 ) . The percent fat mass decreased in all intervention participants ( -2.2 % , p < 0.0001 ) . X(A ) had a greater slope decrease than O(B ) for percent fat mass ( p = 0.00051 ) and triglycerides ( p = 0.0467 ) . In conclusion , high-intensity exercise , within a comprehensive health programme that includes nutrition education , improved the lipid and physiological health profiles of obese children BACKGROUND The current study compares the effectiveness of a condensed 12-week version and a 24-week version of the same pediatric behavioral weight management program . METHODS Children ( n=162 ) between the ages of 8 and 18 years ( baseline BMI z=2.39 ; st and ard deviation=0.29 ) were r and omized to either a 12- or 24-week version of the same behavioral weight management program . Child anthropometric data were recorded at baseline , 6 weeks , 12 weeks , 24 weeks , and 12 months . A two-level longitudinal model was used to examine within- and between-group differences in BMI z change over time . RESULTS A significant group-by-time interaction was found ( β=-0.01 ; st and ard error , < 0.01 ; p<0.01 ) with the 24-week group showing greater reductions in BMI z. Children in the 24-week group showed significant BMI z reductions over time ( z=-5.18 ; p<0.01 ) , but children in the 12-week group did not ( z=-0.85 ; p=0.39 ) . CONCLUSIONS Children in the 24-week program demonstrated greater reductions in BMI z than children in the 12-week group . Therefore , there may be additional benefit to sessions above and beyond the 8- to 12-week minimum suggested for pediatric weight management programs Obesity has become the most common pediatric chronic disease in the modern era . Recent data suggests that unlike obese adults , obese children and adolescents may have decreased bone strength . It was the objective to prospect ively examine the short term effects of a 3 month combined dietary-physical activity intervention on anthropometric measures , body composition , fitness and bone strength in obese children . Twelve obese subjects completed the 3 m intervention and were compared to 12 obese age and gender matched controls . Bone strength was measured using quantitative ultrasound measurements of bone speed of sound ( SOS ) . There were significant differences in changes of body weight ( 0.01 + /- 0.7 vs. 2.3 + /- 0.6 kg , p = 0.033 ) , BMI percentiles ( - 2.8 + /- 1.1 vs. - 0.2 + /- 0.2 % , p = 0.037 ) , body fat percent ( by skinfolds , - 1.5 + /- 0.8 vs. 0.7 + /- 0.5 % , p = 0.035 ) , and endurance time ( 170 + /- 42 vs. 50 + /- 27 s , p = 0.045 ) in the intervention vs. control subjects , respectively . In addition , we found a significant difference in the change of bone SOS between the intervention and control group subjects ( 21.5 + /- 21.6 vs. - 87.0 + /- 37 m/s , p = 0.023 ) . During the critical period of bone development of childhood and adolescence , a combined dietary-physical activity intervention leads to increased bone strength in obese children . These results highlight the importance of multi-disciplinary programs for the treatment of childhood obesity and its complications OBJECTIVE Children who are less fit reportedly have lower performance on tests of cognitive control and differences in brain function . This study examined the effect of an exercise intervention on brain function during two cognitive control tasks in overweight children . DESIGN AND METHODS Participants included 43 unfit , overweight ( BMI ≥ 85th percentile ) children 8- to 11-years old ( 91 % Black ) , who were r and omly divided into either an aerobic exercise ( n = 24 ) or attention control group ( n = 19 ) . Each group was offered a separate instructor-led after-school program every school day for 8 months . Before and after the program , all children performed two cognitive control tasks during functional magnetic resonance imaging ( fMRI ) : antisaccade and flanker . RESULTS Compared to the control group , the exercise group decreased activation in several regions supporting antisaccade performance , including pre central gyrus and posterior parietal cortex , and increased activation in several regions supporting flanker performance , including anterior cingulate and superior frontal gyrus . CONCLUSIONS Exercise may differentially impact these two task conditions , or the paradigms in which cognitive control tasks were presented may be sensitive to distinct types of brain activation that show different effects of exercise . In sum , exercise appears to alter efficiency or flexible modulation of neural circuitry supporting cognitive control in overweight children BACKGROUND Physical Activity Across the Curriculum ( PAAC ) was a three-year cluster r and omized controlled trial to promote physical activity and diminish increases in overweight and obesity in elementary school children . METHODS Twenty-four elementary schools were cluster r and omized to the Physical Activity Across the Curriculum intervention or served as control . All children in grade s two and three were followed to grade s four and five . Physical Activity Across the Curriculum promoted 90 min/wk of moderate to vigorous intensity physically active academic lessons delivered by classroom teachers . Body Mass Index was the primary outcome , daily Physical activity and academic achievement were secondary outcomes . RESULTS The three-year change in Body Mass Index for Physical Activity Across the Curriculum was 2.0+/-1.9 and control 1.9+/-1.9 , respectively ( NS ) . However , change in Body Mass Index from baseline to 3 years was significantly influenced by exposure to Physical Activity Across the Curriculum . Schools with > or = 75 min of Physical Activity Across the Curriculum/wk showed significantly less increase in Body Mass Index at 3 years compared to schools that had < 75 min of Physical Activity Across the Curriculum ( 1.8+/-1.8 vs. 2.4+/-2.0 , p=0.02 ) . Physical Activity Across the Curriculum schools had significantly greater changes in daily Physical activity and academic achievement scores . CONCLUSIONS The Physical Activity Across the Curriculum approach may promote daily Physical activity and academic achievement in elementary school children . Additionally , 75 min of Physical Activity Across the Curriculum activities may attenuate increases in Body Mass Index OBJECTIVE To evaluate whether a child-centered physical activity program , combined with a parent-centered dietary program , was more efficacious than each treatment alone , in preventing unhealthy weight-gain in overweight children . STUDY DESIGN An assessor-blinded r and omized controlled trial involving 165 overweight/obese 5.5- to 9.9- year-old children . Participants were r and omly assigned to 1 of 3 interventions : a parent-centered dietary program ( Diet ) ; a child-centered physical activity program ( Activity ) ; or a combination of both ( Diet+Activity ) . All groups received 10 weekly face-to-face sessions followed by 3 monthly relapse-prevention phone calls . Analysis was by intention-to-treat . The primary outcome was change in body mass index z-score at 6 and 12 months ( n=114 and 106 , respectively ) . RESULTS Body mass index z-scores were reduced at 12-months in all groups , with the Diet ( mean [ 95 % confidence interval ] ) ( -0.39 [ -0.51 to 0.27 ] ) and Diet + Activity ( -0.32 , [ -0.36 , -0.23 ] ) groups showing a greater reduction than the Activity group ( -0.17 [ -0.28 , -0.06 ] ) ( P=.02 ) . Changes in other outcomes ( waist circumference and metabolic profile ) were not statistically significant among groups . CONCLUSION Relative body weight decreased at 6 months and was sustained at 12 months through treatment with a child-centered physical activity program , a parent-centered dietary program , or both . The greatest effect was achieved when a parent-centered dietary component was included OBJECTIVES The primary objective was to determine whether children and their participating parents undergoing family-based behavioral treatment ( FBT ) for obesity show similar dietary changes following treatment , and if so , whether these shared dietary changes explain the similarity in weight change within the parent-child dyad . METHOD Data come from a r and omized controlled trial of 148 parent-child dyads who completed FBT and were followed over a 2-year maintenance phase . Energy-dense , nutrient-poor foods ( " RED " foods ) and fruit and vegetable intake were assessed across time . RESULTS Maintenance of lower RED food intake following FBT predicted weight maintenance in children and in parents ( ps < .01 ) , and dietary and weight changes were correlated within parent-child dyads ( ps < .01 ) . Most interesting , the similarity in long-term weight maintenance between children and their parents was predicted by the similarity in long-term changes in RED food intake between children and their parents ( p < .001 ) . CONCLUSIONS These findings point to the important role of maintaining low energy-dense , nutrient-poor food intake for long-term weight maintenance in children and parents . Furthermore , these results suggest that the correlation between parent and child weight maintenance can be explained in part by similar long-term changes in energy-dense , nutrient-poor food intake OBJECTIVE To assess the impact of a 2-year recreational physical activity program in 1044 fourth- and fifth- grade primary schoolchildren from the Province of Cuenca , Spain . STUDY DESIGN Cluster-r and omized controlled trial with 10 intervention and 10 control schools . The program consisted of 3 90-minute sessions of physical activity per week , during 28 weeks every year . Changes in endpoints between baseline ( September 2004 ) and the end of follow-up ( June 2006 ) were compared between the control and intervention group by using mixed regression models , with adjustment for the baseline endpoint value , age , and the school . RESULTS Compared with control subjects , intervention girls reduced the frequency of overweight ( odds ratio , 0.55 ; 95 % CI , 0.39 - 0.78 ; P<.001 ) . However , intervention was associated with an increase in the percentage of body fat in boys ( 0.97 % ; 95 % CI , 0.14 - 1.81 ; P=.02 ) . Girls in the intervention group had lower total cholesterol level ( -6.86 mg/dL ; 95 % CI , -9.70 - -4.01 ; P<.001 ) and apolipoprotein B level ( -3.61 mg/dL ; 95 % CI , -6.27 - -0.95 ; P=.008 ) than control subjects . Results were similar in boys . CONCLUSION In 2 years , the physical activity program lowered the frequency of overweight in girls and reduced total cholesterol and apolipoprotein B in both girls and boys OBJECTIVE . To evaluate the effect of a pediatric primary care – based intervention , on improved clinical decision support and family management of risk behaviors for childhood overweight . METHODS . An experimental field trial was conducted with 12 intervention sites in urban and rural areas of Maine and nonr and omized control sites . Change was assessed by using clinical and parent measures from 9 intervention and 10 control sites before and during the Maine Youth Overweight Collaborative intervention . Longitudinal information was collected from chart audits of patients aged 5–18 years ( n = 600 ) , systematic sample s of parents collected before ( n = 346 ) and during ( n = 386 ) the intervention in 12 sites , and systematic sample s of parents in 9 intervention ( n = 235 ) and 10 control ( n = 304 ) sites collected during the intervention . Surveys of health care providers ( n = 14 and 17 ) before and during the intervention were also collected . Teams worked over 18 months to implement improvements in clinical decision support , including tracking BMI percentiles , identification of overweight patients , appropriate laboratory tests , counseling of families and patients use of a behavioral screening tool , and other improvements following the chronic-care model targeting patients aged 5 to 18 and their families . RESULTS . Large changes occurred in clinical practice from before to during the Maine Youth Overweight Collaborative : increases in assessment of BMI ( 38%–94 % ) , BMI percentile for age and gender ( 25%–89 % ) , use of the 5 - 2 - 1 - 0 behavioral screening tool ( 0%–82 % ) , and weight classification ( 19%–75 % ) . Parent surveys indicated improvements in providers ’ behavior and rates of counseling . Intervention providers reported improvements in knowledge , attitudes , self-efficacy , and practice . CONCLUSIONS . The Maine Youth Overweight Collaborative intervention improved clinical decision support and family management of risk behaviors , indicating a promising primary care – based approach to address overweight risk among children and youth Objectives : To reduce gain in body mass index ( BMI ) in overweight/mildly obese children in the primary care setting . Design : R and omized controlled trial ( RCT ) nested within a baseline cross-sectional BMI survey . Setting : Twenty nine general practice s , Melbourne , Australia . Participants : ( 1 ) BMI survey : 2112 children visiting their general practitioner ( GP ) April – December 2002 ; ( 2 ) RCT : individually r and omized overweight/mildly obese ( BMI z-score < 3.0 ) children aged 5 years 0 months–9 years 11 months ( 82 intervention , 81 control).Intervention : Four st and ard GP consultations over 12 weeks , targeting change in nutrition , physical activity and sedentary behaviour , supported by purpose - design ed family material s . Main outcome measures : Primary : BMI at 9 and 15 months post-r and omization . Secondary : Parent-reported child nutrition , physical activity and health status ; child-reported health status , body satisfaction and appearance/self-worth . Results : Attrition was 10 % . The adjusted mean difference ( intervention – control ) in BMI was −0.2 kg/m2 ( 95 % CI : −0.6 to 0.1 ; P=0.25 ) at 9 months and −0.0 kg/m2 ( 95 % CI : −0.5 to 0.5 ; P=1.00 ) at 15 months . There was a relative improvement in nutrition scores in the intervention arm at both 9 and 15 months . There was weak evidence of an increase in daily physical activity in the intervention arm . Health status and body image were similar in the trial arms . Conclusions : This intervention did not result in a sustained BMI reduction , despite the improvement in parent-reported nutrition . Brief individualized solution-focused approaches may not be an effective approach to childhood overweight . Alternatively , this intervention may not have been intensive enough or the GP training may have been insufficient ; however , increasing either would have significant cost and re source implication s at a population level OBJECTIVE To determine the effects of placebo vs an encapsulated supplement of fruit and vegetable juice concentrate ( FVJC ) on serum β-carotene levels , insulin resistance , adiposity , and sub clinical inflammation in boys . STUDY DESIGN Thirty age-matched prepubertal boys ( 9 lean and 21 overweight ( OW ) ; age range , 6 - 10 years ) were studied . All participants received nutrition counseling and were r and omized to receive FVJC or placebo capsules for 6 months . Total cholesterol , triglycerides , lipid corrected β-carotene , serum retinol , glucose , insulin , retinol binding protein-4 , leptin , adiponectin , leptin-to-adiponectin ratio , high-sensitivity C-reactive protein , and interleukin-6 were measured before and after the 6-month intervention . Homeostasis model assessment -insulin resistance ( HOMA-IR ) , acute insulin response to intravenous glucose , along with abdominal fat mass ( dual-energy x-ray absorptiometry ) were also determined . RESULTS Baseline β-carotene concentrations correlated inversely with HOMA-IR , leptin-to-adiponectin ratio , and abdominal fat mass ( P ≤ .01 ) . FVJC intake increased β-carotene concentrations ( P ≤ .001 ) but did not influence retinol or retinol binding protein-4 . Retinol insufficiency < 1.047 μM was present in 18 % of the entire cohort at baseline and in 37 % at 6 months . HOMA-IR decreased after supplementation in the OW cohort , when adjusted for percent weight change ( P = .014 ) . The percent change in abdominal fat mass increased in the placebo group and decreased in the FVJC group ( P = .029 ) . CONCLUSIONS A 6-month supplementation with FVJC in the presence of nutritional counseling was associated with an increase in serum β-carotene concentrations and a reduction in adiposity in conjunction with an improvement in insulin resistance in OW boys This prospect i ve , r and omized study investigated the effect of exercise on leptin , insulin , cortisol and lipid profiles in obese children . A total of 40 obese boys aged 10 - 12 years with a body mass index ( BMI ) ≥ 30 kg/m2 were r and omly separated into an exercise group ( n = 20 ) that underwent a 12-week aerobic exercise programme and a non-exercise ( control ) group ( n = 20 ) . The BMI , low-density lipoprotein , cortisol , leptin and insulin levels were significantly lower in the exercise group after 12 weeks compared with baseline values , whereas high-density lipoprotein levels were significantly higher . In contrast , in the control group , low-density lipoprotein , cortisol and leptin levels were significantly higher after 12 weeks compared with baseline values while high-density lipoprotein levels were significantly lower . These findings indicate the importance of regular exercise in the regulation of body weight and protection against cardiovascular risk factors in obese children OBJECTIVE To examine the effectiveness of a family-based behavioral group intervention ( Positively Fit ; PF ) for pediatric obesity relative to a brief family intervention ( BFI ) in a sample of treatment-seeking children and adolescents . METHODS Families ( n = 93 ) were r and omized to treatment condition . Assessment s were conducted at pre- and posttreatment and at 12-month follow-up . Outcome indices included st and ardized body mass index ( BMI ) and quality of life ( QOL ) . RESULTS Results indicated a significant reduction in z BMI at posttreatment and follow-up across both conditions . At follow-up , BFI and PF participants evidence d average reductions of .12 and .19 z BMI units , respectively . Children demonstrated better outcomes than adolescents across both conditions . Results indicated clinical ly significant improvements in parent-reported QOL at postintervention and in self-reported QOL at follow-up for PF participants . CONCLUSIONS Results suggest the effectiveness of family-based interventions for pediatric obesity in clinical setting s among younger children . Neither intervention was effective in terms of reducing z BMI among adolescents PURPOSE To compare the costs of parent-only and family-based group interventions for childhood obesity delivered through Cooperative Extension Services in rural communities . METHODS Ninety-three overweight or obese children ( aged 8 to 14 years ) and their parent(s ) participated in this r and omized controlled trial , which included a 4-month intervention and 6-month follow-up . Families were r and omized to either a behavioral family-based intervention ( n = 33 ) , a behavioral parent-only intervention ( n = 34 ) , or a waitlist control condition ( n = 26 ) . Only program costs data for the parent-only and family-based programs are reported here ( n = 67 ) . Assessment s were completed at baseline , post-treatment ( month 4 ) and follow-up ( month 10 ) . The primary outcome measures were total program costs and cost per child for the parent-only and family interventions . FINDINGS Twenty-six families in the parent-only intervention and 24 families in the family intervention completed all 3 assessment s. As reported previously , both intervention programs led to significantly greater decreases in weight status relative to the control condition at month 10 follow-up . There was no significant difference in weight status change between the parent-only and family interventions . Total program costs for the parent-only and family interventions were 13,546 US dollars and 20,928 , US dollars respectively . Total cost per child for the parent-only and family interventions were 521 US dollars and 872 US dollars , respectively . CONCLUSIONS Parent-only interventions may be a cost-effective alternative treatment for pediatric obesity , especially for families in medically underserved setting Given the increase in obesity in developed and developing countries and its concomitant morbidity , successful treatment approaches are needed . We examined the effect of a structured exercise intervention in overweight children in a slum in Recife , Pernambuco State , Brazil . This was a r and omized , controlled efficacy trial . Seventy-eight children were r and omized . Exercise was supervised , consisting of three 50 ' group aerobics sessions per week for six months . All participants maintained ad libitum diets . Based on intention-to-treat analyses , children in both groups had a significant increase in weight at follow-up ( p-value for within-group increase < or = 0.01 ) . The increase in weight was significantly lower in the exercise group ( mean difference between groups ; -1.37 ; 95%CI : -2.00 ; -0.74 ) . A significant difference ( p = 0.049 ) between the exercise and control groups at six-month follow-up was also found for BMI ( mean difference between groups ; -0.53 ; 95%CI : -1.06 ; -0.002 ) . When we restricted the analyses to children who completed the trial ( intervention = 30 and control = 38 ) , the results were the same . An exercise program for children , sustained for six months , was effective for reducing weight gain in overweight children living in a very poor neighborhood OBJECTIVE To evaluate the Fitwits MD office tool and games for obesity discussion s with 9- to 12-year-olds . METHODS A nonr and omized intervention study using pre- and posttest assessment s in 2 residency programs compared 31 control group and 55 intervention physicians ( 34 previously trained , 21 newly trained to use Fitwits ) . Surveys addressed comfort and competence regarding : obesity prevention and treatment , nutrition , exercise , portion size , body mass index ( BMI ) , and the term " obesity . " We surveyed all groups at baseline and 5 months ( post 1 ) and new trainees 3 months later ( post 2 ) . RESULTS In post 1 , prior trainees reported significantly increased comfort and competence for discussing obesity prevention , portion size , BMI , and " obesity . " In post 2 , new trainees reported significantly increased comfort and competence discussing obesity prevention and treatment , portion size , and BMI . CONCLUSIONS Experience using Fitwits improved residency-based physician comfort and competence in obesity prevention and treatment , portion size , BMI , and " obesity " discussion s with preadolescents OBJECTIVES Single sex after-school physical activity programs show potential to prevent unhealthy weight gain . The aim of this study was to assess the acceptability and potential efficacy of single-sex after-school physical activity programs for overweight and at-risk children from low-income communities . DESIGN 7-month , 2-arm parallel-group , RCT , conducted at an elementary school in a disadvantaged area in Wollongong , Australia ( March-November 2010 ) . METHODS 20 boys and 17 girls were r and omized to intervention ( PA ) or active comparison groups ( HL ) . Primary outcomes included implementation , acceptability , percentage body fat and BMI z-score . RESULTS The PA programs were acceptable with high implementation and enjoyment rates . At 7 months postintervention girls in the PA group displayed greater changes in percentage body fat ( adjust diff . = -1.70 , [ 95 % CI -3.25 , -0.14 ] ; d = -0.83 ) and BMI z-score ( -0.19 [ -0.36 , -0.03 ] ; d= -1.00 ) . At 7 months boys in the PA group showed greater changes in waist circumference ( -3.87 cm [ -7.80 , 0.15 ] ; d= -0.90 ) and waist circumference z-score ( -0.33 [ -0.64 , -0.03 ] ; d= -0.98 ) . For both boys ' and girls ' PA groups , changes in adiposity were not maintained at 12-month follow-up . CONCLUSIONS Single-sex after-school physical activity programs are acceptable and potentially efficacious in preventing unhealthy weight gain among overweight and at-risk children . However improvements are hard to sustain once programs finish operating OBJECTIVES Labelling of food from fast food restaurants at point-of-purchase has been suggested as one strategy to reduce population energy consumption and contribute to reductions in obesity prevalence . The aim of this study was to examine the effects of energy and single traffic light labelling systems on the energy content of child and adult intended food purchases . PARTICIPANTS AND METHODS The study employed a r and omised controlled trial design . English speaking parents of children aged between three and 12 years were recruited from an existing research cohort . Participants were mailed one of three hypothetical fast food menus . Menus differed in their labelling technique – either energy labels , single traffic light labels , or a no-label control . Participants then completed a telephone survey which assessed intended food purchases for both adult and child . The primary trial outcome was total energy of intended food purchase . RESULTS A total of 329 participants completed the follow-up telephone interview . Eighty-two percent of the energy labelling group and 96 % of the single traffic light labelling group reported noticing labelling information on their menu . There were no significant differences in total energy of intended purchases of parents , or intended purchases made by parents for children , between the menu labelling groups , or between menu labelling groups by socio-demographic subgroups . CONCLUSIONS This study provided no evidence to suggest that energy labelling or single traffic light labelling alone were effective in reducing the energy of fast food items selected from hypothetical fast food menus for purchase . Additional complementary public health initiatives promoting the consumption of healthier foods identified by labelling , and which target other key drivers of menu item selection in this setting may be required BACKGROUND Maximising the health of our communities requires a strong foundation of clinical research . Undertaking community based clinical research requires an underst and ing of what motivates practitioners to participate in research and how they experience the process . It has been suggested that a primary care sector with a strong research culture and evidence base is crucial to getting evidence into practice , yet general practice research has been criticised for ignoring clinical research . This article examines why a group of general practitioners took part in clinical research . METHODS Participants completed surveys before and after involvement in the Live , Eat and Play ( LEAP ) study , a r and omised controlled trial to reduce childhood overweight . RESULTS Thirty-four GPs enrolled in LEAP and completed the baseline survey ; 30 delivered the intervention and 29 completed all surveys . Sixtyone percent ( 17 ) of the GPs agreed that their expectations of their participation in the project had been met . Twenty-eight of 29 GPs stated they would participate in similar research if asked again . Responses to open ended questions indicated that the most highly valued reason for participating in research was to learn new clinical skills , up date knowledge and reflect on practice . DISCUSSION General practitioners were driven to participate in research by altruism , the desire to up date their knowledge and clinical skills , and the opportunity to reflect on their practice rather than the promise of ' rewards ' such as quality assurance and continuing medical education points The purpose of this study was to test the hypothesis that in obese children : 1 ) Ventilatory efficiency ( VentE ) is decreased during grade d exercise ; and 2 ) Weight loss through diet alone ( D ) improves VentE , and 3 ) diet associated with exercise training ( DET ) leads to greater improvement in VentE than by D. Thirty-eight obese children ( 10+/-0.2 years ; BMI > 95th percentile ) were r and omly divided into two study groups : D ( n=17 ; BMI = 30+/-1 kg/m ( 2 ) ) and DET ( n=21 ; 28+/-1 kg/m ( 2 ) ) . Ten lean children were included in a control group ( 10+/-0.3 years ; 17+/-0.5 kg/m ( 2 ) ) . All children performed maximal treadmill testing with respiratory gas analysis ( breath-by-breath ) to determine the ventilatory anaerobic threshold ( VAT ) and peak oxygen consumption ( VO ( 2 ) peak ) . VentE was determined by the VE/VCO ( 2 ) method at VAT . Obese children showed lower VO ( 2 ) peak and lower VentE than controls ( p<0.05 ) . After interventions , all obese children reduced body weight ( p<0.05 ) . D group did not improve in terms of VO ( 2 ) peak or VentE ( p>0.05 ) . In contrast , the DET group showed increased VO ( 2 ) peak ( p=0.01 ) and improved VentE ( DeltaVE/VCO (2)=-6.1+/-0.9 ; p=0.01 ) . VentE is decreased in obese children , where weight loss by means of DET , but not D alone , improves VentE and cardiorespiratory fitness during grade d exercise BACKGROUND The high prevalence of obesity in children in the UK warrants continuing public health attention . ' Families for Health ' is a family-based group programme for the treatment of childhood obesity . Significant improvements in body mass index ( BMI ) z-score ( -0.21 , 95 % CI : -0.35 to -0.07 , P = 0.007 ) and other health outcomes were seen in children at a 9-month follow-up . AIM To undertake a 2-year follow-up of families who attended ' Families for Health ' in Coventry , to assess long-term outcomes and costs . METHODS ' Families for Health ' is a 12-week programme with parallel groups for parents and children , addressing parenting skills , healthy lifestyles and emotional well-being . The intervention was delivered at a leisure centre in Coventry , Engl and , with 27 overweight or obese children aged 7 - 13 years ( 18 girls , 9 boys ) and their parents , from 21 families . A ' before- and -after ' evaluation was completed with 19 ( 70 % ) children followed up at 2 years . The primary outcome was change in BMI z-score from baseline ; secondary outcomes were children 's quality of life , parent-child relationships , eating/activity habits and parents ' mental health . Costs to deliver the intervention and to families were recorded . RESULTS Mean change in BMI z-score from baseline was -0.23 ( 95 % CI : -0.42 to -0.03 , P = 0.027 ) at the 2-year follow-up and eight ( 42 % ) children had a clinical ly significant reduction in BMI z-score . Significant improvements were seen in children 's quality of life and eating habits in the home , while there were sustained reductions in unhealthy foods and sedentary behaviour . Fruit and vegetable consumption and parent 's mental health were not significantly different at 2 years . Costs of the programme were £ 517 per family ( £ 402 per child ) , equivalent to £ 2543 per unit reduction in BMI z-score . CONCLUSIONS Improvements in BMI z-score and certain other outcomes associated with the ' Families for Health ' programme were sustained at the 2-year follow-up . ' Families for Health ' is a promising new childhood obesity intervention , and a r and omized controlled trial is now indicated There are few effective obesity interventions directed towards younger children , particularly young minority children . This paper describes the design , intervention , recruitment methods , and baseline data of the ongoing Positive Lifestyles for Active Youngsters ( Team PLAY ) study . This r and omized controlled trial is design ed to test the efficacy of a 6-month , moderately intense , primary care feasible , family-based behavioral intervention , targeting both young children and their parent , in promoting healthy weight change . Participants are 270 overweight and obese children ( ages 4 to 7 years ) and their parents , who were recruited from a primarily African American urban population . Parents and children were instructed in proven cognitive behavioral techniques ( e.g. goal setting , self-talk , stimulus control and reinforcement ) design ed to encourage healthier food choices ( more whole grains , fruits and vegetables , and less concentrated fats and sugar ) , reduce portion sizes , decrease sweetened beverages and increase moderate to vigorous physical activity engagement . The main outcome of this study is change in BMI at two year post enrollment . Recruitment using reactive methods ( mailings , TV ads , pamphlets ) was found to be more successful than using only a proactive approach ( referral through physicians ) . At baseline , most children were very obese with an average BMI z-score of 2.6 . Reported intake of fruits and vegetables and minutes of moderate to vigorous physical activity engagement did not meet national recommendations . If efficacious , Team PLAY would offer a model for obesity treatment directed at families with young children that could be tested and translated to both community and primary care setting BACKGROUND The Texas Childhood Obesity Research Demonstration project ( TX CORD ) uses a systems-oriented approach to address obesity that includes individual and family interventions , community-level action , as well as environmental and policy initiatives . Given that r and omization is seldom possible in community-level intervention studies , TX CORD uses a quasi-experimental design . Comparable intervention and comparison study sites are needed to address internal validity bias . METHODS TX CORD was design ed to be implemented in low-income , ethnically diverse communities in Austin and Houston , Texas . A three-stage Geographical Information System ( GIS ) methodology was used to establish and ascertain the comparability of the intervention and comparison study sites . Census tract ( stage 1 ) and school ( stage 2 ) data were used to identify spatially exclusive geographic areas that were comparable . In stage 3 , study sites were compared on demographic characteristics , socioeconomic status ( SES ) , food assets , and physical activity ( PA ) assets . Student 's t-test was used to examine significant differences between the selected sites . RESULTS The methodology that was used result ed in the selection of catchment areas with demographic and socioeconomic characteristics that fit the target population : ethnically diverse population ; lower-median household income ; and lower home ownership rates . Additionally , the intervention and comparison sites were statistically comparable on demographic and SES variables , as well as food assets and PA assets . CONCLUSIONS This GIS approach can provide research ers , program evaluators , and policy makers with useful tools for both research and practice . Area-level information that allows for robust underst and ing of communities can enhance analytical procedures in community health research and offer significant contributions in terms of community assessment and engagement OBJECTIVE To examine the effects of a multi-component camp-based intervention on inflammatory markers and adipokines in children . METHODS One hundred and fifteen children were recruited in Odense , Denmark ( 2012 - 2014 ) . The participants were r and omly allocated to either the day camp intervention arm ( DCIA ) or the st and ard intervention arm ( SIA ) . The intervention for the DCIA consisted of a 6-week camp-based intervention and a 46-week family-based intervention . The SIA was offered one weekly physical activity session for 6 weeks and one educational meeting . C-reactive protein ( CRP ) , monocyte chemoattractant protein-1 ( MCP1 ) , leptin , and adiponectin were measured in serum at baseline , 6 weeks and 52 weeks . RESULTS In comparison with the SIA , the reductions in CRP ( P=0.003 ) and leptin ( p<0.001 ) were larger in the DCIA at 6 weeks . The intervention effects on leptin were significantly mediated by the changes in body fat mass . No intervention effects on CRP and leptin were seen at 52 weeks . No between-group differences in changes in MCP1 and adiponectin were observed at 6 weeks or 52 weeks . CONCLUSIONS The 6-week camp intervention result ed in reductions in CRP and leptin . The intervention effects did not persist to 52 weeks . The intervention effect on leptin was explained by changes in body fat mass BACKGROUND Over the years schools have reduced physical education and recess time in favor of more academic instruction . Due to the drastic rise in obesity levels among children , some states have begun to m and ate minimum amounts of physical activity ( PA ) that school children receive , causing schools to find alternative methods for increasing PA levels . Physical Activity Across the Curriculum ( PAAC ) is a 3-year r and omized clinical trial incorporating moderate-intensity PA in elementary schools to reduce childhood obesity . This paper describes the rational , design , and methods of the PAAC intervention study . METHODS Twenty-two elementary schools were r and omized to either a control or intervention condition . In schools r and omized to the intervention condition ( PAAC ) , regular classroom teachers were taught how to incorporate PA into st and ard academic lessons . Teachers were asked to accumulate 90 - 100 min/week of PAAC each week through out the 3-year study period . Schools r and omized to the control group did not alter their teaching methods . Direct observation of PA levels in the classroom was collected weekly . Height and weight was measured twice a year to calculate BMI . RESULTS Two years of the intervention have been completed and only one school has left the study . The remaining 21 schools are participating in the final intervention year . CONCLUSIONS The results from the PAAC intervention may provide schools with an alternative method to increase PA levels in children and reduce childhood obesity BACKGROUND The primary care setting offers the opportunity to reach children and parents to encourage healthy lifestyle behaviours , and improve weight status among children . OBJECTIVE Test the feasibility of Helping H AND ( Healthy Activity and Nutrition Directions ) , an obesity intervention for 5- to 8-year-old children in primary care clinics . METHODS A r and omized controlled pilot study of Helping H AND , a 6-month intervention , targeted children with body mass index 85 - 99%tile and their parents . Intervention group attended monthly sessions and self-selected child behaviours and parenting practice s to change . Control group received regular paediatric care and was wait-listed for Helping H AND . Session completion , participant satisfaction , child anthropometrics , dietary intake , physical activity , TV viewing and behaviour-specific parenting practice s were measured pre and post intervention . RESULTS Forty parent-child dyads enrolled : 82.5 % were Hispanic , 80 % had a girl and 65 % reported income ≤ $ 30 , 000/year . There was 20 % attrition from Helping H AND ( attended < 4/6 sessions ) . Families self-selected 4.35 ( SD 1.75 ) behaviours to target during the 6-month programme and each of the seven behaviours was selected by 45 - 80 % of the families . There were no between group differences in the child 's body mass index z-score , dietary intake or physical activity post intervention . Intervention group viewed 14.9 ( SE 2.3 ) h/week of TV post intervention versus control group 23.3 ( SE 2.4 ) h/week ( P < 0.05 ) . CONCLUSION Helping H AND is feasible , due to low attrition , good programme attendance , and clinical ly relevant improvements in some child and parenting behaviours AIM To determine whether a single session of motivational interviewing ( MI ) for feedback of a child 's overweight status promotes engagement in treatment following screening . METHODS One thous and ninety-three children aged 4 - 8 years were recruited through primary and secondary care to attend health screening , including assessment of parenting practice s and motivation ( question naire ) . Families with normal-weight children were informed about their child 's weight but had no further involvement . Parents of overweight ( body mass index ≥ 85th percentile ) children ( n = 271 ) were r and omised to receive weight feedback via MI or best practice care ( BPC ) using a traffic light concept to indicate degree of health risk . Follow-up interviews were held 2 weeks later to examine intervention uptake , changes to motivation and behaviour , and parental response to feedback . RESULTS Recruitment into the intervention was high ( 76 % ) and not altered by feedback condition ( percentage difference 6.6 ( 95 % confidence interval -2.9 , 16.0 ) . High scores on the Health Care Climate Question naire ( rating of the interviewer ) indicated satisfaction with how the information was provided to parents . No differences were observed in multiple indicators of harm . However , self-determined motivation for healthy life-styles was significantly higher in the MI condition at follow-up ( 0.18 : 0.00 , 0.35 ) , after only a single session of MI . CONCLUSIONS MI and BPC were both successful in encouraging parents to participate in a family-based intervention , with MI offering little significant benefit over BPC . A traffic light approach to weight feedback is a suitable way of providing sensitive information to parents not expecting such news HYPOTHESIS Retraining obese adolescents to eat more slowly will lead to beneficial changes in circulating concentrations of gastrointestinal satiety hormones . METHODS Ghrelin and peptide tyrosine-tyrosine were measured during an oral glucose tolerance test , at baseline and at 12 months during a r and omized trial assessing the clinical effectiveness of a device ( M and ometer ) design ed to retrain eating behavior . This computerized scale provided real-time feedback during meals in the intervention arm ( n = 14 ) to slow down the speed of eating . The control group ( n = 13 ) received only st and ard care aim ed at improving lifestyle behavior . The M and ometer elicited greater improvements in weight loss than st and ard care . RESULTS Compared with baseline , only those using the M and ometer exhibited lower mean levels of fasting ghrelin ( 48.14 ± 18.47 vs. 68.45 ± 17.78 pg/ml ; P = 0.002 ) and mean ghrelin area under the curve ( 72.08 ± 24.11 vs. 125.50 ± 29.72 pg/ml × min ; P < 0.001 ) at 12 months . Absolute mean suppression in ghrelin at 60 min was enhanced ( -40.50 ± 21.06 vs. -12.14 ± 19.74 pg/ml × min ; P = 0.001 ) . Peptide tyrosine-tyrosine response at 90 min remained unaltered in the st and ard care arm , whereas those in the M and ometer arm increased ( P < 0.001 ) : the mean 90-min response increased by 72 pg/ml [ 95 % confidence interval ( CI ) 52 - 92 pg/ml ] between baseline and 12 months . In a partial correlation analysis adjusting for change ( Δ ) in body mass index sd scores , Δ meal duration correlated negatively with Δ absolute suppression in ghrelin at 60 min ( r = -0.58 ; P = 0.037 ; 95 % CI -0.79 to -0.27 ) and Δ ghrelin area under the curve ( r = -0.62 ; P = 0.025 ; 95 % CI -0.81 to -0.31 ) . CONCLUSIONS Retraining obese adolescents to eat more slowly has a significant impact on the gastrointestinal hormone response to a carbohydrate load , suggesting that externally modifiable eating behaviors actually regulate the hormonal response to food OBJECTIVE : To determine the effect of exercise training ( ET ) on components of the insulin resistance syndrome ( IRS ) in obese children . DESIGN : R and omized , modified cross-over study , with subjects assigned to one of two conditions : ( 1 ) 4 months of ET followed by 4 months of no-ET ; or ( 2 ) 4 months of no-ET followed by 4 months of ET . Measurements were made at three time points : 0 , 4 and 8 months . SUBJECTS : 79 obese , but otherwise healthy children ( age : 7–11 y , percent fat ( % fat ) 27–61 % ) . MEASUREMENTS : Plasma lipid and lipoprotein concentrations , plasma insulin and glucose concentrations ; % fat ; submaximal heart rate ( HR ) as an index of fitness . EXERCISE TRAINING : ET was offered 5 d/week 40 min/d . For the 73 children who completed 4 months of ET , the mean attendance was 80 % ( that is , 4 d/week ) and the average HR during ET was 157 bpm . RESULTS : Significant ( P<0.05 ) group x time interactions were found for plasma triglyceride ( TG ) and insulin concentrations and % fat . The average change for both groups , from just before ET to just after the 4 month ET was −0.24 mmolċl−1 for TG , −25.4 pmolċl−1 for insulin and −1.6 units for % fat . When Group 1 ceased ET , over the following 4 month period the average change for insulin was + 26.6 pmolċl−1 and for % fat + 1.3 units . CONCLUSION : Some components ( plasma TG , insulin , % fat ) of the IRS are improved as a result of 4 months of ET in obese children . However , the benefits of ET are lost when obese children become less active Abstract This study examined the effects of a 6-week intermittent exercise training , at different intensities , on body composition , functional walking and aerobic endurance in overweight children . Forty-eight overweight children ( age : 10.4 ± 0.9 years ) were r and omly assigned to either intervention or control group . Lower and higher intensity intermittent exercise groups ( LIIE and HIIE ) performed intermittent running three times a week . LIIE performed more intervals at a lower intensity [ 16 intervals at 100 % of individual maximal aerobic speed ( MAS ) , 8 minutes in total ] , and HIIE performed fewer intervals at a higher intensity ( 12 intervals at 120 % of MAS , 6 minutes in total ) . Each interval consisted of a 15-second run at the required speed , followed by a 15-second passive recovery . After 6 weeks , HIIE had a significantly ( p < 0.05 ) higher percentage reduction in sum of skinfolds ( i.e. calf and triceps ) , and significantly ( p < 0.05 ) fewer steps during the functional obstacle performance , as compared with LIIE and control group . Significant improvement ( p < 0.05 ) was found in intermittent aerobic endurance for HIIE as compared to the control group . Higher intensity intermittent training is an effective and time-efficient intervention for improving body composition , functional walking and aerobic endurance in overweight children Low levels of physical activity coupled with high levels of television viewing have been linked with obesity in children . The objective of this study was to assess the efficacy of ' Switch Off-Get Active ' , a 16-week controlled health education intervention , in increasing physical activity and reducing screen time and BMI in primary school children . A secondary objective was to compare children with high and low screen time . Participants were 312 children aged 10.2+/-0.7 years , attending nine schools in areas of social disadvantage . The 10-lesson , teacher-led intervention , conducted in spring 2003 , emphasised self-monitoring , budgeting of time and selective viewing . Differences , adjusted for baseline values by ANCOVA , existed between intervention and control children at follow-up for self-reported physical activity ( intervention + 0.84 30 min blocks/day , 95%CI 0.11 - 1.57 , p<0.05 ) and self-efficacy for physical activity ( p<0.05 ) but not self-reported screen time ( intervention--0.41 blocks/day , 95%CI--0.93 - 0.12 , p=0.13 ) or BMI ( p=0.63 ) . Cross-sectional comparisons at baseline indicated lower physical activity , self-efficacy for physical activity and aerobic fitness and a higher BMI in children with high screen time . In conclusion , health education interventions can increase physical activity in primary school children but follow-ups of longer duration may be needed to demonstrate intervention effects on BMI OBJECTIVE To assess the effects of reducing television viewing and computer use on children 's body mass index ( BMI ) as a risk factor for the development of overweight in young children . DESIGN R and omized controlled clinical trial . SETTING University children 's hospital . PARTICIPANTS Seventy children aged 4 to 7 years whose BMI was at or above the 75th BMI percentile for age and sex . INTERVENTIONS Children were r and omized to an intervention to reduce their television viewing and computer use by 50 % vs a monitoring control group that did not reduce television viewing or computer use . MAIN OUTCOME MEASURES Age- and sex-st and ardized BMI ( z BMI ) , television viewing , energy intake , and physical activity were monitored every 6 months during 2 years . RESULTS Children r and omized to the intervention group showed greater reductions in targeted sedentary behavior ( P < .001 ) , z BMI ( P < .05 ) , and energy intake ( P < .05 ) compared with the monitoring control group . Socioeconomic status moderated z BMI change ( P = .01 ) , with the experimental intervention working better among families of low socioeconomic status . Changes in targeted sedentary behavior mediated changes in z BMI ( P < .05 ) . The change in television viewing was related to the change in energy intake ( P < .001 ) but not to the change in physical activity ( P = .37 ) . CONCLUSIONS Reducing television viewing and computer use may have an important role in preventing obesity and in lowering BMI in young children , and these changes may be related more to changes in energy intake than to changes in physical activity OBJECTIVE Experts recommend that children engage in 60 minutes of daily moderate to vigorous PA ( PA ) , but few meet these goals . Exergames like " Dance Dance Revolution " ( DDR ) ( Konami of America , Redwood City , CA ) have the potential to provide PA . We sought to determine if DDR would boost PA among overweight or obese children . SUBJECTS AND METHODS Children over the 85th percentile for body mass index ( BMI ) and between 9 and 17 years old were r and omly assigned to receive DDR+pedometers ( treatment group ) or pedometers only ( comparison group ) . PA levels were tracked for 12 weeks by self-report , pedometer , and accelerometer data . RESULTS Sixty-five families completed the study . The average BMI percentile of the participant was over 96 percent . Despite r and omization , participants in the treatment ( DDR ) group were more often male , older , and heavier than participants in the comparison group . Self-reported frequency of moderate to vigorous PA increased significantly from baseline to 12 weeks for the treatment group and declined for the comparison group . Accelerometer results indicated a significant decline in moderate activity over time for the comparison group . However , there were no significant between-group differences based on the accelerometer or pedometer data . CONCLUSION Based on self-report measures , DDR may have increased PA levels in obese and overweight children . However , we are led to question the validity of these results because analyses based on objective measures do not confirm them . Accelerometer results indicate that although DDR did not boost PA , it may have helped to slow the decline in moderate to vigorous PA over time SCOPE Whole-grain foods have been reported to affect serum levels of inflammatory cytokines . However , we are aware of no study examining the effect of whole-grain intake on inflammatory biomarkers among children . The present study aim ed to determine the effect of whole-grain intake on serum levels of inflammatory biomarkers in overweight or obese children . METHODS AND RESULTS In this r and omized crossover clinical trial , 44 overweight or obese girls aged 8 - 15 years participated . After a 2-week run-in period , subjects were r and omly assigned to either whole-grain or control groups . Subjects in the whole-grain group were given a list of whole-grain foods and were asked to obtain half of their needed servings of grains from whole-grain foods each day for 6 weeks . Individuals in the control group were also given a list of whole-grain foods and were asked not to consume any of these foods during the intervention phase of the study . A 4-week washout period was applied following which subjects were crossed over to the alternate arm for an additional 6 weeks . Fasting blood sample s were taken before and after each phase of the study to quantify markers of systemic inflammation . Mean age , weight , and BMI of study participants were 11.2 ± 1.49 years , 51.2 ± 10.2 kg , and 23.5 ± 2.5 kg/m(2 ) , respectively . No significant effect of whole-grain intake on weight and BMI was seen compared with the control group . We found a significant effect of whole-grain intake on serum levels of high-sensitive C-reactive protein ( -21.8 versus + 12.1 % , p = 0.03 ) , soluble intercellular adhesion molecule-1 ( -28.4 versus + 6.3 % , p = 0.02 ) , serum amyloid A ( -17.4 versus + 9.9 % , p = 0.02 ) , and leptin ( -9.7 versus + 39.2 % , p = 0.02 ) after 6 weeks . A trend toward the significant effect of whole-grain intake on serum levels of soluble vascular cell adhesion molecule-1 ( -36.2 % versus -7.8 % , p = 0.07 ) was also observed . CONCLUSION This study provides evidence supporting the beneficial effects of whole-grain foods on biomarkers of systemic inflammation in obese children OBJECTIVE To explore factors influencing participation and attrition in a family-led weight-management programme for obese Pacific children . DESIGN Qualitative study used bilingual in-depth interviews at exit and end of an 8-week weight-management programme . SETTING New Zeal and . SUBJECTS Forty-two parents/ primary caregivers of obese children who were r and omised in the intervention weight-management programme . RESULTS Programmatic factors that enhanced retention included : simultaneous delivery to both children and parents as participants ; delivery of the programme in small group setting s at local community venues ; enabling trustworthy and accountable relationships ; providing re sources for travel to venues and regular telephone/text messaging follow-up calls reinforcing programme goals ; and day and time scheduling . Suggested programme improvements included having ethnic-specific Isl and - language delivery and practical sessions like cooking classes and shopping expeditions at local food stores . The research found that unpredictable external life crises like extended family deaths , a change in job shift , family illnesses ( both acute and those requiring chronic management ) and long-term family visitations affected participation and momentum . A loss of momentum through managing life crises was often difficult to overcome for participants , leading them to drop out of the weight-management programme . Most drop-out participants preferred to defer their programme participation with hopes of re-committing to future programmes at another time . CONCLUSIONS In order for weight-management programmes to be effective , participants must be able to complete them . Identifying factors that predict participation and attrition may serve as a basis for programme improvement Intervention studies in youth with obesity that can be translated into primary care are limited . We compared a lifestyle intervention to a brief intervention applied by primary care physicians ( control group ) for treating pediatric obesity in the primary care setting . Seventy-six youth with obesity ( body mass index [ BMI ] > 95th percentile or > 90th percentile plus waist circumference > 90th percentile , aged 9 to 17 years ) participated in a 12-month , r and omized , controlled trial , conducted at a primary care unit in Northern México from June 2006 through October 2007 . Participants r and omized to lifestyle intervention attended a family-centered program consisting of 12 sessions of behavioral curriculum , dietary advice from a registered dietitian ( weekly for the first 3 months and monthly thereafter ) , and monthly consultations with a primary care physician . Control group participants attended monthly consultations with a primary care physician who received a brief training on obesity . Forty-three ( 57 % ) participants completed the 12 months of study . After 12 months , mean changes ( 95 % confidence interval ) in body weight for the lifestyle group and the control group were -0.8 kg ( -3.2 , 1.5 ) vs + 5.6 kg ( 3 , 8.2 ; P<0.001 ) and mean changes in BMI were -1.8 ( -2.6 , -0.9 ) vs + 0.4 ( -0.5 , 1.3 ; P<0.001 ) , respectively . Intention-to-treat analysis at 12 months confirmed significant differences in primary outcomes ( weight -3.5 kg , P=0.02 ; BMI -1.2 , P=0.03 ) in favor of the lifestyle group . This study provides preliminary evidence that primary care physicians supported by a registered dietitian and a behavioral curriculum can be a successful strategy for treating pediatric obesity in the primary care setting The objective of this study was to evaluate demographic and psychosocial predictors of attendance in a family-based behavioral weight management clinical trial . Ninety-three children and adolescents aged 7 - 17 ( Mean age = 11.59 , s.d . = 2.6 ) who were either overweight or obese ( Mean BMI percentile = 98.2 ) and their parents received either a 10-session behavioral treatment or a three-session brief family intervention in the context of a r and omized clinical trial ( 10 ) . Psychosocial and anthropometric measures were obtained before enrollment and at the end of 10 weeks for both treatment groups . Univariate linear regression and hierarchical multiple regression analyses were used to identify predictors of attendance to treatment from an a priori set of hypothesized predictors . Three variables demonstrated significant associations with the dependent variable , percent of treatment sessions attended . Specifically , distance from participant 's home to treatment site , lower gross family income , and youth self-report of depressive symptoms were each associated with lower percent attendance ( all Ps < 0.05 ) . These results corroborate ( i.e. , income , depressive symptoms ) and exp and ( i.e. , distance from treatment site ) previous reports in the literature of potential barriers to effective treatment for pediatric obesity , and suggest the need for research on treatment delivery methods that could increase participation among low-income families ( e.g. , eHealth , mHealth options ) . Depressive symptoms could represent an additional barrier to treatment attendance , suggesting that assessment and treatment for these symptoms may be appropriate before commencing weight management treatment Childhood obesity is associated with an increased carotid intima-media thickness ( IMT ) and stiffness . Increased carotid wall thickening and rigidity are considered markers of sub clinical atherosclerosis . The aim of the present study was to test the effect of two hypocaloric diets of varying glycemic index on weight loss and markers of sub clinical atherosclerosis in obese children . Seventy consecutive obese children attending the Outpatient Weight Clinic of the Department of Pediatrics were invited to participate in an intensive dietary protocol . Twenty-six accepted and were r and omly assigned to two different groups : the first group followed a hypocaloric low-glycemic index diet and the second a hypocaloric high-glycemic index diet . Anthropometric measures and biochemical tests were performed in all children . Quantitative B-mode ultrasound scans were used to measure intima-media thickness ( IMT ) and diameters of the common carotid artery . Considering both groups together , at 6 months , body mass index decreased from 28.3 ± 3.1 to 25.8 ± 3.3 kg/m2 , systolic blood pressure from 119 ± 12 to 110 ± 11 mmHg ( P < 0.001 ) , diastolic blood pressure from 78 ± 8 to 74 ± 7 mmHg ( P < 0.001 ) , IMT from 0.48 ± 0.05 to 0.43 ± 0.07 mm ( P < 0.001 ) , stiffness from 3.57 ± 1.04 to 2.98 ± 0.94 mm ( P = 0.002 ) , and high-sensitivity C-reactive protein from 1.5 ± 0.9 ( values log transformed ) to 0.4 ± 1.1 ( P < 0.001 ) . No differences were detectable in fasting serum triglycerides , total cholesterol , and high-density lipoprotein cholesterol . Insulin resistance ( calculated by the HOmeostatic Model Assessment index [ HOMA ] score ) significantly reduced only in the low-glycemic-index diet group ( P < 0.04 ) . In conclusion , this study confirms a benefit of hypocaloric diets on carotid IMT and stiffness in obese children and demonstrates , for the first time , an amelioration of insulin sensitivity in obese children after a low-glycemic index diet . These results justify the advice to obese children to follow a low-glycemic index diet in order to improve their cardiometabolic profile OBJECTIVES . The intent of this study was to evaluate whether small changes in diet and physical activity , as promoted by the America on the Move initiative , could prevent excessive weight gain in overweight children . METHODS . In this family-intervention study , the America on the Move small-changes approach for weight-gain prevention was evaluated in families with at least 1 child ( 7–14 years old ) who was overweight or at risk for overweight . These children were the primary target of the intervention , and parents were the secondary target . Families were r and omly assigned to either the America on the Move group ( n = 100 ) or the self-monitor – only group ( n = 92 ) . Families who were assigned to the America on the Move group were asked to make 2 small lifestyle changes : ( 1 ) to walk an additional 2000 steps per day above baseline as measured by pedometers and ( 2 ) to eliminate 420 kJ/day ( 100 kcal/day ) from their typical diet by replacing dietary sugar with a noncaloric sweetener . Families who were assigned to the self-monitor group were asked to use pedometers to record physical activity but were not asked to change their diet or physical activity level . RESULTS . During a 6-month period , both groups of children showed significant decreases in BMI for age . However , the America on the Move group compared with the self-monitor group had a significantly higher percentage of target children who maintained or reduced their BMI for age and , consistently , a significantly lower percentage who increased their BMI for age . There was no significant weight gain during the 6-month intervention in parents of either group . CONCLUSIONS . The small-changes approach advocated by America on the Move could be useful for addressing childhood obesity by preventing excess weight gain in families Recent findings of a direct association of obesity and impaired health-related quality of life ( HRQOL ) in children suggest a need for early weight-management interventions that address psychosocial issues and lifestyle . Our aim was to compare the effects of exercise , diet , or diet + exercise on HRQOL in obese children . We hypothesized that HRQOL will improve as a result of the weight-loss intervention and will be correlated with the amount of weight loss achieved by each of the intervention groups . A total of 162 children aged 6 to 11 years with a body mass index ( BMI ) exceeding the 95th percentile were r and omly allocated to a 12-week regimens of diet , exercise , or diet + exercise . Weight , height , and percent fat mass were measured , and parents completed the Pediatric Quality of Life Inventory ( PedsQL ) 4.0 at baseline and at the end of the intervention . The reductions in BMI were significantly greater in the diet and diet + exercise groups than in the exercise group . Pediatric Quality of Life Inventory scores improved significantly , with no differences among the groups . A greater reduction in BMI occurred in children whose parents completed the PedsQL at baseline ( n = 105 ) than in children whose parents did not ( n = 15 ) ( -1.8 + /- 1.3 vs -1.0 + /- 1.5 ; P = .048 ) and in children whose parents completed the PedsQL at the end of the intervention ( n = 73 ) than in children whose parents did not ( n = 47 ) ( -2.0 + /- 1.3 vs -1.3 + /- 1.3 ; P = .013 ) . Weight-management programs that promote a healthy eating and physical activity can serve as an effective tool to improve the low HRQOL of obese children . Parental compliance is an important factor and may be assessed by the parents ' cooperativeness in completing question naires OBJECTIVE To examine whether a protein-sparing modified fast diet and a hypocaloric balanced diet are safe and effective for children in an outpatient weight reduction program . DESIGN R and omization of two groups to either diet , with follow-up at 14.5 months . SETTING Physician or parent referral to outpatient program at Children 's Hospital of New Orleans , La. PARTICIPANTS Nineteen children , ranging in age from 7.5 to 16.9 years , weighing 45 % to 131 % more than the mean weight for age , sex , and height . INTERVENTION During the first 10 weeks , 10 children were placed on a protein-sparing modified fast diet ( 2520 to 3360 J ) , and nine children and adolescents were placed on a hypocaloric balanced diet ( 3360 to 4200 J ) . Subsequently , all participants were placed on a hypocaloric diet ; calories were increased from 4200 to 5040 J in a 3-month period and maintained for 1 year . SELECTION PROCEDURES Children were assigned to one of two diets for the first 10 weeks according to their time of enrollment . MEASUREMENTS /MAIN RESULTS Both diets produced significant weight loss during the first 6 months . However , the protein-sparing modified fast diet produced significantly greater changes in the percentage of overweight at 10 weeks ( -30 % vs -14 % ) and at 6 months ( -32 % vs -18 % ) . At 10 weeks , a significant loss of adipose tissue with preservation of lean body mass occurred in the protein-sparing modified fast group . A transient slowing of growth velocity was noted at 6 months in both dietary groups compared with values at 14.5 months . Growth velocity approached normal levels at 14.5 months compared with st and ards for North American children . When dietary groups were combined , the initial mean blood pressure decreased significantly at all points in the study . The initial mean serum cholesterol value also decreased significantly at 10 weeks . No biochemical or clinical complications were observed . CONCLUSIONS These hypocaloric diets appear to be safe and effective in the short-term management of pediatric obesity . However , these diets should not be used without close medical supervision BACKGROUND Only multi-faceted treatment programs may influence childhood obesity . METHODS Thus our program consists of physical exercise , dietary counseling ( but no caloric reduction ) and psychological support . 17 obese children , aged 7 to 12 years , participated in this combined out-patient therapy program . The children were compared to a control group of 17 obese children who only received an initial dietary instruction . RESULTS After 6 months program children showed a very significant decrease of percentage overweight ( -11.5 % ) , whereas control children showed an increase of + 2.8 % . In contrast to control children program children improved their physical performance rather significantly . Both groups improved in body-esteem , whereas only program children showed a better self-esteem . Positive trends in lipid metabolism did not reach level of significance . CONCLUSIONS We conclude that a combined program of exercise and diet improves short-term results in the treatment of childhood obesity , even without insisting on caloric reduction Background and Aim : Energy intake is a major contributor to energy imbalance and is a key modifiable factor for successful treatment of obesity . Long-term changes in dietary intake from pediatric obesity treatment programs are rarely reported . The aim of this study was to describe the changes in food intake of children from all intervention groups from baseline to 2-year follow-up after a 6-month obesity intervention . Subjects and Methods : Overweight children ( n = 160 , 5–9 years ) , 58 % girls and body mass index z score ( mean ± SD ) 2.89 ± 0.79 , were recruited to the Hunter Illawarra Kids Challenge using the Parent Support r and omized controlled trial . Dietary intake was reported by parents for children at baseline and 2-year follow-up ( n = 87 ) using a food frequency question naire . Linear mixed models were used to determine differences by time . Results : Parents reported decreases in total energy ( total kcal , kcal/kg ) , child percentage of total energy from energy-dense , nutrient-poor foods ( sweetened drinks , potato crisps , sweets , and carry-out foods ) from 42 % ± 1.0 % at baseline to 34.8 % ± 1.0 % at 2 years ( P < 0.001 ) , with an increase in percentage of energy from nutrient-dense foods ( fruits , vegetables , dairy , breads , and cereals ) from 57 % ± 0.9 % at baseline to 65 % ± 1.0 % at 2 years ( P < 0.001 ) . Conclusions : This is the only one of a few studies that report dietary data of overweight children who participated in a treatment program with long-term follow-up . It provides evidence that improvements in food intake can be sustained up to 2 years through decreased consumption of energy-dense , nutrient-poor foods , particularly sweetened drinks , and increased consumption of core foods following an intervention Dietary fibres are frequently used for the treatment of paediatric obesity . The aim of this clinical trial is to evaluate the efficacy of glucomannan in the child obesity management . This experimental design was double blinded with a block r and omisation , alpha = 0.05 , beta = 0.2 and delta = 50 % . The study involved 60 children under 15 years of age ( mean age 11.2 years , mean overweight 46 % ) , 30 of them under glucomannan treatment ( 1 g twice a day for two months ) and 30 under placebo and the same schedule . The drug and the placebo were indistinguishable both for the family and the physician . During the two months study period the children followed a normocaloric diet evaluated every two weeks by a dietetic record book . At the beginning of the study the drug and the placebo groups were comparable in regards to anthropometric data . At the end , the mean overweight of the drug group was decreased from 49.5 % to 41 % and that of the placebo group from 43.9 % to 41.7 % . Both decreases were significant ( p < 0.01 ) , but no significant difference was observed between the drug and the placebo groups . The only significant difference concerned the lipid metabolism . The children under glucomannan treatment manifested a significant decrease of alpha-lipoprotein and an increase of pre-beta-lipoprotein and triglycerides ; the children under placebo manifested only a decrease of triglycerides and apo beta-lipoprotein . We suggest that this metabolic alteration may derive from a primary decrease of alpha-lipoprotein , most likely because of an inadequate water intake . ( ABSTRACT TRUNCATED AT 250 WORDS BACKGROUND Obesity and poor physical fitness constitute a health problem affecting an increasing number of children . Causes include a pervasive " toxic " environment that facilitates increased caloric intake and reduced physical activity . An effective strategy for prevention and treatment of childhood obesity likely includes a collaborative effort in the school setting . OBJECTIVE To determine whether a school-based fitness program can improve body composition , cardiovascular fitness level , and insulin sensitivity in overweight children . DESIGN Fifty overweight middle school children with a body mass index ( BMI ) above the 95th percentile for age were r and omized to lifestyle-focused , fitness-oriented gym classes ( treatment group ) or st and ard gym classes ( control group ) for 9 months . Children underwent evaluation of fasting insulin and glucose levels , body composition by means of dual energy absorptiometry , and maximum oxygen consumption ( V0(2)max ) treadmill testing at baseline ( before the school year ) and at end of the school year . SETTING S Rural middle school and an academic children 's hospital . MAIN OUTCOME MEASURES Baseline test results for cardiovascular fitness , body composition , and fasting insulin and glucose levels . RESULTS At baseline , there were no differences between groups before intervention ( values for age , 12 + /- 0.5 years [ all results , mean + /- SD ] ; BMI [ calculated as weight in kilograms divided by the square of height in meters ] , 31.0 + /- 3.7 ; percentage of body fat , 36.5 % + /- 4.6 % ; lean body mass , 41.4 + /- 8.6 kg ; and V0(2)max , 31.5 + /- 5.1 mL/kg per minute ) . Compared with the control group , the treatment group demonstrated a significantly greater loss of body fat ( loss , -4.1 % + /- 3.4 % vs -1.9 % + /- 2.3 % ; P = .04 ) , greater increase in cardiovascular fitness ( V0(2)max , 2.7 + /- 2.6 vs 0.4 + /- 3.3 mL/kg per minute ; P<.001 ) , and greater improvement in fasting insulin level ( insulin level , -5.1 + /- 5.2 vs 3.0 + /- 14.3 microIU/mL [ -35.4 + /- 36.1 vs 20.8 + /- 99.3 pmol/L ] ; P = .02 ) . CONCLUSIONS Children enrolled in fitness-oriented gym classes showed greater loss of body fat , increase in cardiovascular fitness , and improvement in fasting insulin levels than control subjects . The modification to the school physical education curriculum demonstrates that small but consistent changes in the amount of physical activity has beneficial effects on body composition , fitness , and insulin levels in children . Partnering with school districts should be a part of a public health approach to improving the health of overweight children Background : High-intensity progressive resistance training ( PRT ) improves adiposity and metabolic risk in adults , but has not been investigated in children within a r and omized controlled trial ( RCT ) . Objective : We hypothesized that high-intensity PRT ( 8 weeks , twice a week ) would decrease central adiposity in children , as assessed via waist circumference . Methods Design / Setting / Participants : Concealed r and omization stratified by age and gender was used to allocate rural New Zeal and school students to the wait-list control or PRT group . Intervention : Participants were prescribed two sets ( eight repetitions per set ) of 11 exercises targeting all the major muscle groups at high intensity . Primary Outcome : Waist circumference ; secondary outcomes included whole body fat , muscular fitness ( one repetition maximum ) , cardiorespiratory fitness ( peak oxygen consumption during a treadmill test ) , lipids , insulin sensitivity and fasting glucose . Results : Of the 78 children ( 32 girls and 46 boys ; mean age 12.2(1.3 ) years ) , 51 % were either overweight ( 33 % ) or obese ( 18 % ) . High-intensity PRT significantly improved waist circumference ( mean change PRT −0.8 ( 2.2 ) cm vs + 0.5 ( 1.7 ) cm control ; F=7.59 , P=0.008 ) , fat mass ( mean change PRT + 0.2 ( 1.4 ) kg vs + 1.0 ( 1.2 ) kg control ; F=6.00 , P=0.017 ) , percent body fat ( mean change PRT –0.3 (1.8)% vs + 1.2 (2.1)% control ; F=9.04 , P=0.004 ) , body mass index ( mean change PRT −0.01 ( 0.8 ) kg m−2 vs + 0.4 ( 0.7 ) kg m−2 control ; F=6.02 , P=0.017 ) , upper body strength ( mean change PRT+11.6(6.1 ) kg vs + 2.9(3.7 ) kg control ; F=48.6 , P<0.001 ) and lower body strength ( mean change PRT + 42.9(26.6 ) kg vs + 28.5(26.6 ) kg control ; F=4.72 , P=0.034 ) compared to the control group . Waist circumference decreased the most in those with the greatest baseline relative strength ( r=−0.257 , P=0.036 ) , and greatest relative ( r=−0.400 , P=0.001 ) and absolute ( r=0.340 , P=0.006 ) strength gains during the intervention . Conclusion : Isolated high-intensity PRT significantly improves central and whole body adiposity in association with muscle strength in normal-weight and overweight children . The clinical relevance and sustainability of these changes in adiposity should be addressed in future long-term studies BACKGROUND Non-alcoholic fatty liver disease is the most frequent liver abnormality observed in overweight or obese children and is strongly associated with metabolic syndrome and insulin resistance . OBJECTIVES ( i ) To evaluate the effect of a 22-week multidisciplinary intervention program on hepatic fat fraction in overweight or obese children and ( ii ) to examine the effect of the intervention on cardiometabolic risk factors , self-esteem and well-being . METHODS A total of 160 children , 9 - 11 years , will be recruited by pediatricians and r and omly assigned to control ( N = 80 ) or intervention ( N = 80 ) groups . The control group will receive a family-based lifestyle and psycho-educational program ( 2 days/month ) , while the intervention group will attend the same lifestyle education and psycho-educational program plus the exercise program ( 3 days/week ) . The duration of training sessions will be 90 min of exercise , including warm-up , moderate to vigorous aerobic activities , and strength exercises . The primary outcome is the change in hepatic fat fraction ( magnetic resonance imaging , MRI ) . Secondary outcomes include cardiometabolic risk factors such as total adiposity ( dual Xray absorptiometry ) , visceral adiposity ( MRI ) , functional peak aerobic capacity ( cardiopulmonary exercise testing ) , blood pressure , muscular fitness , speed – agility , and fasting blood insulin , glucose , C-reactive protein , alanine aminotransferase , aspartate aminotransferase , gamma glutamyltransferase , lipid profile and psychological measurements ( question naires ) . All the measurements will be evaluated at baseline prior to r and omization and after the intervention . DISCUSSION This study will provide insight in the efficacy of a multidisciplinary intervention program including healthy lifestyle education , psycho-education and supervised exercise to reduce hepatic fat and cardiometabolic risk in overweight children OBJECTIVE To assess dietary costs during a family-based pediatric obesity intervention . DESIGN Families were r and omized to one of two groups . Dietary and cost data were collected from a parent or child using three 24-hour recalls : at baseline , 6 months , and 12 months . SUBJECTS Thirty-one families with an obese 8- to 12-year-old child entered treatment , with complete dietary data provided from 20 families . INTERVENTION The 20-week behavior modification intervention emphasized increasing diet nutrient-density . Families attended group and individual sessions or group sessions . MAIN OUTCOME MEASURES Energy intake ; percent of energy from protein , fat , and carbohydrate ; servings and percent servings from food groups classified by nutrient density ; and daily food costs . STATISTICAL ANALYSES PERFORMED Mixed analyses of variance , with group as the between-subject factor , and time as the within-subject factor . RESULTS No significant effect of group was found in any analyses . Significant decreases in percent overweight were observed at 6 and 12 months for children ( -10.0+/-8.7 and -8.0+/-10.3 , respectively ) ( mean+/-st and ard deviation ) and parents ( -6.7+/-10.3 and -5.3+/-14.1 ) . Energy intake for parents and children combined significantly decreased from baseline ( 1,881+/-462 ) to 6 months ( 1,412+/-284 ) , and 1 year ( 1,338+/-444 ) . Servings from low-nutrient-dense foods significantly decreased from baseline ( 34.7+/-16.2 ) to 6 months ( 16.0+/-8.6 ) and 1 year ( 18.6+/-9.2 ) , causing a significant increase in diet nutrient density . Dietary cost did not change at 6 months , but significantly decreased from baseline to 1 year ( $ 6.77+/-2.41 to $ 5.04+/-1.80 ) . Cost per 1,000 kcal did not significantly change . APPLICATIONS/ CONCLUSIONS Adopting a lower-energy , nutrient-dense diet did not increase dietary costs over time . Consequently , cost should not be a barrier in the adoption of a healthful diet INTRODUCTION Childhood obesity has become a worldwide epidemic and Icel and ic children have not been exempt from increasing rates of obesity . Epstein´s family-based behavioral treatment for childhood obesity has demonstrated favorable outcomes in research setting s , but research in clinical setting s has been called for . The objective of this study was to replicate and confirm the effects observed in the US research setting . MATERIAL AND METHODS Participants were 84 obese children ( age-range : 8 - 13 years ) and a participating parent . Sixty-one families completed a 12 week treatment lasting 18 weeks , and were followed for one and two years post-treatment . Measurements at baseline and end of treatment included height and weight , daily activity , daily fruit and vegetable consumption , blood pressure , blood profiles and measures of psychological well-being . Measurements also included parental height , weight and depression scores . RESULTS Among treatment completers BMI -SDS ( body-mass index st and ard deviation score ) decreased significantly from pre- to post- treatment ( F(2.60)=110.31 , p<0.001 ) which was maintained at one-year ( F(2.60)=1.33 , p=0.253 ) and two-years ( F(2.60)= 3,19 , p=0.079 ) post treatment . There was a significant reduction in blood pressure ( upper : t(59)=-2.01 , p<0.05 , lower : t(59)=-4.00 , p<0.001 ) . Among a sub sample ( n=23 ) of participants , significant reductions were observed in fasting insulin levels , ( t(22)=6.1 , p<0.05 ) , triglycerides ( t(22)=0.31 , p<0.05 ) and total cholesterol ( t(22)=0.35 , p<0.05 ) . Significant improvements were observed for measures of psychological well-being ( depressive symptoms : ( F(1.59)=6.67 , p<0.05 ) ; anxiety : ( F(1,57)= 4.54 , p%lt;0.05 ) and children´s self-concept ( F(1.59)=19.2 , p<0.001 ) . A significant reduction was observed in parental BMI scores from pre- to post- treatment ( F(1.59)= 71.54 , p%lt;0.001 ) but a significant increase was evident at one year post-treatment ( F(1.59)=41.87 , p%lt;0.001 ) . Improvements were observed for measures of parental depression from pre- to post- treatment ( F(1.60)= 12.93 , p<0.01 ) . CONCLUSION Epstein´s family-based behavioural treatment showed promising effects on weight status , and emotional as well as physical markers , both in the short and long term in a clinical sample of obese Icel and ic children Background Young African American girls have a high risk of obesity . Online behavior change programs promoting healthy diet and physical activity are convenient and may be effective for reducing disparities related to obesity . This report presents the protocol guiding the design and evaluation of a culturally and developmental appropriate online obesity prevention program for young African American girls . Methods / Design The Butterfly Girls and the Quest for Founder ’s Rock is an 8-episode online program delivered as an animated , interactive comic . The program promotes healthy diet and physical activity and is specifically design ed for 8–10 year old African American girls . Girls , parents , and community representatives provided formative feedback on cultural relevance and developmental appropriateness . A three-group ( treatment , comparison , wait-list control ) r and omized design ( n = 390 parent/child dyads ) is employed , with child as the unit of assignment . Change in body mass index is the primary outcome ; change in fruit and vegetable consumption , water , and physical activity are secondary outcomes . Data collection occurs at baseline , approximately 3 months after baseline ( i.e. , completion of the online program ) , and approximately three months later ( i.e. , maintenance assessment ) . Two dietary recalls are collected at each data collection period by trained interviewers using the Nutrient Data System for Research ( NDSR 2012 ) system . Physical activity is objective ly measured by seven days of accelerometry . Psychosocial and process data are also collected . Girls in the treatment and comparison groups will be interviewed at post 1 to obtain information on personal reactions to the program . Discussion This research will develop and evaluate the efficacy of an online program for reducing obesity risk among girls at risk of obesity and related diseases . Online programs offer the potential for wide dissemination , thus reducing disparities related to obesity . Trial Registration AIM Increasing prevalence of obesity and related diseases especially in children and adolescent has gained more scientific attention . The present study was conducted to determine the effects of regular exercise on childhood obesity often associated with clinical conditions such as hypertension , dyslipidemia and diabetes already at a young age . METHODS The subjects were 40 obese children at 11 ± 1 years and with Body Mass Index ( BMI ) of at least 30 kg/m2 who volunteered to the study and r and omly classified into exercising and non-exercising control group . Physical load of the exercising group was first determined by the Karvonen protocol after which to the subjects underwent a 12-week aerobic exercise training program primary consisting of walking and jogging exercise . Blood pressure , biochemical cardiovascular risk factors and body composition were assessed before and after the exercise-training period and compared to the non-exercising control group . RESULTS In the exercising group , statistically significant changes were observed in the circumference of forearm , elbow , calf , knee , waist , chest and hip , as well as skin fold thickness of chest , subscapulae , calf , abdomen , suprailiac and leg . Similarly , total cholesterol , triglyceride , LDL , VLDL and insulin levels were found to be lower and HDL levels higher than in the non-exercising control group . CONCLUSION While treating obesity in children , a major emphasis should be directed towards increasing regular physical activity and supported with dietary interventions . By this approach the risk of other chronic diseases often associated with obesity could be minimized thereby improving the quality of life This study evaluates the results of weight control/obesity counselling in the outpatient nutrition clinic of a children 's hospital . Using a retrospective design , 96 r and omly selected patients referred to the clinic were followed for up to four years using their hospital charts or through information obtained from the referring physician on current weights and heights . At initial assessment , 87 of 96 ( 91 % ) children were classified as obese or severely obese at greater than 120 % of their Ideal Body Weight ( IBW ) ; eight other children would be classified as overweight and one child was within normal weight for height . Forty-nine referrals ( 51 % ) did not return for a follow-up visit after the initial assessment ; weights were available on 18 ( 37 % ) . On follow-up of 65 patients ; 8 % of patients achieved an IBW ; a further 34 % lost weight ; 46 % gained weight ; and 12 % maintained their weight . There was no difference in weight gain or loss by amount of participation in the program or by age or gender . We conclude that the weight control/obesity counselling program in our hospital is ineffective . A multidisciplinary program , based on a nutrition education theory and which includes an evaluation framework and addresses reasons for attrition and family needs , should be developed BACKGROUND & AIMS Lifestyle interventions address primarily obese children , while interventions tailored to overweight but not obese children are scarce . The effectiveness of the lifestyle intervention " Obeldicks light " based on physical activity training , nutrition education , and behavior counseling for overweight children and their parents has been demonstrated by a r and omized controlled trial . Here , we present the 12 months follow-up analysis of these children after end of intervention . METHODS Degree of overweight ( BMI and SDS- BMI ) , waist circumference , skinfold thickness , bioimpedance analyses ( BIA ) , and blood pressure were determined in 76 overweight ( BMI > 90(th)≤97(th ) percentile ) children ( mean age 11.8 ± 1.8years , 67 % females , mean BMI 24.3 ± 1.9 kg/m(2 ) ) participating in the evaluation study of " Obeldicks light " at onset of intervention ( T0 ) , end of 6 months intervention ( T1 ) , 6 months after end of intervention ( T2 ) and 12 months after end of intervention ( T3 ) . Comparisons were performed on an intention-to-treat approach . RESULTS The drop-out rate was 4 % in the intervention period and additional 3 % during follow-up . The children reduced significantly ( p < 0.001 ) their SDS- BMI in the intervention period between T0 and T1 ( -0.27 ± 0.23 ; p < 0.001 ) . This SDS- BMI reduction remained stable at T2 ( T0-T2:-0.26 ± 0.31 ; p < 0.001 ) and T3 ( T0-T3:-0.26 ± 0.39 ; p < 0.001 ) . SDS- BMI reductions were independent from age and gender . Body fat measured by skinfold thickness and BIA , waist circumference , and blood pressure decreased significantly in the intervention period and remained stable in the follow-up period as well . CONCLUSIONS The lifestyle intervention " Obeldicks light " was effective in reducing degree of overweight , fat mass , waist circumference , and blood pressure both at end of intervention and in a 12 months follow-up period BACKGROUND Pathways was the first multicenter American-Indian school-based study to test the effectiveness of an obesity prevention program promoting healthy eating and physical activity . METHODS Pathways employed a nested cohort design in which 41 schools were r and omized to intervention or control conditions and students within these schools were followed as a cohort ( 1,704 third grade rs at baseline ) . The study 's primary endpoint was percent body fat . Secondary endpoints were levels of fat in school lunches ; time spent in physical activity ; and knowledge , attitudes , and behaviors regarding diet and exercise . Quality control ( QC ) included design of data management systems which provided st and ardization and quality assurance of data collection and processing . Data QC procedures at study centers included manuals of operation , training and certification , and monitoring of performance . Process evaluation was conducted to monitor dose and fidelity of the interventions . Registration and tracking systems were used for students and schools . RESULTS No difference in mean percent body fat at fifth grade was found between the intervention and control schools . Percent of calories from fat and saturated fat in school lunches was significantly reduced in the intervention schools as was total energy intake from 24-hour recalls . Significant increases in self-reported physical activity levels and knowledge of healthy behaviors were found for the intervention school students . CONCLUSIONS The Pathways study results provide evidence demonstrating the role schools can play in public health promotion . Its study design and QC systems and procedures provide useful models for other similar school based multi- or single-site studies BACKGROUND The America on the Move ( AOM ) Family Intervention Program has been shown to prevent excess weight gain in overweight children . Providing intervention material s via the internet would have the potential to reach more families but may increase sedentary behavior . The purpose was to evaluate whether delivering the AOM Family Intervention via the internet versus printed workbook would have a similar impact on sedentary behaviors in children . METHODS 131 children ( age 8 - 12 ) were r and omized to receive the AOM Family Intervention via the internet or workbook for 12 weeks . Changes in objective ly measured sedentary time and moderate-to vigorous physical activity ( MVPA ) as well as self-reported screen time were compared between groups . RESULTS There were no significant differences between groups in screen time , sedentary time , or MVPA at the end of the 12 week intervention . Families receiving the intervention via the internet were more likely to remain in the study ( 98 % vs. 82 % , P = .016 ) . CONCLUSIONS Using the internet to deliver the lifestyle intervention did not increase sedentary behavior in children . Attrition rates were lower when the program was delivered by internet versus via printed material s. These results provide support for using the internet to deliver healthy lifestyle programs for children Objective : The study analyzed the effect of a combined environmental and educational intervention solely promoting water consumption on the incidence of overweight among school children . Methods : 2,950 second and third grade rs of 32 elementary schools in socially deprived neighborhoods of two German cities participated in a r and omized controlled intervention trial ( August 2006–June 2007 ) . In intervention schools ( N = 17 ) , water fountains were installed , each child received a water bottle , and teachers performed classroom lessons to promote water consumption . Control schools ( N = 15 ) did not receive any intervention . Body heights and weights were measured at baseline and follow-up to assess the incidence and remission of overweight and obesity during follow-up . The water flow of the fountains was measured regularly during follow-up . Children ’s beverage consumption was self-reported in 24-hour recall question naires before and after intervention . Results : After the intervention , the incidence of overweight was significantly lower in the intervention group ( 3.8 % ) than in the control group ( 6.0 % , p = 0.018 ) . Remission of overweight and obesity did not differ between the groups . Measured water flow of the fountains indicated a sustained use . Conclusion : A simple dietary intervention with the sole focus on the promotion of drinking water effectively reduced the incidence of overweight among school children The obesity epidemic is a global challenge that requires evidence -based intervention to slow the emergence of weight-related illness in children and adolescents . Thus , effective treatments are urgently needed . This study aim ed to analyze whether there is relationship between the initial stage of readiness for behavior change ( SRBC ) and the results obtained through participation in a multidisciplinary program of obesity treatment ( MPOT ) . The study included 113 overweight or obese children and adolescents who participated in an intervention for 16 weeks , in which the categorical variable was the SRBC . The dependent variables included : anthropometric measures of body composition , hemodynamic parameters ( e.g. , blood pressure values ) , and health-related physical fitness . Although stages 1 and 2 had greater improvements in flexibility than those in stage 5 , and stage 1 had greater percentage changes in abdominal strength than those in stage 5 , children and adolescents in the highest stage had greater percentage changes for anthropometric , hemodynamic and cardiorespiratory fitness , suggesting an impact of the stage of change on the effects of a MPOT . This study suggests that SRBC plays a role in obesity treatment in Brazilian children and adolescents and warrants consideration when enrolling patients to intervention INTRODUCTION Twenty-three percent of preschoolers are overweight/obese , which puts these children at risk for the development of chronic health comorbidities . The purpose of this r and omized control pilot study was to determine the feasibility and preliminary effects of a theoretically based , primary care intervention on the physical outcomes of 60 overweight/obese preschool/early school-aged 4- to 8-year-old children . METHODS After recruitment and baseline assessment , parent-child dyads were r and omly assigned to either the treatment or the control condition . Four intervention sessions were conducted with the parents in their child 's primary health care office . The impact of the intervention was evaluated by assessing child anthropometric measures ( e.g. , waist , waist-by-height ratio , and body mass index [ BMI ] ) immediately , 3 months , and 6 months after the intervention period . RESULTS Analysis of variance models suggested that children in the experimental group were found to have reduced waist circumference and waist-by-height ratio immediately after the intervention that persisted for 3 and 6 months ( f = 0.33 , 0.35 , respectively ) . BMI and BMI percentile were not differentially affected . DISCUSSION These promising findings suggest that a primary care-based , parent-focused overweight/obesity treatment program is feasible and demonstrated positive preliminary effects , improving the children 's overall health trajectory BACKGROUND Poor nutrition and inactivity are widespread and contribute to the epidemic problem of childhood obesity . This study examined the effectiveness of a school-based pilot program to improve nutrition and activity in elementary ( ES ) and high school ( HS ) students . METHODS The Improving Meals and Physical Activity in Children and Teens ( IMPACT ) school-based curriculum used a train-the-trainer model to improve activity and nutrition . Nine students were recruited from one rural North Carolina high school and trained in the IMPACT curriculum and leadership skills . Four 4th grade classes at a neighboring elementary school were r and omized to receive the IMPACT curriculum delivered by the HS students over 12 weeks ( two classrooms , 38 students ) versus the st and ard curriculum ( two classrooms , 37 students ) . Pre- and post-intervention surveys were used to assess program effectiveness . RESULTS ES students in the intervention classes reported increased fruit and vegetable intake ( + 0.85 servings/day compared with controls ; p < 0.05 ) and improved knowledge of the food group in which to eat the most servings ( p < 0.01 ) . ES students who participated in the IMPACT curriculum also reported increased intake of calcium-rich foods and grains , though these results were not statistically significant . Similar though nonsignificant improvements in diet behaviors were reported by the HS students who assisted in delivering the 4th grade curriculum . LIMITATIONS Study limitations include small sample size , risk of cross-contamination , and short program duration . CONCLUSIONS ES students who participated in the IMPACT curriculum reported improved dietary behaviors and knowledge . School-based curricula such as IMPACT may help improve nutrition among ES students OBJECTIVE We determined the effect of 4-month periods of physical training ( PT ) and detraining on percent fat ( percent fat ) and bone density of children with obesity . RESEARCH METHODS AND PROCEDURES Subjects were 79 7- to 11-year-old children with obesity ; 34 were white , 44 were black , and 1 was Asian , 26 were male and 53 were female . They were r and omly assigned to two groups : group 1 engaged in PT for the first 4 months , while group 2 engaged in PT during the second 4 months . Body composition was measured with dual energy absorptiometry , and diet was measured with 4 days of recall for each 4-month period . PT was offered 5 days/week for 40 minutes/session , heart rate monitors were worn , and no dietary information was given ; mean attendance was 80 % , and mean heart rate per session was 157 bpm . RESULTS Group by time interactions across the three time-points ( from analysis of variance ) were significant for percent fat ( p = < 0.001 ) and bone density ( p = 0.045 ) . Both groups declined in percent fat during the periods of PT , by an average of 1.6 % fat units ; in the 4 months after cessation of PT , group 1 increased by 1.3 % fat . In both groups , bone density increased more during periods of PT ( 0.025 g/cm2 ) than during periods of no PT ( 0.010 g/cm2 ) . No significant PT vs. no-PT differences were found for dietary intake of energy , macronutrients , or calcium . DISCUSSION This study suggests that regular exercise , without dietary intervention , can enhance the body composition of children with obesity The present study investigated the effects of two observational learning paradigms in modifying the eating behavior of obese children . A total of 18 subjects ranging in age from seven to 12 years and in weight from 74 to 160 lb ( 33 to 72 kg ) were r and omly assigned to three conditions . Intervention consisted of four sessions in which subjects viewed videotapes of their baseline eating behaviors compared with a model eating at a reduced speed . Based on the assumption that children may acquire their parents ' eating behaviors , one condition included videotapes of a same-sex adult model . In order to maximize model-observer similarity , subjects in a second treatment condition observed videotapes of themselves eating at a reduced speed . Subjects in the control condition viewed only their baseline eating behavior videotapes . Dependent measures of eating behavior were found to be significantly affected by both model treatments , while no significant differences were evidence d in the control group AIM The aim of this study was to examine the effects of a 6-week diet and exercise program , with emphasis on strength training , on the physical self-concept , body composition , and physical fitness of young overweight and obese children . METHODS Eighty-two overweight and obese children aged 8 - 11 years were r and omized into a diet-only or a diet- and -strength training group . Self-concept , body composition and physical fitness were measured before and after the 6-week study period using the Physical Self Description Question naires ( PSDQ ) , dual-energy X-ray absorptiometry ( DXA ) , and st and ard fitness tests . Dietary intake was assessed with a food frequency question naire . Total daily energy intake was significantly reduced in both groups with a trend of more reduction in the diet-only group . RESULTS Both groups developed greater confidence in strength . Those in the diet- and -strength training group also improved their endurance self-concept . Body Mass Index ( BMI ) decreased significantly in both groups . Lean mass increased significantly in both groups but significantly more in the diet- and -strength training group ( + 0.8 kg vs + 0.3 kg , P<0.05 ) . H and grip , shuttle run , sit-up , and push-up were significantly improved in both groups , to a significantly greater extent in the diet- and -strength training group . CONCLUSION These findings confirm the 6-week program of either diet-only or diet- and -strength training improved overweight/obese children 's self-perception of muscular strength and body composition . With the diet- and -strength training program , self-concept in endurance also improved and the gain in lean body mass was more than double that of the diet only group BACKGROUND Interactive technologies have the potential to increase the reach and frequency of practical clinical interventions that assist the parents of overweight and at-risk children to promote healthy lifestyle behaviors for their families . DESIGN A practical RCT evaluated the relative effectiveness of three interventions to support parents of overweight or at-risk children to change the home environment to foster more healthful child eating and activity behaviors , thereby reducing child BMI and BMI z-scores . A secondary purpose was to determine the patterns of use and potential dose effect for the highest-intensity intervention . SETTING / PARTICIPANTS Parent- and -child ( aged 8 - 12 years ) dyads ( N=220 ) who received care from Kaiser Permanente Colorado were assigned r and omly to one of the three Family Connections ( FC ) interventions : FC-workbook , FC-group , or FC-interactive voice response ( IVR ) counseling . MAIN OUTCOME MEASURES Child BMI z-scores , as well as symptoms of eating disorders and body image , were assessed at baseline , 6 months , and 12 months . RESULTS The BMI z-scores of children assigned to the FC-IVR intervention were the only ones that decreased from baseline to 6 months ( 0.07 SD ) and from baseline to 12 months ( 0.08 SD , p<0.05 ) . Children whose parents completed at least six of the ten FC-IVR counseling calls had decreased BMI z-scores to a greater extent than children in the FC-workbook or FC-group interventions at both 6 months ( p<0.05 ) and 12 months ( p<0.01 ) . No intervention increased child symptoms of eating disorders or body dissatisfaction at any time point . CONCLUSIONS This trial demonstrated that automated telephone counseling can support the parents of overweight children to reduce the extent to which their children are overweight . TRIAL REGISTRATION NCT00433901 BACKGROUND : Pediatrician-led motivational interviewing can be an effective way of controlling BMI in overweight children in the short term . Its long-term efficacy is unknown . The primary aim was to determine whether the short-term ( 12-month ) impact of family pediatrician-led motivational interviews on the BMI of overweight children could be sustained in the long term ( 24 months ) , in the absence of any other intervention . METHODS : Children were recruited in 2011 by family pediatricians working in the province of Reggio Emilia , Italy , and r and omly allocated to receive either 5 interviews delivered over a 12-month period or usual care . Eligible participants were all 4- to 7-year-old overweight children resident in the province of Reggio Emilia who had been receiving care from the pediatrician for ≥12 months . The primary outcome of this study was individual variation in BMI between the baseline visit and the 24-month follow-up , assessed by pediatricians not blinded to treatment group allocation . RESULTS : Of 419 eligible families , 372 ( 89 % ) participated ; 187 children were r and omized to receive intervention and 185 to usual care . Ninety-five percent of the children attended the 12-month follow-up , and 91 % attended the 24-month follow-up . After the 12-month intervention period , BMI in the intervention group increased less than in the control group ( 0.46 and 0.78 , respectively ; difference −0.32 ; P = .005 ) . At the 24-month follow-up , the difference had disappeared ( 1.52 and 1.56 , respectively ; difference −0.04 ; P = .986 ) . CONCLUSIONS : The intervention lost its effectiveness within 1 year of cessation . Sustainable boosters are required for weight control and obesity prevention The prevalence of obesity in American youth is increasing and treatment of the condition is difficult . We have developed a multi‐disciplinary weight reduction program that extends over 1 y and includes a very low‐calorie diet ( VLCD ) followed by a hypocaloric diet , exercise , and behavior modification . Based on data collected at baseline , at the end of the acute intervention phase ( 10–20 wk ) , and at 1‐y evaluation , we assessed the efficacy of this outpatient weight reduction program in treating obese children and adolescents in a follow‐up of a series of cases . Furthermore , we examined the impact of the approach on growth velocity and maintenance of weight loss at 1 y. Fifty‐six overweight children ( aged 7–17 y ) were recruited during a period of 18 mo to participate in the weight management program ; 52 ( 93 % ) completed the acute phase of treatment and 35 ( 62.5 % ) successfully completed the I‐y program . There was a significant decrease in body weight and body fat , as assessed by weight determinations and skinfold measurements 0 , < 0.0001 ; results not corrected for age ) . The body mass index for the 35 individuals who completed the 1‐y program decreased significantly from 32.7 on entry to 28.72 at 1 y ( p < 0.0001 ; results not corrected for age ) Purpose : To test the effectiveness of an intervention delivered by health professionals outside the school environment to girls identified with issues such as poor body image , low self-esteem , low self-confidence , nonparticipation in sports , or being overweight or underweight . Design : The study ’s design was a stepped-wedge r and omized controlled trial to test the efficacy of an intervention on self-esteem , impairment induced by eating disorders , self-efficacy , body satisfaction , and dieting behaviors . Setting : The study took place at the community health center located in a culturally diverse area of Melbourne , Victoria , Australia . Subjects : Participants were 122 primary and secondary school girls between 10 and 16 years of age . Intervention : Girls on the Go ! is a 10-week program design ed to improve self-esteem , body image , and confidence , using an empowerment model that involved interactive and experiential learning approaches . Weekly themes included body image and self-esteem , safety and assertiveness , a healthy mind , physical activity , healthy eating , trust and confidence , and connections . Measures : Measurements were made using Rosenberg Self-Esteem Scale , clinical interview assessment , health self-efficacy ( included mental health and physical health self-efficacy scales ) , body esteem scale , and the Dutch Eating Behavior Question naire for Children . Analysis : A linear mixed model was used . Results : The intervention led to a significant increase ( p < .05 ) in self-esteem and self-efficacy ( mental and physical health self-efficacy subscales ) , for both primary and secondary school-aged participants and reduced dieting behaviors ( secondary school participants ) . These gains were retained after 6 months of follow-up . Conclusion : This group-based , low-dose intervention , which , although targeting girls with a range of psychological issues and including both overweight and underweight participants , is a successful means of improving self-esteem among girls from diverse cultural background Objectives : To determine whether a school obesity prevention project developed in the United States can be adapted for use in Engl and . Methods : A pilot cluster r and omised controlled trial and interviews with teachers were carried out in 19 primary schools in South West Engl and . Participants included 679 children in year 5 ( age 9–10 ) . Baseline and follow-up assessment s were completed for 323 children ( screen viewing ) and 472 children ( body mass index ) . Sixteen lessons on healthy eating , physical activity and reducing TV viewing were taught over 5 months by teachers . Main outcome measures were hours of screen activities , body mass index , mode of transport to school and teachers ’ views of the intervention . Results : Children from intervention schools spent less time on screen-viewing activities after the intervention but these differences were imprecisely estimated : mean difference in minutes spent on screen viewing at the end of the intervention ( intervention schools minus control schools ) adjusted for baseline levels and clustering within schools was −11.6 ( 95 % CI −42.7 to 19.4 ) for a week day and was −15.4 ( 95 % CI −57.5 to 26.8 ) for a Saturday . There was no difference in mean body mass index or the odds of obesity . Conclusions : It is feasible to transfer this US school-based intervention to UK schools , and it may be effective in reducing the time children spend on screen-based activities . The study has provided information for a full-scale trial , which would require 50 schools ( ∼1250 pupils ) to detect effects on screen viewing and body mass index over 2 years of follow-up OBJECTIVE The aim of this study was to conduct a preliminary evaluation of Children 's Appetite Awareness Training ( CAAT ) , a treatment for childhood obesity which encourages overweight children to eat in response to internal appetite cues . METHOD Overweight children ( ages 6 - 12 years old ) were r and omized to either the CAAT treatment group ( N = 23 ) , to receive 1-h treatment sessions over 6 weeks , or a wait-list group ( N = 24 ) . Weight and height of children and parents in both groups were assessed at pre- and post-treatment ( or equivalent time for wait-list control ) and at a 6-month follow-up for those in the CAAT group . RESULTS The intervention had a significant , short-term effect on the BMI of children who participated . Although at 6-month follow-up , children 's BMI has not increased significantly , the difference between pretreatment and follow-up BMI was no longer significant . DISCUSSION These results are encouraging for the use of CAAT with overweight children . Long-term effectiveness could be enhanced through increasing the duration of the program , adding booster sessions and increased involvement of parents Objective : In general , treatment of childhood obesity focuses on treating the obese children . The results of child-directed treatments are disappointing in the long run . In the current study , it is tested whether a treatment aim ed solely at obese children 's parents results in positive effects on the children 's weight status . In addition , potential predictors of treatment success are identified . Methods : The parents of 98 overweight or obese children ( aged 7–13 years ) were r and omly assigned to either the cognitive-behavioural group treatment ( eight sessions ) or the waiting-list control group . Results : With respect to child body mass index ( BMI ) percentile , the parents ’ treatment was successful in reducing overweight from pretreatment to posttreatment : BMI percentile decreased significantly by 2.4 % in the treatment group , whereas there was no change in the waiting-list control group . There was no significant relapse at follow-up ( 3 months ) . Child BMI percentile did not decrease in the waiting-list control group . In addition , significant main effects of time were found for both groups with respect to eating psychopathology ( decrease ) , self-esteem ( increase ) and negative thoughts ( decrease ) . Finally , parental BMI decreased significantly only in the treatment group . Four predictors were identified with respect to treatment success , namely , lower socioeconomic status , younger age of the child , higher parental attendance and lower BMI percentile of the child before treatment . Conclusions : The parents ’ treatment had significant effects on child and parent BMI . Long-term endurance of these positive effects needs to be studied . Striking are the positive effects of time in the waiting-list control group for some psychological outcome measures . Obviously , waiting for treatment already affects psychological processes ( but not behaviour ) in the children IMPORTANCE Identifying community-based programs that increase physical activity among diverse youth could yield sustainable tools to reduce obesity and obesity disparities . OBJECTIVE To evaluate the impact of a community-based after-school soccer and youth development program , America SCORES , on students ' physical activity , weight status , and fitness . DESIGN Cluster-r and omized trial . Study measures were collected in the fall ( baseline ) , winter ( midpoint ) , and spring ( end point ) of the 2009 - 2010 school year . SETTING After-school programs in 6 schools within a large urban school district . PARTICIPANTS All 4th and 5th grade students in after-school programs at the study schools were eligible . INTERVENTION Three schools were r and omized to receive the SCORES after-school program , delivered via the train-the-trainer model . MAIN OUTCOME MEASURES Change in minutes of after-school moderate-to-vigorous physical activity ( MVPA ) , fitness ( maximal oxygen consumption ) , and body mass index over 1 school year . RESULTS Participants ( n = 156 ) were diverse ( 42 % Latino , 32 % Asian , and 12 % African American ) and 76 ( 49 % ) had a body mass index at or above the 85th percentile . There were no significant group differences in the change in physical activity , fitness , or weight status among all students . However , among students with a body mass index at or above the 85th percentile , SCORES significantly increased MVPA after school ( 3.4 min/d ; 95 % CI , 0.3 - 6.5 ) and on Saturdays ( 18.5 minutes ; 95 % CI , 3.4 - 33.6 ) . CONCLUSIONS AND RELEVANCE Existing community-based programs such as SCORES can increase physical activity among low-income youth , particularly those most at risk for weight-related comorbidities . While evaluating existing programs presents special challenges , partnerships between communities , schools , and research ers are an important component of translational research to address obesity . TRIAL REGISTRATION clinical trials.gov Identifier : NCT01156103 OBJECTIVE To compare the effectiveness and safety of carbohydrate (CHO)-modified diets with a st and ard portion-controlled ( PC ) diet in obese children . STUDY DESIGN Obese children ( n=102 ) aged 7 - 12 years were r and omly assigned to a 3-month intervention of a low-CHO ( LC ) , reduced glycemic load ( RGL ) , or st and ard PC diet , along with weekly dietary counseling and biweekly group exercise . Anthropometry , dietary adherence , and clinical measures were evaluated at baseline and 3 , 6 , and 12 months . Analyses applied intention-to-treat longitudinal mixed models . RESULTS Eighty-five children ( 83 % ) completed the 12-month assessment . Daily caloric intake decreased from baseline to all time points for all diet groups ( P<.0001 ) , although LC diet adherence was persistently lower ( P<.0002 ) . At 3 months , body mass index z score was lower in all diet groups ( LC , -0.27 ± 0.04 ; RGL , -0.20 ± 0.04 ; PC , -0.21 ± 0.04 ; P<.0001 ) and was maintained at 6 months , with similar results for waist circumference and percent body fat . At 12 months , participants in all diet groups had lower body mass index z scores than at baseline ( LC , -0.21 ± 0.04 ; RGL , -0.28 ± 0.04 ; PC , -0.31 ± 0.04 ; P<.0001 ) , and lower percent body fat , but no reductions in waist circumference were maintained . All diets demonstrated some improved clinical measures . CONCLUSION Diets with modified CHO intake were as effective as a PC diet for weight management in obese children . However , the lower adherence to the LC diet suggests that this regimen is more difficult for children to follow , particularly in the long term Abstract We examined effects of a 3-month football training programme in overweight children using comprehensive echocardiography and peripheral arterial tonometry . Twenty preadolescent overweight children ( 17 boys , 3 girls aged 8–12 yrs ; body mass index [ BMI ] ≥ 85th percentile ) participated in a structured 3-month football training programme , consisting of 4 weekly 60–90 min sessions with mean heart rate ( HR ) > 80 % of HRmax ( football group , FG ) . A parallel control group ( CG ) included 11 children ( 7 boys , 4 girls ) of equivalent age from an obesity clinic . After 3 months , systolic blood pressure was unchanged in FG , but had increased in CG ( 112 [ s 6 ] vs. 122 [ 10 ] mmHg , P = 0.02 ) . FG demonstrated increased left ventricular ( LV ) posterior wall diameter ( 0.60 [ 0.07 ] vs. 0.68 [ 0.10 ] cm , P < 0.001 ) and an improved right ventricular systolic function determined by tricuspid annular plane systolic excursion ( TAPSE , 2.01 [ 0.29 ] vs. 2.27 [ 0.28 ] cm , P = 0.003 ) . Measures of LV systolic function showed only discrete alterations and two-dimensional ( 2D ) global strain was not changed . After 3 months , global isovolumetric relaxation time ( IVRTglobal ) had increased in FG ( 64.0 [ 7.5 ] vs. 73.9 [ 9.4 ] ms , P < 0.001 ) while other examined LV diastolic function variables were not altered . No echocardiographic changes were observed in CG . Between-group differences in pre-post delta values were observed for systolic blood pressure , TAPSE , and IVRTglobal ( P = 0.02–0.03 ) . We conclude that short-term football training may have positive structural and functional effects on the cardiovascular system in overweight preadolescent children Childhood obesity may be lessened by parent-focused interventions . A pilot parent-directed trial with 46 parents of overweight and obese elementary school students was conducted at two ethnically diverse public schools in Framingham , Massachusetts . Parents were r and omly assigned to either the Material s Group , which received mailed educational material s , or the Material s plus Personal Encounters Group , which received educational material s through interactions with community health workers ( CHWs ) . Parents completed baseline and post-intervention surveys ; children ’s body mass index ( BMI ) percentiles were measured at baseline and post-intervention . There were no differences in the reduction of children ’s BMI between groups . However , the mean BMI percentile for all children dropped from 94.1 to 90.6 ( p = .005 ) , while there was no change in BMI among a nonr and omized contemporaneous control group . Findings are limited by the lack of a true control group and small sample size . Results from this school nurse and CHW outreach program to parents are encouraging OBJECTIVE Differences in fundamental movement skills and self-perceptions of physical ability and physical appearance of overweight and non-overweight children were investigated . METHOD Overweight ( n = 89 , mean age = 8.75 ± 1.4 years , BMI z-score = 2.22 , SD = 0.46 , 46 % male ) and non-overweight ( n = 27 , mean age = 8.25 ± 1.5 years , BMI z-score = 0.03 , SD = 0.73 , 62.1 % male ) participants enrolled in the KOALA ( Kinder Overweight Activity Lifestyle Actions ) project were included . The overall objective of the KOALA project was to determine in a r and omized controlled trial the effect of a Triple P ( Positive Parenting Program ) , and a family ' Eat Well Be Active ' Scouts Camp program on BMI in overweight children . Baseline between-group differences on measures of fundamental movement skills and self-concept perceptions were analyzed using independent sample s t-tests . Relationships between BMI and these variables were investigated with multiple linear regression . RESULTS Overweight children had lower scores on Bruninks-Oseretsky Test of Motor Performance-2 subtests ( Bilateral Coordination , Upper Limb Coordination , Strength , Balance , and Running Speed and Agility ) , and Physical abilities self-concept than non-overweight children . CONCLUSIONS Children who were overweight had significant fundamental movement skill difficulties , as well as having poorer Physical abilities self-concept perceptions compared to non-overweight children . The association between increasing BMI and poor performance of gross motor tasks has potential implication s for physical activity participation . Future research is needed to determine if fundamental movement skill difficulties and low physical ability self-concept are predisposing factors for children who are overweight or associated outcomes The CHIRP study is a two-arm , pilot r and omized controlled trial assessing the effectiveness of a behavioral family weight management intervention in an important and at-risk population , overweight young children , 3 to 6 years of age , and their parents from underserved rural counties . Participants will include 96 parent-child dyads living in rural counties in north central Florida . Families will be r and omized to one of two conditions : ( a ) behavioral family based intervention or ( b ) a waitlist control . Child and parent participants will be assessed at baseline ( month 0 ) , post-treatment ( month 4 ) , and follow-up ( month 10 ) . Assessment s and intervention sessions will be held at the Cooperative Extension office in each participating rural county . The primary outcome measure is change in child body mass index ( BMI ) z-score . Additional key outcome measures include child dietary intake , physical activity , and parent BMI . This study is unique because ( 1 ) it is one of the few r and omized controlled trails examining a behavioral family intervention to address healthy habits and improved weight status in young overweight and obese children , ( 2 ) addresses health promotion in rural setting s , and ( 3 ) examines intervention delivery in real world community setting s through the Cooperative Extension Service offices . If successful , this research has potential implication s for medically underserved rural communities and preventative health services for young children and their families The aim of this study was to evaluate the effectiveness of the Mind , Exercise , Nutrition , Do it ( MEND ) Program , a multicomponent community-based childhood obesity intervention ( www.mend central .org ) . One hundred and sixteen obese children ( BMI > or= 98 th percentile , UK 1990 reference data ) were r and omly assigned to intervention or waiting list control ( 6-month delayed intervention ) . Parents and children attended eighteen 2-h group educational and physical activity sessions held twice weekly in sports centers and schools , followed by a 12-week free family swimming pass . Waist circumference , BMI , body composition , physical activity level , sedentary activities , cardiovascular fitness , and self-esteem were assessed at baseline and at 6 months . Children were followed up 12 months from baseline ( 0 and 6 months postintervention for the control and intervention group , respectively ) . Participants in the intervention group had a reduced waist circumference z-score ( -0.37 ; P < 0.0001 ) and BMI z-score ( -0.24 ; P < 0.0001 ) at 6 months when compared to the controls . Significant between-group differences were also observed in cardiovascular fitness , physical activity , sedentary behaviors , and self-esteem . Mean attendance for the MEND Program was 86 % . At 12 months , children in the intervention group had reduced their waist and BMI z-scores by 0.47 ( P < 0.0001 ) and 0.23 ( P < 0.0001 ) , respectively , and benefits in cardiovascular fitness , physical activity levels , and self-esteem were sustained . High-attendance rates suggest that families found this intensive community-based intervention acceptable . Further larger controlled trials are currently underway to confirm the promising findings of this initial trial OBJECTIVE To evaluate the effects of behavioral , family-based treatment on disordered eating and child behavior problems for obese 8- to 12-year-old children . STUDY DESIGN We examined disordered eating in children and parents using the Kids ' Eating Disorder Survey ( KEDS ) and the Binge Eating Scale , respectively ; and psychologic problems in children and their parents using the Child Behavior Checklist and Symptom Checklist-90 , respectively , in 47 families who participated in a family-based obesity treatment program . RESULTS Obese children showed significant decreases ( -12.5 + /- 13.5 ) in percent overweight , internalizing problems ( -7.0 + /- 7.3 ) , and total behavior problems ( -4.8 + /- 6.6 ) and increases in behavioral competence ( 3.7 + /- 5.0 ) over 2 years of measurement ; and their parents showed significant decreases in weight ( -5.0 + /- 8.3 kg ) and reductions in parental distress ( -2.3 + /- 7.6 ) and in disturbed eating and weight-related cognition ( -3.2 + /- 5.3 ) . No significant changes were observed in total KEDS ( -0.2 + /- 1.9 ) , weight dissatisfaction ( -0.3 + /- 1.7 ) , or purging/restricting ( 0.2 + /- 0.6 ) scores . Decreases in total KEDS were related to decreases in total behavior problems and externalizing behavior problems . CONCLUSIONS These results document improvements in child behavior problems and competence and no change in symptoms of disordered eating in a st and ardized behavioral weight control program OBJECTIVE To study the effect of a st and ardised training programme focusing on maintenance of fat free mass during weight reduction by energy reduction in obese children . DESIGN R and omised trial of physical training programme and dietary advice ( group A ) versus dietary advice alone ( group B ) . SUBJECTS Thirty obese children and adolescents ( 14 group A , 16 group B ) participated in the 12 week long programme ; 20 children ( 10 group A , 10 group B ) were also reassessed after one year . MEASUREMENTS Fat free mass was estimated from the resistance index , obtained by bioelectrical impedance analysis at baseline , after four , eight , and 12 weeks in all subjects , and after one year in 20 subjects . RESULTS The mean ( SD ) change in fat free mass was significantly different between the two groups after 12 weeks ( group A , 2.68 ( 3.74 ) kg ; group B , 0.43 ( 1.65 ) kg ) . The change in body weight after one year was inversely correlated with the change in fat free mass after 12 weeks ( r = −0.44 ) , as assessed in the 20 subjects . CONCLUSIONS A st and ardised training programme as used in this study can prevent reduction in fat free mass during weight loss in obese children . Reduction in fat free mass during weight reduction might be a risk factor for regain of weight Background Childhood obesity remains a serious concern in the United States and in many other countries . Direct experience preparing and tasting healthful foods and increasing activity during the school day are promising prevention approaches . Engaging parents and families remains an important challenge . Fuel for Fun : Cooking with Kids Plus Parents and Play is a multi-component school- and family-based intervention for 4th grade rs and their families intended to promote positive food and activity environments , policies and behaviors at the individual , family and school levels . This paper describes the design and evaluation plan . Methods / Design Four cohorts of 4th- grade rs and their parents from 8 schools in 2 districts in the same Northern Colorado region are participating in a 4-arm cluster r and omized controlled trial . Theory-based Fuel for Fun consists of 5 components delivered over 1 school year : 1 ) Cooking with Kids - Colorado ; an experiential classroom-based cooking and tasting curriculum , 2 ) Cafeteria Connections ; cafeteria-based reinforcements of classroom food experiences using behavioral economic strategies , 3 ) SPARK active recess ; a playground intervention to engage children in moderate to vigorous activity , 4 ) Fuel for Fun Family ; multi-element supports targeting parents to reinforce the 3 school-based components at home , and 5 ) About Eating ; an online interactive program for parents addressing constructs of eating competence and food re source management . Outcomes include child and parent measures of fruit and vegetable preferences and intake , cooking , physical activity , sedentary behaviors and attitudes . School level data assess lunch plate waste and physical activity at recess . In-depth diet and accelerometry assessment s are collected with a sub sample of parent-child dyads . Data are collected at baseline , immediately post-intervention at 7 months , and at 12 month follow-up . We anticipate recruiting 1320–1584 children and their parents over the length of the project . Discussion The Fuel for Fun study design allows for impact assessment of school- , family- and online parent-based intervention components separately and in combination . Study strengths include use of theory- and evidence -based programs , valid child and parent self-report instruments , and objective measures of food , cooking , and physical activity behaviors at the individual , family and school levels . Parent involvement and engagement is examined through multiple strategies . Trial registration Clinical trials.gov registration number NCT02491294 . Registered 7 July , 2015 Background . Primary care is an ideal setting to treat pediatric obesity . Effective , low-intensity ( ≤25 contact hours over 6 months ) interventions that reduce st and ardized body mass index ( z- BMI ) and can be delivered by primary care providers are needed . Objective . This pilot r and omized controlled trial investigated the effect of 3 low-intensity ( ≤25 contact hours over 6 months ) pediatric obesity treatments on z- BMI . Methods . Twenty-two families ( children 8.0 ± 1.8 years , z- BMI of 2.34 ± 0.48 ) were r and omized into 1 of 3 , 6-month , low-intensity conditions : newsletter ( N ) , newsletter and growth monitoring ( N + GM ) , or newsletter and growth monitoring plus family-based behavioral counseling ( N + GM + BC ) . Anthropometrics and child eating and leisure-time behaviors were measured . Results . Mixed-factor analyses of variance found a significant ( P < .05 ) main effect of time for z- BMI and servings per day of sugar sweetened beverages , with both decreasing over time . Conclusion . Low-intensity obesity treatments can reduce z- BMI and may be more feasible in primary care OBJECTIVE The objective of this study was to examine the efficacy of U.S. primary care paediatric obesity treatment recommendations , within two r and omized trials . METHODS Between November 2005 to September 2007 , 182 families ( children aged 4 - 9 years , body mass index [ BMI ] ≥85th percentile ) were recruited for two separate trials and r and omized within trial to a 6-month intervention . Each trial had one intervention that increased child growth-monitoring frequency and feedback to families ( GROWTH MONITORING ) . Each trial also had two interventions , combining GROWTH MONITORING with an eight-session , behavioural , parent-only intervention targeting two energy-balance behaviours ( Trial 1 : reducing snack foods and sugar-sweetened beverages [ DECREASE ] , and increasing fruits , vegetables and low-fat dairy [ INCREASE ] ; Trial 2 : decreasing sugar-sweetened beverages and increasing physical activity [ TRADITIONAL ] and increasing low-fat milk consumption and reducing television watching [ SUBSTITUTES ] ) . Child st and ardized BMI ( Z BMI ) and energy intake were assessed at 0 , 6 and 12 months . RESULTS In both trials , main effects of time were found for Z BMI , which decreased at 6 and 12 months ( P < 0.01 ) . In Trial 1 , Z BMI reduced from 0 to 6 months , which was maintained from 6 to 12 months ( ΔZ BMI 0 to 12 months = -0.12 ± 0.22 ) . In Trial 2 , Z BMI reduced from 0 to 6 and from 6 to 12 months ( ΔZ BMI 0 - 12 months = -0.16 ± 0.31 ) . For energy intake , main effects of time were found in both trials and intake reduced from 0 to 6 months ( P < 0.05 ) , with Trial 1 reducing intake from 0 to 12 months ( P < 0.05 ) . CONCLUSIONS All interventions improved weight status . Future research should examine effectiveness and translatability of these approaches into primary care setting OBJECTIVE To examine the extent to which an intervention using electronic decision support delivered to pediatricians at the point-of-care of obese children , with or without direct-to-parent outreach , improved health care quality measures for child obesity . DESIGN AND METHODS Process outcomes from a three-arm , cluster-r and omized trial from 14 pediatric practice s in Massachusetts were reported . Participants were 549 children aged 6 - 12 years with body mass index ( BMI ) ≥ 95th percentile . In five practice s ( Intervention-1 ) , pediatricians receive electronic decision support at the point-of-care . In five other practice s ( Intervention-2 ) , pediatricians receive point-of-care decision support and parents receive information about their child 's prior BMI before their scheduled visit . Four practice s receive usual care . The main outcomes were Healthcare Effectiveness Data and Information Set ( HEDIS ) performance measures for child obesity : documentation of BMI percentile and use of counseling codes for nutrition or physical activity . RESULTS Compared to the usual care condition , participants in Intervention-2 , but not Intervention-1 , had substantially higher odds of use of HEDIS codes for BMI percentile documentation ( adjusted OR : 3.97 ; 95 % CI : 1.92 , 8.23 ) and higher prevalence of use of HEDIS codes for counseling for nutrition or physical activity ( adjusted predicted prevalence 20.3 % [ 95 % CI 8.5 , 41.2 ] for Intervention -2 vs. 0.0 % [ 0.0 , 2.0 ] for usual care ) . CONCLUSION An intervention that included both decision support for clinicians and outreach to parents result ed in improved health care quality measures for child obesity This study investigated the effectiveness of cognitive self-management training as an adjunct to the behavioural management of childhood obesity . Twenty-seven overweight children aged 7 - 13 years were r and omly assigned to either behavioural management plus relaxation placebo or a combined behavioural-cognitive self-management approach . Evaluations following the eight treatment sessions revealed a significant reduction in percentage overweight for children in both experimental groups and improvements were maintained at 3- and 6-month follow-ups . Both conditions were also effective in reducing the number of high-risk foods consumed . No difference in outcome was found between treatments at the post-treatment assessment or 3- and 6-month follow-ups . Although a reduction in percentage overweight of around 9 % was found for both procedures , subjects in general remained considerably overweight Obesity prevalence is increasing in the U.S. , especially among children and minority population s. This report describes the design and baseline data of the ongoing Girls health Enrichment Multi-site Studies ( GEMS ) trial ( Memphis site ) , which is testing the efficacy of a 2-year family-based intervention to reduce excessive increase in body mass index ( BMI ) . This r and omized , controlled trial conducted at community centers in Memphis , Tennessee requires major measurements at baseline and at 12 and 24 months post-r and omization . The participants are healthy African-American girls and one parent/caregiver of each girl . Participating girls are of ages 8 - 10 years , with BMI > or=25th percentile of the CDC 2000 growth charts or with one overweight or obese parent/caregiver ( BMI > or=25 kg/m(2 ) ) . The active intervention is design ed to prevent excessive weight gain by promoting healthy eating habits and increasing physical activity . An alternative intervention ( comparison group ) promotes general self-esteem and social efficacy . The main outcome measure is the difference between the two treatment groups in the change in BMI at 2 years . Three hundred and three girls have been r and omly assigned to receive the test intervention ( n=153 ) or the alternative intervention ( n=150 ) . The two groups do not differ in baseline characteristics . At the time of enrollment , the mean age was 9 years , the mean BMI was 22 kg/m(2 ) ( mean BMI percentile=77 th ) , and 41 % were overweight ( BMI > /=95th percentile using CDC 2000 growth charts ) . Participants ' intake of fruits and vegetables ( 1.3 serving/day ) and fats ( 36 % kcal ) , and their participation in moderate-to-vigorous physical activity ( 20 min/day ) , did not meet national recommendations . The GEMS obesity prevention intervention targets improved diet and increased physical activity to reduce excessive weight gain in healthy African-American girls of ages 8 - 10 The characteristics of successful and unsuccessful weight losers were studied in 48 obese children ( relative weight > 120 % ) aged 6 - 15 years who were treated for 1 year and observed for another . Successful weight loss was defined as a decrease in relative weight of > or = 0.8 in the st and ard deviation score ( SDS ) at the end of the study . Thirty-two children were treated intensively , 16 with individual counselling and 16 in group therapy , while the remaining 16 children were treated conventionally in a school health care setting . Three children dropped out of the study . In 2 years , the relative body weight decreased by 1.7 SDS in those who were successful weight losers ( n = 21 , 47 % ) , but remained unchanged in those who had been unsuccessful ( n = 24 ) . At baseline there were no differences between the two groups . At 1 year , the successful weight losers had lower body weight ( P < 0.05 ) , less lean body mass ( 0.05 ) and lower fasting concentrations of circulating insulin ( P < 0.01 ) than the unsuccessful children did . A decrease in mothers ' body mass index ( BMI ) and in documented energy intake over the first year as well as energy intake at 1 year were significant predictors of success at 2 years . The combination of these three predictors result ed in correct classification of about 3/4 of the cases as successful or unsuccessful weight losers . It appears , however , difficult to develop a clinical ly useful model for predicting the treatment outcome in obese children The effects of supervised physical training ( PT ) and lifestyle education ( LSE ) on risk factors for coronary artery disease and non-insulin-dependent diabetes mellitus were compared in obese 7- to 11-yr-old black girls . The subjects were divided into two groups . The PT group ( N = 12 ) completed a 5-d.wk-1 , 10-wk , aerobic training program ; and the LSE group participated in weekly lifestyle discussion s to improve exercise and eating habits . The PT group showed a significant increase in aerobic fitness ( P < 0.05 ) and decrease in percent body fat ( P < 0.05 ) , while the LSE group declined significantly more in dietary energy and percent of energy from fat ( P < 0.05 ) . Fasting insulin did not change significantly . The LSE group declined significantly more than the PT group in glucose ( P < 0.05 ) , and glycohemoglobin declined from baseline in both groups ( P < 0.05 ) . Lipid changes were similar in the two groups : total cholesterol/high density lipoprotein cholesterol ( P < 0.01 ) and triglycerides ( P < 0.05 ) declined , the low density lipoprotein (LDL)/apoproteinB ratio increased ( which indicates a decrease in small dense LDL ) ( P < 0.05 ) and lipoprotein(a ) increased ( P < 0.05 ) . Thus , the interventions were similarly effective in improving some diabetogenic and atherogenic factors , perhaps through different pathways ; i.e. , the PT improved fitness and fatness , while the LSE improved diet . Exercise and diet-induced changes in lipoprotein(a ) require further investigation OBJECTIVE The ability to accurately identify articles about therapy in large bibliographic data bases such as EMBASE is important for research ers and clinicians . Our study aim ed to develop optimal search strategies for detecting sound treatment studies in EMBASE in the year 2000 . METHODS H and search es of journals were compared with retrievals from EMBASE for c and i date search strategies . Six trained research assistants review ed fifty-five journals indexed in EMBASE and rated articles using purpose and quality indicators . C and i date search strategies were developed for identifying treatment articles and then tested , and the retrievals were compared with the h and - search data . The operating characteristics of the strategies were calculated . RESULTS Three thous and eight hundred fifty articles were original studies on treatment , of which 1,256 ( 32.6 % ) were method ologically sound . Combining search terms revealed a top performing strategy ( r and om:.tw . OR clinical trial:.mp . OR exp health care quality ) with sensitivity of 98.9 % and specificity of 72.0 % . Maximizing specificity , a top performing strategy ( double-blind:.mp . OR placebo:.tw . OR blind : .tw . ) achieved a value over 96.0 % , but with compromised sensitivity at 51.7 % . A 3-term strategy achieved the best optimization of sensitivity and specificity ( r and om:.tw . OR placebo:.mp . OR double-blind:.tw . ) , with both these values over 92.0 % . CONCLUSION Search strategies can achieve high performance for retrieving sound treatment studies in EMBASE OBJECTIVE The aim of this study was to compare the effect of a hospital clinic group- versus home-based combined exercise-diet program for the treatment of childhood obesity . METHODS One hundred ten overweight/obese Spanish children and adolescents ( 6 - 16 years ) in 2 intervention groups ( hospital clinic group-based [ n = 45 ] and home-based [ n = 41 ] ) and a sex-age-matched control group ( n = 24 ) were r and omly assigned to participate in a 6-month combined exercise ( aerobic and resistance training ) and Mediterranean diet program . Anthropometric values ( including body weight , height , body mass index , BMI -Z score , and waist circumference ) were measured pre- and postintervention for all the participants . Percentage body fat was also determined with a body fat analyzer ( TANITA TBF-410 M ) . RESULTS Our study showed a significant reduction in percentage body fat and body mass index Z-score among both intervention-group participants ( 4 % , 0.16 , hospital clinic group-based ; 4.4 % , 0.23 , home-based ; P < .0001 ) . There was also a significant reduction in waist circumference in the home-based group ( 4.4 cm ; P = .019 ) . Attendance rates at intervention sessions were equivalent for both intervention groups ( P = .805 ) . CONCLUSIONS The study findings indicate that a simple home-based combined exercise and Mediterranean diet program may be effective among overweight and obese children and adolescents , because it improves body composition , is feasible and can be adopted on a large scale without substantial expenses ABSTRACT A r and omized control trial of a group-based behavioral weight management program targeting parent and child health change using a diverse community sample was conducted . Children and parents were r and omized to an immediate treatment or waitlist condition and completed pre- and post-intervention measures of parent Body Mass Index ( BMI ) , child BMI z-score , child diet , and child physical activity . Families attending the treatment condition did not show greater improvements in outcomes . Child age and number of treatment sessions attended did not relate to health outcomes BACKGROUND This study evaluated the effects of gender on response to a behavioral intervention that rewarded increases in physical activity ( PA ) with increases in access to TV viewing . METHODS We performed a secondary analysis of a clinical trial that r and omized 30 overweight or obese , 8- to 12-year-old children to an intervention ( 8 boys , 6 girls ) or control ( 7 boys , 9 girls ) group . Participants wore accelerometers every day for 8 weeks and attended biweekly meetings to download the activity monitors . For the intervention group , accumulating 400 counts of PA on accelerometers earned 1 hour of TV time , which was controlled by a Token TV electronic device . Controls wore activity monitors but had free access to TV . RESULTS Compared with girls , boys in the intervention group exhibited greater increases in overall daily PA counts ( 110 % versus 40 % , P < .05 ) and minutes per day of moderate-to-vigorous physical activity ( MVPA ; + 18.1 versus + 2.7 , P < .05 ) . Neither boys nor girls in the control group showed significant changes in overall PA or intensity of PA . CONCLUSION Wearing an accelerometer in combination with rewarding PA with TV might be a more effective intervention for increasing overall PA and time spent in MVPA in overweight and obese boys than it is for overweight or obese girls Previous research has shown that the preference for foods used to reinforce behavior change will increase in young children . This study was design ed to assess whether this principle could be used to change the food preferences of older , obese children . Obese children were r and omly assigned to one of two groups , a treatment group in which novel low-calorie foods were presented contingent upon the behavior changes required for weight loss , whereas in the control group the novel low-calorie foods were given for a daily snack and not contingent upon behavior change . Food preferences were tested twice before treatment began to establish the stability of the food preference , and at 8 weeks ( end of treatment ) and 6 months after treatment began . Food preferences were stable before treatment began , and remained stable throughout the treatment and follow-up . Children in both groups lost significant amounts of weight after treatment . Preferences were greater for familiar than unfamiliar foods , and greater for fruits than vegetables . No systematic relationships between parent and child food preference were observed STUDY OBJECTIVE To evaluate the effect of family therapy on childhood obesity . DESIGN Clinical trial . One year follow-up . SETTING Referral from school after screening . PARTICIPANTS Of 1774 children ( aged 10 to 11 ) , screened for obesity , 44 obese children were divided into two treatment groups . In an untreated control group of 50 obese children , screened in the same manner , body mass index ( BMI ) values were recorded twice , at 10 to 11 and at 14 years of age . INTERVENTION Both treatment groups received comparable dietary counseling and medical checkups for a period of 14 to 18 months , while one of the groups also received family therapy . RESULTS At the 1-year follow-up , when the children were 14 years of age , intention-to-treat analyses were made of the weight and height data for 39 of 44 children in the two treatment groups and for 48 of the 50 control children . The increase of BMI in the family therapy group was less than in the conventional treatment group at the end of treatment , and less than in the control group ( P = .04 and P = .02 , respectively ) . Moreover , mean BMI was significantly lower in the family therapy group than in the control group ( P < .05 ) , and the family therapy group also had fewer children with BMI > 30 than the control group ( P = .02 ) . The reduction of triceps , subscapular , and suprailiac skinfold thicknesses , expressed as percentages of the initial values , was significantly greater in the family therapy group than in the conventional treatment group ( P = .03 , P = .005 and P = .002 , respectively ) , and their physical fitness was significantly better ( P < .05 ) . CONCLUSIONS Family therapy seems to be effective in preventing progression to severe obesity during adolescence if the treatment starts at 10 to 11 years of age BACKGROUND The application of health-related quality of life ( HRQOL ) as a pediatric population health measure may facilitate risk assessment and re source allocation , the tracking of community health , the identification of health disparities , and the determination of health outcomes from interventions and policy decisions . OBJECTIVE To determine the feasibility , reliability , and validity of the 23-item PedsQL 4.0 ( Pediatric Quality of Life Inventory ) Generic Core Scales as a measure of pediatric population health for children and adolescents . DESIGN Mail survey in February and March 2001 to 20 031 families with children ages 2 - 16 years throughout the State of California encompassing all new enrollees in the State 's Children 's Health Insurance Program ( SCHIP ) for those months and targeted language groups . METHODS The PedsQL 4.0 Generic Core Scales ( Physical , Emotional , Social , School Functioning ) were completed by 10 241 families through a statewide mail survey to evaluate the HRQOL of new enrollees in SCHIP . RESULTS The PedsQL 4.0 evidence d minimal missing responses , achieved excellent reliability for the Total Scale Score ( alpha = .89 child;.92 parent report ) , and distinguished between healthy children and children with chronic health conditions . The PedsQL 4.0 was also related to indicators of health care access , days missed from school , days sick in bed or too ill to play , and days needing care . CONCLUSION The results demonstrate the feasibility , reliability , and validity of the PedsQL 4.0 as a pediatric population health outcome . Measuring pediatric HRQOL may be a way to evaluate the health outcomes of SCHIP OBJECTIVE There is a critical need for culturally relevant interventions to address obesity among Latino children , who have a greater risk of obesity and diabetes than non-Hispanic white children . To test the impact of a family-centered , culturally tailored obesity intervention delivered through group medical appointments on body mass index ( BMI ) and other measures of cardiovascular risk among Latino children . METHODS In a r and omized controlled trial , 55 parent-child dyads were assigned to Active and Healthy Families ( AHF ) or a usual care wait-list control condition . Dyads were eligible if they spoke Spanish and if the child received care in a federally qualified health center , was aged 5 to 12 years , had a BMI in the 85th percentile or higher , and had not participated in AHF . The 10-week AHF intervention included biweekly group sessions delivered by a registered dietitian , physician , and promotora triad . Sessions covered topics such as parenting , screen time , healthy beverages , physical activity , and stress due to immigration . RESULTS Child BMI ( kg/m(2 ) ) decreased ( -0.50 ) in the AHF group and increased ( + 0.32 ) in the control group , yielding an adjusted difference in change of -0.78 ( 95 % confidence interval [ CI ] -1.28 , -0.27 ) . Children assigned to AHF also exhibited relative improvements over controls in BMI z score ( -0.10 ; 95 % CI -0.19 , -0.02 ) and triglycerides ( -26.8 mg/dL ; 95 % CI -50.1 , -3.6 ) , but no significant between-group differences were observed for blood pressure or other fasting blood measures . CONCLUSIONS AHF result ed in reductions in child BMI , BMI z score , and triglycerides . AHF , which was design ed for low-income Latino families , has potential to reduce health disparities , but future studies are needed to determine long-term impact OBJECTIVE This study was developed as a pilot study to determine if targeted interventions regarding increasing physical activity level through the use of pedometers and fitness DVDs would result in a decrease in BMI in overweight or obese children . METHODS 24 children aged 4 - 17 taking part in " Moving and Losing " were r and omized to ( 1 ) Control Group ; ( 2 ) Pedometer Group ; ( 3 ) DVD Group ; ( 4 ) Pedometer + DVD Group and asked to complete self-report physical activity logs at visit one and two . Baseline , midpoint , and endpoint weight , height , Body Mass Index ( BMI ) were measured for outcome variables . RESULTS Almost half ( 42 % ) of participants turned in their activity logs and pedometers at midpoint , but at endpoint less than a quarter of participants turned in their pedometers and /or activity logs . BMI increased by 4.1 % in the Control Group , 8.7 % in the Pedometer Group , and 6.7 % in the DVD Group . BMI decreased by 0.3 % in the Pedometer + DVD Group . CONCLUSION The use of pedometers and fitness DVDs may not be culturally acceptable in African-American female children and adolescents from South Carolina who are overweight or obese . Further studies should look into in-depth needs assessment s and planning processes that include participants as stakeholders Obese children 8 - 12 years old from 61 families were r and omized to treatment groups that targeted increased exercise , decreased sedentary behaviors , or both ( combined group ) to test the influence of reinforcing children to be more active or less sedentary on child weight change . Significant decreases in percentage overweight were observed after 4 months between the sedentary and the exercise groups ( -19.9 vs. -13.2 ) . At 1 year , the sedentary group had a greater decrease in percentage overweight than did the combined and the exercise groups ( -18.7 vs. -10.3 and -8.7 ) and greater decrease in percentage of body fat ( -4.7 vs. -1.3 ) . All groups improved fitness during treatment and follow-up . Children in the sedentary group increased their liking for high-intensity activity and reported lower caloric intake than did children in the exercise group . These results support the goal of reducing time spent in sedentary activities to improve weight loss Project Energize is a through-school nutrition and activity programme that is being evaluated in a 2-year , cluster-r and omised , longitudinal study . The present paper describes the background of the programme and study , the programme development and delivery , the study methodology including r and omisation , measurement and analysis tools and techniques , and the mix of the study population . The programme is being delivered to sixty-two primary schools with sixty-two control schools , each limb containing about 11,000 students . The children in the evaluation cohort are 5 or 10 years old at enrolment ; the r and omisation protocol has achieved post-consent enrolment of 3,000 evaluation participants , who are comparable by age , sex and school decile . End-point measures include body composition and associated physical characteristics , fitness , home and school environment and practice Obese children were r and omly assigned to a family-based behavioral treatment that included either stimulus control or reinforcement to reduce sedentary behaviors . Significant and equivalent decreases in sedentary behavior and high energy density foods , increases in physical activity and fruits and vegetables , and decreases in st and ardized body mass index ( z- BMI ) were observed . Children who substituted active for sedentary behaviors had significantly greater z- BMI changes at 6 ( -1.21 vs. -0.76 ) and 12 ( -1.05 vs. -0.51 ) months , respectively . Substitution of physically active for sedentary behaviors and changes in activity level predicted 6- and 12-month z- BMI changes . Results suggest stimulus control and reinforcing reduced sedentary behaviors are equivalent ways to decrease sedentary behaviors , and behavioral economic relationships in eating and activity may mediate the effects of treatment CONTEXT Few r and omized controlled trials ( RCTs ) of interventions for the treatment of childhood obesity have taken place outside the Western world . AIM To test whether a good practice intervention for the treatment of childhood obesity would have a greater impact on weight status and other outcomes than a control condition in Kuala Lumpur , Malaysia . METHODS Assessor-blinded RCT of a treatment intervention in 107 obese 7- to 11-year olds . The intervention was relatively low intensity ( 8 hours contact over 26 weeks , group based ) , aim ing to change child sedentary behavior , physical activity , and diet using behavior change counselling . Outcomes were measured at baseline and six months after the start of the intervention . Primary outcome was BMI z-score , other outcomes were weight change , health-related quality of life ( Peds QL ) , objective ly measured physical activity and sedentary behavior ( Actigraph accelerometry over 5 days ) . RESULTS The intervention had no significant effect on BMI z score relative to control . Weight gain was reduced significantly in the intervention group compared to the control group ( + 1.5 kg vs. + 3.5 kg , respectively , t-test p < 0.01 ) . Changes in health-related quality of life and objective ly measured physical activity and sedentary behavior favored the intervention group . CONCLUSIONS Treatment was associated with reduced rate of weight gain , and improvements in physical activity and quality of life . More substantial benefits may require longer term and more intensive interventions which aim for more substantive lifestyle changes UNLABELLED What is already known about this subject Approximately one-fifth of children in the UK are obese . There are currently few , effective interventions available in the UK . There are very little data on relative cost-effectiveness of childhood obesity interventions , which hampers the commissioning of future services . What this study adds Simple multi-component obesity interventions can be provided at relatively low cost per 0.1 body mass index st and ard deviation score ( BMI SDS ) improvement . More intensive and effective interventions incur greater cost per 0.1 BMI SDS reduction but this may be justified given the improved overall BMI SDS reduction attained . OBJECTIVE To describe the costs and outcomes of three models of care for childhood obesity previously evaluated in two 2-arm pilot r and omized trials in Engl and . The treatments were ( i ) a hospital clinic ( control in both trials ) , comprising a multidisciplinary team of consultant , dietitian and exercise specialist ; ( ii ) a nurse-led primary care clinic replicating the service provided by the hospital and ( iii ) an intensive intervention using M and ometer ® , a behaviour modification tool aim ed at encouraging slower eating and better recognition of satiety . METHOD Patient-level data on re sources used to deliver each intervention were collected during the trials . Apart from the cost of the M and ometer ® the majority of cost was staff time , dependent on discipline and grade . Outcome for both trials was body mass index st and ard deviation score ( BMI SDS ) measured at 12 months . RESULTS Cost and outcome data were available for 143 children in total . Cost per child was £ 1749 ( SD £ 243 ) in the M and ometer ® group , £ 301 ( £ 76 ) in the primary care group , and £ 263 ( £ 88 ) and £ 209 ( £ 81 ) in the hospital groups . Mean reduction in BMI SDS was 0.40 ( 0.35 ) , 0.17 ( 0.26 ) , 0.15 ( 0.25 ) and 0.14 ( 0.32 ) , respectively . CONCLUSION Intensive management using M and ometer ® was effective but costly ( £ 432 per 0.1 reduction in BMI SDS ) compared to conventional care ( range £ 153-£173 ) . A total of 26 % children receiving conventional care achieved a clinical ly meaningful reduction in BMI SDS ; however , use of M and ometer ® training may be justified in children not responding to conventional lifestyle interventions OBJECTIVE The authors performed a group-based program for obese children and adolescents in Bavaria , Germany to enable them to establish a health-oriented lifestyle and to reduce overweight . The authors compared this program with a control approach based on the patients ' own initiative . DESIGN This is a controlled clinical trial . SETTING A nutrition program for out patients in a German university hospital . PARTICIPANTS Seventy-three obese patients aged 7 to 15 years ( mean 11.2 years ) were recruited by pediatricians and local newspaper reports and r and omized into intervention and control groups . Children and adolescents in each group were divided into 3 groups according to age--7 - 8 years , 9 - 10 years , and 11 - 13 years . Children were classified overweight ( defined as body mass index ( BMI ) > 90th percentile for age and gender ) , obese ( BMI > 97th percentile ) , and extremely obese ( BMI > 99.5th percentile ) , according to the European Childhood Obesity Group and the German Working Group on Pediatric Obesity , congruent with adult st and ards used to assess overweight and obesity . INTERVENTION Thirty-seven patients ( age 7 - 13 years , mean 10.9 years ) for the 1-year intervention . This intervention consisted of modules for physical activity , nutritional education , and coping strategies . The program was performed twice each week and incorporated parental participation and medical supervision , including laboratory tests . The obese controls ( n = 36 , age 8 - 15 years , mean 11.6 years ) received written therapeutic advice during a visit at 0 and 6 months in the outpatient clinic . MAIN OUTCOME MEASURE The primary outcome variable was the body mass index ( BMI ) z score . ANALYSIS Analysis of variance and t test were used , and a P value < .05 was considered significant . RESULTS There was a reduction of BMI z score in the active treatment group ( P < .05 ) , but not for controls . Moreover , the active group showed beneficial effects for body mass index ( BMI ) , fat mass , and systolic blood pressure 12 months after beginning the intervention . CONCLUSIONS AND IMPLICATION S Group-based programs for young , obese patients can be effective tools for establishing a health-oriented lifestyle and reducing the burden of obesity BACKGROUND . Parenting-skills training may be an effective age-appropriate child behavior-modification strategy to assist parents in addressing childhood overweight . OBJECTIVE . Our goal was to evaluate the relative effectiveness of parenting-skills training as a key strategy for the treatment of overweight children . DESIGN . The design consisted of an assessor-blinded , r and omized , controlled trial involving 111 ( 64 % female ) overweight , prepubertal children 6 to 9 years of age r and omly assigned to parenting-skills training plus intensive lifestyle education , parenting-skills training alone , or a 12-month wait-listed control . Height , BMI , and waist-circumference z score and metabolic profile were assessed at baseline , 6 months , and 12 months ( intention to treat ) . RESULTS . After 12 months , the BMI z score was reduced by ∼10 % with parenting-skills training plus intensive lifestyle education versus ∼5 % with parenting-skills training alone or wait-listing for intervention . Waist-circumference z score fell over 12 months in both intervention groups but not in the control group . There was a significant gender effect , with greater reduction in BMI and waist-circumference z scores in boys compared with girls . CONCLUSION . Parenting-skills training combined with promoting a healthy family lifestyle may be an effective approach to weight management in prepubertal children , particularly boys . Future studies should be powered to allow gender sub analysis BACKGROUND The origins of childhood obesity invariably need to be looked at within a family context and several review s have concluded in favour of parental involvement in the treatment of paediatric obesity . However , there is little consensus on the format , and next to weight outcomes behavioural outcomes also merit more attention when assessing program effectiveness . METHOD In this pilot study , a total of 50 families with overweight children ( aged 6 - 12 ) were r and omly allocated to a parent-led intervention group ( cognitive behavioural training ) or to a waiting list control group ( Study 1 ) . Afterwards , the parents of the waitlist control group also followed the intervention . All children were included in a follow-up study and were compared with a reference group ( Study 2 ) . RESULTS The intervention group as well as the waitlist group ( who had not yet received treatment ) showed a decrease in adjusted BMI over a 6-month period , although the decrease was only significant for the intervention group ( Study 1 ) . All children showed a decrease of 7 % in adjusted BMI from pre to one-year follow-up measurement ( Study 2 ) , while the reference group showed an increase in adjusted BMI over that period . Parents reported significant positive changes in children 's eating behaviour and a significant positive increase in familial health principles . CONCLUSIONS Weight and behavioural outcomes suggest potential for intervention effectiveness . Long-term follow-up is needed to reveal residual benefits of enhanced parenting skills on environmental lifestyle changes OBJECTIVE To describe the impact of a parent-led , family-focused child weight management program on the food intake and activity patterns of pre-pubertal children . METHODS An assessor-blinded , r and omized controlled trial involving 111 ( 64 % female ) overweight , pre-pubertal children 6 - 9 years of age r and omly assigned to parenting-skills training plus intensive diet and activity education ( P + DA ) , parenting-skills training alone ( P ) , or a 12-month wait-listed control ( WLC ) . Study outcomes were assessed at baseline , 6 months , and 12 months . This paper presents data on food intake assessed via a vali date d 54-item parent-completed dietary question naire and activity behaviours assessed via a parent-report 20-item activity question naire . RESULTS Intake of energy-dense nutrient-poor foods was lower in both intervention groups at 6 months ( mean difference , P + DA - 1.5 serves [ CI - 2.0 ; -1.0 ] ; P - 1.0 serves [ -2.0 ; -0.5 ] ) and 12 months ( mean difference P + DA - 1.0 serves [ CI - 2.0 ; -0.5 ] ; P - 1.0 serves [ - 1.5 ; 0.0 ] ) compared to baseline . Intake of vegetables , fruit , breads and cereals , meat and alternatives and dairy foods remained unchanged . Regardless of study group there were significant reductions over time in the reported time spent engaged in small screen activities and an increase in the time reported spent in active play . CONCLUSION A child weight management intervention that promotes food intake in line with national dietary guidelines achieves a reduction in children 's intake of energy-dense , nutrient-poor foods . This was achieved without compromising intake of nutrient-rich food and changes were maintained even once the intervention ceased OBJECTIVE We conducted a study to determine if wearing a pedometer affects weight , body mass index ( BMI ) , or mediators of physical activity among families . METHODS Eighty-seven families were r and omized to 1 of 3 treatments : pedometer plus education ( PE ) , pedometer ( P ) , or control ( C ) . Participants in the PE and P groups wore pedometers and were encouraged to walk 10,000 steps daily for 12 weeks . PE group participants attended 6 sessions on healthy eating and exercise . Participants were surveyed about their knowledge and attitudes about healthy eating and physical activity prior to r and omization , at the end of the intervention , and 9 months later . Their heights and weights were measured and BMI calculated . RESULTS Children 's BMI percentile decreased from baseline to end of intervention ( -0.18 % ) and at 9-month follow-up ( -0.08 % ) but did not differ by treatment . Children 's BMI percentile varied by parental obesity status ( average BMI percentile was 88.7 % for children of obese parents and 78.5 % for children of non-obese parents ) . Parents ' weight decreased slightly by intervention 's end ( 0.6 pounds ) and at 9 months ( 1.2 pounds ) , but change was similar among groups . Attitudes about their physical activity level relative to their peers improved significantly among children and parents wearing the pedometer . Self-efficacy improved for parents wearing the pedometer . Both children and parents felt the pedometer increased their activity level , but most were unlikely to wear it beyond the intervention . CONCLUSIONS The pedometer had little impact on the activity level , weight , or BMI of participants OBJECTIVE Obesity prevalence among Chilean children is 19.4 % . The present study aim ed to assess the effectiveness of a school-based obesity prevention programme . DESIGN Non-r and omized controlled study . The intervention included activities in nutrition and physical activity , fully applied the first year and partially in the second one . Primary outcomes were BMI Z-score ( BMI Z ) and obesity prevalence ; secondary outcomes were waist circumference and triceps skinfold thickness . Time effects were assessed by changes in BMI -related variables by gender and period ( ANOVA and Tukey test ) , while intervention effects were determined by comparing changes in ( i ) obesity prevalence by gender and period ( PROC GENMOD ) and ( ii ) BMI Z according gender , age and period ( PROC MIXED ) . SETTING Primary schools in the Chilean cities of Casablanca ( intervention group ) and Quillota ( control group ) . SUBJECTS One thous and seven hundred and fifty-nine children from three schools ( intervention group ) and 671 from one school ( control group ) . RESULTS Over the two years , obesity prevalence and BMI Z declined significantly in the intervention group ; from 17.0 % to 12.3 % and 14.1 % to 10.3 % in boys and girls , respectively , and from 0.62 to 0.53 and 0.64 to 0.58 , respectively . In the control group , obesity remained stable at about 21 % and 15 % , while BMI Z increased significantly in the second year . BMI Z declined in both genders and all age categories in the intervention group during the first year ( significant only in younger boys ) . No changes occurred during the summer , while during the second year , BMI Z increased in boys and girls from both groups ( significant only in the younger control boys ) . Obesity declined significantly only in boys during the first year . CONCLUSION Effectiveness was greater in the first school year and more evident in younger boys WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT Lifestyle intervention is the most common treatment strategy for children with obesity . Specialized units for the care of children with obesity report significant effects of lifestyle treatment . In children , the physical activity component in lifestyle treatment is often well accepted . WHAT THIS STUDY ADDS Two lifestyle treatment programmes in primary care for children with obesity both gave a reduction of body mass index significantly greater than the change observed in a non-intervention comparison group of children with obesity . Substituting one-third of nurse-led treatment sessions with sessions led by physiotherapists in one of the programmes did not improve the outcome . The efficacy of treatment in primary care seems to be comparable to that reported in the literature . OBJECTIVE To evaluate the efficacy of lifestyle treatment in primary care for children with obesity . METHODS In a multicentre study , sixty-four 9- to 13-year-old children with obesity were r and omized to one of two 12-month lifestyle treatment programmes . The only difference between the programmes was that a physiotherapist substituted the nurse in one-third of the sessions in an attempt to stimulate physical activity . For comparison , children with normal weight and overweight , and an age- , sex- and body mass index-matched non-intervention group of children with obesity were used . RESULTS Anthropometry and laboratory data differed significantly between children with obesity and normal weight at baseline . The follow-up at the end of treatment was attended by 55 children with obesity , 28 and 27 in each treatment arm . The mean ( st and ard deviation ) body mass st and ard deviation score changed by -0.36 ( 0.3 ) in the arm involving a physiotherapist and by -0.33 ( 0.2 ) in the other arm . These outcomes were not significantly different . Both reductions were significantly greater than the change of -0.14 ( 0.3 ) observed in the non-intervention comparison group of children with obesity CONCLUSION The efficacy of treatment in primary care for children with obesity seems to be comparable to that reported in the literature . IS RCT N44919688 OBJECTIVE To evaluate the High Five for Kids intervention effect on television within subgroups , examine participant characteristics associated with process measures and assess perceived helpfulness of television intervention components . METHOD High Five ( r and omized controlled trial of 445 overweight/obese 2 - 7 year-olds in Massachusetts [ 2006 - 2008 ] ) reduced television by 0.36 h/day . 1-year effects on television viewing , stratified by subgroup , were assessed using linear regression . Among intervention participants ( n=253 ) , associations of intervention component helpfulness with television reduction were examined using linear regression and associations of participant characteristics with processes linked to television reduction ( choosing television and completing intervention visits ) were examined using logistic regression . RESULTS High Five reduced television across subgroups . Parents of Latino ( versus white ) children had lower odds of completing ≥2 study visits ( Odds Ratio : 0.39 [ 95 % Confidence Interval : 0.18 , 0.84 ] ) . Parents of black ( versus white ) children had higher odds of choosing television ( Odds Ratio : 2.23 [ 95 % Confidence Interval : 1.08 , 4.59 ] ) , as did parents of obese ( versus overweight ) children and children watching ≥2 h/day ( versus < 2 ) at baseline . Greater perceived helpfulness was associated with greater television reduction . CONCLUSION Clinic-based motivational interviewing reduces television viewing in children . Low cost education approaches ( e.g. , printed material s ) may be well-received . Parents of children at higher obesity risk could be more motivated to reduce television OBJECTIVE To compare liking and other attitudes toward physical activity ( PA ) and television ( TV ) viewing versus PA behavior and time viewing TV at baseline as predictors of response to lifestyle intervention in 30 , 8 to 12 year old overweight/obese children . METHOD Secondary analyses from a r and omized controlled trial design ed to increase PA and reduce sedentary behavior . PA was measured by accelerometers worn by participants every day for 8 weeks . TV viewing at baseline and during intervention was assessed by self-report . RESULTS Multiple regression analyses showed that base rates of PA and TV viewing significantly predicted changes in PA ( Beta = .39 , P < .05 ) and TV viewing ( Beta = .37 , P < .05 ) during the intervention , even after statistically controlling for child age , gender , body mass index , as well as baseline attitudes and liking of PA and TV viewing . However , self-reported liking of TV viewing and PA , perceived adequacy , and predilection were not predictive of response to intervention . CONCLUSIONS Baseline measure of PA and TV viewing behaviors may be better predictors of response to lifestyle intervention than measure of liking and other attitudinal variables of PA . The theoretical and clinical implication s of these findings are discussed BACKGROUND Programs to improve cardiovascular health in schoolchildren need careful scientific evaluation . METHOD In a r and omized controlled trial of nutrition and fitness programs over a period of about 9 months , 1,147 10- to 12-year-olds from 30 schools were allocated to one of five health programs : fitness , fitness + school nutrition , school-based nutrition , school + home nutrition , home-based nutrition , or a control group . Nutrient intake , fitness , anthropometry , blood pressure , and blood cholesterol were measured before and after intervention . RESULTS Fitness increased and diastolic blood pressure and triceps skinfolds decreased significantly for girls in the fitness groups . Baseline consumption of sugar , fat , and fiber was outside national guidelines ; blood cholesterol exceeded recommendations in one-third of children . In girls , fat intake decreased significantly in the two home nutrition groups and fiber intake increased in the school + home nutrition and fitness groups . Boys in the fitness , fitness + school nutrition , and school + home nutrition group reduced sugar intake . Change in sugar intake correlated negatively with change in fat intake in both boys and girls . CONCLUSIONS Teacher-implemented health packages are feasible with minimal training but programs should differ between boys and girls . Fitness programs were more successful than nutrition education particularly in girls . Clearer nutrition messages should prevent reciprocal changes in sugar and fat . For girls , the 3 mm Hg reduction of diastolic blood pressure , less obesity , and increased fitness could translate into a substantial reduction in cardiovascular risk in adult life OBJECTIVE : The present study investigated whether making access to sedentary activities contingent on physical activity would increase physical activity . DESIGN : Experimental . PARTICIPANTS : Thirty-four obese children aged 8–12 y were r and omized to one of three groups in which children had to accumulate 750 or 1500 pedometer counts to earn 10 min of access to video games or movies , or to a control group in which access to sedentary behaviors was provided noncontingently . MEASUREMENTS : Physical activity in the 20 min experimental session was measured by electronic pedometer and triaxial accelerometer ( ie TriTrac ® ) . Activity liking was measured by visual analog scales . Anthropometric and demographic characteristics were also assessed . RESULTS : Children in the 750 and 1500 count contingency groups engaged in significantly more physical activity and spent more time in moderate intensity activity or higher compared with controls . Children in the Contingent 1500 group engaged in more activity and spent more time in moderate or greater intensity activity compared to children in the Contingent 750 group . CONCLUSION : Findings suggest that contingent access to sedentary activities can reinforce physical activity in obese children , and changes in physical activity level depend in part on the targeted physical activity goal Objective To determine whether ascertainment of childhood obesity by surveillance followed by structured secondary prevention in primary care improved outcomes in overweight or mildly obese children . Design R and omised controlled trial nested within a baseline cross sectional survey of body mass index ( BMI ) . R and omisation and outcomes measurement , but not participants , were blinded to group assignment . Setting 45 family practice s ( 66 general practitioners ) in Melbourne , Australia . Participants 3958 children visiting their general practitioner in May 2005-July 2006 were surveyed for BMI . Of these , 258 children aged 5 years 0 months up to their 10th birthday who were overweight or obese by International Obesity Taskforce criteria were r and omised to intervention ( n=139 ) or control ( n=119 ) groups . Children who were very obese ( UK BMI z score ≥3.0 ) were excluded . Intervention Four st and ard consultations over 12 weeks targeting change in nutrition , physical activity , and sedentary behaviour , supported by purpose design ed family material s. Main outcomes measures Primary measure was BMI at 6 and 12 months after r and omisation . Secondary measures were mean activity count/min by 7-day accelerometry , nutrition score from 4-day abbreviated food frequency diary , and child health related quality of life . Differences were adjusted for socioeconomic status , age , sex , and baseline BMI . Results Of 781 eligible children , 258 ( 33 % ) entered the trial ; attrition was 3.1 % at 6 months and 6.2 % at 12 months . Adjusted mean differences ( intervention − control ) at 6 and 12 months were , for BMI , −0.12 ( 95 % CI −0.40 to 0.15 , P=0.4 ) and −0.11 ( −0.45 to 0.22 , P=0.5 ) ; for physical activity in counts/min , 24 ( −4 to 52 , P=0.09 ) and 11 ( −26 to 49 , P=0.6 ) ; and , for nutrition score , 0.2 ( −0.03 to 0.4 , P=0.1 ) and 0.1 ( −0.1 to 0.4 , P=0.2 ) . There was no evidence of harm to the child . Costs to the healthcare system were significantly higher in the intervention arm . Conclusions Primary care screening followed by brief counselling did not improve BMI , physical activity , or nutrition in overweight or mildly obese 5 - 10 year olds , and it would be very costly if universally implemented . These findings are at odds with national policies in countries including the US , UK , and Australia . Trial registration IS RCT N 52511065 ( www.is rct n.org In stepped wedge cluster r and omised trials ( SWTs ) the intervention is rolled out to clusters in a r and om order . Measurements are collected from different individuals during each step ( the time between clusters switching to intervention ) . It remains unclear how to optimise power in SWTs and the circumstances in which SWTs requires fewer clusters to achieve the same power as parallel cluster r and omised trials ( CRTs ) or CRTs with half of all measurements at baseline ( CRT-Bs ) . We consider the design effect for SWTs in terms of the number of measurements per cluster N to investigate how inclusion of baseline measurements in N , and number of steps influence the number of clusters required for a given power . We compared the design effects for SWTs , CRTs and CRT-Bs holding N constant . For SWTs , the number of clusters required is increased by including baseline measurements . Increasing the number of steps reduces the number of clusters , with less marginal effect as the number of steps increases . SWTs with no baseline measurements and many steps require fewer clusters than CRTs when the intracluster correlation ICC > 1/(N+1 ) . CRT-Bs always require more clusters than SWTs with no baseline measurements and more than two steps . A CRT-B and two-step SWT are equivalent design s. To minimise number of clusters , SWTs should exclude baseline measurements . The reduction in number of clusters for SWTs compared to CRTs is greatest when N is large ( e.g. N=100 ) and ICC is high ( e.g. ICC=0.2 ) . SWTs however require a more careful analysis to remove confounding by secular trends Many underserved school-age children do not meet the recommended guidelines for physical activity . While children ultimately depend on parents , they also look to schools for their access to developmentally appropriate physical activity . The present r and omized controlled trial study utilized a community – academic partnered participatory research approach to evaluate the impact of a culturally sensitive , comprehensive , school-based , program , Kids N Fitness © , on body mass index ( BMI ) , and child physical activity behavior , including : daily physical activity , team sports participation , attending PE class , and TV viewing/computer game playing , among underserved children ages 8–12 ( N = 251 ) in Los Angeles County . All measures were collected at baseline , 4 and 12 months post-intervention . Students who participated in the KNF program had significant decreases in BMI Z-score , TV viewing , and an increase in PE class attendance from baseline to the 12 month follow-up . Our study shows the value of utilizing community – academic partnerships and a culturally sensitive , multi-component , collaborative intervention OBJECTIVE To determine whether an exercise intervention using an active video game ( Dance Dance Revolution [ DDR ] ) is effective in improving endothelial dysfunction ( EDF ) and other risk factors in overweight children . DESIGN Thirty-five children ( Body mass index > or = 85(th ) percentile , mean age 10.21+/-1.67 years , 17 females ) with EDF were assessed for flow-mediated dilation ( FMD ) , lipids , insulin , glucose , NO(2)+NO(3 ) , asymmetric dimethylarginine , symmetric dimethylarginine , l-arginine , height , weight , aerobic fitness , and blood pressure . In a sub sample , tumor necrosis factor alpha , interleukin-6 , C-reactive protein , and adiponectin were also assessed . Subjects were r and omly assigned to 12-weeks of aerobic exercise ( EX ) using DDR or to a non-exercising delayed-treatment control group ( DTC ) . RESULTS EX had significant improvements in FMD ( 5.56+/-5.04 % compared with 0.263+/-4.54 % , p=0.008 ) , exercise time on the grade d exercise test ( 53.59+/-91.54 compared with -12.83+/-68.10 seconds , p=0.025 ) , mean arterial pressure ( MAP ) ( -5.62+/-7.03 compared with -1.44+/-2.16 mmHg , p=0.05 ) , weight ( 0.91+/-1.53 compared with 2.43+/-1.80 kg , p=0.017 ) and peak VO(2 ) ( 2.38+/-3.91 compared with -1.23+/-3.18 mg/kg/min , p=0.005 ) compared with the DTC . Thirteen EX subjects achieved normal EDF while ten did not . These groups differed at baseline with regard to total cholesterol ( TC ) and low-density lipoprotein ( LDL ) . CONCLUSION Twelve weeks of DDR-use improved FMD , aerobic fitness , and MAP in overweight children . Improvements occurred without changes in inflammatory markers or nitric oxide production . The results document the need to explore relationships between obesity , endothelial function , inflammation , lipids , exercise intensity , and gender in a larger sample of overweight children IMPORTANCE Evidence of effective treatment of childhood obesity in primary care setting s is limited . OBJECTIVE To examine the extent to which computerized clinical decision support ( CDS ) delivered to pediatric clinicians at the point of care of obese children , with or without individualized family coaching , improved body mass index ( BMI ; calculated as weight in kilograms divided by height in meters squared ) and quality of care . DESIGN , SETTING , AND PARTICIPANTS We conducted a cluster-r and omized , 3-arm clinical trial . We enrolled 549 children aged 6 to 12 years with a BMI at the 95 % percentile or higher from 14 primary care practice s in Massachusetts from October 1 , 2011 , through June 30 , 2012 . Patients were followed up for 1 year ( last follow-up , August 30 , 2013 ) . In intent-to-treat analyses , we used linear mixed-effects models to account for clustering by practice and within each person . INTERVENTIONS In 5 practice s r and omized to CDS , pediatric clinicians received decision support on obesity management , and patients and their families received an intervention for self-guided behavior change . In 5 practice s r and omized to CDS + coaching , decision support was augmented by individualized family coaching . The remaining 4 practice s were r and omized to usual care . MAIN OUTCOMES AND MEASURES Smaller age-associated change in BMI and the Healthcare Effectiveness Data and Information Set ( HEDIS ) performance measures for obesity during the 1-year follow-up . RESULTS At baseline , mean ( SD ) patient age and BMI were 9.8 ( 1.9 ) years and 25.8 ( 4.3 ) , respectively . At 1 year , we obtained BMI from 518 children ( 94.4 % ) and HEDIS measures from 491 visits ( 89.4 % ) . The 3 r and omization arms had different effects on BMI over time ( P = .04 ) . Compared with the usual care arm , BMI increased less in children in the CDS arm during 1 year ( -0.51 [ 95 % CI , -0.91 to -0.11 ] ) . The CDS + coaching arm had a smaller magnitude of effect ( -0.34 [ 95 % CI , -0.75 to 0.07 ] ) . We found substantially greater achievement of childhood obesity HEDIS measures in the CDS arm ( adjusted odds ratio , 2.28 [ 95 % CI , 1.15 - 4.53 ] ) and CDS + coaching arm ( adjusted odds ratio , 2.60 [ 95 % CI , 1.25 - 5.41 ] ) and higher use of HEDIS codes for nutrition or physical activity counseling ( CDS arm , 45 % ; CDS + coaching arm , 25 % ; P < .001 compared with usual care arm ) . CONCLUSIONS AND RELEVANCE An intervention that included computerized CDS for pediatric clinicians and support for self-guided behavior change for families result ed in improved childhood BMI . Both interventions improved the quality of care for childhood obesity . TRIAL REGISTRATION clinical trials.gov Identifier : NCT01537510 Using a prospect i ve , r and omized , controlled design , we examined the effects of behavioral family-based treatment on percent overweight and growth over 10 years in obese 6- to 12-year-old children . Obese children and their parents were r and omized to three groups that were provided similar diet , exercise , and behavior management training but differed in the reinforcement for weight loss and behavior change . The child and parent group reinforced parent and child behavior change and weight loss , the child group reinforced child behavior change and weight loss , and the nonspecific control group reinforced families for attendance . Children in the child and parent group showed significantly greater decreases in percent overweight after 5 and 10 years ( -11.2 % and -7.5 % , respectively ) than children in the nonspecific control group ( + 7.9 % and + 14.3 % , respectively ) . Children in the child group showed increases in percent overweight after 5 and 10 years ( + 2.7 % and + 4.5 % , respectively ) that were midway between those for the child and parent and nonspecific groups and not significantly different from either . At 10 years , child height was related strongly to the height of the parent of the same sex ( r = .78 children were 1.8 cm taller than their parents , with no differences in height between groups Objective Many approaches have been tried in order to tackle the problem of obesity in children , but most of them have failed to achieve long‐term weight loss . Cognitive behaviour therapy tends to predict good prospect s. So far , no studies have investigated the surplus value of introducing a “ healthy‐eating ” lifestyle program instead of a strict diet prescription , in combination with the principles of cognitive behaviour therapy . Therefore , a new program was design ed . The second aim of the study was to evaluate the impact of different forms of therapeutic contact . Subjects and methods : The obese group consisted of 205 children seeking treatment , and a control group of 54 obese school children . The effects of the program were evaluated by means of a pre‐test/post‐test design with a 1‐y follow‐up . Subjects were assigned to different therapeutic conditions : group therapy , individual therapy , summer camp or “ advice in one session ” . Results : A progressive and significant loss of weight for all therapeutic conditions was noticeable . The reduction continued at least 6 months after completing therapy . The control group , however , showed weight evolution in the opposite sense . Conclusions : A replication of the positive effect of CBT was found in a broad sample of clinical ly obese children , even without strict diet prescription . Our hypothesis that group approach will result in a better outcome is borne out Objectives : To evaluate the effectiveness of an intervention to prevent excess weight gain , reduce time spent in screen behaviours , promote participation in and enjoyment of physical activity ( PA ) , and improve fundamental movement skills among children . Participants : In 2002 , 311 children ( 78 % response ; 49 % boys ) , average age 10 years 8 months , were recruited from three government schools in low socioeconomic areas of Melbourne , Australia . Design : Group-r and omized controlled trial . Children were r and omized by class to one of the four conditions : a behavioural modification group ( BM ; n=66 ) ; a fundamental movement skills group ( FMS ; n=74 ) ; a combined BM/FMS group ( BM/FMS ; n=93 ) ; and a control ( usual curriculum ) group ( n=62 ) . Data were collected at baseline , post intervention , 6- and 12-month follow-up periods . Results : BMI data were available for 295 children at baseline and 268 at 12-month follow-up . After adjusting for food intake and PA , there was a significant intervention effect from baseline to post intervention on age- and sex-adjusted BMI in the BM/FMS group compared with controls ( −1.88 kg m−2 , P<0.01 ) , which was maintained at 6- and 12-month follow-up periods ( −1.53 kg m−2 , P<0.05 ) . Children in the BM/FMS group were less likely than controls to be overweight/obese between baseline and post intervention ( adjusted odds ratio (AOR)=0.36 , P<0.05 ) ; also maintained at 12-month follow-up ( AOR=0.38 , P<0.05 ) . Compared with controls , FMS group children recorded higher levels and greater enjoyment of PA ; and BM children recorded higher levels of PA and TV viewing across all four time points . Gender moderated the intervention effects for participation in and enjoyment of PA , and fundamental movement skills . Conclusion : This programme represents a promising approach to preventing excess weight gain and promoting participation in and enjoyment of PA . Examination of the mediators of this intervention and further tailoring of the programme to suit both genders is required ME Jensen , PG Gibson , CE Collins , JM Hilton , LG Wood . Clin Exp Allergy . 2013;43(7):775–784 The goal of this study was to assess if dietary intervention ( DI ) can achieve weight loss in obese asthmatic children and if diet-induced weight loss leads to changes in asthma outcomes . The study evaluated 32 obese ( BMI z score ≥1.64 SD score ) Australian children aged 8 to 17 years , with a physician diagnosis of asthma . Exclusion criteria included unexplained weight change during the past 3 months , inflammatory or endocrine disorders , and respiratory disorders other than asthma . In this 10-week , r and omized controlled trial , 32 obese asthmatic children were r and omized to OBJECTIVE Although there is general agreement that parents should be involved in pediatric obesity treatment , few studies have investigated the effectiveness of interventions that target parents exclusively . Moreover , the effectiveness of this approach has not been adequately assessed with racially diverse families , particularly African Americans(AA ) , a group at high risk for elevated Body Mass Index ( BMI ) . METHODS NOURISH ( Nourishing Our Underst and ing of Role modeling to Improve Support and Health ) is a culturally-sensitive parenting intervention targeting overweight ( AA ) children ( ages 6 - 11 ; M BMI = 98.0%ile ) . Families ( N = 84 ; 61 % AA , 37 % White ) were r and omly assigned to NOURISH or a control group . RESULTS NOURISH families significantly improved on child BMI from pre- to post-testing after adjustment for r and om effects , baseline BMI , and child race . NOURISH parents were very satisfied with the intervention and would recommend it to other parents ; 91 % strongly or moderately agreed that NOURISH helped them eat in a healthier manner . CONCLUSIONS These pilot data suggest that NOURISH is acceptable and , with refinement , offers promise for reducing pediatric BMI . Outcomes , lessons learned , and parent feedback will inform a larger r and omized controlled trial The effects of adding exercise to diet for weight control in obese children were evaluated by r and omizing obese girls to one of two groups : diet and diet plus exercise . During the first 6 weeks of the treatment , children exercised in a supervised three times a week exercise program , in which they walked or ran 3 miles . Significant decreases from baseline weight and in percent overweight were observed for both groups during the year of treatment . Significant decreases in percent overweight were observed at 0 to 2 months and then at 2 to 6 months for the children who were exercising , whereas percent overweight in children in the diet-alone group decreased only from 0 to 2 months . In addition , a significant improvement in fitness was observed only for children in the diet plus exercise group OBJECTIVE To test the effects of a three-year , community-based , multi-component , multi-level , multi- setting ( MMM ) approach for treating overweight and obese children . DESIGN Two-arm , parallel group , r and omized controlled trial with measures at baseline , 12 , 24 , and 36 months after r and omization . PARTICIPANTS Seven through eleven year old , overweight and obese children ( BMI ≥ 85th percentile ) and their parents/caregivers recruited from community locations in low-income , primarily Latino neighborhoods in Northern California . INTERVENTIONS Families are r and omized to the MMM intervention versus a community health education active-placebo comparison intervention . Interventions last for three years for each participant . The MMM intervention includes a community-based after school team sports program design ed specifically for overweight and obese children , a home-based family intervention to reduce screen time , alter the home food/eating environment , and promote self-regulatory skills for eating and activity behavior change , and a primary care behavioral counseling intervention linked to the community and home interventions . The active-placebo comparison intervention includes semi-annual health education home visits , monthly health education newsletters for children and for parents/guardians , and a series of community-based health education events for families . MAIN OUTCOME MEASURE Body mass index trajectory over the three-year study . Secondary outcome measures include waist circumference , triceps skinfold thickness , accelerometer-measured physical activity , 24-hour dietary recalls , screen time and other sedentary behaviors , blood pressure , fasting lipids , glucose , insulin , hemoglobin A1c , C-reactive protein , alanine aminotransferase , and psychosocial measures . CONCLUSIONS The Stanford GOALS trial is testing the efficacy of a novel community-based multi-component , multi-level , multi- setting treatment for childhood overweight and obesity in low-income , Latino families OBJECTIVE Preschool and minority children have not been well represented in obesity treatment studies . This analysis of clinical obesity treatment was carried out within a diverse population of children 2 - 12 years to identify demographic characteristics associated with successful treatment . DESIGN AND METHODS A medical record review captured BMI and demographics for children 2 - 12 years who began treatment during a 42-month period ( n = 479 ) . Associations of body mass index z-score ( BMI -Z ) change with child and family demographics were examined with logistic regression and time-to-event analysis . RESULTS Treatment led to a mean BMI -Z decrease of 0.18 . Half of children with follow-up ( n = 273 ) exceeded the a priori cut-off for successful treatment of -0.1 BMI -Z. Preschoolers and children of Spanish-speakers were more likely to succeed , ( Adjusted OR : 5.8 [ 95 % CI : 2.7 - 12.2 ] and 2.3 [ 95 % CI : 1.1 , 4.9 ] ) . The hazard ratio for treatment failure was 3.7 [ 95 % CI : 2.1 , 6.8 ] for children starting treatment at 6 - 12 years compared to preschoolers , adjusted for other demographics . CONCLUSIONS This mode of treatment was more likely to succeed among children treated before school age and among children whose parents spoke only Spanish . Screening and treatment for obesity in preschoolers and Hispanic immigrant families deserve further prospect i ve study Background : Latino children are disproportionately burdened by obesity . Objective : To assess whether body mass index ( BMI ) change in preadolescents reflected that of their participating parent . Methods : A total of 72 Latino overweight/obese preadolescents ( BMI ≥ 85 % ) and a parent participated in a r and omized controlled trial . The intervention group received 5 monthly 60-minute sessions at a recreation center ( group physical activity , goal setting ) . The control group received 2 st and ard-of-care clinic visits plus a group discussion . Results : Between baseline and 6-month follow-up , 47 % of children ( mean change = -0.37 , SD = 2.48 ) and 63 % of parents ( mean change = -0.88 , SD = 3.53 ) decreased their BMI . Parent — child dyad BMI change was significantly correlated ( r = .53 , P = .001 ) . In linear modeling , those preadolescents in the control group were more likely to lose absolute BMI units ( -0.96 , P = .03 ) ; whereas those who had parents who gained BMI over the time interval were more likely to increase their BMI ( 0.17 , P = .008 ) . Conclusions : Obesity interventions should focus on the parent — child dyad Background : Parent-child treatments have been shown to be superior to child-focused treatments of childhood obesity . Yet until now , the comparative effectiveness of parent-only and parent-child approaches has been little studied . Method : Fifty-six obese children and their families were r and omly assigned to a 16-session cognitive behavioral therapy ( CBT ) for the parents only or for a combined treatment of parents and children . Children ’s percent overweight , the body mass index of their mothers , and behavioral and psychological problems of children and mothers were assessed . Results : Both treatments reduced children ’s percent overweight significantly and equally by 6-month follow-up . Also both treatments provided similar results in reducing general behavior problems ( externalizing and internalizing behavior problems ) , global and social anxiety , and depression . Conclusions : Our results point to a comparable efficacy of the two treatments . Further , psychological well-being of both mothers and children can be improved in a CBT for obese children and their parents . Future studies should focus on finding ways to improve the adherence of families to long-term treatment of obesity in childhood OBJECTIVE The primary goal was to evaluate sex differences in child weight control programs that targeted increasing physical activity ( increase ) or the combination of reducing sedentary behavior and increasing physical activity ( combined ) . A second goal was to evaluate the benefits of family-based interventions on nontargeted siblings . RESEARCH METHODS AND PROCEDURES Sixty-seven families with obese children and 89 siblings were r and omized to interventions that targeted increasing physical activity ( increase ) or the combination of reducing sedentary behavior and increasing physical activity ( combined ) . Targeted participants and nontargeted siblings were followed for 1 year . RESULTS At 12 months , boys showed significantly better percentages of overweight changes ( -15.8 % ) for the combined treatment than girls ( -1.0 % ) , with no significant differences for the increase intervention for boys ( -9.3 % ) or girls ( -7.6 % ) . Boys adhered to treatment better than girls ( p < 0.01 ) . Adherence and predilection for physical activity were significant predictors of targeted child weight loss at 1 year in multiple regression analysis . Predictors of sibling weight loss included age , number of siblings , targeted child percentage of overweight change , and the interaction of group assignment by same sex of treated sibling . DISCUSSION Gender may influence response to programs that attempt to decrease sedentary behavior , and generalization of treatment effects to siblings may depend on the intervention and characteristics of the siblings BACKGROUND Childhood obesity has become a growing public health issue in Taiwan . Obese children have risk factors for type 2 diabetes and cardiovascular disease . In this prospect i ve study , we investigated the effect of a twelve-week heart health education and physical activity program on body weight and risk factors for type 2 diabetes and cardiovascular disease . METHODS Subjects were 120 obese fifth grade rs ( 65 boys and 55 girls , aged 10 - 13 years ( mean 10.6 yrs ) , body mass index ( BMI ) at the 95th percentile or more ) and were r and omly assigned to an intervention group ( n=60 ) or control group ( n=60 ) . The intervention group received a twelve-week heart health education and physical activity program , while the control group did not . In both groups , a series of examinations were done at baseline and post-test , including height , weight , BMI , body fat , blood pressure ( BP ) , physical fitness ( 800-meter running test ) , heart health knowledge , and serum biochemistry . Differences for baseline and post-test data were compared between both groups . RESULTS Mean changes in the intervention group versus control group were significant for weight ( P = 0.024 ) , BMI ( P = 0.047 ) , percentage body fat ( P = 0.008 ) , physical fitness ( 800-meter running test ) ( P = 0.025 ) , heart health knowledge ( P = 0.006 ) , total cholesterol ( P = 0.027 ) , triglycerides ( P = 0.018 ) , high-density lipoprotein cholesterol ( HDL-C ) ( P = 0.009 ) , low-density lipoprotein cholesterol ( LDL-C ) ( P = 0.041 ) , sugar ( P = 0.035 ) , insulin ( P = 0.007 ) , and insulin resistance ( HOMA-IR ) ( P = 0.028 ) . At post-test , weight , BMI , body fat , total cholesterol , triglycerides , LDL-C , sugar , insulin and HOMA-IR had decreased , but HDL-C had increased in the intervention group . CONCLUSIONS A classroom-based weight-control intervention provides educational programs to promote cardiovascular health in children . This intervention is simple , practical , and beneficial for elementary school children There is a worldwide epidemic of obesity with far-reaching consequences for the health of our nation . Prevention of obesity , especially in children , has been deemed by public health policy makers to be one of the most important objectives for our country . This prevention project , called Louisiana ( LA ) Health , will test whether modification of environmental and behavioral factors can prevent inappropriate weight gain in children from rural parishes of Louisiana who are enrolled in the fourth to sixth grade s during Year 1 . The primary aim of the LA Health project is to test the efficacy of two school-based approaches for obesity prevention : primary prevention alone and a combination of primary and secondary prevention which will be compared to a no-intervention control group using a cluster r and omization research design , with 17 school clusters r and omly assigned to the three treatment arms . The study will span 3 years and will provide critical tests of strategies that : 1 ) modify the child 's environment as a primary prevention strategy and 2 ) provide health behavior modification via classroom instruction and internet counseling as a secondary prevention strategy . The study will also recruit a similar sample of students to measure changes in body weight relative to height , gender , and age over the same three-year period OBJECTIVES To investigate the effect of a weight-bearing physical activity program on foot structure and plantar pressures generated by overweight/obese children . DESIGN Descriptive study . METHODS Measurements were collected for a sample of children participating in an obesity treatment trial ( mean±SD 8.5±1.1 y , 29.4 % boys , 2.63±0.61 body mass index z-score ) . Children were r and omised to physical activity ( physical activity ; n=24 ) and no physical activity ( no physical activity ; n=10 ) groups . Foot structure was characterised using anthropometry , an emed ( ® ) AT-4 system quantified pressure distributions and Actigraph accelerometers objective ly measured physical activity . RESULTS After 6 months there was a significant decrease in body mass index z-score ( physical activity : p=0.002 , no physical activity : p<0.001 ) , an increase in foot length ( physical activity : p<0.001 , no physical activity : p<0.001 ) and foot height ( physical activity : p<0.001 , no physical activity : p=0.008 ) , although no change in physical activity . Pressure-time integrals increased after 6 months ( lateral midfoot ; physical activity : p=0.036 , medial forefoot ; physical activity : p=0.002 , no physical activity : p=0.013 , middle forefoot ; physical activity : p=0.044 , lateral forefoot ; physical activity : p=0.043 ) but there were no between-group differences in plantar pressures after the physical activity program . CONCLUSIONS Although changes to foot structure and function in overweight/obese children could not be attributed to participating in the physical activity program , their developing feet may still be at risk of pain and discomfort due to higher plantar pressures and pressure-time integrals . Further research investigating ways to reduce plantar pressures generated by overweight/obese children while they are physically active is warranted BACKGROUND General practitioners ( GPs ) could make an important contribution to management of childhood overweight . However , there are no efficacy data to support this , and the feasibility of this approach is unknown . OBJECTIVES To determine if GPs and families can be recruited to a r and omized controlled trial ( RCT ) , and if GPs can successfully deliver an intervention to families with overweight/obese 5- to 9-year-old children . METHODS A convenience sample of 34 GPs from 29 family medical practice s attended training sessions on management of childhood overweight . Practice staff trained in child anthropometry conducted a cross-sectional body mass index ( BMI ) survey of 5- to 9-year-old children attending these practice s. The intervention focused on achievable goals in nutrition , physical activity and sedentary behaviour , and was delivered in four solution-focused behaviour change consultations over 12 weeks . RESULTS General practitioners were recruited from across the sociodemographic spectrum . All attended at least two of the three education sessions and were retained throughout the trial . Practice staff weighed and measured 2112 children in the BMI survey , of whom 28 % were overweight/obese ( 17.5 % overweight , 10.5 % obese ) , with children drawn from all sociodemographic quintiles . Of the eligible overweight/obese children , 163 ( 40 % ) were recruited and retained in the LEAP RCT ; 96 % of intervention families attended at least their first consultation . CONCLUSIONS Many families are willing to tackle childhood overweight with their GP . In addition , GPs and families can participate successfully in the careful trials that are needed to determine whether an individualized , family-based primary care approach is beneficial , harmful or ineffective OBJECTIVE To evaluate the impact of a school-based obesity prevention program that seeks to change food intake among students at schools in Rosario , Argentina . METHODS This was a prospect i ve study involving 405 children 9 - 11 years of age at six schools in the poor areas of Rosario , Argentina , in May-October 2008 . After matching for socioeconomic status , schools were selected by simple r and omization ; participants were assessed at baseline ( T1 ) and again 6 months later , after completion of the intervention ( T2 ) . The program focused on increasing the children 's knowledge of healthy nutrition and exercise through four workshops ; educating the parents/caregivers ; and offering healthy options at the school snack bar . The main outcome measures were the children 's intake of healthy and unhealthy foods ( assessed with a weekly food frequency question naire ) and their body mass index ( BMI ) . RESULTS Of the 387 children assessed at T1 , 369 were reassessed at T2 ( 205 intervention ; 164 control ) . Girls at the schools where the intervention occurred increased their intake of three of the five healthy food items promoted by the program ( fruits , vegetables , low-sugar cereals ) . Statistical significance was reached for skim milk ( P = 0.03 ) and for pure orange juice ( P = 0.05 ) . Boys of both the intervention and control groups failed to improve their intake of healthy foods , but those of the intervention arm significantly reduced their intake of hamburgers and hot dogs ( P = 0.001 ) . CONCLUSIONS Girls were more amenable to improving their dietary intake . Overall , the program was more likely to increase consumption of healthy food than to decrease intake of unhealthy foods . Gender differences should be taken into account when design ing preventive interventions OBJECTIVE To evaluate the 4-year outcome of a school-based health promotion on weight status as part of the Kiel Obesity Prevention Study ( KOPS ) . RESEARCH METHODS AND PROCEDURES Within a cluster- sample d quasi-r and omized controlled trial , 1764 children at 6 and 10 years of age were assessed between 1996 and 2005 in 32 primary schools in Kiel , North Germany . Six nutrition units followed by 20-minute running games were performed within the first year at school . Prevalence , incidence , and remission of overweight were main outcome measures . RESULTS The 4-year change in BMI was + 11.6 % , with increases in prevalence of overweight and obesity from 5.2 % to 11.1 % and 3.9 % to 5.1 % , respectively . Cumulative 4-year incidence of overweight and obesity was 9.2 % and 3.1 % , respectively . Intervention had no effect on mean BMI . The effect on prevalence was significant in children from families with high socioeconomic status [ odds ratio ( OR ) , 0.35 ; 95 % confidence interval ( CI ) , 0.14 to 0.91 ] and marginally significant in children of normal-weight mothers ( OR , 0.57 ; 95 % CI , 0.33 to 1.00 ) . Cumulative 4-year incidence of overweight was lower only in intervention children from families with high socioeconomic status ( OR , 0.26 ; 95 % CI , 0.07 to 0.87 ) . Remission of overweight was most pronounced in children of normal-weight mothers ( OR , 5.43 ; 95 % CI , 1.28 to 23.01 ) . Prevalence of underweight was unchanged . The intervention had minor but favorable effects on lifestyle . DISCUSSION A school-based health promotion has sustainable effects on remission and incidence of overweight ; it was most pronounced in children of normal-weight mothers and children from families with high socioeconomic status . There was no effect on obesity . The data argue in favor of additional measures of prevention BACKGROUND Effective treatment of childhood obesity requires a multi-factorial approach and should target factors impacting on a child 's environment . OBJECTIVE To explore the impact of three treatment programs on parental child-feeding practice s at 6 , 12 and 24 months post-program . SUBJECTS/INTERVENTION : Overweight children ( n=159 ) aged 5 - 7 years , recruited to the Hunter Illawarra Kids Challenge Using Parent Support ( HIKCUPS ) r and omized controlled trial with three treatment arms ; a dietary modification program , a physical activity skill development program or a combination of both programs . Main outcome measures . The Child Feeding Question naire ( CFQ ) , a vali date d 31-item question naire measuring child-feeding practice s , completed by parents . Statistical analysis . Linear mixed models were used to assess change over time and to determine differences by intervention group . RESULTS A significant decrease ( p<0.01 ) in CFQ domain scores were reported and sustained at 24 months for all groups , in the domain of pressure to eat ( mean+/-SEM , 1.8+/-0.06 , 1.6+/-0.06 ) with increases in degree of monitoring ( 4.0+/-0.07 , 4.2+/-0.06 ) . The domain of restriction showed significant decreases in dietary intervention groups only ( baseline 3.9+/-0.05 , 24 months 3.7+/-0.06 ) , the domain scores for concern were found to be strongly associated with child BMI z-score ( r=0.73 , p < 0.001 ) at baseline only . CONCLUSIONS This study provides evidence that specific child-feeding domains are modifiable in the context of a targeted obesity intervention and further that changes can be sustained over time . HIKCUPS study : National Centre for Clinical Trials ( NCT ) : 00107692 clinical trials.gov Identifier : NCT00107692 http:// clinical trials.gov/ct2/home OBJECTIVE NOURISH is a community-based treatment program for parents of overweight and obese children ( ages 6 - 11 , BMI ≥ 85 th percentile ) . This study examined the impact of Nourishing Our Underst and ing of Role modeling to Improve Support and Health on child and parent dietary intake , secondary trial outcomes . METHODS In Virginia from 2008 to 2009 , this r and omized controlled pilot was implemented and dietary assessment of parents and children conducted at baseline , post-test , and 6-month follow-up . Parents ( 85 % female , 62 % African American , mean BMI = 34.1 ± 9.1 ) were r and omized into intervention ( n=46 ) or control ( n=50 ) groups . Children 's ( mean age=8.6 ± 1.5 ) mean Body Mass Index percentile was 98.1 ± 2.6 . Parents completed 24-hour dietary records for themselves and their child(ren ) . Repeated measures analyses assessed treatment effects over time . T-tests evaluated within-group changes from baseline to post-test and to follow-up , using a modified intent-to-treat approach . RESULTS Both groups reported significant dietary changes , with few treatment effects found . For parents in NOURISH , significant improvements were found in intakes of total kilocalories/day , grams/day of carbohydrates and sugar , and percent calories from protein ( p<0.05 ) . Among control group children , significant improvements in total kilocalories/day and grams/day of carbohydrates and sugar were found ( p<0.05 ) . CONCLUSIONS Among parents who self-select into a childhood obesity program , minimal intervention can elicit short-term dietary changes comparable to those of a structured intervention After-school programs can be implemented by school nurses to facilitate healthy lifestyle choices in children with the goal of decreasing obesity . Kids Living Fit ™ (KLF ) , an after-school program design ed by community hospital nurses , was implemented in elementary schools and focused on best lifestyle choices regarding foods consumed and activities chosen for children in grade s 2 through 5 . Study measures included comparison of body mass index ( BMI ) percentiles for age and gender and waist circumference between two self-selected groups composing a total sample size of 185 participants : the KLF intervention group ( n = 80 ) and the no-intervention/ contrast group ( n = 105 ) . The 12-week intervention included a weekly fitness program and monthly dietitian presentations . Participants completed food and activity diaries and wore pedometers . In pairwise comparisons , the KLF group had a significant decrease in BMI percentile between baseline and follow-up ( −2.3 % ) compared with the contrast group . The KLF group also demonstrated a smaller increase in waist circumference than the contrast group ISSUES ADDRESSED This paper presents the findings from a cluster r and omised controlled evaluation of a preschool-based intervention ( children aged 3 - 6 years ) , on the North Coast of NSW , which aim ed to decrease overweight and obesity prevalence among children by improving fundamental movement skills ( FMS ) , increasing fruit and vegetable intake and decreasing unhealthy food consumption . METHODS The Tooty Fruity Vegie in Preschools program was implemented in 18 preschools for 10 months during 2006 and 2007 . It included nutrition and physical activity strategies . Pre and post intervention evaluation compared intervention and control children and was conducted at the beginning and end of each year . It included FMS testing , lunch box audits and anthropometric measures of children as well as parents ' surveys regarding children 's food intake , physical activity and sedentary behaviours . RESULTS In comparison to controls , children in intervention preschools significantly improved movement skills ( 14.79 units , p<0.001 ) , had more fruit and vegetable serves ( 0.63 serves , p=0.001 ) and were less likely to have unhealthy food items ( p<0.001 ) in their lunch boxes following the intervention . There was also a significant difference in waist circumference growth ( -0.80 cm , p=0.002 ) and a reduction of BMI Z scores ( -0.15 , p=0.022 ) . CONCLUSIONS The 10-month intervention in preschools produced significant changes in children 's food intake , movement skills and indicators of weight status BACKGROUND & AIMS R and omized controlled trials ( RCT ) have demonstrated the effectiveness of lifestyle interventions in obese children . However , the effectiveness of interventions for overweight , but no obese children has not been demonstrated yet by RCTs . METHODS A total of 66 overweight ( BMI > 90th < or = 97th percentile ) children ( mean age 11.5+/-1.6 years , 58 % females , mean BMI 23.4+/-1.5kg/m(2 ) ) were r and omized into a control group ( CG ) ( n=32 ; no intervention for a duration of 6 months ) or intervention group ( IG ) ( n=34 ; 6 months intervention " Obeldicks light " based on physical activity , nutrition education , and behaviour counselling ) . BMI , waist circumference , skinfold thickness , bioimpedance analyses , blood pressure , physical activity based on question naires , and three-day-weighed dietary records were determined at baseline ( T0 ) and 6 months ( T1 ) later . Degree of overweight was calculated as BMI -SDS . Comparisons were performed on an intention-to-treat approach . RESULTS The drop-out rate was 3 % in IG and 16 % in CG . At T1 , 94 % of the children in IG decreased their BMI -SDS and 24 % of them were normal weight . The changes between T0 and T1 in BMI -SDS differed significantly ( p<0.001 ) between IG and CG ( CG : + 0.05+/-0.19 BMI -SDS ; IG : -0.26+/-0.22 BMI -SDS ) . Similar findings were observed for blood pressure , waist circumference , skinfold thickness , and fat mass based on bioimpedance analyses . In the IG , energy , fat and sugar intake decreased significantly between T0 and T1 , while no significant changes were observed in the CG . CONCLUSIONS The lifestyle intervention was associated with an improvement of dietary patterns and was effective in reducing degree of overweight , fat mass , waist circumference , and blood pressure BACKGROUND Underserved children , particularly girls and those in urban communities , do not meet the recommended physical activity guidelines ( > 60min of daily physical activity ) , and this behavior can lead to obesity . The school years are known to be a critical period in the life course for shaping attitudes and behaviors . Children look to schools for much of their access to physical activity . Thus , through the provision of appropriate physical activity programs , schools have the power to influence apt physical activity choices , especially for underserved children where disparities in obesity-related outcomes exist . OBJECTIVES To evaluate the impact of a nurse directed , coordinated , culturally sensitive , school-based , family-centered lifestyle program on activity behaviors and body mass index . DESIGN , SETTING S AND PARTICIPANTS This was a parallel group , r and omized controlled trial utilizing a community-based participatory research approach , through a partnership with a University and 5 community schools . Participants included 251 children ages 8 - 12 from elementary schools in urban , low-income neighborhoods in Los Angeles , USA . METHODS The intervention included Kids N Fitness ( © ) , a 6-week program which met weekly to provide 45min of structured physical activity and a 45min nutrition education class for parents and children . Intervention sites also participated in school-wide wellness activities , including health and counseling services , staff professional development in health promotion , parental education newsletters , and wellness policies for the provision of healthy foods at the school . The Child and Adolescent Trial for Cardiovascular Health School Physical Activity and Nutrition Student Question naire measured physical activity behavior , including : daily physical activity , participation in team sports , attending physical education class , and TV viewing/computer game playing . Anthropometric measures included height , weight , body mass index , resting blood pressure , and waist circumference . Measures were collected at baseline , completion of the intervention phase ( 4 months ) , and 12 months post-intervention . RESULTS Significant results for students in the intervention , included for boys decreases in TV viewing ; and girls increases in daily physical activity , physical education class attendance , and decreases in body mass index z-scores from baseline to the 12 month follow-up . CONCLUSIONS Our study shows the value of utilizing nurses to implement a culturally sensitive , coordinated , intervention to decrease disparities in activity and TV viewing among underserved girls and boys Objective Short sleep duration may contribute to childhood obesity . Amenable to intervention , sleep thus provides a potential path for prevention . The authors aim ed to determine the impact of a behavioural intervention that successfully reduced parent-reported infant sleep problems on adiposity at age 6 . Design 5-year follow-up of a previously reported population -based cluster r and omised trial . Participant allocation was concealed to research ers and data collection blinded . Setting Recruitment from well-child centres in Melbourne , Australia . Participants 328 children ( 174 intervention ) with parent-reported sleep problems at age 7–8 months drawn from 49 centres ( clusters ) . Intervention Behavioural sleep strategies delivered over one to three structured individual nurse consultations from 8 to 10 months , versus usual care . Main outcomes at age 6 years Body mass index ( BMI ) z-score , percentage overweight/obese and waist circumference . Analyses Intention-to-treat regression analyses adjusted for potential confounders . Results Anthropometric data were available for 193 children ( 59 % retention ) at age 6 . There was no evidence of a difference between intervention ( N=101 ) and control ( N=92 ) children for BMI z-score ( adjusted mean difference 0.2 , 95 % CI −0.1 to 0.4 ) , overweight/obese status ( 20 % vs 17 % ; adjusted OR 1.4 , 95 % CI 0.7 to 2.8 ) and waist circumference ( adjusted mean difference −0.3 , 95 % CI −1.6 to 1.1 ) . In posthoc analyses , neither infant nor childhood sleep duration were associated with anthropometric outcomes . Conclusions A brief infant sleep intervention did not reduce overweight/obesity at 6 years . Population -based primary care sleep services seem unlikely to reduce the early childhood obesity epidemic . Trial registration IS RCT OBJECTIVE Preventing weight gain in adults and excessive weight gain in children is a high priority . We evaluated the ability of a family-based program aim ed at increasing steps and cereal consumption ( for breakfast and snacks ) to reduce weight gain in children and adults . RESEARCH METHODS AND PROCEDURES Families ( n = 105 ) with at least one 8- to 12-year-old child who was at-risk-for-overweight or overweight ( design ated as the target child ) were recruited for the study . Eighty-two families were r and omly assigned to receive the family-based intervention and 23 families to the control condition . The 13-week intervention consisted of specific increases in daily steps ( an additional 2000 steps/d ) and consumption of 2 servings/d of ready-to-eat cereal . RESULTS The intervention was successful in increasing walking ( steps ) and cereal consumption . The intervention had positive , significant effects on percentage BMI -for-age and percentage body fat for target children and weight , BMI , and percentage body fat for parents . On further analysis , the positive effects of the intervention were seen largely in target girls and moms , rather than in target boys and dads . DISCUSSION This family-based weight gain prevention program based on small changes holds promise for reducing excessive weight gain in families and especially in growing overweight children OBJECTIVE The objective was to evaluate quality of life ( QOL ) in at-risk-for-overweight and overweight Mexican-American children after participating in 6 months of intensive weight management or self-help . RESEARCH METHODS AND PROCEDURES Eighty sixth- and seventh- grade at-risk-for-overweight ( BMI > or=85th to < 95th percentile ) and overweight ( BMI > or=95th percentile ) Mexican-American children were r and omly assigned to either intensive instructor-led intervention ( ILI ) or self-help ( SH ) . The ILI condition included daily participation for 12 weeks in a school-based program comprised of nutrition education , physical activity , and behavior modification , followed by ongoing monthly maintenance . QOL was assessed at baseline and 6 months via child self-report PedsQL . QOL outcomes were compared across treatment groups , and the impact of change in z BMI on change in QOL was evaluated . RESULTS Children in the ILI condition not only achieved significantly greater weight loss ( z BMI , -0.13 + /- 0.14 ; p < 0.001 ) but also significantly greater physical QOL improvements than those in the SH condition at 6 months ( p < 0.05 ) . Furthermore , physical QOL increases were associated with z BMI reduction ( p < 0.05 ) . However , neither psychosocial nor total QOL was significantly impacted by intervention or z BMI change . DISCUSSION These findings show that even modest decreases in z BMI after weight management result in improved physical QOL in Mexican-American children . These results illustrate the clear need to include evaluation of QOL in the process of identifying effective weight management programs IMPORTANCE Millions of children attend after-school programs in the United States . Increasing physical activity levels of program participants could have a broad effect on children 's health . OBJECTIVE To test the effectiveness of the Out of School Nutrition and Physical Activity ( OSNAP ) Initiative in increasing children 's physical activity levels in existing after-school programs . DESIGN , SETTING , AND PARTICIPANTS Cluster-r and omized controlled trial with matched program pairs . Baseline data were collected September 27 through November 12 , 2010 , with follow-up data collected April 25 through May 27 , 2011 . The date s of our analysis were March 11 , 2014 , through August 18 , 2015 . The setting was 20 after-school programs in Boston , Massachusetts . All children 5 to 12 years old in participating programs were eligible for study inclusion . INTERVENTIONS Ten programs participated in a series of three 3-hour learning collaborative workshops , with additional optional opportunities for training and technical assistance . MAIN OUTCOMES AND MEASURES Change in number of minutes and bouts of moderate to vigorous physical activity , vigorous physical activity , and sedentary activity and change in total accelerometer counts between baseline and follow-up . RESULTS Participants with complete data were 402 racially/ethnically diverse children , with a mean age of 7.7 years . Change in the duration of physical activity opportunities offered to children during program time did not differ between conditions ( -1.2 minutes ; 95 % CI , -14.2 to 12.4 minutes ; P = .87 ) . Change in moderate to vigorous physical activity minutes accumulated by children during program time did not differ significantly by intervention status ( -1.0 ; 95 % CI , -3.3 to 1.3 ; P = .40 ) . Total minutes per day of vigorous physical activity ( 3.2 ; 95 % CI , 1.8 - 4.7 ; P < .001 ) , vigorous physical activity minutes in bouts ( 4.1 ; 95 % CI , 2.7 - 5.6 ; P < .001 ) , and total accelerometer counts per day ( 16,894 ; 95 % CI , 5101 - 28,686 ; P = .01 ) increased significantly during program time among intervention participants compared with control participants . CONCLUSIONS AND RELEVANCE Although programs participating in the OSNAP Initiative did not allot significantly more time for physical activity , they successfully made existing time more vigorously active for children receiving the intervention . TRIAL REGISTRATION clinical trials.gov Identifier : NCT01396473 BACKGROUND Insufficient evidence exists to support obesity prevention in paediatric primary care . OBJECTIVES To test a theory-based behaviour modification intervention delivered by trained paediatric primary care providers for obesity prevention . METHODS Efficacy trial with cluster r and omization ( practice level ) and a 12-session 12-month sweetened beverages decrease intervention or a comprehensive dietary and physical activity intervention , compared with a control intervention among children ages 8 - 12 years . RESULTS A low recruitment rate was observed . The increase in body mass index z-score ( BMI z ) for the 139 subjects ( 11 practice s ) r and omized to any of the two obesity interventions ( combined group ) was less than that of the 33 subjects ( five practice s ) r and omized to the control intervention ( -0.089 , 95 % confidence interval [ CI ] : -0.170 to -0.008 , P = 0.03 ) with a -1.44 kg weight difference ( 95 % CI : -2.98 to + 0.10 kg , P = 0.095 ) . The incidences of obesity and excess weight gain were lower in the obesity interventions , but the number of subjects was small . Post hoc analyses comparing the beverage only to the control intervention also showed an intervention benefit on BMI z ( -0.083 , 95 % CI : -0.165 to -0.001 , P = 0.048 ) . CONCLUSIONS For participating families , an obesity prevention intervention delivered by paediatric primary care clinicians , who are compensated , trained and continuously supported by behavioural specialists , can impact children 's BMI This study tested the effects of mastery criteria and contingent reinforcement in a family-based behavioral weight control program for obese children and their parents over two years . Families with obese children were r and omized to one of two groups . The experimental group was targeted and reinforced for mastery of diet , exercise , weight loss , and parenting skills . The control group was taught behavior-change strategies and provided noncontingent reinforcement at a pace yoked to the experimental group . Both groups received the same behavioral family-based educational components over 6 months of weekly meetings and six monthly follow-up meetings . Results showed significantly better relative weight change at 6 months and 1 year for children in the experimental compared to the control group , but these effects were not maintained at 2 years . These results suggest the introduction of mastery criteria and contingent reinforcement for mastery can improve outcome during treatment in behavioral treatments for childhood obesity BACKGROUND This study aim ed to determine whether oxidative stress was related to cardiovascular risk indices in children , and whether an exercise intervention would reduce oxidative stress . METHODS A r and omized trial of two different doses of exercise and a no-exercise control group included 112 overweight and obese children , 7 - 11 years old . Plasma isoprostane levels were obtained at baseline and after the intervention . Cross-sectional analysis of oxidative stress and metabolic markers at baseline was performed . The effect of the exercise training on oxidative stress was tested . RESULTS Lower isoprostane levels were observed in blacks . At baseline , isoprostane was positively related to measures of fatness ( BMI , waist circumference , percent body fat ) , insulin resistance and β-cell function ( fasting insulin , insulin area under the curve , Matsuda index , disposition index , oral disposition index ) , and several lipid markers ( low-density lipoprotein , triglycerides , total cholesterol ) , and inversely with fitness [ peak oxygen consumption ( VO(2 ) ) ] , independent of race , sex , and cohort . No relation was found with visceral fat , blood pressure , or glycemia . Independent of percent body fat , isoprostane predicted triglycerides , β=0.23 , total cholesterol-to-high-density lipoprotein ( TC/HDL ) ratio , β=0.23 , and insulin resistance ( insulin area under the curve , β=0.24 , Matsuda index , β=-0.21 , oral disposition index , β=0.33 ) . Exercise did not reduce oxidative stress levels , despite reduced fatness and improved fitness in these children . CONCLUSIONS Isoprostane levels were related to several markers of cardiovascular risk at baseline ; however , despite reduced fatness and improved fitness , no effect of exercise was observed on isoprostane levels . To our knowledge , this is the first report in children to demonstrate a correlation of oxidative stress with disposition index , fitness , and TC/HDL ratio , the first to test the effect on oxidative stress of an exercise intervention that reduced body fat , and the first such exercise intervention study to include a substantial proportion of black children There is an urgent need for innovative approaches to pediatric obesity treatment . There is also a dem and for targeted strategies that reduce attrition and improve treatment adherence . Intervening exclusively with parents of overweight children is a novel approach with demonstrated efficacy in reducing child body mass index ( BMI ) percentile . Motivational interviewing ( MI ) , a brief communication style for exploring and resolving ambivalence about behavior change , might enhance treatment engagement when implemented as part of obesity interventions . The aim of this report is to provide the rationale and methods for a novel study of MI with parents in the treatment of their children 's overweight . We design ed and are currently implementing NOURISH+MI , a r and omized controlled trial examining the feasibility and efficacy of an adjunct values-based MI intervention , implemented within a culturally-tailored parent intervention for overweight children ages 5 - 11 years , NOURISH(+ ) ( Nourishing Our Underst and ing of Role modeling to Improve Support and Health ) . Specifically , we are r and omly assigning 60 parents to this adjunctive treatment , and investigating if adding two MI sessions prior to the NOURISH(+ ) group intervention will enhance treatment effects . We will be able to compare NOURISH+MI participants with those from the two NOURISH(+ ) treatment conditions ( NOURISH(+ ) and control ) . We hypothesize that children whose parents participate in NOURISH+MI will demonstrate lower attrition and greater adherence with NOURISH(+ ) , ultimately leading to greater treatment effects , compared with children whose parents are r and omized to NOURISH(+ ) or a control group . Findings will contribute to the emerging literature examining the efficacy of MI within pediatric obesity interventions OBJECTIVE To evaluate the effect of child obesity intervention comprehensive program on the improvement of overweight , obese control and knowledge-attitude- practice . METHODS The study design was under cluster-r and omized controlled trial , with 965 children in the intervention and 895 children in the control groups . Repeated measurement data on child obesity was analyzed through Generalized Estimating Equation models . RESULTS The risk of becoming overweight or obesity in the intervention group was 0.824 times more than children in the control group , showing a reduction of 17.6 % the risk of being overweight or obese ( P = 0.031 ) . In addition , the possibility of increasing one unit of correct rate on obesity related knowledge , children in the intervention group children was 1.044 times ( P = 0.001)than in the control group . On the mean obesity related correct attitude rate , it was 1.023 times ( P = 0.001 ) in the intervention group of the control group . Regarding the possibility of increasing one unit om the mean obesity related behavior score , children in the intervention group was 1.522 times ( P = 0.001)than those in the control group ( P = 0.046 ) . CONCLUSION The comprehensive child obesity intervention program could effectively reduce the risk of developing overweight or obesity and improving the obesity related knowledge , attitude and behavior in children Project STORY is a 3-arm , r and omized , planning and feasibility study assessing the effectiveness of two behavioral weight management interventions in an important and at-risk population , overweight children and their parents in medically underserved rural counties . Participants will include 90 parent-child dyads from rural counties in north central Florida . Families will be r and omized to one of three conditions : ( a ) a Family-Based Behavioral Group Intervention , ( b ) a Parent-Only Behavioral Group Intervention , and ( c ) a waitlist control condition . Child and parent participants will be assessed at baseline ( month 0 ) , post-treatment ( month 4 ) and follow-up ( month 10 ) . Assessment and intervention sessions will be held at Cooperative Extension offices within each local participating county . The primary outcome measure is change in child body mass index ( BMI ) z-score . Additional key outcome measures include child dietary intake , physical activity , self-esteem , body image , and parent BMI . The goals of the study are to ( a ) assess the feasibility of recruitment in rural setting s , ( b ) develop and evaluate training protocol for group leaders , ( c ) determine strategies to increase adherence to monitoring and goal setting protocol , ( d ) evaluate strategies for participant retention , ( e ) assess the relative cost-effectiveness of the interventions , ( f ) assess the acceptability of the intervention to families and Cooperative Extension administrators and personnel , and ( g ) if successful , estimate the sample size needed for a full-scale trial . This research has potential implication s for medically underserved rural communities with limited re sources and preventive health care services . If successful , a Parent-Only intervention program may provide a cost-effective and practical intervention for families in underserved rural communities OBJECTIVE Lifestyle programs can reduce the level of overweight in children ; however , maintenance results and adherence to treatment are difficult to achieve . New technologies , such as the Short Message Service ( SMS ) , might be a promising tool for enhancing interventions . The effect of an SMS approach aim ed at improving treatment results and reducing dropout rates in a pediatric lifestyle intervention , is explored . METHOD Overweight and obese children ( N = 141 ; age 7 - 12 years ) participating in a lifestyle program were r and omly assigned to an intervention group receiving an SMS Maintenance Treatment ( SMSMT ) for 38 weeks ( n = 73 ) or to a control group receiving no SMSMT ( n = 68 ) . Children were asked to send weekly self-monitoring data on exercise , eating behavior , and emotional well-being . In return , they received tailored feedback messages . A differential decrease in BMI was analyzed with repeated measures ANOVA and dropout with logistic regression analysis . RESULTS We found no significant difference in BMI decrease between the two groups after 12 months ; however , we showed that the SMSMT group had 3.25 times less probability of dropping out after 1 year ( p = .01 ) than controls . In the first 3 months of SMSMT , the SMSMT completers sent 0.80 SMSs per week , which reduced to 0.50 SMSs in the final 3 months . Younger children sent more SMSs ( p = .03 ) . CONCLUSIONS These results indicate that SMSMT is effective in reducing dropout rates from a pediatric lifestyle intervention . Future research should examine the effectiveness of SMSMT on weight management and related psychosocial variables Project SPARK evaluates multiple effects of a health-related physical education ( PE ) program for elementary school students . Seven schools were r and omly assigned to one of three conditions : usual PE or control , trained classroom teachers , or PE specialists . The intervention was implemented throughout the fourth and fifth grade s. Data are available from one cohort of 550 children who were measured in the fall and spring of both grade s. Adiposity was assessed by triceps and calf skinfolds , and body mass index ( BMI ) was also measured . Data at each measurement point were analyzed by ANOVAs , covarying for baseline values . At no measurement point were there significant group differences in total skinfold . At both fifth grade measurement points for boys and girls , however , there was a trend for the control group to have higher skinfold values than the two intervention groups . At the final measure , the difference between the highest and lowest groups was about 3 mm for girls and 2 mm for boys . BMI s were significantly lower at some measurement points for boys and girls , but this could be due to increased lean body mass in intervention students . After two years , there was a trend for the children exposed to the PE intervention to have lower levels of body fat , but the differences were not significant Background Approximately one third of New Zeal and children and young people are overweight or obese . A similar proportion ( 33 % ) do not meet recommendations for physical activity , and 70 % do not meet recommendations for screen time . Increased time being sedentary is positively associated with being overweight . There are few family-based interventions aim ed at reducing sedentary behavior in children . The aim of this trial is to determine the effects of a 24 week home-based , family oriented intervention to reduce sedentary screen time on children 's body composition , sedentary behavior , physical activity , and diet . Methods / Design The study design is a pragmatic two-arm parallel r and omized controlled trial . Two hundred and seventy overweight children aged 9 - 12 years and primary caregivers are being recruited . Participants are r and omized to intervention ( family-based screen time intervention ) or control ( no change ) . At the end of the study , the control group is offered the intervention content . Data collection is undertaken at baseline and 24 weeks . The primary trial outcome is child body mass index ( BMI ) and st and ardized body mass index ( z BMI ) . Secondary outcomes are change from baseline to 24 weeks in child percentage body fat ; waist circumference ; self-reported average daily time spent in physical and sedentary activities ; dietary intake ; and enjoyment of physical activity and sedentary behavior . Secondary outcomes for the primary caregiver include change in BMI and self-reported physical activity . Discussion This study provides an excellent example of a theory-based , pragmatic , community-based trial targeting sedentary behavior in overweight children . The study has been specifically design ed to allow for estimation of the consistency of effects on body composition for Māori ( indigenous ) , Pacific and non-Māori/non-Pacific ethnic groups . If effective , this intervention is imminently scalable and could be integrated within existing weight management programs . Trial Registration Objective : We investigated the long-term efficacy of two childhood obesity treatment programs , routine counselling ( two appointments for children ) and group treatment ( 15 sessions separately for children and parents ) in a r and omised controlled trial . As published earlier , group treatment was more effective than routine counselling in the treatment of 7–9 year-old obese children in the short term . Design : The children 's heights and weights were measured 2 and 3 years after the beginning of the intervention and changes in weight for height , body mass index ( BMI ) and BMI st and ard deviation scores were used as outcome measures . Results : There were no significant differences between the treatment arms in the changes of outcome measures from baseline to 2- or 3-years follow-up visits . Conclusion : In conclusion , novel efforts are needed for the improvement of the long-term results of childhood obesity treatment programs Background Community-based programmes for children with excess weight are widely available , but few have been developed to meet the needs of culturally diverse population s. We adapted an existing children ’s weight management programme , focusing on Pakistani and Bangladeshi communities . We report the evaluation of this programme to assess feasibility of programme delivery , acceptability of the programme to participants from diverse communities , and feasibility of methods to inform a future trial . Methods A cluster-r and omised feasibility trial was undertaken in a large UK city . Children ’s weight management programmes ( n = 24 ) were r and omised to be delivered as the adapted or the st and ard programme ( 2:1 ratio ) . Routine data on participant attendance ( n = 243 ) at the sessions were used to estimate the proportion of families completing the adapted and st and ard programmes ( to indicate programme acceptability ) . Families planning to attend the programmes were recruited to participate in the feasibility study ( n = 92 ) . Outcome data were collected from children and parents at baseline , end of programme , and 6 months post-programme . A sub sample ( n = 24 ) of those attending the adapted programme participated in interviews to gain their views of the content and delivery and assess programme acceptability . Feasibility of programme delivery was assessed through observation and consultation with facilitators , and data on costs were collected . Results The proportion of Pakistani and Bangladeshi families and families of all ethnicities completing the adapted programme was similar : 78.8 % ( 95 % CI 64.8–88.2 % ) and 76.3 % ( 95 % CI 67.0–83.6 % ) respectively . OR for completion of adapted vs. st and ard programme was 2.40 ( 95 % CI 1.32–4.34 , p = 0.004 ) . The programme was feasible to deliver with some refinements , and participant interview data showed that the programme was well received . Study participant recruitment was successful , but attrition was high ( 35 % at 6 months ) . Data collection was mostly feasible , but participant burden was high . Data collection on cost of programme delivery was feasible , but costs to families were more challenging to capture . Conclusions This culturally adapted programme was feasible to deliver and highly acceptable to participants , with increased completion rates compared with the st and ard programme . Consideration should be given to a future trial to evaluate its clinical and cost-effectiveness . Trial registration IS RCT N81798055 , registered : OBJECTIVE To assess the effectiveness of parent-only vs family-based interventions for pediatric weight management in underserved rural setting s. DESIGN A 3-arm r and omized controlled clinical trial . SETTING All sessions were conducted at Cooperative Extension Service offices in underserved rural counties . PARTICIPANTS Ninety-three overweight or obese children ( 8 - 14 years old ) and their parent(s ) . INTERVENTION Families were r and omized to ( 1 ) a behavioral family-based intervention , ( 2 ) a behavioral parent-only intervention , or ( 3 ) a wait-list control group . OUTCOME MEASURE The primary outcome measure was change in children 's st and ardized body mass index ( BMI ) . RESULTS Seventy-one children completed posttreatment ( month 4 ) and follow-up ( month 10 ) assessment s. At the month 4 assessment , children in the parent-only intervention demonstrated a greater decrease in BMI z score ( mean difference [ MD ] , 0.127 ; 95 % confidence interval [ CI ] , 0.027 to 0.226 ) than children in the control condition . No significant difference was found between the family-based intervention and the control condition ( MD , 0.065 ; 95 % CI , -0.027 to 0.158 ) . At month 10 follow-up , children in the parent-only and family-based intervention groups demonstrated greater decreases in BMI z score from before treatment compared with those in the control group ( MD , 0.115 ; 95 % CI , 0.003 to 0.220 ; and MD , 0.136 ; 95 % CI , 0.018 to 0.254 , respectively ) . No difference was found in weight status change between the parent-only and family-based interventions at either assessment . CONCLUSIONS A parent-only intervention may be a viable and effective alternative to family-based treatment of childhood overweight . Cooperative Extension Service offices have the potential to serve as effective venues for the dissemination of obesity-related health promotion programs Objective : The aims of this study were to describe the dietary intakes and food behavior changes of overweight and obese children participating in the Hunter Illawarra Kids Challenge Using Parent Support ( HIKCUPS ) study and to describe the impact of a best practice dietary modification program . Design : A multicenter r and omized controlled trial with allocation to one of three intervention arms : ( 1 ) parent-centered nutrition lifestyle program ; ( 2 ) child-centered physical activity skill development program ; or ( 3 ) both the programs . Participants : One hundred and sixty-five overweight , pre-pubertal children 5–9 years of age ( 58 % female ) . Measurements : Dietary intake was assessed at baseline , 6 and 12 months post-commencement of the program using a semiquantitative food frequency question naire . Results : After 6 and 12 months , all groups improved their dietary intake , with no differences detected between groups ( P>0.05 ) . Total quantity of food ( g ) and kJ kg−1 decreased significantly at both time points ( P<0.05 ) . Percent energy derived from core food groups , except fruit , increased significantly at 12 months compared to baseline ( P<0.05 ) , and non-core foods decreased , with the largest decreases being for sweetened drinks ( 5.0±0.4 vs 2.9±0.3 % of energy baseline to 12 months , P<0.001 ) and packaged lunch box snacks ( 5.4±0.3 vs 4.1±0.3 % of energy baseline to 12 months , P<0.001 ) . Conclusion : All treatment groups in the HIKCUPS study appear to be equally efficacious in improving dietary intake in overweight and obese children OBJECTIVE To examine the efficacy of an adjunct motivational and autonomy-enhancing intervention ( self-directed ) for behavioral family-based pediatric obesity relative to the st and ard prescription of uniform behavioral skills use and interventionist goal assignment ( prescribed ) . METHODS In this r and omized clinical trial , 72 overweight/obese children and their parents/caregivers were assigned to either self-directed or prescribed intervention for 20 weeks , with approaches diverging after week 5 . Anthropometric measurements from child and participating parent at baseline , posttreatment , and 3-month , 6-month , 1-year , and 2-year follow-ups were evaluated for change ( n = 59 in follow-up analyses ) . RESULTS The approaches demonstrated similar child body mass index ( BMI ) z-score and parent BMI change from baseline to posttreatment and throughout follow-up , with child and parent weight status lower than baseline at 2 years after treatment cessation . CONCLUSIONS An adjunct motivational and autonomy-enhancing approach to behavioral family-based pediatric obesity treatment is a viable alternative to the st and ard intervention approach OBJECTIVE This study evaluated the feasibility , acceptability , and initial efficacy of an intervention based on Schachter 's externality theory ; the Regulation of Cues ( ROC ) program . METHODS 44 overweight and obese 8 - 12-year-old children and their parents were r and omly assigned to a 4-month ROC program or the control group . Outcomes were assessed at baseline , posttreatment , and 4 months posttreatment and included acceptability and feasibility , body weight , and eating behaviors . RESULTS The ROC program had moderate to high acceptability ratings . Significant improvements were found for the ROC group compared with the control group on child food responsiveness at posttreatment and eating in the absence of hunger at 4 months posttreatment . Improvements were seen for the ROC group compared with the control group on body weight measures and food responsiveness , although these only approached significance . CONCLUSION The ROC intervention may be useful with overweight and obese children . Larger , fully powered studies are needed to further evaluate the efficacy of this model BACKGROUND Cost-effectiveness analyses facilitate the allocation of health care re sources . The aim of the study was to compare the cost-effectiveness of group treatment , already known to be more effective , with routine counseling in obese children . METHOD A prospect i ve 6-month intervention assessed family-based group treatment ( 15 separate sessions for parents and children ) and routine counseling ( two appointments for children ) . Children 's weights and heights were measured at baseline , at the end of the intervention and at follow up 6 months later , and the changes in weight for height and body mass index st and ard deviations scores ( BMI -SDS ) were calculated and used as main outcome measures . The mean costs and effects of the programs were analyzed to produce the incremental cost-effectiveness ratio , which is an estimate of the additional costs per 1 % decrease in weight for height or 0.1 decrease in BMI -SDS . Cost-effectiveness analysis was performed from the perspective of the service provider . RESULTS At the end of the intervention , group treatment costs were 1.4-fold ( non-calculable 6 months later ) when counted per 1 % weight for height decrease , and 3.5-fold ( 2.8-fold 6 months later ) when counted per 0.1 BMI -SDS decrease . Incremental cost-effectiveness ratio estimates were euro 53 when calculated for 1 % weight for height decrease , and euro 266 ( euro 275 6 months later ) when calculated for 0.1 BMI -SDS decrease . CONCLUSIONS Family-based group treatment is more costly compared with individual routine counseling . Salaries form most of the total costs Diogenes is a Pan-European , r and omized , controlled dietary intervention study investigating the effects of dietary protein and glycaemic index on weight (re)gain , metabolic and cardiovascular risk factors in obese and overweight families in eight European centres . The article is method ological in character , and the presentation of ' results ' will be limited to baseline characteristics of the study population s included . A total of 891 families with at least one overweight/obese parent underwent screening . The parents started an initial 8-week low-calorie diet and families with minimum one parent attaining a weight loss of > or = 8 % , were r and omized to one of five energy ad libitum , low-fat ( 25 - 30 E% ) diets for 6 or 12 months : low protein/low glycaemic index , low protein/high glycaemic index , high protein/low glycaemic index , high protein/high glycaemic index or control ( national dietary guidelines ) . At two centres the families were provided dietary instruction plus free foods for 6 months followed by 6-month dietary instruction only . At the remaining six centres the families received dietary instruction only for 6 months . The median weight loss during the low-calorie diet was 10.3 kg ( inter-quartile range : 8.7 - 12.8 kg , n = 775 ) . A total of 773 adults and 784 children were r and omized to the 6-month weight (re)gain prevention phase . Despite major cultural and dietary regional differences in Europe , interventions addressing effects of dietary factors are feasible with a reasonable attrition BACKGROUND Behavioral interventions targeting children with overweight have been successful in facilitating weight loss ; however , there is concern that these programs produce disordered eating attitudes among youth . OBJECTIVE The purpose of this research was to determine whether youth with overweight receiving one of two behavioral interventions were more likely to report an increase in disordered eating attitudes over time compared to a waitlist control and to determine psychosocial predictors of eating-disordered attitudes at 6-month follow-up . DESIGN Participants were r and omized to one of two behavioral lifestyle interventions or a waitlist control . Data were collected at baseline , post-treatment , and 6-month follow-up . PARTICIPANTS / SETTING Participants were 68 youths with overweight , aged 8 to 13 years , and their parent(s ) who lived in rural north central Florida . The project ran from January 2006 to January 2008 . INTERVENTION Each treatment condition consisted of 12 group sessions over 16 weeks . MAIN OUTCOME MEASURES Parents completed a demographic form and the Child Feeding Question naire . Children completed the Children 's Eating Attitudes Test , Schwartz Peer Victimization Scale , and Children 's Body Image Scale . STATISTICAL ANALYSES PERFORMED Mixed 2 × 2 analyses of variance were used to examine the effect of treatment on eating attitudes . Hierarchical linear regression was used to assess whether baseline levels of psychosocial variables predicted disordered eating attitudes at follow-up , controlling for baseline eating attitudes and treatment condition . RESULTS Youth who participated in the behavioral interventions did not report significant increases in disordered eating attitudes over time compared to the waitlist control . Across all conditions , higher levels of body dissatisfaction , peer victimization , parent restrictive feeding practice s , and concern for child weight at baseline predicted higher levels of disordered eating attitudes at follow-up . CONCLUSIONS These findings do not provide evidence that behavioral interventions lead to an increase in unhealthy eating attitudes and behaviors . Future research should examine the effects of incorporating eating disorder prevention in pediatric weight management programs BACKGROUND University – community partnerships through coordinated school health programs ( CSHP ) can play a key role in decreasing child obesity . The main objective of this study was to measure over a 1-year period whether a CSHP with parental , school , and home-based components to promote optimal nutrition will reduce BMI percentiles and z-scores and improve dietary behaviors in a sample of low-income , school-aged children . METHODS The intervention included , Kids Nutrition and Fitness , a 6-week nutrition , physical activity educational after-school program , and school activities , including creation of an Advisory Committee that made wellness policies . A r and omized controlled pilot study evaluated the effectiveness of the intervention that contrasts 251 ( n = 251 ) predominantly Mexican-American 8 to 12 year olds from low-income Los Angeles – based schools . A mixed model of repeated measures analysis assessed changes in BMI percentiles and z-scores , dietary behaviors , food preferences , knowledge , and self-efficacy measured by a reliable/valid question naire . These data were collected at baseline and at 4 and 12 months postintervention . Process measures , collected via focus groups with parents , evaluated parent/community involvement . RESULTS At the 12-month follow-up , children in the intervention group decreased their BMI on average by 2.80 ( p = 0.04 ) and BMI z-scores on average by 0.48 ( p = 0.03 ) and they increased their daily dietary intake of vegetables on average by 1.51 ( p = 0.03 ) , fruit on average by 2.00 ( P = 0.001 ) , and 100 % fruit juice by 1.12 ( p = 0.05 ) . An increase of 1.02 ( p = 0.03 ) was seen in self-efficacy of healthy food choices ( p = 0.03 ) . Parent ( P = 0.04 ) and community ( p = 0.001 ) involvement significantly increased to 100 % participation by the 12-month follow-up . CONCLUSIONS A CSHP using parent and community involvement was effective in reducing the risk of obesity in school-aged Mexican- American children attending low-income schools . The findings need to be examined in a larger , more diverse sample of children The effects of a 5-month intervention of football instruction and practice on the perceived psychological status and body composition of overweight boys were examined . Twelve boys ( 8 - 12 years ; body mass index ≥ 85th percentile ) participated in a structured 5-month football program , consisting of four weekly 60 - 90 min sessions with mean heart rate > 80%HRmax [ football group ( FG ) ] . A control group ( CG ) included eight boys of equivalent age from an obesity clinic located in the same area as the school . Both groups participated in two sessions of 45 - 90-min physical education per week at school . Indicators of perceived psychological status included body image , self-esteem , attraction to participation in physical activity , and perceived physical competence measured with st and ardized question naires . Body composition was evaluated using dual-energy X-ray absorptiometry . From baseline through 5 months , FG improved ( P < 0.05 ) in all indicators of psychological status ( % Δ = + 11.7 to + 29.2 % ) compared with CG ( % Δ = -32.1 to + 0.5 % ) . Changes in percentage body fat and lean body mass , however , did not differ between FG and CG . The findings suggest that a 5-month football intervention program was effective in improving the psychological status of overweight boys but did not significantly alter body composition OBJECTIVE Adiposity may be associated with poorer cognitive function in children . The purpose of the study was to examine the effects of an obesity intervention on cognitive function in children . METHODS One hundred and fifteen children were r and omly allocated to either the Day Camp Intervention Arm ( DCIA ) or the St and ard Intervention Arm ( SIA ) . Children in the DCIA participated in a 6-week day camp intervention and a subsequent 46-week family-based intervention . The camp intervention mainly consisted of physical exercise and health classes . The SIA was offered one weekly physical exercise session for 6 weeks and one educational meeting . Anthropometrics and cognitive function were measured at baseline , 6 weeks , and 52 weeks . RESULTS At 6 weeks , the improvement in visuospatial construction skills was larger in the DCIA than the SIA ( st and ardized mean difference , 0.47 , 95 % CI , 0.08 to 0.86 , P = 0.02 ) . At 52 weeks , the improvements in emotional control ( st and ardized mean difference , -0.42 , 95 % CI , -0.68 to -0.16 , P = 0.002 ) and monitoring ( st and ardized mean difference , -0.32 , 95 % CI , -0.63 to -0.02 , P = 0.04 ) were larger in the DCIA than the SIA . No group differences were observed in changes in other cognitive outcomes . CONCLUSIONS The obesity intervention may benefit emotional control , monitoring , and visuospatial construction skills in children Childhood obesity is a complex and multifaceted health problem linked to elevated risk for chronic diseases , such as diabetes , cancer , hypertension , and cardiovascular disease.1,2 Although research has increased dramatically in the past 2 decades , questions regarding factors driving overweight and obesity remain , particularly among youth of color who experience disproportionate rates of obesity and comorbid health conditions.3 Adolescence is a critical period in the developmental trajectory,4 in part because overweight and obese adolescents are more likely to remain overweight and /or obese in adulthood.3 Overweight and obesity have been associated with adverse symptoms and intra- and interpersonal psychological , social , and emotional issues that continue into adulthood , including depression and anxiety , social withdrawal , feeling worthless , lower self-esteem , and behavioral problems.5–7 Poor mental health may lead to increases in weight due to fluctuations in appetite , obesogenic behaviors ( eg , overeating ) to cope with negative mood , sedentary behavior , and increased isolation.8 Chronic stress or experiences of discrimination may also influence physiology and behaviors that affect weight gain.9 On the other h and , increased body mass index ( BMI ) could result in adverse emotional outcomes over time due to weight-based stigma , bullying , or poor self-esteem.5,6 The few longitudinal studies that have examined the association between emotional health and physical health outcomes have primarily taken a narrow focus of mental health symptoms ( e.g. , only examining depression)10 or behavioral concerns ( e.g. , conduct).11 Physical outcomes , including BMI , were often collected by self-report12 and /or retrospectively.13 Furthermore , they have been limited to predominantly White sample s of older adolescents or adults.12,13 Persistent racial and ethnic disparities in overweight and obesity further complicate research as well as clinical prevention and intervention efforts . Black and Latino youth experience disproportionate levels of overweight and obesity beginning as early as preschool and are more likely to remain obese as adults compared with Whites.14 Blacks and Latinos also are at disproportionate risk for multiple negative health conditions associated with overweight and obesity , such as diabetes.14,15 Reasons for such disparities remain poorly understood and understudied . Although emotional health has been associated with weight in both adults and youth,16 prior research has been limited to cross-sectional studies .17 Longitudinal , prospect i ve design s are critical to explicate the association between emotional health and BMI among Black and Latino youth . The primary objective of this study is to examine whether negative emotional symptoms prospect ively predict increases in BMI z-scores ( BMI -z ) across 2 years among a sample of predominantly Black and Latino , urban youth . We hypothesize that more negative emotional symptoms measured at baseline ( grade s 5 and 6 ) would predict increases in BMI -z scores 2 years later . Results can inform programs and interventions aim ed at reducing obesity in youth of color Background : This study evaluated the effect of an intervention for reducing excess weight gain in primary school-age children in Tehran . Methods : A cluster-r and omized controlled trial was conducted in 12 primary schools in Tehran . Three hundred thirty-four pupils , 167 in the intervention and 167 in the comparison group , determined to be overweight or obese based on World Health Organization st and ards , were recruited for the study . The intervention included nutrition education and increased physical activity ( PA ) for the pupils , lifestyle modification for parents , and a change in food items sold at the schools ’ canteens . The entire intervention lasted approximately 18 weeks . Measures were taken before and immediately after the intervention . Results : The intervention significantly reduced body mass index Z-score and hip circumference ( p = .003 and p < .001 , respectively ) . Waist circumference increased in both groups , but the increase was higher in the comparison group ( p = .001 ) . No significant difference was seen in time spent on TV viewing between groups ( p = .08 ) . Vigorous PA increased in the intervention group ( p < .001 ) , while the comparison group showed an increase in moderate activity only ( p < .001 ) . Energy intake increased significantly in the intervention group ( p < .001 ) . Neither triceps skinfold thickness nor time spent on the computer changed in the intervention group ( p = .51 and p = .1 , respectively ) , while they increased in the comparison group ( p < .001 and p = .004 , respectively ) . Conclusion : The study provides a successful model for the implementation of similar interventions throughout the country Aims : Although childhood obesity is becoming increasingly prevalent , treatment options are limited and the continued development of effective treatment strategies is necessary . It is equally important to explore involvement of other re sources in society , such as sports associations . This study was design ed to investigate the possibility of reducing the degree of obesity in obese children by focusing on physical activity as an intervention . Methods : Seventy-six children ( 40 boys ) aged 8—12 years ( mean age 10.5 years , mean body mass index ( BMI ) 28.9 , st and ard deviation ( SD ) 3.0 ; mean BMI z-score 3.24 , SD 0.49 ) were invited to participate in a one-week sports camp and six-month support system . After the camp a sports coach from a local sports club supported the child during participation in a chosen sport for six months . Weight , height , body composition ( using dual energy x-ray absorptiometry and magnetic resonance imaging ) , and lifestyle ( using a question naire ) were measured at baseline and after 12 months . Data were pooled from two camps , one with a self-selected control group and one r and omized controlled trial . Results : Twelve months after the camp the intervention group had a significant decrease in BMI z-score ( baseline BMI z-score 3.22 ; follow up 3.10 , p = 0.023 ) . The control group also reduced their BMI z-score ( baseline BMI z-score 3.27 ; follow up 3.18 , p = 0.022 ) . No differences were found in baseline values , follow-up values , or changes in BMI z-score between groups , nor between boys and girls . Conclusions : The focus on physical activity as an intervention had no effect on degree of obesity when compared with a waiting list control group Objective To determine whether general practice surveillance for childhood obesity , followed by obesity management across primary and tertiary care setting s using a shared care model , improves body mass index and related outcomes in obese children aged 3 - 10 years . Design R and omised controlled trial . Setting 22 family practice s ( 35 participating general practitioners ) and a tertiary weight management service ( three paediatricians , two dietitians ) in Melbourne , Australia . Participants Children aged 3 - 10 years with body mass index above the 95th centile recruited through their general practice between July 2009 and April 2010 . Intervention Children were r and omly allocated to one tertiary appointment followed by up to 11 general practice consultations over one year , supported by shared care , web based software ( intervention ) or “ usual care ” ( control ) . Research ers collecting outcome measurements , but not participants , were blinded to group assignment . Main outcome measures Children ’s body mass index z score ( primary outcome ) , body fat percentage , waist circumference , physical activity , quality of diet , health related quality of life , self esteem , and body dissatisfaction and parents ’ body mass index ( all 15 months post-enrolment ) . Results 118 ( 60 intervention , 56 control ) children were recruited and 107 ( 91 % ) were retained and analysed ( 56 intervention , 51 control ) . All retained intervention children attended the tertiary appointment and their general practitioner for at least one ( mean 3.5 ( SD 2.5 , range 1 - 11 ) ) weight management consultation . At outcome , children in the two trial arms had similar body mass index ( adjusted mean difference −0.1 ( 95 % confidence interval −0.7 to 0.5 ; P=0.7 ) ) and body mass index z score ( −0.05 ( −0.14 to 0.03 ) ; P=0.2 ) . Similarly , no evidence was found of benefit or harm on any secondary outcome . Outcomes varied widely in the combined cohort ( mean change in body mass index z score −0.20 ( SD 0.25 , range −0.97 - 0.47 ) ; 26 % of children resolved from obese to overweight and 2 % to normal weight . Conclusions Although feasible , not harmful , and highly rated by both families and general practitioners , the shared care model of primary and tertiary care management did not lead to better body mass index or other outcomes for the intervention group compared with the control group . Improvements in body mass index in both groups highlight the value of untreated controls when determining efficacy . Trial registration Australian New Zeal and Clinical Trials Registry ACTRN12608000055303 OBJECTIVE : Early weight change is associated with overall weight loss treatment response in adults but has been relatively unexplored in youth . We investigated the importance of early weight change in a pediatric weight control trial . METHODS : Overweight children aged 7 to 12 years ( n = 204 ) participated in a r and omized controlled trial of 2 weight maintenance treatments ( MTs ) after a 20-week family-based behavioral weight loss treatment ( FBT ) . Hierarchical regression was used to investigate the relation between children 's percentage weight change at sessions 4 , 6 , and 8 of FBT and BMI z-score reductions after FBT and at the 2-year follow-up . Correlations and hierarchical regression were used to identify child and parent factors associated with children 's early weight change . RESULTS : Children 's percentage weight change by FBT session 8 was the best predictor of BMI z-score reductions after FBT and at 2-year follow-up . Percentage weight change in children at session 8 was associated with better FBT attendance and with greater percentage weight change in parents at FBT session 8 . CONCLUSIONS : Early weight change seems to be related to treatment response through the end of treatment and 2-year follow-up . Future research should include investigation of strategies to promote early weight change in children and parents and identification of mechanisms through which early weight change is related to overall treatment response Basic research has shown that increasing variety increases energy intake , and repeated consumption of the same food increases habituation to those foods and reduces consumption . Twenty-four families with overweight/obese 8 - 12 year-old children and overweight/obese parents were r and omly assigned to 6months of usual family based treatment ( FBT ) or FBT plus reduced variety of high energy-dense foods ( FBT+Variety ) . Intention to treat mixed model ANOVA showed between group differences in child percent overweight ( FBT+Variety-15.4 % vs. FBT-8.9 % , p=0.017 ) and parent BMI ( FBT+Variety-3.7kg/m(2 ) vs. FBT-2.3kg/m(2 ) ; p=0.017 ) . Positive relationships were observed between child z BMI and parent BMI changes ( r=0.51 , p=0.018 ) , and between reductions in food variety of high energy-dense foods and reductions in child z BMI ( r=0.54 , p=0.02 ) and parent BMI ( r=0.45 , p=0.08 ) . These pilot data suggest that reducing the variety of high energy dense foods and repeating meals within the context of FBT result ed in improved child and parent weight changes at six months . This represents easy to implement changes that reduce choice and may reduce response burden on families . Reducing variety may be a complement to st and ard FBT that enhances weight loss . Long term studies are needed to assess maintenance of these changes BACKGROUND In Hispanic children and adolescents , the prevalence of obesity and insulin resistance is considerably greater than in non-Hispanic white children . A low-glycemic load diet ( LGD ) has been proposed as an effective dietary intervention for pediatric obesity , but to our knowledge , no published study has examined the effects of an LGD in obese Hispanic children . OBJECTIVE We compared the effects of an LGD and a low-fat diet ( LFD ) on body composition and components of metabolic syndrome in obese Hispanic youth . DESIGN Obese Hispanic children ( 7 - 15 y of age ) were r and omly assigned to consume an LGD or an LFD in a 2-y intervention program . Body composition and laboratory assessment s were obtained at baseline and 3 , 12 , and 24 mo after intervention . RESULTS In 113 children who were r and omly assigned , 79 % of both groups completed 3 mo of treatment ; 58 % of LGD and 55 % of LFD subjects attended 24-mo follow-up . Compared with the LFD , the LGD decreased the glycemic load per kilocalories of reported food intakes in participants at 3 mo ( P = 0.02 ) . Both groups had a decreased BMI z score ( P < 0.003 ) , which was expressed as a st and ard z score relative to CDC age- and sex-specific norms , and improved waist circumference and systolic blood pressure ( P < 0.05 ) at 3 , 12 , and 24 mo after intervention . However , there were no significant differences between groups for changes in BMI , insulin resistance , or components of metabolic syndrome ( all P > 0.5 ) . CONCLUSIONS We showed no evidence that an LGD and an LFD differ in efficacy for the reduction of BMI or aspects of metabolic syndrome in obese Hispanic youth . Both diets decreased the BMI z score when prescribed in the context of a culturally adapted , comprehensive weight-reduction program BACKGROUND Around one in five children in Engl and is obese when they leave primary school . Thus far , it has not been demonstrated that primary care interventions to manage childhood obesity can achieve significant weight reduction . Training obese children to eat more slowly as an adjunct to other healthy lifestyle behaviour change has been shown to increase weight reduction in a hospital setting . OBJECTIVES This pilot study aim ed to test recruitment strategies , treatment adherence , clinic attendance and participants ' experiences of using a device [ M and olean ® ( previously M and ometer ® , Mikrodidakt AB , Lund , Sweden ) ] to slow down speed of eating as an adjunct to dietary and activity advice in treating obesity in primary school-aged children . DESIGN A two-arm , parallel , r and omised controlled trial with a qualitative study embedded within the pilot . R and omisation occurred after informed consent and baseline measures were collected . Participants were r and omised by the Bristol R and omised Trials Collaboration r and omisation service with allocation stratified by hub and minimised by age of the child , gender , and baseline body mass index ( BMI ) st and ard deviation score ( BMI z-value ) of the child , and by BMI of the study parent ( obese/not obese ) . SETTING General practice s across Bristol , North Somerset and South Gloucestershire primary care trusts . PARTICIPANTS Children ( BMI ≥ 95th percentile ) aged 5 - 11 years and their families . INTERVENTION St and ard care comprised dietary and activity advice by trained practice nurses . Adjunctive M and olean training ( the intervention ) educated participants to eat meals more slowly and to rate levels of fullness ( satiety ) . M and olean is a small computer device attached to a weighing scale that provides visual and oral feedback during meals while generating a visual representation of levels of satiety during the meal . Participants were encouraged to eat their main meal each day from the M and olean . One parent was also given a M and olean to use when eating with the child . OUTCOME MEASURES Outcomes for the pilot were recruitment of 36 families to the trial in the 9-month pilot phase , that meals would be eaten at least five times a week off a M and olean by 90 % of patients r and omised to the intervention arm , that 80 % of patients in both arms would attend the weight management clinic appointment 3 months post r and omisation and that > 60 % of children using M and olean would demonstrate a reduction in speed of eating from baseline within 3 months of r and omisation . RESULTS None of the criteria for progression to the main trial were reached . Despite numerous pathways being available for referral , only 21 ( 13 to st and ard care , eight to intervention arm ; 58 % ) of the target 36 families were recruited in the pilot phase . Less than 20 % of those r and omised to M and olean used the device at least five times a week . The > 60 % target for slowing down of eating speed by 3 months was unmet . Attendance at the weight management clinic in general practice hubs for both arms of the study at 3 months was 44 % against a target of 80 % . CONCLUSIONS This pilot trial failed to meet its objectives in terms of recruitment , treatment adherence , demonstration of a reduction in speed of eating in sufficient numbers of children , and attendance at follow-up appointments . Despite a high prevalence of childhood obesity in the geographical area and practice s signing up for the trial , this study , like many others , demonstrates a failure of families to engage with and respond to primary care weight management interventions . We need to underst and why the target population seems inured to the health message that childhood obesity is a significant health-care issue and identify the barriers to seeking help and then acting on positive health behaviour retraining . Only when we have fully understood the general public 's perceptions of childhood obesity and have identified ways of engaging target population s can we hope to develop interventions that can work in a primary or community-based setting . TRIAL REGISTRATION Current Controlled Trials IS RCT N90561114 . FUNDING This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol . 18 , No. 47 . See the NIHR Journals Library website for further project information Abstract Objective : To assess the effects of resistance exercise training on body composition and muscular strength in obese prepubertal children . Design : Study participants , who were between the ages of 8 and 12 years , met Tanner I ( stage ) criteria , had a body mass index ⩾ 95th percentile for age and sex , were r and omized to either high-repetition , moderate-intensity resistance training ( n = 12 ) or to the non-intervention control group ( n = 7 ) for 12 weeks . Exercise training was performed twice a week for 75 minutes per session . Body composition was assessed using dual energy x-ray absorptiometry and muscular strength was evaluated using a 1-repetition-maximum test . Results : Exercise-group participants attended 98 % of the 24 total sessions and showed a significant increase in body weight ( 57.6 ± 13.5 vs 59.6 ± 14.1 kg ) , height ( 144.9 ± 9 vs 146.6 ± 10.4 cm ) , lean body mass ( 32.6 ± 6.8 vs 34.0 ± 7.0 kg ) , lean body mass index ( lean body mass in kg/height2 ; 15.3 ± 1.6 vs 15.6 ± 1.5 kg/m2 ) , arm strength ( 28.4 ± 5.8 vs 31.2 ± 6.0 kg ) , and leg strength ( 89.4 ± 31.7 vs 113.4 ± 34 2 kg ) from baseline measures ( P < 0.05 ) . Control group participants also showed significant increases in weight , height , and lean body mass from baseline measures ( P < 0.05 ) but not in arm or leg strength . When the changes in participant body composition and muscular strength were compared between the exercise and control groups , significant differences were found in leg lean mass and leg strength ( P < 0.05 ) . There were no changes in percent body fat and fat mass index [ FM/height2 ( kg/m2 ) ] in either group . Conclusion : Resistance training increases leg lean mass and leg strength in obese prepubertal youth and may have a positive effect on overall physical activity and health Background : Childhood and adolescent obesity constitute a significant public health concern . Family health care setting s with multidisciplinary teams provide an opportunity for weight loss treatment . The objective of this study was to examine the effect of intensive treatment design ed to reduce weight using a parent-child lifestyle modification intervention in a family health care clinic for obese and overweight children who had failed previous treatment attempts . Methods : This was a practice -based 6-month intervention at Maccabi Health Care Services , an Israeli health maintenance organization , consisting of parental education , individual child consultation , and physical activity classes . We included in the intervention 100 obese or overweight children aged 5 to 14 years and their parents and 943 comparison children and their parents . Changes in body mass index z-scores , adjusted for socioeconomic status , were analyzed , with a follow-up at 14 months and a delayed follow-up at an average of 46.7 months . Results : The mean z-score after the intervention was lower in the intervention group compared to the comparison group ( 1.74 and 1.95 , respectively ; P = .019 ) . The intervention group sustained the reduction in z-score after an average of 46.7 months ( P < .001 ) . Of the overweight or obese children , 13 % became normal weight after the intervention , compared with 4 % of the comparison children . Conclusion : This multidisciplinary team treatment of children and their parents in family health care clinics positively affected measures of childhood obesity . Additional r and omized trials are required to verify these findings |
11,570 | 14,513,064 | Surgery result ed in a significantly greater loss of weight ( 23–37 kg more weight ) than nonsurgical treatment , which was maintained to 8 years and led to improvements in quality of life and comorbidities .
: Surgery for morbid obesity appears to be clinical ly and cost effective .
Because of the nature of the evidence , particularly the uncertainty in the clinical and economic evaluations , it is difficult to distinguish between the different surgical procedures | OBJECTIVE : To assess the clinical and cost effectiveness of surgery for people with morbid obesity . | Eighty-seven morbidly obese patients were prospect ively r and omized to two operations : gastric bypass was performed on 42 and gastric partition on 45 . Gastric bypass proved to be more effective ; gastric bypass patients lost 15 % more of their original weight at 12 months and 21 % more at 18 months . There were no failures in the gastric bypass group ; 28 of the 45 operations failed in the gastric partition group . An additional 60 patients underwent gastric bypass since the completion of the study . In the total series of 147 patients who underwent gastric bypass or gastric partition , there was no mortality , and the surgical complication rate was 12 % . Because the gastric pouches and the anastomoses were similar in the two operations , the superiority of the gastric bypass may well be due to a heretofore unexplained effect of distal gastric and duodenal exclusion The present status of 38 patients comprising a clinical trial of jejunoileal and gastric bypass for the treatment of morbid obesity , begun four years ago at North Carolina Memorial Hospital , is reported . Weight loss was greater in patients treated by jejunoileal bypass than those treated by gastric bypass . The poorer weight loss noted in the gastric bypass patients is associated with an excessively large proximal gastric pouch , which had characterized the 19 gastric bypass operations done prior to May 1977 . The weight loss achieved with the current version of the gastric bypass , a smaller proximal gastric pouch , is comparable to that achieved with jejunoileal bypass . The objective and subjective sequelae and complications of jejunoileal bypass are more common and more serious than those of gastric bypass . Gastric bypass is the better operation for the treatment of morbid obesity For 2 years , 12 Danish hospitals have conducted a r and omized clinical trial to evaluate the hazards and benefits of jejunoileal bypass operations for severe obesity . At present ( January , 1976 ) , there are 92 operated and 46 unoperated patients . There has been no mortality in the operated group . One control patient has died . Weight loss is significantly better in the operated group , but not always satisfactory . The well-known postoperative complications have not been deterring in frequency or seriousness . On the whole , but not invariably , the operation has been followed by an improvement in psychosocial status Background : The feasibility of laparoscopic Roux-en-Y gastric bypass ( Lap-RYGBP ) for morbid obesity is well documented . In a prospect i ve r and omized trial , we compared laparoscopic and open surgery . Methods : 51 patients ( 48 females , mean ( ± SD ) age 36 ± 9 years and BMI 42 ± 4 kg/m2 ) were r and omly allocated to either laparoscopy ( n=30 ) or open surgery ( n=21 ) . All patients were followed for a minimum of 1 year . Results : In the laparoscopy group , 7 patients ( 23 % ) were converted to open surgery due to various procedural difficulties . In an analysis , with the converted patients excluded , the morphine doses used postoperatively were significantly ( p < 0.005 ) lower in the laparoscopic group compared to the open group . Likewise , postoperative hospital stay was shorter ( 4 vs 6 days , p<0.025 ) . Six patients in the laparoscopy group had to be re-operated due to Roux-limb obstruction in the mesocolic tunnel within 5 weeks . The weight loss expressed in decrease in mean BMI units after year was 14 and 13 after 1 ± 3 ± 3 laparoscopy and open surgery , respectively ( not significant ) . Conclusions : Both laparoscopic and open RYGBP are effective and well received surgical procedures in morbid obesity . Reduced postoperative pain , shorter hospital stay and shorter sick-leave are obvious benefits of laparoscopy but conversions and /or reoperations in 1/4 of the patients indicate that Lap-RYGBP at present must be considered an investigational procedure OBJECTIVE To examine the effect of a large , long st and ing and intentional weight reduction on the incidence of diabetes , hypertension and lipid disturbances in severely obese individuals as compared to weight-stable obese controls . RESEARCH METHODS AND PROCEDURES The ongoing prospect i ve SOS ( Swedish Obese Subjects ) intervention consists of a surgically treated group and a matched control group obtaining conventional obesity treatment . This report is based on 845 surgically treated patients and 845 controls ( BMI 41.0+/-4.6 kg/m2 ( mean+/-st and ard deviation [ S ] ) ) followed for 2 years . RESULTS Surgically treated patients lost 28+/-15 kg and controls 0.5+/-8.9 kg ( p<0.0001 ) . Two-year incidence of hypertension , diabetes , hyperinsulinemia , and lipid disturbances was compared in the two treatment groups . Adjusted odds ratios ( 95 % CI ) for the surgically treated group versus controls were 0.38 ( 0.22 , 0.65 ) for hypertension , 0.02 ( 0.00 , 0.16 ) for diabetes , 0.10 ( 0.03 , 0.28 ) for hyperinsulinemia , 0 . 10 ( 0.04 , 0.25 ) for hypertriglyceridemia , 0.28 ( 0.16 , 0.49 ) for low HDL-cholesterol and 1.24 ( 0.84 , 1.8 ) for hypercholesterolemia . Compared to controls , the 2-year recovery rates from hypertension , diabetes , hypo-HDL , and hypertriglyceridemia were significantly higher in the surgically treated group . DISCUSSION Intentional weight loss in the obese causes a marked reduction in the 2-year incidence of hypertension , diabetes and some lipid disturbances . The results suggest that severe obesity can and should be treated 57 morbidly obese patients were r and omized and operated upon with gastric bypass ( GBY ) or gastroplasty ( GPL ) . The patients were followed for three years . GBY had a slightly higher early complication rate but a significantly ( p less than 0.001 ) greater weight loss . GBY lost 42.3 + /- 10.9 kg after one year and 38.4 + /- 12.3 kg after three years compared to 29.9 + /- 10.0 kg one year and 24.7 + /- 13.1 kg three years after GPL . No GBY but 10 GPL patients were reoperated upon due to failure to lose or to maintain lost weight . An endoscopic method was developed for postoperative measurement of stoma diameter . Use of this method showed no significant difference in stoma diameter between GBY and GPL . A correlation between weight loss and stoma diameter was found one year after GPL but not after GBY . Also a correlation between peroperative pouch volume and weight loss was seen after GPL but not after GBY . The two methods differed in emptying rate of a semi-solid test meal from the upper gastric pouch . For both methods the energy intake was highly reduced postoperatively , but significantly more after GBY . For a number of nutrients the intake was below minimum recommended levels . Fat cell weight was reduced postoperatively , most pronounced for the abdominal regions and least for the femoral-gluteal regions . The reduction was also significantly more pronounced after GBY than after GPL . Calculated fat cell number was significantly reduced after both methods . It is concluded that the effect on body weight of GPL and GBY can not be explained by the same mode of action . In GPL mechanical fractures such as pouch volume and stoma size are of great importance , which is in accordance with earlier theories . In contrast to this , the results of GBY can not be satisfactorily explained by such mechanical factors and additional mechanisms , probably of neuro-endocrinologic origin , must be sought for A prospect i ve r and omized clinical trial was undertaken to compare the effects of gastric bypass with Roux-en-Y gastro-jejunostomy and a gastric partitioning procedure . Operative groups were comparable , with regard to preoperative weight , age , sex , historic findings and operative complications . Postoperative weight loss was followed for one year . Patients receiving the gastric partitioning procedure showed significantly poorer weight loss as early as three months postoperatively than did those receiving gastric bypass . This poorer performance persisted throughout the study period Fifty-one morbidly obese women were r and omized to surgical treatment with gastric bypass ( GBY ) or gastroplasty ( GPL ) . Their dietary intake was assessed preoperatively and 12 months postoperatively by two methods : diet history and 4-day weighted intake . Their protein intake was also checked against urinary nitrogen losses . There was a good correspondence between the results of the two dietary methods and also between estimated protein intake and urinary loss . This makes the results reliable . After 1 year the GBY patients demonstrated a mean weight loss of 41.6 + /- 10.8 kg ( P less than 0.001 versus GPL ) and a mean energy intake preoperatively of about 2400 kcal/day and postoperatively of 1050 kcal/day ( P less than 0.05 versus GPL ) . The GPL patients lost 28.9 + /- 9.6 kg as a mean and had a preoperative intake of about 2500 kcal/day and a postoperative intake of about 1300 kcal/day . There were only minor changes in the quality of the food from the preoperative to the postoperative situation . Postoperatively the daily intake of several nutrients was below minimum values of recommended or required intake The beneficial effects of weight loss in the obese have been widely accepted . Still , there is a lack of controlled studies displaying large maintained weight losses over long periods ( > 4 years ) . We wanted to examine the results of long-st and ing intentional weight loss on the development of diabetes and hypertension in severely obese individuals over an 8-year period . In the ongoing prospect i ve Swedish Obese Subjects ( SOS ) study , 346 patients awaiting gastric surgery were matched with 346 obese control subjects on 18 variables by a computerized matching program . The controls were drawn from a registry consisting of 1508 obese potential controls examined at primary health care centers in Sweden . Of the 692 selected patients ( body mass index 41.2+/-4.7 kg/m(2 ) [ mean+/-SD ] ) , 483 ( 70 % ) were followed for 8 years . No significant weight changes occurred in the obese control group over 8 years . Gastric surgery result ed in a maximum weight loss of -31.1+/-13.6 kg after 1 year . After 8 years , the maintained weight loss was still 20.1+/-15.7 kg ( 16.3+/-12.3 % ) . Whereas this weight reduction had a dramatic effect on the 8-year incidence of diabetes ( odds ratio 0.16 , 95 % CI 0.07 to 0.36 ) , it had no effect on the 8-year incidence of hypertension ( odds ratio 1.01 , 95 % CI 0.61 to 1.67 ) . A differentiated risk factor response was identified : a maintained weight reduction of 16 % strongly counteracted the development of diabetes over 8 years but showed no long-term effect on the incidence of hypertension Vertical b and ed gastroplasty ( VBGP ) was compared with Roux-en-Y gastric bypass ( RYGBP ) in a r and omized prospect i ve trial that included preoperative dietary separation of " sweets eaters " versus " non-sweets eaters . " R and omization was stopped at 9 months after 20 patients had undergone each procedure because a greater weight loss ( p less than 0.05 ) was noted after RYGBP than VBGP . This difference became more significant ( p less than 0.001 ) at each 3-month interval through 3 years , when patients who had VBGPs had lost 37 + /- 20 % of excess weight compared with 64 + /- 19 % for patients who had RYGBPs . The members of the groups were comparable with regard to age , sex , eating habits , morbidity rates before surgery , ideal body weight , and weight before surgery . Although there was no significant difference between the loss of excess weight in " sweets eaters " ( 69 + /- 17 % ) or " non-sweets eaters " ( 67 + /- 17 % ) after RYGBP at 1 year , " sweets eaters " who had VBGPs lost significantly less excess weight ( 36 + /- 13 % ) than did " non-sweets eaters " who had VBGPs ( 57 + /- 18 % ) , p less than 0.02 , or " sweets eaters " who had RYGBPs , p less than 0.0001 . No significant differences were noted for electrolytes , renal or liver function tests , and most vitamins between patients who had VBGPs and RYGBPs ; however , patients who had RYGBPs had lower ( p less than 0.05 ) serum vitamin B12 levels ( 286 + /- 149 pg/dl ) than did patients who had VBGPs ( 461 + /- 226 pg/dl ) at 2 years . By 3 years , the vitamin B12 levels were equal in members of the two groups . Five patients who had RYGBPs required endoscopic stomal dilatation for stomal stenosis and one had a marginal ulcer develop , which responded to cimetidine . RYGBP was clearly superior to VBGP for " sweets eaters , " probably because of the development of dumping syndrome symptoms . However , RYGBP was associated with a larger number of correctable problems . Thus , it is important to evaluate a patient 's eating habits before surgery for morbid obesity ; " non-sweets eaters " probably should be treated with VBGP and " sweets eaters " with RYGBP Horizontal and vertical b and ed gastroplasty ( GP ) were compared as to their effectiveness and side-effects in patients pre-treated for morbid obesity with a very-low-calorie formula diet ( VLCD ) . The pre-treatment served to select the compliant patients , to minimize the surgical hazard , and to optimize the total weight reduction . Seventy-four consecutive patients ( median age 34 years , median body weight 125.1 kg , and median overweight 93 per cent ) were included according to the criteria for entry . The median weight loss on VLCD was 25.7 kg ( range , 5.8 - 92.6 kg ) and the median overweight reduction reached 46 per cent of the initial overweight ( range , 9 - 83 per cent ) . Only few and mild side-effects were observed . Sixty-nine per cent of the patients fulfilled our criterion for surgery by reducing their initial overweight by at least 40 per cent . Of these , 23 and 22 patients were assigned respectively to either vertical b and ed or to horizontal GP . Patients and dietitians were not informed of the assignment . A significant weight loss occurred in both groups . Three months after surgery weight loss after vertical b and ed GP proved to be the larger ( P less than 0.001 ) . The difference became even more pronounced due to an earlier regain among patients treated with the horizontal GP . Thus , at 12 months , the net weight loss after surgery was 9.7 kg ( range , -28.2 - 28.7 kg ) in the vertical b and ed GP group and -1.0 kg ( range , -15.0 - 36.5 kg ) in patients treated with horizontal GP ( P less than 0.0005 ) . At this time , the total weight loss in the groups was 48.5 kg ( range , 6.4 - 104.0 kg ) and 32.6 ( range , 3.7 - 125.1 kg ) respectively ( P less than 0.02 ) , and the total reduction of overweight was greater in the group treated with vertical b and ed GP ( 80 per cent ( range , 10 - 96 ) versus 56 per cent ( range , 8 - 92 ) , P less than 0.005 ) . There were no deaths , and side-effects to VLCD as well as to GP were generally mild . It is concluded that vertical b and ed GP is more effective than horizontal GP and that the former operation adds a significant weight loss to that obtained by VLCD . The combined treatments offer a weight reduction comparable to that observed after jejunoileal bypass . However , some regain within 1 year makes it question able if the vertical b and ed GP is sufficient to prevent weight regain A r and omized prospect i ve evaluation of the gastric and jejunoileal bypass procedures for morbid obesity was performed . The gastric bypass was performed predominantly as a 90 % gastric exclusion with a Roux-en-Y reconstitution . The jejunoileal bypass was an end-to-end anastomosis between 30 cm of jejunum and 25 cm of terminal ileum , the bypassed segment of small bowel being decompressed by an end-to-side ileocolostomy . There were 32 patients in the gastric group and 27 in the jejunoileal group . The two groups were comparable in age , preoperative weight and height . There were no postoperative deaths , but the gastric bypass operation was associated with a slightly higher early complication rate indicating it is a more technically dem and ing procedure . Late sequellae were more prominent in the jejunoileal bypass group and included significant diarrhea in 56 % and need for medication in 74 % . Kidney stones and cholelithiasis also complicated the jejunoileal group and were not seen after gastric bypass . All patients showed fatty metamorphosis on the original liver biopsy . This had worsened in 75 % of the jejunoileal group at one year whereas it had improved or was stable in all of the patients in the gastric group OBJECTIVE : To examine the effects of weight loss on health-related quality of life ( HRQL ) in subjects with severe obesity . DESIGN : Controlled clinical trial of the outcomes of surgical vs conventional weight reduction treatment . SUBJECTS : The first 487 surgical cases and their conventionally treated , matched controls were followed for two years in the Swedish Obese Subjects ( SOS ) intervention study . MEASUREMENTS : A battery of generic and study -specific self- assessment instruments or subscales was used to characterize HRQL in the severely obese ( BMI ) ≥34 kg/m2 for males and BMI ≥38 kg/m2 for females ) . Measures of general health perceptions ( general health rating index ; current health ) , mental well-being ( mood adjective check list ; pleasantness , activation and calmness ) , mood disorders ( hospital anxiety and depression scale ; anxiety and depression ) and social interaction ( sickness impact profile ) , were supplemented by obesity-specific modules on obesity-related psychosocial problems and eating behavior ( three-factor eating question naire ; restrained eating , disinhibition and perceived hunger ) . Assessment s were conducted prior to treatment and repeated after 6 , 12 and 24 months . RESULTS : Poor HRQL before intervention was dramatically improved after gastric restriction surgery , while only minor fluctuations in HRQL scores were observed in the conventionally treated controls . Peak values were observed in the surgical group at 6 or 12 months after intervention with a slight to moderate decrease at the two-year follow-up . The positive changes in HRQL after two years were related to the magnitude of weight loss , that is , the greater the weight reduction , the greater the HRQL improvements . Eating behavior improved accordingly . CONCLUSION : Quality of life in the severely obese is improved by substantial weight loss . Most patients benefit from weight reduction surgery , while HRQL in surgical patients with minor reduction in overweight is less positive . Further research is needed to determine outcome predictors of the surgical management of severe obesity and to ensure that HRQL improvements are maintained OBJECTIVE To compare the clinical results of adjustable gastric b and ing and vertical b and ed gastroplasty for morbid obesity . DESIGN Prospect i ve r and omised trial . SETTING University hospital , Sweden . PATIENTS 59 morbidly obese patients , listed for obesity surgery . INTERVENTIONS Adjustable gastric b and ing ( n = 29 ) or vertical b and ed gastroplasty ( n = 30 ) . MAIN OUTCOME MEASURES Weight loss , complications , need for revisional surgery , reflux symptoms and the patient 's own evaluation . RESULTS Five years after surgery the mean ( SEM ) weight reduction for adjustable gastric b and ing was 43 ( 3.0 ) kg and for vertical b and ed gastroplasty 35 ( 4.8 ) kg . One patient in each group died of unrelated causes during follow-up and 3 and 2 patients , respectively , were lost to follow-up . One patient in the vertical b and ed group required reoperation for an anastomotic leak on the third postoperative day . A total of 3 patients in the adjustable group required reoperation and 11 in the vertical b and ed group . CONCLUSIONS Adjustable gastric b and ing carries a smaller risk of reoperation than vertical b and ed gastroplasty and the weight reduction is in the same order of magnitude The efficacy of three gastric restriction operations were compared in a prospect i ve r and omized study of 310 morbidly obese subjects . The median patient age was 34 years ( range , 18 to 62 years ) . They were predominantly female ( 13:1 ) and had a median pre-operative weight that was 198 % of their ideal weight ( range , 160 % to 318 % ) . There was an equitable dispersion of perceived risk factors between the groups under study and there were no deaths during the perioperative period . Compliance with follow-up at 3 years was 91 % . When success was defined as a loss of more than 50 % of excess weight or a current pregnancy , the success rates at 3 years were 17 % for gastrogastrostomy , 48 % for vertical gastroplasty , and 67 % for Roux-en-Y gastric bypass ( p less than 0.001 ) . Although the gastric bypass operation took longer to perform , there were similar outcome patterns for the three groups during the postoperative period . We conclude that the Roux-en-Y gastric bypass is the preferred procedure for the surgical treatment of morbid obesity To investigate the effects of obesity and weight loss on cardiovascular autonomic function , we examined 28 obese patients referred for weight-reducing gastroplasty , 24 obese patients who received dietary recommendations , and 28 lean subjects . Body weight , blood pressure , and 24-hour urinary norepinephrine excretion were measured , and time and frequency domain indexes of heart rate variability ( HRV ) were obtained from 24-hour Holter recordings . A measure of long-term HRV , the SD of all normal RR intervals ( SDANN ) , was used as an index of sympathetic activity and the high-frequency ( HF ) component of the frequency domain , reflecting short-term HRV , as an estimate of vagal activity . All 3 study groups were investigated at baseline , and the 2 obese groups were reexamined at 1-year follow-up . Obese patients had higher blood pressure , higher urinary norepinephrine excretion , and attenuated SDANN and HF values than lean subjects ( p < 0.01 ) . Obese patients treated with surgery had a mean weight loss of 32 kg ( 28 % ) , whereas the obese group treated with dietary recommendations remained weight stable ( p < 0.001 ) . At follow-up the weight-loss group displayed decreases in blood pressure and norepinephrine excretion and showed increments in SDANN and HF values . These changes were significantly greater than those observed in the obese control group ( p < 0.05 ) . Our findings suggest that obese patients have increased sympathetic activity and a withdrawal of vagal activity and that these autonomic disturbances improve after weight loss Background : A prospect i ve , r and omized trial comparing vertical b and ed gastroplasty ( VBG ) and gastric bypass ( GB ) was performed on 106 patients between 1987 and 1990 . Methods and Results : Failures of these two operations ( manifested by failure to lose weight , late weight gain or intolerance of adequate oral intake ) were treated by means of a third operation , isolated gastric bypass ( IGB ) , in which the small gastric pouch was isolated from the gastric fundus . The latter operation was significantly better than VBG or GB and achieved a 63 % success rate , i.e. body mass index ( BMI ) < 35 kg m−2 and less than 50 % excess weight . During the year following this trial an additional 54 patients underwent IGB . When this operation was performed for morbid obesity and was the initial procedure , 96 % of the patients achieved a successful result . If IGB was performed as a revision procedure or for super obesity ( BMI > 50 kg m−2 ) , the success rate was 63 % with 100 % follow-up at 40 months . Major morbidity occurred in six of the 160 patients who underwent 195 operations ( the trial period and subsequent year ) . There were no deaths and follow-up was 98 % . Conclusions : The ideal gastric operation based on this study emphasizes the following requirements : a small pouch ( < 15ml ) totally separated from the stomach , a pouch not dependent on staples , placed in the dependent position to prevent stasis , constructed without foreign material and with an anastomosis which permits ingestion of solid food A r and omized prospect i ve comparison of 50 modified Gomez gastric partitioning to 50 subtotal gastric exclusion ( bypass ) operations is presented . Smaller pouch sizes than are generally recommended were used , along with accurate calibration of the outlet size by suturing around a 30F bougie in both operations . It is believed that these techniques improved weight loss with minimal increase in side effects , but some increase in the length of hospital stay to ensure adequate fluid intake . Significantly better weight loss and less need for reoperation was found with gastric exclusion , and the complication rates were similar . Either operation requires meticulous attention to detail and follow-up to achieve low mortality and morbidity rates and good weight loss ; but , if these are accomplished , the best end results statistically strongly favor subtotal gastric exclusion Fifty-seven morbidly obese patients were r and omized into two surgical treatment groups , gastric bypass ( n = 29 ) and gastroplasty ( n = 28 ) . Studies of the gastric emptying with radionuclide-labelled food were performed preoperatively ( 12 patients ) and postoperatively at 2 months ( 28 patients ) and 12 months ( 49 patients ) . Pouch emptying after gastric bypass was slower at 2 months than at 12 months . After gastroplasty the emptying rate was the same at 2 and 12 months and the same as that of gastric bypass at 12 months . A statistically significant correlation between stoma diameter and emptying rate was seen 1 year after gastroplasty but not after gastric bypass . No correlation between emptying rate and weight loss was shown in either group . Differences in the mechanisms of action between these two methods are apparent and are discussed OBJECTIVES : To analyse sick leave and disability pension among surgically and conventionally treated obese patients . DESIGN : A prospect i ve study over five years . Differences in sick leave and disability pension were analysed using multiple and logistic regressions . Possible confounding factors were analysed and controlled for . SETTING : Nine counties in Sweden . SUBJECTS : 369 surgically treated patients and 371 matched obese controls , included in the Swedish Obese Subjects ( SOS ) study . At baseline , mean body mass index ( BMI ) was 42 kg/m2 in surgical patients and 41 kg/m2 in controls . After four years of treatment , weight reduction was 20 % among surgical patients while the control patients kept their initial weight . INTERVENTION : Gastric bariatric surgery . MEASUREMENTS : Days of sick leave plus disability pension , and days of disability pension . RESULTS : In the year prior to treatment , adjusted average number of days of sickness due to sick leave plus disability pension was similar in surgical patients and controls . Compared with controls , the surgical group had 35 % more days of sickness during the first year after initiation of treatment , but 10–14 % fewer days during years 2–3 . During year four , days of sickness tended to be lower in the surgical group ( P=0.07 ) . In the sub-group , aged above the median , surgical patients had 14–18 % fewer days of sickness than controls , during years 2–3 after initiation of treatment This difference did not occur in the group below median age . CONCLUSION : Surgical treatment of obesity results in a reduction of sick leave and disability pension , compared to controls , particularly in subjects aged 47–60 Fifty-seven patients allocated at r and om to either diet supported by gastroplasty or very-low-calorie diet ( VLCD ) were followed for 5 years . One patient was lost to follow-up 1 year after surgery . Data were analyzed by survival statistics and success was liberally defined as a maintained weight loss of at least 10 kg . The cumulative success rate declined steadily in both groups , but it remained higher in the gastroplasty group ( 16 versus 3 percent , the 95 percent confidence limits being 11 - 21 percent and 1 - 5 percent , respectively ; P less than 0.05 ) . At 5 years , eight of 27 gastroplasty patients ( 30 percent , 95 percent confidence limits 14 - 50 percent ) had not relapsed . Of 30 VLCD patients , relapse had not occurred in five ( 17 percent , 6 - 35 percent ) . The weight loss of patients without relapse did not differ significantly ( medians of gastroplasty and VLCD patients 18 kg and 27 kg , respectively ) . Complications and side-effects were more numerous and serious among the gastroplasty patients . Although in this long-term study , the horizontal gastroplasty proved to be somewhat more effective than the diet alone , the surgical risks and the unsatisfactory maintenance of weight loss speak against the use of this operation Objective To compare outcomes , quality of life ( QOL ) , and costs of laparoscopic and open gastric bypass ( GBP ) . Summary Background Data Laparoscopic GBP has been reported to be a safe and effective approach for the treatment of morbid obesity . The authors performed a prospect i ve r and omized trial to compare outcomes , QOL , and costs of laparoscopic GBP with those of open GBP . Methods From May 1999 to March 2001 , 155 patients with a body mass index ( BMI ) of 40 to 60 kg/m2 were r and omly assigned to undergo laparoscopic ( n = 79 ) or open ( n = 76 ) GBP . The two groups were similar in age , sex ratio , mean BMI , and comorbidities . Main outcome measures included operative time , estimated blood loss , length of hospital stay , operative complications , percentage of excess body weight loss , and time to return to activities of daily living and work . Changes in QOL were assessed using the SF-36 Health Survey and the bariatric analysis of reporting outcome system ( BAROS ) . Operative and hospital costs of the two operations were also compared . Results There were no deaths in either group . Mean operative time was longer for laparoscopic GBP than for open GBP , but operative blood loss was less . Two ( 2.5 % ) of the 79 patients in the laparoscopic group required conversion to laparotomy . Median length of hospital stay was shorter for laparoscopic GBP patients ( 3 vs 4 days ) . The rate of postoperative anastomotic leak was similar between groups . Wound-related complications such as infection ( 10.5 vs 1.3 % ) and incisional hernia ( 7.9 vs 0 % ) were more common after open GBP ; late anastomotic stricture was less frequent after open GBP ( 2.6 vs 11.4 % ) . Time to return to activities of daily living and work were shorter after laparoscopic GBP than after open GBP . Weight loss at 1 year was similar between groups . Preoperative SF-36 scores were similar between groups ; however , at 1 month after surgery , laparoscopic patients had better physical conditioning , social functioning , general health , and less body pain than open GBP patients . At 6 months , the BAROS outcome was classified as good or better in 97 % of laparoscopic GBP patients compared with 82 % of open GBP patients . Operative costs were higher for laparoscopic GBP patients , but hospital costs were lower . Conclusions Laparoscopic GBP is a safe and cost-effective alternative to open GBP . Despite a longer operative time , patients undergoing laparoscopic GBP benefited from less blood loss , a shorter hospital stay , and faster convalescence . Laparoscopic GBP patients had comparable weight loss at 1 year but a more rapid improvement in QOL than open GBP patients . The higher initial operative costs for laparoscopic GBP were adequately offset by the lower hospital costs Fifty-one morbidly obese women were r and omized and operated upon with either gastroplasty or gastric bypass . The patients were studied preoperatively and 12 months after surgery . The weight loss was significantly larger after gastric bypass . Fat cell weight was determined from subcutaneous fat biopsies of the epigastric , hypogastric , femoral and gluteal regions . Intra-abdominal biopsies were also taken during the operation . Fat cell weight decreased significantly in all subcutaneous regions . Fat cell number , derived from calculated body fat and measured mean subcutaneous fat cell weight , decreased significantly in both treatment groups BACKGROUND Obese people frequently suffer from shortness of breath and chest discomfort on exertion , and they often have a sedentary lifestyle . In the present study of patients with severe obesity , we investigated the effects of surgically induced weight loss on cardiorespiratory symptoms and leisure-time physical activity . METHODS The Swedish Obese Subjects study is an ongoing intervention trial of obesity consisting of 1 surgically treated group and 1 matched control group . Information on smoking habits , hypertension , diabetes , and sleep apnea was obtained from 1210 surgical cases and 1099 controls who were observed for 2 years . Patients were also asked about symptoms of breathlessness and chest pain and their levels of leisure-time physical activity . RESULTS The surgically treated group displayed a mean weight loss of 28 kg ( 23 % ) compared with the control group in which the average weight remained unchanged ( P<.001 ) . The rates of hypertension , diabetes , and apneas during sleep decreased in surgical cases compared with controls ( P<.001 ) , while smoking habits remained largely the same . The surgical group also displayed highly significant improvements in dyspnea and chest pain and increases in physical activity compared with the control group ( P<.001 ) . The odds ratio for self-reported breathlessness , chest discomfort , or sedentary behavior after 2 years decreased progressively with the degree of weight loss . Furthermore , patients who recovered from apneas during sleep reduced their odds of having dyspnea and chest discomfort at follow-up , independent of changes in weight . CONCLUSIONS Surgically induced weight loss in patients with severe obesity is associated with a marked relief in symptoms of dyspnea and chest pain and promotes increased leisure-time physical activity . Sleep-disordered breathing may be involved in the pathophysiology of breathlessness and chest discomfort in obese subjects OBJECTIVE To perform the first prospect i ve trial of laparoscopic versus open adjustable silicone gastric b and ing ( ASGB ) in patients with morbid obesity . SUMMARY BACKGROUND DATA Vertical b and ed gastroplasty has been used for many years to treat morbid obesity , but the size of the stoma has remained a source of failure after the procedure . ASGB has the advantages of maintaining gastric integrity and the potential for readjustment of the b and , if needed . It has been suggested that laparoscopic ASGB , recently introduced to reduce postoperative complications and hospital stay , has a negative impact on outcome . METHODS Fifty patients with morbid obesity of > 5 years ' duration and a body-mass index ( BMI ) > 40 kg/m2 were r and omized to undergo laparoscopic or open ASGB . The difficulty of the procedure , surgical time , postoperative complications , and hospital stay were assessed . Stoma adjustments , long-term complications , readmissions , weight loss , and BMI were determined . RESULTS All procedures were successfully carried out . Of 25 patients assigned to laparoscopic ASGB , 2 were converted to an open procedure . Surgical time was significantly longer for laparoscopic ASGB ( 150 minutes vs. 76 minutes for open ASGB ) . There was no difference in complications . Mean hospital stay was 5.9 days for the laparoscopic procedure versus 7.2 days for open ASGB ( p < 0.05 ) . The total number of readmissions ( 6 vs. 15 ) and overall hospital stay in the first year ( 7.8 vs. 11.8 days ) were lower after laparoscopic ASGB ( p < 0.05 ) . Weight and BMI were reduced significantly in both groups , but there was no difference between the groups . CONCLUSION Laparoscopic and open ASGB were equally effective in terms of early ( first-year ) weight loss , reduction of BMI , and postoperative complications . The laparoscopic procedure was associated with a shorter initial hospital stay and fewer readmissions during follow-up and is therefore the preferred treatment in morbidly obese patients undergoing ASGB In a r and omised clinical trial to assess the value of intestinal bypass in the treatment of gross obesity 130 patients who underwent end-to-side jejunoileostomy ( with either a 1/3 or a 3/1 ratio between jejunum and ileum left in continuity ) were compared with 66 non-surgically treated patients . All patients in the study had gross , long-st and ing , treatment-resistant obesity with result ant somatic , psychic , or social problems ; none were alcoholic or had liver disease or other conditions which made them poor surgical risks . Most subjects were observed for more than 3 years . Median weight loss within 24 months was 42.9 kg in the bypass group , compared with 5.9 kg in the control group . No deaths occurred among those who underwent surgery . Patients who underwent intestinal bypass also had a better improvement in quality of life and a higher degree of patient satisfaction . Complications of the operation were , however , common and occasionally severe Blood pressure ( BP ) was followed simultaneously with body weight in 134 morbidly obese patients r and omized to either jejunoileal bypass ( 101 patients ) or dietary treatment ( 33 patients ) . After a median observation time of 24 months ( range 12 - 48 months ) body weight fell significantly from a median of 124.0 kg to 81.2 kg in the jejunoileal bypass patients whilst median BP decreased significantly from 140/85 mmHg to 120/80 mmHg . In the patients treated with diet , body weight decreased significantly from a median of 129.0 kg to 119.0 kg after a median observation time of 18 months ( range 9 - 36 months ) whereas the median BP of 140/90 mmHg was unaffected . The fall in BP after weight loss was significantly positively correlated with the height of BP before the weight loss . The correlation could not be explained by a greater weight loss in the patients with initially high BP . Furthermore , a significantly positive correlation between BP changes and body weight changes was demonstrated , but this correlation was lesser than the above-mentioned . The study shows that the beneficial effect of a weight loss upon BP in obese patients is greater the higher the initial BP is , but also that a normal BP is only little affected and explained mainly by cuff artifact A prospect i ve , r and omized trial comparing vertical b and ed gastroplasty ( VBG ) and vertical gastric bypass ( GB ) for obesity was completed in 106 patients who did not differ in baseline body mass index ( BMI = kg/m2 ) or length of follow-up . The goal of this surgery was to return patients to within 50 % of their ideal weight , i.e. , a body mass index less than 35 kg/m2 , and to accomplish this while maintaining a low risk for malnutrition as well as other morbidity and mortality . Success was defined as a BMI less than 35 kg/m2 because the mortality risk increases rapidly above this degree of obesity . Surgical failures were encountered in 43 % of the 54 patients in the VBG group , all of whom had division between the vertical staple lines . The main causes of failure were stenosis and enlargement of the gastroplasty orifice . Surgery failed in 23 % of the GB-treated patients , due to perforation of the vertical staple line . An isolated gastric bypass ( IGB ) not dependent on staples was performed as the remedial operation for the failures of both VBG and GB . IGB was significantly better than VBG or GB , with a success rate of 83 % compared with 39 % for VBG and 58 % for GB . Subsequent experience since completion of this r and omized trial in 54 consecutive patients supports IGB for primary , as well as remedial , operations for the morbidly obese ( BMI = 40 to 50 kg/m2 ) , as well as for patients who are super obese ( BMI greater than 50 kg/m2 ) In 57 consecutive morbidly obese patients r and omized to gastric bypass ( 29 ) or gastroplasty ( 28 ) the stoma size was measured by a simple and reproducible endoscopical method at 2 , 6 and 12 months postoperatively . The stomata enlarged with time but no difference in stoma size between the groups was observed . With gastroplasty at each measurement an increasing correlation , at one year statistically significant , was found between weight loss and stoma size . Gastroplasty patients with smaller stomata lost more weight than those with larger stomata . After gastric bypass no such correlation appeared but these patients lost more weight ( 42.3 kg versus 29.9 kg , p less than 0.001 ) . This suggest that some additional factor regulating weight loss other than stoma size is at work in this method We compared the weight-reducing effect of diet and gastroplasty with that of diet alone in a r and omized trial in 60 morbidly obese patients followed for two years . Initial median body weight was 120 kg in patients r and omly assigned to gastroplasty plus diet and 115 kg in those assigned to diet alone . Maximum weight losses did not differ significantly between the groups ( 26.1 kg in the gastroplasty group and 22.0 kg in the group treated with diet alone , P greater than 0.05 ) . The risk of a Type II error with a true difference larger than 9.5 kg was less than 5 per cent . However , the group treated with diet alone regained significantly more weight after maximum weight loss had been achieved , so that the gastroplasty group had a more favorable net outcome at two years ( P less than 0.05 ) A prospect i ve , r and omized clinical trial has been conducted in 38 morbidly obese patients to compare jejunoileal bypass ( 19 patients ) with gastric bypass ( 19 patients ) . At this point the patients have been followed up for periods of from 1 month to 2 years , and 12 patients in each surgical group have been observed for 6 months or longer after operation . There was one death among the 38 patients , a woman with a gastric bypass who developed a pulmonary embolus 22 days postoperatively . Gastric bypass result ed in somewhat greater weight loss than jejunoileal bypass . Although the follow-up period has been short , jejunoileal bypass has result ed in greater morbidity and expense to the patient than gastric bypass . In particular , gastric bypass did not cause progression of liver lesions in any of the 6 patients who had liver biopsies 1 year postoperatively , while jejunoileal bypass was associated with development of fatty metamorphosis in the liver of 3 patients after 1 year . The entry of new patients into the clinical trial has been discontinued because we believe there is sufficient evidence to indicate that gastric bypass is superior to jejunoileal bypass in the treatment of morbid obesity . RésuméNous avons réalisé un essai clinique prospect if et r and omisé destiné à comparer le court-circuit jéjunoiléal ( 19 cas ) et le court-circuit gastrique ( 19 cas ) comme traitement de l'obésité grave chez 38 patients . Actuellement , les malades ont été suivis pendant 1 mois à 2 ans et 12 patients dans chaque groupe ont pu être observés pendant plus de 6 mois après l'intervention . Il y eut un décès , une femme qui mourut d'embolie pulmonaire 22 jours après avoir subi un court-circuit gastrique . Le by-pass gastrique entraîne une perte de poids un peu plus importante que le court-circuit jéjuno-iléal . Quoique la période d'observation soit courte , il apparaît que les courtcircuits jéjuno-iléaux sont grevés d'une plus gr and e morbidité que les by-pass gastriques . En particulier , le by-pass gastrique n'a pas entraîné de progression des lésions hépatiques chez les 6 malades qui ont subi une biopsie hépatique un an après l'intervention alors que le by-pass jéjuno-iléal s'est accompagné de métamorphose graisseuse chez 3 patients au bout d'un an . Nous avons arrêté cet essai thérapeutique contrôlé parce que nous croyons qu'il existe des preuves suffisantes de la supériorité du by-pass gastrique dans le traitement de l'obésité grave Fifty-seven morbidly obese patients were r and omized to gastric bypass ( 29 ) or gastroplasty ( 28 ) and observed for 24 months postoperatively . Operating time and hospital stay were longer and peroperative and postoperative complications somewhat more common in the bypass than in the gastroplasty group . But weight loss at 1 year was significantly greater and failures significantly fewer after gastric bypass . Four gastroplasties were converted to bypass after 18 - 24 months because of failure to lose weight . Gastric bypass was judged to be much the preferable of the two operations . Dumping occurred in some patients with bypass but not after gastroplasty . Dumping was not associated with greater weight loss . Peroperatively measured pouch volume showed significant correlation with weight loss after gastroplasty , but not after bypass . Peroperative pouch volume and postoperatively measured stoma diameter were co-acting factors , which in multiple regression analysis could explain observed variance in weight loss to about 40 % after gastroplasty , but to a negligible degree after gastric bypass Background : a prospect i ve r and omized study was undertaken to compare the outcome of vertical b and ed gastroplasty ( VBG ) and gastric bypass ( GBP ) in patients with clinical ly severe obesity . Methods : eligibility criteria included Class IV obesity , < 50 years old and a history of at least one attempt of non-operative weight loss . Patients were managed conservatively for 3 months prior to surgery . Patients were followed post-operatively and monitored for early and late complications and their weight loss outcome for up to 5 years . Results : 44 patients were recruited . Two patients withdrew within 4 weeks and were excluded . Twenty subjects had a GBP and 22 a VBG . There were no significant differences with respect to age , gender , maximum or pre-operative weight between the groups ( p > 0.05 ) . Patients who underwent GBP demonstrated significantly greater post-operative weight loss ( p < 0.05 ) which was apparent from 6 months onwards . There were no deaths , pulmonary emboli , post-operative leaks or wound dehiscence . There were no instances of staple-line disruption . Symptomatic ulcer disease , confirmed endoscopically , developed in 25 % of GBP patients . Nine patients developed gallstones post-operatively of whom five were in the VBG and four in the GBP group . Conclusions : weight loss following GBP was maintained , while VBG patients slowly regained |
11,571 | 26,337,175 | Spinal mobility measures do not reflect levels of inflammation at either the sacroiliac joints and /or the spine | The study aim ed to determine , using systematic review and meta- analysis , the level of evidence supporting the construct validity of spinal mobility tests for assessing patients with ankylosing spondylitis . | Objective : To vali date and refine two sets of c and i date criteria for the classification/diagnosis of axial spondyloarthritis ( SpA ) . Methods : All Assessment of SpondyloArthritis international Society ( ASAS ) members were invited to include consecutively new patients with chronic ( ⩾3 months ) back pain of unknown origin that began before 45 years of age . The c and i date criteria were first tested in the entire cohort of 649 patients from 25 centres , and then refined in a r and om selection of 40 % of cases and thereafter vali date d in the remaining 60 % . Results : Upon diagnostic work-up , axial SpA was diagnosed in 60.2 % of the cohort . Of these , 70 % did not fulfil modified New York criteria and , therefore , were classified as having “ non-radiographic ” axial SpA. Refinement of the c and i date criteria result ed in new ASAS classification criteria that are defined as : the presence of sacroiliitis by radiography or by magnetic resonance imaging ( MRI ) plus at least one SpA feature ( “ imaging arm ” ) or the presence of HLA-B27 plus at least two SpA features ( “ clinical arm ” ) . The sensitivity and specificity of the entire set of the new criteria were 82.9 % and 84.4 % , and for the imaging arm alone 66.2 % and 97.3 % , respectively . The specificity of the new criteria was much better than that of the European Spondylarthropathy Study Group criteria modified for MRI ( sensitivity 85.1 % , specificity 65.1 % ) and slightly better than that of the modified Amor criteria ( sensitivity 82.9 , specificity 77.5 % ) . Conclusion : The new ASAS classification criteria for axial SpA can reliably classify patients for clinical studies and may help rheumatologists in clinical practice in diagnosing axial SpA in those with chronic back pain . Trial registration number : NCT00328068 Study Design . In 151 adult patients with ankylosing spondylitis who participated in an inpatient rehabilitation program of 3–4 weeks , 10 different range of motion ( ROM ) values were measured , and their lumbar spine and sacroiliac joints were radiographed . Objectives . To determine whether a correlation obtained between restriction of ROM and progression of radiologic findings in ankylosing spondylitis , together with a high enough reliability level in measurements . Summary of Background Data . A significant correlation was observed between the restriction of eight ROMs : the Schober test , thoracolumbar rotation , thoracolumbar flexion , cervical rotation , occiput-wall distance , chin-chest distance , chest expansion , finger-floor distance , and overall radiologic changes in both lumbar spine and sacroiliac joints ; straight leg raise did not correlate , and vital capacity only with sacroiliac joint changes . Spearman 's correlation coefficients for ROMs were slightly higher to lumbar spine changes than to sacroiliac joint changes . A corresponding correlation was also observed between spinal mobility restrictions and six detailed changes in lumbar roentgenogram : syndesmophytes , apophyseal arthritis , sclerotic anterior borders of vertebrae , straightened anterior surface of vertebrae , and ossification of interspinous and anterior longitudinal ligaments . Other detailed lumbar spine findings did not correlate . As assessed by erythrocyte sedimentation rate values the disease activity increased in the course of radiologic progression , decreasing again , however , to the end stage . Methods . Conventional methods with a tape and ( Myrin ) inclinometer were used to measure thoracolumbar flexion , cervical rotation , occiput-wall distance , chin-chest distance , finger-floor distance , chest expansion , vital capacity , and straight leg raise . In addition , a new method of thoracolumbar rotation and a new modification of the Schober test were introduced . Thirty-nine patients were r and omized for a reliability assessment using repeated measurements of ROMs . Radiologic changes were evaluated ( in a masked fashion ) using the method of Dale and Vinje . Results . The reliability of all ROMs was good ( except for interraler intraclass correlation coefficients of chest expansion : 0.53 ) . Conclusions : The clear correlation between radiologic sacroiliac joint and lumbar spine progression and eight ROMs showed that these are useful noninvasive measurements of disease progression and severity in ankylosing spondylitis that can be used in daily practice OBJECTIVE To evaluate a magnetic resonance imaging ( MRI ) scoring system for the assessment of spinal inflammation in patients with ankylosing spondylitis ( AS ) who participated in a r and omized , placebo-controlled trial of infliximab , and to examine whether infliximab is also effective for the reduction of MRI-proven spinal inflammation . METHODS Twenty patients with AS ( 9 women and 11 men , mean age 40.9 years ) were examined at baseline and after 3 months . Nine patients had received infusions of infliximab ( 5 mg/kg body weight ) at weeks 0 , 2 , and 6 , and 11 patients had received placebo . Three MRI sequences and 2 scoring systems were used . Chronic lesions were evaluated by T1-weighted turbo spin-echo ( TSE ) sequences and were assigned a chronicity score . Active lesions were evaluated either by repetition of T1-weighted TSE sequences after infusion of gadolinium-diethylenetriaminepentaacetic acid ( Gd-DTPA ) or by short tau inversion recovery ( STIR ) sequences , and were assigned an activity score . The 40 images were evaluated twice by 2 readers who were blinded to the names of the patients and the date s of the examinations , and were analyzed in relation to the clinical results . RESULTS Active spinal lesions were detected in 15 of 20 patients ( 75 % ) ; the frequency as determined by STIR was equal in the 2 groups . At baseline , the total MRI scores determined using Gd-DTPA , STIR , and T1 were 112.5 , 156 , and 253.5 , respectively . The interrater variance and intrarater variance were , respectively , 6.4 and 7.7 for the active lesion score as determined by Gd-DTPA , 15.7 and 5.3 for the active lesion score as determined by STIR sequence , and 167.3 and 75.5 for the chronic lesion score as determined by T1 sequence . Based on the means of the scores assigned by the 2 readers , the active lesion score as determined by Gd-DTPA improved by 40 % in the infliximab group compared with 6 % in the placebo group , the active lesion score as determined by STIR improved by 60 % in the infliximab group but deteriorated by 21 % in the placebo group , and the chronic lesion score as determined by T1 improved by 7 % in the infliximab group but worsened by 35 % in the placebo group . Five patients in the infliximab group and 2 in the placebo group were clinical responders . The acute MRI changes correlated with clinical improvement as assessed by the Bath Ankylosing Spondylitis Disease Activity Index . CONCLUSION This novel MRI scoring system performed well in assessing acute inflammation by using STIR and post-Gd-DTPA sequences . In correlation with clinical improvement in patients with active AS who were treated with infliximab , significant regression of spinal inflammation was shown by using the MRI activity scores OBJECTIVE To develop a reproducible and simple radiologic scoring system for the spine in patients with ankylosing spondylitis ( AS ) : the Bath Ankylosing Spondylitis Radiology Index for the spine ( BASRI-s ) . METHODS Radiographs of 470 patients with AS were scored using the New York criteria for the sacroiliac joints and , similarly , grading the lumbar and cervical spine on a scale of 0 - 4 ( for normal , suspicious , mild , moderate , and severe ) . These 3 scores were added together to produce the BASRI-s score ( scored 2 - 12 ) . Radiographs of 188 patients were used to test reproducibility . Blinded radiographs of 89 non-AS patients were included , r and omly , to assess disease specificity . Sensitivity to change was assessed using 177 radiographs from 58 AS patients . RESULTS Intra- and interobserver variation showed 75 - 86 % and 73 - 79 % complete agreement at all sites , respectively . Specificities of 0.83 - 0.89 suggested that the lumbar and cervical spine BASRI scores were disease specific . Sensitivity to change became apparent at 2 years ( P < 0.001 ) . Using a lateral view and an anteroposterior view of the lumbar spine was more sensitive than using a lateral view alone . Grading a set of radiographs ( sacroiliac joints , lumbar spine , and cervical spine ) took 30 seconds . CONCLUSION BASRI is a reliable method for grading radiographic changes in patients with AS . It is disease specific , sensitive to change , valid , simple , and rapid to perform OBJECTIVE To evaluate the role of MRI in predicting a Bath Ankylosing Spondylitis Disease Activity Index ( BASDAI ) improvement of at least 50 % ( BASDAI 50 ) upon anti-tumour necrosis factor ( TNF ) therapy of active ankylosing spondylitis ( AS ) . METHODS MRIs from patients with active AS who participated in r and omised controlled trials were analysed with respect to presence and extent of active inflammatory lesions as detected in the spine ( n = 46 ) , sacroiliac ( SI ) joints ( n = 42 ) and both sites ( n = 26 ) . Univariate and multivariate logistic regression analyses were applied to evaluate MRI and clinical data in predicting a BASDAI 50 response . RESULTS The Berlin MRI spine score ( odds ratio ( OR ) 1.16 , 95 % CI 1.02 to 1.33 ) and disease duration ( OR 0.9 , 95 % CI 0.63 to 0.97 ) were statistically significant predictors of a BASDAI 50 response using regression analysis while there was only a trend for C-reactive protein ( CRP ) . The likelihood ratio ( LR ) for achievement of BASDAI 50 was increased in patients with a Berlin MRI spine score > /=11 ( LR 6.7 ) , disease duration < 10 years ( LR 4.2 ) and CRP > /=40 mg/litre ( LR 3.4 ) . All patients with two or three of these predictors improved clinical ly ( as assessed by BASDAI ) by at least 45 % . Disease duration > 20 years , normal CRP and no active inflammatory lesion in the spine were highly predictive of not achieving BASDAI 50 . A trend was only found for the MRI score of SI joints to be predictive . CONCLUSIONS Widespread inflammation in the spine as detected by MRI contributes to predicting a BASDAI 50 response in active patients with AS treated with anti-TNF agents Objective To study the relationship between spinal mobility , radiographic damage of the spine and spinal inflammation as assessed by MRI in patients with ankylosing spondylitis ( AS ) . Methods In this sub analysis of the Ankylosing Spondylitis Study for the Evaluation of Recombinant Infliximab Therapy cohort , 214 patients , representing an 80 % r and om sample , were investigated . Only baseline data were used . MRI inflammation was assessed by the AS spinal MRI activity ( ASspiMRI-a ) score , structural damage by the modified Stoke AS Spine Score ( mSASSS ) and spinal mobility by the linear definition of the Bath Ankylosing Spondylitis Metrology Index ( BASMI ) . Univariate correlations were calculated on baseline values using Spearman rank correlation . Independent associations between the variables of interest were investigated by multivariate linear regression analysis . Associations with clinical disease activity , C-reactive protein , disease duration , age , gender , body mass index and HLA-B27 status were also investigated . Subanalyses were performed according to disease duration . Results BASMI correlated moderately well with mSASSS ( Spearman 's ρ=0.6 ) and weakly with ASspiMRI-a ( ρ=0.3 ) . A best-fit model for BASMI included both mSASSS ( regression coefficient (B)=0.865 , p<0.001 ) and ASspiMRI-a ( B=0.236 , p=0.018 ) . In patients with a disease duration ≤3 years , B was greater for ASspiMRI-a than for mSASSS ( 0.595 vs 0.380 ) , while in patients with a disease duration > 3 years B was greater for mSASSS than for ASspiMRI-a ( 0.924 vs 0.156 ) . Conclusion Spinal mobility impairment in AS is independently determined both by irreversible spinal damage and by reversible spinal inflammation . Spinal mobility impairment is more influenced by spinal inflammation in early disease , and by structural damage in later disease Study Design . A prospect i ve , controlled clinical study performed in a tertiary care center . Objective . To determine reliability and validity of low-tech measurements in assessment of range of motion ( ROM ) of lumbar flexion in ankylosing spondylitis ( AS ) . Summary of Background Data . ROM measurements of lumbar flexion in patients with AS and healthy subjects are evaluated using original Schober test ( OST ) , modified Schober index ( MSI ) , and modified-modified Schober test ( MMST ) and compared with radiography . Methods . Fifty patients with AS and 17 healthy subjects were included . A tape measure was used for measuring OST , MSI , and MMST , and goniometer was used for measuring angle of lumbar ROM on lateral radiographical views in erect position and maximal forward bending position . Results . Angle between L1 and S1 vertebrae displayed a change upon flexion by 18.2 ° ± 18.7 ° in AS group and 30.4 ° ± 11.1 ° in controls ( P = 0.002 ) . Angle between L3 and S1 vertebrae was detected to change upon flexion by 25.3 ° ± 25.4 ° in AS group and 46.7 ° ± 14.2 ° in controls ( P = 0.0001 ) . A weak correlation was observed between MSI , OST , and L1–S1 radiographical mobility measurements as ( P = 0.018 and P = 0.063 ) and MSI , OST , and L3–S1 radiographical mobility measurements as ( P = 0.009 and P = 0.024 ) , respectively for AS . There were correlations between MSI , OST , and radiographical mobility measurements in patients with AS ( r = 0.333 , P = 0.018 , and r = 0.363 , P = 0.009 , respectively ) . There was a correlation between OST and radiographical mobility measurements in controls ( r = −0.504 , P = 0.039 ) . Intrarater reliability was determined to be excellent for OST , MSI , and MMST . Conclusion . Despite excellent intrarater reliabilities for OST , MSI , and MMST , only a weak correlation could be established between OST , MSI , and MMST and radiographical analysis . MMST was found not to reflect lumbar spine angular motions . Although MSI reflected spinal mobility better than OST , both seemed to reflect lumbar spine angular motion poorly OBJECTIVE Magnetic resonance imaging ( MRI ) of the spine is increasingly important in the assessment of inflammatory activity in clinical trials with patients with ankylosing spondylitis ( AS ) . We investigated feasibility , inter-reader reliability , sensitivity to change , and discriminatory ability of 3 different scoring methods for MRI activity and change in activity of the spine in patients with AS . METHODS Thirty sets of spinal MRI at baseline and after 24 weeks of followup , derived from a r and omized clinical trial comparing a tumor necrosis factor (TNF)-blocking drug ( n = 20 ) with placebo ( n = 10 ) and selected to cover a wide range of activity at baseline and change in activity , were presented electronically in a partial latin-square design to 9 experienced readers from different countries ( Europe , Canada ) . Readers scored each set of MRI 3 times , using 3 different methods including the Ankylosing Spondylitis spine Magnetic Resonance Imaging-activity [ ASspiMRI-a , grading activity ( 0 - 6 ) per vertebral unit in 23 units ] ; the Berlin modification of the ASspiMRI-a ; and the Spondyloarthritis Research Consortium of Canada ( SPARCC ) scoring system , which scores the 6 vertebral units considered by the reader as the most abnormal , with additional scores for " depth " and " intensity . " Both the order of the methods used by each reader and the timepoints ( before/after treatment ) were r and omized . Feasibility of each scoring system was evaluated by measuring the mean time needed to score each set of MRI , and inter-reader reliability was evaluated by smallest detectable change ( SDC ) and by intraclass correlation coefficients ( ICC ) for all readers together and for all possible reader pairs separately . Sensitivity to change was investigated by calculating Guyatt 's effect size on change scores . Discriminatory ability was assessed using Z-scores ( Mann-Whitney test ) comparing change in score between patients treated with TNF-blocking drug and placebo . RESULTS The mean time to score one set of MRI was shortest for the Berlin method . SDC was lowest for the Berlin method and highest for SPARCC . Overall inter-reader ICC per method were between 0.49 and 0.77 for scoring activity status , and between 0.46 and 0.72 for scoring activity change . ICC for all possible reader pairs showed much more fluctuation per method , with lowest observed values of about 0.05 ( very low agreement ) and highest observed values over 0.90 ( excellent agreement ) . In general , ICC for SPARCC were consistently higher than for other systems . Sensitivity to change differed per reader , and was more consistent with SPARCC than with the other methods , but was in general excellent for all 3 methods . Discrimination between groups ( TNF-blocker vs placebo ) assessed by Z-scores was good and comparable among methods . CONCLUSION This experiment demonstrates the feasibility of multiple-reader MRI scoring exercises for method comparison , provides evidence for the feasibility , reliability , sensitivity to change , and discriminatory capacity of all 3 tested scoring systems to be used in assessing spinal activity on MRI in patients with AS in clinical trials . On the basis of these results it is not possible to prioritize one of the 3 methods OBJECTIVE To develop and compare c and i date improvement criteria for anti-TNFalpha treatment in ankylosing spondylitis with optimal discriminating capacity between treatment and placebo . METHODS Data from two r and omised controlled trials which included 99 patients treated with infliximab or etanercept were used to evaluate 50 c and i date improvement criteria . These were developed on the basis of pain , patient 's global assessment , function , morning stiffness , spinal mobility , and C reactive protein . Different levels of improvement in each domain ( 20 - 60 % ) were used to define Boolean type criteria . These criteria were compared with different percentages of improvement on the BASDAI and with modified ASAS improvement criteria . Bootstrap methods were applied to calculate 95 % confidence intervals ( CI ) of the chi(2 ) test values to select the best c and i date improvement criteria . RESULTS The best performing improvement criteria were " 20 % improvement in five of six domains " ( chi(2 ) = 31.9 ( 95 % CI , 18.0 to 46.9 ) ) with a low placebo response of 2.9 % and a high response to infliximab of 67.7 % ; and " ASAS 40 % improvement " ( chi(2 ) = 26.5 ( 13.3 to 41.1 ) ) , with response to placebo of 5.7 % and response to infliximab of 64.7 % . The good discriminating capacity of the two improvement criteria was confirmed by the combined data set of the infliximab and etanercept trial . CONCLUSIONS The " five of six " improvement criterion has the advantage of including the objective domains spinal mobility and acute phase reactants , but requires only 20 % improvement . The ASAS 40 % improvement criterion has the advantage of setting a high threshold , but only in patient reported outcomes . The choice between these improvement criteria needs to be based on further validation from upcoming trials OBJECTIVE To investigate the diagnostic value of magnetic resonance imaging ( MRI ) in the detection of early sacroiliitis . METHODS Twenty-five consecutive HLA-B27 positive patients with inflammatory low back pain and < or = grade 2 unilateral sacroiliitis on conventional radiography ( modified New York criteria ) were studied . Erythrocyte sedimentation rate , C-reactive protein , plain radiography ( PR ) , and MRI of the sacroiliac ( SI ) joints were obtained at study entry and PR of the SI joints after 3 years . Each radiograph and MR image set was interpreted independently . SI joints were scored according to the modified New York Criteria for radiological sacroiliitis . MRI scans were also scored for the presence of subchondral marrow edema . The relationship between > or = grade 2 sacroiliitis ( by modified New York criteria for radiological sacroiliitis ) shown on MRI and the subsequent development of > or = grade 2 sacroiliitis on PR after 3 years was investigated . RESULTS At study entry > or = grade 2 sacroiliitis was found on MRI in 36 of 50 SI joints . Edema was found in 20 of 50 SI joints . After 3 years > or = grade 2 sacroiliitis was found on PR in 21 of 44 SI joints . The positive predictive value of > or = grade 2 sacroiliitis on MRI for the development of > or = grade 2 sacroiliitis on PR after 3 years was 60 % ; sensitivity was 85 % and specificity 47 % . CONCLUSION Our data suggest that MRI of the SI joints can be used to identify sacroiliitis earlier than PR |
11,572 | 26,645,543 | There were moderate effects for psychological interventions compared with active controls , treatment as usual and waiting list controls in reducing health care use , with confidence in the findings .
No benefits were found for medication reduction , but with less confidence in this result .
The results are encouraging for the potential of routine psychological intervention to reduce posttreatment health care use , with associated cost savings , but it is likely that the range and complexity of problems affecting work necessitate additional intervention over st and ard group psychological intervention | Psychological interventions for chronic pain and its consequences have been shown to improve mood , disability , pain , and catastrophic thinking , but there has been no systematic review specifically of their effects on health care use or time lost from work as treatment outcomes in mixed chronic pain .
We conducted a systematic review and meta- analysis to evaluate the effectiveness of psychological therapies for chronic pain ( excluding headache ) in adults for these outcomes . | Study Design . A r and omized trial . Objective . To evaluate the effectiveness of a semi-intensive multidisciplinary rehabilitation for patients with chronic low back pain in an outpatient setting . Summary and Background Data . Systematic review s have shown that there is strong evidence that intensive multidisciplinary treatment ( > 100 hours ) , which includes functional restoration , improves function among chronic patients with low back pain , and moderate evidence that it reduces pain but contradictory evidence regarding improvement of working ability . However , there is paucity of data whether semi-intensive outpatient multidisciplinary rehabilitation in groups is more effective than individual physiotherapy . Material s and Methods . A total of 120 women employed as healthcare and social care professionals with nonspecific chronic low back pain were recruited from two occupational healthcare centers . The patients were r and omized into two intervention programs . Multidisciplinary rehabilitation ( n = 59 ) was conducted in groups and comprised of physical training , workplace interventions , back school , relaxation training , and cognitive-behavioral stress management methods for 70 hours . The individual physiotherapy ( n = 61 ) included physical exercise and passive treatment methods administered for 10 hours . Main outcome measures were : back pain and sciatic pain intensity , disability , sick leaves , healthcare consumption , symptoms of depression , and beliefs of working ability after 2 years . Results . There were no statistically significant differences between the two treatment groups in main outcome measures just after rehabilitation , at 6- , at 12- , or 24-month follow-up . In both intervention arms , however , the before- and -after comparison showed favorable effects , and the effects were still maintained at 2 years follow-up . Conclusions . The results of this study indicate that semilight outpatient multidisciplinary rehabilitation program for female chronic low back pain patients does not offer incremental benefits when compared with rehabilitation carried out by a physiotherapist having a cognitive-behavioral way of administering the treatment Background Psychosocial prognostic factors are important in the development of chronic pain , but treatment providers often lack knowledge and skills to assess and address these risk factors . Objective The aim of this study was to examine the effects on outcomes ( pain and disability ) in patients of a course about psychosocial prognostic factors for physical therapists . Design This study was a r and omized , controlled trial . Setting The setting was primary care practice . Participants Forty-two primary care physical therapists attended an 8-day university course ( over 8 weeks ) aim ed at identifying and addressing psychosocial risk factors . Intervention The physical therapists were r and omly assigned to either the course or a waiting list . They treated consecutive patients with acute and subacute musculoskeletal pain both before and after the course . Measurements We measured physical therapists ' attitudes and beliefs about psychosocial factors , knowledge , and skills before and after the course . We measured patients ' pain , disability , catastrophizing , and mood at the start of treatment and at a 6-month follow-up . Methods The physical therapists were r and omly assigned to either the course or a waiting list . They treated consecutive patients with acute and subacute musculoskeletal pain both before and after the course . Results Pain and disability outcomes in all patients of physical therapists who had participated in the course or in patients at risk of developing long-term disability who had higher levels of catastrophizing or depression were not significantly different from those outcomes in patients of physical therapists who had not participated in the course . Pain and disability outcomes in patients with a low risk of developing long-term disability— and pain outcomes in patients with a high risk of developing long-term disability — were not dependent upon whether the attitudes and beliefs of their physical therapists changed during the course . However , disability outcomes in patients with a high risk of developing long-term disability may have been influenced by whether the attitudes and beliefs of their physical therapists changed . Limitations A limitation of this study was that actual practice behavior was not measured . Conclusions An 8-day university course for physical therapists did not improve outcomes in a group of patients as a whole or in patients with a risk of developing long-term disability . However , patients who had a risk of developing long-term disability and had higher levels of catastrophizing or depression may have shown greater reductions in disability if the attitudes and beliefs of their physical therapists changed during the course & NA ; A cognitive – behavioral return‐to‐work focused program was evaluated in a r and omized controlled design , and the effects were compared between two groups of women with musculoskeletal pain . One group of patients ( n=36 ) had a history of long‐term sick leave ( > 12 months ) at the start of the program and the other ( n=36 ) had a history of short‐term sick leave ( 2–6 months ) . The outpatient treatment program , conducted by a psychologist , included 12 sessions with the primary aim to help the patients return‐to‐work . The treatment first included teaching of coping strategies such as applied relaxation , stress management , grade d activity training and pacing . Thereafter the patients were taught how to manage difficulties at their return‐to‐work and how to generalize coping strategies to different risk factors at their work places . The control condition received treatment‐as‐usual . The results showed that the cognitive – behavioral return‐to‐work program was more effective than the treatment‐as‐usual control condition in reducing the number of days on sick leave for patients on short‐term sick leave , but not for patients on long‐term sick leave . The treatment program also helped the patients on short‐term sick leave to increase their ability to control and decrease pain and to increase their general activity level compared to the control condition . These results underscore the need for an early return‐to‐work focused rehabilitation to prevent long‐term sick leave and disability Background : Non-specific chronic low back pain disorders have been proven resistant to change , and there is still a lack of clear evidence for one specific treatment intervention being superior to another . Methods : This r and omized controlled trial aim ed to investigate the efficacy of a behavioural approach to management , classification-based cognitive functional therapy , compared with traditional manual therapy and exercise . Linear mixed models were used to estimate the group differences in treatment effects . Primary outcomes at 12-month follow-up were Oswestry Disability Index and pain intensity , measured with numeric rating scale . Inclusion criteria were as follows : age between 18 and 65 years , diagnosed with non-specific chronic low back pain for > 3 months , localized pain from T12 to gluteal folds , provoked with postures , movement and activities . Oswestry Disability Index had to be > 14 % and pain intensity last 14 days > 2/10 . A total of 121 patients were r and omized to either classification-based cognitive functional therapy group n = 62 ) or manual therapy and exercise group ( n > = 59 ) . Results : The classification-based cognitive functional therapy group displayed significantly superior outcomes to the manual therapy and exercise group , both statistically ( p < 0.001 ) and clinical ly . For Oswestry Disability Index , the classification-based cognitive functional therapy group improved by 13.7 points , and the manual therapy and exercise group by 5.5 points . For pain intensity , the classification-based cognitive functional therapy improved by 3.2 points , and the manual therapy and exercise group by 1.5 points . Conclusions : The classification-based cognitive functional therapy produced superior outcomes for non-specific chronic low back pain compared with traditional manual therapy and exercise & NA ; Psychological and social factors have been shown , separately , to predict outcome in individuals with chronic low back pain . Few previous studies , however , have integrated both psychological and social factors , using prospect i ve study of clinic population s of low back pain patients , to identify which are the most important targets for treatment . One hundred and eight patients with chronic low back pain , newly referred to an orthopaedic outpatient clinic , completed assessment s of demographic characteristics , details of back pain , measures of anxiety and depression ( Hospital Anxiety and Depression Scale , HADS ) , fearful beliefs about pain ( Fear Avoidance Beliefs Question naire ) , social stresses ( Life Events and Difficulties Schedule ) and physical aspects of health‐related quality of life [ SF‐36 Physical Component summary Score scale ( PCS ) ] . Six months later subjects completed the SF‐36 PCS and the number of healthcare contacts during follow‐up was recorded . Independent predictors of SF‐36 PCS at 6‐month follow‐up were duration of pain [ ( st and ardised regression coefficient ( β ) = −0.18 , p = 0.04 ) , HADS score ( β ) = −0.27 , p = 0.003 ] and back pain related social difficulties ( β = −0.42 , p < 0.0005 ) . Number of healthcare contacts over the 6 months ranged from 1 to 29 , and was independently predicted by perceived cause of pain [ Incident Rate Ratio ( IRR ) = 1.46 , p = 0.03 ] , Fear Avoidance Beliefs about work ( IRR = 1.02 , p = 0.009 ) and back pain related social difficulties ( IRR = 1.16 , p = 0.03 ) . To conclude , anxiety , depression , fear avoidance beliefs relating to work and back pain related stresses predict impairment in subsequent physical health‐related quality of life and number of healthcare contacts . Interventions targeting these psychosocial variables in clinic patients may lead to improved quality of life and healthcare costs BACKGROUND Cognitive-behavioural treatment can nowadays be delivered through the Internet . This form of treatment can have various advantages with regard to availability and accessibility . Previous studies showed that Internet-based treatment for chronic pain is effective compared to waiting-list control groups . METHODS We conducted a r and omized controlled trial comparing an Internet-based cognitive-behavioural intervention with e-mail therapist contact to a face-to-face cognitive-behavioural group intervention . Of the 72 participants who were r and omly assigned to an Internet or a group course , 50 participants completed the intervention . Participants were assessed at baseline ( T0 ) , immediately after the 7-week course ( T1 ) and at the booster session 2 months later ( T2 ) . Pain-related catastrophizing was the primary outcome measure . Pain intensity , fatigue , pain-related interference , locus of control , pain coping , global health-related quality of life and medical expenses were secondary outcome variables . RESULTS Significant improvement was found on catastrophizing , pain coping , locus of control and aspects of global health-related quality of life in both the Internet and the group courses directly after the course and at the booster session . Pain intensity was improved in both courses at the booster session . At T2 , improvement in catastrophizing , pain intensity , pain coping and some quality of life dimensions was significantly greater in completers of the Internet course than in the group course . Furthermore , the Internet course was cost-effective compared to the group course . CONCLUSIONS We conclude that the Internet-based cognitive-behavioural intervention was at least as effective as the face-to-face group intervention and , on some outcome measures appeared to be even more effective SUMMARY OF BACKGROUND DATA The incidence of chronic pain is higher among immigrants in Europe than among the native European population . Therapeutic interventions in this population are far less effective than in patients for whom these programmes were originally developed . OBJECTIVES In a r and omised trial , we investigated whether a cognitive behavioural treatment ( CBT ) programme supplemented with culturally sensitive aspects ( CsCBT ) improves pain intensity , pain disability and quality of life among immigrant patients , compared with a treatment of culturally sensitive exercise therapy ( CsET ) alone . Furthermore , we investigated whether healthcare costs would decrease . METHODS First-generation Turkish immigrants residing in Switzerl and ( 20 - 65 years of age ) who suffered from chronic pain were enrolled in the trial . Patients were r and omised to attend either CsCBT or CsET . The CsCBT intervention was based upon a manualised cognitive-behavioural group treatment programme for chronic pain patients and adapted to the needs of a Turkish immigrant population . The CsET intervention was based on principles of exercise therapy for treatment of nonspecific low back pain . RESULTS A total of 116 out patients were recruited between October 2004 and November 2006 . The intervention was completed by 89 patients ( 77 % ) . A total of 78 subjects ( 67 % ) completed follow-up , 12 months after the completion of the intervention programme . The intervention showed no effects in reducing pain , pain disability or quality of life . The analysis of healthcare utilisation yielded no intervention effect . CONCLUSIONS Cognitive behavioural intervention is feasible with immigrants with chronic disabling pain , but the evidence -based CBT programme , as well as exercise therapy supplemented with culturally sensitive aspects , showed no improvement & NA ; Mindfulness‐based stress reduction ( MBSR ) is a structured 8‐week group program teaching mindfulness meditation and mindful yoga exercises . MBSR aims to help participants develop nonjudgmental awareness of moment‐to‐moment experience . Fibromyalgia is a clinical syndrome with chronic pain , fatigue , and insomnia as major symptoms . Efficacy of MBSR for enhanced well‐being of fibromyalgia patients was investigated in a 3‐armed trial , which was a follow‐up to an earlier quasi‐r and omized investigation . A total of 177 female patients were r and omized to one of the following : ( 1 ) MBSR , ( 2 ) an active control procedure controlling for nonspecific effects of MBSR , or ( 3 ) a wait list . The major outcome was health‐related quality of life ( HRQoL ) 2 months post‐treatment . Secondary outcomes were disorder‐specific quality of life , depression , pain , anxiety , somatic complaints , and a proposed index of mindfulness . Of the patients , 82 % completed the study . There were no significant differences between groups on primary outcome , but patients overall improved in HRQoL at short‐term follow‐up ( P = 0.004 ) . Post hoc analyses showed that only MBSR manifested a significant pre‐to‐post‐intervention improvement in HRQoL ( P = 0.02 ) . Furthermore , multivariate analysis of secondary measures indicated modest benefits for MBSR patients . MBSR yielded significant pre‐to‐post‐intervention improvements in 6 of 8 secondary outcome variables , the active control in 3 , and the wait list in 2 . In conclusion , primary outcome analyses did not support the efficacy of MBSR in fibromyalgia , although patients in the MBSR arm appeared to benefit most . Effect sizes were small compared to the earlier , quasi‐r and omized investigation . Several method ological aspects are discussed , e.g. , patient burden , treatment preference and motivation , that may provide explanations for differences . In a 3‐armed r and omized controlled trial in female patients suffering from fibromyalgia , patients benefited modestly from a mindfulness‐based stress reduction intervention & NA ; Little is known about the relationship between chronic pain status and overall use of healthcare . We examined whether disabling chronic pain was associated with more frequent use of healthcare in three setting s : primary care , emergency departments , and hospital admissions . We used data from Computer‐Assisted Telephone Interviews ( CATI ) of 17,543 residents in New South Wales , Australia aged 16 and over who were r and omly sample d using a population ‐based two‐stage stratified sample and r and om digit dialling methods . The overall response rate was 70.8 % . Compared to chronic pain respondents with no or limited pain‐related disability , those with most pain‐related disability reported more : primary care visits in the last 2 weeks and last 12 months ( adjusted mean number of visits 0.59 vs 0.40 and 10.72 vs 4.81 , both P<0.005 ) ; hospital admissions ( 0.46 vs 0.18 , P<0.005 ) ; and emergency department visits ( 0.85 vs 0.17 , P>0.005 ) . In modelling , having chronic pain per se , or having chronic pain with any level of activity interference predicted health care use after adjusting for age , gender , self‐rated health , psychological distress , comorbidity and access to care . Higher levels of pain‐related disability predicted health care use more than other pain status variables . There was a strong association between pain‐related disability and greater use of services . Further work is needed to underst and the nature of this association . Given the fluctuating course of chronic pain over time , there is a significant segment of the population that may be at risk of developing higher levels of disability associated with increased use of services Background In the industrial world , non-specific back and neck pain ( BNP ) is the largest diagnostic group underlying sick-listing . For patients with subacute and chronic (= full-time sick-listed for 43 – 84 and 85 – 730 days , respectively ) BNP , cognitive-behavioural rehabilitation was compared with primary care . The specific aim was to answer the question : within an 18-month follow-up , will the outcomes differ in respect of sick-listing and number of health-care visits ? Methods After stratification by age ( ≤ 44/≥ 45 years ) and subacute/chronic BNP , 125 Swedish primary -care patients were r and omly allocated to cognitive-behavioural rehabilitation ( rehabilitation group ) or continued primary care ( primary -care group ) . Outcome measures were Return-to-work share ( percentage ) and Return-to-work chance ( hazard ratios ) over 18 months , Net days ( crude sick-listing days × degree ) , and the number of Visits ( to physicians , physiotherapists etc . ) over 18 months and the three component six-month periods . Descriptive statistics , Cox regression and mixed-linear models were used . Results All patients : Return-to-work share and Return-to-work chance were equivalent between the groups . Net days and Visits were equivalent over 18 months but decreased significantly more rapidly for the rehabilitation group over the six-month periods ( p < .05 ) . Subacute patients : Return-to-work share was equivalent . Return-to-work chance was significantly greater for the rehabilitation group ( hazard ratio 3.5 [ 95%CI1.001 – 12.2 ] ) . Net days were equivalent over 18 months but decreased significantly more rapidly for the rehabilitation group over the six-month periods and there were 31 days fewer in the third period . Visits showed similar though non-significant differences and there were half as many in the third period . Chronic patients : Return-to-work share , Return-to-work chance and Net days were equivalent . Visits were equivalent over 18 months but tended to decrease more rapidly for the rehabilitation group and there were half as many in the third period ( non-significant ) . Conclusion The results were equivalent over 18 months . However , there were indications that cognitive-behavioural rehabilitation in the longer run might be superior to primary care . For subacute BNP , it might be superior in terms of sick-listing and health-care visits ; for chronic BNP , in terms of health-care visits only . More conclusive results concerning this possible long-term effect might require a longer follow-up . Trial registration NCT00488735 & NA ; This paper reports the development of a scale for assessing the quality of reports of r and omised controlled trials for psychological treatments . The Delphi method was used in which a panel of 15–12 experts generated statements relating to treatment and design components of trials . After three rounds , statements with high consensus agreement were review ed by a second expert panel and rewritten as a scale . Evidence to support the reliability and validity of the scale is reported . Three expert and five novice raters assessed sets of 31 and 25 published trials to establish scale reliability ( ICC ranges from 0.91 to 0.41 for experts and novices , respectively ) and item reliability ( Kappa and inter‐rater agreement ) . The total scale score discriminated between trials globally judged as good and poor by experts , and trial quality was shown to be a function of year of publication . Uses for the scale are suggested This study aim ed to examine the effectiveness of a multidisciplinary intervention with aftercare ( MD ) compared to aerobic exercise ( AE ) and usual care ( UC ) in recently diagnosed patients with fibromyalgia ( FM ) . In a Zelen-like design , eligible patients from the outpatient rheumatology clinics of three medical centres in the South of the Netherl and s were consecutively recruited and pre-r and omised to MD ( n = 108 ) , AE ( n = 47 ) or UC ( n = 48 ) . MD consisted of a 12-week course of sociotherapy , physiotherapy , psychotherapy and creative arts therapy ( three half days per week ) , followed by five aftercare meetings in 9 months . AE was given twice a week in a 12-week course . UC varied but incorporated at least education and lifestyle advice . Primary outcomes were health-related quality of life ( HR-Qol ) , participation and health care utilisation . Secondary outcome was the Fibromyalgia Impact Question naire ( FIQ ) . Total follow-up duration of the study was 21–24 months . As willingness to participate in AE was limited , this group has been analysed but interpretation of the data is considered arguable . Within the MD group , a statistically significantly improved HR-Qol and a statistically significant reduction in number of hours sick leave , number of contacts with general practitioners and number of contacts with medical specialists was found . Moreover , statistically significant improvements were found on the FIQ , which increased after the intervention . However , no statistically significant between-group differences were found at the endpoint of the study . MD seemed to yield positive effects , but firm conclusions with regard to effectiveness can not be formulated due to small between-group differences and limitations of the study & NA ; Multidisciplinary programmes using a vocational approach can enhance work return in chronic pain patients , but little is known about the long‐term effects of rehabilitation . The current study examined the patterns of sickness absence 10 years after participation in 3 treatment groups ( physiotherapy , cognitive behavioural therapy , and vocational multidisciplinary rehabilitation ) in comparison to a control group receiving treatment‐as‐usual . Cost‐effectiveness was also assessed . Two hundred fourteen patients participated in a r and omized controlled trial and were followed‐up via register data 10 years after the interventions . On average , persons in multidisciplinary rehabilitation had 42.98 fewer days on sickness absence per year compared to those treated‐as‐usual ( 95 % confidence interval −82.45 to −3.52 , P = 0.03 ) . The corresponding reduction of sickness absence after physiotherapy and cognitive behavioural therapy was not significantly different from the control group . The effect of rehabilitation seems to be more pronounced for disability pension than for sick leave . The economic analyses showed substantial cost savings for individuals in the multidisciplinary group compared to the control group . Intensive multidisciplinary rehabilitation for persistent back and neck pain reduces sickness absence 10 years after intervention and shows greater cost reductions than physiotherapy and cognitive behavioural therapy alone Study Design The authors conducted a controlled clinical trial with 1-year follow-up to define the effectiveness of an intensive physical and psychosocial training program on patients with low back pain . Summary of Background Data The intervention group included 152 patients ( mean age 40.5 yr , Million index 45.1/100 ) , and the reference group included 141 patients ( mean age 40.4 yr , Million index 44.5/100 ) . Methods The progressive intervention program consisted of intensive physical training and psychosocial activation . The outcomes were physical and psychosocial measures , the pain and disability index ( Million ) , sick leaves , and occupational h and icap . Results The intervention was more efficient with respect to physical measures and pain and disability index . There were only mild or no differences in changes between the study groups in psychology variables , sick leaves , or retirement . Conclusions The intervention program could improve physical disability , but to improve occupational h and icap , activities of the whole society ( social legislation , labor market policy ) are needed BACKGROUND Multisomatoform disorder is characterised by severe and disabling bodily symptoms , and pain is one of the most common and impairing of these . Furthermore , these bodily symptoms can not be explained by an underlying organic disorder . Patients with multisomatoform disorder are commonly found at all levels of healthcare and are typically difficult to treat for physicians as well as for mental health specialists . AIMS To test whether brief psychodynamic interpersonal therapy ( PIT ) effectively improves the physical quality of life in patients who have had multisomatoform disorder for at least 2 years . METHOD We recruited 211 patients ( from six German academic outpatient centres ) who met the criteria for multisomatoform disorder for a r and omised , controlled , 12-week , parallelgroup trial from 1 July 2006 to 1 January 2009 ( International St and ard R and omised Controlled Trial Number IS RCT N23215121 ) . We r and omly assigned the patients to receive either 12 weekly sessions of PIT ( n = 107 ) or three sessions of enhanced medical care ( EMC , n = 104 ) . The physical component summary of the Short Form Health Survey ( SF-36 ) was the pre-specified primary outcome at a 9-month follow-up . RESULTS Psychodynamic interpersonal therapy improved patients ' physical quality of life at follow-up better than EMC ( mean improvement in SF-36 score : PIT 5.3 , EMC 2.2 ) , with a small to medium between-group effect size ( d = 0.42 , 95 % CI 0.15 - 0.69 , P = 0.001 ) . We also observed a significant improvement in somatisation but not in depression , health anxiety or healthcare utilisation . CONCLUSIONS This trial documents the long-term efficacy of brief PIT for improving the physical quality of life in patients with multiple , difficult-to-treat , medically unexplained symptoms Objective : To determine the effectiveness of adding psychoeducational treatment implemented in general practice to usual care for patients with fibromyalgia ( FM ) , and to analyze the cost-utility of the intervention from health care and societal perspectives . Methods : Twelve-month r and omized controlled trial . A total of 216 primary care patients meeting the American College of Rheumatology criteria for FM participated in the study . The intervention included 9 , 2-hour sessions of psychoeducation ( 5 sessions of education about the illness+4 sessions of autogenic relaxation ) added to usual care provided by a multidisciplinary group in general practice was compared to usual care in the public health system . Results : At 12-month follow-up , patients who received psychoeducation showed greater improvement in global functional status ( Cohen d=0.36 ; −2.49 to 3.81 ) , physical functioning ( Cohen d=0.56 ; 0.08 to 1.00 ) , days feeling well ( Cohen d=0.40 ; −0.16 to 1.02 ) , pain ( Cohen d= 0.35 ; −0.04 to 0.80 ) , morning fatigue ( Cohen d=0.24 ; −0.20 to 0.76 ) , stiffness ( Cohen d=0.34 ; −0.10 to 0.87 ) , and depression ( Cohen d=0.30 ; −0.26 to 0.93 ) . Mean incremental cost per person receiving the intervention was & OV0556;−215.49 ( −615.13 to 287.81 ) from the health care perspective , and & OV0556;−197.32 ( −785.12 to 395.74 ) from the societal perspective . The incremental gain in quality -adjusted life-years per person was 0.12 ( 0.06 to 0.19 ) , yielding a “ dominant ” intervention from both perspectives . The sensitivity analysis suggested that the intervention was cost-effective even imputing all missing data . Discussion : Our findings demonstrate the long-term clinical effectiveness of a psychoeducational treatment program for FM implemented at primary care level and the cost-utility from a health care and societal perspective . Trial Registration : OBJECTIVE To evaluate the efficacy of operant pain treatment for fibromyalgia syndrome ( FMS ) in an inpatient setting . METHODS Sixty-one patients who fulfilled the American College of Rheumatology criteria for FMS were r and omly assigned to the operant pain treatment group ( OTG ; n = 40 ) or a st and ardized medical program with an emphasis on physical therapy ( PTG ; n = 21 ) . Pain assessment s were performed before , immediately after , 6 months after , and 15 months after treatment . RESULTS The OTG patients reported a significant and stable reduction in pain intensity , interference , solicitous behavior of the spouse , medication , pain behaviors , number of doctor visits , and days at a hospital as well as an increase in sleeping time . Sixty-five percent of the OTG compared with none of the patients in the PTG showed clinical ly significant improvement . CONCLUSION These results suggest that operant pain treatment provided in an inpatient setting is an effective treatment for FMS , whereas a purely somatically oriented program may lead to a deterioration of the pain problem A cognitive behavioral multidisciplinary pain management program was evaluated in two separate outcome studies ; one controlled study ( study I ) and one study conducted on a consecutive sample with a long-term follow-up ( study II ) . The 4-week inpatient treatment program included education sessions , goal setting , grade d activity training , pacing , applied relaxation , cognitive techniques , social skills training , drug reduction methods , contingency management of pain behaviors , and planning of work return . The outcome of study I showed significant between-group differences in favor of the treatment group on measures of occupational training at 1-month follow-up , activity level in the sparetime at post-treatment and at follow-up , and decreased catastrophizing and pain behaviors at post-treatment . In study II significant improvements over time were found on measures of sick leave , pain intensity , pain interference , life control , affective distress , activity level in the sparetime , physical fitness and use of analgetics at 2-month follow-up and at 1-year follow-up . The results of the two outcome studies reported show that cognitive behavioral multidisciplinary pain management programs can successfully be applied to Swedish musculoskeletal pain patients OBJECTIVES The present study evaluated the cost-effectiveness of a behavioral grade d exercise therapy ( GET ) program compared with usual care ( UC ) in terms of the performance of daily activities by patients with chronic shoulder complaints in primary care . METHODS A total of 176 patients were r and omly assigned either to GET ( n=87 ) or to UC ( n=89 ) . Clinical outcomes ( main complaints , shoulder disability [ SDQ ] and generic health-related quality of life [ EQ-5D ] , and costs [ intervention costs , direct health care costs , direct non-health-related costs , and indirect costs ] ) were assessed during the 12-week treatment period and at 52 weeks of follow-up . RESULTS Results showed that GET was more effective than UC in restoring daily activities as assessed by the main complaints instrument after the 12-week treatment period ( p = .049 ; mean difference , 7.5 ; confidence interval [ CI ] , 0.0 - 15.0 ) . These effects lasted for at least 52 weeks ( p = .025 ; mean difference 9.2 ; CI , 1.2 - 17.3 ) . No statistically significant differences were found on the SDQ or EQ5D . GET significantly reduced direct health care costs ( p = .000 ) and direct non-health care costs ( p = .029 ) . Nevertheless , total costs during the 1-year follow-up period were significantly higher ( p = .001 ; GET = Euro 530 versus UC = Euro 377 ) due to the higher costs of the intervention . Incremental cost-effectiveness ratios for the main complaints ( 0 - 100 ) , SDQ ( 0 - 100 ) , and EQ-5D ( -1.0 - 1.0 ) were Euro 7 , Euro 74 , and Euro 5278 per unit of improvement , respectively . CONCLUSIONS GET proved to be more effective in the short- and long-term and reduces direct health care costs and direct non-health care costs but is associated with higher costs of the intervention itself & NA ; The aim of the present study was to evaluate the long‐term outcome of a behavioural medicine rehabilitation programme and the outcome of its two main components , compared to a ‘ treatment‐as‐usual ’ control group . The study employed a 4 × 5 repeated‐ measures design with four groups and five assessment periods during a 3‐year follow‐up . The group studied consisted of blue‐collar and service/care workers on sick leave , identified in a nationwide health insurance scheme in Sweden . After inclusion , the subjects were r and omised to one of the four conditions : behaviour‐oriented physiotherapy ( PT ) , cognitive behavioural therapy ( CBT ) , behavioural medicine rehabilitation consisting of PT+CBT ( BM ) and a ‘ treatment‐as‐usual ’ control group ( CG ) . Outcome variables were sick leave , early retirement and health‐related quality of life . A cost‐effectiveness analysis , comparing the programmes , was made . The results showed , consistently , the full‐time behavioural medicine programme being superior to the three other conditions . The strongest effect was found on females . Regarding sick leave , the mean difference in the per‐ protocol analysis between the BM programme and the control group was 201 days , thus reducing sick leave by about two‐thirds of a working year . Rehabilitating women has a substantial impact on costs for production losses , whereas rehabilitating men seem to be effortless with no significant effect on either health or costs . In conclusion , a full‐time behavioural medicine programme is a cost‐effective method for improving health and increasing return to work in women working in blue‐collar or service/care occupations and suffering from back/neck pain Forty-eight dysfunctional patients ( i.e. , high levels of pain , interference , and affective distress and low levels of perceived control ) with temporom and ibular disorders ( TMDs ) were r and omly assigned either to a treatment consisting of an intraoral appliance ( IA ) and stress management with biofeedback ( SM ) plus nondirective , supportive counseling ( SC ) -- IA + SM + SC -- or to a customized treatment that included cognitive therapy ( CT ) with the IA and SM -- IA + SM + CT . Both treatment groups reported statistically significant reductions on a set of physical , psychosocial , and behavioral measures posttreatment and at a 6-month follow-up . However , the intervention that included CT demonstrated significantly greater reductions in pain , depression , and medication use . Only the groups receiving the treatment that included the CT demonstrated continued improvements to the follow-up on pain associated with muscle palpation , self-reported pain severity , depression , and use of medications . These results support the efficacy of the tailored treatment for dysfunctional TMD Acceptance and commitment therapy ( ACT ) is a developing approach for chronic pain . The current study was design ed to pilot test a brief , widely inclusive , local access format of ACT in a UK primary care setting . Seventy-three participants ( 68.5 % women ) were r and omized to either ACT or treatment as usual ( TAU ) . Many of the participants were aged 65 years or older ( 27.6 % ) , were diagnosed with fibromyalgia ( 30.2 % ) and depression ( 40.3 % ) , and had longst and ing pain ( median = 10 years ) . St and ard clinical outcome measures included disability , depression , physical functioning , emotional functioning , and rated improvement . Process measures included pain-related and general psychological acceptance . The recruitment target was met within 6 months , and 72.9 % of those allocated to ACT completed treatment . Immediately post treatment , relative to TAU , participants in ACT demonstrated lower depression and higher ratings of overall improvement . At a 3-month follow-up , again relative to TAU , those in ACT demonstrated lower disability , less depression , and significantly higher pain acceptance ; d = .58 , .59 , and .64 , respectively . Analyses based on intention-to-treat and on treatment “ completers , ” perhaps predictably , revealed more sobering and more encouraging results , respectively . A larger trial of ACT delivered in primary care , in the format employed here , appears feasible with some recommended adjustments in the methods used here ( Trial registration : IS RCT N49827391 ) . Perspective This article presents a pilot r and omized controlled trial of ACT for chronic pain in a primary care setting in the United Kingdom . Both positive clinical outcomes and ways to improve future trials are reported In this study , three types of treatments for chronic musculoskeletal pain were compared . Fifty-seven patients who suffered from chronic back pain and 21 patients who suffered from temporom and ibular pain and dysfunction were r and omly assigned to either electromyographic ( EMG ) biofeedback , cognitive-behavioral therapy , or conservative medical treatment . At posttreatment , improvements were noted in all three treatment groups , with the biofeedback group displaying the most substantial change . At the 6- and 24-month follow-up , only the biofeedback group maintained significant reductions in pain severity , interference , affective distress , pain-related use of the health care system , stress-related reactivity of the affected muscles , and an increase in active coping self-statements . Treatment outcome was predicted by chronicity and treatment-specific variables . Analysis of attrition showed a significant effect for therapist and extent of somatic pathology . Results suggest that pain patients who suffer from musculoskeletal pain problems and display few physical disabilities may profit the most from short-term EMG biofeedback treatment This paper discusses the rationale for and content of a newly developed treatment for shoulder complaints , and describes a r and omised study which is currently being conducted to test effectiveness of the treatment . In current practice , approximately 50 % of all patients with shoulder complaints mention limitations in the performance of daily activities and persisting pain after six months . To improve the functional ability of patients with chronic shoulder complaints , despite their pain , we have developed an operant behavioural and time-contingent grade d exercise therapy programme for use in a primary care setting . We present the theory and conceptual model underlying this programme , report on its development and content , and describe the design of a r and omised clinical trial to evaluate the programme 's effectiveness and cost-effectiveness . One hundred and thirty-two patients who suffer from shoulder complaints for at least 3 months are being recruited in general practice . After inclusion in the study , patients are allocated r and omly to the grade d exercise therapy programme or to usual care . Question naires will be used to measure factors like severity of the main complaint , functional limitations of daily activities , perceived recovery , global health status , shoulder pain , generic health-related quality of life , and costs . These factors will be assessed at baseline , during treatment ( 6 weeks ) , and after treatment ( 12 , 26 , and 52 weeks ) & NA ; The aim of the present study was to evaluate the outcome of a behavioral medicine ( BM ) rehabilitation program and the outcome of its two main components , compared to a ‘ treatment‐as‐usual ’ control group ( CG ) . The study employed a 4 × 4 repeated‐ measures design with four groups and four assessment periods ( pre‐treatment , post‐treatment , 6‐month follow‐up , and 18‐month follow‐up ) . The group studied consisted of subjects on sick leave identified in a nationwide health insurance scheme in Sweden . After inclusion , the subjects were r and omized to one of four conditions , which were : ( 1 ) behavior‐oriented physical therapy ( PT ) ; ( 2 ) cognitive behavioral therapy ( CBT ) ; ( 3 ) BM rehabilitation consisting of PT+CBT ( BM ) ; ( 4 ) a ‘ treatment‐as‐usual ’ CG . The treatments were given over a period of 4 weeks , PT and CBT on a part‐time basis and BM on a full‐time basis . Outcome variables were sick leave , early retirement , and health‐related quality of life ( measured using the Short Form Health Survey , SF‐36 ) . The results showed that the risk of being granted full‐time early retirement was significantly lower for females in PT and CBT compared to the CG during the 18‐month follow‐up period . However , the total absence from work ( sick listing plus early retirement ) in days over the 18‐month follow‐up period was not significantly different in the CG compared to the treatments . On the SF‐36 , women in CBT and BM reported a significantly better health‐related quality of life than women in the CG at the 18‐month follow‐up . No significant differences for men were found on the SF‐36 scales . In conclusion , the results revealed gender differences in the outcome of the treatments and that the components of this BM program yielded as good results as the whole program & NA ; Inpatient and outpatient cognitive behavioural pain management programmers for mixed chronic pain patients were compared . Patients were r and omly allocated to the 4 week inpatient programme or to the 8 half day per week outpatient programme , or to a waiting list control group . Staff , teaching material s , and setting were the same for the two treatment groups . Patients were assessed pre‐treatment , and at 1 month after discharge , and treated patients also at 6 months and 1 year after discharge , by assessors blind to treatment group ; assessment s included physical , functional and psychological measures , and medication use . In total , 121 mixed chronic pain patients ( mean age 50 years ; mean chronicity 8.1 years ) were included in the study , following medical examination to ensure that no further medical treatment was appropriate . There was no change in the control group ; in patients and out patients , comparable before treatment , both made significant improvements in physical performance and psychological function , and reduced medication use . In patients made greater gains , and maintained them better at 1 year ; they also used less health care than out patients . There were no outst and ing predictors of improvement other than treatment group OBJECTIVE Two psychological interventions for rheumatoid arthritis ( RA ) are cognitive-behavioral coping skills training ( CST ) and written emotional disclosure ( WED ) . These approaches have developed independently , and their combination may be more effective than either one alone . Furthermore , most studies of each intervention have method ological limitations , and each needs further testing . METHOD We r and omized 264 adults with RA in a 2 × 2 factorial design to 1 of 2 writing conditions ( WED vs. control writing ) followed by 1 of 2 training conditions ( CST vs. arthritis education control training ) . Patient-reported pain and functioning , blinded evaluations of disease activity and walking speed , and an inflammatory marker ( C-reactive protein ) were assessed at baseline and 1- , 4- , and 12-month follow-ups . RESULTS Completion of each intervention was high ( > 90 % of patients ) , and attrition was low ( 10.2 % at 12-month follow-up ) . Hierarchical linear modeling of treatment effects over the follow-up period , and analyses of covariance at each assessment point , revealed no interactions between writing and training ; however , both interventions had main effects on outcomes , with small effect sizes . Compared with control training , CST decreased pain and psychological symptoms through 12 months . The effects of WED were mixed : Compared with control writing , WED reduced disease activity and physical disability at 1 month only , but WED had more pain than control writing on 1 of 2 measures at 4 and 12 months . CONCLUSIONS The combination of WED and CST does not improve outcomes , perhaps because each intervention has unique effects at different time points . CST improves health status in RA and is recommended for patients , whereas WED has limited benefits and needs strengthening or better targeting to appropriate patients |
11,573 | 29,985,221 | Recent evidence confirms the ergogenic effects of RMT and explores different loading protocol s , such as concurrent exercise and RMT ( i.e. , “ functional ” RMT ) .
These studies suggest that adapting new training protocol s may have an additive improvement effect , but evidence of the efficacy of such an approach is conflicting thus far .
Importantly , changes in ventilatory efficiency , oxygen delivery , cytokine release , motor recruitment patterns , and respiratory muscle fatigue resistance are highlighted as potential mechanistic factors linking RMT with performance improvements . | Abstract Shei , R-J. Recent advancements in our underst and ing of the ergogenic effect of respiratory muscle training in healthy humans : a systematic review .
J Strength Cond Res 32(9 ) : 2674–2685 , 2018—Respiratory muscle training ( RMT ) has been shown to be an effective ergogenic aid for sport performance .
Respiratory muscle training has been documented to improve performance in a wide range of exercise modalities including running , cycling , swimming , and rowing .
The physiological effects of RMT that may explain the improvements in performance have been proposed to include diaphragm hypertrophy , muscle fiber – type switching , improved neural control of the respiratory muscles , increased respiratory muscle economy , attenuation of the respiratory muscle metaboreflex , and decreases in perceived breathlessness and exertion . | Whole-body active warm-ups ( AWU ) and inspiratory muscle warm-up ( IMW ) prior to exercise improves performance on some endurance exercise tasks . This study investigated the effects of AWU with and without IMW upon 2.4-km running time-trial performance while carrying a 25-kg backpack , a common task and backpack load in physically dem and ing occupations . Participants ( n = 9 ) performed five 2.4-km running time-trials with a 25-kg thoracic load preceded in r and om order by ( i ) IMW comprising 2 × 30 inspiratory efforts against a pressure-threshold load of 40 % maximal inspiratory pressure ( PImax ) , ( ii ) 10-min unloaded running ( AWU ) at lactate turnpoint ( 10.33 ± 1.58 km·h-1 ) , ( iii ) placebo IMW ( PLA ) comprising 5-min breathing using a sham device , ( iv ) AWU+IMW , and ( v ) AWU+PLA . Pooled baseline PImax was similar between trials and increased by 7 % and 6 % following IMW and AWU+IMW ( P < 0.05 ) . Relative to baseline , pooled PImax was reduced by 9 % after the time-trial , which was not different between trials ( P > 0.05 ) . Time-trial performance was not different between any trials . Whole-body AWU and IMW performed alone or combination have no ergogenic effect upon high-intensity , short- duration performance when carrying a 25-kg load in a backpack Fatigue of the respiratory muscles during intense exercise might compromise leg blood flow , thereby constraining oxygen uptake ( Vo(2 ) ) and limiting exercise tolerance . We tested the hypothesis that inspiratory muscle training ( IMT ) would reduce inspiratory muscle fatigue , speed Vo(2 ) kinetics and enhance exercise tolerance . Sixteen recreationally active subjects ( mean + or - SD , age 22 + or - 4 yr ) were r and omly assigned to receive 4 wk of either pressure threshold IMT [ 30 breaths twice daily at approximately 50 % of maximum inspiratory pressure ( MIP ) ] or sham treatment ( 60 breaths once daily at approximately 15 % of MIP ) . The subjects completed moderate- , severe- and maximal-intensity " step " exercise transitions on a cycle ergometer before ( Pre ) and after ( Post ) the 4-wk intervention period for determination of Vo(2 ) kinetics and exercise tolerance . There were no significant changes in the physiological variables of interest after Sham . After IMT , baseline MIP was significantly increased ( Pre vs. Post : 155 + or - 22 vs. 181 + or - 21 cmH(2)O ; P < 0.001 ) , and the degree of inspiratory muscle fatigue was reduced after severe- and maximal-intensity exercise . During severe exercise , the Vo(2 ) slow component was reduced ( Pre vs. Post : 0.60 + or - 0.20 vs. 0.53 + or - 0.24 l/min ; P < 0.05 ) and exercise tolerance was enhanced ( Pre vs. Post : 765 + or - 249 vs. 1,061 + or - 304 s ; P < 0.01 ) . Similarly , during maximal exercise , the Vo(2 ) slow component was reduced ( Pre vs. Post : 0.28 + or - 0.14 vs. 0.18 + or - 0.07 l/min ; P < 0.05 ) and exercise tolerance was enhanced ( Pre vs. Post : 177 + or - 24 vs. 208 + or - 37 s ; P < 0.01 ) . Four weeks of IMT , which reduced inspiratory muscle fatigue , result ed in a reduced Vo(2 ) slow-component amplitude and an improved exercise tolerance during severe- and maximal-intensity exercise . The results indicate that the enhanced exercise tolerance observed after IMT might be related , at least in part , to improved Vo(2 ) dynamics , presumably as a consequence of increased blood flow to the exercising limbs The purpose was to determine the effect of moderate-intensity exercise training ( ET ) on inspiratory muscle fatigue ( IMF ) and if an additional inspiratory load during ET ( ET+IL ) would further improve inspiratory muscle strength , IMF , and time-trial performance . 15 subjects were r and omly divided to ET ( n=8 ) and ET+IL groups ( n=7 ) . All subjects completed six weeks of exercise training three days/week at ∼70%V̇O2peak for 30min . The ET+IL group breathed through an inspiratory muscle trainer ( 15 % PImax ) during exercise . 5-mile , and 30-min time-trials were performed pre-training , weeks three and six . Inspiratory muscle strength increased ( p<0.05 ) for both groups to a similar ( p>0.05 ) extent . ET and ET+IL groups improved ( p<0.05 ) 5-mile time-trial performance ( ∼10 % and ∼18 % ) and the ET+IL group was significantly faster than ET at week 6 . ET and ET+IL groups experienced less ( p<0.05 ) IMF compared to pre-training following the 5-mile time-trial . In conclusion , these data suggest ET leads to less IMF , ET+IL improves inspiratory muscle strength and IMF , but not different than ET alone Inspiratory threshold loading ( ITL ) induces cortical activation . It is sustained over time and is resistant to distraction , suggesting automaticity . We hypothesized that ITL-induced changes in cerebral activation may differ between single-breath ITL and continuous ITL , with differences resembling those observed after cortical automatization of motor tasks . We analyzed the brain blood oxygen level dependent ( BOLD ) signal of 11 naive healthy volunteers during 5 min of r and om , single-breath ITL and 5 min of continuous ITL . Single-breath ITL increased BOLD in many areas ( premotor cortices , bilateral insula , cerebellum , reticular formation of the lateral mesencephalon ) and decreased BOLD in regions co-localizing with the default mode network . Continuous ITL induced signal changes in a limited number of areas ( supplementary motor area ) . These differences are comparable to those observed before and after overlearning of motor tasks . We conclude that the respiratory-related cortical activation observed in response to ITL is likely due to automated , attention-independent mechanisms . Also , ITL activates cortical circuits right from the first breath Inspiratory muscle training ( IMT ) has been shown to improve time trial performance in competitive athletes across a range of sports . Surprisingly , however , the effect of specific IMT on surface swimming performance remains un-investigated . Similarly , it is not known whether any ergogenic influence of IMT upon swimming performance is confined to specific race distances . To determine the influence of IMT upon swimming performance over 3 competitive distances , 16 competitive club-level swimmers were assigned at r and om to either an experimental ( pressure threshold IMT ) or sham IMT placebo control group . Participants performed a series of physiological and performance tests , before and following 6 weeks of IMT , including ( 1 ) an incremental swim test to the limit of tolerance to determine lactate , heart rate and perceived exertion responses ; ( 2 ) st and ard measures of lung function ( forced vital capacity , forced expiratory volume in 1 s , peak expiratory flow ) and maximal inspiratory pressure ( MIP ) ; and ( 3 ) 100 , 200 and 400 m swim time trials . Training utilised a h and -held pressure threshold device and consisted of 30 repetitions , twice per day . Relative to control , the IMT group showed the following percentage changes in swim times : 100 m , −1.70 % ( 90 % confidence limits , ±1.4 % ) , 200 m , −1.5 % ( ±1.0 ) , and 400 m , 0.6 % ( ±1.2 ) . Large effects were observed for MIP and rates of perceived exertion . In conclusion , 6 weeks of IMT has a small positive effect on swimming performance in club-level trained swimmers in events shorter than 400 Inspiratory muscle training ( IMT ) has consistently been shown to reduce exertional dyspnea in health and disease ; however , the physiological mechanisms remain poorly understood . A growing body of literature suggests that dyspnea intensity can be explained largely by an awareness of increased neural respiratory drive , as measured indirectly using diaphragmatic electromyography ( EMGdi ) . Accordingly , we sought to determine whether improvements in dyspnea following IMT can be explained by decreases in inspiratory muscle electromyography ( EMG ) activity . Twenty-five young , healthy , recreationally active men completed a detailed familiarization visit followed by two maximal incremental cycle exercise tests separated by 5 wk of r and omly assigned pressure threshold IMT or sham control ( SC ) training . The IMT group ( n = 12 ) performed 30 inspiratory efforts twice daily against a 30-repetition maximum intensity . The SC group ( n = 13 ) performed a daily bout of 60 inspiratory efforts against 10 % maximal inspiratory pressure ( MIP ) , with no weekly adjustments . Dyspnea intensity was measured throughout exercise using the modified 0 - 10 Borg scale . Sternocleidomastoid and scalene EMG was measured using surface electrodes , whereas EMGdi was measured using a multipair esophageal electrode catheter . IMT significantly improved MIP ( pre : -138 ± 45 vs. post : -160 ± 43 cmH2O , P < 0.01 ) , whereas the SC intervention did not . Dyspnea was significantly reduced at the highest equivalent work rate ( pre : 7.6 ± 2.5 vs. post : 6.8 ± 2.9 Borg units , P < 0.05 ) , but not in the SC group , with no between-group interaction effects . There were no significant differences in respiratory muscle EMG during exercise in either group . Improvements in dyspnea intensity ratings following IMT in healthy humans can not be explained by changes in the electrical activity of the inspiratory muscles . NEW & NOTEWORTHY Exertional dyspnea intensity is thought to reflect an increased awareness of neural respiratory drive , which is measured indirectly using diaphragmatic electromyography ( EMGdi ) . We examined the effects of inspiratory muscle training ( IMT ) on dyspnea , EMGdi , and EMG of accessory inspiratory muscles . IMT significantly reduced submaximal dyspnea intensity ratings but did not change EMG of any inspiratory muscles . Improvements in exertional dyspnea following IMT may be the result of nonphysiological factors or physiological adaptations unrelated to neural respiratory drive ABSTRACT This study was conducted to determine the effects of inspiratory muscle training ( IMT ) on respiratory and peripheral muscles oxygenation during a maximal exercise tolerance test and on repeated-sprint ability ( RSA ) performance in professional women football players . Eighteen athletes were r and omly assigned to one of the following groups : SHAM ( n = 8) or IMT ( n = 10 ) . After a maximal incremental exercise test , all participants performed ( on a different day ) a time-to-exhaustion ( Tlim ) test . Peripheral and respiratory muscles oxygenation by near-infrared spectroscopy , breath-by-breath ventilatory and metabolic variables , and blood lactate concentration were measured . The RSA test was performed on a grass field . After a 6 week intervention , all athletes were reevaluated . Both groups showed increases in inspiratory muscles strength , exercise tolerance and RSA performance , however only the IMT group presented lower deoxyhemoglobin and total hemoglobin blood concentrations on intercostal muscles concomitantly to an increased oxyhemoglobin and total hemoglobin blood concentrations on vastus lateralis muscle during Tlim . In conclusion , these results may indicate the potential role of IMT to attenuate inspiratory muscles metaboreflex and consequently improve oxygen and blood supply to limb muscles during high-intensity exercise , with a potential impact on inspiratory muscle strength , exercise tolerance and sprints performance in professional women football players We have recently demonstrated that changes in the work of breathing during maximal exercise affect leg blood flow and leg vascular conductance ( C. A. Harms , M. A. Babcock , S. R. McClaran , D. F. Pegelow , G. A. Nickele , W. B. Nelson , and J. A. Dempsey . J. Appl . Physiol . 82 : 1573 - 1583 , 1997 ) . Our present study examined the effects of changes in the work of breathing on cardiac output ( CO ) during maximal exercise . Eight male cyclists [ maximal O2 consumption ( VO2 max ) : 62 + /- 5 ml . kg-1 . min-1 ] performed repeated 2.5-min bouts of cycle exercise at VO2 max . Inspiratory muscle work was either 1 ) at control levels [ inspiratory esophageal pressure ( Pes ) : -27.8 + /- 0.6 cmH2O ] , 2 ) reduced via a proportional-assist ventilator ( Pes : -16.3 + /- 0.5 cmH2O ) , or 3 ) increased via resistive loads ( Pes : -35.6 + /- 0.8 cmH2O ) . O2 contents measured in arterial and mixed venous blood were used to calculate CO via the direct Fick method . Stroke volume , CO , and pulmonary O2 consumption ( VO2 ) were not different ( P > 0.05 ) between control and loaded trials at VO2 max but were lower (-8 , -9 , and -7 % , respectively ) than control with inspiratory muscle unloading at VO2 max . The arterial-mixed venous O2 difference was unchanged with unloading or loading . We combined these findings with our recent study to show that the respiratory muscle work normally expended during maximal exercise has two significant effects on the cardiovascular system : 1 ) up to 14 - 16 % of the CO is directed to the respiratory muscles ; and 2 ) local reflex vasoconstriction significantly compromises blood flow to leg locomotor muscles Background Whether or not isolated endurance training of the respiratory muscles improves whole-body endurance exercise performance is controversial , with some studies reporting enhancements of 50 % or more , and others reporting no change . Twenty fit ( VO2 max 56.0 ml/kg/min ) , experienced cyclists were r and omly assigned to three groups . The experimental group ( n = 10 ) trained their respiratory muscles via 20 , 45 min sessions of hyperpnea . The placebo group ( n = 4 ) underwent " sham " training ( 20 , 5 min sessions ) , and the control group ( n = 6 ) did no training . Results After training , the experimental group increased their respiratory muscle endurance capacity by 12 % . Performance on a bicycle time trial test design ed to last about 40 min improved by 4.7 % ( 9 of 10 subjects showed improvement ) . There were no test-re-test improvements in either respiratory muscle or bicycle exercise endurance performance in the placebo group , nor in the control group . After training , the experimental group had significantly higher ventilatory output and VO2 , and lower PCO2 , during constant work-rate exercise ; the placebo and control groups did not show these changes . The perceived respiratory effort was unchanged in spite of the higher ventilation rate after training . Conclusions The results suggest that respiratory muscle endurance training improves cycling performance in fit , experienced cyclists . The relative hyperventilation with no change in respiratory effort sensations suggest that respiratory muscle training allows subjects to tolerate the higher exercise ventilatory response without more dyspnea . Whether or not this can explain the enhanced performance is unknown Abstract Faghy , MA and Brown , PI . Preloaded time trial to assess load carriage performance . J Strength Cond Res 28(12 ) : 3354–3362 , 2014—The relevance and importance of load carriage in recreational and occupational tasks has stimulated a large body of research . Exercise protocol s have been criticized for a lack of relevance to occupational activities ; accordingly , the aim of this study was to assess the reliability of a preloaded time-trial protocol for load carriage assessment . After full familiarization , 8 healthy males performed 2 trials separated by 1 week . Each trial comprised 60-minute walking at 6.5 km·h−1 and 0 % gradient ( LC ) , 15 minutes seated recovery followed by a 2.4-km time-trial ( LCTT ) . All trials were performed wearing a 25-kg backpack . Performance time was 16.71 ± 1.82 minutes and 16.37 ± 1.78 minutes for LCTT 1 and 2 , respectively with a mean difference of −0.34 ± 0.89 minutes . Using log ratio limits of agreement , the mean bias was 1.02 and r and om error component of the agreement ratio was 1.11 . The intraclass correlation was 0.85 , coefficient of variation was 10.5 % , and Cohen 's d was 0.35 . The protocol demonstrated a very good level of reliability . We present a novel and reliable preloaded time-trial protocol that more closely reflects operational activities and can be used to quantify load carriage performance . This protocol provides greater ecologically validity regarding physical dem and s of load carriage activities than those adopted previously and provides an excellent tool for the strength and conditioning practitioner to assess individual load carriage performance The aim of this study was to analyse the influence of inspiratory muscle training ( IMT ) on ventilatory efficiency , in normoxia and hypoxia , and to investigate the relationship between ventilatory efficiency and cycling performance . Sixteen sport students ( 23.05 ± 4.7 years ; 175.11 ± 7.1 cm ; 67.0 ± 19.4 kg ; 46.4 ± 8.7 ml·kg−1·min−1 ) were r and omly assigned to an inspiratory muscle training group ( IMTG ) and a control group ( CG ) . The IMTG performed two training sessions/day [ 30 inspiratory breaths , 50 % peak inspiratory pressure ( Pimax ) , 5 days/week , 6-weeks ] . Before and after the training period subjects carried out an incremental exercise test to exhaustion with gas analysis , lung function testing , and a cycling time trial test in hypoxia and normoxia . Simulated hypoxia ( FiO2 = 16.45 % ) , significantly altered the ventilatory efficiency response in all subjects ( p < 0.05 ) . Pimax increased significantly in the IMTG whereas no changes occurred in the CG ( time × group , p < 0.05 ) . Within group analyses showed that the IMTG improved ventilatory efficiency ( VE/VCO2 slope ; EqCO2VT2 ) in hypoxia ( p < 0.05 ) and cycling time trial performance [ WTTmax ( W ) ; WTTmean ( W ) ; PTF(W ) ] ( p < 0.05 ) in hypoxia and normoxia . Significant correlations were not found in hypoxia nor normoxia found between ventilatory efficiency parameters ( VE/VCO2 slope ; LEqCO2 ; EqCO2VT2 ) and time trial performance . On the contrary the oxygen uptake efficiency slope ( OUES ) was highly correlated with cycling time trial performance ( r = 0.89 ; r = 0.82 ; p < 0.001 ) under both conditions . Even though no interaction effect was found , the within group analysis may suggest that IMT reduces the negative effects of hypoxia on ventilatory efficiency . In addition , the data suggest that OUES plays an important role in submaximal cycling performance Respiratory muscles can fatigue during prolonged and maximal exercise , thus reducing performance . The respiratory system is challenged during underwater exercise due to increased hydrostatic pressure and breathing resistance . The purpose of this study was to determine if two different respiratory muscle training protocol s enhance respiratory function and swimming performance in divers . Thirty male subjects ( 23.4 ± 4.3 years ) participated . They were r and omized to a placebo ( PRMT ) , endurance ( ERMT ) , or resistance respiratory muscle training ( RRMT ) protocol . Training sessions were 30 min/day , 5 days/week , for 4 weeks . PRMT consisted of 10-s breath-holds once/minute , ERMT consisted of isocapnic hyperpnea , and RRMT consisted of a vital capacity maneuver against 50 cm H2O resistance every 30 s. The PRMT group had no significant changes in any measured variable . Underwater and surface endurance swim time to exhaustion significantly increased after RRMT ( 66 % , P < 0.001 ; 33 % , P = 0.003 ) and ERMT ( 26 % , P = 0.038 ; 38 % , P < 0.001 ) . Breathing frequency ( fb ) during the underwater endurance swim decreased in RRMT ( 23 % , P = 0.034 ) and tidal volume ( VT ) increased in both the RRMT ( 12 % , P = 0.004 ) and ERMT ( 7 % , P = 0.027 ) groups . Respiratory endurance increased in ERMT ( 216.7 % ) and RRMT ( 30.7 % ) . Maximal inspiratory and expiratory pressures increased following RRMT ( 12 % , P = 0.015 , and 15 % , P = 0.011 , respectively ) . Results from this study indicate that respiratory muscle fatigue is a limiting factor for underwater swimming performance , and that targeted respiratory muscle training ( RRMT > ERMT ) improves respiratory muscle and underwater swimming performance We evaluated the effects of a 5 week ( 25 sessions ) ; ( 30 - 35 min/day , 5 days/week ) , respiratory muscle training ( RMT ) program in nine competitive male cyclists . The experimental design included inspiratory resistance strength training ( 3 - 5 min/session ) and hyperpnea endurance training ( 30 min/session ) , a placebo group which used a sham hypoxic trainer ( n=8 ) , and three exercise performance tests , including a highly reproducible 8 km time trial test . RMT intensity , measured once a week in terms of accumulated inspiratory pressure and the level of sustainable hyperpnea increased significantly after 5 weeks ( + 64 % and + 19 % , respectively ) . The RMT group showed a significant 8 % increase in maximal inspiratory pressure ( P<0.05 ) while the placebo group showed only a 3.7 % increase ( P>0.10 ) . RMT and placebo groups both showed significant increases in the fixed work-rate endurance test performance time ( + 26 % and + 16 % , respectively ) and in the peak work-rate achieved during the incremental maximal oxygen consumption ( V(O2)max ) test ( + 9 and + 6 % ) . The 8 km time trial performance increased 1.8+/-1.2 % ( or 15+/-10 sec ; P<0.01 ) in the RMT group with 8 of 9 subjects increasing ; the placebo group showed a variable non-significant change in 5 of 8 subjects ( -0.3+/-2.7 % , P=0.07 ) . The changes observed in these three performance tests were not , however , significantly different between the RMT and placebo groups . Heart rate , ventilation , or venous blood lactate , at equal work-rates during the incremental exercise test or at equal times during the fixed work-rate endurance test were not changed significantly across these exercise trials in either group . We propose that the effect of RMT on exercise performance in highly trained cyclists does not exceed that in a placebo group . Significant placebo and test familiarization effects must be accounted for in experimental design s utilizing performance tests which are critically dependent on volitional effort Although respiratory muscle functions can influence swimming performance , respiratory muscle training ( RMT ) is not routinely used for improving fin-swimmers ´ performance . The aim of our study was to verify the benefit of a one month of RMT in young fin-swimmers . We assessed the effect of this training on respiratory muscles and on maximal underwater swimming distance . 28 fin-swimmers were r and omly divided into an experimental group ( EG ) and a control group ( CG ) . The study finished with 20 fin-swimmers ( EG : n = 12 ; average age 12.0 ; weight 47.4 kg ; height 1.58 m ; CG : n = 8 ; age 11.5 ; weight 49.6 kg ; height 1.53 m ) . Both group performed regular swimming training , during which the EG used Threshold PEP ( positive expiratory pressure ) and IMT ( inspiratory muscle trainer ) for RMT for one month . After one-month washout period , the CG also performed RMT . RMT showed significant improvement of inspiratory muscles in both groups ( Z = < 1.96 ; 2.59 > ; p < 0.05 ) . Significant improvement was observed also in apnoea ( AP ) max ( ZCG = 2.03 ; p < 0.05 ; ZEG=2.93 ; p < 0.01 ) . A long-term effect was observed in the respiratory muscle strength and AP max in the EG ( ZEG = 2.52 ; p < 0.05 ) . RMT in fin-swimmers improves both respiratory muscle strength and the performance in AP max The purpose of this study was to assess the efficacy of inspiratory flow resistive loading ( IFRL ) on respiratory muscle function , exercise performance and cardiopulmonary and metabolic responses to exercise . Twenty-four recreational road runners ( 12 male ) were r and omly assigned from each gender into an IFRL group ( n=8 ) and sham-IFRL group ( n=8 ) , which performed IFRL for 6 weeks , or a control group ( n=8 ) . Strength ( + 43.9%Delta ) , endurance ( + 26.6%Delta ) , maximum power output ( + 41.9%Delta ) and work capacity ( + 38.5%Delta ) of the inspiratory muscles were significantly increased ( P<0.05 ) at rest following the study period in IFRL group only . In addition , ventilation ( -25.7%Delta ) , oxygen consumption ( -13.3%Delta ) , breathing frequency ( -11.9%Delta ) , tidal volume ( -16.0%Delta ) , heart rate ( HR ) ( -13.1%Delta ) , blood lactate concentration ( -38.9%Delta ) and the perceptual response ( -33.5%Delta ) to constant workload exercise were significantly attenuated ( P<0.05 ) , concomitant with a significant improvement ( P<0.05 ) in endurance exercise capacity ( + 16.4%Delta ) during a treadmill run set at 80 % VO2max in IFRL group only . These data suggest that IFRL can alter breathing mechanics , attenuate the oxygen cost , ventilation , HR , blood lactate and the perceptual response during constant workload exercise and improve endurance exercise performance in recreational runners This study examined the effects of respiratory muscle endurance training ( RMET ) on ventilatory and endurance performance among moderately trained , male cyclists . Nine subjects initially completed two cycling VO2 max tests , two endurance cycling tests for time at 95 % VO2 max , a 15-s MVV test , and an endurance breathing test for time at 100 % MVV . Four subjects then underwent 3 weeks of strenuous RMET while five served as controls . Mean posttest 15-s MVV and endurance breathing time were significantly higher in the RMET group ( 243 + /- 14 l X min-1 and 804 + /- 94 s ) than in the control group ( 205 + /- 6 l X min-1 and 48 + /- 8 s ) . No significant group differences in VO2 max or endurance cycling time at 95 % VO2 max were observed following RMET . Results of this exploratory study indicated that RMET improved ventilatory power and endurance , but did not alter VO2 max or endurance cycling performance among moderately trained , male cyclists Altitude training and respiratory muscle training ( RMT ) have been reported to improve performance in elite and well-trained athletes . Several devices ( altitude and RMT ) have been developed to help athletes gain the competitive edge . The Elevation Training Mask 2.0 ( ETM ) purportedly simulates altitude training and has been suggested to increase aerobic capacity ( VO2max ) , endurance performance , and lung function . Twenty-four moderately trained subjects completed 6 weeks of high-intensity cycle ergometer training . Subjects were r and omized into a mask ( n = 12 ) or control ( n = 12 ) group . Pre and post-training tests included VO2max , pulmonary function , maximal inspiration pressure , hemoglobin and hematocrit . No significant differences were found in pulmonary function or hematological variables between or within groups . There was a significant improvement in VO2max and PPO in both the control ( 13.5 % and 9.9 % ) and mask ( 16.5 % and 13.6 % ) groups . There was no difference in the magnitude of improvement between groups . Only the mask group had significant improvements in ventilatory threshold ( VT ) ( 13.9 % ) , power output ( PO ) at VT ( 19.3 % ) , respiratory compensation threshold ( RCT ) ( 10.2 % ) , and PO at RCT ( 16.4 % ) from pre to post-testing . The trends for improvements in VT and PO at VT between groups were similar to improvements in RCT and PO at RCT , but did not reach statistical significance ( VT p = 0.06 , PO at VT p = 0.170 ) . Wearing the ETM while participating in a 6-week high-intensity cycle ergometer training program does not appear to act as a simulator of altitude , but more like a respiratory muscle training device . Wearing the ETM may improve specific markers of endurance performance beyond the improvements seen with interval training alone . Key pointsWearing the ETM during a 6-week high-intensity cycle ergometer training program may improve performance variables , such as VO2max , PPO , VT , PO at VT , RCT and PO at RCT .Wearing the ETM did not improve lung function , inspiratory muscle strength , or stimulate changes in hemoglobin or hematocrit levels . The ETM does not simulate altitude , but works more like an respiratory training device The purpose of this study was to determine the effects of inspiratory muscle training ( IMT ) on exercise in hypoxia ( H ) and normoxia ( N ) . A 4-week IMT program was implemented with 12 healthy subjects using an inspiratory muscle trainer set at either 15 % ( C ; n=5 ) or 50 % ( IMT ; n=7 ) maximal inspiratory mouth pressure ( PImax ) . Two treadmill tests ( 85 % VO2max ) to exhaustion and measures of diaphragm thickness ( Tdi ) and function were completed before and after training in H and N. Significant increases of 8 - 12 % and 24.5+/-3.1 % in Tdi and PImax , respectively , were seen in the IMT group . Time to exhaustion remained unchanged in all conditions . Inspiratory muscle fatigue ( downward arrowPImax ) following exercise was reduced approximately 10 % ( P<0.05 ) in IMT after both N and H. During H , IMT reduced ( P<0.05 ) VO2 by 8 - 12 % , cardiac output by 14+/-2 % , ventilation by 25+/-3 % ; and increased arterial oxygen saturation by 4+/-1 % and lung diffusing capacity by 22+/-3 % . Ratings of perceived exertion and dyspnea were also significantly reduced . These data suggest that IMT significantly improves structural and functional physiologic measures in hypoxic exercise The purpose of this study was to examine respiratory muscle training ( RMT ) combined with 9 weeks of resistance and endurance training on rowing performance and cardiopulmonary responses . Twenty-seven rowers ( mean ± SD : age = 27 ± 9 years ; height = 176.9 ± 10.8 cm ; and body mass = 76.1 ± 12.6 kg ) were r and omly assigned to an inspiratory only ( n = 13 ) or expiratory only ( n = 14 ) training group . Both RMT programs were 3 sets of 10 reps , 6 d/wk in addition to an identical 3 d/wk resistance and 3 d/wk endurance training program . Both groups showed similar improvements in 2000 m rowing performance , cardiorespiratory fitness , strength , and maximum inspiratory ( PImax ) and expiratory ( PEmax ) pressures ( p < .05 ) . It was concluded that there were no additional benefits of 9 weeks of inspiratory or expiratory RMT on simulated 2000 m rowing performance or cardiopulmonary responses when combined with resistance and endurance training in rowers PURPOSE This study evaluated the influence of simulated 20- and 40-km time trials upon postexercise inspiratory muscle function of trained competitive cyclists . In addition , we examined the influence of specific inspiratory muscle training ( IMT ) upon the responses observed . METHODS Using a double-blind placebo-controlled design , 16 male cyclists ( mean + /- SEM VO2max 64 + /- 2 mL.kg-1.min-1 ) were assigned r and omly to either an experimental ( IMT ) or sham-training control ( placebo ) group . Maximum static and dynamic inspiratory muscle function was assessed immediately pre- and < 2 , 10 , and 30 min post-simulated 20- and 40-km time trials before and after 6-wk of IMT or sham-IMT . RESULTS Maximum inspiratory mouth pressure ( P0 ) measured within 2 min of completing the 20- and 40-km time trial rides was reduced by 18 % and 13 % , respectively , and remained below preexercise values at 30 min . The 20- and 40-km time trials induced a reduction in inspiratory flow rate at 30 % P0 by 14 % and 6 % in the IMT group versus 13 % and 7 % for the placebo group , and also remained below preexercise values at 30 min . There was also a significant slowing of inspiratory muscle relaxation rate postexercise ; these trends were almost completely reversed by 30 min postexercise . Significant improvements in 20- and 40-km time trial performance were seen ( 3.8 + /- 1.7 % and 4.6 + /- 1.9 % , respectively ; P < 0.05 ) and postexercise reductions in muscle function were attenuated with IMT . CONCLUSION These data support existing evidence that there is significant global inspiratory muscle fatigue after sustained heavy endurance exercise . Furthermore , the present study provides new evidence that performance enhancements observed after IMT are accompanied by a decrease in inspiratory muscle fatigue Well-trained endurance athletes frequently have a lower peripheral chemoreceptor ( pR(c ) ) sensitivity and a lower minute ventilation ( E ) during exercise compared to untrained individuals . We speculated that the decreased pR(c ) response may be specifically associated with repeated exposure to the high rates of ventilation occurring during exercise training . We therefore examined the effect of respiratory muscle training ( RMT ; 20x 30 min sessions of voluntary normocapnic hyperpnea ) on the pR(c ) sensitivity during exercise and on cycling performance . RMT was chosen to achieve a high E , similar to that of heavy exercise , while avoiding the other accompanying effects of whole body exercise . 20 trained male cyclists were r and omized into RMT ( N=10 ) or control ( N=10 ) groups . Subjects ' pR(c ) response was assessed by a modified Dejours O(2 ) test ( 10 - 12 breaths of 100 % O(2 ) , repeated 4 - 6 times ) during cycling exercise at 40 % of the maximal work capacity ( ( max ) ) . Cycling performance was measured during a cycling test to exhaustion ( 85 % ( max ) ) . The RMT group exhibited a significantly reduced pR(c ) sensitivity ( mean + /- S.D. ) compared to the control group ( -5.8+/-6.0 % versus 0.1+/-4.6 % , P<0.5 ) . Cycling endurance improved significantly after RMT in comparison to the control group ( + 3.26+/-4.98 versus -1.46+/-3.67 min , P<0.05 ) . However , these changes in pR(c ) response were not significantly correlated with exercise ventilation or cycling endurance time . We conclude that the high levels of ventilation achieved during exercise , as simulated by RMT in this study , appear to be accompanied by a reduction in pR(c ) sensitivity ; however , the role of the pR(c ) in the control of ventilation during exercise seems to be minor It is unknown which respiratory muscles are mainly activated by respiratory muscle training . This study evaluated Inspiratory Pressure Threshold Loading ( IPTL ) , Inspiratory Flow Resistive Loading ( IFRL ) and Voluntary Isocapnic Hyperpnea ( VIH ) with regard to electromyographic ( EMG ) activation of the sternocleidomastoid muscle ( SCM ) , parasternal muscles ( PARA ) and the diaphragm ( DIA ) in r and omized order . Surface EMG were analyzed at the end of each training session and normalized using the peak EMG recorded during maximum inspiratory maneuvers ( Sniff nasal pressure : SnPna , maximal inspiratory mouth occlusion pressure : PImax ) . 41 healthy participants were included . Maximal activation was achieved for SCM by SnPna ; the PImax activated predominantly PARA and DIA . Activations of SCM and PARA were higher in IPTL and VIH than for IFRL ( p<0.05 ) . DIA was higher applying IPTL compared to IFRL or VIH ( p<0.05 ) . IPTL , IFRL and VIH differ in activation of inspiratory respiratory muscles . Whereas all methods mainly stimulate accessory respiratory muscles , diaphragm activation was predominant in IPTL Abstract Guy , JH , Edwards , AM , and Deakin , GB . Inspiratory muscle training improves exercise tolerance in recreational soccer players without concomitant gain in soccer-specific fitness . J Strength Cond Res 28(2 ) : 483–491 , 2014—This study investigated whether the addition of inspiratory muscle training ( IMT ) to an existing program of preseason soccer training would augment performance indices such as exercise tolerance and sports-specific performance beyond the use of preseason training alone . Thirty-one men were r and omized across 3 groups : experimental ( EXP : n = 12 ) , placebo ( PLA : n = 9 ) , and control ( CON : n = 10 ) . The EXP and PLA completed a 6-week preseason program ( 2 × weekly sessions ) in addition to concurrent IMT with either an IMT load ( EXP ) or negligible ( PLA ) inspiratory resistance . Control group did not use an IMT device or undertake soccer training . All participants performed the following tests before and after the 6-week period : st and ard spirometry ; maximal inspiratory mouth pressure ( MIP ) ; multistage fitness test ( MSFT ) ; and a soccer-specific fitness test ( SSFT ) . After 6-weeks training , EXP significantly improved : MIP ( p = 0.002 ) ; MSFT distance covered ( p = 0.02 ) ; and post-SSFT blood lactate ( BLa ) ( p = 0.04 ) . No other outcomes from the SSFT were changed . Pre- to posttraining performance outcomes for PLA and CON were unchanged . These findings suggest the addition of IMT to preseason soccer training improved exercise tolerance ( MSFT distance covered ) but had little effect on soccer-specific fitness indices beyond a slightly reduced posttraining SSFT BLa . In conclusion , there may be benefit for soccer players to incorporate IMT to their preseason training but the effect is not conclusive . It is likely that a greater preseason training stimulus would be particularly meaningful for this population if fitness gains are a priority and evoke a stronger IMT response BACKGROUND Few studies investigated the effects of the respiratory muscle training ( RMT ) in soccer although exhaustive high intensity exercise is known to lead to muscle fatigue in respiratory muscles . The purpose of this study was to investigate the effect of RMT on pulmonary function and aerobic endurance in soccer players . METHODS Eighteen male soccer players ( mean age 22.2±1.4 years ) participated in this study . Participants were assigned r and omly to either an RMT or a control ( CON ) group . The RMT group performed a 15-minute endurance training of respiratory muscles twice a week for 5 weeks . The CON group did not receive RMT during this period . All participants were evaluated for aerobic endurance using 20-meter shuttle run test ( 20-MST ) , pulmonary function , maximal inspiratory mouth pressure ( MIP ) , and maximal expiratory mouth pressure ( MEP ) using spirometry . RESULTS There was a significant improvement in RMT group ( 14 % ) as compared to CON group ( 4 % ) in MIP measurement ( P=0.04 ) . No significant differences were observed in forced vital capacity ( FVC ) , forced expiratory volume in 1 second ( FEV1 ) , maximum voluntary ventilation ( MVV ) , and MEP after a five week of RMT ( P>0.05 ) . Similarly , there was no difference in 20-MST in the RMT group compared to CON group ( P>0.05 ) . CONCLUSIONS We concluded that a five week of RMT increased MIP , but FVC , FEV1 , MVV , MEP and aerobic endurance did not improve in soccer players . The RMT in addition to soccer training may improve MIP but not the tolerance to high intensity exercise BACKGROUND AND PURPOSE Previous investigations have demonstrated that a regimen of high-intensity inspiratory muscle training ( IMT ) result ed in changes in ventilatory function and exercise capacity in patients with chronic lung disease , although the effect of high-intensity IMT in subjects who are healthy is yet to be determined . The purpose of this study , therefore , was to examine whether high-intensity IMT result ed in changes in ventilatory function and exercise capacity in subjects who were healthy . SUBJECTS Twenty subjects were r and omly assigned to 2 groups . METHODS The training group completed an 8-week program of IMT set at 80 % of maximal effort . The control group did not participate in any form of training . Baseline and posttraining measures of body composition , pulmonary function , inspiratory muscle function ( including maximal and sustained maximal inspiratory pressures [ MIP and SMIP ] ) , relaxed and contracted diaphragm thickness and thickening ratio ( Tdi.rel , Tdi.cont , and TR ) , and exercise capacity were determined . RESULTS The training group demonstrated significant increases in MIP , SMIP , Tdi.cont , TR , VC , total lung capacity , and exercise capacity compared with the control group , which demonstrated no change from baseline measurements at 8 weeks . DISCUSSION AND CONCLUSION The findings of this study suggest that high-intensity IMT results in increased contracted diaphragm thickness and increased lung volumes and exercise capacity in people who are healthy |
11,574 | 30,584,023 | Subgroup analysis showed that the use of carmustine and thiotepa as a conditioning regimen carried the lowest risk of transplant‐related mortality .
The thiotepa , busulfan , and cyclophosphamide regimen , on the other h and , showed numerically superior OS and PFS rates .
This systematic review and meta‐ analysis provides estimates response and survival after ASCT and suggests improved rates compared to the historical data | Background : Primary central nervous system lymphoma ( PCNSL ) is an aggressive form of non‐Hodgkin lymphoma .
Methotrexate is first‐line chemotherapy .
Autologous stem‐cell transplantation ( ASCT ) is increasingly used as an alternative consolidative treatment to whole‐brain radiotherapy .
Micro‐ Abstract : While primary central nervous system lymphoma is sensitive to methotrexate chemotherapy , more than half of patients will experience relapse within 5 years .
Autologous stem‐cell transplantation ( ASCT ) is increasingly used as consolidative treatment . | To investigate safety and efficacy of high-dose chemotherapy followed by autologous stem cell transplantation ( HCT-ASCT ) in relapsed/refractory ( r/r ) primary central nervous system lymphoma ( PCNSL ) , we conducted a single-arm multicentre study for immunocompetent patients ( < 66 years ) with PCNSL failing high-dose methotrexate)-based chemotherapy . Induction consisted of two courses of rituximab ( 375 mg/m2 ) , high-dose cytarabine ( 2 × 3 g/m2 ) and thiotepa ( 40 mg/m2 ) with collection of stem cells in between . Conditioning for HCT-ASCT consisted of rituximab 375 mg/m2 , carmustine 400 mg/m2 and thiotepa ( 4 × 5 mg/kg ) . Patients commenced HCT-ASCT irrespective of response after induction . Patients not achieving complete remission ( CR ) after HCT-ASCT received whole-brain radiotherapy . Primary end point was CR after HCT-ASCT . We enrolled 39 patients ; median age and Karnofsky performance score are 57 years and 90 % , respectively . About 28 patients had relapsed and 8 refractory disease . About 22 patients responded to induction and 32 patients commenced HCT-ASCT . About 22 patients ( 56.4 % ) achieved CR after HCT-ASCT . Respective 2-year progression-free survival ( PFS ) and overall survival ( OS ) rates were 46.0 % ( median PFS 12.4 months ) and 56.4 % ; median OS not reached . We recorded four treatment-related deaths . Thiotepa-based HCT-ASCT is an effective treatment option in eligible patients with r/r PCNSL . Comparative studies are needed to further scrutinise the role of HCT-ASCT in the salvage setting Treatment of primary central nervous system lymphoma ( PCNSL ) improved in recent years . However , the high neurotoxicity and low survival rates associated with this condition remain unresolved . We report 13 consecutive patients with PCNSL for whom upfront melphalan , cyclophosphamide , etoposide , and dexamethasone ( known as LEED ) followed by autologous stem-cell transplantation ( ASCT ) was planned at the Anjo Kosei Hospital . All patients were pathologically diagnosed with diffuse large B-cell lymphoma and were negative for human immunodeficiency virus . All patients were to receive three cycles of high-dose methotrexate-based induction chemotherapy , two cycles of high-dose AraC-based chemotherapy , and LEED followed by ASCT . All 13 patients achieved a partial response , and the 3-year overall survival ( OS ) rate was 76.2 % . Seven of the 13 patients were alive at the last follow-up , without any adverse events , including neurotoxicity . Six of the 13 ( 46.2 % ) patients underwent ASCT and the 3-year OS rate was 80.0 % . Although this study included only a limited number of patients , these preliminary signs of efficacy and tolerability merit further consideration . To make further improvements in survival , the rate of patients undergoing ASCT should be increased . Other prospect i ve studies involving greater numbers of patients are required to confirm these findings BACKGROUND High-dose methotrexate-based chemotherapy is st and ard for primary CNS lymphoma , but most patients relapse . High-dose chemotherapy with autologous stem cell transplantation ( HCT-ASCT ) is supposed to overcome the blood-brain barrier and eliminate residual disease in the CNS . We aim ed to investigate the safety and efficacy of HCT-ASCT in patients with newly diagnosed primary CNS lymphoma . METHODS In this prospect i ve , single-arm , phase 2 trial , we recruited patients aged 18 - 65 years with newly diagnosed primary CNS lymphoma and immunocompetence , with no limitation on clinical performance status , from 15 hospitals in Germany . Patients received five courses of intravenous rituximab 375 mg/m(2 ) ( 7 days before first high-dose methotrexate course and then every 10 days ) and four courses of intravenous high-dose methotrexate 8000 mg/m(2 ) ( every 10 days ) and then two courses of intravenous rituximab 375 mg/m(2 ) ( day 1 ) , cytarabine 3 g/m(2 ) ( days 2 and 3 ) , and thiotepa 40 mg/m(2 ) ( day 3 ) . 3 weeks after the last course , patients commenced intravenous HCT-ASCT ( rituximab 375 mg/m(2 ) [ day 1 ] , carmustine 400 mg/m(2 ) [ day 2 ] , thiotepa 2 × 5 mg/kg [ days 3 and 4 ] , and infusion of stem cells [ day 7 ] ) , irrespective of response status after induction . We restricted radiotherapy to patients without complete response after HCT-ASCT . The primary endpoint was complete response at day 30 after HCT-ASCT in all registered eligible patients who received at least 1 day of study treatment . This trial is registered at Clinical Trials.gov , number NCT00647049 . FINDINGS Between Jan 18 , 2007 , and May 23 , 2011 , we recruited 81 patients , of whom two ( 2 % ) were excluded , therefore we included 79 ( 98 % ) patients in the analysis . All patients started induction treatment ; 73 ( 92 % ) commenced HCT-ASCT . 61 ( 77·2 % [ 95 % CI 66·1 - 86·6 ] ) patients achieved a complete response . During induction treatment , the most common grade 3 toxicity was anaemia ( 37 [ 47 % ] ) and the most common grade 4 toxicity was thrombocytopenia ( 50 [ 63 % ] ) . During HCT-ASCT , the most common grade 3 toxicity was fever ( 50 [ 68 % ] of 73 ) and the most common grade 4 toxicity was leucopenia ( 68 [ 93 % ] of 73 ) . We recorded four ( 5 % ) treatment-related deaths ( three [ 4 % ] during induction and one [ 1 % ] 4 weeks after HCT-ASCT ) . INTERPRETATION HCT-ASCT with thiotepa and carmustine is an effective treatment option in young patients with newly diagnosed primary CNS lymphoma , but further comparative studies are needed . FUNDING University Hospital Freiburg and Amgen The optimum treatment of primary CNS lymphoma ( PCNSL ) is not yet determined . The objective of this study was to assess the safety and efficacy of initial methotrexate-based chemotherapy followed by high-dose chemotherapy ( HDT ) with autologous stem cell transplantation ( ASCT ) in patients with newly diagnosed PCNSL . Twenty-five patients received two courses of initial chemotherapy combining methotrexate , etoposide , carmustine and methylprednisolone , and one course of ifosfamide – cytarabine followed by peripheral stem cell collection . Seventeen responsive patients then received HDT using carmustine , etoposide , cytarabine and melphalan with autologous stem cell rescue . After ASCT for responding patients or after salvage therapy for non-responders , whole brain radiation therapy at a dose of 30 Gy was delivered . The objective response rate to the induction chemotherapy was 84 % . Four of the 21 responding patients did not have ASCT because of toxicity or refusal . With a median follow-up time of 34 months , the projected event free survival rate is 46 % at 4 years . Projected overall survival is 64 % at 4 years . Sixteen patients are actually in continuous complete response . No evidence of late treatment-related toxicity was observed . This treatment approach appears feasible in newly diagnosed PCNSL with encouraging results In the GRADE approach , r and omized trials start as high- quality evidence and observational studies as low- quality evidence , but both can be rated down if most of the relevant evidence comes from studies that suffer from a high risk of bias . Well-established limitations of r and omized trials include failure to conceal allocation , failure to blind , loss to follow-up , and failure to appropriately consider the intention-to-treat principle . More recently recognized limitations include stopping early for apparent benefit and selective reporting of outcomes according to the results . Key limitations of observational studies include use of inappropriate controls and failure to adequately adjust for prognostic imbalance . Risk of bias may vary across outcomes ( e.g. , loss to follow-up may be far less for all-cause mortality than for quality of life ) , a consideration that many systematic review s ignore . In deciding whether to rate down for risk of bias -- whether for r and omized trials or observational studies -- authors should not take an approach that averages across studies . Rather , for any individual outcome , when there are some studies with a high risk , and some with a low risk of bias , they should consider including only the studies with a lower risk of bias BACKGROUND We investigated the efficacy and safety of t and em high-dose methotrexate ( HD-MTX ) induction followed by high-dose busulfan/thiotepa ( HD-BuTT ) with autologous peripheral blood stem-cell transplantation ( aPBSCT ) and response-adapted whole-brain radiation therapy ( WBRT ) in patients with newly diagnosed primary central nervous system lymphoma . PATIENTS AND METHODS Twenty-three patients were treated with HD-MTX on days 1 and 10 . In case of at least a partial remission ( PR ) , HD-BuTT followed by aPBSCT was given . Patients without response to induction or without complete remission ( CR ) after HD-BuTT received WBRT . RESULTS Sixteen patients received HD-MTX and HD-BuTT achieving a CR/PR rate of 69%/13 % . CR/PR rates for all patients ( n = 23 ) were 70%/13 % . There were three deaths during therapy . With longer follow-up three neurotoxic deaths occurred in irradiated patients ( n = 9 ) , while no persistent neurotoxicity was seen after HD-BuTT without subsequent WBRT . At a median follow-up of 15 months ( range 1 - 69 ) median event-free survival ( EFS ) and overall survival ( OS ) for all patients were 17 and 20 months ( Kaplan-Meier ) , after HD-BuTT 27 months and " not reached " , respectively . Estimated 2-year EFS and OS were 45 % and 48 % for all patients versus 56 % and 61 % for the HD-BuTT group , respectively . CONCLUSION MTX induction followed by HD-BuTT is an effective and very short time-on-treatment regimen . Median survival for patients treated with high-dose chemotherapy is not reached yet . The induction regimen needs optimisation . In this study WBRT was associated with a high incidence of severe neurotoxicity High-dose methotrexate-based chemotherapy is the mainstay of treatment of primary central nervous system lymphoma ( PCNSL ) , but relapses remain frequent . High-dose chemotherapy ( HDC ) with autologous stem-cell transplant ( ASCT ) may provide an alternative to address chemoresistance and overcome the blood-brain barrier . In this single-center phase-2 study , newly diagnosed PCNSL patients received 5 to 7 cycles of chemotherapy with rituximab , methotrexate ( 3.5 g/m(2 ) ) , procarbazine , and vincristine ( R-MPV ) . Those with a complete or partial response proceeded with consolidation HDC with thiotepa , cyclophosphamide , and busulfan , followed by ASCT and no radiotherapy . Primary end point was 1-year progression-free survival ( PFS ) , N = 32 . Median age was 57 , and median Karnofsky performance status 80 . Following R-MPV , objective response rate was 97 % , and 26 ( 81 % ) patients proceeded with HDC-ASCT . Among all patients , median PFS and overall survival ( OS ) were not reached ( median follow-up : 45 months ) . Two-year PFS was 79 % ( 95 % confidence interval [ CI ] , 58 - 90 ) , with no events observed beyond 2 years . Two-year OS was 81 % ( 95 % CI , 63 - 91 ) . In transplanted patients , 2-year PFS and OS were 81 % . There were 3 treatment-related deaths . Prospect i ve neuropsychological evaluations suggested relatively stable cognitive functions posttransplant . In conclusion , this treatment was associated with excellent disease control and survival , an acceptable toxicity profile , and no evidence of neurotoxicity thus far . This trial was registered at www . clinical trials.gov as NCT00596154 BACKGROUND Chemotherapy with high-dose methotrexate is the conventional approach to treat primary CNS lymphomas , but superiority of polychemotherapy compared with high-dose methotrexate alone is unproven . We assessed the effect of adding high-dose cytarabine to methotrexate in patients with newly diagnosed primary CNS lymphoma . METHODS This open , r and omised , phase 2 trial was undertaken in 24 centres in six countries . 79 patients with non-Hodgkin lymphoma exclusively localised into the CNS , cranial nerves , or eyes , aged 18 - 75 years , and with Eastern Cooperative Oncology Group performance status of 3 or lower and measurable disease were central ly r and omly assigned by computer to receive four courses of either methotrexate 3.5 g/m(2 ) on day 1 ( n=40 ) or methotrexate 3.5 g/m(2 ) on day 1 plus cytarabine 2 g/m(2 ) twice a day on days 2 - 3 ( n=39 ) . Both regimens were administered every 3 weeks and were followed by whole-brain irradiation . The primary endpoint was complete remission rate after chemotherapy . Analysis was by intention to treat . This study is registered with Clinical Trials.gov , number NCT00210314 . FINDINGS All r and omly assigned participants were analysed . After chemotherapy , seven patients given methotrexate and 18 given methotrexate plus cytarabine achieved a complete remission , with a complete remission rate of 18 % ( 95 % CI 6 - 30 ) and 46 % ( 31 - 61 ) , respectively , ( p=0.006 ) . Nine patients receiving methotrexate and nine receiving methotrexate plus cytarabine achieved a partial response , with an overall response rate of 40 % ( 25 - 55 ) and 69 % ( 55 - 83 ) , respectively , ( p=0.009 ) . Grade 3 - 4 haematological toxicity was more common in the methotrexate plus cytarabine group than in the methotrexate group ( 36 [ 92 % ] vs six [ 15 % ] ) . Four patients died of toxic effects ( three vs one ) . INTERPRETATION In patients aged 75 years and younger with primary CNS lymphoma , the addition of high-dose cytarabine to high-dose methotrexate provides improved outcome with acceptable toxicity compared with high-dose methotrexate alone . FUNDING Swiss Cancer League The addition of rituximab ( R ) to chemotherapy improves outcomes in patients with systemic B‐cell non‐Hodgkin lymphomas , but the impact in patients with primary central nervous system lymphoma ( PCNSL ) receiving high‐dose methotrexate ( HDMTX ) is unknown . Patients diagnosed with PCNSL at the British Columbia Cancer Agency ( BCCA ) between 2000 and 2013 were treated with ≥1 cycle of HDMTX 8 g/m2 every 2 weeks , to best response or 10 cycles . After 2006 , rituximab 375 mg/m2 was given every 2 weeks with HDMTX for a total of 4 doses . 49 ( 66 % ) patients received HDMTX alone and 25 ( 34 % ) HDMTX+R , with a median of 5 ( range 1–10 ) HDMTX cycles , and no difference between groups . The median follow‐up was 5 years : 8.8 years ( range 3.15–13.5 years ) HDMTX and 1.9 years ( range 0.5–7 years ) HDMTX+R. The 5‐year PFS was 17 % , with no difference between groups ( HR : 0.75 , 95 % CI : 0.41–1.35 ; P = 0.33 ) . The 5‐year OS was 38 % , with no difference between the groups OS ( HR : 0.73 , 95 % CI : 0.35–1.52 ; P = 0.39 ) . In this retrospective study comparing two subgroups of patients treated in different eras , the addition of R to HDMTX did not appear to improve outcomes in PCNSL , possibly consistent with its known poor CNS penetration . It is possible that with a larger sample size , longer follow‐up , or different rituximab dosing/schedule , the addition of rituximab may lead to a statistically significant improvement in outcomes . Prospect i ve r and omized trials currently in progress will more definitively estimate the impact of the addition of rituximab to HDMTX‐based chemotherapy for PCNSL . Am . J. Hematol . 90:1149–1154 , 2015 . © 2015 Wiley Periodicals , PURPOSE The prognosis of relapsing primary CNS lymphoma ( PCNSL ) is poor . We report the results of a prospect i ve multicenter trial of intensive chemotherapy followed by autologous hematopoietic stem-cell rescue ( IC + HCR ) in immunocompetent adult patients with PCNSL or intraocular lymphoma ( IOL ) after failure of high-dose methotrexate-based treatment . PATIENTS AND METHODS Salvage treatment consisted of two cycles of high-dose cytarabine and etoposide ( CYVE ) . Intensive chemotherapy combined thiotepa , busulfan , and cyclophosphamide . Forty-three patients ( median age , 52 years ; range , 23 to 65 years ) were included , with relapse ( n = 22 ) , refractory disease ( n = 17 ) , or a partial response to first-line treatment ( n = 4 ) . The response to CYVE was not assessable in three cases because of treatment-related death . Twenty patients ( 47 % ) were chemosensitive to CYVE : 15 of them proceeded to IC + HCR . IC + HCR was also administered to 12 patients who did not respond to CYVE . All but one of the 27 patients who underwent IC + HCR entered complete remission . RESULTS With a median follow-up of 36 months , the median overall survival was 18.3 months in the overall population , and 58.6 months among patients who completed IC + HCR . The respective median progression-free survival ( PFS ) times after IC + HCR were 11.6 and 41.1 months . The 2-year overall survival probability was 45 % in the whole population and 69 % among the 27 patients who received IC + HCR . The 2-year PFS probability was 43 % among all the patients and 58 % in the IC + HCR sub population . CONCLUSION IC + HCR is an effective treatment for refractory and recurrent PCNSL High‐dose thiotepa , busulfan , and cyclophosphamide ( TBC ) with autologous stem cell transplantation ( ASCT ) has been used in patients with central nervous system ( CNS ) involvement by non‐Hodgkin lymphoma ( NHL ) . Despite limited penetration into the CNS , rituximab is active in primary CNS NHL . Therefore , high‐dose rituximab was combined with TBC for ASCT in patients with CNS NHL PURPOSE To improve survival and reduce toxicity in primary CNS lymphoma ( PCNSL ) treatment , we conducted a multicenter phase II study with early high-dose chemotherapy ( HDT ) and autologous stem-cell transplantation ( ASCT ) followed by hyperfractionated whole-brain radiotherapy ( WBRT ) for newly diagnosed PCNSL patients younger than 65 years of age . PATIENTS AND METHODS Chemotherapy included three steps : three cycles of methotrexate ( 8 g/m2 ) ; cytarabine ( AraC ; two doses of 3 g/m2 ) and thiotepa ( 40 mg/m2 ) followed by stem-cell harvest ; HDT with carmustine ( 400 mg/m2 ) and thiotepa ( two doses of 5 mg/kg body weight ) followed by ASCT . WBRT ( 45 Gy , two doses of 1 Gy/d ) was administered for consolidation . RESULTS Thirty patients with PCNSL younger than 65 years of age ( median , 54 years ; range , 27 years to 64 years ) were enrolled ( nine pilot-phase ; 21 phase II ) . Twenty-eight patients responded to methotrexate : six patients with complete remission ( CR ) , 15 patients with partial remission ( PR ) , and seven patients with stable disease ( SD ) with clinical improvement . Of 26 patients proceeding to AraC and thiotepa , 10 patients achieved CR , 14 patients achieved PR , one patient experienced SD with clinical improvement , and one patient suffered disease progression . Twenty-three patients received HDT plus ASCT , result ing in 15 patients with CRs and eight patients with PRs . After WBRT , 21 of 21 patients had CRs . One patient died from liver failure after methotrexate . HDT was well tolerated apart from WHO grade 3/4 cytopenia . With a median follow-up of 63 months ( range , 4 months to 84 months ) , 5-year overall survival probability is 69 % for all patients and 87 % for the 23 patients receiving HDT plus ASCT . The 5-year probability of relapse-related death is 21 % for all patients ( n = 30 ) and 8.7 % for patients treated with HDT plus ASCT ( n = 23 ) . CONCLUSION Sequential systemic methotrexate and AraC and thiotepa followed by HDT plus ASCT and hyperfractionated WBRT is very effective with little toxicity as initial therapy for PCNSL In this retrospective multicentre study , we investigated the outcomes of elderly primary central nervous system lymphoma ( PCNSL ) patients ( ⩾65 years ) who underwent high-dose chemotherapy followed by autologous stem cell transplantation ( HDT-ASCT ) at 11 centres between 2003 and 2016 . End points included remission , progression-free survival ( PFS ) , overall survival ( OS ) and treatment-related mortality . We identified 52 patients ( median age 68.5 years , median Karnofsky Performance Status before HDT-ASCT 80 % ) who all underwent thiotepa-based HDT-ASCT . Fifteen patients ( 28.8 % ) received HDT-ASCT as first-line treatment and 37 ( 71.2 % ) received it as second or subsequent line . Remission status before HDT-ASCT was : CR 34.6 % , PR 51.9 % , stable disease 3.8 % and progressive disease 9.6 % . Following completion of HDT-ASCT , 36 patients ( 69.2 % ) achieved CR ( 21.2 % first-line setting and 48.1 % second or subsequent line setting ) and 9 ( 17.3 % ) PR ( 5.8 % first-line setting and 11.5 % second or subsequent line setting ) . With a median follow-up of 22 months after HDT-ASCT , median PFS and OS were reached after 51.1 and 122.3 months , respectively . The 2-year PFS and OS rates were 62.0 % and 70.8 % , respectively . We observed two HDT-ASCT-associated deaths ( 3.8 % ) . In selected elderly PCNSL patients , HDT-ASCT , using thiotepa-based conditioning regimes , is feasible and effective . Further prospect i ve and comparative studies are warranted to further evaluate the role of HDT-ASCT in elderly PCNSL patients PURPOSE To assess the feasibility and efficacy of intensive chemotherapy with hematopoietic stem-cell rescue ( IC + HCR ) in patients with refractory or recurrent primary CNS lymphoma ( PCNSL ) or intraocular lymphoma ( IOL ) . PATIENTS AND METHODS IC consisted of thiotepa 250 mg/m(2)/d days -9 through -7 , busulfan 10 mg/kg ( total dose ) days -6 through -4 , and cyclophosphamide 60 mg/kg/d days -3 and -2 . Intravenous clonazepam 2 mg/d was given prophylactically from the day before initiation of busulfan therapy to the day after completion of busulfan therapy . Patients with refractory or recurrent PCNSL underwent IC + HCR only if they were chemosensitive to two cycles of salvage treatment with cytarabine ( 2 g/m(2)/d days 2 through 5 and 50 mg/m(2)/d days 1 through 5 in a 12-hour infusion ) and etoposide ( VP-16 ; 200 mg/m(2)/d days 2 through 5 ) ( CYVE ) . Patients with IOL refractory to high-dose methotrexate ( MTX ) and cytarabine entered the IC + HCR program directly . RESULTS Twenty-two patients ( 10 with relapses , 12 with refractory disease ) were enrolled . Twenty patients entered the IC + HCR program : twelve entered after CYVE treatment , seven entered directly , and one had previously been retreated with high-dose MTX . Before IC , eight patients were in complete remission ( CR ) , four were in partial remission ( PR ) , one had stable disease , and seven had refractory disease . After IC + HCR , 16 patients entered CR , two remained in PR , one had stable disease , and one had disease progression . Fourteen patients remained alive ( median follow-up time , 41.5 months ) . The overall probability of survival at 3 years was 63.7 % . After IC , that probability was 60 % and the 3-year probability of event-free survival was 53 % . Seven patients had neurologic adverse events during the entire procedure . CONCLUSION IC + HCR proved feasible and effective in patients with refractory or recurrent PCNSL or IOL . The entire procedure seemed to be most toxic in patients > or = 60 years . A prospect i ve multicenter study is ongoing PURPOSE Concerns regarding neurocognitive toxicity of whole-brain radiotherapy ( WBRT ) have motivated development of alternative , dose-intensive chemotherapeutic strategies as consolidation in primary CNS lymphoma ( PCNSL ) . We performed a multicenter study of high-dose consolidation , without WBRT , in PCNSL . Objectives were to determine : one , rate of complete response ( CR ) after remission induction therapy with methotrexate , temozolomide , and rituximab ( MT-R ) ; two , feasibility of a two-step approach using high-dose consolidation with etoposide plus cytarabine ( EA ) ; three , progression-free survival ( PFS ) ; and four , correlation between clinical and molecular prognostic factors and outcome . PATIENTS AND METHODS Forty-four patients with newly diagnosed PCNSL were treated with induction MT-R , and patients who achieved CR received EA consolidation . We performed a prospect i ve analysis of molecular prognostic biomarkers in PCNSL in the setting of a clinical trial . RESULTS The rate of CR to MT-R was 66 % . The overall 2-year PFS was 0.57 , with median follow-up of 4.9 years . The 2-year time to progression was 0.59 , and for patients who completed consolidation , it was 0.77 . Patients age > 60 years did as well as younger patients , and the most significant clinical prognostic variable was treatment delay . High BCL6 expression correlated with shorter survival . CONCLUSION CALGB 50202 demonstrates for the first time to our knowledge that dose-intensive consolidation for PCNSL is feasible in the multicenter setting and yields rates of PFS and OS at least comparable to those of regimens involving WBRT . On the basis of these encouraging results , an intergroup study has been activated comparing EA consolidation with myeloablative chemotherapy in this r and omized trial in PCNSL , in which neither arm involves WBRT BACKGROUND Treatment of relapsed/refractory ( R/R ) primary CNS lymphoma ( PCNSL ) is poorly defined , because r and omized trials and large studies are lacking . The aim of this study was to analyze the characteristics , management , and outcome of R/R PCNSL patients after first-line therapy in a nationwide cohort . METHODS We analyzed R/R PCNSL patients following first-line treatment who had been prospect ively registered in the data base of the French network for oculocerebral lymphoma ( LOC ) between 2011 and 2014 . RESULTS Among 563 PCNSL patients treated with first-line therapy , we identified 256 with relapsed ( n = 93 , 16.5 % ) or refractory ( n = 163 , 29.0 % ) disease . Patients who were asymptomatic at relapse/progression ( 25.5 % ) , mostly diagnosed on routine follow-up neuroimaging , tended to have a better outcome . Patients who received salvage therapy followed by consolidation ( mostly intensive chemotherapy plus autologous hematopoietic stem cell transplantation [ ICT + AHSCT ] ) experienced prolonged survival compared with those who did not receive salvage or consolidation therapy . Independent prognostic factors at first relapse/progression were : KPS ≥ 70 vs KPS < 70 ) , sensitivity to first-line therapy ( relapsed vs refractory disease ) , duration of first remission ( progression-free survival [ PFS ] ≥1 y vs < 1 y ) , and management at relapse/progression ( palliative care vs salvage therapy ) . Patients who relapsed early after first-line therapy ( ie , PFS < 1 y ) had a poor outcome , comparable to that of refractory patients . Conversely , patients experiencing late relapses ( PFS ≥ 1 y ) and /or undergoing consolidation with ICT + AHSCT experienced prolonged survival . CONCLUSIONS About a third of PCNSL patients are primary refractory to first line treatment . We identified several independent prognostic factors that can guide the management of R/R PCNSL patients PURPOSE To assess the safety and efficacy of intensive methotrexate-based chemotherapy followed by high-dose chemotherapy ( HDT ) with autologous stem-cell rescue in patients with newly diagnosed primary CNS lymphoma ( PCNSL ) . PATIENTS AND METHODS Twenty-eight patients received induction chemotherapy using high-dose systemic methotrexate ( 3.5 g/m2 ) and cytarabine ( 3 g/m2 daily for 2 days ) . Fourteen patients with chemosensitive disease evident on neuroimaging then received high-dose therapy using carmustine , etoposide , cytarabine , and melphalan with autologous stem-cell rescue . RESULTS The objective response rate to the induction-phase chemotherapy was 57 % , and median overall survival is not yet assessable , with a median follow-up time of 28 months . The overall median event-free survival time is 5.6 months for all patients and 9.3 months for 14 patients who underwent transplantation . Six of these 14 patients ( 43 % ) remained disease-free at last follow-up . Treatment was well tolerated ; there was one transplantation-related death . Prospect i ve neuropsychologic evaluations have revealed no evidence of treatment-related neurotoxicity . CONCLUSION This treatment approach is feasible in patients with newly diagnosed PCNSL without evidence of significant related neurotoxicity . Although the transplantation results are similar to those achieved in patients with aggressive or poor-prognosis systemic lymphoma , the low response rate to induction chemotherapy and the significant number of patients who experienced relapse soon after HDT suggest that more aggressive induction chemotherapy may be warranted BACKGROUND The International Extranodal Lymphoma Study Group-32 ( IELSG32 ) trial is an international r and omised phase 2 study that addresses two key clinical questions in the treatment of patients with newly diagnosed primary CNS lymphoma . Results of the first r and omisation have demonstrated that methotrexate , cytarabine , thiotepa , and rituximab ( called the MATRix regimen ) is the induction combination associated with significantly better outcome compared with the other induction combinations tested . Here , we report the results of the second r and omisation that addresses the efficacy of myeloablative chemotherapy supported by autologous stem-cell transplantation ( ASCT ) , as an alternative to whole-brain radiotherapy ( WBRT ) , as consolidation after high-dose-methotrexate-based chemoimmunotherapy . METHODS HIV-negative patients ( aged 18 - 70 years ) with newly diagnosed primary CNS lymphoma and an Eastern Cooperative Oncology Group performance status of 0 - 3 were r and omly assigned to receive four courses of methotrexate 3·5 g/m2 on day 1 plus cytarabine 2 g/m2 twice daily on days 2 and 3 ( group A ) ; or the same combination plus two doses of rituximab 375 mg/m2 on days -5 and 0 ( group B ) ; or the same methotrexate-cytarabine-rituximab combination plus thiotepa 30 mg/m2 on day 4 ( group C ) , with the three groups repeating treatment every 3 weeks . Patients with responsive or stable disease after induction treatment , with adequate autologous peripheral blood stem-cell collection , and without persistent iatrogenic side-effects , were eligible for the second r and omisation between WBRT ( photons of 4 - 10 MeV ; five fractions per week ; fraction size 180 cGy ; started within 4 weeks from the last induction course ; group D ) and carmustine-thiotepa conditioned ASCT ( carmustine 400 mg/m2 on day -6 , and thiotepa 5 mg/kg every 12 h on days -5 and -4 , followed by reinfusion of autologous peripheral blood stem cells ; group E ) . A permuted block r and omised design was adopted for both r and omisations , and a computer-generated r and omisation list was used within each stratum . No masking after assignment to intervention was adopted . The primary endpoint was 2-year progression-free survival , with induction group and response to induction chemotherapy as stratification parameters . Analyses were done on a modified intention-to-treat basis . This study is registered with Clinical Trials.gov , number NCT01011920 . FINDINGS Between Feb 19 , 2010 , and Aug 27 , 2014 , 227 patients were recruited from 53 centres in five countries . 219 of 227 enrolled patients were assessable . Of the 122 patients eligible for the second r and omisation , 118 patients were r and omly assigned to WBRT or ASCT ( 59 patients per group ) and constitute the study population . WBRT and ASCT were both effective , and achieved the predetermined efficacy threshold of at least 40 progression-free survivors at 2 years among the first 52 patients in both groups D and E. There were no significant differences in 2-year progression-free survival between WBRT and ASCT : 80 % ( 95 % CI 70 - 90 ) in group D and 69 % ( 59 - 79 ) in group E ( hazard ratio 1·50 , 95 % CI 0·83 - 2·71 ; p=0·17 ) . Both consolidation therapies were well tolerated . Grade 4 non-haematological toxicity was uncommon ; as expected , haematological toxicity was more common in patients treated with ASCT than in those who received WBRT . Two toxic deaths ( infections ) were recorded , both in patients who received ASCT . INTERPRETATION WBRT and ASCT are both feasible and effective as consolidation therapies after high-dose methotrexate-based chemoimmunotherapy in patients aged 70 years or younger with primary CNS lymphoma . The risks and implication s of cognitive impairment after WBRT should be considered at the time of therapeutic decision . FUNDING Agenzia Italiana del Farmaco , Cancer Research UK , Oncosuisse , and Swiss National Science Foundation The treatment of primary central nervous system lymphoma ( PCNSL ) has been considerably improved over recent years . In this article , we report six cases of PCNSL treated by first-line induction chemotherapy followed by intensive chemotherapy and autologous stem cell transplantation ( ASCT ) . Six immunocompetent patients presenting with a PCNSL , confirmed by thoraco-abdomino-pelvic computer tomography scan and bone marrow biopsy , were treated with induction chemotherapy followed by BEAM intensive chemotherapy and ASCT and radiotherapy . At the end of the treatment , all the patients were in complete remission . After a median follow-up of 41.5 months ( 17 - 70 months ) , four patients were alive without signs of relapse ( median survival : 35.5 months ) . Two patients died from relapse at 19 and 23 months . The neurotoxicity was low with epilepsy in one patient and persistent left side dysesthesia in another one . These results are fairly encouraging . Other studies with greater numbers of patients and longer follow-up are needed to confirm this study PURPOSE A multicenter phase II study was conducted to assess the efficacy of rituximab , methotrexate , procarbazine , and vincristine ( R-MPV ) followed by consolidation reduced-dose whole-brain radiotherapy ( rdWBRT ) and cytarabine in primary CNS lymphoma . PATIENTS AND METHODS Patients received induction chemotherapy with R-MPV ( five to seven cycles ) ; those achieving a complete response ( CR ) received rdWBRT ( 23.4 Gy ) , and otherwise , st and ard WBRT was offered ( 45 Gy ) . Consolidation cytarabine was given after the radiotherapy . The primary end point was 2-year progression-free survival ( PFS ) in patients receiving rdWBRT . Exploratory end points included prospect i ve neuropsychological evaluation , analysis of magnetic resonance imaging ( MRI ) white matter changes using the Fazekas scale , and evaluation of the apparent diffusion coefficient ( ADC ) as a prognostic factor . RESULTS Fifty-two patients were enrolled , with median age of 60 years ( range , 30 to 79 years ) and median Karnofsky performance score of 70 ( range , 50 to 100 ) . Thirty-one patients ( 60 % ) achieved a CR after R-MPV and received rdWBRT . The 2-year PFS for this group was 77 % ; median PFS was 7.7 years . Median overall survival ( OS ) was not reached ( median follow-up for survivors , 5.9 years ) ; 3-year OS was 87 % . The overall ( N = 52 ) median PFS was 3.3 years , and median OS was 6.6 years . Cognitive assessment showed improvement in executive function ( P < .01 ) and verbal memory ( P < .05 ) after chemotherapy , and follow-up scores remained relatively stable across the various domains ( n = 12 ) . All examined MRIs ( n = 28 ) displayed a Fazekas score of ≤ 3 , and no patient developed scores of 4 to 5 ; differences in ADC values did not predict response ( P = .15 ) , PFS ( P = .27 ) , or OS ( P = .33 ) . CONCLUSION R-MPV combined with consolidation rdWBRT and cytarabine is associated with high response rates , long-term disease control , and minimal neurotoxicity BACKGROUND St and ard treatment for patients with primary CNS lymphoma remains to be defined . Active therapies are often associated with increased risk of haematological or neurological toxicity . In this trial , we addressed the tolerability and efficacy of adding rituximab with or without thiotepa to methotrexate-cytarabine combination therapy ( the MATRix regimen ) , followed by a second r and omisation comparing consolidation with whole-brain radiotherapy or autologous stem cell transplantation in patients with primary CNS lymphoma . We report the results of the first r and omisation in this Article . METHODS For the international r and omised phase 2 International Extranodal Lymphoma Study Group-32 ( IELSG32 ) trial , HIV-negative patients ( aged 18 - 70 years ) with newly diagnosed primary CNS lymphoma and measurable disease were enrolled from 53 cancer centres in five European countries ( Denmark , Germany , Italy , Switzerl and , and the UK ) and r and omly assigned ( 1:1:1 ) to receive four courses of methotrexate 3·5 g/m(2 ) on day 1 plus cytarabine 2 g/m(2 ) twice daily on days 2 and 3 ( group A ) ; or the same combination plus two doses of rituximab 375 mg/m(2 ) on days -5 and 0 ( group B ) ; or the same methotrexate-cytarabine-rituximab combination plus thiotepa 30 mg/m(2 ) on day 4 ( group C ) , with the three groups repeating treatment every 3 weeks . Patients with responsive or stable disease after the first stage were then r and omly allocated between whole-brain radiotherapy and autologous stem cell transplantation . A permuted blocks r and omised design ( block size four ) was used for both r and omisations , and a computer-generated r and omisation list was used within each stratum to preserve allocation concealment . R and omisation was stratified by IELSG risk score ( low vs intermediate vs high ) . No masking after assignment to intervention was used . The primary endpoint of the first r and omisation was the complete remission rate , analysed by modified intention to treat . This study is registered with Clinical Trials.gov , number NCT01011920 . FINDINGS Between Feb 19 , 2010 , and Aug 27 , 2014 , 227 eligible patients were recruited . 219 of these 227 enrolled patients were assessable . At median follow-up of 30 months ( IQR 22 - 38 ) , patients treated with rituximab and thiotepa had a complete remission rate of 49 % ( 95 % CI 38 - 60 ) , compared with 23 % ( 14 - 31 ) of those treated with methotrexate-cytarabine alone ( hazard ratio 0·46 , 95 % CI 0·28 - 0·74 ) and 30 % ( 21 - 42 ) of those treated with methotrexate-cytarabine plus rituximab ( 0·61 , 0·40 - 0·94 ) . Grade 4 haematological toxicity was more frequent in patients treated with methotrexate-cytarabine plus rituximab and thiotepa , but infective complications were similar in the three groups . The most common grade 3 - 4 adverse events in all three groups were neutropenia , thrombocytopenia , anaemia , and febrile neutropenia or infections . 13 ( 6 % ) patients died of toxicity . INTERPRETATION With the limitations of a r and omised phase 2 study design , the IELSG32 trial provides a high level of evidence supporting the use of MATRix combination as the new st and ard chemoimmunotherapy for patients aged up to 70 years with newly diagnosed primary CNS lymphoma and as the control group for future r and omised trials . FUNDING Associazione Italiana del Farmaco , Cancer Research UK , Oncosuisse , and Swiss National Foundation Abstract Treatment of primary central nervous system lymphoma ( PCNSL ) with high-dose methotrexate-based chemotherapy and whole-brain radiotherapy ( WBRT ) is associated with high rates of relapse and severe neurotoxicity . In an attempt to improve upon these poor results , we treated 21 patients with PCNSL aged 34–69 years ( median 56 ) with high-dose thiotepa , busulfan , cyclophosphamide ( TBC ) and autologous stem cell transplant ( ASCT ) as part of front-line therapy , without WBRT . Patient characteristics included : Karnofsky performance status ( KPS ) < 70 % ( n = 17 ) , age > 60 years ( n = 8) , deep brain involvement ( n = 16 ) . Treatment-induced neurotoxicity was not observed in any of these patients . Currently , 11 of 21 patients ( 52 % ) are alive and progression-free at a median follow-up of 60 ( 7–125 ) months post-ASCT . Causes of death included progressive PCNSL ( n = 4 ) , progressive systemic lymphoma ( n = 1 ) , early treatment-related mortality ( TRM , n = 3 ) and two late deaths from pneumonia 3 years post-ASCT . All patients who died of TRM were over 60 years of age and had poor performance status . In conclusion , TBC/ASCT offers potential long-term progression-free survival without neurotoxicity when used as part of upfront therapy for PCNSL . However , efforts to reduce TRM through improved patient selection and possibly through decreased intensity of the TBC regimen for older or less fit patients are recommended We investigated the feasibility of i.v . BU , CY and etoposide ( BUCYE ) , followed by auto-SCT ( ASCT ) in patients with newly diagnosed primary central nervous system lymphoma ( PCNSL ) . The planned treatment consisted of induction chemotherapy with five cycles of high-dose MTX and two cycles of high-dose cytarabine followed by conditioning with BUCYE ( BU 3.2 mg/m2 , day −7 to day −5 ; CY 50 mg/kg , day −3 to day −2 and etoposide 200 mg/m2 , twice a day , days −5 and −4 ) and then ASCT . Between May 2005 and November 2008 , 11 consecutive PCNSL patients were treated . All patients completed the treatment as planned , with no cases of treatment-related death or veno-occlusive disease . After BUCYE and ASCT , 10 patients achieved complete response ( CR ) or unconfirmed CR ( CRu ) . Two patients , one partial response and one CRu , received further whole-brain radiotherapy , with all achieving CR . At a median follow-up of 25.0 months ( 8.8–50.7 months ) , six patients had relapsed , with a median event-free interval of 15.0 months ( 95 % confidence interval , 4.5–25.6 months ) . Median survival time was not reached yet with a 2-year survival rate of 88.9 % . The current treatment was feasible with a favorable tolerance profile . However , further regimen optimization is necessary because of high relapse rate BACKGROUND The optimal treatment strategy in patients with aggressive B cell central nervous system lymphoma suitable to receive intensive therapy is unknown . The benefit of incorporating rituximab in systemic therapy remains unclear . We performed a retrospective study examining the impact of rituximab in the context of concomitant therapies , including methotrexate , cytarabine , and radiotherapy , in patients treated with curative intent at 4 university teaching hospitals during 1996 - 2011 . METHODS A retrospective study of CNS lymphoma cases treated at the participating institutions was performed in accordance with institutional ethical guidelines . Patients were included if they received a diagnosis of primary diffuse large B cell lymphoma of the CNS , were HIV negative , and were treated with curative intent . RESULTS One hundred twenty patients aged 21 - 81 years were identified . Rituximab recipients and nonrecipients were similar , except for rituximab recipients being more likely to have received a diagnosis after 2004 . The median follow-up of surviving patients was 30 months . The 5-year overall survival was 46 % . Univariate analysis revealed age ≤60 years , ECOG performance status ≤1 , normal lactate dehydrogenase , diagnosis after 2004 , and treatment with cytarabine and rituximab as predictive of favorable overall survival . Multivariate analysis identified age to be an independent predictor of overall survival , with a trend toward improved survival from the other variables that were significant in univariate analyses . CONCLUSIONS In this retrospective analysis , the addition of rituximab to high-dose methotrexate-based chemotherapy in patients with aggressive B cell CNS lymphoma was associated with improved overall survival . Further studies are underway to prospect ively vali date these findings |
11,575 | 30,604,099 | Nevertheless , there is preliminary evidence that the use of biofeedback can improve both physiological and psychological indicators of stress .
Biofeedback could provide an accessible and low-cost addition to stress interventions . | Current mental healthcare systems experience difficulties meeting the challenges of a growing population with elevated stress symptoms .
Outpatient stress management interventions have already proven to be effective in routine care and recent technological advances now allow to exp and such interventions , for example by adding a physiological component like biofeedback .
Adding biofeedback to stress management interventions appears promising , but there is a lack of insight into the general conceptualization and evaluation of the result ing interventions , both in relation to psychological and physiological stress indicators . | Background Physicians often experience work-related stress that may lead to personal harm and impaired professional performance . Biofeedback has been used to manage stress in various population s. Objective To determine whether a biofeedback-based stress management tool , consisting of rhythmic breathing , actively self-generated positive emotions and a portable biofeedback device , reduces physician stress . Design R and omized controlled trial measuring efficacy of a stress-reduction intervention over 28 days , with a 28-day open-label trial extension to assess effectiveness . Setting Urban tertiary care hospital . Participants Forty staff physicians ( 23 men and 17 women ) from various medical practice s ( 1 from primary care , 30 from a medical specialty and 9 from a surgical specialty ) were recruited by means of electronic mail , regular mail and posters placed in the physicians ’ lounge and throughout the hospital . Intervention Physicians in the intervention group were instructed to use a biofeedback-based stress management tool three times daily . Participants in both the control and intervention groups received twice-weekly support visits from the research team over 28 days , with the intervention group also receiving re-inforcement in the use of the stress management tool during these support visits . During the 28-day extension period , both the control and the intervention groups received the intervention , but without intensive support from the research team . Main outcome measure Stress was measured with a scale developed to capture short-term changes in global perceptions of stress for physicians ( maximum score 200 ) . Results During the r and omized controlled trial ( days 0 to 28 ) , the mean stress score declined significantly for the intervention group ( change –14.7 , st and ard deviation [ SD ] 23.8 ; p = 0.013 ) but not for the control group ( change –2.2 , SD 8.4 ; p = 0.30 ) . The difference in mean score change between the groups was 12.5 ( p = 0.048 ) . The lower mean stress scores in the intervention group were maintained during the trial extension to day 56 . The mean stress score for the control group changed significantly during the 28-day extension period ( change –8.5 , SD 7.6 ; p < 0.001 ) . Conclusion A biofeedback-based stress management tool may be a simple and effective stress-reduction strategy for physicians Biofeedback application is an evidence -based technique to induce relaxation . A primary mechanism of action is the improvement of self-efficacy , which is needed to facilitate the translation of health behavioral intentions into action . Obesity is often associated with low self-efficacy and dysfunctional eating patterns , including comfort eating as an inexpedient relaxation technique . This is the first study investigating the effects of biofeedback on self-efficacy and relaxation in obesity . In the present experiment , 31 women , mean body mass index 35.5 kg/m² , were r and omized to a food-specific biofeedback paradigm , a non-specific relaxation biofeedback paradigm , or a waiting list control . Eight sessions of biofeedback of the electrodermal activity were performed while presenting either a challenging food stimulus or a non-specific l and scape stimulus . Self-efficacy , stress , ability to relax , eating behavior , and electrodermal activity were assessed before , directly after , and 3 months after the intervention . The food-specific biofeedback predominantly showed effects on food-related self-efficacy and perceived stress . The non-specific relaxation biofeedback showed effects on the ability to relax . Self-reported improvements were confirmed by corresponding decrease in the electrodermal reaction to food stimuli . Biofeedback treatment is effective in improving self-efficacy in individuals with obesity and might therefore be a valuable additional intervention in obesity treatment A large proportion of children experience sub clinical levels of anxiety and cognitive-behavioral therapy ( CBT ) aim ed at preventing anxiety disorders is moderately effective . However , most at-risk children do not seek help or drop out of programs prematurely because of stigma , lack of motivation , and accessibility barriers . Applied games have received increased attention as viable alternatives and have shown promising results , but direct comparisons between applied games and the gold-st and ard CBT are lacking . Our aim was to investigate whether the applied game MindLight is as effective as CBT ( i.e. , Coping Cat ) within an indicated prevention context . We conducted a r and omized controlled non-inferiority trial with a sample of 174 children ( 7- to 12-year olds ) with elevated levels of anxiety , comparing MindLight to CBT . Anxiety was assessed with self- and parent-reports at pre- and post-program , and at 3- and 6-month follow-ups . Intention-to-treat and completers-only confidence interval approach and latent growth curve modeling showed an overall significant quadratic decrease in child- and parent-reported anxiety symptoms over time and , as predicted , the magnitude of improvement was the same for MindLight and CBT . The within-group effect sizes were small to medium at post-test ( − 0.32 to − 0.63 ) , and medium to large ( − 0.60 to − 1.07 ) at 3- and 6-month follow-ups . Furthermore , MindLight and CBT were rated equally anxiety inducing , difficult , and appealing ; CBT was rated as more relevant to daily life than MindLight . The current study adds to the growing research on applied games for mental health and shows that these games hold potential as alternative delivery models for evidence -based therapeutic techniques Although r and omized studies have high internal validity , generalizability of the estimated causal effect from r and omized clinical trials to real-world clinical or educational practice may be limited . We consider the implication of r and omized assignment to treatment , as compared with choice of preferred treatment as it occurs in real-world conditions . Compliance , engagement , or motivation may be better with a preferred treatment , and this can complicate the generalizability of results from r and omized trials . The doubly r and omized preference trial ( DRPT ) is a hybrid r and omized and nonr and omized design that allows for estimation of the causal effect of r and omization versus treatment preference . In the DRPT , individuals are first r and omized to either r and omized assignment or choice assignment . Those in the r and omized assignment group are then r and omized to treatment or control , and those in the choice group receive their preference of treatment versus control . Using the potential outcomes framework , we apply the algebra of conditional independence to show how the DRPT can be used to derive an unbiased estimate of the causal effect of r and omization versus preference for each of the treatment and comparison conditions . Also , we show how these results can be implemented using full matching on the propensity score . The methodology is illustrated with a DRPT of introductory psychology students who were r and omized to r and omized assignment or preference of mathematics versus vocabulary training . We found a small to moderate benefit of preference versus r and omization with respect to the mathematics outcome for those who received mathematics training 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 : Chronic pain is an emotionally and physically debilitating form of pain that activates the body 's stress response and over time can result in lowered heart rate variability ( HRV ) power , which is associated with reduced resiliency and lower self-regulatory capacity . This pilot project was intended to determine the effective-ness of HRV coherence biofeedback ( HRVCB ) as a pain and stress management intervention for veterans with chronic pain and to estimate the effect sizes . It was hypothesized that HRVCB will increase parasympathetic activity result ing in higher HRV coherence measured as power and decrease self-reported pain symptoms in chronic pain patients . Study design : Fourteen veterans receiving treatment for chronic pain were enrolled in the pre-post intervention study . They were r and omly assigned , with 8 subjects enrolled in the treatment group and 6 in the control group . The treatment group received biofeedback intervention plus st and ard care , and the other group received st and ard care only . The treatment group received four HRVCB training sessions as the intervention . Measures : Pre-post measurements of HRV amplitude , HRV power spectrum variables , cardiac coherence , and self-ratings of perceived pain , stress , negative emotions , and physical activity limitation were made for both treatment and control groups . Results : The mean pain severity for all subjects at baseline , using the self-scored Brief Pain Inventory ( BPI ) , was 26.71 ( SD=4.46 ; range=21—35 ) indicating a moderate to severe perceived pain level across the study subjects . There was no significant difference between the treatment and control groups at baseline on any of the measures . Post-HRVCB , the treatment group was significantly higher on coherence ( P=.01 ) and lower ( P=.02 ) on pain ratings than the control group . The treatment group showed marked and statistically significant ( 1-tailed ) increases over the baseline in coherence ratio ( 191 % , P=.04 ) and marked , significant ( 1-tailed ) reduction in pain ratings ( 36 % , P<.001 ) , stress perception ( 16 % , P=.02 ) , negative emotions ( 49 % , P<.001 ) , and physical activity limitation ( 42 % , P<.001 ) . Significant between-group effects on all measures were found when pre-training values were used as covariates . Conclusions : HRVCB intervention was effective in increasing HRV coherence measured as power in the upper range of the LF b and and reduced perceived pain , stress , negative emotions , and physical activity limitation in veterans suffering from chronic pain . HRVCB shows promise as an effective non-pharmacological intervention to support st and ard treatments for chronic pain BACKGROUND Patients with coronary heart disease ( CHD ) who experience depressed mood or psychological stress exhibit decreased vagal control of heart rate ( HR ) , as assessed by spectral analysis of HR variability ( HRV ) . Myocardial infa rct ion and sudden cardiac death are independently associated with depression and stress , as well as impaired vagal HR control . This study examined whether a behavioral neurocardiac intervention to reduce stress or depression can augment cardiovagal modulation in CHD patients . We hypothesized that ( 1 ) cognitive-behavioral training with HRV biofeedback would augment vagal recovery from acute stress , and ( 2 ) vagal regulation of HR would be inversely associated with stress and depression after treatment . METHODS This r and omized controlled trial enrolled 46 CHD patients from 3 clinics of CHD risk reduction in Toronto and Vancouver , Canada . Subjects were r and omized to five 1.5-hour sessions of HRV biofeedback or an active control condition . Outcome was assessed by absolute and normalized high-frequency spectral components ( 0.15 - 0.50 Hz ) of HRV , and by the Perceived Stress Scale and Centre for Epidemiologic Studies in Depression scale . RESULTS Both groups reduced symptoms on the Perceived Stress Scale ( P = .001 ) and Centre for Epidemiologic Studies in Depression scale ( P = .004 ) . Hierarchical linear regression determined that improved psychological adjustment was significantly associated with the high-frequency index of vagal HR modulation only in the HRV biofeedback group . Adjusted R 2 was as follows : HRV biofeedback group , 0.86 for stress ( P = .02 ) and 0.81 for depression ( P = .03 ) ; versus the active control group , 0.04 ( P = .57 ) and 0.13 ( P = .95 ) , respectively . CONCLUSION A novel behavioral neurocardiac intervention , HRV biofeedback , can augment vagal HR regulation while facilitating psychological adjustment to CHD Introduction : Stress is one of the leading global causes of disease and premature mortality . Despite this , interventions aim ed at reducing stress have low adherence rates . The proliferation of mobile phone devices along with gaming-style applications allows for a unique opportunity to broaden the reach and appeal of stress-reduction interventions in modern society . We assessed the effectiveness of two smartphone applications games combined with biofeedback in reducing stress . Methods : We compared a control game to gaming-style smartphone applications combined with a skin conductance biofeedback device ( the Pip ) . Fifty participants aged between 18 and 35 completed the Trier Social Stress Test . They were then r and omly assigned to the intervention ( biofeedback game ) or control group ( a non-biofeedback game ) for thirty minutes . Perceived stress , heart rate and mood were measured before and after participants had played the games . Results : A mixed factorial ANOVA showed a significant interaction between time and game type in predicting perceived stress [ F(1,48 ) = 14.19 , p < 0.001 ] . Participants in the biofeedback intervention had significantly reduced stress compared to the control group . There was also a significant interaction between time and game in predicting heart rate [ F(1,48 ) = 6.41 , p < 0.05 ] . Participants in the biofeedback intervention showed significant reductions in heart rate compared to the control group . Discussion : This illustrates the potential for gaming-style smartphone applications combined with biofeedback as stress reduction interventions The aim of this study was to examine the effect of resonant breathing biofeedback training for reducing stress among manufacturing operators . Resonant breathing biofeedback works by teaching people to recognize their involuntary heart rate variability and to control patterns of this physiological response . Thirty-six female operators from an electronic manufacturing factory were r and omly assigned as the experimental group ( n = 19 ) and the control group ( n = 17 ) . The participants of the intervention received 5 weekly sessions of biofeedback training . Physiological stress profiles and self-perceived depression , anxiety , and stress scale ( DASS ) were assessed at pre- and post-intervention . Results indicated that depression , anxiety , and stress significantly decreased after the training in the experimental group ; they were supported by a significant increase in physiological measures . Overall , these results support the potential application of resonant biofeedback training to reduce negative emotional symptoms among industrial workers BACKGROUND Relaxation , mindfulness , social support , and education ( RMSSE ) have been shown to improve emotional symptoms , coping , and fatigue in multiple sclerosis ( MS ) . Biofeedback was trialed as a psychological intervention , design ed to improve self-control , in two groups of patients with MS . Both groups received RMSSE , and one group additionally received biofeedback . METHODS Forty people with relapsing-remitting MS were recruited from three sites in Sydney , Australia . The mean disability score ( Exp and ed Disability Status Scale ; EDSS ) was 2.41 ± 1.46 ( 95 % confidence interval [ CI ] , 1.46 - 3.36 ) ; the mean age in years was 45.9 ± 12.42 ( 95 % CI , 41.92 - 49.87 ) . Participants were r and omly assigned to two active treatment groups ( n = 20 per group ) . All participants received one 1-hour session per week for 3 weeks of RMSSE , while biofeedback equipment measured breathing rate and muscle tension . Members of one group used biofeedback screens to regulate physiological response . RESULTS Whole-group pre- and post-treatment scores demonstrated a reduction of 38 % for anxiety and 39 % for depression scores ( P = .007 and P = .009 , respectively ) . A post-treatment comparison failed to demonstrate any significant difference between the two active treatment groups in anxiety and depression scores . The biofeedback group showed significant pre- to post-treatment improvement or trends toward improvement in anxiety , fatigue , and stress ( P = .05 , .02 , and .03 , respectively ) . Comparison of pre-post treatment results between groups showed improvements for the biofeedback group in breathing rate and muscle tension ( P = .06 and .09 ) . CONCLUSIONS For relapsing-remitting MS patients receiving biofeedback in addition to RMSSE , there was a demonstrable reduction in anxiety , fatigue , and stress . There was also a trend toward significant reduction of breathing rate and muscle tension in favor of biofeedback Abstract The current study examined the efficacy of heart rate variability ( HRV ) biofeedback using emWave , a publicly available biofeedback device , to determine whether training affected physiological tone and stress responses . Twenty-seven individuals aged 18–30 years were r and omized to a treatment or no-treatment control group . Treatment participants underwent 4–8 sessions of emWave intervention , and all participants attended pre-treatment and post-treatment assessment sessions during which acute stressors were administered . Physiological data were collected at rest , during stress , and following stress . emWave treatment did not confer changes in tonic measures of HRV or in HRV recovery following stress . However , treatment participants exhibited higher parasympathetic responses ( i.e. , pNN50 ) during stress presentations at the post-treatment session than their control counterparts . No treatment effects were evident on self-reported measures of stress , psychological symptoms , or affect . Overall , results from the current study suggest that the emWave may confer some limited treatment effects by increasing HRV during exposure to stress . Additional development and testing of the emWave treatment protocol is necessary before it can be recommended for regular use in clinical setting s , including the determination of what physiological changes are clinical ly meaningful during HRV biofeedback training Preterm birth is a highly prevalent phenomenon that was shown to be associated with mental stress during pregnancy ( Rich-Edwards and Grizzard in Am J Obstet Gynecol 192(5 Suppl):S30–S35 , 2005 ) . We aim ed to assess the effects of heart rate variability (HRV)-biofeedback in patients with preterm labour . Therefore , we conducted a controlled r and omized parallel group study in 48 female patients aged 19–38 years ( median = 29 ) with preterm labour at gestational week 24th–32nd ( median = 29th ) . In this study , one group ( n = 24 ) attended six sessions of HRV-biofeedback over 2 weeks whereas patients of the other group ( n = 24 ) were assigned to control sessions . In the HRV-biofeedback treated group , perception of chronic stress was decreased 4 weeks after completion of training compared to baseline ( p < 0.05 ) but there was no change in the control group . In the HRV-biofeedback group , preterm birth was seen in 3 patients ( 13 % ) whereas in the control group , preterm delivery occurred in 8 patients ( 33 % , p = n.s . ) . There was no difference in birth weight between groups and HRV remained unchanged . In conclusion , our study demonstrates that HRV-biofeedback can reduce chronic stress in patients with preterm labour when administered as an adjunct to routine care . However , it remains unclear whether stress reduction through HRV-biofeedback has a beneficial effect on preterm birth |
11,576 | 30,829,052 | Conclusion and Relevance : This systematic review identified several AF patient knowledge gaps about their condition and its treatment that can inform the development of AF patient education programs | Background : Patient education facilitates construction of a correct illness representation , improves beliefs about medications , and improves knowledge , factors that have been associated with better adherence .
Objective : Our objective was to characterize the published literature about atrial fibrillation ( AF ) patients ’ disease and medication knowledge to identify knowledge gaps and misconceptions to inform AF patient education strategies . | Introduction Reporting r and omised controlled trials is a key element in order to disseminate research findings . The CONSORT statement was introduced to improve the reporting quality . We assessed the adherence to the CONSORT statement of r and omised controlled trials published 2011 in the top ten ranked journals of critical care medicine ( ISI Web of Knowledge 2011 , Thomson Reuters , London UK ) . Methods Design . We performed a retrospective cross sectional data analysis . Setting . This study was executed at the University Hospital of RWTH , Aachen . Participants . We selected the following top ten listed journals according to ISI Web of Knowledge ( Thomson Reuters , London , UK ) critical care medicine ranking in the year 2011 : American Journal of Respiratory and Critical Care Medicine , Critical Care Medicine , Intensive Care Medicine , CHEST , Critical Care , Journal of Neurotrauma , Resuscitation , Pediatric Critical Care Medicine , Shock and Minerva Anestesiologica . Main outcome measures . We screened the online table of contents of each included journal , to identify the r and omised controlled trials . The adherence to the items of the CONSORT Checklist in each trial was evaluated . Additionally we correlated the citation frequency of the articles and the impact factor of the respective journal with the amount of reported items per trial . Results We analysed 119 r and omised controlled trials and found , 15 years after the implementation of the CONSORT statement , that a median of 61,1 % of the checklist-items were reported . Only 55.5 % of the articles were identified as r and omised trials in their titles . The citation frequency of the trials correlated significantly ( rs = 0,433 ; p<0,001 and r = 0,331 ; p<0,001 ) to the CONSORT statement adherence . The impact factor showed also a significant correlation to the CONSORT adherence ( r = 0,386 ; p<0,001 ) . Conclusion The reporting quality of r and omised controlled trials in the field of critical care medicine remains poor and needs considerable improvement Background Stroke prevention in atrial fibrillation ( AF ) , most commonly with warfarin , requires maintenance of a narrow therapeutic target ( INR 2.0 to 3.0 ) and is often poorly controlled in practice . Poor patient-underst and ing surrounding AF and its treatment may contribute to the patient ’s willingness to adhere to recommendations . Method A theory-driven intervention , developed using patient interviews and focus groups , consisting of a one-off group session ( 1–6 patients ) utilising an “ expert-patient ” focussed DVD , educational booklet , self-monitoring diary and worksheet , was compared in a r and omised controlled trial ( IS RCT N93952605 ) against usual care , with patient postal follow-ups at 1 , 2 , 6 , and 12-months . Ninety-seven warfarin-naïve AF patients were r and omised to intervention ( n=46 , mean age ( SD ) 72.0 ( 8.2 ) , 67.4 % men ) , or usual care ( n=51 , mean age ( SD ) 73.7 ( 8.1 ) , 62.7 % men ) , stratified by age , sex , and recruitment centre . Primary endpoint was time within therapeutic range ( TTR ) ; secondary endpoints included knowledge , quality of life , anxiety/depression , beliefs about medication , and illness perceptions . Main Findings Intervention patients had significantly higher TTR than usual care at 6-months ( 76.2 % vs. 71.3 % ; p=0.035 ) ; at 12-months these differences were not significant ( 76.0 % vs. 70.0 % ; p=0.44 ) . Knowledge increased significantly across time ( F ( 3 , 47 ) = 6.4 ; p<0.01 ) , but there were no differences between groups ( F ( 1 , 47 ) = 3.3 ; p = 0.07 ) . At 6-months , knowledge scores predicted TTR ( r=0.245 ; p=0.04 ) . Patients ’ scores on subscales representing their perception of the general harm and overuse of medication , as well as the perceived necessity of their AF specific medications predicted TTR at 6- and 12-months . Conclusions A theory-driven educational intervention significantly improves TTR in AF patients initiating warfarin during the first 6-months . Adverse clinical outcomes may potentially be reduced by improving patients ’ underst and ing of the necessity of warfarin and reducing their perception of treatment harm . Improving education provision for AF patients is essential to ensure efficacious and safe treatment . The trial is registered with Current Controlled Trials , IS RCT N93952605 , and details are available at www.controlled-trials.com/IS RCT N93952605 Background Effective and safe management of oral anticoagulant treatment ( OAT ) requires a high level of patient knowledge and adherence . The aim of this study was to assess patient knowledge about OAT and factors associated with patient knowledge . Methods This is a baseline survey of a cluster-r and omized controlled trial in 22 general practice s with an educational intervention for patients or their caregivers . We assessed knowledge about general information on OAT and key facts regarding nutrition , drug-interactions and other safety pre caution s of 345 patients at baseline . Results Participants rated their knowledge about OAT as excellent to good ( 56 % ) , moderate ( 36 % ) or poor ( 8 % ) . However , there was a discrepancy between self-rated knowledge and evaluated actual knowledge and we observed serious knowledge gaps . Half of the participants ( 49 % ) were unaware of dietary recommendations . The majority ( 80 % ) did not know which non-prescription analgesic is the safest and 73 % indicated they would not inform pharmacists about OAT . Many participants ( 35 - 75 % ) would not recognize important emergency situations . After adjustment in a multivariate analysis , older age and less than 10 years education remained significantly associated with lower overall score , but not with self-rated knowledge . Conclusions Patients have relevant knowledge gaps , potentially affecting safe and effective OAT . There is a need to assess patient knowledge and for structured education programs . Trial registration Deutsches Register Klinischer Studien ( German Clinical Trials Register ) : DRKS00000586.Universal Trial Number ( UTN U1111 - 1118 - 3464 ) BACKGROUND The knowledge of warning symptoms and risk factors for stroke has not been studied among patients with stroke in developing countries . AIMS We aim ed to assess the knowledge of stroke among patients with stroke and their relatives . SETTING S AND DESIGN Prospect i ve tertiary referral hospital-based study in Northwest India . MATERIAL S AND METHODS Trained nurses and medical interns interviewed patients with stroke and transient ischemic attack and their relatives about their knowledge of stroke symptoms and risk factors . STATISTICAL ANALYSIS Univariable and multivariable logistic regression were used . RESULTS Of the 147 subjects interviewed , 102 ( 69 % ) were patients and 45 ( 31 % ) were relatives . There were 99 ( 67 % ) men and 48 ( 33 % ) women and the mean age was 59.7+/-14.1 years . Sixty-two percent of respondents recognized paralysis of one side as a warning symptom and 54 % recognized hypertension as a risk factor for stroke . In the multivariable logistic regression analysis , higher education was associated with the knowledge of correct organ involvement in stroke ( OR 2.6 , CI 1.1- 6.1 , P = 0.02 ) , whereas younger age ( OR 2.7 , CI 1.1 - 7.0 , P = 0.04 ) and higher education ( OR 4.1 , CI 1.5 - 10.9 , P = 0.005 ) correlated with a better knowledge regarding warning symptoms of stroke . CONCLUSIONS In this study cohort , in general , there is lack of awareness of major warning symptoms , risk factors , organ involvement and self-recognition of stroke . However younger age and education status were associated with better knowledge . There is an urgent need for awareness programs about stroke in this study cohort OBJECTIVE Previous research has demonstrated that patients with atrial fibrillation ( AF ) possess very little knowledge of their disease , the consequences of AF and the benefits /risks of anti-coagulant therapy . The aim of this pilot study was to examine patient 's knowledge and perceptions of AF and their anticoagulant treatment before and after a brief educational intervention . MATERIAL S AND METHODS Ninety-three patients ( 47 male ; mean ( S.D. ) age 67.3 ( 11.6 ) years ) completed the baseline interview to assess their knowledge and perceptions of AF . All patients were given an information booklet which explained what AF was , associated symptoms , the possible causes and consequences of AF , treatment options and their benefits /risks , what the INR is and what factors may effect it . The booklet was explained to each patient by the research er and given to the patient to take away for reference . Thirty-three ( 35.5 % ) patients ( 12 men ; mean ( S.D. ) age 68.0 ( 13.6 ) years ) completed the follow-up assessment to re-assess their knowledge and perceptions of AF . RESULTS Only 49 % of patients could name their cardiac condition at baseline , although the majority were aware that AF was an arrhythmia ( 80 % baseline vs. 91 % follow-up ) . Only about half the patients perceived AF as a serious condition or were aware that AF predisposes to thromboembolism at baseline . Following the educational intervention there was a non-significant increase in patient knowledge of the risks associated with AF . Of those who completed both question naires , 52 % were aware that anticoagulants prevented blood clots , which increased to 70 % post-intervention . However , few patients were aware of the benefit of stroke prevention associated with anticoagulants at baseline ( 21 % ) or after the educational intervention ( 27 % ) . The intervention had little effect on increasing awareness of the bleeding risks associated with anticoagulants , although three in five people appeared to appreciate these risks . However , the educational intervention significantly improved patient 's knowledge of the target INR range and factors that may affect INR levels ( p=0.001 and p=0.014 , respectively ) for those who completed both question naires . CONCLUSIONS Most patients with AF possess very limited knowledge about their cardiac condition , its consequences , and how anticoagulant treatment can benefit them . This pilot study has demonstrated that a brief educational intervention with an information booklet can help to somewhat improve their knowledge about anticoagulation therapy for AF Of 125 patients aged 65 years or over , with atrial fibrillation taking warfarin for at least 12 months , with a st and ard deviation ( SD ) of prothrombin time , expressed as the International Normalized Ratio ( INR ) > 0·5 over the previous 6 months , 40 were r and omized to continue with usual clinic care and 85 to receive education about warfarin . Of these , 44 were r and omized to self‐monitor their INR and 41 returned to clinic . Compared with the previous 6 months there was a significant increase in percentage time within the therapeutic range for the 6 months following education [ 61·1 vs. 70·4 ; mean difference 8·8 ; 95 % confidence interval ( CI ) : −0·2–17·8 ; P = 0·054 ] and following education and self‐monitoring ( 57 vs. 71·1 ; mean difference 14·1 ; 95 % CI : 6·7–21·5 ; P < 0·001 ) , compared with those patients following usual clinic care ( 60·0 vs. 63·2 ; mean difference 3·2 ; 95 % CI : −7·3–13·7 ) . Using the same comparative periods , the INR SD fell by 0·24 ( P < 0·0001 ) in the group allocated to education and self‐monitoring , 0·26 ( P < 0·0001 ) in the group receiving education alone and 0·16 ( P = 0·003 ) in the control group . Inter‐group differences were not statistically significant ( intervention groups 0·26 ± 0·30 vs. control 0·16 ± 0·3 , P = 0·10 ) . Quality ‐of‐life measurements and health beliefs about warfarin were unchanged ( apart from emotional role limitation ) with education or education and self‐monitoring . Patient education regarding anticoagulation therapy could be a cost‐effective initiative and is worthy of further study |
11,577 | 26,566,930 | Bacteriological results were as often expressed in terms of positivity as negativity , with varying definitions of culture conversion . | Tuberculosis ( TB ) remains a major killer amongst the infectious diseases .
Current treatment involves a four-drug regimen for at least 6 months .
New drugs and regimens are required to shorten treatment duration , reduce toxicity and combat drug resistance , but the optimal methodology to define the critical path for novel regimens is not well defined .
We undertook a systematic review to summarise outcomes reported in Phase II trials of patients with newly diagnosed pulmonary TB to assess the need for a core outcome set . | The early bactericidal and sterilizing activities of ciprofloxacin were evaluated in the treatment of adult patients with smear positive pulmonary tuberculosis . Two r and omized prospect i ve studies were performed in Northern Tanzania . In study 1 , ten patients received either 750 mg ciprofloxacin or 300 ng isoniazid daily for 7 days . Counts of colony-forming units ( cfu ) of Mycobacterium tuberculosis in early morning sputum were performed . In study 2 , twenty patients received either a st and ard regimen of rifampin ( R ) , isoniazid ( H ) , pyrazinamide ( Z ) , and ethambutol ( E ) ( regimen HRZE ) or a trial regimen of ciprofloxacin ( C ) , isoniazid ( H ) , and rifampin ( R ) ( regimen HRC ) . Sputum colony counts were performed for 8 wk . Patients were tested for antibodies to human immunodeficiency virus (HIV)-1 . The results demonstrate that ciprofloxacin alone has useful early bactericidal activity , result ing in a mean daily fall of 0.20 log10cfu/ml/day during 7 days compared with 0.25 log10cfu/ml/day for isoniazid . When HRZE and HRC regimens were compared , the HRC regimen appeared to be inferior in its sterilizing ability , with a culture conversion rate of 67 % at 2 months compared with 100 % for HRZE . The difference in outcome was most marked in HIV-1 positive patients . The role of ciprofloxacin in combination regimens may be as a bactericidal rather than a sterilizing agent Previously untreated patients with smear-positive pulmonary tuberculosis were r and omly allocated to treatment with 600 , 300 , 150 or 75 mg doses of rifabutin ( LM427 , ansamycin ) , 600 , 300 or 150 mg of rifampicin , 300 mg isoniazid or to no drug daily for 2 days . The fall in viable counts of Mycobacterium tuberculosis in sputum collection s during the 2 days , termed the early bactericidal activity ( EBA ) , was estimated from counts of colony-forming units ( cfu ) on selective 7H-11 agar medium . The EBA for rifabutin ranged from -0.039 ( an increase in counts ) to 0.049 log10 cfu/ml/day whereas the EBA increased from 0.071 for 150 mg rifampicin to 0.293 log10 cfu/ml/day for 600 mg rifampicin and was 0.43 log10 cfu/ml/day for 300 mg isoniazid . The difference between the EBAs for rifabutin and rifampicin just attained significance ( P = 0.05 ) suggesting that rifabutin was inactive or less active than rifampicin against the extracellular bacilli in pulmonary cavities . Peak plasma concentrations of rifabutin after the initial doses were found to be proportional to dose size and were approximately 7 times lower than those after the same dose size of rifampicin . The lower EBA of rifabutin as compared to rifampicin is probably due to the low plasma concentrations which are not fully compensated for by slightly greater antituberculosis activity of rifabutin in vitro ABSTRACT We studied the early bactericidal activity of twice the st and ard dose of rifampin in subjects with pulmonary tuberculosis evidence d by positive smears . The observed mean 2-day activity was almost double that reported at the st and ard dose . Further studies are warranted to establish whether higher rifampin doses might assist in shortening tuberculosis treatment ABSTRACT Bedaquiline is a new antituberculosis agent targeting ATP synthase . This r and omized , double-blinded study enrolling 68 sputum smear-positive pulmonary tuberculosis patients evaluated the 14-day early bactericidal activity of daily doses of 100 mg , 200 mg , 300 mg , and 400 mg bedaquiline , preceded by loading doses of 200 mg , 400 mg , 500 mg , and 700 mg , respectively , on the first treatment day and 100 mg , 300 mg , 400 mg , and 500 mg on the second treatment day . All groups showed activity with a mean ( st and ard deviation ) daily fall in log10 CFU over 14 days of 0.040 ( 0.068 ) , 0.056 ( 0.051 ) , 0.077 ( 0.064 ) , and 0.104 ( 0.077 ) in the 100-mg , 200-mg , 300-mg , and 400-mg groups , respectively . The linear trend for dose was significant ( P = 0.001 ) , and activity in the 400-mg dose group was greater than that in the 100-mg group ( P = 0.014 ) . All of the bedaquiline groups showed significant bactericidal activity that was continued to the end of the 14-day evaluation period . The finding of a linear trend for dose suggests that the highest dose compatible with safety considerations should be taken forward to longer-term clinical studies The clinical utility of therapeutic drug monitoring in tuberculosis has not been adequately evaluated by controlled clinical trials . To examine the relationship between slow culture conversion and peak plasma rifampicin level ( Cmax-rfm ) in a case-control study , patients with persistence of positive sputum smear despite at least 8 weeks of directly observed treatment with st and ard pyrazinamide-containing regimens were enrolled prospect ively in government chest clinics from 16 December 2005 to 15 November 2006 . Patients with multidrug-resistant tuberculosis , human immunodeficiency virus infection , or poor treatment adherence were excluded . Cases referred to patients with persistence of positive culture whereas controls had negative culture despite positive smear . Blood was checked at 2 and 4 hours post-dosing to capture Cmax-rfm . A cohort of 88 patients was identified . After excluding 16 patients , there were 36 controls and 36 cases . None had symptoms of malabsorption . Cmax-rfm was below 6 mg/l among 47 % of controls and 44 % of cases . Univariate and multiple logistic regression analyses showed no significant association between slow culture conversion and Cmax-rfm after logarithmic transformation . Thus , there is probably no association between Cmax-rfm and slow culture conversion It is widely acknowledged that new regimens are urgently needed for the treatment of tuberculosis . The primary endpoint in the Phase III trials is a composite outcome of failure at the end of treatment or relapse after stopping treatment . Such trials are usually both long and expensive . Valid surrogate endpoints measured during or at the end of treatment could dramatically reduce both the time and cost of assessing the effectiveness of new regimens . The objective of this study was to evaluate sputum culture results on solid media during treatment as surrogate endpoints for poor outcome . Data were obtained from twelve r and omised controlled trials conducted by the British Medical Research Council in the 1970s and 80s in East Africa and East Asia , consisting of 6974 participants and 49 different treatment regimens . The month two culture result was shown to be a poor surrogate in East Africa but a good surrogate in Hong Kong . In contrast , the month three culture was a good surrogate in trials conducted in East Africa but not in Hong Kong . As well as differences in location , ethnicity and probable strain of Mycobacteria tuberculosis , Hong Kong trials more often evaluated regimens with rifampicin throughout and intermittent regimens , and patients in East African trials more often presented with extensive cavitation and were slower to convert to culture negative during treatment . An endpoint that is a summary measure of the longitudinal profile of culture results over time or that is able to detect the presence of M. tuberculosis later in treatment is more likely to be a better endpoint for a phase II trial than a culture result at a single time point and may prove to be an acceptable surrogate . More data are needed before any endpoint can be used as a surrogate in a confirmatory phase III trial BACKGROUND Rifapentine administered 5 days per week has potent activity in mouse models of antituberculosis chemotherapy , but efficacy and safety data are limited in humans . We compared the antimicrobial activity and safety of rifapentine vs rifampin during the first 8 weeks of pulmonary tuberculosis treatment . METHODS In total , 531 adults with sputum smear-positive pulmonary tuberculosis were r and omized to rifapentine 10 mg/kg/dose or rifampin 10 mg/kg/dose , administered 5 days per week for 8 weeks ( intensive phase ) , with isoniazid , pyrazinamide , and ethambutol . Co primary outcomes were negative sputum culture on liquid and on solid media at completion of intensive phase . RESULTS Negative cultures on solid media occurred in 145 of 174 participants ( 83.3 % ) in the rifampin group and 171 of 198 participants ( 86.4 % ) in the rifapentine group ( difference , 3.0 % ; 95 % confidence interval [ CI ] : -4.3 , 10.5 ) ; negative cultures in liquid media occurred in 110 of 169 ( 65.1 % ) in the rifampin group and 133 of 196 ( 67.9 % ) in the rifapentine group ( difference , 2.8 % ; 95 % CI : -6.9 , 12.4 ) . Among 529 participants who received study therapy , 40 of 254 participants ( 15.7 % ) in the rifampin group and 40 of 275 participants ( 14.5 % ) in the rifapentine group prematurely discontinued treatment ( P=.79 ) . CONCLUSIONS The rifapentine regimen was safe but not significantly more active than a st and ard rifampin regimen , by the surrogate endpoint of culture status at completion of intensive phase . Assessment of higher exposures to rifapentine for tuberculosis treatment is warranted . CLINICAL TRIALS REGISTRATION NCT00694629 RATIONALE Moxifloxacin has potent activity against Mycobacterium tuberculosis in vitro and in a mouse model of antituberculosis ( TB ) chemotherapy , but data regarding its activity in humans are limited . OBJECTIVES Our objective was to compare the antimicrobial activity and safety of moxifloxacin versus isoniazid during the first 8 weeks of combination therapy for pulmonary TB . METHODS Adults with sputum smear-positive pulmonary TB were r and omly assigned to receive either moxifloxacin 400 mg plus isoniazid placebo , or isoniazid 300 mg plus moxifloxacin placebo , administered 5 days/week for 8 weeks , in addition to rifampin , pyrazinamide , and ethambutol . All doses were directly observed . Sputum was collected for culture every 2 weeks . The primary outcome was negative sputum culture at completion of 8 weeks of treatment . MEASUREMENTS AND MAIN RESULTS Of 433 participants enrolled , 328 were eligible for the primary efficacy analysis . Of these , 35 ( 11 % ) were HIV positive , 248 ( 76 % ) had cavitation on baseline chest radiograph , and 213 ( 65 % ) were enrolled at African sites . Negative cultures at Week 8 were observed in 90/164 ( 54.9 % ) participants in the isoniazid arm , and 99/164 ( 60.4 % ) in the moxifloxacin arm ( P = 0.37 ) . In multivariate analysis , cavitation and enrollment at an African site were associated with lower likelihood of Week-8 culture negativity . The proportion of participants who discontinued assigned treatment was 31/214 ( 14.5 % ) for the moxifloxacin group versus 22/205 ( 10.7 % ) for the isoniazid group ( RR , 1.35 ; 95 % CI , 0.81 , 2.25 ) . CONCLUSIONS Substitution of moxifloxacin for isoniazid result ed in a small but statistically nonsignificant increase in Week-8 culture negativity RATIONALE Moxifloxacin has promising pre clinical activity against Mycobacterium tuberculosis , but has not been evaluated in multidrug treatment of tuberculosis in humans . OBJECTIVE To compare the impact of moxifloxacin versus ethambutol , both in combination with isoniazid , rifampin , and pyrazinamide , on sputum culture conversion at 2 mo as a measure of the potential sterilizing activity of alternate induction regimens . METHODS Adults with smear-positive pulmonary tuberculosis were r and omized in a factorial design to receive moxifloxacin ( 400 mg ) versus ethambutol given 5 d/wk versus 3 d/wk ( after 2 wk of daily therapy ) . All doses were directly observed . MEASUREMENTS The primary endpoint was sputum culture status at 2 mo of treatment . RESULTS Of 336 patients enrolled , 277 ( 82 % ) were eligible for the efficacy analysis , 186 ( 67 % ) were male , 175 ( 63 % ) were enrolled at African sites , 206 ( 74 % ) had cavitation on chest radiograph , and 60 ( 22 % ) had HIV infection . Two-month cultures were negative in 71 % of patients ( 99 of 139 ) treated with moxifloxacin versus 71 % ( 98 of 138 ) treated with ethambutol ( p = 0.97 ) . Patients receiving moxifloxacin , however , more often had negative cultures after 4 wk of treatment . Patients treated with moxifloxacin more often reported nausea ( 22 vs. 9 % , p = 0.002 ) , but similar proportions completed study treatment ( 88 vs. 89 % ) . Dosing frequency had little effect on 2-mo culture status or tolerability of therapy . CONCLUSIONS The addition of moxifloxacin to isoniazid , rifampin , and pyrazinamide did not affect 2-mo sputum culture status but did show increased activity at earlier time points SETTING Current treatment for pulmonary tuberculosis ( TB ) might be shortened by the incorporation of fluoroquinolones ( FQs ) . OBJECTIVES A Phase II study aim ed to assess the sterilising activities of three novel regimens containing FQs before a Phase III trial of a 4-month regimen containing gatifloxacin ( GFX ) . DESIGN A total of 217 newly diagnosed smear-positive patients were r and omly allocated to one of four regimens : isoniazid ( INH ) , pyrazinamide and rifampicin ( RMP ) with either ethambutol , GFX , moxifloxacin ( MFX ) or ofloxacin ( OFX ) for 2 months . At the end of the study , RMP and INH were given for 4 months . The rates of elimination of Mycobacterium tuberculosis were compared in the regimens using non-linear mixed effects modelling of the serial sputum colony counts ( SSCC ) during the first 8 weeks . RESULTS After adjustment for covariates , MFX substitution appeared superior during the early phase of a bi-exponential fall in colony counts , but significant and similar acceleration of bacillary elimination during the late phase occurred with both GFX and MFX ( P = 0.002 ) . Substitution of OFX had no effect . These findings were supported by estimates of time to conversion , using Cox regression , but there were no significant differences in proportions culture-negative at 8 weeks . CONCLUSIONS GFX and MFX improve the sterilising activity of regimens and might shorten treatment ; their progression into Phase III trials therefore seems warranted RATIONALE Comparison of the early bactericidal activity ( EBA ) of rifapentine and its pharmacokinetics with those of rifampin to determine the cause of poor clinical response and regrowth between doses , leading to rifamycin monoresistance at relapse . OBJECTIVES Determination of the dose size of rifapentine that gives sufficient drug exposure to prevent regrowth . METHODS EBA study over initial 5 days of treatment of 123 patients , half at Durban and half at Cape Town , who received single rifapentine doses of 300 , 600 , 900 , or 1,200 mg rifapentine or five daily doses of 150 , 300 , or 600 mg rifampin , with a pharmacokinetic study on 58 patients measuring st and ard parameters for each dose size of rifamycin and their desacetyl metabolites . RESULTS The EBAs for both rifamycins were similar , with a linear relationship to log dose at lower doses and a curvilinear response at higher doses giving a plateau at 1,136 mg rifapentine . The area under the concentration-time curve ( AUC ) divided by the minimal inhibitory concentration ( MIC ) agreed well for both rifamycins on the assumption that the only free 2 % of free rifapentine and the 14 % of free rifampin after plasma binding were active in the lesions . CONCLUSIONS Only the free proportions of the rifamycins were active in lesions . From consideration of the pulse size and the duration of the postantibiotic lag , a 1,200-mg dose of rifapentine seemed necessary to improve response and to prevent regrowth between doses , and hence rifamycin monoresistance A number of 75 adults with pulmonary tuberculosis ( M. tuberculosis positive at microscopy and in cultures ) were r and omly selected for one of the following therapeutical regimens , administered under close surveillance in hospital during 3 months : --INH5 mg/kg body weight+RMP10 mg/kg body weight+EMB25 mg/kg body weight daily ; --INH15 mg/kg body weight+RMP10 mg/kg body weight+EMB40 mg/kg body weight , intermitent administration ( 2/7 ) . Disappearance of the Mycobacterium from the sputum was studied quantitatively both by microscopy and in cultures ; the sputum sample s were collected in the morning three days running every week during the period of 13 weeks surveillance . Processing of the results showed that in the material studied the initial intermittent administration of the drugs was just as efficient as daily administration irrespective of the criterion used for comparison ( moment of negativation , rate of disappearance of the Mycobacterium and /or proportion of negative cases , dynamics of the decrease in the number of bacilli eliminated in the course of the treatment , regression of the radiologic alterations ) Early bactericidal activity ( EBA ) of antituberculosis drugs is the rate of decrease in the concentration of tubercle bacilli sputum during the initial days of therapy . The study reported here was design ed to optimize the methodology for obtaining precise EBA measurements . The study compared the results with two versus five treatment days ; overnight sputum collection s with early morning collection s ; and quantitative smears for acid-fast bacilli ( AFB ) with quantitative cultures . Isoniazid ( INH ) was used as a model drug . Among 28 smear-positive patients enrolled in the study in five cities in the United States , 16 were evaluable ( INH-susceptible tuberculosis [ TB ] and adequate sputum collection s ) . The mean baseline bacterial load was 6.69 log10 cfu/ml ( SE = 0.24 ) . Quantitative culture of 10- or 12-h sputum collection s obtained on two baseline days and treatment Day 5 was the optimal method for EBA measurement . The mean 5-d EBA was 0.21 log10 cfu/ml/d ( SE = 0.03 ; p < 0.001 ) and the EBA appeared to be constant during the first five treatment days . On the basis of these data , multiarm studies of investigational drugs will require 25 evaluable subjects per arm to detect ( 80 % power and two-tailed alpha of 0.05 ) an EBA at least 50 % as large as the EBA of INH . In countries with a low incidence of TB , the usefulness of this methodology for rapidly assessing new antituberculosis agents may be limited by the relatively large number of subjects required to compare EBA values across treatment arms OBJECTIVE To evaluate the early bactericidal activity ( EBA ) of the new fluoroquinolones levofloxacin , gatifloxacin and moxifloxacin in patients with pulmonary tuberculosis ( PTB ) . DESIGN R and omized , open-label trial . Forty adults with newly diagnosed smear-positive PTB ( 10 per arm ) were assigned to receive isoniazid ( INH ) 300 mg , levofloxacin 1000 mg , gatifloxacin 400 mg , or moxifloxacin 400 mg daily for 7 days . Sputum for quantitative culture was collected for 2 days before and daily during 7 days of monotherapy . Bactericidal activity was estimated by measuring the decline in bacilli during the first 2 days ( EBA 0 - 2 ) and last 5 days of monotherapy ( extended EBA , EBA 2 - 7 ) . Laboratory staff were blinded to treatment assignment . RESULTS The EBA 0 - 2 of INH ( 0.67 log10 cfu/ml/day ) was greater than that of moxifloxacin and gatifloxacin ( 0.33 and 0.35 log10 cfu/ml/day , respectively ) , but not of levofloxacin 1000 mg daily ( 0.45 log10 cfu/ml/day ) ( P = 0.14 ) . Bactericidal activity between days 2 and 7 was similar for all three fluoroquinolones . In a pooled comparison , the EBA 2 - 7 of the fluoroquinolones was greater than for INH . CONCLUSION Moxifloxacin , gatifloxacin , and high-dose levofloxacin have excellent EBA , only slightly less than for INH , and greater extended EBA . These drugs warrant further study in the treatment of drug-susceptible TB ABSTRACT Moxifloxacin is the most active fluoroquinolone against Mycobacterium tuberculosis in vitro . However , data about the efficacy in patients are not available . We enrolled 17 patients with tuberculosis in a prospect i ve , r and omized study . After 5 days of monotherapy with either moxifloxacin or isoniazid , we detected significant decreases in mean CFU per milliliter in sputum in both groups . The calculated early bactericidal activities for isoniazid and moxifloxacin were 0.209 and 0.273 log10 CFU per ml of sputum per day , respectively . According to the data from our study , moxifloxacin exhibits an early bactericidal activity that is comparable to that of isoniazid The early bactericidal activity ( EBA ) of ciprofloxacin ( CIP ) was measured in 80 patients with previously untreated , smear-positive pulmonary tuberculosis by counting viable bacilli in sputum collection s during the first 2 d of treatment . Groups of about 10 patients were treated daily with grade d doses of CIP or with 300 mg isoniazid or with no drug . The mean EBA , defined as the fall in log CFU/ ml sputum/d , increased from -0.011 in the no drug group to 0.046 , 0.092 , 0.121 , and 0.205 in the groups receiving 250 , 500 , 1,000 , or 1,500 mg CIP , respectively , a highly significant trend . These results demonstrate the antimycobacterial activity of CIP in high dosage , though the mean EBAs of 0.55 and 0.66 in two groups receiving isoniazid were much higher THE R AND OMIZED controlled trial ( RCT ) , more than any other methodology , can have a powerful and immediate impact on patient care . Ideally , the report of such an evaluation needs to convey to the reader relevant information concerning the design , conduct , analysis , and generalizability of the trial . This information should provide the reader with the ability to make informed judgments regarding the internal and external validity of the trial . Accurate and complete reporting also benefits editors and review ers in their deliberations regarding su bmi tted manuscripts . For RCTs to ultimately benefit patients , the published report should be of the highest possible st and ard ABSTRACT PA-824 is a novel nitroimidazo-oxazine being evaluated for its potential to improve tuberculosis ( TB ) therapy . This r and omized study evaluated safety , tolerability , pharmacokinetics , and extended early bactericidal activity of PA-824 in drug-sensitive , sputum smear-positive , adult pulmonary tuberculosis patients . Fifteen patients per cohort received 1 of 4 doses of oral PA-824 : 200 , 600 , 1,000 , or 1,200 mg per day for 14 days . Eight subjects received once daily st and ard antituberculosis treatment as positive control . The primary efficacy endpoint was the mean rate of change in log CFU of Mycobacterium tuberculosis in sputum incubated on agar plates from serial overnight sputum collection s , expressed as log10 CFU/day/ml ( ± st and ard deviation [ SD ] ) . The drug demonstrated increases that were dose linear but less than dose proportional in serum concentrations in doses from 200 to 1,000 mg daily . Dosing of 1,200 mg gave no additional exposure compared to 1,000 mg daily . The mean daily CFU fall under st and ard treatment was 0.148 ( ±0.055 ) , consistent with that found in previous studies . The mean daily fall under PA-824 was 0.098 ( ±0.072 ) and was equivalent for all four dosages . PA-824 appeared safe and well tolerated ; the incidence of adverse events potentially related to PA-824 appeared dose related . We conclude that PA-824 demonstrated bactericidal activity over the dose range of 200 to 1,200 mg daily over 14 days . Because maximum efficacy was unexpectedly achieved at the lowest dosage tested , the activity of lower dosages should now be explored SETTING This pilot study was conducted at the Joint Clinical Research Centre ( JCRC ) in Kampala , Ug and a , where tuberculosis ( TB ) is an epidemic health problem aggravated by the HIV-1 p and emic . OBJECTIVE To evaluate the feasibility of a larger phase III trial utilizing rifabutin as a substitute for rifampicin in short-course therapy for pulmonary TB . DESIGN Single-blind r and omized trial in 50 patients with new onset smear- and culture-positive pulmonary tuberculosis and HIV-1 infection . Comparison of daily , intermittently supervised 6-month treatment regimens of rifabutin versus rifampicin , together with isoniazid , ethambutol and pyrazinamide . RESULTS Rifabutin- and rifampicin-containing regimens had comparable efficiency . However , rifabutin-treated patients had significantly more rapid clearance of acid-fast bacilli from sputum at 2 months ( P < 0.05 , Fisher exact test ) and over the entire study period ( P < 0.05 , logrank test ) than rifampicin-treated patients . The presence of cavitary disease was associated with a longer sputum conversion time for patients treated with either regimen . No major adverse events requiring dosage reduction or withdrawal of any study medication were seen in either treatment group . Mean absolute peripheral blood CD4 T lymphocyte counts increased by 28 % from week 0 to week 12 in all subjects ( 334 - 427/microliters , respectively ) . An unexpected finding was the isolation of Mycobacterium africanum from 49 % of the sputum cultures . This is the first report indicating a high prevalence of M. africanum in human TB in Ug and a. CONCLUSION Short-course antituberculosis regimens containing rifabutin or rifampicin are both safe and efficacious in the treatment of HIV-1 associated tuberculosis . Rifabutin-containing regimens were associated with earlier sputum smear and culture conversion BACKGROUND Delamanid ( OPC-67683 ) is a novel mycolic acid bio synthesis inhibitor active against Mycobacterium tuberculosis at a low minimum inhibitory concentration . METHODS Forty-eight patients with smear-positive tuberculosis ( 63 % male ; 54.7 ± 9.9 kg ; 30.7 ± 10.8 years ) were r and omly assigned to receive delamanid 100 , 200 , 300 or 400 mg daily for 14 days . Colony forming units ( cfu ) of M. tuberculosis were counted on agar plates from overnight sputum collection s to calculate early bactericidal activity ( EBA ) , defined as fall in log(10 ) cfu/ml sputum/day . RESULTS The EBA of delamanid was monophasic and not significantly different between dosages ; however , more patients receiving 200 mg ( 70 % ) and 300 mg ( 80 % ) experienced a response of ≥0.9 log(10 ) cfu/ml sputum decline over 14 days than those receiving 100 mg ( 45 % ) and 400 mg ( 27 % ) . The average EBA of all dosages combined ( 0.040 ± 0.056 log(10 ) cfu/ml sputum/day ) was significant from day 2 onward . Delamanid exposure was less than dosage-proportional , reaching a plateau at 300 mg , likely due to dose-limited absorption . Moderate but significant correlation was found between C(max ) and EBA , indicating exposure dependence . Delamanid was well tolerated without significant toxicity . CONCLUSIONS Delamanid at all dosages was safe , well tolerated and demonstrated significant exposure-dependent EBA over 14 days , supporting further investigation of its pharmacokinetics and anti-tuberculosis activity ABSTRACT Rifalazil , also known as KRM-1648 or benzoxazinorifamycin , is a new semisynthetic rifamycin with a long half-life of approximately 60 h. Rifalazil has potent bactericidal activity againstMycobacterium tuberculosis in vitro and in animal models of tuberculosis ( TB ) . Prior studies in healthy volunteers showed that once-weekly doses of 25 to 50 mg of rifalazil were well tolerated . In this r and omized , open-label , active-controlled phase II clinical trial , 65 subjects with sputum smear-positive pulmonary TB received one of the following regimens for the first 2 weeks of therapy : 16 subjects received isoniazid ( INH ) ( 5 mg/kg of body weight ) daily ; 16 received INH ( 5 mg/kg ) and rifampin ( 10 mg/kg ) daily ; 17 received INH ( 5 mg/kg ) daily plus 10 mg of rifalazil once weekly ; and 16 received INH ( 5 mg/kg ) daily and 25 mg of rifalazil once weekly . All subjects were then put on 6 months of st and ard TB therapy . Pretreatment and day 15 sputum CFU of M. tuberculosis were measured to assess the bactericidal activity of each regimen . The number of drug-related adverse experiences was low and not significantly different among treatment arms . A transient decrease in absolute neutrophil count to less than 2,000 cells/mm3 was detected in 10 to 20 % of patients in the rifalazil- and rifampin-containing treatment arms without clinical consequences . Decreases in CFU counts were comparable among the four treatment arms ; however , the CFU results were statistically inconclusive due to the variability in the control arms . Acquired drug resistance did not occur in any patient . Studies focused on determining a maximum tolerated dose will help eluci date the full anti-TB effect of rifalazil Some beta-lactam antibiotics are active in vitro against Mycobacterium tuberculosis . There are anecdotal reports of successful treatment of tuberculosis caused by multiple-drug-resistant strains of M. tuberculosis with regimens that included amoxicillin/clavulanate . Reduction of M. tuberculosis in the sputum of patients with pulmonary tuberculosis during administration of amoxicillin/clavulanate was measured by a quantitative culture method to determine the activity in vivo . Patients were r and omized to receive isoniazid , ofloxacin , or amoxicillin/clavulanate for 7 days . Isoniazid was the most effective agent , reducing M. tuberculosis after 2 days at a mean rate ( + /- st and ard deviation ) of 0.60 + /- 0.30 log10 cfu/mL per day , compared with 0.32 + /- 0.05 and 0.34 + /- 0.03 for ofloxacin and amoxicillin/clavulanate , respectively . The early bactericidal activity of amoxicillin/clavulanate was comparable to that reported for antituberculous agents other than isoniazid . Further studies of beta-lactam antibiotics with in vitro activity against M. tuberculosis are warranted to define their role in treatment of tuberculosis RATIONALE Linezolid , the first oxazolidinone approved for clinical use , has effective in vitro and promising in vivo activity against Mycobacterium tuberculosis . OBJECTIVES To evaluate the early and extended early bactericidal activity of linezolid in patients with pulmonary tuberculosis . METHODS R and omized open label trial . Thirty patients with newly diagnosed smear-positive pulmonary tuberculosis ( 10 per arm ) were assigned to receive isoniazid ( 300 mg daily ) and linezolid ( 600 mg twice daily or 600 mg once daily ) for 7 days . Sputum for quantitative culture was collected for 2 days before and then daily during 7 days of study drug administration . Bactericidal activity was estimated by measuring the decline in bacilli during the first 2 days ( early bactericidal activity ) and the last 5 days of study drug administration ( extended early bactericidal activity ) . MEASUREMENTS AND MAIN RESULTS The mean early bactericidal activity of isoniazid ( 0.67 log10 cfu/ml/d ) was greater than that of linezolid twice and once daily ( 0.26 and 0.18 log10 cfu/ml/d , respectively ) . The extended early bactericidal activity of linezolid between Days 2 and 7 was minimal . CONCLUSIONS Linezolid has modest early bactericidal activity against rapidly dividing tubercle bacilli in patients with cavitary pulmonary tuberculosis during the first 2 days of administration , but little extended early bactericidal activity . Clinical trial registered with www . clinical trials.gov ( NCT00396084 ) The bactericidal action of two therapeutic regimens on Mycobacterium tuberculosis was assessed by viable counts in serial sputum sample s in 49 pulmonary tuberculosis patients being treated with rifampicin ( R ) , ethambutol ( Emb ) , isoniazid ( I ) and pyrazinamide ( Z ) together in a single dose thrice weekly ( REmbIZ3 ) or with REmb and IZ on alternate days ( REmb3IZ3alt ) . In both groups of patients , there was a significant reduction ( P < or = 0.02 ) in the colony forming units ( cfu ) of M. tuberculosis per ml of sputum during the first two days of treatment itself . This early bactericidal action ( EBA ) as well as the reduction in counts during the subsequent days of treatment were similar ( P > 0.2 ) for both REmbIZ3 and REmb3IZ3alt regimens indicating that splitting up REmbIZ into REmb on one day and IZ on the next day in short course chemotherapy ( SCC ) regimens may not affect the bactericidal action of the regimens BACKGROUND New treatments are needed to shorten the time required to cure tuberculosis and to treat drug-resistant strains . The fluoroquinolone moxifloxacin is a promising new agent that might have additive activity to existing antituberculosis agents . We assessed the activity and safety of moxifloxacin in the initial stage of tuberculosis treatment . METHODS We undertook a phase II , double-blind , r and omised controlled trial of a regimen that included moxifloxacin in adults with sputum smear-positive tuberculosis at one hospital in Rio de Janeiro , Brazil . 170 participants received isoniazid , rifampicin , and pyrazinamide at st and ard doses and were assigned by permuted block r and omisation to receive either moxifloxacin ( 400 mg ) with an ethambutol placebo ( n=85 ) or ethambutol ( 15 - 20 mg/kg ) plus moxifloxacin placebo ( n=85 ) 5 days per week for 8 weeks . The primary endpoint was the proportion of patients whose sputum culture had converted to negative by week 8 . Analysis was by modified intention to treat ( ITT ) ; patients whose baseline cultures were negative , contaminated , or contained drug-resistant Mycobacterium tuberculosis were excluded from the analysis . Additionally , all missing 8-week results were deemed treatment failures . This study is registered with Clinical Trials.gov , number NCT00082173 . FINDINGS 74 patients assigned to the moxifloxacin group and 72 in the ethambutol group were included in the modified ITT population . 125 patients had 8-week data ( moxifloxacin n=64 , ethambutol n=61 ) ; the main reason for absence of data was culture contamination . At 8 weeks , culture conversion to negative had occurred in 59 ( 80 % ) of 74 patients in the moxifloxacin group compared with 45 ( 63 % ) of 72 in the ethambutol group ( difference 17.2 % , 95 % CI 2.8 - 31.7 ; p=0.03 ) . There were 16 adverse events ( eight in each group ) in 12 patients . Only one event was judged related to study drug ( grade 3 cutaneous reaction in the ethambutol group ) . INTERPRETATION Moxifloxacin improved culture conversion in the initial phase of tuberculosis treatment . Trials to assess whether moxifloxacin can be used to shorten the duration of tuberculosis treatment are justified |
11,578 | 24,282,112 | Both studies failed to find any statistical differences in terms of adherence to the intervention and occurrence of other asthma-related complications . | BACKGROUND Asthma is one of the most common long-term conditions worldwide , which places considerable pressure on patients , communities and health systems .
The major international clinical guidelines now recommend the inclusion of self management programmes in the routine management of patients with asthma .
These programmes have been associated with improved outcomes in patients with asthma .
However , the implementation of self management programmes in clinical practice , and their uptake by patients , is still poor .
Recent developments in mobile technology , such as smartphone and tablet computer apps , could help develop a platform for the delivery of self management interventions that are highly customisable , low-cost and easily accessible .
OBJECTIVES To assess the effectiveness , cost-effectiveness and feasibility of using smartphone and tablet apps to facilitate the self management of individuals with asthma . | Objective To determine whether mobile phone based monitoring improves asthma control compared with st and ard paper based monitoring strategies . Design Multicentre r and omised controlled trial with cost effectiveness analysis . Setting UK primary care . Participants 288 adolescents and adults with poorly controlled asthma ( asthma control question naire ( ACQ ) score ≥1.5 ) from 32 practice s. Intervention Participants were central ly r and omised to twice daily recording and mobile phone based transmission of symptoms , drug use , and peak flow with immediate feedback prompting action according to an agreed plan or paper based monitoring . Main outcome measures Changes in scores on asthma control question naire and self efficacy ( knowledge , attitude , and self efficacy asthma question naire ( KASE-AQ ) ) at six months after r and omisation . Assessment of outcomes was blinded . Analysis was on an intention to treat basis . Results There was no significant difference in the change in asthma control or self efficacy between the two groups ( ACQ : mean change 0.75 in mobile group v 0.73 in paper group , mean difference in change −0.02 ( 95 % confidence interval −0.23 to 0.19 ) ; KASE-AQ score : mean change −4.4 v −2.4 , mean difference 2.0 ( −0.3 to 4.2 ) ) . The numbers of patients who had acute exacerbations , steroid courses , and unscheduled consultations were similar in both groups , with similar healthcare costs . Overall , the mobile phone service was more expensive because of the expenses of telemonitoring . Conclusions Mobile technology does not improve asthma control or increase self efficacy compared with paper based monitoring when both groups received clinical care to guidelines st and ards . The mobile technology was not cost effective . Trial registration Clinical Trials NCT00512837 AIMS There is increasing international interest in using emerging technologies to enhance chronic disease management . We aim ed to explore the attitudes of patients and primary care professionals to using mobile technology in order to monitor asthma . METHODS A piloted question naire containing closed and open-ended questions assessing attitudes to using electronic self-monitoring was posted to a r and om sample of general practitioners , asthma nurses , and people with asthma ( 12 years and over ) in Lothian and Kent , UK , with 2 reminders . In addition to descriptive statistics , patient and clinician responses were compared using Chi-squared or independent sample t-tests . Free-text responses were analysed thematically . RESULTS Responses were obtained from 130/300 professionals ( 43 % ) and 202/389 patients ( 52 % ) . Patients rated the technology positively and considered that it may help clinicians to provide care , especially during acute attacks . Although rated similarly , professionals were more sceptical about benefits . Both professionals and patients had concerns about the time and cost implication s. Of the respondents , 28 professionals ( 10 % ) and 62 patients ( 16 % ) returned uncompleted question naires citing lack of perceived relevance . CONCLUSIONS The low completion rate probably reflects the current status of mobile phone-facilitated care as a minority interest for ' early adopters ' of technology . Even for the enthusiastic minority , using mobile phone technology raised questions of clinical benefit , impact on self-management , and concerns about workload and cost , which will need to be addressed prior to wider acceptance The self-management of asthma can improve clinical outcomes . Recently , mobile telephones have been widely used as an efficient , instant personal communication tool . This study investigated whether a self-care system will achieve better asthma control through a mobile telephone-based interactive programme . This was a prospect i ve , controlled study in outpatient clinics . From 120 consecutive patients with moderate-to-severe persistent asthma , 89 were eventually recruited for the study , with 43 in the mobile telephone group ( with a mobile telephone-based interactive asthma self-care system ) . In the mobile telephone group , mean±sem peak expiratory flow rate significantly increased at 4 ( 378.2±9.3 L·min−1 ; n = 43 ; p = 0.020 ) , 5 ( 378.2±9.2 L·min−1 ; n = 43 ; p = 0.008 ) and 6 months ( 382.7±8.6 L·min−1 ; n = 43 ; p = 0.001 ) compared to the control group . Mean±sem forced expiratory volume in 1 s significantly increased at 6 months ( 65.2±3.2 % predicted ; n = 43 ; p<0.05 ) . Patients in the mobile telephone group had better quality of life after 3 months , as determined using the Short Form-12 ® physical component score , and fewer episodes of exacerbation and unscheduled visits than the control group . Patients in the mobile telephone group significantly increased their mean daily dose of either systemic or inhaled corticosteroids compared with the control group . The mobile telephone-based interactive self-care system provides a convenient and practical self-monitoring and -management of asthma , and improves asthma control Objectives : To determine whether well trained lay people could deliver asthma self-management education with comparable outcomes to that achieved by primary care based practice nurses . Design : R and omised equivalence trial . Setting : 39 general practice s in West London and North West Engl and . Participants : 567 patients with asthma who were on regular maintenance therapy . 15 lay educators were recruited and trained to deliver asthma self-management education . Intervention : An initial consultation of up to 45 min offered either by a lay educator or a practice based primary care nurse , followed by a second shorter face to face consultation and telephone follow-up for 1 year . Main outcome measures : Unscheduled need for healthcare . Secondary outcome measures : Patient satisfaction and need for courses of oral steroids . Results : 567 patients were r and omised to care by a nurse ( n = 287 ) or a lay educator ( n = 280 ) and 146 and 171 , respectively , attended the first face to face educational session . During the first two consultations , management changes were made in 35/146 patients seen by a practice nurse ( 24.0 % ) and in 56/171 patients ( 32.7 % ) seen by a lay educator . For 418/567 patients ( 73.7 % ) , we have 1 year data on use of unscheduled healthcare . Under an intention to treat approach , 61/205 patients ( 29.8 % ) in the nurse led group required unscheduled care compared with 65/213 ( 30.5 % ) in the lay led group ( 90 % CI for difference −8.1 % to 6.6 % ; 95 % CI for difference −9.5 % to 8.0 % ) . The 90 % CI contained the predetermined equivalence region ( −5 % to + 5 % ) giving an inconclusive result regarding the equivalence of the two approaches . Despite the fact that all patients had been prescribed regular maintenance therapy , 122/418 patients ( 29.2 % ) required courses of steroid tablets during the course of 1 year . Patient satisfaction following the initial face to face consultation was similar in both groups . Conclusions : It is possible to recruit and train lay educators to deliver a discrete area of respiratory care , with comparable outcomes to those seen by nurses . Trial registration number : AIM To evaluate patient underst and ing of their asthma and determine patient preferences regarding the delivery of asthma care and treatment . METHODS Adults with asthma receiving treatment for mild to moderate asthma were recruited to a two-part study : a qualitative phase using a semi-structured interview schedule followed by a quantitative phase based on a structured interview schedule . All interviews were undertaken face-to-face . SETTING AND SUBJECTS A r and om sample of 40 patients with mild to moderate asthma from seven areas of the UK took part in the qualitative phase of the study . In the quantitative phase , 517 patients on treatment for mild to moderate asthma were interviewed in person by market research ers . This population was achieved using a quota sampling approach that also achieved a representative demographic profile . Initial contact was made in door-to-door calls . Interviews took place in 64 locations across the UK . RESULTS Ninety-one percent ( n=468 ) of respondents felt their asthma was under control , yet two-thirds ( n=339 ) experienced symptoms at least 2 - 3 times a week . Only 24 % ( n=123 ) felt their asthma could improve over time , and 71 % ( n=366 ) received no advice from healthcare professionals on how their asthma might change in the future . Fourteen percent ( n=74 ) of respondents had no ongoing contact with any healthcare professional regarding their asthma . Fifty-eight percent ( n=301 ) were very satisfied with their asthma care , but this dropped to 33 % ( n=173 ) when respondents were shown asthma guidelines regarding what to expect from treatment . Sixty-two percent ( n=318 ) of respondents said their asthma varied at different times of the day , and 86 % ( n=444 ) stated that their asthma varied at different times of the year . Eighty percent ( n=414 ) of respondents had never been provided with a written , personal asthma action plan recommending changes patients could make themselves to prescribed treatment according to symptom severity , though 68 % ( n=353 ) said they would feel comfortable following such a plan . CONCLUSIONS Most patients have low expectations of what can be achieved by asthma management and do not realise their condition can be improved . Many are resigned to the effects of poor asthma control until made aware that guidelines indicate this can be better . Given that many are receptive to the notion of written , personal asthma action plans , the implementation of these , supported by appropriate education , could help patients achieve improved asthma control BACKGROUND Adherence to medication regimens is poor in the management of chronic diseases , including asthma . OBJECTIVE To determine whether an audiovisual reminder device improves adherence with inhaled corticosteroid ( ICS ) therapy in adult asthma . METHODS A r and omized open-label parallel group study of 110 adult or adolescent subjects with asthma was undertaken . Subjects were r and omized to receive 24 weeks of fluticasone propionate 250 microg , 1 actuation twice daily via a metered dose inhaler ( MDI ) with or without an audiovisual reminder function ( AVRF ) . All MDIs had electronic covert adherence monitors . The primary outcome variable was adherence , defined as the proportion of medication taken as prescribed over the final 12 weeks of the study . Adherence was also assessed as the proportion of subjects who took > 50 % , > 80 % , or > 90 % of prescribed medication . RESULTS The proportion of medication taken in the last 12 weeks was greater in the AVRF group ( 93 % ) compared with the control group ( 74 % ) , with a difference of 18 % ( 95 % confidence interval [ CI ] 10 - 26 % ; P < .0001 ) . The proportion of subjects taking > 50 % , > 80 % , or > 90 % of their medication was greater in the AVRF group , with a ratio of proportions adherent of 1.33 ( 95 % CI , 1.10 - 1.61 ; P = .003 ) , 2.27 ( 95 % CI , 1.56 - 3.3 ; P < .0001 ) , and 3.25 ( 95 % CI , 1.74 - 6.1 % ; P < .0001 ) , respectively . CONCLUSION An audiovisual reminder function can significantly improve adherence with ICS therapy in adult asthma . CLINICAL IMPLICATION S An audiovisual reminder function has potential to improve adherence with medication regimens across a wide spectrum of diseases , in both research and clinical practice Objective . To evaluate the impact of peak flow or symptom-based self – management plans on asthma control and patients ' quality of life and to determine the main psychosocial factors that affect compliance with these plans . Methods . The study sample consisted of 63 patients with persistent asthma out patients . Data collection included demographics , pulmonary functions , symptom scores , and asthma control parameters recorded over the previous 2 consecutive years . A st and ard asthma self-management education program including personal action plans was given to the patients who were r and omly divided into peak flow meter ( PFM ) ( n = 31 ) or symptom-based ( n = 32 ) action plan groups . Patients were then assessed prospect ively for various study outcomes including symptoms , drug compliance , psychiatric co-morbidities , quality of life , and asthma control over the next 12 months . Psychiatric co-morbidities were assessed using Rotter 's Internal and External Locus of Control Scale ( RIELCS ) , Beck Depression Inventory ( BDI ) , Structured Clinical Interview for DSM-IV ( SCID-I ) , Spielberger State-Trait-Anxiety Inventory ( STAI ) , and Short Form-36 ( SF-36 ) . Results . Of the 63 patients ( 79 % female ; mean age 43 ) , 85 % of them had moderately or severely persistent asthma . Baseline demographics , clinical parameters , psychiatric diagnosis , and quality of life were not different between groups . Personal asthma plans increased optimal asthma control significantly . Emergency visits , antibiotic treatments , systemic corticosteroid treatments , and unscheduled visits were fewer than the previous year . Control parameters were better in the PFM group . After the self-management education , the quality of life dimensions , i.e. , vitality , total mental and general scores of both groups increased . Frequency of psychiatric co-morbidities decreased from 61.9 % to 49.2 % . However , state anxiety levels were increased in both groups . These increases were statistically significant in the PFM group . Compliance with the action plans was better in the PFM group . Higher BDI scores were associated with worse compliance . No statistically significant association was found between demographic parameters and the compliance . Although the compliance had decreased in both groups after 6 months , this decrease was greater in the symptom group . Higher RIELCS and mental health scores were associated with better compliance . Conclusion . Introduction of self-management plans improved illness control and quality of life in asthma patients . Use of the PFM and the presence of higher RIELCS and lower BDI scores can be used to predict compliance with the action plans RATIONALE Poor adherence to asthma controller medications results in poor treatment outcomes . OBJECTIVES To compare controller medication adherence and clinical outcomes in 612 adults with poorly controlled asthma r and omized to one of two different treatment decision-making models or to usual care . METHODS In shared decision making ( SDM ) , nonphysician clinicians and patients negotiated a treatment regimen that accommo date d patient goals and preferences . In clinician decision making , treatment was prescribed without specifically eliciting patient goals /preferences . The otherwise identical intervention protocol s both provided asthma education and involved two in-person and three brief phone encounters . MEASUREMENTS AND MAIN RESULTS Refill adherence was measured using continuous medication acquisition ( CMA ) indices-the total days ' supply acquired per year divided by 365 days . Cumulative controller medication dose was measured in beclomethasone canister equivalents . In follow-up Year 1 , compared with usual care , SDM result ed in : significantly better controller adherence ( CMA , 0.67 vs. 0.46 ; P < 0.0001 ) and long-acting beta-agonist adherence ( CMA , 0.51 vs. 0.40 ; P = 0.0225 ) ; higher cumulative controller medication dose ( canister equivalent , 10.9 vs. 5.2 ; P < 0.0001 ) ; significantly better clinical outcomes ( asthma-related quality of life , health care use , rescue medication use , asthma control , and lung function ) . In Year 2 , compared with usual care , SDM result ed in significantly lower rescue medication use , the sole clinical outcome available for that year . Compared with clinician decision making , SDM result ed in : significantly better controller adherence ( CMA , 0.67 vs. 0.59 ; P = 0.03 ) and long-acting beta-agonist adherence ( CMA , 0.51 vs. 0.41 ; P = 0.0143 ) ; higher cumulative controller dose ( CMA , 10.9 vs. 9.1 ; P = 0.005 ) ; and quantitatively , but not significantly , better outcomes on all clinical measures . CONCLUSIONS Negotiating patients ' treatment decisions significantly improves adherence to asthma pharmacotherapy and clinical outcomes . Clinical trials registered with www . clinical trials.gov ( NCT00217945 and NCT00149526 ) The aim of the study was to assess the effectiveness of a computerized limited asthma education program , design ed to suit young people . The study was conducted with 97 young adults ( 18 - 25 years ) with asthma , 48 were r and omized to the intervention group and 49 to the control group , and they were followed for 12 months . The intervention group completed an interactive computer program of 30-min duration providing information about asthma , mechanisms , trigger factors , allergies and medication use , which was followed by a 30-min discussion with a specialized asthma nurse . The control group followed the routine schedule for asthma out patients . The outcomes of the study were number of hospital admissions , emergency visits , asthma symptoms , knowledge about asthma , lung function and quality of life . No effect was found regarding admission to hospital , emergency visits , prevalence of respiratory symptoms , knowledge of asthma or quality of life . However , forced exhaled volume in 1s ( FEV(1 ) ) increased significantly , mainly among the atopic subjects . In conclusion , an intervention with a limited asthma education program did not show an effect on asthma symptoms , asthma knowledge or quality of life parameters Context Patient self-management is an essential component of asthma care , and the Internet is a medium to potentially support patients in self-management . Contribution This r and omized trial compared Internet-based asthma self-management with usual care and found modest improvements in asthma control and lung function with the Internet intervention , but found no reduction in exacerbations and changes in asthma-related quality of life that were less than clinical ly significant at 12 months . Implication Although Internet-based self management can improve some asthma outcomes , the improvements were small and the program did not reduce the number of exacerbations . The Editors Asthma is a chronic disorder of the airways that is characterized by recurring respiratory symptoms , variable airflow obstruction , airway hyperresponsiveness , and underlying inflammation ( 1 , 2 ) . Recent clinical guidelines for the management of asthma distinguish 4 essential components of asthma care : assessment and monitoring , patient education , control of environmental and comorbid factors that affect asthma , and drug treatment . With appropriate medical care , well-informed and empowered patients can control their asthma and live full , active lives ( 1 , 2 ) . However , despite the availability of monitoring tools and effective therapy , asthma control is suboptimal in many patients worldwide , and long-term management falls far short of the goals set in the guidelines ( 3 ) . Self-monitoring , education , and specific medical care are important aspects in improving the lives of patients with asthma ( 1 , 2 ) . However , many patients with mild or moderate persistent asthma do not attend checkups regularly or visit their physician with symptoms of the disease ( 4 ) . In addition , in practice , both patients and their health care providers are reluctant to use written self-management plans ( 5 ) . Internet technology is increasingly seen as an appealing tool to support self-management for patients with chronic disease in remote and underserved population s ( 68 ) . However , to date , studies on Internet-based asthma self-management show only short-term improvements in asthma control , lung function , and quality of life ( 911 ) . Long-term studies on the effect of Internet-based self-management , including all its essential features , are not available . Therefore , we developed a guided self-management tool for adult patients with asthma that included Internet-based home monitoring and treatment advice ( action plan ) , online education , and remote Web communication with a specialized asthma nurse . The goal of our study was to assess the long-term clinical effectiveness of Internet-based self-management education compared with usual physician-provided care alone . Methods Design Overview We conducted a 12-month , multicenter , nonblinded , r and omized , controlled trial . We r and omly assigned patients to Internet-based self-management ( Internet group ) as an adjunct to usual care or to usual physician-provided care alone ( usual care group ) . The Internet-based self-management program included weekly asthma control monitoring and treatment advice , online and group education , and remote Web communications with a specialized asthma nurse . The intervention continued for 12 months after enrollment . The Medical Ethics Committee of the Leiden University Medical Center , Leiden , the Netherl and s , approved the study . Setting and Participants We recruited patients from 37 general practice s ( 69 general practitioners ) in the Leiden and The Hague area and the Outpatient Clinic of the Department of Pulmonology at the Leiden University Medical Center from September 2005 to September 2006 . Inclusion criteria were physician-diagnosed asthma coded according to the International Classification of Primary Care in the electronic medical record ( 12 ) , age 18 to 50 years , prescription of inhaled corticosteroids for at least 3 months in the previous year , no serious comorbid conditions that interfered with asthma treatment , access to the Internet at home , and mastery of the Dutch language . We excluded patients who were receiving maintenance oral glucocorticosteroid treatment . On the basis of diagnosis , age , prescribed asthma medication , and comorbid conditions , we sent eligible patients an invitation letter followed by 1 reminder letter after 2 to 4 weeks if they did not respond to the first . We continued this process until a total of 200 patients had entered the study ( September 2006 ) . All participants gave written consent . R and omization and Intervention In a 2-week baseline period before r and omization , we collected data on patient demographic characteristics , asthma-related quality of life , symptom control , lung function , and medication level . We provided basic education about core information on asthma , action of medications , and inhaler technique instructions to all patients . We trained all participants to measure FEV1 daily with a h and -held electronic spirometer ( PiKo-1 , Ferraris Respiratory , Hertford , United Kingdom ) and to report the highest value of 3 measurements in the morning before taking medication ( 2 , 13 ) . They were shown how to report these values on a personal page on a secure Web application by using a login password ( or how to report by mobile telephone text message ) . Patients were also asked to report their nighttime and daytime asthma symptom scores on this Internet page or by text message . We asked all participants to complete the Asthma Control Question naire on their personal Internet page each week ( 14 ) . We did not give any patients feedback about lung function or asthma control . After the 2-week baseline period , we r and omly assigned participants to either the Internet group or the usual care group . We stratified according to care provider ( primary vs. subspecialty care ) and asthma control at baseline ( 15 ) . We r and omly assigned patients to the 2 groups ( 1:1 ratio ) by using a computer-generated , permuted-block scheme . Allocation took place by computer after collection of the baseline data , ensuring concealment of allocation . The Internet-based self-management program consisted of the 4 principal components of asthma self-management and was accessed through the specially design ed Web site , which allowed monitoring through the Web site ( or text message on a mobile telephone ) , use of an Internet-based treatment plan , online education , and Web communications with a specialized asthma nurse ( 16 ) . Patients monitored their asthma weekly by completing an electronic version of the Asthma Control Question naire on the Web site and instantly received feedback on the current state of their asthma control along with advice on how to adjust their treatment according to a predefined algorithm and treatment plan ( Table 1 and Appendix Figures 1 , 2 , 3 , 4 , and 5 ) . Depending on the scores su bmi tted , patients received 4 types of self-treatment advice . When 4 consecutive Asthma Control Question naire scores were 0.5 or less , patients were advised to decrease treatment according to treatment plan . When 2 consecutive scores were greater than 0.5 but less than 1.0 , patients were advised to increase treatment according to treatment plan . When 1 score was 1.0 or more but less than 1.5 , patients were advised to immediately increase treatment according to treatment plan . Finally , when 1 score was 1.5 or more , patients were advised to immediately increase treatment and contact the asthma nurse . Table 1 . Treatment Plan Appendix Figure 1 . Algorithm based on consecutive ACQ scores to adjust medical treatment . * ACQ = Asthma Control Question naire . At entry of the algorithm , the evaluation period is bypassed . The evaluation period starts after treatment was stepped up . The optimal control period starts after 1 ACQ score 0.5 and ends after 1 ACQ score > 0.5 . Appendix Figure 2 . Screen shot of daily lung function and symptom monitoring . Appendix Figure 3 . Screen shot of feedback on daily lung function and symptom monitoring . Appendix Figure 4 . Screen shot of weekly Asthma Control Question naire monitoring . Appendix Figure 5 . Screen shot of feedback on Asthma Control Question naire , treatment advice according to personalized treatment plan , and results of past 6 months . We advised no medication changes during the 4 weeks after treatment was stepped up ( evaluation period ) . In addition to weekly assessment s , patients could optionally report daily symptoms and lung function and were able to contact our asthma nurse though the Web or by telephone . Thus , any acute deterioration warranting a visit to the general practitioner or hospital could be detected ( Appendix Figures 2 and 3 ) . We aim ed to empower patients to use the Internet-based self-management tool and to develop a patientprovider partnership in asthma care ( 2 ) . Self-management education consisted of both Web-based and face-to-face , group-based education . Web-based education included asthma information , news , frequently asked questions , and interactive communication with a respiratory nurse specialist . We scheduled 2 group-based education sessions , which lasted 45 to 60 minutes , for patients in the Internet-based self-management group within 6 weeks after entering the trial . Both sessions included exploration of a patient 's interests and previous knowledge ( negotiating an agenda and patient-centered education ) , personalized feedback , and empowerment of self-management ( self-efficacy and implementing a plan for change ) ( 2 , 17 ) . The first educational session also included pathophysiology of asthma , information on the Web-based action plan , and information and review of inhalation technique . The second educational session gave information about the mechanisms and side effects of medication and explained trigger avoidance . Patients in the usual care group received asthma care according to the Dutch general practice guidelines on asthma management in adults , which recommend a medical review and treatment adjustment every 2 to 4 weeks in unstable asthma and medical review once or twice The CYMPLA trial . Mobile phone-based str rct rred intervention to achieve asthma control in patients with rncontrolled persistent asthma : a pragmatic r and omised controlled |
11,579 | 27,087,044 | One head‐to‐head study of very low‐ quality evidence comparing FAEs with methotrexate reported comparable efficacy and dropout rates , although FAEs caused more flushing . | Summary Fumaric acid esters ( FAEs ) are licensed for the treatment of moderate‐to‐severe psoriasis in Germany but are also used off‐label in many other countries .
We conducted this systematic review to synthesize the highest‐ quality evidence for the benefits and risks of FAEs for psoriasis . | Acitretin , the principal and free acid metabolite of etretinate , was used to treat patients with stable , plaque-type psoriasis . For the first 8 weeks , 38 patients received placebo or acitretin , 10 , 25 , 50 , or 75 mg daily , in a double-blind manner . After the double-blind phase , the patients were allowed to continue for a total of 6 months of acitretin therapy at an average dosage of 50 mg/day . When the patients flared after stopping therapy , an additional 6-month course of acitretin therapy was offered . Acitretin , which was as effective as etretinate , had to be given at a dosage of 50 mg/day or more to obtain a significant benefit . Side effects frequently occurred in patients receiving acitretin , 25 mg/day or more , but were generally mild and did not warrant discontinuation of therapy . They were similar to those of etretinate therapy ; cheilitis , peeling of palms and soles , and alopecia occurred most frequently . The most common abnormal laboratory test results were elevations in serum triglycerides and , to a lesser extent , serum cholesterol and liver transaminase levels . Acitretin , in view of its much shorter half-life and similar efficacy and side-effect profile compared with etretinate , may be a preferable therapy for psoriasis , especially in women of childbearing age Acitretin , the active metabolite of etretinate , has the clinical advantage of a much shorter terminal elimination half-life . We report the results of a double-blind , placebo-controlled trial of acitretin ( Soriatane ) in 15 patients with moderate to severe psoriasis . Patients received 25 mg or 50 mg daily of acitretin or placebo in a double-blind fashion for 8 weeks and then were given 25 to 75 mg acitretin daily during an open study . Only two placebo patients completed the double-blind phase ; one patient 's psoriasis worsened , and one showed no significant change . All 15 patients then completed at least 8 weeks with 25 to 75 mg acitretin daily , with a moderate change in erythema , scaling , and in duration ( mean 28 % to 37 % improvement ) but with minimal change in the percentage of body surface area involved . Prolonged treatment ( greater than or equal to 20 weeks ) with acitretin result ed in further significant improvement and a 44 % reduction of involved surface area from baseline Acitretin , a metabolite of etretinate , was given to 38 patients for the treatment of psoriasis . During the first 8 weeks patients received either placebo , 10 mg , 25 mg , 50 mg , or 75 mg of acitretin daily in a double-blind manner . The dosages of 10 mg and 25 mg daily did not achieve any statistically significant improvement in psoriasis over placebo ; however , both the 50 and 75 mg dosages were statistically significantly better than placebo . Side effects were primarily mucocutaneous and occurred in most patients receiving 25 mg or more of acitretin daily . After the double-blind period , patients continued treatment in an open fashion until they had received a total of 24 weeks of acitretin therapy . Most patients received 50 mg of acitretin daily , which adequately cleared their psoriasis . After approximately 3 months without acitretin , most patients required retreatment . Subsequent 24-week courses of therapy were generally effective and well tolerated . The most common laboratory abnormalities were elevations of triglyceride , cholesterol , and liver transaminase levels . The efficacy and side effects of acitretin appear to be similar to those of etretinate ; the principal advantage of acitretin is its shorter half-life . Although acitretin is a potent teratogen , its rapid elimination makes it a viable treatment for psoriasis among women of childbearing potential BACKGROUND Psoriasis vulgaris may benefit from treatment with fumaric acid and /or its derivatives ; however , because different preparations have been used , results have been contradictory and difficult to interpret . OBJECTIVE The purpose of this clinical trial was to evaluate the therapeutic value of fumaric acid derivatives . METHODS A r and omized double-blind study was carried out in patients with psoriasis , comparing a well-characterized formulation of fumaric acid derivatives with placebo . RESULTS The results indicated statistically significant superiority of the fumaric acid derivatives over placebo . Adverse events ( flush , gastrointestinal disturbances ) were initially relatively frequent , but decreased thereafter . CONCLUSION Fumaric acid derivatives were found to be effective and safe in the treatment of psoriasis In a 4-month double-blind study the effects of dimethylfumaric acid esters ( DMFAE-EC ) and DMFAE plus salts of monoethylfumaric acid esters ( fumaric acid combination , FAC-EC ) in enteric-coated tablets were compared in 22 respectively 23 patients with psoriasis . In both groups about 50 % showed a considerable improvement , i.e. the initial score was more than halved . The therapeutic effects showed no significant differences in both groups with respect to the total psoriasis score or the different parameters . In the FAC-EC group the effects were obtained more rapidly . Most frequently observed side effects in both groups were flushings , stomachache and diarrhea . Due to these complaints 3 respectively 8 patients discontinued therapy . Eosinophilia , leukopenia and lymphopenia were the most frequently observed differences in lab tests . It was concluded that FAC-EC had no significantly better effect than monotherapy with DMFAE-EC . Moreover , enteric coating of the tablets did not prevent stomach complaints . Until more information has been obtained about the pharmacokinetics , the toxicity and optimal composition of the drug , the fumaric acid therapy in psoriasis should be seen as experimental Background : Calcipotriol is an established topical therapy for psoriasis vulgaris . Objective : This study aim ed to investigate whether the addition of calcipotriol to fumaric acid ester ( FAE ) monotherapy had an additive efficacy and an FAE-sparing effect in patients with severe plaque psoriasis . Methods : This multicentre , r and omised , double-blind , vehicle-controlled study included 143 patients for up to 13 weeks treatment . Group A received FAE tablets ( Fumaderm ® ) with an increasing daily dosage from 105 to 1,075 mg + ointment vehicle . Group B received FAE tablets + calcipotriol ointment ( 50 µg/g ) . Ointments were applied twice daily . Clinical response was assessed using percentage changes in the Psoriasis Area and Severity Index ( PASI ) , from baseline to treatment end . Results : The mean percentage change in the PASI was –76.1 % in group B and –51.9 % in group A , the difference between treatments was –24.2 % ( 95 % CI from –34.2 to –14.2 % ; p < 0.001 ) . Group B responded more rapidly to treatment . Investigators ’ and patients ’ overall efficacy assessment s were significantly more favourable for group B ( p ≤ 0.001 ) . Group B was prescribed less FAE than group A. This difference was greatest at the last visit ( mean daily dose 529 and 685 mg , respectively ; p = 0.006 ) . Overall adverse events in the two groups were similar . Conclusion : This study shows that the combination of calcipotriol and FAEs is significantly more effective and faster acting than FAE monotherapy in the treatment of severe plaque psoriasis . The combination has a slight FEA-sparing effect and therefore a superior benefit/risk ratio |
11,580 | 28,265,583 | We found that significantly improved OS was noted for PC patients utilizing specific immunotherapy and an improved immune response was also observed .
In conclusion , specific immunotherapy was superior in prolonging the survival time and enhancing immunological responses in PC patients | Specific immunotherapies , including vaccines with autologous tumor cells and tumor antigen-specific monoclonal antibodies , are important treatments for PC patients . | Wilms tumor gene ( WT1 ) protein is an attractive target for cancer immunotherapy . We aim ed to investigate the feasibility of a combination therapy consisting of gemcitabine and WT1 peptide – based vaccine for patients with advanced pancreatic cancer and to make initial assessment s of its clinical efficacy and immunologic response . Thirty-two HLA-A*24:02 + patients with advanced pancreatic cancer were enrolled . Patients received HLA-A*24:02-restricted , modified 9-mer WT1 peptide ( 3 mg/body ) emulsified with Montanide ISA51 adjuvant ( WT1 vaccine ) intradermally biweekly and gemcitabine ( 1000 mg/m2 ) on days 1 , 8 , and 15 of a 28-day cycle . This combination therapy was well tolerated . The frequencies of grade 3–4 adverse events for this combination therapy were similar to those for gemcitabine alone . Objective response rate was 20.0 % ( 6/30 evaluable patients ) . Median survival time and 1-year survival rate were 8.1 months and 29 % , respectively . The association between longer survival and positive delayed-type hypersensitivity to WT1 peptide was statistically significant , and longer survivors featured a higher frequency of memory-phenotype WT1-specific cytotoxic T lymphocytes both before and after treatment . WT1 vaccine in combination with gemcitabine was well tolerated for patients with advanced pancreatic cancer . Delayed-type hypersensitivity-positivity to WT1 peptide and a higher frequency of memory-phenotype WT1-specific cytotoxic T lymphocytes could be useful prognostic markers for survival in the combination therapy with gemcitabine and WT1 vaccine . Further clinical investigation is warranted to determine the effectiveness of this combination therapy Background Advanced pancreatic cancer has a poor prognosis , and the current st and ard of care ( gemcitabine based chemotherapy ) provides a small survival advantage . However the drawback is the accompanying systemic toxicity , which targeted treatments may overcome . This study aim ed to evaluate the safety and tolerability of KAb201 , an anti-carcinoembryonic antigen monoclonal antibody , labelled with I131 in pancreatic cancer ( IS RCT N 16857581 ) . Methods Patients with histological/cytological proven inoperable adenocarcinoma of the head of pancreas were r and omised to receive KAb 201 via either the intra-arterial or intravenous delivery route . The dose limiting toxicities within each group were determined . Patients were assessed for safety and efficacy and followed up until death . Results Between February 2003 and July 2005 , 25 patients were enrolled . Nineteen patients were r and omised , 9 to the intravenous and 10 to the intra-arterial arms . In the intra-arterial arm , dose limiting toxicity was seen in 2/6 ( 33 % ) patients at 50 mCi whereas in the intravenous arm , dose limiting toxicity was noted in 1/6 patients at 50 mCi , but did not occur at 75 mCi (0/3).The overall response rate was 6 % ( 1/18 ) . Median overall survival was 5.2 months ( 95 % confidence interval = 3.3 to 9 months ) , with no significant difference between the intravenous and intra-arterial arms ( log rank test p = 0.79 ) . One patient was still alive at the time of this analysis . Conclusion Dose limiting toxicity for KAb201 with I131 by the intra-arterial route was 50 mCi , while dose limiting toxicity was not reached in the intravenous arm Genetically modified lymphoblastoid cell lines ( LCL ) have been shown to be an attractive alternative source of antigen-presenting cells for cancer vaccination in vitro . We tested their application in patients with pancreatic cancer in a phase I clinical trial . As a model tumor antigen , we selected the point-mutated ( codon 12 ) Ki-Ras p21 oncogene ( muRas ) frequently ( ∼85 % ) present in pancreatic adenocarcinoma . Autologous LCLs were established in vitro by spontaneous outgrowth from peripheral blood lymphocytes of seven pancreatic carcinoma patients and were genetically modified with an episomal Epstein-Barr virus (EBV)-based expression vector to express muRas ( muRas-LCL ) . Weekly vaccinations with subcutaneous injection of 5 × 10(6 ) muRas-LCL were done . In six of seven patients , therapeutic vaccination elicited a T-cell response with an increase in the frequency of muRas-specific precursor cytotoxic T lymphocytes in the peripheral blood and positive delayed-type hypersensitivity reactions at the injection site . Besides local reactions and flu-like symptoms , there were no signs of toxicity and no acute EBV infection , onset of EBV-associated lymphoma , or other severe complications . A clinical response ( stable disease ) was observed for a short time period ( 2 - 4 months ) in four of seven patients ( 57 % ) , mostly in earlier tumor stages . Our results indicate that LCL presenting genetically modified antigen represent a valuable and easily available tool for in vivo autologous tumor vaccination . LCL can be transfected with any known tumor antigen and therefore should be further clinical ly investigated Background Dendritic cell (DC)-based and cytokine-induced killer cell (CIK)-based therapy can induce specific antitumor T-cell responses . This clinical pilot study examined the safety , the feasibility , and the outcome of tumor-specific immunotherapy for patients with advanced pancreatic adenocarcinoma . Methods Alpha-Gal epitopes were synthesis ed on pancreatic carcinoma cell membranes with α1,3-galactosyltransferase in vitro . Subsequently , the addition of natural human anti-Gal IgG to the processed membranes result ed in opsonization and effective phagocytosis by DCs , which were co-cultured with newly differentiated CIKs from bone marrow stem cells to generate tumor-specific immune responders ex vivo . Fourteen patients with inoperable stage III/IV pancreatic adenocarcinoma were enrolled in the study ; the treatment procedure consisted of injections of DCs and CIKs . Results Clinical observation showed that the procedure was safe and lacked serious side effects . Tests showed that 12 patients had strong positive delayed-type IV hypersensitivity to the autologous cancer cell lysate ; robust systemic cytotoxicity elicited by interferon (IFN)γ expression by peripheral blood mononuclear cells ; and significant increases in CD3+CD8 + , CD3+CD45RO+ , and CD3+CD56 + cells in peripheral blood lymphocytes after 3 injections . During the follow up , the percentages of CD3+CD8 + , CD3+CD45RO+ , and CD3+CD56 + cells returned to the normal range at 6 to 9 months after the third injection and IFNγ expression in the cells stayed at the higher level from the third injection to 24 months after the treatment . Conclusions This new tumor-specific immunotherapy is safe , feasible , and has great potential for pancreatic carcinoma treatment We evaluated the safety of , and clinical and immune responses to personalized peptide vaccination with gemcitabine ( GEM ) as the first line therapy in patients with non-resectable pancreatic cancer . Pre-vaccination peripheral blood mononuclear cells ( P BMC s ) and plasma were prepared to examine cellular and humoral responses to 14 and 16 peptides in human leukocyte antigen (HLA)-A24 + or -A2 + patients , respectively . Only the reactive peptides ( maximum of 4 ) were administered weekly at 3 mg/peptide . GEM was administered at 1000 mg/m(2 ) per week for 3 weeks , followed by 1 week of rest . Twenty-one patients with untreated and non-resectable pancreatic cancer were enrolled . The combination therapy was generally well tolerated . Boosting of cellular and humoral responses to the vaccinated peptides was observed in the post-vaccination ( eighth ) P BMC s and plasma from 14 of 18 and 13 of 18 patients tested , respectively . The best clinical responses were 7 cases of partial response , 9 cases of stable disease , and 5 cases of progressive disease . Median survival time of all 21 patients was 9.0 months ( 95 % CI , 6 - 15.5 months ) with a one year survival rate of 38 % . Immune boosting in both cellular and humoral responses was well correlated with overall survival with a hazard ratio of 0.2 ( 95 % CI , 0.06 - 0.73 ; log-rank p=0.0239 ) . These results suggest a potential clinical benefit of this combination therapy for non-resectable pancreatic cancer patients as the first line therapy . Further exploration of this approach is warranted Background We previously developed an immunotherapy treatment utilizing a cancer vaccine reagent KIF20A-66 in order to treat pancreatic cancer . KIF20A-66 is HLA-A24-restricted epitope peptide derived from KIF20A , a member of kinesin super family protein 20A that is significantly transactivated in pancreatic cancer . In this report , we further demonstrated non-r and omized , open-label , single centered phase I/II clinical trial of immunotherapy using the KIF20A-66 peptide for the patients with advanced pancreatic cancer . Methods Vaccination was performed to the patients with metastatic pancreatic cancer , in whom gemcitabine-based therapy had failed . In phase I study , KIF20A-66 peptide was subcutaneously injected weekly in a dose-escalation manner ( doses of 1.0 and 3.0 mg/body , 6 patients /1 cohort ) . After safety was assessed , phase II study was conducted using 3.0 mg of KIF20A-66 peptide . Results KIF20A-66 peptide vaccination was well tolerated in the doses we examined and tumor responses after 1 month of the treatment were evaluated . Among 29 patients who completed one course of the treatment at least , stable disease ( SD ) was found in 21 cases , while progressive disease ( PD ) was found in 8 cases , indicating that the disease control rate was 72 % . Objective tumor shrinkage was observed in 8 cases , including 1 case of complete response ( CR ) . The median survival time ( MST ) and progression free survival time ( PFS ) were 142 days and 56 days , respectively . These results clearly demonstrate that overall survival of the patients was significantly prolonged , compared to the historical controls of 9 cases with unmatched HLA in the same hospital ( MST : 83 days ) , as well as 81 cases in our and other hospitals ( MST : 63 days ) . Conclusion The patients vaccinated with KIF20A-66 peptide had better prognosis than the control group with best supportive care ( BSC ) . Thus , we concluded that KIF20A-66 vaccination is significantly effective as an immunotherapy against advanced pancreatic cancer . KIF20A-66 peptide was well tolerable in the dose of either 1.0 mg or 3.0 mg/body , and effectively induced peptide-specific response of cytotoxic T lymphocyte ( CTL ) . Further clinical study using this peptide is a promising approach for advanced pancreatic cancer to achieve high potential benefit for better prognosis . Clinical trial registration UMIN-CTR , number Purpose : We performed a phase I trial to investigate the safety , clinical responses , and Wilms ' tumor 1 (WT1)-specific immune responses following treatment with dendritic cells ( DC ) pulsed with a mixture of three types of WT1 peptides , including both MHC class I and II – restricted epitopes , in combination with chemotherapy . Experimental Design : Ten stage IV patients with pancreatic ductal adenocarcinoma ( PDA ) and 1 patient with intrahepatic cholangiocarcinoma ( ICC ) who were HLA-positive for A*02:01 , A*02:06 , A*24:02 , DRB1 * 04:05 , DRB1 * 08:03 , DRB1 * 15:01 , DRB1 * 15:02 , DPB1 * 05:01 , or DPB1 * 09:01 were enrolled . The patients received one course of gemcitabine followed by biweekly intradermal vaccinations with mature DCs pulsed with MHC class I ( DC/WT1-I ; 2 PDA and 1 ICC ) , II ( DC/WT1-II ; 1 PDA ) , or I/II – restricted WT1 peptides ( DC/WT1-I/II ; 7 PDA ) , and gemcitabine . Results : The combination therapy was well tolerated . WT1-specific IFNγ-producing CD4 + T cells were significantly increased following treatment with DC/WT1-I/II . WT1 peptide-specific delayed-type hypersensitivity ( DTH ) was detected in 4 of the 7 patients with PDA vaccinated with DC/WT1-I/II and in 0 of the 3 patients with PDA vaccinated with DC/WT1-I or DC/WT1-II . The WT1-specific DTH-positive patients showed significantly improved overall survival ( OS ) and progression-free survival ( PFS ) compared with the negative control patients . In particular , all 3 patients with PDA with strong DTH reactions had a median OS of 717 days . Conclusions : The activation of WT1-specific immune responses by DC/WT1-I/II combined with chemotherapy may be associated with disease stability in advanced pancreatic cancer . Clin Cancer Res ; 20(16 ) ; 4228–39 . © 2014 AACR KIF20A ( RAB6KIFL ) belongs to the kinesin superfamily of motor proteins , which play critical roles in the trafficking of molecules and organelles during the growth of pancreatic cancer . Immunotherapy using a previously identified epitope peptide for KIF20A is expected to improve clinical outcomes . A phase I clinical trial combining KIF20A-derived peptide with gemcitabine ( GEM ) was therefore conducted among patients with advanced pancreatic cancer who had received prior therapy such as chemotherapy and /or radiotherapy . GEM was administered at a dose of 1000 mg/m2 on days 1 , 8 , and 15 in a 28-day cycle . The KIF20A-derived peptide was injected subcutaneously on a weekly basis in a dose-escalation manner ( doses of 0.5 , 1 , and 3 mg/body ; 3 patients /cohort ) . Safety and immunologic parameters were assessed . No severe adverse effects of grade 3 or higher related to KIF20A-derived peptide were observed . Of the 9 patients who completed at least one course of treatment , interferon-&ggr ; (IFN-&ggr;)-producing cells were induced in 4 of 9 patients ( P2 , P3 , P6 , and P7 ) , and IFN-&ggr;-producing cells were increased in 4 of the 9 patients ( P1 , P5 , P8 , and P9 ) . Four of the 9 patients achieved stable disease . The disease control rate was 44 % . The median survival time after first vaccination was 173 days and 1-year survival rate was 11.1 % . IFN-&ggr;-producing cells were induced by the KIF20A-derived peptide vaccine at a high rate , even in combination with GEM . These results suggest that this combination therapy will be feasible and promising for the treatment of advanced pancreatic cancer Patients with inoperable pancreatic cancer have a dismal prognosis with a mean life expectancy of 3–6 months . New treatment modalities are thus urgently needed . Telomerase is expressed in 85–90 % of pancreas cancer , and immunogenic telomerase peptides have been characterised . A phase I/II study was conducted to investigate the safety , tolerability , and immunogenecity of telomerase peptide vaccination . Survival of the patients was also recorded . Forty-eight patients with non-resectable pancreatic cancer received intradermal injections of the telomerase peptide GV1001 at three dose levels , in combination with granulocyte – macrophage colony-stimulating factor . The treatment period was 10 weeks . Monthly booster vaccinations were offered as follow-up treatment . Immune responses were measured as delayed-type hypersensitivity skin reaction and in vitro T-cell proliferation . GV1001 was well tolerated . Immune responses were observed in 24 of 38 evaluable patients , with the highest ratio ( 75 % ) in the intermediate dose group . Twenty-seven evaluable patients completed the study . Median survival for the intermediate dose-group was 8.6 months , significantly longer for the low- ( P=0.006 ) and high-dose groups ( P=0.05 ) . One-year survival for the evaluable patients in the intermediate dose group was 25 % . The results demonstrate that GV1001 is immunogenic and safe to use . The survival data indicate that induction of an immune response is correlated with prolonged survival , and the vaccine may offer a new treatment option for pancreatic cancer patients , encouraging further clinical studies CD4+CD25 + regulatory T cells are involved in the prevention of autoimmune diseases and in tumor-induced tolerance . We previously demonstrated in tumor-bearing rodents that one injection of cyclophosphamide could significantly decrease both numbers and suppressive functions of regulatory T cells , facilitating vaccine-induced tumor rejection . In humans , iterative low dosing of cyclophosphamide , referred to as “ metronomic ” therapy , has recently been used in patients with advanced chemotherapy resistant cancers with the aim of reducing tumor angiogenesis . Here we show that oral administration of metronomic cyclophosphamide in advanced cancer patients induces a profound and selective reduction of circulating regulatory T cells , associated with a suppression of their inhibitory functions on conventional T cells and NK cells leading to a restoration of peripheral T cell proliferation and innate killing activities . Therefore , metronomic regimen of cyclophosphamide does not only affect tumor angiogenesis but also strongly curtails immunosuppressive regulatory T cells , favoring a better control of tumor progression . Altogether these data support cyclophosphamide regimen as a valuable treatment for reducing tumor-induced immune tolerance before setting to work anticancer immunotherapy Survivin , a member of the inhibitor of apoptosis protein ( IAP ) family containing a single baculovirus IAP repeat domain , is highly expressed in cancerous tissues but not in normal counterparts . Our group identified an HLA‐A24‐restricted antigenic peptide , survivin‐2B80–88 ( AYACNTSTL ) , that is recognized by CD8 + CTLs and functions as an immunogenic molecule in patients with cancers of various histological origins such as colon , breast , lung , oral , and urogenital malignancies . Subsequent clinical trials with this epitope peptide alone result ed in clinical and immunological responses . However , these were not strong enough for routine clinical use as a therapeutic cancer vaccine , and our previous study of colon cancer patients indicated that treatment with a vaccination protocol of survivin‐2B80–88 plus incomplete Freund 's adjuvant ( IFA ) and α‐interferon ( IFNα ) conferred overt clinical improvement and enhanced the immunological responses of patients . In the current study , we further investigated whether this vaccination protocol could efficiently provide not only improved immune responses but also better clinical outcomes for advanced pancreatic cancers . Tetramer and enzyme‐linked immunosorbent spot analysis data indicated that more than 50 % of the patients had positive clinical and immunological responses . In contrast , assessment of treatment with IFNα only to another group of cancer patients result ed in no obvious increase in the frequency of survivin‐2B80‐88 peptide‐specific CTLs . Taken together , our data clearly indicate that a vaccination protocol of survivin‐2B80‐88 plus IFA and IFNα is very effective and useful in immunotherapy for this type of poor‐prognosis neoplasm . This trial was registered with the UMIN Clinical Trials Registry , no. UMIN000000905 . ( Cancer Sci 2013 ; 104 : 124–129 Purpose To determine the feasibility , safety and histological change of preoperative endoscopic ultrasound-guided fine-needle injection ( PEU-FNI ) of immature DCs ( iDCs ) with OK-432 in pancreatic cancer patients . Methods Nine patients enrolled in the trial ( DC group ) and were compared with 15 patients operated on without iDC injection ( non-DC group ) . Adverse events of PEU-FNI and postoperative complications were evaluated according to CTC-AE ver.3.0 and the Clavien – Dindo classification/ISGPF definition , respectively . Histological changes within the tumor and lymph nodes were evaluated by immunohistochemical examination of infiltrating inflammatory cells ( CD4 + , CD8 + , Foxp3 + and CD83 + ) . Results There were no severe toxicities following PEU-FNI , except for one transient grade 3 fever , and there were no significant differences in the incidence of postoperative complications between the two groups . Colliquative necrosis and diffusely scattered TUNEL-positive cells were observed at the injection sites . CD83 + cells significantly accumulated in the regional lymph nodes of the DC group as well as Foxp3 + cells in the regional and distant lymph nodes . The two DC group patients , one of which was stage IV with distant lymph node metastasis , survived more than 5 years without requiring adjuvant theraphy . Conclusion PEU-FNI was feasible and safe , and further study needs to confirm and enhance antitumor responses Pre clinical reports support the concept of synergy between cancer vaccines and immune checkpoint blockade in nonimmunogenic tumors . In particular , cytotoxic T lymphocyte-associated antigen-4 ( CTLA-4 ) antibodies have been successfully combined with GM-CSF cell-based vaccines ( GVAX ) . Ipilimumab ( anti-CTLA-4 ) has been tested as a single agent in patients with pancreatic ductal adenocarcinoma ( PDA ) result ing in a delayed response at a dose of 3 mg/kg . Our study evaluated ipilimumab 10 mg/kg ( arm 1 ) and ipilimumab 10 mg/kg+GVAX ( arm 2 ) . A total of 30 patients with previously treated advanced PDA were r and omized ( 1:1 ) . Induction doses were administered every 3 weeks for a total of 4 doses followed by maintenance dosing every 12 weeks . Two patients in arm 1 showed evidence of stable disease ( 7 and 22 wk ) but none demonstrated CA19 - 9 biochemical responses . In contrast , 3 patients in arm 2 had evidence of prolonged disease stabilization ( 31 , 71 , and 81 wk ) and 7 patients experienced CA19 - 9 declines . In 2 of these patients , disease stabilization occurred after an initial period of progression . The median overall survival ( OS ) ( 3.6 vs. 5.7 mo , hazards ratio : 0.51 , P=0.072 ) and 1 year OS ( 7 vs. 27 % ) favored arm 2 . Similar to prior ipilimumab studies , 20 % of patients in each arm had grade 3/4 immune-related adverse events . Among patients with OS>4.3 months , there was an increase in the peak mesothelin-specific T cells ( P=0.014 ) and enhancement of the T-cell repertoire ( P=0.031 ) . In conclusion , checkpoint blockade in combination with GVAX has the potential for clinical benefit and should be evaluated in a larger study BACKGROUND The American College of Surgeons Oncology Group sought to confirm the efficacy of a novel interferon-based chemoradiation regimen in a multicenter phase II trial . PATIENTS AND METHODS Patients with resected ( R0/R1 ) adenocarcinoma of the pancreatic head were treated with adjuvant interferon-alfa-2b ( 3 million units s.c . on days 1 , 3 , and 5 of each week for 5.5 weeks ) , cisplatin ( 30 mg/m(2 ) i.v . weekly for 6 weeks ) , and continuous infusion 5-fluorouracil ( 5-FU ; 175 mg·m(2)/day for 38 days ) concurrently with external-beam radiation ( 50.4 Gy ) . Chemoradiation was followed by two 6-week courses of continuous infusion 5-FU ( 200 mg·m(2)/day ) . The primary study end point was 18-month overall survival from protocol enrollment ( OS18 ) ; an OS18 ≥65 % was considered a positive study outcome . RESULTS Eighty-nine patients were enrolled . Eighty-four patients were assessable for toxicity . The all-cause grade ≥3 toxicity rate was 95 % ( 80 patients ) during therapy . No long-term toxicity or toxicity-related deaths were noted . At 36-month median follow-up , the OS18 was 69 % [ 95 % confidence interval ( CI ) 60 % to 80 % ] ; the median disease-free survival and overall survival were 14.1 months ( 95 % CI 11.0 - 20.1 months ) and 25.4 months ( 95 % CI 23.4 - 34.1 months ) , respectively . CONCLUSIONS Notwithst and ing promising multi-institutional efficacy results , further development of this regimen will require additional modifications to mitigate toxic effects BACKGROUND Pancreatic cancer has a poor prognosis . The clinical efficacy of immunotherapy using both dendritic cells pulsed with MUC1 peptide ( MUC1-DC ) and , cytotoxic T lymphocyte ( CTL ) sensitized with a pancreatic cancer , YPK-1 , expressing MUC1 ( MUC1-CTL ) was evaluated . PATIENTS AND METHODS Twenty patients with unresectable or recurrent pancreatic cancer were enrolled . Peripheral blood mononuclear cells ( P BMC s ) were separated into adherent cells for induction of MUC1-DCs and floating cells for MUC1-CTLs . MUC1-DCs were generated by culture with granulocyte monocyte colony stimulating factor ( GM-CSF ) and interleukin-4 ( IL-4 ) and then exposed to MUC1 peptide and TNF-alpha . MUC1-CTLs were induced by co-culture with YPK-1 and then with interleukin-2 ( IL-2 ) . MUC1-DCs were injected intradermally and MUC1-CTLs were given intravenously . RESULTS Patients were treated from 2 to 15 times . One patient with multiple lung metastases experienced a complete response . Five patients had stable disease . The mean survival time was 9.8 months . No grade II-IV toxicity was observed . CONCLUSION Adoptive immunotherapy with MUC1-DC and MUC1-CTL may be feasible and effective for pancreatic cancer K-RAS mutations are frequently found in adenocarcinomas of the pancreas , and induction of immunity against mutant ras can therefore be of possible clinical benefit in patients with pancreatic cancer . We present data from a clinical phase I/II trial involving patients with adenocarcinoma of the pancreas vaccinated by i.d . injection of synthetic mutant ras peptides in combination with granulocyte-macrophage colony-stimulating factor . Forty-eight patients ( 10 surgically resected and 38 with advanced disease ) were treated on an outpatient basis . Peptide-specific immunity was induced in 25 of 43 ( 58 % ) evaluable patients , indicating that the protocol used is very potent and capable of eliciting immune responses even in patients with end-stage disease . Patients followed-up for longer periods showed evidence of induction of long-lived immunological memory against the ras mutations . CD4(+ ) T cells reactive with an Arg12 mutation also present in the tumor could be isolated from a tumor biopsy , demonstrating that activated , ras-specific T cells were able to selectively accumulate in the tumor . Vaccination was well tolerated in all patients . Patients with advanced cancer demonstrating an immune response to the peptide vaccine showed prolonged survival from the start of treatment compared to non-responders ( median survival 148 days vs. 61 days , respectively ; p = 0.0002 ) . Although a limited number of patients were included in our study , the association between prolonged survival and an immune response against the vaccine suggests that a clinical benefit of ras peptide vaccination may be obtained for this group of patients PURPOSE The prognosis for advanced pancreatic cancer remains poor . Gastrin acts as a growth factor for pancreatic cancer . We describe the first study of the antigastrin immunogen G17DT in pancreatic cancer . Our aims were to determine the antibody response , safety , tolerability , and preliminary evidence of efficacy of G17DT in advanced pancreatic cancer . PATIENTS AND METHODS Thirty patients with advanced pancreatic cancer were immunized with three doses of either 100 micro g or 250 micro g of G17DT . RESULTS In the whole group , 20 ( 67 % ) of 30 patients produced an antibody response . The 250- micro g dose result ed in a significantly greater response rate of 82 % compared with 46 % for the 100- micro g group ( P = .018 ) . The most significant side effects , seen in three patients , were local abscess and /or fever . The median survival for the whole group from the date of the first immunization was 187 days ; median survival was 217 days for the antibody responders and 121 days for the antibody nonresponders . The difference in survival between the antibody responders and nonresponders was significant ( P = .0023 ) . CONCLUSION Patients with advanced pancreatic cancer are able to mount an adequate antibody response to G17DT . The 250- micro g dose is superior to the 100- micro g dose , and it appears to be generally well tolerated . Antibody responders demonstrate significantly greater survival than antibody nonresponders . Phase III studies are currently underway in order to determine efficacy Human type I interferons ( IFNs ) include IFN-β and 12 subtypes of IFN-α . During viral infection , infiltrating memory CD4(+ ) T cells are exposed to IFNs , but their impact on memory T-cell function is poorly understood . To address this , we pretreated P BMC s with different IFNs for 16 h before stimulation with Staphylococcus aureus enterotoxin B and measured cytokine expression by flow cytometry . IFN-α8 and -α10 most potently enhanced expression of IFN-γ , IL-2 , and IL-4 . Potency among the subtypes differed most at doses between 10 and 100 U/mL. While enhancement of IL-2 and IL-4 correlated with the time of preincubation with type I IFN , IFN-γ production was enhanced best when IFN-α was added immediately preceding or simultaneously with T-cell stimulation . Comparison of T-cell responses to multiple doses of Staphylococcus aureus enterotoxin B and to peptide libraries from RSV or CMV demonstrated that IFN-α best enhanced cytokine expression when CD4(+ ) T cells were suboptimally stimulated . We conclude that type I IFNs enhance Th1 and Th2 function with dose dependency and subtype specificity , and best when T-cell stimulation is suboptimal . While type I IFNs may beneficially enhance CD4(+ ) T-cell memory responses to vaccines or viral pathogens , they may also enhance the function of resident Th2 cells and exacerbate allergic inflammation Pancreatic cancer is one of the most aggressive cancers with a median survival time ( MST ) of < 6 months in chemotherapy-resistant patients . Therefore , the development of novel treatment modalities is needed . In the present study , a phase II study of personalized peptide vaccination ( PPV ) was conducted , in which vaccine antigens were selected and administered based on the pre-existing IgG responses to 31 different pooled peptides , for 41 chemotherapy-resistant advanced pancreatic cancer patients . No vaccine-related severe adverse events were observed . IgG responses specific to at least one of the vaccine peptides were augmented in 14 of 36 patients ( 39 % ) and in 18 of 19 patients ( 95 % ) tested after the 5th and 11th vaccination , respectively . MST from the first vaccination was 7.9 months with a 1-year survival rate of 26.8 % . Higher serum amyloid A ( SAA ) and C-reactive protein ( CRP ) levels in pre-vaccination plasma were unfavorable factors for overall survival ( OS ) . Due to the safety profile and the potential clinical efficacy , the conduction of additional clinical trials of PPV for chemotherapy-resistant advanced pancreatic cancer patients is warranted |
11,581 | 10,582,628 | While the former category yields few encouraging results , the latter group of studies is more promising .
In particular , stress management may prove to be an effective way to increase the quality of life .
The domain of complementary medicine may lie in the care for HIV-infected individuals with a view of increasing their quality of life . | Complementary treatments are often used by HIV-infected individuals .
Yet little is known about their effectiveness .
The aim of this systematic review was therefore to summarize the published evidence for or against the effectiveness of complementary therapies in HIV-positive people . | We wished to determine the short-term safety and efficacy of a Chinese medicinal herb preparation in treating symptoms of human immunodeficiency virus ( HIV ) infection in a 12-week r and omized , double-blind , placebo-controlled clinical trial in a University-affiliated acquired immunodeficiency syndrome ( AIDS ) clinic at a public general hospital . Thirty adults with symptomatic HIV infection , no previous AIDS-defining diagnosis , and CD4 + counts of 0.200 - 0.499 x 10(9)/L ( 200 - 499/mm3 ) received 28 tablets each day of either a st and ardized oral preparation of 31 Chinese herbs or a cellulose placebo . Primary outcome measures were changes in life satisfaction , perceived health , and number and severity of symptoms . Other outcomes included adherence , and changes in weight , CD4 + count , depression , anxiety , physical and social function , and mental health . Two placebo- and no herb-treated subjects had mild adverse events ( AE ) . Subjects on both arms reported taking 94 % of prescribed tablets . No differences between treatment groups reached the p < 0.05 level . Life satisfaction improved in herb-treated [ + 0.86 , 95 % confidence interval ( CI ) : + 0.29 , + 1.43 ] but not in placebo-treated subjects ( + 0.20 , 95 % CI -0.35 , + 0.75 ) . Number of symptoms was reduced in subjects receiving herbs ( -2.2 , 95 % CI -4.1 , -0.3 ) but not in those receiving placebo ( -0.3 , 95 % CI -3.2 , + 2.7 ) . There were trends toward greater improvements among herb-treated subjects on all symptom subscales except dermatologic . Believing that one was receiving herbs was strongly associated with reporting that the treatment had helped ( p < 0.005 ) , but not with changes in life satisfaction or symptoms . There were improvements in life satisfaction and symptoms among subjects receiving the herbal therapy . Whether Chinese herbs are effective in the management of symptomatic HIV infection can be adequately addressed only by larger trials of longer duration Assigned r and omly 28 neonates born to HIV-positive mothers to a massage therapy or control group . The treatment infants were given three 15-minute massages daily for 10 days . The massaged group showed superior performance on almost every Brazelton newborn cluster score and had a greater daily weight gain at the end of the treatment period unlike the control group who showed declining performance CONTEXT Peripheral neuropathy is common in persons infected with the human immunodeficiency virus ( HIV ) but few data on symptomatic treatment are available . OBJECTIVE To evaluate the efficacy of a st and ardized acupuncture regimen ( SAR ) and amitriptyline hydrochloride for the relief of pain due to HIV-related peripheral neuropathy in HIV-infected patients . DESIGN R and omized , placebo-controlled , multicenter clinical trial . Each site enrolled patients into 1 of the following 3 options : ( 1 ) a modified double-blind 2 x 2 factorial design of SAR , amitriptyline , or the combination compared with placebo , ( 2 ) a modified double-blind design of an SAR vs control points , or ( 3 ) a double-blind design of amitriptyline vs placebo . SETTING Terry Beirn Community Programs for Clinical Research on AIDS ( HIV primary care providers ) in 10 US cities . PATIENTS Patients with HIV-associated , symptomatic , lower-extremity peripheral neuropathy . Of 250 patients enrolled , 239 were in the acupuncture comparison ( 125 in the factorial option and 114 in the SAR option vs control points option ) , and 136 patients were in the amitriptyline comparison ( 125 in the factorial option and 11 in amitriptyline option vs placebo option ) . INTERVENTIONS St and ardized acupuncture regimen vs control points , amitriptyline ( 75 mg/d ) vs placebo , or both for 14 weeks . MAIN OUTCOME MEASURE Changes in mean pain scores at 6 and 14 weeks , using a pain scale ranging from 0.0 ( no pain ) to 1.75 ( extremely intense ) , recorded daily . RESULTS Patients in all 4 groups showed reduction in mean pain scores at 6 and 14 weeks compared with baseline values . For both the acupuncture and amitriptyline comparisons , changes in pain score were not significantly different between the 2 groups . At 6 weeks , the estimated difference in pain reduction for patients in the SAR group compared with those in the control points group ( a negative value indicates a greater reduction for the " active " treatment ) was 0.01 ( 95 % confidence interval [ CI ] , -0.11 to 0.12 ; P=.88 ) and for patients in the amitriptyline group vs those in the placebo group was -0.07 ( 95 % CI , -0.22 to 0.08 ; P=.38 ) . At 14 weeks , the difference for those in the SAR group compared with those in the control points group was -0.08 ( 95 % CI , -0.21 to 0.06 ; P=.26 ) and for amitriptyline compared with placebo was 0.00 ( 95 % CI , -0.18 to 0.19 ; P=.99 ) . CONCLUSIONS In this study , neither acupuncture nor amitriptyline was more effective than placebo in relieving pain caused by HIV-related peripheral neuropathy A pretest-posttest design ( with a 6-week wait-list control and a 6-month comparison group ) was used to compare the effectiveness of a 6-week stress management training program with st and ard outpatient care for 45 men with HIV disease . Outcomes included stress levels , coping patterns , quality of life , psychological distress , illness-related uncertainty , and CD4 + T-lymphocyte levels . At 6 weeks , intervention was associated with increases in the emotional well-being dimension of quality of life . After 6 months , the intervention group had a relative decline in HIV-related intrusive thinking , indicating that stress management training may have buffered illness-related psychological distress over time The objective of the present study was to compare the efficacy and safety of two doses of SPV(30 ) in HIV asymptomatic patients . The study was design ed as a r and omized double-blind multicentre trial of two doses of SPV(30 ) ( 990 mg/d and 1980 mg/d ) versus placebo . 145 previously untreated subjects with asymptomatic HIV infection ( CDC group IV ) and CD4 cell counts between 250 and 500 × 10(6)/1 were recruited . There was a statistically significant difference in therapeutic failures between groups in favor of SPV(30 ) 990 mg including decreases of CD4 cell count < 200 × 10(6)/1 and /or number of clinical aggravations ( progression to AIDS or AIDS related complex ) . The treatment groups differed statistically in the rate of disease progression also in favor of SPV(30 ) 990 mg/d . Fewer patients receiving SPV(30 ) 990 mg/d had at the end an increase of viral load greater than 0.5 log ( P = 0.029 ) . No severe side-effects were reported in the 3 groups . From these results we conclude that SPV(30 ) 990 mg/d has beneficial effects in HIV asymptomatic patients and appears to delay the progression of HIV disease This study tested the effects of a 10-week group cognitive-behavioral stress management ( CBSM ) intervention on mood and immunologic parameters in HIV-seropositive gay men whose disease had progressed to a symptomatic stage . Men were r and omized to either CBSM or a modified waiting-list control group . The CBSM intervention significantly decreased self-reported dysphoria , anxiety , and total distress . Individuals who practice d relaxation more consistently had significantly greater drops in dysphoria . The intervention also decreased herpes simplex virus-Type 2 ( HSV-2 ) immunoglobulin G antibody titers . The control group showed no significant changes in either mood or antibody titers . Individual difference analyses revealed that decreases in dysphoria significantly predicted lower HSV-2 antibody titers by the end of the 10-week period . Neither group displayed changes in HSV-Type 1 antibody titers or in CD4 + or CD8 + cell numbers We tested the impact of stress management training on sexual behavior and immune functioning in 64 gay men infected with human immunodeficiency virus ( HIV ) . Subjects r and omized to the stress management group met for eight two-hour sessions and one all day retreat to learn systematic relaxation , health behavior change , and stress management skills . Compared to those r and omized to a wait list control , treatment subjects reported significantly fewer sexual partners in the prior month at post-test ( 1.10 vs 2.29 for controls ) . There were no differences between groups in lymphocyte numbers and function Objective Reduced levels of serum carnitines ( 3-hydroxy-4-N-trimethyl-ammonio-butanoate ) are found in most patients treated with zidovudine . However , since serum carnitines do not strictly reflect cellular concentrations we examined whether a carnitine depletion could be found in peripheral blood mononuclear cells ( P BMC ) from AIDS patients with normal serum carnitine levels . In addition , we explored whether it was posssible to relate the host 's immunoreactivity to the content of carnitine in P BMC and whether carnitine levels can be corrected by oral supplementation of L-carnitine . Design Immunopharmacologic study . Methods Twenty male patients with advanced AIDS ( Centers for Disease Control and Prevention stage IVCI ) and normal serum levels of carnitines were enrolled . Patients were r and omly assigned to receive either L-carnitine ( 6g/day ) or placebo for 2 weeks . At baseline and at the end of the trial , we measured carnitines in both sera and P BMC , serum triglycerides , CD4 cell counts , and the frequency of cells entering the S and G2-M phases of cell cycle following mitogen stimulation . Results Concentrations of total carnitine in P BMC from AIDS patients was lower than in healthy controls . A significant trend towards the restoration of appropriate intracellular carnitine levels was found in patients treated with high-dose L-carnitine and was associated with an increased frequency of S and G2-M cells following mitogen stimulation . Furthermore , at the end of the trial we found a strong reduction in serum triglycerides in the L-carnitine group compared with baseline levels . Conclusions Our data indicate that carnitine deficiency occurs in P BMC from patients with advanced AIDS , despite normal serum concentrations . The increase in cellular carnitine content strongly improved lymphocyte proliferative responsiveness to mitogens . Because carnitine status is an important contributing factor to immune function in patients with advanced AIDS , we therefore believe that L-carnitine supplementation could have a role as a complementary therapy for HIV-infected individuals The use of vitamin A therapy during human immunodeficiency virus ( HIV ) infection is under clinical investigation , and vitamin A could potentially modulate HIV replication because the virus genome contains a retinoic acid response element . A r and omized , double-masked , placebo-controlled clinical trial was conducted to determine the impact of single high-dose vitamin A supplementation , 60-mg retinol equivalent ( 200,000 IU ) , on HIV load and CD4 lymphocyte count . HIV-infected injection drug users ( 120 ) were r and omly allocated to receive vitamin A or placebo . Plasma vitamin A level , CD4 lymphocyte count , and HIV load were measured at baseline and 2 and 4 weeks after treatment . Vitamin A supplementation had no significant impact on HIV load or CD4 lymphocyte count at 2 and 4 weeks after treatment . This study suggests that high-dose vitamin A supplementation does not influence HIV load Objectives : The HIV-infected population is known to be oxidatively stressed and deficient in antioxidant micronutrients . Since in vitro replication of HIV is increased with oxidative stress , this study assessed the effect of antioxidant vitamin supplementation on lipid peroxidation , a measure of oxidative stress , and viral load in humans . Design : A r and omized placebo-controlled , double-blind study . Methods : Forty-nine HIV-positive patients were r and omized to receive supplements of both DL-α-tocopherol acetate ( 800 IU daily ) and vitamin C ( 1000 mg daily ) , or matched placebo , for 3 months . Plasma antioxidant micronutrient status , breath pentane output , plasma lipid peroxides , malondialdehyde and viral load were measured at baseline and at 3 months . New or recurrent infections for the 6-month period after study entry were also recorded . Results : The vitamin group ( n = 26 ) had an increase in plasma concentrations of α-tocopherol ( P < 0.0005 ) and vitamin C ( P < 0.005 ) and a reduction in lipid peroxidation measured by breath pentane ( P < 0.025 ) , plasma lipid peroxides ( P < 0.01 ) and malondialdehyde ( P < 0.0005 ) when compared with controls ( n = 23 ) . There was also a trend towards a reduction in viral load ( mean ± SD changes over 3 months , −0.45 ± 0.39 versus + 0.50 ± 0.40 log10 copies/ml ; P = 0.1 ; 95 % confidence interval , −0.21 to −2.14 ) . The number of infections reported was nine in the vitamin group and seven in the placebo group . Conclusion : Supplements of vitamin E and C reduce oxidative stress in HIV and produce a trend towards a reduction in viral load . This is worthy of larger clinical trials , especially in HIV-infected persons who can not afford new combination therapies This study evaluated the effects of a behavioral stress-management program on anxiety , mood , self-esteem , and T-cell count in a group of HIV-positive men who were asymptomatic except for T-cell counts below 400 . The program consisted of 20 biweekly sessions of progressive muscle relaxation and electromyograph biofeedback-assisted relaxation training , meditation , and hypnosis . Ten subjects were r and omly assigned to either a treatment group or a no-treatment control group , and the 2 groups were compared on pre- to posttreatment changes in the dependent measures . Analysis showed that , compared with the no-treatment group , the treatment group showed significant improvement on all the dependent measures , which was maintained at a 1-mo . follow-up . Since stress is known to compromise the immune system , these results suggest that stress management to reduce arousal of the nervous system and anxiety would be an appropriate component of a treatment regimen for HIV infection We examined the efficacy of relaxation techniques in a sample of HIV patients without AIDS in the early stages after infection , by comparing the three groups : relaxation group ( progressive muscle relaxation and modified autogenic training ) ; ordinary supportive psychotherapy group , and finally no psychiatric treatment group . Scores for anxiety , fatigue , depression and confusion , as measured by the profile of mood states ( POMS ) , were significantly lower after relaxation than before . There were no significant differences in the POMS scores ( except for anger ) among the three groups . These two results suggest that a combination of progressive muscle relaxation and modified autogenic training is a useful method , which can be easily employed in HIV patients without AIDS |
11,582 | 29,290,918 | CONCLUSION The laparoscopic approach offers the same quality of the resected specimen as the open approach in complete mesocolic excision with central vascular ligation for colon cancer .
The laparoscopic complete mesocolic excision with central vascular ligation is superior in all perioperative results and at least non-inferior in long-term oncological outcomes | AIM To compare the effectiveness of laparoscopic complete mesocolic excision ( CME ) with central vascular ligation ( L-CME ) with its open ( O-CME ) counterpart . | BACKGROUND : Meta-analyses of r and omized controlled trials support the use of laparoscopically assisted resection for colon cancer . The evidence supporting its use in rectal cancer is weak . OBJECTIVE : The purpose of this work was to investigate the uptake of laparoscopically assisted resection for colon and rectal cancer and to compare short- and long-term outcomes using population data . DESIGN : This was a retrospective cohort study using linked administrative health data . SETTING S : The study encompassed all of the public and private hospitals in New South Wales , Australia , between 2000 and 2008 . PATIENTS : A total of 27,947 patients with colon or rectal cancer undergoing surgery with curative intent were included in the study . MAIN OUTCOME MEASURES : We summarized the proportion of resections performed laparoscopically . Short-term outcomes were extended stay , 28-day readmission , 28-day emergency readmission , 30- and 90-day mortality , and 90-day readmission with pulmonary embolism or deep-vein thrombosis . Long-term outcomes were all-cause and cancer-specific death and admission with obstruction or incisional hernia repair . RESULTS : Laparoscopic procedures increased between 2000 and 2008 for colon ( 1.5%–20.7 % ) and rectal cancer ( 0.6%–15.5 % ) . Laparoscopic procedures reduced rates of extended stay ( OR , 0.60 ; 95 % CI , 0.49–0.72 ) and 28-day readmission ( OR , 0.86 ; 95 % CI , 0.74–0.99 ) for colon cancer . For rectal cancer , laparoscopic procedures had lower rates of 28-day readmission ( OR , 0.58 ; 95 % CI , 0.42–0.78 ) and 28-day emergency readmission ( OR , 0.54 ; 95 % CI , 0.34–0.85 ) . Laparoscopic procedures improved cancer-specific survival for rectal cancer ( HR , 0.71 ; 95 % CI , 0.51–1.00 ) . Survival benefits were observed for laparoscopically assisted colon resection in higher-caseload hospitals but not lower-caseload hospitals . LIMITATIONS : It was not possible to identify laparoscopically assisted resections converted to open procedures because of the cl aims -based nature of the data . CONCLUSIONS : Despite increases in laparoscopically assisted resections for colon and rectal cancer , the majority of resections are still treated by open procedures . Our data suggest that laparoscopic resection reduces the lengths of stay and rates of readmission and may result in improved cancer-specific survival for both colon and rectal resections Background : Complete mesocolic excision ( CME ) and a high ( apical ) vascular tie may improve oncologic outcome after surgery for colon cancer . Our primary aim was to emulate a previous national result of 73.8 % overall survival ( OS ) with both the open and laparoscopic techniques . Methods : A prospect i ve study of radical colon cancer was initiated in a Norwegian community teaching hospital in 2007 and comprised a consecutive group of 251 patients with TNM stages I-III that had surgery according to the CME principle . Oncological outcome was assessed as OS , disease-free survival ( DFS ) and cancer-specific survival ( CSS ) , as well as time to recurrence ( TTR ) , using Cox regression analysis . Results : In-hospital mortality was 3.6 % , 2.3 % for laparoscopic surgery and 4.9 % for open management . Significantly more patients in the open CME group developed complications in the short term ( p < 0.001 ) . Twelve or more lymph nodes were retrieved from 82.9 % ( 208/251 ) of the specimens . Overall 3-year OS was 84.5 % , DFS 77.4 % , CSS 91.5 % and TTR 86.8 % . The surgical approach was not a significant predictor for any of the survival parameters . Conclusions : There was no survival difference between open and laparoscopic CME colonic resections , and the present OS improved from a previous OS from 2000 BACKGROUND Minimally invasive , laparoscopically assisted surgery was first considered in 1990 for patients undergoing colectomy for cancer . Concern that this approach would compromise survival by failing to achieve a proper oncologic resection or adequate staging or by altering patterns of recurrence ( based on frequent reports of tumor recurrences within surgical wounds ) prompted a controlled trial evaluation . METHODS We conducted a noninferiority trial at 48 institutions and r and omly assigned 872 patients with adenocarcinoma of the colon to undergo open or laparoscopically assisted colectomy performed by credentialed surgeons . The median follow-up was 4.4 years . The primary end point was the time to tumor recurrence . RESULTS At three years , the rates of recurrence were similar in the two groups--16 percent among patients in the group that underwent laparoscopically assisted surgery and 18 percent among patients in the open-colectomy group ( two-sided P=0.32 ; hazard ratio for recurrence , 0.86 ; 95 percent confidence interval , 0.63 to 1.17 ) . Recurrence rates in surgical wounds were less than 1 percent in both groups ( P=0.50 ) . The overall survival rate at three years was also very similar in the two groups ( 86 percent in the laparoscopic-surgery group and 85 percent in the open-colectomy group ; P=0.51 ; hazard ratio for death in the laparoscopic-surgery group , 0.91 ; 95 percent confidence interval , 0.68 to 1.21 ) , with no significant difference between groups in the time to recurrence or overall survival for patients with any stage of cancer . Perioperative recovery was faster in the laparoscopic-surgery group than in the open-colectomy group , as reflected by a shorter median hospital stay ( five days vs. six days , P<0.001 ) and briefer use of parenteral narcotics ( three days vs. four days , P<0.001 ) and oral analgesics ( one day vs. two days , P=0.02 ) . The rates of intraoperative complications , 30-day postoperative mortality , complications at discharge and 60 days , hospital readmission , and reoperation were very similar between groups . CONCLUSIONS In this multi-institutional study , the rates of recurrent cancer were similar after laparoscopically assisted colectomy and open colectomy , suggesting that the laparoscopic approach is an acceptable alternative to open surgery for colon cancer Background and aims Evidence demonstrating improved short-term outcomes with laparoscopic surgery compared with open surgery for colorectal cancer is accumulating . In addition , programmes optimising peri-operative care for major abdominal surgery are becoming widespread . Evaluating laparoscopic surgery and enhanced recovery programmes usually focuses on short-term recovery . The aim of this study was to compare recovery after laparoscopic and open surgery for colorectal cancer up to 1 year post-operatively , using a combination of self-report and observer data . Patients / Methods From January 2002 to March 2004 , 62 patients were r and omised ( 2:1 ) to receive laparoscopic ( n = 43 ) or open surgery ( n = 19 ) within an enhanced recovery programme . Functional outcomes up to 1 year were assessed using interview-administered question naires . Results / Findings Question naire and health-related quality of life data were obtained in over 85 % of patients . Patients undergoing laparoscopic surgery felt fully recovered and resumed driving more quickly than those having open surgery ( p = 0.016 and p = 0.048 respectively ) . Fifty-eight percent of patients having open surgery felt fully recovered by 12 months versus 88 % of laparoscopic patients .Interpretation/ Conclusion Within an enhanced recovery programme , patients undergoing laparoscopic surgery recovered more quickly than after open resection . Both approaches however , were associated with slow recovery despite a relatively short hospital stay BACKGROUND The safety and short-term benefits of laparoscopic colectomy for cancer remain debatable . The multicentre COLOR ( COlon cancer Laparoscopic or Open Resection ) trial was done to assess the safety and benefit of laparoscopic resection compared with open resection for curative treatment of patients with cancer of the right or left colon . METHODS 627 patients were r and omly assigned to laparoscopic surgery and 621 patients to open surgery . The primary endpoint was cancer-free survival 3 years after surgery . Secondary outcomes were short-term morbidity and mortality , number of positive resection margins , local recurrence , port-site or wound-site recurrence , metastasis , overall survival , and blood loss during surgery . Analysis was by intention to treat . Here , clinical characteristics , operative findings , and postoperative outcome are reported . FINDINGS Patients assigned laparoscopic resection had less blood loss compared with those assigned open resection ( median 100 mL [ range 0 - 2700 ] vs 175 mL [ 0 - 2000 ] , p<0.0001 ) , although laparoscopic surgery lasted 30 min longer than did open surgery ( p<0.0001 ) . Conversion to open surgery was needed for 91 ( 17 % ) patients undergoing the laparoscopic procedure . Radicality of resection as assessed by number of removed lymph nodes and length of resected oral and aboral bowel did not differ between groups . Laparoscopic colectomy was associated with earlier recovery of bowel function ( p<0.0001 ) , need for fewer analgesics , and with a shorter hospital stay ( p<0.0001 ) compared with open colectomy . Morbidity and mortality 28 days after colectomy did not differ between groups . INTERPRETATION Laparoscopic surgery can be used for safe and radical resection of cancer in the right , left , and sigmoid colon Background : We compared the perioperative parameters and outcomes achieved with h and -assisted laparoscopic colectomy ( HALC ) vs open colectomy ( OC ) for the management of benign and malignant colorectal disease , including cancer patients treated with curative intent . Methods : Sixty eligible patients were r and omized to either HALC ( n = 30 ) or OC ( n = 30 ) treatment groups . We used Pearson ’s chi-square and two- sample t-tests to compare the differences in demographics and perioperative parameters . Results : There were no significant differences in age , gender distribution , disease pattern , operative procedure , comorbidity , or history of abdominal surgery . The HALC patients had significantly shorter hospital stays and incision lengths , faster recovery of gastrointestinal function , less analgesic use and blood loss , and lower pain scores on postoperative days 1 , 3 , and 14 . There were no significant differences in operative time , complications , or time to return to normal activity . Conclusion : H and -assisted laparoscopic colectomy ( HALC ) is safe and produces better therapeutic results in terms of perioperative parameters than OC OBJECTIVE The quality of surgery with D3 resection in r and omized controlled clinical trial [ Japan Clinical Oncology Group study ( JCOG0404 ) ] was assessed by evaluation of the photo documentation of both open and laparoscopic surgeries . METHODS A multi-institutional r and omized-controlled trial ( JCOG0404 ) was conducted to evaluate open and laparoscopic D3 resection ( complete mesocolic excision + ligation and dissection at the root of the main vessels ) for Stage II/III colon cancer ( UMIN-CTR number C000000105 ) . A total of 1057 ( open , 528 ; laparoscopic , 529 ) eligible patients were enrolled . For quality control , it was ensured that the surgeries were performed by accredited surgeons , and a central committee review ed each surgery on the basis of the su bmi tted photographs of the resected field , specimen and skin incision . RESULTS For right-sided tumors , the rate of D3 resection was 98.5 % ( 131/133 ) in the open arm and 100 % ( 136/136 ) in the laparoscopic arm , and for left-sided tumors , they were 97.9 % ( 322/329 ) and 98.2 % ( 320/326 ) , respectively . Sufficient length of the resected longitudinal margin was ensured in all cases . The skin incisions made in all the cases were < 8 cm as defined in the protocol in laparoscopic arm . CONCLUSIONS Completion of high quality surgery with D3 resection was confirmed in JCOG0404 by central peer review of photographs of the surgical procedures in addition to operator regulations . This study suggests that the central review of the photo documentation is one of the important tools to assure a quality control of surgical technique in the Phase III r and omized-controlled study Objective : The aim of this study was to compare the long-term outcome of laparoscopy-assisted colectomy ( LAC ) and open colectomy ( OC ) for nonmetastatic colon cancer . Methods : From November 1993 to July 1998 all patients with adenocarcinoma of the colon were assessed for entry in this single center , clinical ly r and omized trial . Adjuvant therapy and postoperative follow-up were similar in both groups . The primary endpoint was cancer-related survival and secondary endpoints were probability of overall survival and probability of being free of recurrence . Data were analyzed according the intention-to-treat principle . Results : Two hundred and nineteen patients entered the study ( 111 LAC group and 108 OC group ) . The median follow-up was 95 months ( range , 77–133 ) . There was a tendency of higher cancer-related survival ( P = 0.07 , NS ) and overall survival ( P = 0.06 , NS ) for the LAC group . Probability of cancer-related survival was higher in the LAC group ( P = 0.02 ) when compared with OC . The regression analysis showed that LAC was independently associated with a reduced risk of tumor relapse ( hazard ratio 0.47 , 95 % CI 0.23–0.94 ) , death from a cancer-related cause ( 0.44 , 0.21–0.92 ) and death from any cause ( 0.59 , 0.35–0.98 ) . Conclusions : LAC is more effective than OC in the treatment of colon cancer Background : Laparoscopy has revolutionized many abdominal surgical procedures . Laparoscopic colectomy has become increasingly popular . The short- and long-term benefits and satisfactory surgical oncological treatment of colorectal cancer by laparoscopic-assisted resection remain topical . The long-term outcomes of all international r and omized controlled trials are still awaited , and short-term outcomes are important in the interim . Methods : Between January 1998 and April 2005 , a multicenter , prospect i ve , r and omized clinical trial in patients with colon cancer was conducted . Six hundred and one eligible patients were recruited by 33 surgeons from 31 Australian and New Zeal and centers . Patients were allocated to colectomy by either laparoscopic-assisted surgery ( n = 294 ) or open surgery ( n = 298 ) . Patient demographics and secondary end-points , such as operative and postoperative complications , length of hospital stay , and histopathological data , will be presented in this article . Analysis was by intention-to-treat . Survival will be reported only as the study matures . Results : Histopathological parameters were similar between the two groups , except in regard to distal resection margins . There was no statistically significant difference found in postoperative complications , reoperation rate , or perioperative mortality . Statistically significant differences in quicker return of gastrointestinal function and shorter hospital stay were identified in favor of laparoscopic-assisted resection . A statistically significant increased rate of infective complications was seen in cases converted from laparoscopic-assisted to open procedures but with no difference in reoperation or in-hospital mortality . Conclusions : Laparoscopic-assisted colonic resection gives significant improvements in return of gastrointestinal function and length of stay , with an increased operative time and no difference in the postoperative complication rate BACKGROUND To investigate the similarities and differences of laparoscopic complete mesocolic excision ( CME ) to a colon resection with a D3 lymphadenectomy for the stage II/III left-sided colon carcinoma . METHODS Patients between July 2011 and August 2014 were r and omized into D3 and CME groups . Mesenteric area , log odds of positive lymph nodes ( LODDS ) , and other operative parameters were collected and assessed . RESULTS The average specimen sizes were 5730 ± 828 mm(2 ) in superior rectal artery (SRA)-preserving D3 , 8145 ± 1022 mm(2 ) in SRA-nonpreserving D3 , and 8745 ± 1039 mm(2 ) in the CME group ; the differences were significant ( P < .0001 ) . The number of lymph nodes collected from CME specimens was larger , but the CME specimens did not contain an elevated value of LODDS or positive nodes or lymph node ratio ( LNR ) . There were also no significant differences between recovery times of bowel function . Although it took more operation time in D3 approach , especially in SRA-preserving D3 operation , the difference was not significant . Concerning the leakage rate ( P = .34 ) and vessel-related complications ( P = .64 ) , there were no significant differences either . CONCLUSIONS Both st and ard D3 resection and CME could achieve a high quality of mesocolic plane grade for stage II/III colon cancer . The LODDS and LNR were comparable , and those were not relevant to mesenteric size Introduction Minimal invasive surgical approach can achieve quick functional recovery . However , the oncologic outcome for cancer is still a concern . This study aims to compare the oncologic outcome between laparoscopic and open methods in the curative resection of Stage II or III left-sided colon cancers . Methods In consideration of statistical power up to 90 % , 286 eligible patients with curable left-sided colon cancer ( Tumor-Node-Metastasis Stage II and Stage III disease ) requiring the takedown of colonic splenic flexure to facilitate a curative left hemicolectomy were recruited r and omly and equally allocated to the laparoscopic and open group . The primary endpoint was time-to-recurrence of tumor . Data was analyzed according to intention-to-treat principle . Results Postr and omization exclusion occurred because of metastatic disease detected intraoperatively occurred in 13 patients and because of patient withdrawal from trial in 4 . Therefore , 135 and 134 patients actually comprised the laparoscopic and open group , respectively . The median follow-up of patient was 40 months ( range : 18–72 months ) . The oncologic results were similar ( P = 0.362 , one-sided log-rank test ) in laparoscopic and open group of patients , with the estimated cumulative recurrence rate of 13.2 % ( 9/68 ) versus 17.2 % ( 11/64 ) in Stage II disease and 20.9 % ( 14/67 ) versus 25.7 % ( 18/70 ) in Stage III disease , respectively . The recurrence patterns were similar between the two groups . Both open and laparoscopic groups were comparable in the number of dissected lymph node ( 15.6 ± 3.0 vs. 16.0 ± 6.0 , P = 0.489 ) , various demographic and clinicopathologic parameters . Conclusions The estimated cumulative recurrence rate for the surgery of Stage II or III left-sided colon cancers was the same between laparoscopic and open methods Objective : A r and omized controlled trial to confirm the non-inferiority of laparoscopic surgery to open surgery in terms of overall survival was conducted , and short-term surgical outcomes are demonstrated . Background : The efficacy and safety outcome of laparoscopic surgery for clinical stages II/III colon cancer undergoing Japanese D3 dissection are still unclear . Methods : Eligibility criteria included colon cancer ; tumor located in the cecum , ascending , sigmoid , or rectosigmoid colon ; T3 or T4 without involvement of other organs ; N0–2 ; and M0 . Patients were r and omized preoperatively and underwent tumor resection with D3 dissection . Safety analyses were conducted by per- protocol set . Results : A total of 1057 patients were r and omized between October 2004 and March 2009 . By per- protocol set , 524 patients who underwent open surgery and 533 patients who underwent laparoscopic surgery were analyzed . D3 dissection was performed in 521 ( 99.4 % ) patients in the open surgery arm and 529 ( 99.2 % ) patients in the laparoscopic surgery arm . Conversion to open surgery was needed for 29 ( 5.4 % ) patients . Patients assigned to laparoscopic surgery had less blood loss ( P < 0.001 ) , although laparoscopic surgery lasted 52 minutes longer ( P < 0.001 ) . Laparoscopic surgery was associated with a shorter time to pass first flatus , decreased use of analgesics after 5 postoperative days , and a shorter hospital stay . Morbidity [ 14.3 % ( 76/533 ) vs 22.3 % ( 117/524 ) , P < 0.001 ] was lower in the laparoscopic surgery arm . Conclusions : Short-term surgical safety and clinical benefits of laparoscopic D3 dissection were demonstrated . The primary endpoint will be reported after the primary analysis , planned for 2014 Background : Because of specific method ological difficulties in conducting r and omized trials , surgical research remains dependent predominantly on observational or non‐r and omized studies . Few vali date d instruments are available to determine the method ological quality of such studies either from the reader 's perspective or for the purpose of meta‐ analysis . The aim of the present study was to develop and vali date such an instrument Objective : Laparoscopic colectomy has been proved to be both technically and oncologically feasible . However , the approach has been criticized for its procedural complexity and long operative time as a result of the loss of tactile feedback and absence of depth perception . The advent of h and -access devices offered a potential solution to these problems . This r and omized controlled trial aims to compare h and -assisted laparoscopic colectomy ( HALC ) with open colectomy ( OC ) in the management of right-sided colonic cancer . Methods : Adult patients with nonmetastatic carcinoma of cancer or ascending colon were recruited . Patients were excluded if they presented with surgical emergencies , had synchronous tumors on work-up , or when the tumor was larger than 6.5 cm in any dimension or preoperative imaging . Recruited patients were r and omized to undergo either HALC or OC by the same surgical team . Outcome measures included operative time , blood loss , postoperative pain score and analgesic requirement , length of hospital stay , postoperative complications , as well as disease recurrence and patient survival . Results : Eighty-one patients ( HALC = 41 , OC = 40 ) were successfully recruited . The 2 groups were matched for age , gender distribution , body mass index , and comorbidities . No significant difference was observed between the 2 groups in the distribution of tumors and the final histopathological staging . HALC took significantly longer than OC ( 110 min vs. 97.5 minutes , P = 0.003 ) but result ed in significantly less blood loss ( 35 mL vs. 50 mL , P = 0.005 ) . Patients after HALC experienced significantly less pain , required significantly less parenteral and enteral analgesia , recovered faster , and was associated with a shorter length of stay ( 7 days vs. 9 days , P = 0.004 ) . With median follow-up of 28 to 30 months , no difference was observed in terms of disease recurrence , and the 5-year survival rates remained similar ( 83 % vs. 74 % , P = 0.90 ) . Conclusion : HALC retained the same short-term benefits of the pure laparoscopic approach . The technique is associated with a slightly increased but acceptable operative time . Aside as a useful adjunct in complex laparoscopic procedures , the h and -assisted laparoscopic technique is also a useful , if not more effective , alternative for patients with right-sided colonic cancer AIM Over recent years there has been a new focus on the quality of colon cancer surgery following the description and introduction of complete mesocolic excision ( CME ) . In the same period , laparoscopic surgery has been widely applied to the treatment of colon cancer . We aim ed to evaluate the introduction of both CME and laparoscopic-assisted surgery at Aarhus University Hospital , Denmark between 2008 and 2011 . Secondly we aim ed to evaluate the impact on the quality of surgery of post-operative team meetings where pathologists demonstrated the plane of surgery on the specimens . METHOD A series of 209 consecutive and prospect ively collected colon cancer specimens were evaluated by assessing the plane of surgery and measuring the amount of tissue resected . Multivariate analyses were used to control for influencing factors . RESULTS The proportion of specimens resected in the mesocolic plane was high and increased significantly following the introduction of post-operative team meetings ( 52%-76 % , p = 0.02 ) . Laparoscopic surgery enhanced the distance between the tumour and the arterial tie by a mean of 27 mm ( p < 0.0001 ) and the distance between the nearest bowel wall and the arterial tie by 26 mm ( p < 0.0001 ) when compared to an open approach . Factors such as body mass index and age influenced the outcome for surgical quality . CONCLUSION Implementation of CME and laparoscopic-assisted surgery for colon cancer is a challenge and requires continuous training and feedback . Post-operative multidisciplinary team meetings may be a key element in this process Background / Aim : Laparoscopic complete mesocolic excision ( CME ) used in the treatment of transverse colon cancer has been question ed on the basis of the technical challenges . The aim of this study was to evaluate the medium- and long-term clinical and survival outcomes after laparoscopic and open CME for transverse colon cancer and to compare the 2 approaches . Methods : This study was a retrospective non-r and omized study of patients with prospect ively registered data on open and laparoscopic CME for transverse colon cancer tumour-node-metastasis stages I-III operated on between 2007 and 2014 . This was a single-centre study in a community teaching hospital . A total of 56 patients with transverse colon cancer were included , excluding those with tumours in the colonic flexures . The outcome aims were 4-year time to recurrence ( TTR ) and cancer-specific survival ( CSS ) . Morbidity was also measured . Results : The 4-year TTR was 93.9 % in the laparoscopic group and 91.3 % in the open group ( p = 0.71 ) . The 4-year CSS was 97.0 % in the laparoscopic group and 91.3 % in the open group ( p = 0.42 ) . Limitations : This was a prospect i ve single-institution study with a small sample size . Conclusion : Results of the study suggest that the laparoscopic CME approach might be the preferred approach for transverse colon cancer , especially regarding its benefits in terms of short-term morbidity , length of stay and oncological outcome PURPOSE The aim of the current study is to report the long-term outcomes after laparoscopic-assisted surgery compared with conventional open surgery within the context of the UK MRC CLASICC trial . Results from r and omized trials have indicated that laparoscopic surgery for colon cancer is as effective as open surgery in the short term . Few data are available on rectal cancer , and long-term data on survival and recurrence are now required . METHODS The United Kingdom Medical Research Council Conventional versus Laparoscopic-Assisted Surgery in Colorectal Cancer ( UK MRC CLASICC ; clinical trials number IS RCT N 74883561 ) trial study comparing conventional versus laparoscopic-assisted surgery in patients with cancer of the colon and rectum . The r and omization ratio was 2:1 in favor of laparoscopic surgery . Long-term outcomes ( 3-year overall survival [ OS ] , disease-free survival [ DFS ] , local recurrence , and quality of life [ QoL ] ) have now been determined on an intention-to-treat basis . RESULTS Seven hundred ninety-four patients were recruited ( 526 laparoscopic and 268 open ) . Overall , there were no differences in the long-term outcomes . The differences in survival rates were OS of 1.8 % ( 95 % CI , -5.2 % to 8.8 % ; P = .55 ) , DFS of -1.4 % ( 95 % CI , -9.5 % to 6.7 % ; P = .70 ) , local recurrence of -0.8 % ( 95 % CI , -5.7 % to 4.2 % ; P = .76 ) , and QoL ( P > .01 for all scales ) . Higher positivity of the circumferential resection margin was reported after laparoscopic anterior resection ( AR ) , but it did not translate into an increased incidence of local recurrence . CONCLUSION Successful laparoscopic-assisted surgery for colon cancer is as effective as open surgery in terms of oncological outcomes and preservation of QoL. Long-term outcomes for patients with rectal cancer were similar in those undergoing abdominoperineal resection and AR , and support the continued use of laparoscopic surgery in these patients Since 2001 we have conducted a prospect i ve r and omised study of right laparoscopic-assisted hemicolectomy vs open right hemicolectomy for right colon cancer in order to assess the differences in intraoperative and postoperative results as well as oncological clearance . Thirty-three patients with right colon cancer received laparoscopic-assisted right hemicolectomy ( LRH ) and were compared with 33 patients who underwent open right hemicolectomy ( ORH ) . We analysed morbidity and mortality , number of postoperative days of starving , postoperative days tolerating a liquid diet and a soft diet , duration of postoperative ileus , as well as the distance of the resection margin from the tumour ( < 5 cm or > 5 cm ) , and the number of lymph nodes found in the resected specimen . We also compared the length of operative time , blood loss , and any associated surgery . Morbidity occurred in 1 patient undergoing LRH ( 3.0 % ) as against 4 patients ( 12.1 % ) in the ORH group ( p < 0.05 ) . Postoperative ileus lasted 3.15 days ( range : 3 - 5 days ) in the LRH group vs 3.0 days ( range : 1 - 4 days ) in the ORH group . Median operative time was 251 min ( range : 130 - 360 min ) in the LRH group vs 222.9 min ( range : 135 - 360 min ) in the ORH group , while blood loss amounted to a median of 135 mi ( range : 100 - 300 ml ; SD + /- 42.9 mi ) in the LRH group vs. 404.1 ml ( range : 250 - 1000 ml ; SD + /- 159.3 ml ) in the ORH group ( p < 0.05 ) . The distance of the resection margin from the tumour was more than 5 cm in both groups . In the LRH group a median of 12.7 lymph nodes were removed ( range : 9 - 31 ; SD + /- 4.5 ) vs. 18 lymph nodes in the ORH group ( range : 8 - 29 ; SD + /- 3.9 ) ( p < 0.05 ) . Associated surgery was performed in 15.1 % of cases in both groups . In our experience LRH presents a statistically significant advantage in terms of morbidity and blood loss compared to ORH . Equivalent oncological clearance was obtained , fulfilling the stated criteria of 5 cm free resection margins and number of lymph nodes resected , though we removed fewer lymph nodes in LRH compared to ORH ( p < 0.05 ) BACKGROUND : Evidence demonstrates short-term benefits of laparoscopic surgery for colon cancer . The situation for rectal cancer is less clear . OBJECTIVES : This review assessed the use and short-term outcomes of elective open and laparoscopic colon and rectal cancer resections within an area health service . DESIGN : This was a multicenter , retrospective review of a prospect i ve data base . SETTING S : All elective colon and rectal cancer resections in the western zone of Sydney South West Area Health Service from 2001 until 2008 were included . PATIENTS : Included were 1721 patients who underwent either a laparoscopic colon ( n = 434 ) or rectal ( n = 157 ) resection or an open colon ( n = 742 ) or rectal ( n = 388 ) resection . MAIN OUTCOME MEASURES : Outcome measures included operating time , blood loss , adequacy of resection , conversion rate , intensive care unit admission , length of stay , and 26 acute postoperative complications . RESULTS : Patients were matched for age , sex , ASA , BMI , and tumor stage . Laparoscopic surgery increased in frequency . Fewer patients experienced a complication in both the laparoscopic colon ( 28.8 vs 54.4 % ; p < 0.0001 ) and rectal ( 41.4 vs 60.3 % ; p < 0.0001 ) group irrespective of age . Laparoscopic operating time for colon and rectal cancer was 24.1 minutes ( p < 0.0001 ) and 25.8 minutes ( p < 0.0001 ) longer , with a low conversion-to-open rate ( 6.5 % and 8.3 % ; p = 0.44 ) . Laparoscopic surgery result ed in fewer transfusions ( 0.4 vs 0.7units ; p = 0.0028 ) and length of stay ( 7 vs 10 days ; p = 0.0011 ) for colon cancers , and reduced intraoperative hemoglobin drop ( 20.5 vs 24.8 ; p = 0.029 ) and intensive care unit admissions ( 26.8 vs 36.3 % ; p = 0.032 ) for rectal cancers . LIMITATIONS : This was a nonr and omized study with rectal cancers more often resected with the open technique ( 71.2 vs 28.8 % ; p < 0.001 ) . CONCLUSIONS : Within an area health service , elective laparoscopic resection for colon and rectal cancer had improved short-term outcomes in comparison with open surgery BACKGROUND Laparoscopic surgery for colon cancer has been proven safe , but debate continues over whether the available long-term survival data justify implementation of laparoscopic techniques in surgery for colon cancer . The aim of the COlon cancer Laparoscopic or Open Resection ( COLOR ) trial was to compare 3-year disease-free survival and overall survival after laparoscopic and open resection of solitary colon cancer . METHODS Between March 7 , 1997 , and March 6 , 2003 , patients recruited from 29 European hospitals with a solitary cancer of the right or left colon and a body-mass index up to 30 kg/m(2 ) were r and omly assigned to either laparoscopic or open surgery as curative treatment in this non-inferiority r and omised trial . Disease-free survival at 3 years after surgery was the primary outcome , with a prespecified non-inferiority boundary at 7 % difference between groups . Secondary outcomes were short-term morbidity and mortality , number of positive resection margins , local recurrence , port-site or wound-site recurrence , and blood loss during surgery . Neither patients nor health-care providers were blinded to patient groupings . Analysis was by intention-to-treat . This trial is registered with Clinical Trials.gov , number NCT00387842 . FINDINGS During the recruitment period , 1248 patients were r and omly assigned to either open surgery ( n=621 ) or laparoscopic surgery ( n=627 ) . 172 were excluded after r and omisation , mainly because of the presence of distant metastases or benign disease , leaving 1076 patients eligible for analysis ( 542 assigned open surgery and 534 assigned laparoscopic surgery ) . Median follow-up was 53 months ( range 0.03 - 60 ) . Positive resection margins , number of lymph nodes removed , and morbidity and mortality were similar in both groups . The combined 3-year disease-free survival for all stages was 74.2 % ( 95 % CI 70.4 - 78.0 ) in the laparoscopic group and 76.2 % ( 72.6 - 79.8 ) in the open-surgery group ( p=0.70 by log-rank test ) ; the difference in disease-free survival after 3 years was 2.0 % ( 95 % CI -3.2 to 7.2 ) . The hazard ratio ( HR ) for disease-free survival ( open vs laparoscopic surgery ) was 0.92 ( 95 % CI 0.74 - 1.15 ) . The combined 3-year overall survival for all stages was 81.8 % ( 78.4 - 85.1 ) in the laparoscopic group and 84.2 % ( 81.1 - 87.3 ) in the open-surgery group ( p=0.45 by log-rank test ) ; the difference in overall survival after 3 years was 2.4 % ( 95 % CI -2.1 to 7.0 ; HR 0.95 [ 0.74 - 1.22 ] ) . INTERPRETATION Our trial could not rule out a difference in disease-free survival at 3 years in favour of open colectomy because the upper limit of the 95 % CI for the difference just exceeded the predetermined non-inferiority boundary of 7 % . However , the difference in disease-free survival between groups was small and , we believe , clinical ly acceptable , justifying the implementation of laparoscopic surgery into daily practice . Further studies should address whether laparoscopic surgery is superior to open surgery in this setting Purpose : Oncologic concerns from high wound recurrence rates prompted a multi-institutional r and omized trial to test the hypothesis that disease-free and overall survival are equivalent , regardless of whether patients receive laparoscopic-assisted or open colectomy . Methods : Eight hundred seventy-two patients with curable colon cancer were r and omly assigned to undergo laparoscopic-assisted or open colectomy at 1 of 48 institutions by 1 of 66 credentialed surgeons . Patients were followed for 8 years , with 5-year data on 90 % of patients . The primary end point was time to recurrence , tested using a noninferiority trial design . Secondary endpoints included overall survival and disease-free survival . ( Kaplan – Meier ) Results : As of March 1 , 2007 , 170 patients have recurred and 252 have died . Patients have been followed a median of 7 years ( range 5–10 years ) . Disease-free 5-year survival ( Open 68.4 % , Laparoscopic 69.2 % , P = 0.94 ) and overall 5-year survival ( Open 74.6 % , Laparoscopic 76.4 % , P = 0.93 ) are similar for the 2 groups . Overall recurrence rates were similar for the 2 groups ( Open 21.8 % , Laparoscopic 19.4 % , P = 0.25 ) . These recurrences were distributed similarly between the 2 treatment groups . Sites of first recurrence were distributed similarly between the treatment arms ( Open : wound 0.5 % , liver 5.8 % , lung 4.6 % , other 8.4 % ; Laparoscopic : wound 0.9 % , liver 5.5 % , lung 4.6 % , other 6.1 % ) . Conclusion : Laparoscopic colectomy for curable colon cancer is not inferior to open surgery based on long-term oncologic endpoints from a prospect i ve r and omized trial OBJECTIVE To explore the differences in long-term outcomes between laparoscopic and open complete mesocolic excision(CME ) for colon cancer . METHODS A total of 273 patients with colon cancer who underwent CME at the Fujian Medical University Union Hospital from September 2000 to December 2008 were divided into laparoscopic(LP , n=147 ) and open(OP , n=126 ) groups in a non-r and om manner . The oncologic and long-term outcomes were compared . RESULTS No significant differences were seen in the length of distal and proximal margin , and number of lymph nodes(all P>0.05 ) . Median postoperative follow up was 50 months . Local regional recurrence rates ( LP 6.1 % vs. OP 7.9 % ) and distal metastasis rates(LP 23.8 % vs. OP 16.7 % ) were similar between the two groups(all P>0.05 ) . The 5-year overall survival rates ( LP 69.4 % vs. OP 74.0 % , P=0.840 ) and 5-year disease-free survival rates(LP 68.5 % vs. OP 70.9 % , P=0.668 ) between the two groups were not statistically different . CONCLUSIONS Laparoscopic CME has the same oncologic clearance effects compared with open CME for colon cancer . It might become a new st and ardized surgery for colon cancer 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 |
11,583 | 18,310,730 | The panel concluded that sealants are effective in caries prevention and that sealants can prevent the progression of early noncavitated carious lesions .
The evidence indicates that sealants can be used effectively to prevent the initiation and progression of dental caries | BACKGROUND This article presents evidence -based clinical recommendations for use of pit- and -fissure sealants developed by an expert panel convened by the American Dental Association Council on Scientific Affairs .
The panel addressed the following clinical questions : Under what circumstances should sealants be placed to prevent caries ?
Does placing sealants over early ( noncavitated ) lesions prevent progression of the lesion ?
Are there conditions that favor the placement of resin-based versus .
glass ionomer cement sealants in terms of retention or caries prevention ?
Are there any techniques that could improve sealants ' retention and effectiveness in caries prevention ? | BACKGROUND The authors examined several restorative material s to evaluate their ability to inhibit demineralization and enhance remineralization of incipient carious lesions on the interproximal enamel of teeth adjacent to those restored with the material s. METHODS Twenty-one subjects in need of a crown on a m and ibular molar and a Class II inlay on an adjacent tooth took part in this six-phase study . Artificial enamel lesions were created and positioned within the interproximal portion of a crown . Lesions were photographed with polarized light microscopy and characterized before and after 30-day intraoral exposures . Each phase included the placement of a new section in the crown model and a new Class II inlay restorative material in the adjacent tooth . RESULTS Results demonstrated that nonfluori date d resin composite , fluori date d resin composite and resin-modified glass ionomer restorative material s , when placed in subjects who brushed with a fluori date d dentifrice , demonstrated significantly ( P < .05 ) less enamel demineralization than the nonfluori date d resin composite control placed in subjects who brushed with a nonfluori date d dentifrice . The resin-modified glass ionomer cement , however , even when brushed with a nonfluori date d dentifrice , exhibited significantly ( P < .05 ) less demineralization than the nonfluori date d resin composite control brushed with a nonfluori date d dentifrice . CONCLUSIONS Resin-modified glass ionomer cement appears to significantly inhibit demineralization of interproximal enamel of teeth adjacent to those restored with the material . CLINICAL IMPLICATION S Resin-modified glass ionomer cement restorations can enhance prevention of enamel demineralization on adjacent teeth AIM The purpose of the study was to determine the retention of glassionomer sealants in primary teeth of preschool children . METHODS Fissure sealants ( Fuji II LC ) were placed on primary molars , without conditioner , by two experienced dentists under good clinical conditions in well equipped clinics and with the assistance of a chair side dental assistant . Sealants were scored as " fully retained " , " partly retained " , or " completely lost " after two years . RESULTS There were 65 children included , out of which 29 had all primary molars . Mean age at the time of sealing was slightly less than 41/2 years . Mean follow-up time was two years . About 75 % of the sealants placed in second primary molars were fully or partly retained after 12 months , compared with less that 50 % of the sealants placed in first primary molars . New carious lesions were too few to allow for an assessment of whether the sealants were effective in preventing caries . CONCLUSION Retention rates for glass ionomer fissure sealants were satisfactory . However , high quality r and omised clinical trials to estimate the caries preventive effect are still needed AIM This was to evaluate the efficacy of pit and fissure sealant ( FS ) using two different application techniques for caries prevention assessed at five and ten years . METHODS The study was conducted using Delton(R ) pit and fissures sealant applied with either rubber dam ( RD ) ( Group A : 50 children , 200 first permanent molars , 120 second permanent molars ) or cotton wool rolls ( CR ) ( Group B : 50 children , 200 first permanent molars , 112 second permanent molars ) . At five and ten years FS were evaluated for retention , loss and incidence of occlusal and proximal carious lesions recorded . STATISTICS The data were analysed with the Chi- square test comparing the results obtained for first permanent molars and second permanent molars at five and ten years . RESULTS There was no statistical difference between results in the two groups ( p < or = 0.05 ) . The highest retention rate , 81.7 % , was found for second permanent molars sealed under RD at the five year assessment . The lowest , 64.3 % also for second molars sealed under CR humidity control at ten years . CONCLUSIONS Pit and fissure sealants are a valid preventive approach that can be applied with similar results with rubber dam or cotton rolls This study compared two techniques for placing sealant in an elementary school setting . Eighty-five children in grade s 1 to 4 in two schools were assigned r and omly to two sealant treatment groups : 1 ) acid etch technique ( AE ) , and 2 ) air abrasion with no acid etch ( KCP-1000 ) . Noncarious , nonfilled occlusal , distolingual and buccal pit surfaces of first permanent molars were sealed . A total of 300 teeth received sealants , and 230 were evaluated at 6 months . Rates of complete sealant retention at 6 months were : occlusal surfaces , 97 % for AE and 96 % for KCP-1000 ; distolingual surfaces , 82 % for AE and 49 % for KCP-1000 ; and buccal surfaces , 77 % for AE and 7 % for KCP-1000 . Differences in complete retention at 6 months between AE and KCP-1000 were not significant for occlusal surfaces ( P = 0.14 ) but were significant for buccal and distolingual surfaces ( P < 0.0001 ) . Results suggest that sealants placed with air abrasion have retention rates for occlusal surfaces similar to AE . More research is needed to identify factors contributing to low retention rates on other surfaces for KCP-1000 The aim of the present trial was to ( 1 ) compare the caries-preventive effect of glass ionomer sealants , placed according to the atraumatic restorative treatment ( ART ) procedure , with composite resin sealants over time and ( 2 ) investigate the caries-preventive effect after complete disappearance of sealant material . Forty-six boys and 57 girls , mean age 7.8 years , were r and omly divided into two treatment groups in a parallel-group study design . A light-polymerized composite resin sealant material and a high-viscosity glass ionomer were each placed in 180 fully erupted first molars in their respective treatment groups . Evaluation took place annually for 5 years by calibrated examiners . After 5 years , 86 % composite resin and 88 % glass ionomer sealants did not survive . Three categories of re-exposure periods for caries development in pits and fissures after complete loss of sealants were distinguished : 0–1 , 1–2 and 2–3 years . In the 2- to 3-year group , 13 and 3 % of pits and fissures previously sealed with composite resin and glass ionomer , respectively , were diagnosed as having developed a dentine lesion . The relative risks ( 95 % CI ) of dentine lesion development in surfaces sealed with glass ionomer compared to those sealed with composite resin after 3 , 4 and 5 years were 0.22 ( 0.06–0.82 ) , 0.32 ( 0.14–0.73 ) and 0.28 ( 0.13–0.61 ) , respectively . The relative risks of dentine lesion development in pits and fissures previously sealed with glass ionomer compared with composite resin over re-exposure periods of 1–2 and 2–3 years were 0.26 ( 0.14–0.48 ) and 0.25 ( 0.09–0.68 ) , respectively . We conclude that the caries-preventive effect of high-viscosity glass ionomer sealants , placed using the ART procedure , was between 3.1 and 4.5 times higher than that of composite resin sealants after 3–5 years . Furthermore , high-viscosity ( ART ) glass ionomer sealants appear to have a four times higher chance of preventing caries development in re-exposed pits and fissures of occlusal surfaces in first molars than light-cured composite resin sealant material over a 1- to 3-year period . A well- design ed clinical trial using different types of oral health personnel should be implemented to confirm these initial results Retention of sealant material is the main determinant for the caries preventive eect of sealants . This may partly explain the low interest in using ® ssure sealants in young children , where sucient moisture control may be dicult to obtain . Consequently , almost no data are available in the literature on the eect of ® ssure sealants in young pre-school children . The purpose of the present communication is to report the retention of a light polymerized ® ssure sealant ( Prisma -Shield ) and an autopolymerized sealant ( Delton ) in primary molars of young children . The study included 52 children ( 25 boys and 27 girls ) with a median age of 3 years 7 months ( range 2 years 11 months to 4 years 11 months ) who were attending municipal dental clinics for regular dental care in and around the municipality of AÊ rhus and in the paediatric dentistry section of the department . All children were examined by the same dentist ( E.H. ) , who also placed all the sealants . Caries was diagnosed at the cavitation level and only children with pairs of sound primary molars were included . The teeth within each tooth pair were r and omly assigned to sealing with Delton or Prisma -Shield . The manufacturer 's instructions were carefully followed for both material s. Mean follow-up period was 2.8 years ( range 2.0±3.3 years ) , at which time 20 pairs of upper second molars , two pairs of upper ® rst molars , 28 pairs of lower second molars , and one pair of lower ® rst molars were re-examined . Complete retention was found in 70.6 % of the teeth sealed with Delton and in 76.5 % of the teeth sealed with Prisma -Shield ( Table 1 ) . The slightly better retention of the light polymerized ® ssure sealant could be due to the shorter period of moisture control needed for placing a light polymerized sealant . However , McNemar 's test showed that the dierence was not statistically signi ® cant in this group ( P = 0.49 ) . Table 2 shows that caries development after sealing was low with both types of material s ( 5.9 % for Delton and 9.8 % for Prisma -Shield ) . 67 % ( four out of six ) of the pairs with dierent caries development in the two teeth developed caries in the tooth sealed with Prisma -Shield , but not in the tooth sealed with Prisma -Shield . The 95 % con ® dence limits for this parameter calculated according to the method described by Armitage & Berry [ 1 ] were 0.045 and 3.49 and included the value 0.5 , indicating no dierence in caries development after the two sealants PURPOSE To evaluate the 2-year clinical sealant success when using Prompt L-Pop ( 3M-ESPE ) , the first self-etching adhesive , as the sole etching and adhesive step prior to sealant placement . METHODS Patients ages 7 - 13 years with matched pairs of permanent molars needing sealants were enrolled into an ongoing clinical study of sealant success . First and /or second permanent molars were r and omly assigned to control ( sealant only after phosphoric acid etch ) or Prompt plus sealant groups in a split-mouth , matched pair study design . St and ard methods were used for sealant ( Delton , Dentsply ) placement , except for the Prompt group in which the self-etching adhesive was brushed on the surface , air thinned , followed by immediate placement of the sealant and polymerization . All sealants were placed using appropriate cotton-roll isolation and a dental assistant . Sealant scoring was done at 24 months using strict clinical criteria for failure , previously published , and photos of the sealed surfaces were archived on video . RESULTS Percentages of sealants scored as successful ( no significant loss of material or need for repair ) through 24 months were : ( a ) Occlusal sealants : Control = 61 % , versus Prompt = 61 % ; ( b ) Bu/Lingual sealants : Control = 54 % , versus Prompt = 62 % ; McNemar 's Chi Square tests indicate no difference in success between the Prompt sealants and their matched controls ( P > 0.80 ) . Time of placement for sealants , timed from start of the etch step through polymerization , averaged 3.1 minutes for Control and 1.8 minutes for Prompt . We conclude that Prompt L-Pop self-etching adhesive is effective in bonding sealant to enamel and that the simplified method dramatically shortens treatment time and treatment complexity OBJECTIVE To compare the retention and the caries preventive effect of a glass-ionomer developed for fissure sealing ( Fuji III ) and a chemically polymerized resin-based fissure sealant ( Delton ) . DESIGN A split mouth r and omized design using contralateral teeth . SETTING WHO Regional Demonstration , Training and Research Center for Oral Health , Damascus , Syrian Arab Republic . SAMPLE AND METHODS 179 children , 7 years old at the start of the study , were recruited from schools close to the Center . Only children with at least one pair of permanent first molars that were caries free or only had incipient lesions were included in the study . Follow-up examinations for sealant retention were done after 6 months , 1 year , 2 years and 3 years . The number of children available for reexamination was 129 ( after 6 months ) ; 121 ( after 1 year ) ; 115 ( after 2 years ) and 116 ( after 3 years ) . Four dental hygienists were trained in the sealant procedures and did approximately one fourth of the sealants each . RESULTS After 3 years the glass-ionomer sealant was completely lost in almost 90 % of the teeth compared to less than 10 % of the resin sealed teeth . After 3 years the relative risk of a tooth sealed with glass-ionomer over that of a tooth sealed with resin was 3.38 ( 95 % CL : 1.98 ; 5.79 ) . This finding was consistent over type of tooth . CONCLUSIONS The glass-ionomer sealant tested in the present study had poorer retention and less caries protective effect than the resin-based sealant used The purpose of this study was to evaluate the retention of fissure sealants , applied with 4 different combinations of isolation and preparation of occlusal surface . In 95 children aged 7 - 8 years , having all four first permanent molars fully erupted and caries free , a chemically initiated tinted fissure sealant was placed with the following 4 different methods in every child . 1 ) Tooth 16 : Cotton rolls isolation and cleaning of occlusal surface using a bristle brush and non-fluori date d paste . 2 ) Tooth 26 : Rubber dam isolation and mechanical preparation of pits and fissures using a round bur No. 0 in a slow h and -piece . 3 ) Tooth 36 : Rubber dam isolation and cleaning of occlusal surface using a bristle brush and non-fluori date d paste . 4 ) Tooth 46 : Isolation with cotton rolls and mechanical preparation of pits and fissures using a round bur No. 0 in a slow h and -piece . Eighty children were available for re-examination 4 years later ( 320 teeth ) . The 4 methods of application showed the following success rates of full retention : 1 ) 81 % 2 ) 88 % 3 ) 91 % 4 ) 93 % . Although statistical analysis of the results revealed only marginal statistically significant difference among the four different methods of application ( p = 0.091 ) , there was statistical significant difference ( p = 0.031 ) between methods 1 and 4 . No differences were detected among the remaining methods . The present trial revealed best sealant retention using a combination of cotton rolls isolation and mechanical preparation of the occlusal surface . ( ABSTRACT TRUNCATED AT 250 WORDS The purpose of the study was to evaluate whether the clinical effectiveness of pit and fissure sealant was increased ( as demonstrated by an increased retention rate ) when a bonding agent was used prior to the placement of the sealant . Two pit and fissure sealants , Concise Light Cured White Sealant and Prisma Shield Light Cured Sealant , were placed in vivo with and without the use of the bonding agents , Scotchbond 2 and Prisma Universal Bond . After 2 years , 55 % of the sample was available for recall . The retention rates for the sealants were 77 % for Concise with Scotchbond 2 , 84 % for Concise with no bonding agent , 77 % for Prisma Shield with Universal Bond , and 77 % for Prisma Shield with no bonding agent . Results of this study indicated that the use of a bonding agent prior to the application of a pit and fissure sealant does not increase the retention rate BACKGROUND Long-term retention of pit and fissure sealants is essential for their success . The aim of this study was to compare the retention rates of sealants placed with acid-etching and air abrasion followed by acid etching . METHODS Sixteen subjects aged 16 and 17 years were included in the study . Using a half-mouth design , the authors performed fissure preparation with phosphoric acid gel on r and omly assigned maxillary and m and ibular permanent premolars and molars from one side of the mouth ( Group I ) and performed air abrasion followed by acid etching on the contralateral side of the mouth ( Group II ) . The authors applied sealant material on 162 teeth , and they evaluated the sealants as complete retention , partial loss or total loss at six , 12 and 24 months . RESULTS While fissure sealant retention rates were not significantly different for the two techniques at six months ( P = .97 ) , the retention rates for the teeth in Group II were significantly higher at 12 ( P = .025 ) and 24 months ( P = .002 ) . Molar retention rates were significantly less than those for premolars at each evaluation period ( P < .05 ) . CONCLUSION The sealant retention rates at 12 and 24 months were higher in Group II ( air abrasion followed by acid etching ) . CLINICAL IMPLICATION S As air abrasion followed by acid etching result ed in significantly higher sealant retention rates , this method could be a good choice for fissure preparation before sealant placement for long-term success OBJECTIVE This study compared time required and 12-month retention for two methods of sealant placement : traditional acid-etch technique and air-abrasion technique without acid etch . METHODS Sealants were placed on the permanent first molars of 84 children in grade s 1 - 4 who were r and omly assigned to treatment groups . All sealants were placed in a school setting by the same clinician . Chair time required for sealant placement was recorded , and retention rates were determined for each technique 12 months after placement . RESULTS Mean chair time for placement of sealants on four first molars using the air-abrasion technique was significantly less than for the acid-etch technique ( 7:36 minutes vs 10:56 minutes ) . Fifty-eight children were available at 12-month follow-up ; an examiner not involved in sealant placement and masked as to the technique used determined retention . Rates of complete retention for occlusal surfaces were not significantly different for the two techniques , although the rate for acid etch was higher than that for air abrasion ( 95 % vs 87 % ) . The complete retention rates for the acid-etch technique were significantly higher than air abrasion for buccal and distolingual surfaces . These rates were 65 percent and 58 percent , respectively , for acid etch and 6 percent and 28 percent , respectively , for air abrasion . CONCLUSION Although more research is needed to improve air-abrasion applications , it does not appear that air abrasion without acid etching offers a significant advantage over traditional sealant placement methods and , in fact , appears to be inferior to the acid-etch technique for use in public health setting BACKGROUND Limited information is available regarding potentially estrogenic bisphenol A , or BPA , released from dental sealants . This study determined the rate- and time-course of BPA released from a dental sealant ( Delton Opaque Light-cure Pit and Fissure Sealant , Preventive Care/Dentsply ) when applied at a dosage of 8 milligrams ( one tooth ) or 32 mg ( 8 mg on each of four teeth ) to 40 healthy adults . METHODS The authors recruited 40 healthy subjects ( 18 men and 22 women , 20 - 55 years of age ) who did not have histories of pit and fissure sealant placement or composite resin restorations . The authors collected saliva ( 30 milliliters ) and blood ( 7 mL ) specimens from all subjects immediately before sealant placement ( baseline ) and at one hour , three hours , one day , three days and five days after sealant placement . They used high-pressure liquid chromatography to determine BPA ( detection sensitivity 5 parts per billion , or ppb ) in all specimens . RESULTS The authors detected BPA in some saliva specimens ( 5.8 - 105.6 ppb ) collected at one hour and three hours . The BPA , however , was not detectable beyond three hours or in any of the serum specimens . For the one- and three-hour saliva sample s , the BPA concentration in the high-dose ( 32 mg ) group was significantly greater than in the low-dose ( 8 mg ) group ( P < .05 , Wilcoxon signed rank test ) . In the high-dose group , there was a significant decrease in saliva BPA concentrations from one hour to three hours ( P < .01 , Wilcoxon signed rank test ) . CONCLUSION This study showed that BPA released orally from a dental sealant may not be absorbed or may be present in nondetectable amounts in systemic circulation . The concern about potential estrogenicity of sealant may be unfounded OBJECTIVES The objective of this study was to assess the effect of a one-bottle bonding agent on sealant success after 3 , 6 , 12 , and 24 months . METHOD AND MATERIAL S The sample group consisted of 30 schoolchildren ( 8 to 10 years of age ) who had all their permanent first molars sound and unsealed . Occlusal sealants were placed on first molars according to a split-mouth design . Sealant scoring occurred at 3 , 6 , 12 , and 24 months and was performed by two clinicians blinded to the treatment group . Fisher 's exact test was used to analyze the data . RESULTS The clinical ly acceptable marginal integrity rates for sealants with a bonding agent after 3 , 6 , 12 , and 24 months were 93 % , 93 % , 83 % , and 79 % , respectively . For sealants without a bonding agent , the clinical ly acceptable marginal integrity rates after 3 , 6 , 12 , and 24 months were 90 % , 88 % , 81 % , and 77 % . The rates for no color change in sealants with a bonding agent after 3 , 6 , 12 , and 24 months were 96 % , 93 % , 81 % , and 75 % , respectively . For sealants without a bonding agent , the no color change rates after 3 , 6 , 12 , and 24 months were 93 % , 93 % , 79 % , and 72 % . After 24 months , 73 % of the sample group were available for recall . The retention rates for sealants with and without a bonding agent after 24 months were 79 % and 75 % , respectively . The results of the statistical analysis showed that there were no differences among the sealants with and without bonding agents evaluated in relation to marginal integrity , marginal discoloration , and anatomic form . CONCLUSION The success of a sealant is related to whether the sealant is applied under optimal conditions . The results of this study show that at the 2-year mark , the placement of a bonding agent under sealants did not significantly affect the clinical success of sealants A clinical trial of 4047 single applications of Nuva Seal placed on the occlusal surfaces of primary molars , permanent first and second molars and premolars by 250 dental students showed that the sealants were not well retained . The sealant was fully retained on 86 % of all permanent posterior teeth at 3 months , on 76 % at 6 months , 58 % at 12 months , 52 % at 24 months and 41 % at 36 months . At 4 years , complete sealant coverage was shown by 14 % of primary molars , 25 % of permanent molars and 68 % of premolars . Permanent m and ibular molars and premolars were superior to permanent maxillary molars and premolars in fully retaining sealants . Following sealant failure , i.e. providing partial coverage or missing , permanent maxillary molars and premolars were more prone to occlusal caries than permanent m and ibular molars and premolars . At 4 years , caries was diagnosed in 40 % of applications to permanent molars and in 9 % of applications to premolars . Twelve instances of caries under apparently intact sealants were seen OBJECTIVES Very little independent research has been done on the new self-etching primer/adhesives in dentistry . A recent clinical study compared two sealant application techniques involving self-etching primer adhesives and the traditional phosphoric acid etch . The purpose of this study was to compare these two techniques in an Iowa school-based sealant program . METHODS Twelve-month sealant retention data on 208 students from the Des Moines , Iowa , school-based sealant program were analyzed retrospectively . RESULTS Sealant retention reported at the person level showed that 60 percent of the students who received sealants at the five schools had to be recalled at one year to have one or more surfaces resealed . A logistic regression model at the person level demonstrated that the phosphoric acid technique was six times as likely to have retention of all the sealed tooth surfaces as those sealed with Prompt-L-Pop . CONCLUSIONS In this study , many students had to be recalled to the chair 12 months after sealant application due to incomplete retention . Though sealants were retained in larger numbers with phosphoric acid , overall sealant retention at the tooth level was lower than previously published for clinical studies and school-based programs . Examining retention data at the person level , however , allows program administrators to plan re sources more effectively and reevaluate sealant protocol to ensure as few children return for sealant reapplication Glass ionomer ( GI ) , applied as a pit and fissure sealant , has been shown to be a promising method for caries prevention . It has also been suggested that when GI is used as a sealant material , it can prevent caries , even if partly or totally lost . As there is no need for resealing GI , it may be more cost-effective when compared to a resin-based ( RB ) sealant . This study evaluated the factors influencing the time needed to apply a sealant as a factor in determining the possible costs of the effectiveness of RB compared to GI sealants . To study this , children born between 1980 and 1983 , who had their appropriate second molars sealed between 1993 and 1997 , were assessed . The study was then based on a r and om sub- sample of this group , comprising 140 teeth : 86 sealed with RB ( Delton ) and 54 with GI ( Fuji III ) . For a hygienist working alone , the whole procedure of applying a sealant , beginning with the cleaning of the tooth and ending with the finished sealant , took , on average , 344 ( + /- 59 ) seconds with RB , and 599 seconds ( + /- 89 ) with GI . This difference in time was found to be statistically significant at p < 0.01 . No statistically significant difference existed in the mean time required to apply a sealant between the left ( 410 + /- 140 seconds ) and the right ( 448 + /- 149 seconds ) sides ; however , the m and ibular teeth required longer for application of the sealant than did the maxillary teeth ( 447 + /- 161 seconds vs. 408 + /- 125 seconds , respectively ; p < 0.01 ) . It was also found that a dentist , working with chairside assistance , took 20 % less time to apply either sealant material than did the hygienist working alone . It was concluded that GI sealants , whether resealed or not , can not be as cost-effective as RB sealants , when the expense of placement in time ( and thus costs ) is used as the basis of efficacy OBJECTIVE To evaluate the retention and caries preventive effect of two glass ionomers used as fissure sealants : one resin modified glass ionomer ( A ) and one conventional glass-ionomer cement ( B ) . SAMPLE S AND METHODS The permanent first molars of 100 children , 6 - 8 years of age at the start of the study , were sealed . Material A was applied on one side ( right side , upper , and lower ) and material B was applied on the contralateral side ( left side , upper , and lower ) of the mouth . The control group was composed of 108 children who did not receive fissure sealant but received oral health education . After 5 years , 64.0 % of the children of the experimental group and 73.0 % of the children of the control group were available for reexamination . RESULTS Material A was completely lost in 74.2 % and material B in 89.0 % ( Wilcoxon matched pairs test , P < 0.05 ) . Total retention rate was 1.6 % for material s A and B. After 5 years , caries increment was 21.5 % for the experimental group and 34.2 % for the control group ( chi2-test , P < 0.05 ) . CONCLUSION Sealing pits and fissures with glass-ionomer cements was effective in preventing caries Abstract Fissure sealing using partially filled resins is an established caries preventive practice . Glass ionomer cement ( GIC ) sealants may offer additional advantages due to their ability to bond chemically to enamel and release fluoride . The aim of this study was to compare the caries preventive effect and retention of a GIC and a resin-based sealant . Ketac-fil ® was tested against a chemically cured resin-based material ( Delton ® ) using a split mouth design . Perth ( Western Australia ) schoolchildren ( n= 465 ) , mean age 7 yr±0.72 ( S.D. ) , received sealants on the occlusal surfaces of sound homologous permanent first molar pairs . Test ( GIC ) and control ( resin ) sealants were systematic ally allocated to left and right sides based on the child 's month of birth , and were placed by dental therapists . After 3.64±0.11 yr , 415 children were examined by different clinicians , and the clinical status of the teeth and the extent of sealant retention recorded . Sealants were deemed retained when at least 2/3 of the fissure pattern was still sealed . In 252 tooth pairs , neither sealant was retained to this extent . In 71 pairs , the GIC was not retained and the resin sealant retained . In 40 pairs the reverse occurred ( McNemar 's test , χ2= 8.66 , P < 0.005 ) . Net gain ( additional lesions prevented by the test agent per 100 treatments ) was 6.1%(95 % CI 3.3 % , 8.9 % ) . Effectiveness of the GIC was 80.6 % ( 95 % CI 59.6 % , 90.7 % ) . The relative risk of caries in test teeth was 0.19 ( 95 % CI 0.09 , 0.40 ) . The study suggests that complete retention of GIC sealant is not necessary for caries prevention in newly erupted permanent first molars Background : Caries levels in pre-school children remain high in some areas of the UK . Studies of glass ionomer fissure sealants show their potential for caries prevention in permanent teeth , but their use in primary teeth has not been reported . Aim : To determine whether a glass ionomer fissure sealant placed on primary molars in pre-school children at high risk of developing dental caries can decrease the incidence of dental caries . Material : 508 children aged 18–30 months from high caries areas of South Wales with caries-free first primary molars were recruited to the trial after informed consent . Methods : This was a placebo-controlled individual r and omised controlled trial ( RCT ) . All children ( n = 508 ) received a st and ard package of dental health education . Children in the test group ( n = 241 ) had their first primary molars sealed with glass ionomer . All the children were re-examined once at varying intervals between 12 and 30 months . Results : Analysis of the caries data revealed no significant difference between test and control groups for any of the parameters examined . Examination of the confidence intervals showed no indication that there might be a difference even if the sample size had been increased . Conclusion : There is no evidence that the intervention as used in this population had any effect on caries incidence and it can not be recommended as a clinical procedure PURPOSE Pit and fissure sealants reduce occlusal caries when proper patient selection and application techniques are followed . To increase retention rate of sealants over time , good adaptation and deep sealant penetration are important . Studies remain inconclusive , however , as to determining if the bur preparation of pits and fissures would increase the adaptation and penetration thus improving sealant retention . The aim of this study was to assess if tooth preparation prior to sealant application improves sealant retention . METHODS In this prospect i ve cohort study , 43 children and adolescents from 4 Hutterites colonies were , for 3 years , bussed to the University of Manitoba pediatric dental clinic , Winnipeg , Manitoba , Canada , for comprehensive dental care including sealant placement using st and ard procedures . These came from a community with homogeneous social economical status , dietary habits , fluoride intake , and lifestyles . The decision of tooth preparation prior to sealant application was made ad hoc . Of 122 treated permanent posterior teeth , 54 had been treated as preventive resin restorations ( PRRs , type A or B ) and 68 were nonprepared sealants . RESULTS After 1 year , teeth prepared ( type B PRRs ) and restored with flowable composite resins had significantly ( P<.01 ) lower retention rates ( 27 % vs 63 % ) than did teeth with nonprepared sealants or typeA PRRs . Teeth prepared ( type B PRRs ) were also significantly ( P<.001 ) more likely to have caries on follow-up examination ( 50 % vs 11 % ) than were teeth with nonprepared sealants or type A PRRs . CONCLUSIONS These results suggest that preventive resin type B restorations restored with flowable composites are not helpful in terms of retention or caries reduction The aim of this community-oriented study was to evaluate different methods to prevent fissure caries . The following products and measures were tested : 1 ) glass ionomer cement ( GIC ) applied by dentist ; 2 ) same material applied by short term ( 3 days ) trained personnel ( teachers ) ; 3 ) application of a 0.5 % HF solution three times ; 4 ) an established autopolymerized resin based sealant ( Delton ) . The study was performed in Bangkok , Thail and , a city in a developing country experiencing increasing caries prevalence . Children with at least three sound permanent molars from two age groups , 7 - 8 and 12 - 13-yr-olds respectively were chosen from very low to medium socioeconomic level families . 1264 children were systematic ally assigned to experiment or control groups based on school and DMFT . For the younger age group , the 2 yr mean DFS occlusal increment in the Control group was 0.66 surfaces . Significantly lower increments were observed in the GIC experimental group : 0.17 surfaces applied by the teachers and 0.32 applied by dentist , corresponding to 74 % and 52 % reductions , respectively . The mean increment in the HF group was 0.44 surfaces , a 33 % reduction in relation to the Control group . For the 12 - 13-yr-olds , the mean occlusal surface DF increment was 0.70 surfaces in the Control group . Almost no occlusal increment was found in the Delton group , 0.05 DFS , a 93 % reduction . In the GIC Dentist group , the DFS increment was 0.48 and in the Teacher group 0.56 , corresponding to 31 % and 20 % reduction , respectively . A slight and nonsignificant increase of caries in relation to the Control group was observed in the HF group . ( ABSTRACT TRUNCATED AT 250 WORDS PURPOSE To evaluate the retention and caries-preventive effectiveness of two ionomeric material s ( conventional and resin-modified ) , used as fissure sealants . MATERIAL S AND METHODS 100 children ( 6 - 8 years old ) with a total of 400 permanent first molars received 200 conventional glass-ionomer ( Ketac Bond ) and 200 resin-modified glass-ionomer ( Vitremer ) sealants . Additionally , 108 children constituted the control group ( 432 teeth ) . Two dentists assisted by dental hygienists performed the sealant application . Clinical evaluations were carried out 6 , 12 , 24 , and 36 months after the sealant application by two other dentists , not carrying out clinical procedures , previously calibrated ( Kappa > 0.75 ) . RESULTS Total retention rates of 26 % , 12 % , 3 % , and 4 % for Ketac Bond and 61 % , 31 % , 14 % , and 13 % for Vitremer , being 6 , 12 , 24 , and 36 months after clinical evaluation , respectively . The differences between the two material s were statistically significant . The experimental groups showed a caries incidence of 93 % , 78 % , 49 % , and 56 % lower than the control group ( P < 0.01 ) for the four evaluation periods , respectively . In conclusion , the retention rates of ionomeric material s were low . Nevertheless , these material s showed a cariostatic effect , supported by statistically lower caries incidence in experimental groups compared to control group . Presence of active incipient caries was statistically associated with caries incidence in the first molars after 36 months , in relation to either experimental or control group Recent in vitro work and a short clinical study suggest that adding a bonding agent layer between sealant and saliva-contaminated enamel allows for adequate bond strength and retention of resin sealants and may improve success of all sealant applications . This five-year clinical study scored 617 occlusal and 441 buccal/lingual molar sealants , with use of a split-mouth design , with half receiving sealant alone and half bonding agent plus sealant . Treatment effects and potential risk factors for sealant failure were tested by means of a Cox regression model . Three bonding agent groups were analyzed for treatment effect : Tenure primer , Scotchbond Multi- Purpose , and 3 single-bottle dentin bonding agents as a third group . The single-bottle group was successful in reducing risk of sealant failure , with a hazard ratio ( HR ) of 0.53 ( p = 0.014 ) for occlusal and 0.35 ( p = 0.006 ) for buccal/lingual sealants . Scotchbond was detrimental to occlusal sealant success , with a HR of 2.96 ( p = 0.0003 ) . Tenure primer was neutral , showing HRs close to 1.0 . Variables that affected success differed between occlusal and buccal/lingual sealants , suggesting that failures on these two surfaces may be dependent upon differing factors . Early eruption stage was a significant risk factor for both surfaces ( HR = 2.91 , p = 0.00001 , occlusal ; and HR = 1.52 , p = 0.015 , buccal/lingual ) . Behavior ( HR = 1.96 , p = 0.0007 ) , salivary problems ( HR = 1.73 , p = 0.002 ) , and visually apparent variations in enamel ( HR = 1.51 , p = 0.018 ) were significant risk factors for occlusal sealants only . In addition to completing detailed analyses of risk factors for sealant survival , this study shows that single-bottle bonding agents protect sealant survival , yielding half the usual risk of failure for occlusal sealants and one-third the risk of failure for buccal/lingual sealants To evaluate the retention and caries experience effects of three different material s used as fissure sealants after 24 months of clinical application : a resin-modified glass ionomer cement ( A ) , a flowable resin composite ( B ) and a compomer ( C ) . One hundred and seventeen ( 117 ) teeth were sealed with material A , 119 teeth with material B and 120 teeth with material C. Children were r and omly assigned . Each one received only one of the material s studied . Plaque index , dmft score and socioeconomic level were scored at baseline . The clinical exams were conducted 6 , 12 and 24 months after application of the sealant . Statistical analysis ( Kruskal-Wallis ) revealed that there were statistically significant differences between the retention rates of groups A and B and between groups B and C after 2 years , with material B showing better results . After 2 years , 3.1 % of the teeth of group A , 4.3 % of group B and 6.7 % of group C were Carious+Filled . There was no evidence of association between caries presence after 2 years and plaque index , dmft score and socioeconomic level . These results suggest that flowable resin composite had a satisfactory retention after this period of evaluation and all three material s were effective on occlusal caries prevention We describe a r and om effects model for caries lesion development and progression based on considering the effects of the pH fluctuations over time in microbial dental plaque as a Wiener process with a single absorptive barrier . The model predicts that the period of greatest risk to developing caries occurs shortly after eruption , but thereafter the longer a surface survives without developing a lesion , the less likely will it be that a lesion will subsequently develop . The model is able to anticipate why the effect of water fluoridation on caries prevalence is most pronounced when caries is diagnosed at cavity level . This model offers one way in which the variability which characterizes the complex ecosystem associated with dental caries may be considered a subject of interest for enhancing our underst and ing of its pathogenesis and epidemiology |
11,584 | 30,267,719 | Conclusion : Laser‐assisted PDT is more efficient but not more painful than PDT or laser treatment only | Background : Photodynamic therapy ( PDT ) is an effective intervention for actinic keratosis and field cancerization .
Ablative fractional lasers may facilitate the delivery of photosensitizers and thereby improve the effects of PDT .
Objective : To summarize the current evidence on the efficacy and safety of laser‐assisted PDT . | BACKGROUND / PURPOSE A relatively long incubation time is needed for photosensitizer absorption in conventional photodynamic therapy ( PDT ) for actinic keratosis ( AK ) . The use of ablative CO2 fractional lasers ( AFXLs ) to increase drug delivery could shorten the incubation time . Here , we aim ed to compare the efficacy between AFXL-assisted PDT with a short incubation time and conventional PDT for AK . METHODS Patients with histopathologically confirmed facial AK were r and omly divided into two groups . The lesions were histopathologically classified into grade s I-III . In the AFXL-assisted PDT group , an ablative fractional laser was used for pretreatment , prior to the application of methyl aminolevulinate , with an incubation time of 90 min . Irradiation was performed with a 630-nm light-emitting diode . In the conventional PDT group , the incubation time was 180 min . All the patients received two rounds of PDT at 2-week intervals and underwent clinical or histological evaluation at 10 weeks after the first PDT course . RESULTS Twenty-two patients underwent conventional PDT and 24 patients underwent AFXL-assisted PDT . Thirty-four AKs were included in the conventional PDT group , and 35 AKs were included in the AFXL-assisted PDT group . The clearance rate was 64.7 % in the conventional PDT and 71.4 % in the AFXL-assisted PDT group ; no significant differences in the clearance rate were noted between the groups ( P = 0.55 ) . The clearance rates for each grade also did not significantly differ between the two groups . CONCLUSIONS The use of AFXL before PDT reduced the incubation time , but yielded similar treatment efficacy as compared to conventional PDT BACKGROUND Iontophoresis is a transdermal drug-delivery technique that enhances the transport of ionic species across membranes and may have significant benefit for the treatment of actinic keratosis ( AK ) by ablative fractional laser-primed photodynamic therapy ( AFL-PDT ) . The aims of this study were to compare the efficacy , recurrence rate , cosmetic outcome and safety of iontophoresis-assisted AFL-PDT with 2h of incubation vs. those of conventional AFL-PDT with 2- and 3-h incubation in patients with facial and scalp AK . METHODS Patients were r and omly assigned to iontophoresis-assisted AFL-PDT with a 2-h incubation time ( group A ) and conventional AFL-PDT with a 2-h ( group B ) and 3-h ( group C ) incubation time . All patients underwent AFL-PDT , and group A patients were assigned to treatment with iontophoresis after methyl-aminolevulinate ( MAL ) application . After 2 or 3h , MAL-applied lesions were irradiated using a red light . Patients were followed up at 1-week , 3 months and 12 months after treatment . Efficacy , cosmetic outcomes and adverse events were assessed . RESULTS In total , 41 patients ( 160 AK lesions ) completed the study and were evaluated . Efficacy was significantly higher in Group A ( 88.7 % ) than in Group B ( 73.2 % ) ; the efficacy of groups A and C ( 92.2 % ) at 3 months follow-up was comparable . The recurrence rates were not significantly different between the groups at 12 months ( P=0.841 ) . The three groups did not differ in terms of cosmetic outcomes and safety . CONCLUSIONS Iontophoresis-assisted AFL-PDT showed higher efficacy than AFL-PDT with short incubation time . Iontophoresis may effectively reduce the incubation time in AFL-PDT BACKGROUND Photodynamic therapy ( PDT ) with methyl aminolevulinate ( MAL ) is effective for treating multiple actinic keratoses ( AKs ) . Ablative fractional laser ( FL ) creates vertical channels that may facilitate MAL delivery and improve PDT response . OBJECTIVE To evaluate the efficacy of FL-assisted PDT ( FL-PDT ) in treating facial AKs in Korean patients . METHODS A prospect i ve r and omized non-blinded trial initially evaluated 271 facial AKs in 45 patients . All patients underwent one session of MAL-PDT using a red light-emitting diode lamp at 37 J/cm(2 ) , and 23 patients with 135 AK lesions were r and omly assigned to pre-treatment with a 2940-nm ablative fractional erbium : Yag laser . Patients were followed up at 1 , 2 and 4 weeks and every month until 6 and 12 months post-treatment . Response , adverse events , cosmetic outcome and patient satisfaction were documented . Finally , a total of 236 facial AKs in 40 patients were enrolled and analysed in this study . RESULTS FL-PDT was significantly more effective than MAL-PDT at treating all AK grade s ( 86.9 % vs. 61.2 % ; P < 0.001 ) . The efficacy of FL-PDT was most pronounced in treating Olsen grade III AKs ( 69.4 % vs. 32.5 % ; P = 0.001 ) . FL-PDT also showed a lower lesion recurrence rate than MAL-PDT ( 9.7 % vs. 26.6 % ; P = 0.004 ) . Excellent or good cosmetic outcome was reported in > 90 % cases . Erythema and hyperpigmentation intensities were higher in the FL-PDT group ( P > 0.05 ) . Side-effects were more frequent in the FL-PDT group , but these were mild and well tolerated ( P > 0.05 ) . CONCLUSION FL-PDT is effective for treating AKs , especially moderate-to-thick lesions BACKGROUND Aminolevulinic acid ( ALA ) photodynamic therapy ( PDT ) is an established treatment option for actinic keratosis ( AK ) , and recently fractional carbon dioxide ( CO2 ) laser was shown to improve outcomes ; but studies of short incubation photosensitizer are lacking . OBJECTIVE Assess the efficacy of short incubation ALA followed by blue light PDT with and without previous fractional CO2 treatment for the treatment of AK . METHODS R and omized , paired split- design , controlled trial of fractional CO2 followed by ultrashort 15-minute versus 30-minute incubation ALA and blue light PDT for the treatment of AK on the face . RESULTS The complete clearance rates ( CRs ) at 8 weeks after ALA PDT with and without FxCO2 at 30- and 15-minute ALA incubation times were 89.78 % ( + FxCO2 ) versus 71.20 % CR ( −FxCO2 ) at 30′ , and 86.38 % ( + FxCO2 ) versus 69.23 % ( −FxCO2 ) at 15′ ALA incubation . All lesion improvements were statistically significant . CONCLUSION This r and omized , comparative paired group controlled clinical study demonstrates that ultrashort 15- and 30-minute incubation ALA PDTs are of limited efficacy for the treatment of AK . Pretreatment with fractional ablative resurfacing yields statistically significant greater AK clearance with ALA-PDT at ultrashort ALA incubations followed by blue light BACKGROUND AND OBJECTIVE Continuous wave lasers or incoherent lamps are used effectively for photodynamic therapy ( PDT ) . As the mechanism of action of pulsed lasers in PDT is not known , we investigated the efficacy of PDT with 5-aminolevulinic acid ( ALA ) using a long-pulse ( 1.5 ms ) tunable flashlamp-pumped pulsed dye laser ( LPDL ) in vitro and in vivo . STUDY DESIGN / MATERIAL S AND METHODS HaCaT human keratinocytes were incubated with ALA ( 3 mmol/l ) and irradiated ( 0 - 50 J/cm(2 ) ) using the LPDL at 585 nm , 595 nm , or 600 nm vs. an incoherent light source ( 580 - 740 nm ) . Topical ALA-PDT was performed on 24 patients with actinic keratoses ( AK ) on the head ( n = 200 ) after incubation with a 20 % ALA emulsion and irradiation by either an incoherent light source ( 160 mW/cm(2 ) , 60 - 160 J/cm(2 ) ) or the LPDL ( 585 nm , 18 J/cm(2 ) ) . RESULTS Maximal cytotoxic effects in vitro were achieved using the LPDL at 585 nm or the incoherent lamp ( 50 J/cm(2 ) ) . Sodium azide , a quencher of singlet oxygen , significantly reduced cell killing , suggesting that the cytotoxic effects are mainly mediated by singlet oxygen . This is supported by an increase of lipid peroxides as determined by malondialdehyde after adding D(2)O. Complete remission was achieved in 79 % of 100 AK treated by ALA and the LPDL and in 84 % of 100 AK treated by ALA and the incoherent lamp . Pain during light treatment was significantly reduced by using the LPDL . Control lesions ( LPDL without ALA ) did not clear . CONCLUSION These results show the in vitro and in vivo efficacy of ALA-PDT using a pulsed light source mediated by singlet oxygen BACKGROUND AND OBJECTIVE Photodynamic therapy ( PDT ) with 5-aminolevulinic acid ( ALA ) and intense pulsed light ( IPL ) is a relatively new combination for the treatment of actinic keratosis ( AK ) and photodamage . The objective of this study was to determine the effect of increasing the fluence of IPL on the outcome of patients with these skin conditions . METHODS Patients ( N = 24 ) were r and omly assigned to five treatment treatment groups : control ( IPL alone ) and ALA with 20 , 25 , 40 , and 50 J/cm(2 ) fluence of IPL . Each patient received a single treatment . ALA was applied twice and allowed to incubate 2 h before IPL irradiation . Results were evaluated 5 - 7 days and 8 weeks after treatment . Clearance of AK lesions was evaluated by counting lesions before and after treatment , and improvement in photodamage was assessed by comparing pre- and post-treatment photographs . Statistical evaluation was based at nonparametric tests with a cut-off level at p < 0.10 and a confidence interval at 95 % . RESULTS Responses to treatment were greatest in patients who received ALA and IPL fluences of 40 and 50 J/cm(2 ) . Responses were " marked " in 19 % of the patients receiving 50 J and " moderate " in 19 % of the patients receiving 40 J. Compared to the mean pre-treatment AK grade s , the mean post-treatment grade s were 56 % lower in the 50 J treatment group , 32 % lower in the 25 J group , 50 % lower in the 40 J group , 20 % lower in the 20 J group , and 7 % lower in the control group . Erythema , edema , crusts and erosion , and pain did not cause any patient to discontinue the study . CONCLUSION AK clearance , but not photorejuvenation , appears to improve with increasing fluence at the ALA PDT-IPL levels used in this study without serious adverse effects BACKGROUND Unmet needs exist in actinic keratosis ( AK ) treatment . Daylight photodynamic therapy ( DL-PDT ) has shown good efficacy and safety results compared to conventional PDT ( c-PDT ) in a recent Phase III multi-centre r and omised controlled trial in Australia among 100 subjects with AKs . OBJECTIVES Demonstrate non-inferior efficacy and superior safety of DL-PDT compared to c-PDT in treating multiple mild and /or moderate facial/scalp AKs . METHODS Phase III , 12 week , multi-centre , r and omised , investigator-blinded , controlled , intra-individual study conducted at different latitudes in Europe . AKs of adult subjects were treated once with methyl aminolevulinate ( MAL ) DL-PDT on one side of the face and MAL c-PDT contralaterally . Endpoints for DL-PDT concerned efficacy ( non-inferiority regarding complete lesion response at week 12 ) and safety ( superiority regarding subject 's assessment of pain after treatment , on an 11-point numeric rating scale ) . Safety evaluation also included incidence of adverse events . Subject satisfaction was described using a question naire at baseline and last visit . RESULTS At week 12 , the total lesion complete response rate with DL-PDT was similar ( non-inferior ) to c-PDT ( 70 % vs. 74 % , respectively ; 95 % CI [ -9.5 ; 2.4 ] in PP analysis , confirmed in ITT analysis ) . In addition , efficacy of DL-PDT was demonstrated regardless of weather conditions ( sunny or cloudy ) . DL-PDT was nearly painless compared to c-PDT ( 0.7 vs. 4.4 , respectively ; P < 0.001 ) , better tolerated and result ed in higher subject satisfaction . CONCLUSION DL-PDT in comparison with c-PDT was as effective , better tolerated and nearly painless with high patient satisfaction , and may be considered a treatment of choice to meet needs of patients with mild or moderate facial/scalp AKs Background Transplant recipients have an increased propensity to develop multiple actinic keratoses , which demonstrate an increased transformation rate into invasive squamous cell carcinoma BACKGROUND Photodynamic therapy ( PDT ) using methyl aminolevulinate ( MAL ) is an effective first-line treatment for actinic keratosis ( AK ) . Erbium : yttrium-aluminium-garnet ( Er : YAG ) ablative fractional laser-assisted MAL-PDT ( AFL-PDT ) has shown significant benefit for the treatment of AK . OBJECTIVES The objectives of this study were to compare the efficacy , recurrence rate , cosmetic outcome and safety between AFL-PDT with 2 and 3 h of incubation vs. Conventional MAL-PDT in patients with facial and scalp AK . METHODS This prospect i ve r and omized trial initially enrolled 440 facial and scalp AK lesions in 93 patients . Patients were r and omly assigned to AFL-PDT with a 2-h incubation time ( 2h-AFL-PDT ) , 3h-AFL-PDT and 3h-MAL-PDT . All patients underwent one session of MAL-PDT using a red light-emitting diode lamp at 37 J/cm(2 ) , and AFL-PDT groups were assigned to pretreatment with Er : YAG AFL . Patients were followed up at 1 week , 3 months and 12 months post treatment . Efficacy , cosmetic outcomes and adverse events were assessed . Finally , 427 facial AK lesions in 88 patients were analysed in this study . RESULTS Three months after the last treatment session , 3h-AFL-PDT ( 91.7 % ) was significantly more effective than 2h-AFL-PDT ( 76.8 % ) and 3h-MAL-PDT ( 65.6 % , P < 0.001 ) , and differences in efficacy remained significant at the 12-month follow-up . The recurrence rate was significantly lower for 3h-AFL-PDT ( 7.5 % ) than for 3h-MAL-PDT ( 22.1 % ) at 12 months ( P = 0.002);however , no significant difference was found between 2h-AFL-PDT and 3h-MAL-PDT . No significant difference was found in cosmetic outcomes or safety between the three groups . CONCLUSIONS We recommend 3h-AFL-PDT rather than classic MAL-PDT or short-incubation AFL-PDT for treating AK |
11,585 | 30,431,589 | DEX also increased the odds of hypotension by odds ratio ( OR ) 4.40 ( 95 % CI [ 1.37 , 14.17 ] , P = .01 ) ; however , there was no statistically significant difference for intraoperative fentanyl consumption and the incidence of the bradycardia .
Conclusions DEX combined with LAs in PVB significantly improved postoperative pain scores , prolonged the duration of analgesia , reduced postoperative analgesic consumption , and increased the odds of hypotension . | Background Dexmedetomidine ( DEX ) improves postoperative pain scores and prolongs the duration of blockage when combined with local anesthetics ( LAs ) for neuraxial and brachial plexus block ; however , there is little information about the effectiveness of DEX as an adjuvant to LAs in paravertebral block ( PVB ) .
Therefore , a systematic review and meta- analysis were performed to evaluate the safety and efficacy of DEX combined with LAs in PVB . | BACKGROUND There is little systematic research on the efficacy and tolerability of the addition of adjunctive analgesic agents in paravertebral analgesia . The addition of adjunctive analgesics , such as fentanyl and clonidine , to local anesthetics has been shown to enhance the quality and duration of sensory neural blockades , and decrease the dose of local anesthetic and supplemental analgesia . OBJECTIVES Investigation of the safety and the analgesic efficacy of adding 1 μg/kg dexmedetomidine to bupivacaine 0.25 % in thoracic paravertebral blocks ( PVB ) in patients undergoing modified radical mastectomy . STUDY DESIGN A r and omized , double-blind trial . SETTING Academic medical center . METHODS Sixty American Society of Anesthesiologists physical status -I - III patients were r and omly assigned to receive thoracicPVB with either 20 mL of bupivacaine 0.25 % ( Group B , n = 30 ) , or 20 mL of bupivacaine 0.25 % + 1 μg/kg dexmedetomidine ( Group BD , n= 30 ) . Assessment parameters included hemodynamics , sedation score , pain severity , time of first analgesics request , total analgesic consumption , and side effects in the first 48 hours . RESULTS There was a significant reduction in pulse rate and diastolic blood pressure starting at 30 minutes in both groups , but more evidence d in group BD ( P < 0.001 ) . Intraoperative Systolic blood pressure showed a significant reduction at 30 minutes in both groups ( P < 0.001 ) then returned to baseline level at 120 minutes in both groups . There was a significant increase in pulse rate starting 2 hours postoperative until 48 hours postoperatively in group B but only after 12 hours until 48 hours in group BD ( P < 0.001 ) . The time of the first rescue analgesic requirement was significantly prolonged in the group BD ( 8.16 ± 42 hours ) in comparison to group B ( 6.48 ± 5.24 hours ) ( P = 0.04 ) . The mean total consumption of intravenous tramadol rescue analgesia in the postanesthesia care unit in the firtst 48 hours postoperatively was significantly decreased in group BD ( 150.19 ± 76.98 mg ) compared to group B ( 194.44 ± 63.91 mg ) ( P = 0.03 ) . No significant serious adverse effects were recorded during the study . LIMITATIONS This study is limited by its sample size . CONCLUSION The addition of dexmedetomidine 1 μg/kg to bupivacaine 0.25 % in thoracic PVB in patients undergoing modified radical mastectomy improves the quality and the duration of analgesia and also provides an analgesic sparing effect with no serious side effects Background : The present study aim ed to assess the efficacy and safety of thoracic paravertebral regional anesthesia ( TPVBRA ) in patients with breast cancer surgery . Methods : In total , 72 patients undergoing breast cancer surgery were r and omly divided into an intervention group and a control group ; each group contained 36 subjects . Both groups received TPVBRA with 20 mL 0.25 % bupivacaine . In addition , subjects in the intervention group also received an additional 1 & mgr;g/kg dexmedetomidine . Heart rate ( HR ) , systolic blood pressure ( SBP ) , diastolic blood pressure ( DBP ) , pain intensity ( measured by visual analogue scale , VAS ) , and analgesic consumption were assessed ; adverse events were also recorded . Results : Significant differences were observed in HR ( P < .05 ) , SBP ( P < .05 ) , and DBP ( P < .05 ) at the 30-minute point during surgery between the 2 groups . In addition , the time of the first administration of analgesia ( P = .043 ) and the mean consumption of analgesic agents ( P = .035 ) in the intervention group were much better than those in the control group . However , no significant differences in HR or VAS were found at any time point after surgery ( P > .05 ) . Furthermore , similar adverse events were detected in both groups ( P > .05 ) . Conclusion : The results of this study showed that TPVBRA combined with bupivacaine and dexmedetomidine can enhance the duration and quality of analgesia without serious adverse events OBJECTIVE The goals of this study were to examine agreement and estimate differences in sensitivity between pain assessment scales . DESIGN Multiple simultaneous pain assessment s by patients in acute pain after oral surgery were used to compare a four-category verbal rating scale ( VRS-4 ) and an 11-point numeric rating scale ( NRS-11 ) with a 100-mm visual analog scale ( VAS ) . The sensitivity of the scales ( i.e. , their ability [ power ] to detect differences between treatments ) was compared in a simulation model by sampling from true pairs of observations using varying treatment differences of predetermined size . RESULTS There was considerable variability in VAS scores within each VRS-4 or NRS-11 category both between patients and for repeated measures from the same patient . Simulation experiments showed that the VAS was systematic ally more powerful than the VRS-4 in all simulations performed . The sensitivity of the VAS and NRS-11 was approximately equal . CONCLUSIONS In this acute pain model , the VRS-4 was less sensitive than the VAS . The simulation results demonstrated similar sensitivity of the NRS-11 and VAS when comparing acute postoperative pain intensity . The choice between the VAS and NRS-11 can thus be based on subjective preferences BACKGROUND Dexmedetomidine is an α-2-receptor agonist which might be used as an additive to local anaesthetics for various regional anaesthetic techniques . We therefore design ed this prospect i ve , double-blinded , controlled volunteer study to investigate the effects of dexmedetomidine as an adjuvant to ropivacaine on peripheral nerve block . METHODS Ultrasound-guided ulnar nerve block ( UNB ) was performed in 36 volunteers with either 3 ml ropivacaine 0.75 % ( R ) , 3 ml ropivacaine 0.75 % plus 20 µg dexmedetomidine ( RpD ) , or 3 ml ropivacaine 0.75 % plus systemic 20 µg dexmedetomidine ( RsD ) . UNB-related sensory and motor scores were evaluated . RESULTS Sensory onset time of UNB was not different between the study groups , whereas motor onset time was significantly faster in Group RpD when compared with the other study groups [ mean ( sd ) ] [ 21 ( 15 ) vs 43 ( 25 ) min in Group RsD and 47 ( 36 ) min in Group R , P<0.05 Group RpD vs other groups ] . The duration of sensory block was 350 ( 54 ) min in Group R , 555 ( 118 ) min in Group RpD , and 395 ( 40 ) min in Group RsD ( P<0.01 Group RpD vs other groups , P<0.05 Group RsD vs Group R ) . Motor block duration was similar to the duration of sensory block . CONCLUSIONS A profound prolongation of UNB of ∼60 % was detected with perineural dexmedetomidine when added to 0.75 % ropivacaine . The systemic administration of 20 µg dexmedetomidine result ed in a prolongation of ∼10 % during UNB with 0.75 % ropivacaine . Eudra-CT No. : 2012 - 000030 - 19 Various analgesic modalities have been tried to prolong the duration and to improve the quality of postoperative analgesia for the early rehabilitation and discharge from hospital after nephrectomy . Using local anaesthetic along with perineural steroids as adjuvant may prove promising for peripheral nerve block , especially paravertebral block ( PVB ) . This article aims to assess the efficacy of dexamethasone with bupivacaine as adjuvant for single bolus injection of thoracic PVB in patients undergoing elective nephrectomy . Sixty patients of American Society of Anesthesiologists physical status I and II were r and omly assigned to 2 groups of 30 patients each . Group D patients received 8 mg ( 2 mL ) of dexamethasone mixed to 18 mL of 0.25 % bupivacaine , whereas patients in group B received 18 mL of 0.25 % bupivacaine and 2 mL of 0.9 % saline as placebo to make a total volume of 20 mL infiltrated in PVB . Degree of analgesia achieved and duration of analgesia were recorded in each group along with total dose requirement of rescue analgesic and side effects in first 24 hours postoperatively . Group D patients with dexamethasone had VAS score of 0–3 after 09 minutes of block up to 610.48 ± 12.24 minutes and after 16 minutes up to 402.34 ± 28.12 minutes in another group B patient , respectively . The total dose of intravenous fentanyl in the first 24 hours postoperatively in group D was 98.6 ± 14.14 & mgr;g as compared with 147.6 ± 18.22 & mgr;g in group B. No other significant side effects were noted except for nausea and vomiting in 5 patients of placebo group . Dexamethasone , along with bupivacaine as adjunct for thoracic PVB , helps in improving the quality and enhancing the postoperative analgesia duration in patients undergoing nephrectomy Background and Objectives Research suggests that the addition of dexmedetomidine to local anesthetics can prolong peripheral nerve blocks ; however , clinical safety data are limited , and interscalene blocks have not been studied . The present study was design ed to test the hypothesis that dexmedetomidine added to ropivacaine would safely enhance the duration of analgesia without adverse effects when compared with ropivacaine alone . Methods We conducted a single-center , prospect i ve , r and omized , triple-blind , controlled trial of 62 patients undergoing elective shoulder surgery under general anesthesia with an interscalene block . Patients underwent ultrasound-guided interscalene blocks using either 12 mL of 0.5 % ropivacaine or 0.5 % ropivacaine plus 150-µg dexmedetomidine . The primary outcomes were self-reported duration of the nerve block and safety assessment ( adverse effects and neurological sequelae ) . Data were analyzed in a blinded fashion . Results The median duration of the nerve block was 18 hours ( 95 % confidence interval , 18–20 ) in the dexmedetomidine group and 14 hours ( 95 % confidence interval , 14–16 ) in the ropivacaine group ( P = 0.0001 ) . Dexmedetomidine also lowered pain scores for the first 14 hours postoperatively and significantly hastened the time to sensory ( P = 0.04 ) and motor ( P = 0.002 ) block onset . Dexmedetomidine lowered heart rate but blood pressures were stable . Plasma levels of ropivacaine were not different between groups , and plasma dexmedetomidine levels were relatively low . There were no adverse events or neurological sequelae . Conclusions Dexmedetomidine added to ropivacaine for interscalene blocks increased the duration of the nerve block and improved postoperative pain . These additional efficacy and safety data should encourage further study of peripheral perineural dexmedetomidine in humans Background This study determined the responses to increasing plasma concentrations of dexmedetomidine in humans . Methods Ten healthy men ( 20–27 yr ) provided informed consent and were monitored ( underwent electrocardiography , measured arterial , central venous [ CVP ] and pulmonary artery [ PAP ] pressures , cardiac output , oxygen saturation , end-tidal carbon dioxide [ ETCO2 ] , respiration , blood gas , and catecholamines ) . Hemodynamic measurements , blood sampling , and psychometric , cold pressor , and baroreflex tests were performed at rest and during sequential 40-min intravenous target infusions of dexmedetomidine ( 0.5 , 0.8 , 1.2 , 2.0 , 3.2 , 5.0 , and 8.0 ng/ml ; baroreflex testing only at 0.5 and 0.8 ng/ml ) . Results The initial dose of dexmedetomidine decreased catecholamines 45–76 % and eliminated the norepinephrine increase that was seen during the cold pressor test . Catecholamine suppression persisted in subsequent infusions . The first two doses of dexmedetomidine increased sedation 38 and 65 % , and lowered mean arterial pressure by 13 % , but did not change central venous pressure or pulmonary artery pressure . Subsequent higher doses increased sedation , all pressures , and calculated vascular resistance , and result ed in significant decreases in heart rate , cardiac output , and stroke volume . Recall and recognition decreased at a dose of more than 0.7 ng/ml . The pain rating and mean arterial pressure increase to cold pressor test progressively diminished as the dexmedetomidine dose increased . The baroreflex heart rate slowing as a result of phenylephrine challenge was potentiated at both doses of dexmedetomidine . Respiratory variables were minimally changed during infusions , whereas acid – base was unchanged . Conclusions Increasing concentrations of dexmedetomidine in humans result ed in progressive increases in sedation and analgesia , decreases in heart rate , cardiac output , and memory . A biphasic ( low , then high ) dose – response relation for mean arterial pressure , pulmonary arterial pressure , and vascular resistances , and an attenuation of the cold pressor response also were observed Background : Dexmedetomidine ( DEX ) is a highly selective α2‐adrenoceptor agonist that has been used increasingly in children . However , the effect of caudal DEX has not been evaluated before in children . This prospect i ve r and omized double‐blinded study was design ed to evaluate the analgesic efficacy of caudal DEX with bupivacaine in providing pain relief over a 24‐h period OBJECTIVES Thoracic paravertebral block ( TPVB ) is reported to have advantages in postoperative pain management in unilateral thoracic surgeries . Previous studies have demonstrated that dexmedetomidine could be used as an adjuvant to local anesthetics , with the aim of prolonging the duration of neural blockade . However , little is known about whether such a combination could improve the quality of postoperative analgesia compared with local anesthetic only when TPVB is used for patients undergoing video-assisted thoracoscopic surgery ( VATS ) . DESIGN A prospect i ve , r and omized , controlled study . SETTING Single-center university hospital . PARTICIPANTS The study included 60 patients undergoing VATS under general anesthesia . INTERVENTIONS The patients were allocated r and omly into the following 2 groups : 0.375 % ropivacaine , 20 mL only ( group R , n = 30 ) , and 0.375 % ropivacaine , 20 mL plus 1 μg/kg of dexmedetomidine ( group RD , n = 30 ) . At the end of surgery , TPVB guided using ultrasound was performed at 4 points-T4 - 5 , T5 - 6 , T6 - 7 , and T7 - 8-of the surgical side ; 5 mL of solution were injected at each point . Postoperatively , the intravenous nonsteroidal anti-inflammatory drug flurbiprofen was used as part of multimodal analgesia . MEASUREMENTS AND MAIN RESULTS Pain scores at rest and during coughing were evaluated by a blinded observer in the postanesthesia care unit postoperatively at 1 , 2 , 4 , 8 , 12 , 24 , 36 , and 48 hours , and the dermatomal levels of sensory blockade , postoperative requirements for rescue analgesia , adverse events , and patient satisfaction also were recorded . There was a significant reduction in postoperative pain scores at rest starting from the postoperative 8th hour until the 48th hour and during coughing starting at the postoperative 4th hour until the 48th hour in the group RD compared with those in group R ( p = 0.043 ) . The dermatomal levels of sensory blockade were comparable in the 2 groups . Patient satisfaction after surgery was significantly higher in the group RD than in group R ( p < 0.001 ) . Total consumption of the intravenous rescue analgesic morphine and adverse events were not significantly different between the 2 groups . CONCLUSIONS Compared with ropivacaine only , the addition of dexmedetomidine , 1 μg/kg , to local anesthetic for multilevel TPVB in patients undergoing VATS prolonged the duration of postoperative analgesia and improved patient satisfaction without serious side effects when combined with postoperative intravenous nonsteroidal anti-inflammatory drug administration Background : Dexmedetomidine used as an adjuvant to local anesthetics may prolong the duration of peripheral nerve blocks . Whether this is mediated by a perineural or systemic mechanism remains unknown . The authors hypothesized that dexmedetomidine has a peripheral mechanism of action . Methods : The authors conducted a r and omized , paired , triple-blind trial in healthy volunteers . All received bilateral saphenous nerve blocks with 20 ml ropivacaine , 0.5 % , plus 1 ml dexmedetomidine , 100 µg/ml , in one thigh and 20 ml ropivacaine 0.5 % plus 1 ml saline in the other thigh . The primary outcome measure was the duration of block assessed by temperature sensation ( alcohol swab ) . The secondary outcome measure was the duration of block assessed by pinprick , pain during tonic heat stimulation , warmth detection threshold , and heat pain detection threshold . Results : All 21 enrolled volunteers completed the trial . The mean duration of block assessed by temperature sensation in the leg receiving ropivacaine plus dexmedetomidine was 22 h ( 95 % CI , 21 to 24 ) compared to 20 h ( 95 % CI , 19 to 21 ) in the leg receiving ropivacaine plus placebo with a mean difference of 2 h ( 95 % CI , 1 to 3 ; P = 0.001 ) . The duration of block was also significantly longer in the leg receiving dexmedetomidine when assessed by pinprick , pain during tonic heat stimulation , and warmth detection threshold but not heat pain detection threshold . One participant experienced numbness in an area in the leg receiving dexmedetomidine . Conclusions : Dexmedetomidine prolongs the duration of a saphenous nerve block by a peripheral mechanism when controlling for systemic effects but not necessarily to a clinical ly relevant extent Abstract Purpose This study evaluated the analgesic efficacy of dexmedetomidine in combination with bupivacaine for single-shot paravertebral block ( PVB ) in patients undergoing major breast cancer surgery . Methods This prospect i ve , r and omized double blind study was conducted in 45 ASA I/II/III females , aged ≥18 years , undergoing modified radical mastectomy or breast conservation surgery with axillary lymph node dissection . Patients in group PB ( paravertebral – bupivacaine ) received PVB with 0.5 % bupivacaine 0.3 ml/kg with 1 ml normal saline ; group PBD ( paravertebral – bupivacaine – dexmedetomidine ) received PVB with 0.5 % bupivacaine 0.3 ml/kg and dexmedetomidine 1 μg/kg in a volume of 1 ml ; and group C ( control ) patients were given a sham block ( a subcutaneous injection with 2 ml normal saline ) before receiving general anesthesia ( GA ) . All patients received analgesia by fentanyl intraoperatively and morphine patient-controlled analgesia postoperatively . Results The control group patients required more intraoperative fentanyl than the other two groups . Patients receiving dexmedetomidine had lower morphine consumption ( p < 0.001 ) , pain scores and incidence of postoperative nausea/vomiting ( p = 0.011 ) ; longer time to first analgesic request ; earlier time to mobilize ; and better satisfaction scores . Heart rate and blood pressure values during the intraoperative period were also lower at many time points in this group . However , the incidence of hypotension and bradycardia were statistically similar in all groups . Conclusions PVB using dexmedetomidine 1 µg/kg added to 0.5 % bupivacaine in patients undergoing major breast cancer surgery under GA provides analgesia of longer duration with decreased postoperative opioid consumption and lower incidence of nausea/vomiting compared to PVB with bupivacaine alone or no PVB Background and Aims : Thoracic paravertebral block ( TPB ) is one of the effective methods for management of post-operative pain in thoracic surgeries . The aim of the study was to evaluate effectiveness of addition of dexmedetomidine to paravertebral block with bupivacaine in improving the postoperative pain relief and pulmonary functions in patients undergoing thoracic surgeries . Methods : A prospect i ve r and omized double-blinded study was performed on forty patients scheduled for thoracic surgery . A paravertebral catheter was secured under ultrasound guidance preoperatively for all patients . Group B ( n = 20 ) received a bolus dose of 0.25 % bupivacaine at 0.3 mL/kg followed by continuous infusion of 0.125 % bupivacaine 0.1 mL/kg/h . Group ( BD ) received a bolus dose of 0.25 % bupivacaine + dexmedetomidine 1 μg/kg at 0.3 mL/kg followed by continuous infusion of dexmedetomidine 0.2 μg/kg/h + 0.125 % bupivacaine 0.1 mL/kg/h . Anaesthesia technique was st and ardized for all patients . Postoperatively , all patients were assessed during first 24 hours for intraoperative fentanyl and post-operative morphine requirements , Visual Analogue Scores ( VAS ) scores at rest and during cough , and postoperative pulmonary functions . Results : Post-operative morphine consumption in the first 24 hours and intraoperative fentanyl requirement were significantly less in group BD ( 2.95 ± 1.986 mg , 80.75 ± 31.551μg respectively ) compared to group B ( 9.85 ± 3.468 mg , 186 ± 39.683 μg respectively ) . Group BD showed less VAS scores during cough and better postoperative pulmonary functions ( P < 0.05 ) . Conclusion : Addition of dexmedetomidine to paravertebral bupivacaine in patients undergoing thoracic surgeries provides more effective analgesia with improvement in post-operative pulmonary functions Forty-five patients were allocated r and omly to receive either a single intrathoracic block of four intercostal nerves , a continuous thoracic extradural infusion or a continuous paravertebral infusion of bupivacaine . Patients were allowed additional i.v . boluses of morphine via a PCA device . Segmental spread of pinprick analgesia was comparable in the groups for up to 20 h. Up to 2 h after the block , plasma concentrations of bupivacaine were greater in the intercostal group and there was large interindividual variation . There were no significant differences between the groups in pain , morphine consumption , respiratory function or adverse events . Moderate to severe respiratory depression was detected in 14 patients more than 2 h after operation |
11,586 | 30,461,103 | The overall key theme to emerge was adaptation , with patients demonstrating how they adapted to the various impacts .
This review demonstrates that varicose veins have a wide range of symptoms and may have a significant impact on quality of life ; people made significant adaptations to enable them to live their lives as fully as possible .
The use of PROMs to gather information about quality of life and symptoms is well established globally ; however , PROMs currently used may not capture the full extent of the impact on patient 's quality of life | AIM To identify the symptoms and quality of life impacts that are important from the perspective of patients with varicose veins and to compare identified themes to items in varicose vein patient-reported outcome measures ( PROMs ) .
BACKGROUND Varicose veins are common worldwide and are considered a chronic condition with implication s for quality of life .
Treatment is predominantly conservative ; therefore , underst and ing patients ' experiences of living with varicose veins is important to inform the provision of clinical care .
PROMs are often used to collect data about patients ' quality of life . | Introduction No existing patient-reported outcome instrument focuses solely on assessment of varicose veins symptoms that are bothersome to patients . Methods The VVSymQ ® instrument is a five-item patient-reported outcome that assesses symptoms most important to patients with varicose veins ( heaviness , achiness , swelling , throbbing and itching ) . This paper describes how the VVSymQ ® instrument was incorporated into an electronic daily diary to monitor key outcomes over time and capture treatment benefit in two r and omized , controlled , phase 3 clinical trials . Results Patients were highly compliant in completing the electronic daily diary , and the VVSymQ ® instrument demonstrated ability to detect overall change and ability to detect change that is meaningful to patients . Conclusion The VVSymQ ® instrument is a reliable , valid instrument responsive to measuring change in the patient experience of varicose vein symptoms pre- and post-intervention , and is uniquely focused on patient-reported symptoms compared with other widely used question naires completed by clinicians OBJECTIVE The natural history in the general population of chronic venous disease in the legs is not well understood . This has limited our ability to predict which patients will deteriorate and to assign clinical priorities . The aims of this study were to describe the progression of trunk varicose veins and chronic venous insufficiency ( CVI ) in the general population , to identify important lifestyle and clinical prognostic factors , and to determine the relationship between venous reflux and progression . METHODS The Edinburgh Vein Study is a population -based cohort study in which r and omly selected adults aged 18 to 64 years had an examination at baseline . This included a question naire on lifestyle and clinical factors , st and ardized assessment and classification of venous disease in the legs , and duplex scan to detect venous reflux in eight segments of each leg . A follow-up examination 13 years later included a reclassification of venous disease to ascertain progression in the development or increase in severity of varicose veins and CVI . RESULTS Among 1566 adults seen at baseline , 880 had a follow-up examination , of whom 334 had trunk varicose veins or CVI at baseline and composed the study sample . The mean ( st and ard deviation ) duration of follow-up was 13.4 ( 0.4 ) years . Progression was found in 193 ( 57.8 % ) , equivalent to 4.3 % ( 95 % confidence interval [ CI ] , 3.7 - 4.9 ) annually . In 270 subjects with only varicose veins at baseline , 86 ( 31.9 % ) developed CVI , with the rate increasing consistently with age ( P = .04 ) . Almost all subjects ( 98 % ) with both varicose veins and CVI at baseline deteriorated . Progression of chronic venous disease did not differ by gender or leg , but a family history of varicose veins and history of deep venous thrombosis increased risk ( odds ratio [ OR ] , 1.85 [ 95 % CI , 1.14 - 1.30 ] and 4.10 [ 95 % CI , 1.07 - 15.71 ] , respectively ) . Overweight was associated with increased risk of CVI in those with varicose veins ( OR , 1.85 ; 95 % CI , 1.10 - 3.12 ) . Reflux in the superficial system increased the likelihood of progression , especially in combination with deep reflux ( OR , 2.57 ; 95 % CI , 1.55 - 4.25 ) and when located in the small saphenous vein ( OR , 4.73 ; 95 % CI , 1.37 - 16.39 ) . CONCLUSIONS Nearly half of the general population with chronic venous disease deteriorated during 13 years , and almost one third with varicose veins developed skin changes of CVI , increasing their risk of ulceration . Age , family history of varicose veins , history of deep venous thrombosis , overweight , and superficial reflux , especially in the small saphenous vein and with deep reflux , might influence the risk of progression |
11,587 | 23,543,570 | There is no evidence from r and omised controlled trials to evaluate the effectiveness and safety of different methods of administering subcutaneous heparin ( UFH or LMWH ) to pregnant women | BACKGROUND Pregnant women with a history of venous thromboembolism ( VTE ) , antithrombin deficiency , or other risk factors for VTE , need heparin ( unfractionated heparin ( UFH ) or low-molecular weight heparin ( LMWH ) ) prophylaxis , mainly through administering subcutaneously .
Several methods of administering heparin ( UFH or LMWH ) subcutaneously have been introduced to prevent adverse pregnant outcomes .
The effectiveness and safety of different methods administering subcutaneous heparin ( UFH or LMWH ) during pregnancy have not been systematic ally evaluated .
OBJECTIVES To compare the effectiveness and safety of different methods of administering subcutaneous heparin ( UFH or LMWH ) to pregnant women . | Women with a history of venous thromboembolism ( VTE ) , thrombophilia or both may be at increased risk of thrombosis during pregnancy , but the optimal management strategy is not well defined in clinical guidelines because of limited trial data . A strategy of risk assessment and heparin prophylaxis was evaluated in pregnant women at increased risk of VTE . In a prospect i ve trial ( Efficacy of Thromboprophylaxis as an Intervention during . Gravidity [ EThIG ] ) , 810 pregnant women were assigned to one of three management strategies according to pre-defined risk factors related to history of VTE and thrombophilic profile . Low-risk women ( group I ) , received 50 - 100 IU dalteparin/kg body weight/day for 14 days postpartum , or earlier when additional risk factors occurred . Women at high ( group II ) or very high risk ( group III ) received dalteparin from enrollment until six weeks postpartum ( 50 - 100 IU and 100 - 200 IU/kg/day , respectively ) . Objective ly confirmed , symptomatic VTE occurred in 5/810 women ( 0.6 % ; 95 % confidence interval [ CI ] , 0.2 to 1.5 % ) ( group I , 0 of 225 ; II , 3/469 ; III , 2/116 ) . The rate of serious bleeding was 3.0 % ( 95 % CI , 1.9 to 4.4 % ) ; 1.1 % ( 95 % CI , 0.5 to 2.2 % ) was possibly dalteparin-related . There was no evidence of heparin-induced thrombocytopenia , one case of osteoporosis , and rates of miscarriage and stillbirth were similar to previous , retrospective studies . Risk-stratified heparin prophylaxis was associated with a low incidence of symptomaticVTE and few clinical ly important adverse events . Antepartum heparin prophylaxis is , therefore , warranted in pregnant women with idiopathic thrombosis or symptomatic thrombophilia Intravenous heparin followed by oral anticoagulant therapy ( e. g. with coumarin ) is still the most widely used treatment for deep venous thromboembolism . Self-administered subcutaneous injections of heparin have been thought of as a promising alternative to coumarin , but the high doses required for ongoing prophylaxis have raised concerns about the possible development of bone disease . Certainly , long-term heparin therapy has been reported to cause osteoporosis in both laboratory animals and humans . This study aim ed to compare the efficacy and safety of unfractionated ( UF ) heparin with that of a low molecular weight heparin ( Fragmin , Kabi Pharmacia ) in the prevention of recurrent deep venous thrombosis ( DVT ) and pulmonary embolism ( PE ) in a consecutive series of patients with contraindications to coumarin therapy . The patients comprised 40 men and 40 women , aged between 19 and 92 years ( mean age , 68 years ) . They had all previously been diagnosed as having acute DVT and had been treated with conventional doses of heparin while in hospital . All patients had at least one of the following conditions : recent blood loss ( either spontaneous or during admission while receiving heparin therapy ) ; active gastroduodenal ulcer disease ; psychological or physical inability or unwillingness to underst and and accept the need for regular laboratory monitoring during coumarin treatment ; chronic alcoholism ; dementia ; pregnancy ; recent neurosurgery , and pericardial effusion ; or were over 80 years of age . They were r and omly allocated to receive either UF heparin , 10,000 IU s.c . b.d . , or Fragmin , 5000 IU anti-Factor Xa s.c . b.d . , for a period of 3 - 6 months . ( ABSTRACT TRUNCATED AT 250 WORDS We have previously reported that long-term therapy with warfarin is effective for preventing recurrent venous thromboembolism in patients with proximal-vein thrombosis but that there is an appreciable risk of hemorrhage . To determine whether that risk could be reduced without a loss of effectiveness , we r and omly allocated 96 patients with proximal-vein thrombosis to a group receiving less intense anticoagulant therapy , with a mean prothrombin time of 26.9 seconds using the Manchester comparative reagent ( corresponding Simplastin time , 15 seconds ) , or a group given more intense therapy , with a mean Simplastin time of 19.4 seconds ( corresponding prothrombin time 41 seconds with the Manchester comparative reagent ) ( P less than 0.001 ) . Two of 47 patients ( 4 per cent ) in the less intensely treated group had hemorrhagic complications , as compared with 11 of 49 patients ( 22 per cent ) in the more intensely anticoagulated group ( P = 0.015 by the two-tailed test ) . This difference was due to minor bleeding episodes . The frequency of recurrent venous thromboembolism was low in both groups ( 2 per cent ) . Our findings indicate that less intense anticoagulant therapy is associated with a low frequency of recurrent venous thromboembolism ( 2 per cent ) and a reduced risk of hemorrhage OBJECTIVE To assess the maternal response to low molecular weight heparin during pregnancy , by estimation of plasma anti-Xa activity , at three specified gestation points and in the nonpregnant state . METHODS A longitudinal , prospect i ve , observational study was set in a tertiary referral recurrent miscarriage clinic . Twenty-four women , attending consecutively , were invited to participate and gave informed consent . Each woman had a history of recurring pregnancy loss and positive preconception screening for antiphospholipid syndrome . After confirmation of a viable pregnancy all subjects began taking 5000 IU of dalteparin once daily subcutaneously . Serial measurement of plasma anti-Xa activity after administration of dalteparin was performed at three st and ard gestation points ( 12 , 24 , and 36 weeks ) and in the nonpregnant state ( 6 weeks postpartum ) . RESULTS Peak anti-Xa levels occurred at 4 hours postbolus in pregnancy , as compared with 2 hours in the nonpregnant state . The mean anti-Xa levels at 12 , 24 , and 36 weeks ' gestation were significantly reduced , at 2 hours postinjection , as compared with the nonpregnant state ( P < .001 , P < .01 , P < .001 , respectively ) . The lowest dose – response curve was at 36 weeks ' gestation . A repeated- measures analysis of variance found a significant difference ( P < .05 ) between the 36-week group and the postterm group but not between any of the other groups . CONCLUSION During pregnancy , differences in the pharmacokinetics of low molecular weight heparin were observed , with an overall reduction in anti-Xa activity . On the basis of this study it is question able to extrapolate dosing and lack of dose monitoring , in pregnant women , using data derived from a nonpregnant OBJECTIVE The purpose of this study was to compare the use of low-dose aspirin alone with heparin and low-dose aspirin in the treatment of the antiphospholipid antibody syndrome . STUDY DESIGN A prospect i ve , single-center trial included 50 patients who were alternately assigned to treatment . Each patient had at least three consecutive spontaneous pregnancy losses , positive antiphospholipid antibodies on two occasions , and a complete evaluation . Data were compared by chi(2 ) analysis and Fisher 's exact test . RESULTS Viable infants were delivered of 11 of 25 ( 44 % ) women treated with aspirin and 20 of 25 ( 80 % ) women treated with heparin and aspirin ( p < 0.05 ) . There were no significant differences between the low-dose aspirin and the heparin plus low-dose aspirin groups with respect to gestational age at delivery ( 37.8 + /- 2.1 vs 37.2 + /- 3.4 weeks ) , number of cesarean sections ( 18 % vs 20 % ) , or complications . CONCLUSION Heparin plus low-dose aspirin provides a significantly better pregnancy outcome than low-dose aspirin alone does for antiphospholipid antibody-associated recurrent pregnancy loss OBJECTIVES To determine if a prophylactic dose of dalteparin , 5000 IU daily , and if the adjusted-weight dalteparin therapeutic dose of 100 IU/kg twice daily are appropriate in pregnancy . METHOD Anti-Xa activity levels were used to assess prophylactic ( 33 women ) and therapeutic ( 15 women ) dalteparin dosage throughout pregnancy . Analysis of variance was used and P-values less than 0.05 were considered statistically significant . RESULTS In the prophylactic group , anti-Xa activity levels did not vary significantly throughout pregnancy ( P=0.15 ) . The initial dalteparin dose was modified on the first anti-Xa activity measurement in eight women , whose weight was statistically different from those remaining on the initial dose ( P<0.001 ) . The adjusted-weight therapeutic dalteparin dose induced adequate anti-Xa activity levels . CONCLUSIONS Dalteparin , 5000 IU daily , is suitable for most pregnant women and does not need to be modified in the third trimester . A therapeutic dalteparin dose adjusted according to pregnancy weight is appropriate BACKGROUND The aim of this study was to assess the effect of long-term low molecular weight heparin ( LMWH ) on bone mineral density ( BMD ) during pregnancy . METHODS Fifty-five patients with recurrent miscarriage and known thrombophilia ( antiphospholipid syndrome ) were followed through pregnancy in an ethically approved prospect i ve observational study . All women had dual energy X-ray absorptiometry ( DEXA ) scans at the lumbar spine ( L1-L4 ) performed within 6 months prior to conception and in the immediate post-natal period , within 6 weeks of delivery . LMWH ( 5000 U/day ) plus low-dose aspirin was commenced after a positive urine pregnancy test and continued throughout pregnancy and after delivery until 6 weeks post-partum . A group of 20 volunteers with recurrent miscarriage , not requiring any treatment intervention , acted as controls and were monitored in an identical fashion . RESULTS Characteristics were not significantly different between treated patients and controls . Both groups showed a similar loss in lumbar spine ( L1-L4 ) BMD by the end of the pregnancy [ LMWH 4.17 % or 0.045 g/cm(3 ) , 95 % confidence interval ( CI ) 0.036 - 0.062 versus control 3.56 % or 0.043 g/cm(3 ) , 95 % CI 0.027 - 0.059 ] . However , the difference in bone loss between the groups was not statistically significant ( 0.002 g/cm(3 ) , CI -0.0124 to 0.00865 ; P = 0.88 ) . No patient suffered vertebral fracture . CONCLUSIONS Bone loss associated with the use of long-term LMWH is not significantly different from physiological losses during pregnancy Mechanical valve thrombosis is a life-threatening event , while pregnancy is associated with a hypercoagulable state . Thus , in pregnant women with mechanical valves , adequate anticoagulation becomes even more critical . This prospect i ve study was conducted to establish a uniform anticoagulation regimen for these women . A total of 250 pregnancies in 245 women with mechanical heart valves were evaluated . The patients were divided into 2 groups : group 1 ( n = 150 ) took oral warfarin throughout pregnancy and group 2 ( n = 100 ) received subcutaneous heparin in the 1st trimester and oral warfarin for the other trimesters . Both groups received heparin at the time of delivery . There were no coumarin-induced fetal malformations . Minor thromboembolic episodes took place in 5 women in group 1 and 3 in group 2 . Valve thrombosis occurred in 1 woman in group 2 and led to 1 maternal death in this series . The incidence of spontaneous abortion was similar between the groups . We conclude that warfarin is safe and convenient to use during pregnancy . The teratogenic effects of warfarin during the 1st trimester are overstated , and switching to heparin is not m and atory BACKGROUND Women with a history of venous thromboembolism may be at increased risk for venous thromboembolic events during pregnancy . In these women , the decision to give or withhold heparin in the antepartum period is controversial , because accurate estimates of the frequency of recurrent thromboembolic events if antepartum heparin is withheld are not available . METHODS We prospect ively studied 125 pregnant women with a single previous episode of venous thromboembolism . Antepartum heparin was withheld , but anticoagulant therapy was given for four to six weeks post partum . Our primary objective was to determine the rate of antepartum recurrence of venous thromboembolism . Laboratory studies were performed to identify thrombophilia in 95 women . RESULTS Three of the 125 women ( 2.4 percent ) had an antepartum recurrence of venous thromboembolism ( 95 percent confidence interval , 0.2 to 6.9 percent ) . There were no recurrences in the 44 women who had no evidence of thrombophilia and who also had a previous episode of thrombosis that was associated with a temporary risk factor . Among the 51 women with abnormal laboratory results or a previous episode of idiopathic thrombosis , or both , 3 ( 5.9 percent ) had an antepartum recurrence of venous thromboembolism ( 95 percent confidence interval , 1.2 to 16.2 percent ) . CONCLUSIONS The risk of recurrent antepartum venous thromboembolism in women with a history of venous thromboembolism is low , and therefore routine antepartum prophylaxis with heparin is not warranted OBJECTIVE The purpose of this study was to conduct pilot studies for large r and omized controlled trials to compare low-molecular-weight heparin with placebo for antenatal thromboprophylaxis ( trial 1 ) , and for thromboprophylaxis after cesarean delivery ( trial 2 ) . STUDY DESIGN Multicenter r and omized controlled trials ( trial 1 , 23 units ; trial 2 , 8 units ) were conducted . Pregnant women at increased risk for thromboembolic disease were eligible for trial 1 ; women who underwent cesarean delivery were eligible for trial 2 . The interventions were once daily injections of low-molecular-weight heparin or placebo . Primary outcomes were as follows : trial 1 , confirmed symptomatic thromboembolic events and symptomatic osteoporotic fractures ; trial 2 , confirmed symptomatic thromboembolic events and wound complications . RESULTS Sixteen women were recruited for trial 1 ; 1 woman in the placebo group had a symptomatic thromboembolic event . One hundred forty-one women were recruited for trial 2 ; 1 woman in the low molecular weight heparin group had a symptomatic thromboembolic event . CONCLUSION Poor recruitment indicates that large-scale trials using these design s would be difficult . Collection of data on the number of women that are eligible and the reasons for nonrecruitment in future trials of these interventions would allow a better underst and ing of the reasons for poor recruitment Despite considerable recent advances in diagnostic techniques for lower-limb deep venous thrombosis ( DVT ) , current methods have disadvantages . Ultrasonography , the most accurate noninvasive test , is widely available and cheap . As such , it has largely replaced venography as the test of first choice for symptomatic DVT . In a recent meta- analysis , the sensitivity of ultrasonography was 89 % overall for symptomatic DVT and 97 % for above-knee thrombosis ( 1 ) . Large outcome studies have shown that patients may be safely left untreated after a negative result on ultrasonography if they have a low clinical risk score , a low d-dimer level , or a negative result on repeated ultrasonography at 1 week ( 2 - 4 ) . However , these strategies may be complex and still require 3 % to 34 % of out patients and most in patients to undergo repeated ultrasonography at 1 week ( 2 - 4 ) . In practice , retesting after 1 week is inconvenient , and physicians often rely on a single test or request immediate venography ( 5 ) . Other problems with ultrasonography include poor sensitivity for asymptomatic disease , difficulties in diagnosing DVT recurrence , and limited visualization in the pelvis ( 1 , 6 , 7 ) . Impedance plethysmography is also commonly used ; however , it has a lower diagnostic accuracy than ultrasonography and has similar weaknesses in the setting of recurrent thrombosis , asymptomatic DVT , and DVT below the knee or in the pelvis ( 1 , 4 , 6 ) . Computed tomography and magnetic resonance imaging techniques can visualize DVT above the knee and in the pelvis but in general are unsuccessful below the knee ( 8 - 10 ) . The ability of these techniques to diagnose DVT recurrence and asymptomatic disease has not been tested . Venography is the reference st and ard diagnostic test , but it has in large part been replaced by noninvasive tests . In clinical practice , it is the most reliable test for the diagnosis of asymptomatic thrombosis and thrombosis isolated within the calf or pelvis . However , imaging in the pelvis is inadequate in up to 24 % of normal studies , and the proximal extent of thrombosis is frequently not delineated in patients with above-knee DVT ( 11 ) . Underfilling of vessels and vessels overlying one another also create problems with venography below the knee . Studies have shown that interobserver variability for venography is high ( 10 % to 16 % ) , especially below the knee ( = 0.46 to 0.73 below the knee and 0.46 to 0.84 above the knee ) ( 12 , 13 ) . In addition , a high proportion of studies are nondiagnostic for possible DVT recurrence ( 1 , 6 ) . A noninvasive test is needed that accurately diagnoses above-knee DVT and thrombus below the knee , in the pelvis , and in asymptomatic limbs . Unlike most imaging techniques , which identify thrombus as filling defects , magnetic resonance direct thrombus imaging ( MRDTI ) visualizes thrombus against a suppressed background ( 14 ) . In an unblinded comparison with venography , we previously showed that MRDTI precisely visualizes acute deep venous thrombus ( 14 , 15 ) . In the current study , we sought to assess prospect ively whether MRDTI is a reliable diagnostic test for suspected acute symptomatic DVT . Methods The ethics committee at our institution granted approval for the study , and all participants gave written informed consent . With the exceptions of pregnant women , patients with known contrast allergy , and those with renal failure , all patients with DVT suspected on the basis of lower limb symptoms are investigated by using venography at our institution . Participants were recruited after routine venography was done between May 1998 and September 1999 . During this time , 338 consecutive patients underwent routine contrast venography . Consecutive patients with positive venograms were selected , along with one quarter of those with negative venograms , according to a predetermined r and om sequence . This protocol was chosen to equalize the numbers of positive and negative cases and was based on a 6-month audit of venograms in our institution that found that 22 % of venograms were positive . Clinical diagnostic criteria were not used , and the decision to request investigation for suspected DVT had been made by the attending clinician ; however , patients who did not have leg symptoms were not recruited . Other exclusion criteria were failed or inconclusive venography , failed or inconclusive MRDTI , contraindications to MRI , and claustrophobia ( Figure 1 ) . Individual venous segments that were nondiagnostic at venography were also excluded from analysis . Figure 1 . Outline of the study . Magnetic resonance direct thrombus imaging was performed on all patients recruited within 48 hours of venography . The scans were interpreted by an experienced radiologist ( review er A ) and by a nonradiologist ( review er B ) trained to read MRDTI scans . For venograms and MRDTI scans , the review ers noted the presence or absence of DVT ; the diagnostic classification of DVT , divided into isolated calf DVT , femoropopliteal DVT , and ileofemoral DVT ; and the presence of thrombus in the calf , femoropopliteal , and iliac venous segments . Venograms were obtained and initially reported by the radiologists on duty . This initial report was used to make recruitment decisions ; if the results were discordant with those of MRDTI , ultrasonography was also performed . However , ultrasonography was not used in the calculations of the accuracy of MRDTI . After completion of the study , venograms were interpreted by an independent radiologist , and these results were used as the gold st and ard against which MRDTI was compared . Results of MRDTI and venography were reported without knowledge of the results of other tests and the other readings . The d-dimer level was measured in all patients at the time of the MRDTI scan by using the Nycocard ( Nycomed Pharma AS , Asker , Norway ) technique ( normal level < 0.3 mg/L ) . Venography Venography was performed by cannulating a dorsal pedal vein with a 21-gauge needle and rapidly injecting 50 to 100 mL of iodinated contrast medium ( I2 , 300 mg/mL ) , with the patient supine and tilted 30 degrees with his or her feet downward . A tourniquet was applied above the ankle . Anteroposterior and two oblique views of the deep calf and popliteal veins were obtained . Views of the femoral and iliac veins were then obtained . The study result was considered positive if intraluminal filling defects were seen or persistent nonfilling of veins with a sharp cut-off was detected . Magnetic Resonance Imaging Magnetic resonance imaging was performed by using a 1.5-Tesla unit ( Siemens Vision , Erlangen , Germany ) with a T1-weighted magnetization-prepared three-dimensional gradient-echo sequence . The sequence included a water-only excitation radiofrequency pulse to abolish the fat signal , and the effective inversion time was chosen to nullify the blood signal . Imaging was performed from the ankle to the inferior vena cava in two imaging blocks with a total acquisition time of 12 minutes by using a 55-cm body coil . Both legs were imaged simultaneously . Scanning was performed by radiographers in all cases . Image assessment involved reading of coronal source data and st and ard image reconstruction techniques . Acute thrombus was diagnosed on the basis of its high signal against the suppressed background ( Figure 2 ) . Figure 2 . Magnetic resonance direct thrombus imaging in three patients . A. arrows B. arrows C. single arrows double arrow Ultrasonography Color flow and compression ultrasonographic images of the symptomatic limb from the common femoral vein distally were obtained by using a 5-MHz linear array transducer . As much of the superficial femoral vein as possible was imaged , together with the popliteal vein and the calf veins . Augmentation of flow was used to verify patency . Examinations were performed by senior radiologists , and DVT was confirmed in all cases by noncompressibility on gray-scale images . The sonographer was unaware of the other test results , but in cases of possible isolated calf thrombosis , he or she was told to concentrate the examination below the knee to maximize accuracy in this region . Statistical Analysis Sensitivity and specificity were calculated for the overall diagnosis of DVT ; diagnosis of isolated calf DVT , femoropopliteal DVT , and ileofemoral DVT ; and presence of thrombus in the calf , femoropopliteal vein , and iliac vein . Exact CIs were calculated . Interobserver error was calculated for these observations by using the weighted statistic with equally spaced weights for positive , nondiagnostic , and negative studies . Confidence intervals for the statistic were calculated from asymptotic estimations of the st and ard error . Calculations were performed by using SPSS software ( SPSS , Inc. , Chicago , Illinois ) . Results One hundred four patients were recruited according to our protocol ( Figure 1 ) . The time between venography and MRDTI was less than 8 hours in 28 patients , 8 to 24 hours in 44 patients , and 24 to 48 hours in 32 patients . Age ranged from 20 to 95 years , and symptom onset varied from 1 to 35 days . Ninety-five patients were referred from medical specialties and 9 from surgical specialties ; 47 were in patients and 57 were out patients . Both review ers reported that 3 of 5 patients with ipsilateral total hip replacements had nondiagnostic MRDTI scans . Venography diagnosed femoropopliteal DVT in 1 of these patients and was negative in 2 patients . These 3 patients were excluded from further analysis , leaving 101 patients in the study . One patient could tolerate only the first scanning block from ankle to thigh level owing to claustrophobia ; however , femoropopliteal DVT could still be diagnosed . All other patients tolerated MRI . Eighteen of 148 patients ( 12 % ) were excluded from the study . Fifteen patients could not undergo MRI because of contraindications ( 9 patients ) or claustrophobia ( 6 patients ) , and 3 patients had inconclusive results on MRDTI . Venography failed ( 29 patients ) or was inconclusive ( 11 patients ) in 12 % of patients ( 40 of 338 ) . Venography was Venous thromboembolism remains an important cause of maternal mortality . For women at risk during pregnancy , the recommended venous thromboembolismprophylaxis is unfractionated heparin . Low molecular weight heparins , such as dalteparin , also may be suitable , but r and omised trials have not been performed . Pregnant women ( 105 ) with confirmed previous or current thromboembolism were r and omised to receive either unfractionated heparin twice daily ( mean 20569 IU/day ) or dalteparin once daily ( mean 4631 IU anti-factor Xa units/day ) subcutaneously for thromboprophylaxis during pregnancy and postpartum period . Recurrence of venous thromboembolism and safety of treatments were assessed . Dalteparin administered once daily was safe and effective in thromboprophylaxis during pregnancy and postpartum Abstract Objective : To determine whether treatment with low dose aspirin and heparin leads to a higher rate of live births than that achieved with low dose aspirin alone in women with a history of recurrent miscarriage associated with phospholipid antibodies ( or antiphospholipid antibodies ) , lupus anticoagulant , and cardiolipin antibodies ( or anticardiolipin antibodies ) . Design : R and omised controlled trial . Setting : Specialist clinic for recurrent miscarriages . Subjects : 90 women ( median age 33 ( range 22 - 43 ) ) with a history of recurrent miscarriage ( median number 4 ( range 3 - 15 ) ) and persistently positive results for phospholipid antibodies . Intervention : Either low dose aspirin ( 75 mg daily ) or low dose aspirin and 5000 U of unfractionated heparin subcutaneously 12 hourly . All women started treatment with low dose aspirin when they had a positive urine pregnancy test . Women were r and omly allocated an intervention when fetal heart activity was seen on ultrasonography . Treatment was stopped at the time of miscarriage or at 34 weeks ' gestation . Main outcome measures : Rate of live births with the two treatments . Results : There was no significant difference in the two groups in age or the number and gestation of previous miscarriages . The rate of live births with low dose aspirin and heparin was 71 % ( 32/45 pregnancies ) and 42 % ( 19/45 pregnancies ) with low dose aspirin alone ( odds ratio 3.37 ( 95 % confidence interval 1.40 to 8.10 ) ) . More than 90 % of miscarriages occurred in the first trimester . There was no difference in outcome between the two treatments in pregnancies that advanced beyond 13 weeks ' gestation . Twelve of the 51 successful pregnancies ( 24 % ) were delivered before 37 weeks ' gestation . Women r and omly allocated aspirin and heparin had a median decrease in lumbar spine bone density of 5.4 % ( range -8.6 % to 1.7 % ) . Conclusion : Treatment with aspirin and heparin leads to a significantly higher rate of live births in women with a history of recurrent miscarriage associated with phospholipid antibodies than that achieved with aspirin alone . Key messages The prognosis for pregnancies in women with recurrent miscarriage associated with phospholipid antibodies is poor This r and omised controlled trial found that the prognosis improved with low dose aspirin and was further improved with the addition of low dose heparin to the aspirin This combination may promote successful embryonic implantation in the early stages of pregnancy and protect against thrombosis of the uteroplacental vasculature after successful placentation Most miscarriages occurred before 13 weeks ' gestation Nearly a quarter of the successful pregnancies were delivered prematurely ( before 37 weeks ' gestation ) , so close surveillance is necessary Long term use of low dose heparin was associated with few BACKGROUND The use of subcutaneous heparin , the therapy of choice for women requiring anticoagulant prophylaxis during pregnancy , is problematic because of the discomfort produced by repeated injections . An indwelling subcutaneous Teflon catheter that can be left in place for 1 week recently became available for use as an entry port for parenteral therapy . Since the use of this catheter has the potential to overcome some of the problems of long-term heparin therapy , we decided to compare this Teflon catheter with twice-daily subcutaneous injections in women requiring heparin during pregnancy . METHODS In a r and omized , multiple-crossover study , patients alternated every 2 weeks between having heparin administered through the indwelling Teflon catheter and receiving heparin via subcutaneous injections . After each 4-week cycle , patients completed a question naire design ed to determine their preferred method of heparin administration . The side effects , doses , and anticoagulant activity of heparin with the two delivery systems were also compared . RESULTS Twelve patients completed one to five 4-week cycles of heparin therapy . Ten of the patients selected the Teflon catheter as the preferred route of heparin administration ( P = .04 ) and 11 patients reported that the catheter caused less pain and bruising than twice-daily subcutaneous injections ( P < .01 ) . Five patients developed urticarial reactions at the sites of heparin injections . These reactions tended to be more severe when the Teflon catheter was used , and two women discontinued using the catheter after the first cycle because of this complication . There were no differences in heparin dose requirements or achieved activated partial thromboplastin times between the two routes of heparin administration . CONCLUSIONS Most pregnant women in our study preferred to have subcutaneous heparin administered through an indwelling Teflon catheter rather than by twice-daily injections . Heparin given through the Teflon catheter was bioavailable and caused less local bruising than twice-daily injections . Urticarial reactions to heparin tended to be more severe with the use of the Teflon catheter and result ed in the discontinuation of the device 's use in two of 12 patients Seventeen women with previously verified thromboembolism were included in a pharmacokinetic evaluation of dalteparin during the third trimester of pregnancy . The bioavailability of morning subcutaneous administration of dalteparin ( crossover study ) was also compared with that in the evening . Fifteen women injected themselves subcutaneously with 5000 IU and two with 2500 IU dalteparin once daily . An anti-FXa activity of 0.20 - 0.40 IU/ml 3 h after injection was obtained . The means + /- SD , when comparing morning and evening doses for 5000 IU , were : Cmax 0.21 + /- 0.05 and 0.20 + /- 0.05 IU anti-FXa/ml , AUC 0 - 24 h 1.97 + /- 0.46 and 1.93 + /- 0.55 IU x h/ml and tmax 3.71 + /- 0.89 and 4.32 + /- 1.60 h , respectively ( NS ) . The two regimens were equivalent . A measurable anticoagulant effect was still observed 16 h after injection of 5000 IU dalteparin . The half-lives after a morning and an evening dose of 5000 IU dalteparin were 4.92 + /- 2.80 and 3.87 + /- 1.15 h , respectively ( NS ) . There were no changes in thrombin marker levels during the two pharmacokinetic measurements |
11,588 | 27,865,585 | PTSD is prevalent during pregnancy and after birth and may increase postpartum if not identified and treated . | BACKGROUND Previous review s have provided preliminary insights into risk factors and possible prevalence of Post-traumatic Stress Disorder ( PTSD ) postpartum with no attempt to examine prenatal PTSD .
This study aim ed to assess the prevalence of PTSD during pregnancy and after birth , and the course of PTSD over this time . | BACKGROUND The purpose of this study was to determine the association between posttraumatic stress disorder ( PTSD ) , diagnosed prospect ively during pregnancy , and the risk of delivering a low birth weight ( < 2500 g ) or preterm ( < 37 weeks gestational age ) infant . METHODS Pregnant women were recruited from obstetrics clinics and screened for major and minor depressive disorder , panic disorder , PTSD , and substance use . Current episodes of PTSD were diagnosed according to the MINI International Neuropsychiatric Interview , and pregnancy outcomes were abstract ed from hospital records . RESULTS Among the 1100 women included in analysis , 31 ( 3 % ) were in episode for PTSD during pregnancy . Substance use in pregnancy , panic disorder , major and minor depressive disorder , and prior preterm delivery were significantly associated with a diagnosis of PTSD . Preterm delivery was non-significantly higher in pregnant women with ( 16.1 % ) compared to those without ( 7.0 % ) PTSD ( OR=2.82 , 95 % C.I. 0.95 , 8.38 ) . Low birth weight ( LBW ) was present in 6.5 % of women and was not significantly associated with a diagnosis of PTSD in pregnancy after adjusting for potential confounders . However , LBW was significantly associated with minor depressive disorder ( OR=1.82 , 95 % C.I. 1.01 , 3.29 ) . LIMITATIONS There was a low prevalence of PTSD in this cohort , result ing in limited power . CONCLUSIONS These data suggest a possible association between PTSD and preterm delivery . Coupled with the association found between LBW and a depressive disorder , these results support the utility of screening for mental health disorders in pregnancy BACKGROUND Childbirth has been linked to postpartum impairment . However , controversy exists regarding the onset and prevalence of post-traumatic stress disorder ( PTSD ) after childbirth , with seminal studies being limited by method ological issues . This longitudinal prospect i ve study examined the prevalence of PTSD following childbirth in a large sample while controlling for pre-existing PTSD and affective symptomatology . METHOD Pregnant women in their third trimester were recruited over a 12-month period and interviewed to identify PTSD and anxiety and depressive symptoms during the last trimester of pregnancy , 4 - 6 weeks postpartum , 12 weeks postpartum and 24 weeks postpartum . RESULTS Of the 1067 women approached , 933 were recruited into the study . In total , 866 ( 93 % ) were retained to 4 - 6 weeks , 826 ( 89 % ) were retained to 12 weeks and 776 ( 83 % ) were retained to 24 weeks . Results indicated that , uncontrolled , 3.6 % of women met PTSD criteria at 4 - 6 weeks postpartum , 6.3 % at 12 weeks postpartum and 5.8 % at 24 weeks postpartum . When controlling for PTSD and partial PTSD due to previous traumatic events as well as clinical ly significant anxiety and depression during pregnancy , PTSD rates were less at 1.2 % at 4 - 6 weeks , 3.1 % at 12 weeks and 3.1 % at 24 weeks postpartum . CONCLUSIONS This is the first study to demonstrate the occurrence of full criteria PTSD result ing from childbirth after controlling for pre-existing PTSD and partial PTSD and clinical ly significant depression and anxiety in pregnancy . The findings indicate that PTSD can result from a traumatic birth experience , though this is not the normative response BACKGROUND AND OBJECTIVES Pregnant women face considerable barriers to smoking cessation . The purpose of this study was to determine the prevalence of major depressive disorder ( MDD ) and post-traumatic stress disorder ( PTSD ) and response to smoking cessation treatment in pregnant smokers participating in a r and omized , placebo-controlled trial of nicotine gum . METHODS Participants were 194 low-income , ethnically diverse pregnant smokers . RESULTS Utilizing a structured interview , 45 % and 18 % of the subjects met criteria for a lifetime diagnosis of MDD and PTSD , respectively . There was no difference in response to treatment , based on the presence of either of these psychiatric disorders . CONCLUSIONS Cumulatively , these findings provide evidence of the high degree of unmet mental health needs in pregnant smokers . SCIENTIFIC SIGNIFICANCE Pregnant women with a history of MDD and PTSD appear to be as likely to benefit from smoking cessation treatment as those without such a history OBJECTIVE To test the effectiveness of a trauma-specific , psychoeducational intervention for pregnant women with a history of childhood maltreatment on six intrapartum and postpartum psychological outcomes . DESIGN Quasi-experimental study comparing women from a single-group , pretest-posttest pilot intervention study with women matched from a prospect i ve observational study . SETTING Rural and university-based prenatal clinics . PARTICIPANTS Pregnant women entered the study by responding to an advertisement or by referral from a maternity care provider . Women could take part whether or not they met posttraumatic stress disorder diagnostic criteria . Outcomes data exist for 17 pilot intervention study participants and 43 matched observational study participants . INTERVENTIONS Participants in the observational study received usual care . Participants in the pilot intervention study received usual care plus the intervention , a fully manualized , self- study program supported by weekly phone tutoring sessions with a health professional . MAIN OUTCOME MEASURES The National Women 's Study PTSD Module , the Peritraumatic Dissociation Experience Question naire , the Perception of Care Question naire , the Postpartum Depression Screening Scale , the Postpartum Bonding Question naire , and a semantic differential appraisal of the labor experience . RESULTS Participants in the intervention study had better scores on all measures . Differences in means between participants in the intervention study and participants in the observational study equated to medium effect sized for dissociation during labor , rating of labor experience , and perception of care in labor and small effect sizes for postpartum posttraumatic stress disorder ( PTSD ) symptoms , postpartum depression symptoms , and motherinfant bonding . CONCLUSION This trauma-specific intervention reaches and benefits pregnant women with a history of childhood maltreatment OBJECTIVE The purpose of this study was to examine symptoms of posttraumatic stress disorder ( PTSD ) in a community sample of low-income pregnant women who met the DSM-IV diagnostic criteria for the disorder . METHOD Pregnant women ( N=948 ) were screened for trauma , PTSD , depression , and co-occurring illicit substance use . PTSD symptoms were compared in traumatized pregnant women and a sample of nonpregnant traumatized women from the National Comorbidity Survey . RESULTS Suicidal thoughts and a high degree of psychiatric comorbidity were common in pregnant women with PTSD . Pregnant women were selectively and significantly less likely to endorse reexperiencing symptoms of PTSD ( 29.5 % , N=82 ) , compared to nonpregnant women ( 79.4 % , N=464 ) . CONCLUSIONS PTSD in pregnancy was associated with comorbidity , poor health behaviors , and lower recall of memory-related PTSD symptoms . Further prospect i ve study is needed IMPORTANCE Posttraumatic stress disorder ( PTSD ) occurs in about 8 % of pregnant women . Stressful conditions , including PTSD , are inconsistently linked to preterm birth . Psychotropic treatment has been frequently associated with preterm birth . Identifying whether the psychiatric illness or its treatment is independently associated with preterm birth may help clinicians and patients when making management decisions . OBJECTIVE To determine whether a likely diagnosis of PTSD or antidepressant and benzodiazepine treatment during pregnancy is associated with risk of preterm birth . We hypothesized that pregnant women who likely had PTSD and women receiving antidepressant or anxiolytic treatment would be more likely to experience preterm birth . DESIGN , SETTING , AND PARTICIPANTS Longitudinal , prospect i ve cohort study of 2654 women who were recruited before 17 completed weeks of pregnancy from 137 obstetrical practice s in Connecticut and Western Massachusetts . EXPOSURES Posttraumatic stress disorder , major depressive episode , and use of antidepressant and benzodiazepine medications . MAIN OUTCOMES AND MEASURES Preterm birth , operationalized as delivery prior to 37 completed weeks of pregnancy . Likely psychiatric diagnoses were generated through administration of the Composite International Diagnostic Interview and the Modified PTSD Symptom Scale . Data on medication use were gathered at each participant interview . RESULTS Recursive partitioning analysis showed elevated rates of preterm birth among women with PTSD . A further split of the PTSD node showed high rates for women who met criteria for a major depressive episode , which suggests an interaction between these 2 exposures . Logistic regression analysis confirmed risk for women who likely had both conditions ( odds ratio [ OR ] , 4.08 [ 95 % CI , 1.27 - 13.15 ] ) . For each point increase on the Modified PTSD Symptom Scale ( range , 0 - 110 ) , the risk of preterm birth increased by 1 % to 2 % . The odds of preterm birth are high for women who used a serotonin reuptake inhibitor ( OR , 1.55 [ 95 % CI , 1.02 - 2.36 ] ) and women who used a benzodiazepine medication ( OR , 1.99 [ 95 % CI , 0.98 - 4.03 ] ) . CONCLUSIONS AND RELEVANCE Women with likely diagnoses of both PTSD and a major depressive episode are at a 4-fold increased risk of preterm birth ; this risk is greater than , and independent of , antidepressant and benzodiazepine use and is not simply a function of mood or anxiety symptoms Background : Many women experience childbirth as traumatic and 2 % develop post-traumatic stress disorder . This study examined the role of health practitioner support and personal control during birth as predictors of post-traumatic stress ( PTS ) symptoms , adjusting for vulnerability factors of prior trauma , depression , control beliefs and birth intervention . It also investigated interactions between support , prior trauma and birth intervention and their association with PTS symptoms . Methods : A prospect i ve longitudinal survey of 138 women recruited from UK NHS maternity clinics . Measures were taken in pregnancy , 3 weeks and 3 months after the birth . Results : Support and control during birth were not predictive of postnatal PTS symptoms . However , support was predictive of PTS symptoms in a subset of women with prior trauma ( β = −0.41 , R 2 = 16 % ) at both 3-weeks and 3-months postpartum . The interaction of birth intervention and support was associated with PTS symptoms 3 months after birth , the relationship between support and PTS symptoms was stronger in women experiencing more intervention . Conclusions : Low support from health practitioners is predictive of postnatal PTS symptoms in women who have a history of trauma . Longer term effects of low support on postnatal PTS symptoms are also found in women who had more intervention during birth Background Prenatal assessment for psychosocial risk factors and prevention and intervention is scarce and , in most cases , nonexistent in obstetrical care . In this study we aim ed to evaluate if the KINDEX , a short instrument developed in Germany , is a useful tool in the h and s of non-trained medical staff , in order to identify and refer women in psychosocial risk to the adequate mental health and social services . We also examined the criterion-related concurrent validity of the tool through a validation interview carried out by an expert clinical psychologist . Our final objective was to achieve the cultural adaptation of the KINDEX Greek Version and to offer a valid tool for the psychosocial risk assessment to the obstetric care providers . Methods Two obstetricians and five midwives carried out 93 KINDEX interviews ( duration 20 minutes ) with pregnant women to assess psychosocial risk factors present during pregnancy . Afterwards they referred women who they identified having two or more psychosocial risk factors to the mental health attention unit of the hospital . During the validation procedure an expert clinical psychologist carried out diagnostic interviews with a r and omized sub sample of 50 pregnant women based on established diagnostic instruments for stress and psychopathology , like the PSS-14 , ESI , PDS , HSCL-25 . Results Significant correlations between the results obtained through the assessment using the KINDEX and the risk areas of stress , psychopathology and trauma load assessed in the validation interview demonstrate the criterion-related concurrent validity of the KINDEX . The referral accuracy of the medical staff is confirmed through comparisons between pregnant women who have and have not been referred to the mental health attention unit . Conclusions Prenatal screenings for psychosocial risks like the KINDEX are feasible in public health setting s in Greece . In addition , validity was confirmed in high correlations between the KINDEX results and the results of the validation interviews . The KINDEX Greek version can be considered a valid tool , which can be used by non-trained medical staff providing obstetrical care to identify high-risk women and refer them to adequate mental health and social services . These kind of assessment s are indispensable for the promotion of a healthy family environment and child development Background High levels of stress due to diverse psychosocial factors have a direct impact on the mothers ’ wellbeing during pregnancy and both direct and indirect effects on the fetus . In most cases , psychosocial risk factors present during pregnancy will not disappear after delivery and might influence the parent-child relationship , affecting the healthy development of the offspring in the long term . We introduce a short innovative prenatal assessment to detect psychosocial risk factors through an easy to use instrument for obstetrical medical staff in the daily clinical practice , the KINDEX Spanish Version . Methods In the present study midwives and gynecologists interviewed one hundred nineteen pregnant women in a public health center using the KINDEX Spanish Version . Sixty-seven women were then r and omly selected to participate in an extended st and ardized validation interview conducted by a clinical psychologist using established question naires to assesses current stress ( ESI , PSS-14 ) , symptoms of psychopathology ( HSCL-25 , PDS ) and traumatic experiences ( PDS , CFV ) . Ethical approval was granted and informed consent was required for participation in this study . Results The KINDEX sum score , as assessed by medical staff , correlated significantly with stress , psychopathology and trauma as measured during the clinical expert interview . The KINDEX shows strong concurrent validity . Its use by medical staff in daily clinical practice is feasible for public health context s. Certain items in the KINDEX are related to the respective scales assessing the same risks ( e.g . PSS-4 as the shorter version of the PSS-14 and items from the ESI ) used in the validation interview . Conclusions The KINDEX Spanish Version is a valid tool in the h and s of medical staff to identify women with multiple psychosocial risk factors in public health setting s. The KINDEX Spanish Version could serve as a base-instrument for the referral of at-risk women to appropriate psychosocial intervention . Such early interventions could prove pivotal in preventing undesirable mother-child relationships and adverse child development This study aim ed to describe the prevalence of psychiatric disorders and to identify the factors associated with Current Suicide Risk ( CSR ) in the first trimester of pregnancy . The Mini-International Neuropsychiatric Interview ( M.I.N.I. ) was employed to diagnose mental disorders in 239 women enrolled in a prospect i ve cohort in Rio de Janeiro , Brazil . Serum lipids , leptin and socio-economic status were the independent variables . CSR , the dependent variable , was entered as binary ( yes/no ) variable into crude and adjusted Poisson regression models with robust variances . CSR was found to be the main psychiatric syndrome ( 18.4 % ) , followed by agoraphobia ( 17.2 % ) , major depressive disorder ( 15.1 % ) and generalized anxiety disorder ( 10.5 % ) . Women with CSR showed higher mean levels of cholesterol ( 169.2 vs. 159.2 ; p=0.017 ) , high density lipoprotein ( 50.4 vs. 47.7 ; p=0.031 ) and low density lipoprotein ( 102.8 vs. 95.6 ; p=0.022 ) when compared to women without CSR . The adjusted regression model showed a higher prevalence ratio ( PR ) of CSR among pregnant women with generalized anxiety disorder ( PR=2.70 , 95 % CI : 1.36 - 5.37 ) , with ≥ two parturitions ( PR=2.46 , 95 % CI : 1.22 - 4.93 ) , and with major depressive disorder ( PR=2.11 , 95 % CI : 1.08 - 4.12 ) . We have shown that generalized anxiety disorder , major depressive disorder and higher parity are associated with CSR in the first trimester of pregnancy OBJECTIVE The goals of the present study were to estimate the incidence and course of full and partial Post-Traumatic Stress Disorder ( PTSD ) following childbirth and to prospect ively identify factors associated with the development of PTSD symptoms at 1month following childbirth . METHODS The sample comprised 308 women , with assessment s at four time points : 25 - 40weeks gestation , 4 - 6weeks postpartum , 3 and 6months postpartum . Current and prior PTSD were assessed by the Structured Clinical Interview for DSM-IV ( SCID-I ) and the Modified PTSD Symptom Scale Self-Report ( MPSS-SR ) . RESULTS Incidence rates of PTSD varied according to time of measurement and instrument used , with higher rates of full and partial PTSD using the MPSS-SR at 1month postpartum ( 7.6 % and 16.6 % , respectively ) . Multivariate logistic regression showed that higher anxiety sensitivity ( OR=1.75 ; 95 % CI=1.19‒2.57 , p=.005 ) , history of sexual trauma ( OR=2.81 ; 95 % CI=1.07‒7.37 , p=.036 ) , a more negative childbirth experience than expected ( OR=0.96 ; 95 % CI=0.94‒0.98 , p=.001 ) , and less available social support at 1month postpartum ( OR=0.40 ; 95 % CI=0.17‒0.96 , p=.041 ) independently predicted full or partial PTSD at 1month following childbirth . CONCLUSION Our results indicate that a history of sexual trauma and anxiety sensitivity can increase the probability of developing PTSD after childbirth . The findings highlight the importance of screening and providing more tailored services for women at high risk INTRODUCTION Research is needed that prospect ively characterizes the intergenerational pattern of effects of childhood maltreatment and lifetime posttraumatic stress disorder ( PTSD ) on women 's mental health in pregnancy and on postpartum mental health and bonding outcomes . This prospect i ve study included 566 nulliparous women in 3 cohorts : PTSD-positive , trauma-exposed resilient , and not exposed to trauma . METHODS Trauma history , PTSD diagnosis , and depression diagnosis were ascertained using st and ardized telephone interviews with women who were pregnant at less than 28 gestational weeks . A 6-week-postpartum interview reassessed interim trauma , labor experience , PTSD , depression , and bonding outcomes . RESULTS Regression modeling indicates that posttraumatic stress in pregnancy , alone , or comorbid with depression is associated with postpartum depression ( R(2 ) = .204 ; P < .001 ) . Postpartum depression alone or comorbid with posttraumatic stress was associated with impaired bonding ( R(2 ) = .195 ; P < .001 ) . In both models , higher quality of life ratings in pregnancy were associated with better outcomes , while reported dissociation in labor was a risk for worse outcomes . The effect of a history of childhood maltreatment on both postpartum mental health and bonding outcomes was mediated by preexisting mental health status . DISCUSSION Pregnancy represents an opportune time to interrupt the pattern of intergenerational transmission of abuse and psychiatric vulnerability . Further dyadic research is warranted beyond 6 weeks postpartum . Trauma-informed interventions for women who enter care with abuse-related PTSD or depression should be developed and tested OBJECTIVE Studies have suggested that women with pregnancy anxiety may be at greater risk of postnatal depression ( PND ) . However , due to the high comorbidity between anxiety and depressive disorders , this finding may be confounded by the association between prenatal depression and postnatal depression . The aim of the present prospect i ve study was to assess whether anxiety disorder ( AD ) during pregnancy is an independent predictor of intensity of postnatal depressive symptoms . METHOD The MATQUID cohort survey was conducted on pregnant women ( n = 497 ) attending a state maternity hospital . Psychiatric status during pregnancy was assessed during the third trimester using a structured diagnostic interview . Intense postnatal depressive symptoms at 6 weeks post-partum were defined by a score > 12 on the Edinburgh Postnatal Depression Scale ( EPDS ) . RESULTS Nearly one out of four women ( 24.1 % ) presented with at least one pregnancy AD , and 29 ( 5.8 % ) presented with a score > 12 on the EPDS . After adjustment for presence of major depression during pregnancy and other confounding factors , women with pregnancy AD were nearly three times more likely to present with intense postnatal depressive symptoms ( OR = 2.7 , 95%CI 1.1 - 6.3 , P = 0.03 ) . CONCLUSION Promoting the recognition and management of AD in pregnant women may be of interest for the prevention of postnatal depression Prevalence of crime and noncrime civilian traumatic events , lifetime posttraumatic stress disorder ( PTSD ) , and PTSD in the past 6 months were assessed in a sample of U.S. adult women ( N = 4,008 ) . R and om digit-dial telephone methods were used to identify study participants . Structured telephone interviews for assessment of specific crime or other traumatic event history and PTSD were conducted by trained female interviewers . Lifetime exposure to any type of traumatic event was 69 % , whereas exposure to crimes that included sexual or aggravated assault or homicide of a close relative or friend occurred among 36 % . Overall sample prevalence of PTSD was 12.3 % lifetime and 4.6 % within the past 6 months . The rate of PTSD was significantly higher among crime versus noncrime victims ( 25.8 % vs. 9.4 % ) . History of incidents that included direct threat to life or receipt of injury was a risk factor for PTSD . Findings are compared with data from other epidemiological studies . Results are discussed as they relate to PTSD etiology Traumatic birth experiences may lead to serious psychological impairment . Recent studies show that a considerable number of women can develop post-traumatic stress disorder ( PTSD ) , in some cases in a subsyndromal form . Until now , the possibility that postpartum psychological symptoms might be a continuum of a pre-existing disorder in pregnancy has rarely been considered . This study therefore aim ed to evaluate the proportion of women who develop post-traumatic stress disorder as a result of childbirth . Material s and Methods : 56 multiparous women were recruited for the study . The diagnosis of PTSD was made according to the criteria for psychological disorders in the DSM-IV ( Diagnostics and Statistical Manual of Mental Disorders ) . The data were collected in structured interviews in the 30th to 38th week of gestation and in the 6th week post partum . Results : Of the 56 women participating , 52 ( 93 % ) completed the survey . Uncontrolled results showed that 21.15 % of the multiparous women met the full diagnostic PTSD criteria in the 6th week post partum . After the exclusion of all cases already characterised by all criteria or a subsyndromal form of PTSD caused by previous traumatisation , the PTSD rate was below 8 % at 6 weeks postpartum (= incidence rate of PTSD post partum ) . Conclusions : The present study is the first prospect i ve longitudinal study to demonstrate the occurrence of full criteria PTSD in multiparous women as a result of childbirth after having excluded pre-existing PTSD . The results of our study show a high prevalence rate of PTSD during pregnancy . A number of women report all aspects of post-traumatic stress disorder as a result of childbirth OBJECTIVE For parents , the premature birth of a child represents a traumatic event for which they are poorly prepared . To date , the focus of scientific interest has been on maternal psychological stress responses , such as anxiety and depression , or on appropriate coping mechanisms , whereas only scant attention has been paid to the traumatic aspect of the maternal experience after very low-birth-weight ( VLBW ) birth . The present study is the first to investigate the posttraumatic stress response of mothers after the birth of a VLBW infant in a prospect i ve longitudinal study . METHODS Fifty mothers of VLBW infants were examined at four measuring time points ( 1 - 3 days pp , 14 days pp and 6 and 14 months pp ) with respect to posttraumatic symptoms [ Impact of Event Scale ( IES-R ) ] , psychiatric diagnosis ( SKID I for DSM-IV ) and the extent of depression [ Beck Depression Inventory ( BDI ) and Montgomery Asberg Depression Scale ( MADRS ) ] and anxiety [ State-Trait Anxiety Inventory ( STAI ) and Hamilton Anxiety Scale ( HAMA ) ] . The control group comprised a group of 30 mothers after the uncomplicated spontaneous birth of a healthy child . RESULTS At all four measuring timepoints ( except 6 months pp ) , the mothers of the premature infants recorded significantly higher values for traumatic experience and depressive symptoms and anxiety compared with the controls . In contrast to the mothers in the control group , the mothers of the premature infants displayed no significant reduction in posttraumatic symptoms ( IES-total ) , even 14 months after birth . CONCLUSION The results indicate that the situation of a mother who has given birth to a VLBW infant is a complex , with long-term traumatic event necessitating ongoing emotional support extending beyond the period immediately after the birth A growing body of research has examined the potential for positive change following challenging and traumatic events , this is known as posttraumatic growth ( PTG ) . Childbirth is a valuable opportunity to extend previous work on PTG as it allows the role of different variables to be considered prospect ively . The aim of this study was to prospect ively examine correlates of PTG after birth , including sociodemographic and obstetric variables , social support and psychological distress , using a prospect i ve , longitudinal design . A total of 125 women completed question naires during their third trimester of pregnancy and 8 weeks after birth . At least a small degree of positive change following childbirth was reported by 47.9 % of women ; however , average levels of growth were lower than generally reported in other studies . A regression model of age , type of delivery , posttraumatic stress symptoms during pregnancy and general distress after birth significantly predicted 32 % of the variance in growth after childbirth . The strongest predictors of growth were operative delivery ( β 0.23–0.30 ) and posttraumatic stress symptoms in pregnancy ( β 0.32 ) . These findings emphasise the importance of assessing pre-event characteristics when considering the development of PTG after a challenging event |
11,589 | 32,321,088 | The quality of care given by telepsychiatry both through video conferencing as well as web- and application-based is comparable to that of face-to-face therapy .
Patient satisfaction , quality of doctor-patient relationship also remains high , with lower costs and shorter therapeutic time when compared to face-to-face therapy .
CONCLUSION Various studies have shown that telepsychiatry is an effective solution for the management of PTSD .
Studies have also reported that the quality of treatment through telepsychiatry is as effective as face-to-face therapy , with greater efficiency . | INTRODUCTION Post-traumatic stress disorder ( PTSD ) is one of the most common psychiatric disorders found among victims of disaster , kidnapping , accidents , sexual assaults and war in Indonesia .
However , lacking and unequal distribution of psychiatric medical personnel remains a barrier to its management .
This review aims to introduce and evaluate the potential contribution of telepsychiatry to the management of PTSD based on published literature .
Telepsychiatry is an innovative use of technology to aid the delivery of PTSD treatments in areas difficult to reach . | Background Guided self-help interventions for PTSD ( post-traumatic stress disorder ) are a promising tool for the dissemination of contemporary psychological treatment . Objective This study investigated the efficacy of the Chinese version of the My Trauma Recovery ( CMTR ) website . Methods In an urban context , 90 survivors of different trauma types were recruited via Internet advertisements and allocated to a r and omized controlled trial ( RCT ) with a waiting list control condition . In addition , in a rural context , 93 survivors mainly of the 2008 Sichuan earthquake were recruited in-person for a parallel RCT in which the website intervention was conducted in a counseling center and guided by volunteers . Assessment was completed online on a professional Chinese survey website . The primary outcome measure was the Post-traumatic Diagnostic Scale ( PDS ) ; secondary outcome measures were Symptom Checklist 90-Depression ( SCL-D ) , Trauma Coping Self-Efficacy Scale ( CSE ) , Post-traumatic Cognitive Changes ( PCC ) , and Social Functioning Impairment ( SFI ) question naires adopted from the My Trauma Recovery website . Results For the urban sample , findings indicated a significant group × time interaction in post-traumatic symptom severity ( F 1,88=7.65 , P=.007 ) . CMTR reduced post-traumatic symptoms significantly with high effect size after one month of treatment ( F 1,45=15.13 , Cohen ’s d=0.81 , P<.001 ) and the reduction was sustained over a 3-month follow-up ( F 1,45=17.29 , Cohen ’s d=0.87 , P<.001 ) . In the rural sample , the group × time interaction was also significant in post-traumatic symptom severity ( F 1,91=5.35 , P=.02 ) . Post-traumatic symptoms decreased significantly after treatment ( F 1,48=43.97 , Cohen ’s d=1.34 , P<.001 ) and during the follow-up period ( F 1,48=24.22 , Cohen ’s d=0.99 , P<.001 ) . Additional outcome measures ( post-traumatic cognitive changes , depression ) indicated a range of positive effects , in particular in the urban sample ( group × time interactions : F 1,88=5.32 - 8.37 , all Ps<.03 ) , contributing to the positive evidence for self-help interventions . Differences in the effects in the two RCTs are exploratorily explained by sociodemographic , motivational , and setting feature differences between the two sample s. Conclusions These findings give support for the short-term efficacy of CMTR in the two Chinese population s and contribute to the literature that self-help Web-based programs can be used to provide mental health help for traumatized persons . Trial Registration Australia New Zeal and Clinical Trials Registry ( ANZCTR ) : ACTRN12611000951954 ; https://www.anzctr.org.au/Trial/ Registration /Trial Review .aspx?ACTRN=12611000951954 ( Archived by WebCite at http://www.webcitation.org/6G7WyNODk ) Online therapy offers many advantages over face-to-face therapy . Interapy includes psychoeducation , screening , effect measures , and a protocol -driven treatment via the Internet for people suffering from posttraumatic stress . The present article reports the results of a controlled trial on the Internet-driven treatment of posttraumatic stress and grief in a group of people who manifested mild to relatively severe trauma symptoms . Participants in the treatment condition ( n=69 ) improved significantly more than participants in the waiting-list control condition ( n=32 ) on trauma-related symptoms and general psychopathology . The effect sizes were large . On most subscales , more than 50 % of the treated participants showed reliable change and clinical ly significant improvement , with the highest percentages being found for depression and avoidance BACKGROUND Posttraumatic stress disorder ( PTSD ) is a severe and disabling condition and few receive appropriate care . Internet-based treatment of PTSD shows promise in reducing barriers to care and preliminary evidence suggests it is efficacious in treating symptoms of PTSD . METHODOLOGY Forty-two individuals with a diagnosis of PTSD confirmed by clinician interview completed a r and omized controlled comparison of Internet-based cognitive behavioral therapy ( CBT ) with a waitlist control condition . PRINCIPLE FINDINGS Large pre- to posttreatment effect sizes ( ESs ) were found for the Treatment group on measures of PTSD symptoms , depression , anxiety , and disability . A small between-group ES was found for PTSD symptoms and moderate between-group ESs were found for depression , anxiety , and disability . CONCLUSIONS Results provide preliminary support for Internet-based CBT as an efficacious treatment for individuals with a confirmed primary diagnosis of PTSD This study was an open trial evaluation of a 10-week therapist-assisted cognitive behavior therapy ( CBT ) internet intervention ( PTSD Online ) undertaken with people with a primary clinical diagnosis of posttraumatic stress disorder ( PTSD ) ( n=22 ) at pre- assessment . Participants were re-assessed at post- assessment and 3-month follow-up . Significant improvements on PTSD severity ratings and related PTSD symptomatology were observed at post- assessment and maintained at 3-month follow-up . At post- assessment , 69.2 % of the sample showed clinical ly significant improvement and 77 % of the sample at follow-up assessment . Non-significant , yet improved , change was observed on all other general psychological measures . Overall , treatment satisfaction was good ( 69 % ) , participant therapeutic alliance ratings were high ( 87.5 % ) , and the average total therapist time required was 194.5 min . PTSD Online appears to be an efficacious treatment option for people with PTSD that can be provided entirely remotely , with far less therapist time than traditional face-to-face treatment , and without compromising therapeutic alliance Background In recent years , armed conflicts in the Middle East have result ed in high rates of exposure to traumatic events . Despite the increasing dem and of mental health care provision , ongoing violence limits conventional approaches of mental health care provision . Internet-based interventions for posttraumatic stress disorder ( PTSD ) have proved feasible and effective in Western countries , but their applicability and efficacy in war and conflict regions remains unknown . Objective This study investigated the efficacy of a cognitive behavioral Internet-based intervention for war-traumatized Arab patients , with focus on Iraq . Methods A total of 159 individuals with PTSD participated in a parallel group r and omized trial . Participants were r and omly allocated by a computer-generated sequence to a treatment group ( n=79 ) or a waiting list control group ( n=80 ) . The treatment group received 2 weekly 45-minute cognitive behavioral interventions via Internet over a 5-week period ( 10 sessions in total ) . The primary outcome was recovery from posttraumatic stress symptoms . Results Posttraumatic stress symptoms were significantly reduced from baseline to posttreatment ( intention-to-treat analysis ) in the treatment group relative to the control group ( F1,157=44.29 , P<.001 , d=0.92 ) . Treatment effects were sustained at 3-month follow-up . Completer analysis indicated that 29 of 47 patients ( 62 % ) in the treatment group had recovered from posttraumatic stress symptoms at posttreatment ( reliable change and Posttraumatic Stress Diagnostic Scale score < 20 ) versus 1 patient ( 2 % ) in the control group ( OR 74.19 , 95 % CI 9.93 - 585.8 , P<.001 ) indicating that the chance of recovering was 74.19 times higher in the treatment than in the control group . Conclusions The results indicate , even in unstable and insecure setting s with ongoing exposure to human rights violations through war and dictatorships , people with posttraumatic stress symptoms benefit from a cognitive behavioral treatment provided entirely through the Internet . This method of delivery could improve patients ’ access to humanitarian aid in the form of e-mental health services . Trial Registration Australian New Zeal and Clinical Trial Registry , ACTRN12611001019998 ; https://www.anzctr.org.au/Trial/ Registration /Trial Review .aspx?id=347505 ( Archived by WebCite at http://www.webcitation.org/6Wto4HCdH ) OBJECTIVE The use of interactive videoconferencing to provide psychiatric services to geographically remote regions , often referred to as telepsychiatry , has gained wide acceptance . However , it is not known whether clinical outcomes of telepsychiatry are as good as those achieved through face-to-face contact . This study compared a variety of clinical outcomes after psychiatric consultation and , where needed , brief follow-up for out patients referred to a psychiatric clinic in Canada who were r and omly assigned to be examined face to face or by telepsychiatry . METHODS A total of 495 patients in Ontario , Canada , referred by their family physician for psychiatric consultation were r and omly assigned to be examined face to face ( N=254 ) or by telepsychiatry ( N=241 ) . The treating psychiatrists had the option of providing monthly follow-up appointments for up to four months . The study tested the equivalence of the two forms of service delivery on a variety of outcome measures . RESULTS Psychiatric consultation and follow-up delivered by telepsychiatry produced clinical outcomes that were equivalent to those achieved when the service was provided face to face . Patients in the two groups expressed similar levels of satisfaction with service . An analysis limited to the cost of providing the clinical service indicated that telepsychiatry was at least 10 % less expensive per patient than service provided face to face . CONCLUSIONS Psychiatric consultation and short-term follow-up can be as effective when delivered by telepsychiatry as when provided face to face . These findings do not necessarily mean that other types of mental health services , for example , various types of psychotherapy , are as effective when provided by telepsychiatry OBJECTIVE This r and omized controlled trial examined the effectiveness of a nurse assisted online cognitive-behavioral self-management intervention for war-related posttraumatic stress disorder ( PTSD ) , compared to optimized usual primary care PTSD Treatment ( OUC ) to reduce PTSD symptoms . METHOD Participants were 80 veterans of recent military conflicts with PTSD as assessed by the PTSD Checklist ( PCL ) seeking primary care treatment at one of three Veterans Affairs ( VA ) and four Army clinics . DESTRESS-PC consisted of logins to a secure website three times per week for 6 weeks with monitoring by a study nurse . All participants received nurse care management in the form of phone check-ins every two weeks and feedback to their primary care providers . Blinded raters assessed outcomes 6 , 12 , and 18 weeks post-r and omization . RESULTS DESTRESS-PC was associated with a significantly greater decrease in PTSD symptoms compared to OUC ( F(3 , 186)=3.72 , p=.012 ) . The effect was largest at the 12-week assessment ( ∆PCL=12.6±16.6 versus 5.7±12.5 , p<0.05 ) with the treatment effect disappearing by the 18-week follow-up . Notably , there was a dose effect ; number of logins correlated significantly with PTSD outcomes , with more logins associated with greater PTSD symptom improvement . None of the secondary outcomes ( depression , anxiety , somatic symptoms , and functional status ) showed statistically significant improvement ; however , the treatment effect on depression approached significance ( F(3 , 186)=2.17 , p=.093 ) . CONCLUSIONS DESTRESS-PC shows promise as a means of delivering effective , early PTSD treatment in primary care . Larger trials are needed Background : The loss of a child during pregnancy causes significant psychological distress for many women and their partners , and may lead to long-lasting psychiatric disorders . Internet-based interventions using exposure techniques and cognitive restructuring have proved effective for posttraumatic stress disorder ( PTSD ) and prolonged grief . This study compared the effects of an Internet-based intervention for parents after prenatal loss with a waiting list condition ( WLC ) . Methods : The Impact of Event Scale - Revised assessed symptoms of PTSD ; the Inventory of Complicated Grief and the Brief Symptom Inventory assessed depression , anxiety , and general mental health . The 228 participants ( 92 % female ) were r and omly allocated to a treatment group ( TG ; n = 115 ) or a WLC group ( n = 113 ) . The TG received a 5-week cognitive behavioral intervention including ( 1 ) self-confrontation , ( 2 ) cognitive restructuring , and ( 3 ) social sharing . Results : The TG showed significantly reduced symptoms of posttraumatic stress , prolonged grief , depression , and anxiety relative to the WLC control group . Intention-to-treat analysis revealed treatment effects of between d = 0.84 and d = 1.02 for posttraumatic stress and prolonged grief from pre- to posttreatment time points . Further significant improvement in all symptoms of PTSD and prolonged grief was found from the posttreatment evaluation to the 12-month follow-up . The attrition rate of 14 % was relatively low . Conclusions : The Internet-based intervention proved to be a feasible and cost-effective treatment , reducing symptoms of posttraumatic stress , grief , depression , anxiety , and general mental health after pregnancy loss . Low-threshold e-health interventions should be further evaluated and implemented routinely to improve psychological support after pregnancy loss |
11,590 | 32,325,024 | Reduced SE was attributed to high wake after sleep onset rather than sleep onset latency .
Athletes ' sleep duration was found to be short with low SE , in comparison to the general consensus for non-athlete healthy adults .
Notable sleep issues were revealed in young athletes .
Sleep quality and architecture tend to change across different training periods | PURPOSE This systematic review aims to describe objective sleep parameters for athletes under different conditions and address potential sleep issues in this specific population . | A popular method to attempt to enhance performance is for athletes to sleep at natural or simulated moderate altitude ( SMA ) when training daily near sea level . Based on our previous observation of periodic breathing in athletes sleeping at SMA , we hypothesised that athletes ' sleep quality would also suffer with hypoxia . Using two typical protocol s of nocturnal SMA ( 2650 m ) , we examined the effect on the sleep physiology of 14 male endurance-trained athletes . The selected protocol s were Consecutive ( 15 successive exposure nights ) and Intermittent ( 3x 5 successive exposure nights , interspersed with 2 normoxic nights ) and athletes were r and omly assigned to follow either one . We monitored sleep for two successive nights under baseline conditions ( B ; normoxia , 600 m ) and then at weekly intervals ( nights 1 , 8 and 15 ( N1 , N8 and N15 , respectively ) ) of the protocol s. Since there was no significant difference in response between the protocol s being followed ( based on n=7 , for each group ) we are unable to support a preference for either one , although the likelihood of a Type II error must be acknowledged . For all athletes ( n=14 ) , respiratory disturbance and arousal responses between B and N1 , although large in magnitude , were highly individual and not statistically significant . However , SpO2 decreased at N1 versus B ( p<0.001 ) and remained lower on N8 ( p<0.001 ) and N15 ( p<0.001 ) , not returning to baseline level . Compared to B , arousals were more frequent on N8 ( p=0.02 ) and N15 ( p=0.01 ) . The percent of rapid eye movement sleep ( REM ) increased from N1 to N8 ( p=0.03 ) and N15 ( p=0.01 ) . Overall , sleeping at 2650 m causes sleep disturbance in susceptible athletes , yet there was some improvement in REM sleep over the study duration OBJECTIVES To assess sleep patterns and associations between sleep and match performance in elite Australian female basketball players . DESIGN Prospect i ve cohort study . METHODS Seventeen elite female basketball players were monitored across two consecutive in-season competitions ( 30 weeks ) . Total sleep time and sleep efficiency were determined using triaxial accelerometers for Baseline , Pre-match , Match-day and Post-match timings . Match performance was determined using the basketball efficiency statistic ( EFF ) . The effects of match schedule ( Regular versus Double-Header ; Home versus Away ) and sleep on EFF were assessed . RESULTS The Double-Header condition changed the pattern of sleep when compared with the Regular condition ( F(3,48)=3.763 , P=0.017 ) , where total sleep time Post-match was 11 % less for Double-Header ( mean±SD ; 7.2±1.4h ) compared with Regular ( 8.0±1.3h ; P=0.007 ) . Total sleep time for Double-Header was greater Pre-match ( 8.2±1.7h ) compared with Baseline ( 7.1±1.6h ; P=0.022 ) and Match-day ( 7.3±1.5h ; P=0.007 ) . Small correlations existed between sleep metrics at Pre-match and EFF for pooled data ( r=-0.39 to -0.22 ; P≥0.238 ) . Relationships between total sleep time and EFF ranged from moderate negative to large positive correlations for individual players ( r=-0.37 to 0.62 ) and reached significance for one player ( r=0.60 ; P=0.025 ) . CONCLUSIONS Match schedule can affect the sleep patterns of elite female basketball players . A large degree of inter-individual variability existed in the relationship between sleep and match performance ; nevertheless , sleep monitoring might assist in the optimisation of performance for some athletes To determine whether exercise duration effects the recovery sleep following exercise , eight fit male endurance athletes , ages 23 - 42 yr , had their sleep electrophysiologically studied . This was done on four separate occasions : after a day on which no specific exercise was performed ; after a day of a 15-km run ; after a 42.2-km run day ; after a day in which the athletes participated in a strenuous ultra-triathlon . Sleep patterns following the no exercise day and the 15-km and the 42.2-km run days were similar . The sleep pattern of the ultra-triathlon day when compared with the other three days showed significantly increased wakefulness and delayed and decreased rapid eye movement ( REM ) sleep . The duration of slow wave sleep ( SWS ) in the first 6 h after lights out , however , was no different . The increased wakefulness and decreased REM clearly indicate increased stress after the ultra-triathlon . REM sleep appears to be a more sensitive index of exercise induced stress than SWS PURPOSE This study aim ed to examine whether ( i ) objective markers of sleep quantity and quality are altered in endurance athletes experiencing overreaching in response to an overload training program and ( ii ) potential reduced sleep quality would be accompanied with a higher prevalence of upper respiratory tract infections in this population . METHODS Twenty-seven trained male triathletes were r and omly assigned to either overload ( n = 18 ) or normal ( CTL , n = 9 ) training groups . Respective training programs included a 1-wk moderate training phase followed by a 3-wk period of overload or normal training , respectively , and then a subsequent 2-wk taper . Maximal aerobic power and oxygen uptake ( VO2max ) from incremental cycle ergometry were measured after each phase , whereas mood states and incidences of illness were determined from question naires . Sleep was monitored every night of the 6 wk using wristwatch actigraphy . RESULTS Of the 18 overload training group subjects , 9 were diagnosed as functionally overreached ( F-OR ) after the overload period , as based on declines in performance and VO2max with concomitant high perceived fatigue ( P < 0.05 ) , whereas the other 9 overload subjects showed no decline in performance ( AF , P > 0.05 ) . There was a significant time-group interaction for sleep duration ( SD ) , sleep efficiency ( SE ) , and immobile time ( IT ) . Only the F-OR group demonstrated a decrease in these three parameters ( -7.9 % ± 6.7 % , -1.6 % ± 0.7 % , and -7.6 % ± 6.6 % for SD , SE , and IT , respectively , P < 0.05 ) , which was reversed during the subsequent taper phase . Higher prevalence of upper respiratory tract infections were also reported in F-OR ( 67 % , 22 % , and 11 % incidence rate for F-OR , AF , and CTL , respectively ) . CONCLUSION This study confirms sleep disturbances and increased illness in endurance athletes who present with symptoms of F-OR during periods of high volume training Background Tart Montmorency cherries have been reported to contain high levels of phytochemicals including melatonin , a molecule critical in regulating the sleep-wake cycle in humans . Purpose The aim of our investigation was to ascertain whether ingestion of a tart cherry juice concentrate would increase the urinary melatonin levels in healthy adults and improve sleep quality . Methods In a r and omised , double-blind , placebo-controlled , crossover design , 20 volunteers consumed either a placebo or tart cherry juice concentrate for 7 days . Measures of sleep quality recorded by actigraphy and subjective sleep question naires were completed . Sequential urine sample s over 48 h were collected and urinary 6-sulfatoxymelatonin ( major metabolite of melatonin ) determined ; cosinor analysis was used to determine melatonin circadian rhythm ( mesor , acrophase and amplitude ) . In addition , total urinary melatonin content was determined over the sample d period . Trial differences were determined using a repeated measures ANOVA . Results Total melatonin content was significantly elevated ( P < 0.05 ) in the cherry juice group , whilst no differences were shown between baseline and placebo trials . There were significant increases in time in bed , total sleep time and sleep efficiency total ( P < 0.05 ) with cherry juice supplementation . Although there was no difference in timing of the melatonin circardian rhythm , there was a trend to a higher mesor and amplitude . Conclusions These data suggest that consumption of a tart cherry juice concentrate provides an increase in exogenous melatonin that is beneficial in improving sleep duration and quality in healthy men and women and might be of benefit in managing disturbed sleep Purpose In athletes , caffeine use is common although its effects on sleep have not been widely studied . This r and omised , double-blind , placebo-controlled crossover trial investigated the effects of late-afternoon caffeine and carbohydrate-electrolyte ( CEB ) co-ingestion on cycling performance and nocturnal sleep . Methods Six male cyclists/triathletes ( age 27.5 ± 6.9 years ) completed an afternoon training session ( TS ; cycling 80 min ; 65 % VO2max ) followed by a 5 kJ kg−1 cycling time trial ( TT ) . Caffeine ( split dose 2 × 3 mg kg−1 ) or placebo was administered 1 h prior and 40 min into the TS . A 7.4 % CEB ( 3 ml kg−1 every 15 min ) was administered during the TS , followed 30 min after by a st and ardised evening meal . Participants retired at their usual bedtime and indices of sleep duration and quality were monitored via polysomnography . Data : mean ± SD . Results All participants performed better in the caffeine TT ( caffeine 19.7 ± 3.3 ; placebo 20.5 ± 3.5 min ; p = 0.006 ) , while ratings of perceived exertion ( caffeine 12.0 ± 0.6 ; placebo 12.9 ± 0.7 ; p = 0.004 ) and heart rate ( caffeine 175 ± 6 ; placebo 167 ± 11 bpm ; p = 0.085 ) were lower in the caffeine TS . Caffeine intake induced significant disruptions to a number of sleep indices including increased sleep onset latency ( caffeine 51.1 ± 34.7 ; placebo 10.2 ± 4.2 min ; p = 0.028 ) and decreased sleep efficiency ( caffeine 76.1 ± 19.6 ; placebo 91.5 ± 4.2 % ; p = 0.028 ) , rapid eye movement sleep ( caffeine 62.1 ± 19.6 ; placebo 85.8 ± 24.7 min ; p = 0.028 ) and total sleep time ( caffeine 391 ± 97 ; placebo 464 ± 49 min ; p = 0.028 ) . Conclusions This study supports a performance-enhancing effect of caffeine , although athletes ( especially those using caffeine for late-afternoon/evening training and competition ) should consider its deleterious effects on sleep OBJECTIVES To evaluate sleep in professional football players and describe clinical features of players at risk for sleep for sleep-disordered breathing ( SDB ) . METHODS The Multivariable Apnea Prediction ( MAP ) index was used to stratify players into high ( MAP > or = 0.5 ) and low ( MAP<0.5 ) risk for SDB . Players from both risk groups were r and omly selected for overnight polysomnography , with over-sampling from the High-risk group . Of 302 players from eight professional football teams ; 52 underwent attended polysomnography . Anthropometrics including neck circumference , airway size ( Mallampati score , maxillary overjet ) and sleepiness measured by Epworth scores ( ESS ) were recorded . The primary outcome measures were ESS and an apnea-hypopnea index ( AHI ) > or = 10 . RESULTS Ninety-two percent of players were < 30 years old ( mean ( SD ) age : 25.5+/-2.7 years ) with large necks ( 45.2+/-3.6 cm ) and elevated BMI ( 31.5+/-4.6 ) . More than 20 % of players had an ESS>10 with ESS highest in habitual snorers . An AHI of > or = 10 was found in 13 ( 34 % , 95 % confidence interval ( CI ) 21 - 50 % ) high-risk players but only one ( 7 % , 95 % CI 1 - 31 % ) of 14 low-risk players . Offensive ( 9 ) or defensive ( 3 ) linemen accounted for the majority of the positive cases . Based on our sample , we estimate the prevalence of SDB to be 14 % ( 2 - 25 % ) . CONCLUSIONS Excessive daytime sleepiness ( EDS ) is present in a large fraction of professional football players . Some but not all of this may be due to an increased prevalence of SDB . Further study is required to underst and all of the factors responsible for EDS and to determine which of the biggest players will have SDB , which may impact not only performance and productivity but also future health INTRODUCTION Elite athletes frequently undergo periods of intensified training ( IT ) within their normal training program . These periods can lead athletes into functional overreaching , characterized by high perceived fatigue , impaired sleep , and performance . Because whole-body cryostimulation ( WBC ) has been proven to be an effective recovery method in the short term ( < 76 h ) , we investigated whether daily WBC sessions during IT could prevent exercise and sleep-related signs of overreaching . METHODS After a normal training week ( BASE ) , 10 elite synchronized swimmers performed two 2-wk IT periods in a r and omized crossover fashion using WBC daily ( ITWBC ) or not ( ITCON ) , separated by 9 d of light training . Swim time trials ( 400 m ) were performed at BASE and after each IT to quantify blood lactate ( [La]B ) , HR ( HR400 ) , salivary alpha amylase ( [α-amylase]s400 ) , and cortisol ( [cortisol]s400 ) responses . Swimmers wore a wrist actigraph nightly to monitor sleep patterns . RESULTS Swim speed ( 400 m ) , [La]B400 , and [α-amylase]s400 decreased from BASE to ITCON , although no significant changes were found after ITWBC . Decreased swim speed was correlated to decreased HR400 and [cortisol]s400 . During ITCON , significant decreases in actual sleep duration ( -21 ± 7 min ) and sleep efficiency ( -1.9 % ± 0.8 % ) were observed , with increased sleep latency ( + 11 ± 5 min ) and fatigue compared with BASE , although these variables did not change during ITWBC . Using a qualitative statistical analysis , we observed that daily WBC use result ed in a 98 % , 59 % , 66 % , and 78 % chance of preserving these respective variables compared with ITCON . CONCLUSION WBC use during IT helped mitigate the signs of functional overreaching observed during ITCON , such as reduced sleep quantity , increased fatigue , and impaired exercise capacity . These results support the daily use of WBC by athletes seeking to avoid functional overreaching during key periods of competition preparation Abstract Objectives : To improve well-being and performance indicators in a group of Australian Football League ( AFL ) players via a six-week sleep optimisation programme . Design : Prospect i ve intervention study following observations suggestive of reduced sleep and excessive daytime sleepiness in an AFL group . Methods : Athletes from the Adelaide Football Club were invited to participate if they had played AFL senior-level football for 1–5 years , or if they had excessive daytime sleepiness ( Epworth Sleepiness Scale [ ESS ] > 10 ) , measured via ESS . An initial education session explained normal sleep needs , and how to achieve increased sleep duration and quality . Participants ( n = 25 ) received ongoing feedback on their sleep , and a mid-programme education and feedback session . Sleep duration , quality and related outcomes were measured during week one and at the conclusion of the six-week intervention period using sleep diaries , actigraphy , ESS , Pittsburgh Sleep Quality Index , Profile of Mood States , Training Distress Scale , Perceived Stress Scale and the Psychomotor Vigilance Task . Results : Sleep diaries demonstrated an increase in total sleep time of approximately 20 min ( 498.8 ± 53.8 to 518.7 ± 34.3 ; p < .05 ) and a 2 % increase in sleep efficiency ( p < 0.05 ) . There was a corresponding increase in vigour ( p < 0.001 ) and decrease in fatigue ( p < 0.05 ) . Conclusions : Improvements in measures of sleep efficiency , fatigue and vigour indicate that a sleep optimisation programme may improve athletes ’ well-being . More research is required into the effects of sleep optimisation on athletic performance PURPOSE Sleeping in a hypoxic environment is becoming increasingly popular among athletes attempting to simulate a " live high , train low " training regime . The purpose of this study was to investigate the acute effects ( one night ) of sleeping in a normobaric hypoxic tent ( NH ) ( PO(2 ) = 110 mm Hg approximately 2500 m ) upon markers of sleep physiology and quality , compared with sleep in a normal ambient environment ( BL ) ( PO(2 ) = 159 mm Hg approximately sea level ) and sleep in a normobaric normoxic tent ( NN ) ( PO(2 ) = 159 mm Hg ) . METHODS Eight male recreational athletes ( age 34.5 + /- 6.9 yr ; stature 169.1 + /- 8.7 cm ; mass 69.3 + /- 8.2 kg ; VO(2max ) 56.4 + /- 8.3 mL.kg(-1).min(-1 ) ) participated in the study using a r and omized , double-blind crossover design . Polysomnographic studies were undertaken to measure sleep stages , arterial oxygen saturation ( SpO(2 ) ) , heart rate ( HR ) , and the Respiratory Disturbance Index ( RDI ) . The Leeds Sleep Evaluation Question naire ( LSEQ ) was used to measure subjective sleep quality . RESULTS NH ( 89.9 + /- 4.8 % ) result ed in a significantly lower ( P < 0.05 ) SpO(2 ) compared with both BL ( 95.7 + /- 1.5 % ) and NN ( 93.5 + /- 4.0 % ) . Heart rate was significantly higher ( P < 0.05 ) in NH ( 51.5 + /- 7.6 beats.min(-1 ) ) compared with NN ( 48.3 + /- 6.9 beats.min(-1 ) ) but was similar versus BL ( 50.3 + /- 4.3 beats.min(-1 ) ) . RDI ( counts.h ) and RDI ( total counts ) were lowest in BL ( 3.5 + /- 2.5 ; 18.1 + /- 7.9 ) and highest in NH ( 36.8 + /- 42.7 ; 221.9 + /- 254.5 ) . The difference in RDI ( counts.h(-1 ) and total counts ) between NH and BL was significant ( P < 0.05 ) . The LSEQ revealed that subjects ' " behavior following waking " score was significantly ( P < 0.05 ) lower in NH ( 40.9 + /- 9.2 ) compared with BL ( 52.3 + /- 8.3 ) . CONCLUSION This study presents evidence that sleep in a normobaric hypoxic tent at a simulated altitude of 2500 m may affect sleep parameters in some individuals . This type of analysis may be useful in the early identification of poorly responding individuals to simulated altitude environments ABSTRACT Elite soccer players are at risk of reduced recovery following periods of sleep disruption , particularly following late-night matches . It remains unknown whether improving sleep quality or quantity in such scenarios can improve post-match recovery . Therefore , the aim of this study was to investigate the effect of an acute sleep hygiene strategy ( SHS ) on physical and perceptual recovery of players following a late-night soccer match . In a r and omised cross-over design , two highly-trained amateur teams ( 20 players ) played two late-night ( 20:45 ) friendly matches against each other seven days apart . Players completed an SHS after the match or proceeded with their normal post-game routine ( NSHS ) . Over the ensuing 48 h , objective sleep parameters ( sleep duration , onset latency , efficiency , wake episodes ) , countermovement jump ( CMJ ; height , force production ) , YoYo Intermittent Recovery test ( YYIR2 ; distance , maximum heart rate , lactate ) , venous blood ( creatine kinase , urea and c-reactive protein ) and perceived recovery and stress markers were collected . Sleep duration was significantly greater in SHS compared to NSHS on match night ( P = 0.002 , d = 1.50 ) , with NSHS significantly less than baseline ( P < 0.001 , d = 1.95 ) . Significant greater wake episodes occurred on match night for SHS ( P = 0.04 , d = 1.01 ) , without significant differences between- or within-conditions for sleep onset latency ( P = 0.12 ) , efficiency ( P = 0.39 ) or wake episode duration ( P = 0.07 ) . No significant differences were observed between conditions for any physical performance or venous blood marker ( all P > 0.05 ) ; although maximum heart rate during the YYIR2 was significantly higher in NSHS than SHS at 36 h post-match ( P = 0.01 ; d = 0.81 ) . There were no significant differences between conditions for perceptual “ overall recovery ” ( P = 0.47 ) or “ overall stress ” ( P = 0.17 ) . Overall , an acute SHS improved sleep quantity following a late-night soccer match ; albeit without any improvement in physical performance , perceptual recovery or blood-borne markers of muscle damage and inflammation The purpose of the current study was to examine the effect of interstate air travel on the quality and quantity of sleep in elite Australian Rules football players . Ten elite male athletes , who were members of a Western Australian-based Australian Football League ( AFL ) team , participated in the study . Sleep pattern was assessed by measuring sleep duration ( SLD ) , sleep efficiency ( SE ) , number of wakings ( NW ) and total wake time after sleep onset ( WT ) using a wrist-worn actigraph . Subjective sleep quality ( SQ ) was assessed using a scale of sleep rating . Throughout the 2002 AFL season , measurements were obtained on the night before ( N1 ) , the night of ( N2 ) and the night after ( N3 ) home and away games . Baseline measurements were obtained from five consecutive non-game nights . Compared to baseline , SLD on N1 was increased when home and away ( by 51 and 105 mins respectively , p<0.05 ) , while all other measures of sleep pattern were unchanged . On N2 , SLD was decreased to a similar degree whether home or away ( by 68 and 64 mins respectively , p<0.05 ) , while all other measures of sleep pattern were unchanged . By N3 all measures of sleep pattern had returned to baseline values . Relative to baseline , perception of SQ was worst on N2 of a home game . This study has shown that interstate travel by elite AFL players has no adverse effects on sleep pattern on the night before a game Exercise in the heat is a common occurrence among athletes and often is intentional in order to gain heat acclimation benefits , however , little is known about how such training may affect sleep . Therefore , this study investigated five days of training in the heat of varying intensity and duration and inclusion of cold-water immersion ( CWI ) recovery on sleep quantity and quality . Thirty recreationally-trained male participants completed five days of heat training ( HT ) and were r and omised into three interventions including ( i ) 90 min cycling at 40 % power at maximal aerobic capacity ( Pmax ) with 15 min passive recovery ( 90HT ) ; ( ii ) 90 min cycling at 40 % Pmax with 15 min CWI recovery ( 90CWI ) ; or ( iii ) 30 min cycling alternating between 40 % and 70 % Pmax , with 15 min passive recovery ( 30HT ) . Sleep quality and quantity were assessed using Actigraphy and sleep diaries during five baseline nights ( BASE ) and five nights of HT which included subjective sleep quality and objective assessment s of sleep quantity and quality . Total time asleep and perceived sleep quality were reduced , while awake duration and wake after sleep onset ( WASO ) were increased ( p = 0.001 - 0.01 ) during HT compared to BASE . Latency was shorter for 30HT compared to 90HT during HT ( p = 0.02 ) , however , no differences between interventions for all other sleep variables ( p > 0.05 ) . The reduction in total sleep time due to increases in average wake duration during HT may be due to the unaccustomed increased in training frequency . Of note , reducing training in the heat duration per day improved sleep latency and sleep quality with no effect on total sleep time , while the addition of CWI has minimal effect on sleep quality or quantity Abstract The effectiveness of a nap as a recovery strategy for endurance exercise is unknown and therefore the present study investigated the effect of napping on endurance exercise performance . Eleven trained male runners completed this r and omised crossover study . On two occasions , runners completed treadmill running for 30 min at 75 % ⩒O2max in the morning , returning that evening to run for 20 min at 60 % ⩒O2max , and then to exhaustion at 90 % ⩒O2max . On one trial , runners had an afternoon nap approximately 90 min before the evening exercise ( NAP ) whilst on the other , runners did not ( CON ) . All runners napped ( 20 ± 10 min ) , but time to exhaustion ( TTE ) was not improved in all runners ( NAP 596 ± 148 s vs. CON 589 ± 216 s , P = .83 ) . Runners that improved TTE after the nap slept less at night than those that did not improve TTE ( night-time sleep 6.4 ± 0.7 h vs. 7.5 ± 0.4 h , P < .01 ) . Furthermore , night-time sleep predicted change in TTE , indicating that runners sleeping least at night improved TTE the most after the nap compared to CON ( r2 = −0.76 , P = .001 ) . In runners that improved TTE , ratings of perceived exertion ( RPE ) were lower during the TTE on NAP than CON compared to runners that did not improve ( −0.4 ± 0.6 vs. 0 ± 0 , P = .05 ) . Reduced exercising sense of effort ( RPE ) may account for the improved TTE after the nap . In conclusion , a short afternoon nap improves endurance performance in runners that obtain less than 7 h night-time sleep PURPOSE The purpose of the research was to investigate the sport-specific performance effect of a brief afternoon nap on high-level Asian adolescent student-athletes that were habitually short sleepers . METHODS In the studies , participants were r and omly assigned to a nap or non-nap ( reading ) condition . In the first study , 12 male shooters ( 13.8 ± 1.0 yrs ) performed a shooting assessment ( 20 competition shots ) with heart rate variability monitored during the assessment . In the second study , 19 male track & field athletes ( 14.8 ± 1.1 yrs ) performed a 20 m sprint performance assessment . Subjective measures of sleepiness and alertness were obtained in both studies . RESULTS The brief nap had no effect on any measure of shooting performance ( p > 0.05 ) and autonomic function ( p > 0.05 ) in shooters . However , fastest 20 m sprint times increased significantly ( p < 0.05 ) from 3.385 ± 0.128 sec to 3.411 ± 0.143 sec , with mean 2 m times trending towards significance ( p < 0.1 ) amongst the track & field athletes . No significant differences were observed in any other measures . CONCLUSIONS The results of the research indicate varying effects of naps between sport-specific performance measures . Napping had no effect on shooting performance while a negative effect existed in 20-m sprint performance , potentially due to sleep inertia . Considering these findings , some caution is warranted when advocating naps for adolescent athletes ABSTRACT This study examined the efficacy of daytime napping to supplement night-time sleep in athletes . Twelve well-trained male soccer players completed three conditions in a r and omised , counterbalanced order : 9 h in bed overnight with no daytime nap ( 9 h + 0 h ) ; 8 h in bed overnight with a 1-h daytime nap ( 8 h + 1 h ) ; and 7 h in bed overnight with a 2-h daytime nap ( 7 h + 2 h ) . Sleep was assessed using polysomnography . The total amount of sleep obtained in the three conditions was similar , i.e. 8.1 h ( 9 h + 0 h ) , 8.2 h ( 8 h + 1 h ) , and 8.0 h ( 7 h + 2 h ) . Daytime napping may be an effective strategy to supplement athletes ’ night-time sleep Purpose : The aim of this study was to investigate objective and subjective sleep quality , daytime tiredness and sleepiness in response to a late-evening high intensity interval training ( HIIT ) session in neither-type soccer players that habitually trained late in the day . This is the first study that considered both athletes ’ chronotype and habitual training time as crucial factors when assessing sleep quality in relation to an evening physical task . Methods : In this longitudinal , prospect i ve , observational study , 14 Italian soccer players were recruited ( mean age : 26.1 ± 4.5 years ; height : 1.81 ± 0.06 m ; weight : 78.9 ± 6.1 kg ) and performed an extra-routine 4 × 4-min HIIT session at 09:00 p.m. Players used to train always between 09:00 and 11:00 p.m during the competitive season . All subjects wore an actigraph to evaluate their objective sleep parameters and a sleep diary was used to record subjective values of sleep quality , daytime tiredness , and daytime sleepiness . All data were analyzed as : the mean of the two nights before ( PRE ) , the night after ( POST 1 ) , and the mean of the two nights after ( POST 2 ) the extra-routine HIIT session . The subjects ’ chronotype was assessed by the morningness-eveningness question naire ( MEQ ) . Results : All players were classified as N-types ( mean MEQ score : 49.4 ± 3.7 ) . None of the actigraph parameters nor the subjective values of sleep quality , tiredness , and sleepiness showed significant changes in PRE , POST 1 , and POST 2 . Conclusion : The results of our study added more information regarding sleep quality outcomes in response to a late-evening HIIT session . Athletic trainers and medical staff should always control for chronotype and habitual training time when assessing variations to sleep quality in athletes Sleeping problems can affect physiological adaptations and the recovery process . The aim of this study was to analyse the effect of the intensity and the hour of the training session on sleep quality and cardiac autonomic activity in amateur ultra-endurance athletes . We used a comparative , r and omized crossover design to test the effect of moderate ( M ) or vigorous ( V ) intensity and morning ( m ) or evening ( e ) training journey , separated by 72 h of recovery , on actigraphic and subjective sleep quality and nocturnal cardiac autonomic activity in fourteen ultra-endurance male runners . No significant differences among training sessions were found in nocturnal heart rate variability or in subjective sleep quality , but participants experienced significantly higher calm sleep after Mm than Me ( p = 0.028 ; ES = 0.7 ) and more refreshed after awakening when they performed a Me than Vm ( p = 0.04 ; ES = 0.6 ) . Higher sleep efficiency was found when the training is performed in the morning compared to the evening sessions in both intensities , and it was also observed in Me vs Ve ( p = 0.012 ; ES = 0.8 ) . Significantly lower numbers of awakenings were observed when the training was performed in the morning , and actual sleep time was significantly lower when participants performed a vigorous training session compared to a moderate one ( Vm vs Mm : p = 0.035 ; ES = 0.6 ; Ve vs Mm : p = 0.036 ; ES = 0.6 ) . Moderate exercise performed in the morning had a higher sleep efficiency compared to other types of training and intensity training is more important than the time of the day of training on sleep quality The aim of the current study was to investigate the effect of the glycemic index of post-exercise meals on sleep quality and quantity , and assess whether those changes could affect the next day ’s exercise performance . Following a baseline/familiarization phase , 10 recreationally trained male volunteers ( 23.2 ± 1.8 years ) underwent two double-blinded , r and omized , counterbalanced crossover trials . In both trials , participants performed sprint interval training ( SIT ) in the evening . Post-exercise , participants consumed a meal with a high ( HGI ) or low ( LGI ) glycemic index . Sleep parameters were assessed by a full night polysomnography ( PSG ) . The following morning , exercise performance was evaluated by the countermovement jump ( CMJ ) test , a visual reaction time ( VRT ) test and a 5-km cycling time trial ( TT ) . Total sleep time ( TST ) and sleep efficiency were greater in the HGI trial compared to the LGI trial ( p < 0.05 ) , while sleep onset latency was shortened by four-fold ( p < 0.05 ) and VRT decreased by 8.9 % ( p < 0.05 ) in the HGI trial compared to the LGI trial . The performance in both 5-km TT and CMJ did not differ between trials . A moderate to strong correlation was found between the difference in TST and the VRT between the two trials ( p < 0.05 ) . In conclusion , this is the first study to show that a high glycemic index meal , following a single spring interval training session , can improve both sleep duration and sleep efficiency , while reducing in parallel sleep onset latency . Those improvements in sleep did not affect jumping ability and aerobic endurance performance . In contrast , the visual reaction time performance increased proportionally to sleep improvements ABSTRACT The correct expression of circadian rhythmicity is crucial for the body homeostasis . The rest-activity circadian rhythms ( RARs ) are involved in the control of the sleep-wake cycle and altered RARs could lead to a compromised health status . Many studies focused on examining sleep behavior and circadian rhythms in physically active subjects or athletes but , unexpectedly , no data on RARs are available . Therefore , we studied the existence of the RAR in athletes and the possible difference in RAR ’s characteristics among sport disciplines . The study had a prospect i ve observational design and RARs were recorded for five consecutive training days through actigraphy ( Actiwatch 2 actigraph ; Philips Respironics , OR , USA ) in 43 athletes ( mean age : 25.6 ± 3.2 years ) . Athletes competed in three different disciplines and had different training schedules and competition levels : professional triathletes ( N = 10 ; 6 females and 4 males ) had 2 morning ( 08:30–12:00 ) and 1 afternoon ( 15:00–17:00 ) training sessions , professional volleyball players ( N = 19 ; 12 females and 7 males ) used to train once in the morning ( 09:00–11:30 ) and once in the afternoon ( 15:00–18:00 ) , and non-professional soccer players ( N = 14 ; all males ) trained always late in the evening ( 20:30–22:30 ) . To determine the existence of RARs , the activity counts ( A.C. ) data were analyzed using the single and the population mean cosinor method ; a one-way analysis of variance ( ANOVA ) followed by the Tukey – Kramer post-hoc test was used for the comparison of RAR characteristics among soccer , volleyball and triathlon athletes . Partial eta squared ( ήp2 ) was used to determine the magnitude of the effect for significant outcomes ( α = 0.05 ) in ANOVA . The presence of a significant RAR both for each of the 43 athletes ( p < 0.001 ) and for the three categories of athletes ( p < 0.001 ) was observed . RARs differed among sport disciplines : the Midline Estimating Statistic of Rhythm ( MESOR ) was significantly higher in triathletes ( mean : 347 A.C. with 95 % Confidence Interval [ CI ] : 314–379 ) compared to both volleyball ( mean : 188 A.C. with 95 % CI : 173–203 ; p < 0.001 ) and soccer players ( mean : 289 A.C. with 95 % CI : 267–312 ; p < 0.01 ) with ήp2 = 0.72 . Amplitude ( A ) values showed the same significant trend of MESOR data ( ANOVA : p < 0.001 ; ήp2 = 0.65 ) while the acrophase ( Φ ) occurred at 18:28 for soccer players , significantly later than triathlon ( 15:20 h ; p < 0.001 ) and volleyball players ( 16:24 h ; p < 0.001 ) ( ANOVA : p < 0.001 ; ήp2 = 0.84 ) . The higher training duration and intensity reached by triathlon athletes in the morning sessions caused a phase advance of their RAR ’s acrophase Φ and higher MESOR and A amplitude compared to volleyball players and triathletes . Therefore , different sport disciplines require different training schedules , training loads and intensities that translate into different RARs . Strength coaches and medical staff of professional teams should strongly consider actigraphy as a practical and powerful tool to monitor RARs , sleep behavior , and the activity levels of their athletes ; highlighting potential circadian disruptions through actigraphy could be helpful to prevent musculoskeletal injuries Abstract During the competitive season , soccer players are likely exposed to numerous factors that may disrupt the process of sleep . The current investigation looked to evaluate a practical sleep hygiene strategy ( 10-min showering at ∼40 ° C before lights out ) , within a group of 11 youth soccer players in comparison to normal sleeping conditions ( control ) . Each condition consisted of three days within a r and omised crossover trial design . Sleep information was collected using a commercial wireless bedside sleep monitor . Measures of skin temperature were evaluated using iButton skin thermistors to establish both distal and proximal skin temperatures and distal to proximal gradient . The shower intervention elevated distal skin temperature by 1.1 ° C ( 95 % CI : 0.1–2.1 ° C , p = .04 ) on average prior to lights out . The elevation in distal temperature was also present during the first 30-min following lights out ( 1.0 ° C , 95 % CI : 0.4–1.6 ° C , p < .01 ) . The distal to proximal gradient also showed a significant effect between the conditions within the first 30-min after lights out ( 0.7 ° C , 95 % CI : 0.3–1.2 ° C , p < .01 ) . On average the sleep latency of the youth soccer players was −7-min lower ( 95 % CI : −13 to −2 min , p < .01 ) and sleep efficiency + 2 % higher ( 95 % CI : 1–3 % ; p < .01 ) in the shower condition . These findings demonstrate that a warm shower performed before lights out may offer a practical strategy to promote thermoregulatory changes that may advance sleep onset latency and improve sleep efficiency in athletes |
11,591 | 24,945,514 | The literature revealed moderate evidence that the presence of fixed appliances influences the quantity and quality of oral microbiota | OBJECTIVE To investigate whether there is scientific evidence to support the hypothesis that the presence of orthodontic fixed appliances influences the oral microbiota . | OBJECTIVE To determine the effects of fixed orthodontic appliances on periodontal health and microbiological composition of subgingival dental plaque . MATERIAL AND METHODS This prospect i ve longitudinal self-controlled study was conducted on 32 adolescents ( 13 males , 19 females ) , who were scheduled for fixed orthodontic treatment between 2002 and 2005 . Dental plaque accumulation , gingival inflammation and pocket probing depth were measured at the mesio-vestibular angle of the examined group of teeth followed by collection of subgingival dental plaque sample s in the same points . These periodontal indices and microbiological parameters were determined prior to the placement of fixed appliances and 1 , 3 and 6 months after the beginning of orthodontic treatment . RESULTS All values of both clinical and microbiological parameters started to increase after the placement of fixed appliances . Maximum values were reached 3 months after fixed appliance placement followed by their decrease in the last registration period of 6 months after the placement of fixed appliances . CONCLUSIONS Treatment with fixed appliances in adolescents may transitionally increase the values of all periodontal indices and stimulate the growth of periodontopathogenic bacteria , but without destructive effects on deep periodontal tissues BACKGROUND The outcome of microbiological diagnostics may depend on the sampling technique . It was the aim of the present study to compare two widely used sampling techniques for subgingival bacteria using quantitative real-time polymerase chain reaction . METHODS Twenty patients with chronic periodontitis were r and omized into two groups . In group A , sample s were taken first with a paper point and then with a curet at the same site ( single-rooted teeth with probing depth > 5 mm ) before scaling and root planing and after 10 weeks . The sampling sequence was reversed in group B. The analysis enabled the quantification of Actinobacillus actinomycetemcomitans , Fusobacterium nucleatum , Porphyromonas gingivalis , Prevotella intermedia , Treponema denticola , and Tannerella forsythensis and total bacterial counts ( TBCs ) . Statistical analysis included t test , kappa , and Spearman correlation . RESULTS Higher TBC was harvested with curets than by paper points ( P = 0.008 ) . The plaque composition with regard to total target pathogens was similar for both sampling techniques . A strong positive correlation was found between curet and paper point sample s for TBC and single target bacteria . CONCLUSIONS Overall , there was a relatively good agreement for the results of paper point and curet sampling . Thus , both techniques seem to be suitable for microbiological diagnostics BACKGROUND Patients with fixed orthodontic appliances often experience an absolute increase in the number of Streptococci mutans colony-forming units ( cfu ) . The aim of this investigation was to study the development of biofilm and S. mutans cfu in connection with stainless steel ligatures and elastomeric rings in orthodontic patients treated with and without 0.4 % stannous fluoride gel ( SFG ) . MATERIAL Forty-seven patients were divided into 2 groups : those treated with 0.4 % SFG for 4 minutes ( experimental ) and those without 0.4 % SFG ( control ) . In each patient , elastomeric rings were used for ligation on 1 side of the dental arch midline , and stainless steel ligatures were used on the opposite side . Saliva sample s were collected before and after appliance placement . At 15 and 30 days after appliance placement , biofilm sample s from the stainless steel ligatures and the elastomeric rings were collected and subjected to microbiologic procedures and scanning electron microscopy ( SEM ) analysis . RESULTS The numbers of S. mutans cfu in the saliva and biofilm were not statistically different between the teeth fitted with elastomeric rings and stainless steel ligatures , or between the experimental and control groups . SEM analysis showed biofilm formation on both ligature ties . CONCLUSIONS Topical application of 0.4 % SFG in orthodontic patients with elastomeric rings or stainless steel ligatures does not cause a significant decrease in S. mutans cfu in the saliva and biofilm Fixed or removable orthodontic appliances impede the maintenance of oral hygiene and result in plaque accumulation . Plaque retention surrounding orthodontic appliances leads to enamel demineralization caused by organic acids produced by bacteria in the dental plaque . Many studies have evaluated the effects of fixed orthodontic appliances on microbial flora and periodontal status , but only a few have evaluated the method of ligation as an additional factor . The aim of this study was to determine the changes in microbial flora and periodontal status after orthodontic bonding and to determine whether two different archwire ligation techniques affect these changes . A total of 21 orthodontic patients scheduled for fixed orthodontic treatment were selected for this split-mouth study . Two commonly used auxiliaries ( elastomeric rings and ligature wires ) for tying archwires were tested . Microbial and periodontal records were obtained before bonding ( T0 ) , one week later ( T1 ) , and five weeks after bonding ( T2 ) . Paired t-test and Wilcoxon signed rank test were used to compare the groups statistically . Although , teeth ligated with elastomeric rings exhibited slightly greater numbers of microorganisms than teeth ligated with steel ligature wires , the differences were not statistically significant and could be ignored . The two archwire ligation techniques showed no significant differences in the gingival index , bonded bracket plaque index , or pocket depths of the bonded teeth . However , teeth ligated with elastomeric rings were more prone to bleeding . Therefore , elastomeric ring use is not recommended in patients with poor oral hygiene The aim of this investigation was to evaluate the prevalence of C and ida and Enterobacteriaceae in a group of adolescents during fixed orthodontic appliance ( FOA ) therapy . The experimental group was recruited from a larger sample of orthodontic patients who were clinical ly examined once to obtain baseline data before active treatment . The group comprised 27 subjects ; 13 males , 14 females ( mean age 15.5 + /- 2.3 years ) . Thereafter , the experimental group was examined three times during a 3 month follow-up period after insertion of the FOA . The whole mouth plaque score was obtained , and the oral cavity was then sample d for C and ida species and Enterobacteriaceae using three different microbiological culture techniques , namely the oral rinse , pooled plaque and the imprint culture . A significant increase in c and idal numbers was observed after FOA insertion when the imprint technique was used ( P < 0.001 ) , although the overall c and idal prevalence rates obtained using the oral rinse and pooled plaque techniques did not demonstrate such a change . The predominant C and ida species isolated was C. albicans and the number of coliform carriers significantly increased after the insertion of a FOA , as detected by the oral rinse ( P < 0.05 ) and the pooled plaque ( P < 0.05 ) techniques . In total , eight coliform species were isolated following FOA therapy compared with the three species isolated before insertion of the appliance . The results also revealed a significant increase in plaque index due to the introduction of a FOA . Taken together , these data imply that insertion of a FOA is likely to promote oral carriage of C and ida and coliform species . Furthermore , it appears that routine oral hygiene instruction and information on appliance hygiene given to these patients may not necessarily reduce plaque accumulation and possible attendant effects . Further work with a larger cohort is required to confirm these findings White spot or areas of decalcification are carious lesions of varying extent . The incidence and severity of white spots after a full term of orthodontic treatment were studied among patients in the separate private practice s of two of the authors . To establish a base line of comparison , the presence of white spots in a r and om sample of untreated persons was observed . The incidence of white spots among patients treated by a multibonded technique was recorded at the time of debonding . In addition , white spots were sought in the before- and after-treatment Kodachrome slides of persons whose maxillary incisors had been h and ed . It was found that individual teeth , b and ed or bonded , exhibited significantly more white spot formation than was found in the control group . For the teeth studied , there was no difference in white spot formation in those that were b and ed or bonded . The labiogingival area of the maxillary lateral incisors had the highest incidence of white spots . When studied by segments , the highest incidence occurred among the maxillary incisors ; the lowest was in the maxillary posterior segment . No white spots were found on the lingual surfaces of m and ibular canines and incisors after prolonged use of a canine-to-canine bonded retainer . These findings suggest a relationship between resistance to white spot formation and the rate of salivary flow . Despite the lack of any preventive fluoride program among the study groups , 50 % of the patients demonstrated resistance to white spot formation . The obvious degree of latrogenic damage during orthodontic treatment suggests the need for preventive programs using fluoride . Further clinical research is needed |
11,592 | 21,954,480 | CONCLUSIONS Benefits and harms vary among atypical antipsychotic medications for off-label use .
For global behavioral symptom scores associated with dementia in elderly patients , small but statistically significant benefits were observed for aripiprazole , olanzapine , and risperidone .
Quetiapine was associated with benefits in the treatment of generalized anxiety disorder , and risperidone was associated with benefits in the treatment of obsessive-compulsive disorder ; however , adverse events were common | CONTEXT Atypical antipsychotic medications are commonly used for off-label conditions such as agitation in dementia , anxiety , and obsessive-compulsive disorder .
OBJECTIVE To perform a systematic review on the efficacy and safety of atypical antipsychotic medications for use in conditions lacking approval for labeling and marketing by the US Food and Drug Administration . | BACKGROUND Behavioural and psychological symptoms of dementia ( BPSD ) can not be regarded as a single clinical syndrome , but rather as a heterogeneous group of symptoms , each of which can be considered as possible targets for therapy . OBJECTIVE To compare the efficacy of risperidone and haloperidol on specific manifestations of BPSD . METHODS A post-hoc analysis was conducted using data from an 18-week , r and omized , double-blind , crossover head-to-head trial of risperidone vs haloperidol in treating 114 nursing-home residents with BPSD . Dependent variables were item scores of the Korean versions of the Behavioural Pathology in Alzheimer 's Disease Rating Scale ( BEHAVE-AD-K ) and Cohen-Mansfield Agitation Inventory ( CMAI-K ) . RESULTS On the BEHAVE-AD-K , risperidone was significantly more effective than haloperidol in treating w and ering ( p = 0.0496 ) , agitation ( p = 0.0091 ) , diurnal rhythm disturbances ( p = 0.0137 ) , anxiety regarding upcoming events ( p = 0.0002 ) , and other anxieties ( p = 0.0088 ) . On the CMAI-K , risperidone was significantly more effective in treating physical sexual advances ( p = 0.0202 ) , pacing and aim less w and ering ( p = 0.0123 ) , intentional falling ( p = 0.0398 ) , hoarding things ( p = 0.0499 ) , performing repetitious mannerisms ( p = 0.0048 ) , repetitive sentence or questions ( p = 0.0025 ) , complaining ( p = 0.0101 ) , and negativism ( p = 0.0027 ) . Haloperidol was not significantly superior to risperidone on any individual item in either scale . CONCLUSIONS When comparing treatment effects on individual symptoms frequently occurring in patients with dementia , risperidone significantly improved symptoms of agitation , w and ering , diurnal rhythm disturbance and anxieties , among other symptoms , compared with haloperidol OBJECTIVES The objectives of this study were to evaluate the efficacy , safety , and tolerability of quetiapine for treating psychosis in patients with probable/possible Alzheimer disease and assess its impact on other psychopathology and social and daily functioning . METHOD The authors conducted a multicenter , double-blind , placebo-controlled , r and omized trial of flexibly dosed quetiapine and haloperidol . Primary outcomes were change in total Brief Psychiatric Rating Scale ( BPRS ) and Clinical Global Impressions-Severity of Illness ( CGI-S ) scores at week 10 . Secondary outcomes included BPRS factors , Neuropsychiatric Inventory ( NPI ) , Multidimensional Observation Scale for Elderly Subjects ( MOSES ) , and Physical Self-Maintenance Scale ( PSMS ) . RESULTS Two hundred eighty-four participants ( mean age : 83.2 years ) were r and omized ; 63.4 % completed ; and mean Mini-Mental State Examination score was 12.8 . Median of the mean daily dose was 96.9 mg for quetiapine and 1.9 mg for haloperidol . No differential benefit was seen on any psychosis measure . BPRS agitation factor scores improved with quetiapine versus placebo and not quetiapine versus haloperidol . BPRS anergia scores worsened with haloperidol versus quetiapine but not quetiapine versus placebo . No NPI factors showed change , including the agitation factor . MOSES Withdrawal Subscale and PSMS total scores worsened with haloperidol versus quetiapine . Somnolence occurred in 25.3 % , 36.2 % , and 4.1 % of the quetiapine , haloperidol , and placebo groups , respectively ; parkinsonism was most prevalent in the haloperidol group ; other safety and tolerability measures differed little among groups . CONCLUSION All treatment groups showed improvement in measures of psychosis without significant differences between them when planned comparisons were performed . Participants treated with quetiapine or haloperidol showed inconsistent evidence of improvement in agitation . Tolerability was better with quetiapine compared with haloperidol SETTING Treating elderly patients with Alzheimer 's disease ( AD ) and behavioral and psychological symptoms of dementia ( BPSD ) is challenging due to the increased risk of iatrogenic movement disorders with old neuroleptics and the seemingly increasing risk of cardiovascular events with newer atypical agents . Quetiapine is an atypical antipsychotic agent that warrants further investigation . OBJECTIVES To assess tolerability , safety , and clinical benefit of quetiapine in AD patients with BPSD . PARTICIPANTS AND DESIGN AD patients with BPSD participated in a 6-week r and omized , double-blind , placebo-controlled trial . Quetiapine was increased on the basis of clinical response and tolerability . Primary efficacy assessment s included the Neuropsychiatric Inventory ( NPI ) and Clinical Global Impression of Change ( CGI-C ) . Secondary efficacy measures included the Mini-Mental State Examination ( MMSE ) , the Simpson-Angus Scale ( SAS ) and the Abnormal Involuntary Movement Scale ( AIMS ) . RESULTS Forty patients ( 26 women ) , mean age 82.2 ( SD 6.4 ) years were enrolled , 27 completed treatment . Median dose of quetiapine was 200 mg/day . Significant NPI total scores reductions ( 79 % for placebo and 68.5 % for quetiapine ) were observed . The CGI-C score decreased significantly in the quetiapine group ( p = 0.009 at 6 weeks ) and did not change significantly in the placebo group ( p = 0.48 ) . The MMSE , AIMS , SAS scores and adverse events did not differ significantly between the two arms . CONCLUSIONS Quetiapine did not significantly improve psychosis scores . It did not cause cognitive and motor deterioration . These results might possibly be due to small sample size Objective : Previous studies stressed the role of decision-making functioning in predicting antiobsessive treatment outcome with serotonin reuptake inhibitors drugs in patients with obsessive-compulsive disorder . Nevertheless , the use of an augmentation strategy with atypical antipsychotic drugs has proved to be effective in obsessive-compulsive patients nonresponding to serotonin reuptake inhibitors treatment . We investigated whether the performance at the Iowa Gambling Task ( IGT ) , a used neuropsychologic task which assesses decision-making , can be an effective criterion for pharmacologic treatment choice in these patients and whether the use of different treatment strategies , according IGT performance , can increase the rate of antiobsessive outcome . Method : Thirty patients with obsessive-compulsive disorder were treated in a single-blind design with fluvoxamine plus placebo or fluvoxamine plus risperidone according to their IGT performance . Treatment outcome was recorded after 6 and 12 weeks . Results : Patients with good IGT performance showed a good antiobsessive treatment outcome with fluvoxamine only , while only adopting an augmentation strategy with risperidone , the number of responders patients within the subjects with bad IGT performance increased . Conclusions : IGT performance may be considered an effective criterion for pharmacologic treatment choice in obsessive-compulsive patients given that antiobsessive treatment outcome is increased to 85 % of responders choosing an appropriate drug strategy according to the IGT performance OBJECTIVE To compare citalopram and risperidone for the treatment of psychotic symptoms and agitation associated with dementia , with a priori hypotheses that risperidone would be more efficacious for psychosis and citalopram for agitation . METHODS A 12-week r and omized , controlled trial in nondepressed patients with dementia hospitalized because of behavioral symptoms ( N = 103 ) was conducted at the University of Pittsburgh Medical Center . Participants were consecutively recruited on an inpatient unit if they had at least one moderate to severe target symptom ( aggression , agitation , hostility , suspiciousness , hallucinations , or delusions ) . Once they improved sufficiently , they were discharged to nursing homes , personal care homes , or residential homes for continued treatment . Planned pre-post and mixed model analyses of the main outcome measures of Neurobehavioral Rating Scale and Side Effect Rating Scale at baseline and at weekly/biweekly intervals were conducted . RESULTS Completion rates did not differ for citalopram and risperidone ( overall completion rate : 44 % ) . Agitation symptoms ( aggression , agitation , or hostility ) and psychotic symptoms ( suspiciousness , hallucinations , or delusions ) decreased in both treatment groups but the improvement did not differ significantly between the two groups . There was a significant increase in side effect burden with risperidone but not with citalopram such that the two groups differed significantly . CONCLUSION No statistical difference was found in the efficacy of citalopram and risperidone for the treatment of either agitation or psychotic symptoms in patients with dementia . These findings need to be replicated before citalopram or other serotonergic antidepressants can be recommended as alternatives to antipsychotics for the treatment of agitation or psychotic symptoms associated with dementia Background Although serotonin reuptake inhibitors are effective in the treatment of OCD , many patients fail to respond to these agents . Growing evidence from open-label and placebo-controlled trials suggests a role for augmentation of SRIs with atypical antipsychotics in OCD . Quetiapine is generally well tolerated and previous open-label data has produced mixed results in OCD and additional controlled data is needed . Methods We undertook a double-blind , r and omised , parallel-group , flexible-dose , placebo-controlled study of quetiapine augmentation in subjects who had responded inadequately to open-label treatment with an SRI for 12 weeks . Following informed consent and screening , forty-two subjects were r and omised to either placebo or quetiapine for six weeks . Results There was significant improvement from baseline to endpoint on the Yale-Brown Obsessive-Compulsive Scale in both the quetiapine and placebo groups ( quetiapine , n = 20 , p < 0.0001 ; placebo , n = 21 , p = 0.001 ) with 40 % ( n = 8) of quetiapine and 47.6 % ( n = 10 ) of placebo treated subjects being classified as responders . Quetiapine did not demonstrate a significant benefit over placebo at the end of the six-week treatment period ( p = .636 ) . Similarly quetiapine failed to separate from placebo in the subgroup of subjects ( n = 10 ) with co-morbid tics . Quetiapine was generally well tolerated . Conclusions In this study , quetiapine augmentation was no more effective than placebo augmentation of SRIs . A number of limitations in study design make comparisons with previous studies in this area difficult and probably contributed to our negative findings . Future work in this important clinical area should address these limitations The objective of this study was to evaluate the efficacy and tolerability of extended release quetiapine fumarate ( quetiapine XR ) as maintenance monotherapy for patients with generalized anxiety disorder ( GAD ) . Time-to-event ( anxiety symptom recurrence ; maximum 52 weeks ) multicenter , r and omized-withdrawal , parallel-group , double-blind , placebo-controlled study of quetiapine XR ( 50–300 mg/day ) following open-label run-in ( 4–8 weeks ) and open-label stabilization ( ≥12 weeks ) . Primary variable : time from r and omization to anxiety event . Secondary variables included : Hamilton Anxiety Rating Scale ( HAM-A ) total , HAM-A psychic/somatic anxiety factors , Clinical Global Impression-Severity of Illness ( CGI-S ) , and Quality of Life , Enjoyment and Satisfaction Question naire ( Q-LES-Q ) scores ; adverse events ( AE ) reporting . Four hundred and thirty-two patients , stabilized on quetiapine XR , were r and omized to continue quetiapine XR ( N=216 ) or switch to placebo ( N=216 ) . Risk of anxiety symptom recurrence was significantly reduced by 81 % for quetiapine XR versus placebo : hazard ratio=0.19 ( 95 % confidence interval 0.12–0.31 ; P<0.001 ) . Fewer patients receiving quetiapine XR ( N=22 , 10.2 % ) than placebo ( N=84 , 38.9 % ) experienced anxiety symptom recurrence . Significant differences were observed between quetiapine XR and placebo in : HAM-A total , psychic/somatic , CGI-S ( all P<0.001 ) and Q-LES-Q ( P<0.05 ) scores . AEs ( > 10 % ) during open-label treatment were dry mouth , sedation , somnolence , dizziness , fatigue , and constipation . During r and omized treatment , the most common AEs for quetiapine XR were headache and nasopharyngitis . Quetiapine XR monotherapy reduced the risk of anxiety symptom recurrence in patients with GAD stabilized on quetiapine XR , with tolerability results consistent with the known profile of quetiapine Context Recent reports suggest that antipsychotics are associated with increased risk for death in patients with dementia . Contribution This large , population -based study from Canada assessed the risk for death after dispensation of antipsychotics in older adults with dementia . New use of antipsychotics compared with nonuse was associated with increased risk for death at 30 days . Conventional agents were associated with higher risks than were atypical agents . Caution Sensitivity analyses showed that unmeasured confounders might diminish or erase observed associations . Implication Both conventional and atypical antipsychotics may be associated with an increased risk for death in elderly persons with dementia . The Editors Various challenging behavioral and psychological symptoms commonly develop in older adults with dementia and predispose them and their caregivers to poor outcomes ( 1 ) . Nonpharmacologic strategies are recommended as first-line management for these symptoms ( 2 ) , but they may be difficult to implement in clinical practice ( 3 ) . For many reasons , antipsychotic medications are routinely prescribed in this setting ( 4 , 5 ) . Conventional antipsychotics , such as haloperidol , have been available since the 1950s . Meta-analyses of clinical trials evaluating conventional antipsychotics to treat agitation in dementia show that these agents have modest efficacy and important adverse effects compared with placebo ( 6 , 7 ) . In the past decade , use of newer atypical antipsychotics has been rapidly increasing in clinical practice because these agents were thought to produce fewer adverse effects than conventional agents ( 2 ) . A Canadian study found that the prevalence of antipsychotic use in older adults increased from 2.2 % in 1993 to 3.0 % at the end of 2002 . In that study , atypical antipsychotics , which were unavailable in 1993 , accounted for 82.5 % of all antipsychotics dispensed in 2002 ( 8) . Short-term r and omized , controlled trials ( RCTs ) have studied the role of atypical antipsychotics in the management of behavioral and psychological symptoms of dementia ( 2 , 9 ) . An RCT involving 421 out patients with Alzheimer disease and psychosis , aggression , or agitation concluded that the adverse effects of these newer drugs offset their advantages ( 10 ) . As a result , improvements in behavioral symptoms with antipsychotic drug treatment do not necessarily lead to improvements in overall quality of life for patients or their caregivers ( 11 ) . In April 2005 , the U.S. Food and Drug Administration ( FDA ) issued a public health advisory that the use of atypical antipsychotics to treat elderly patients with dementia was associated with an increased risk for death compared with placebo ( 12 ) . In June 2005 , Health Canada issued a similar warning and additional data ( 13 ) . These warnings stem from review s of RCTs that involve the atypical agents risperidone , olanzapine , quetiapine , and aripiprazole . The mortality rate was approximately 1.6 to 1.7 times higher than with placebo and was greater with antipsychotics than with placebo in 15 of the 17 trials review ed by the U.S. FDA ( 12 ) . The warnings extend to all currently available atypical antipsychotics . Other publications have provided support for these warnings and have raised further safety concerns about older conventional antipsychotics ( 1416 ) . Important questions remain unanswered . Although RCTs provide the best evidence of treatment efficacy and harm , the individual RCTs in this case had low event rates . Reliable estimates of the mortality risk were generated only when data were combined by meta- analysis ( 14 ) . Furthermore , these RCTs were generally short in duration and could not provide information about the long-term effect of antipsychotics on mortality ( 14 , 17 ) . Finally , these trials provide estimates of harm primarily for atypical antipsychotics . Relatively few data are available on harms associated with older conventional antipsychotics . Studies suggest that important differences may exist in the safety profiles of conventional and atypical agents ( 15 , 16 , 18 , 19 ) . Using population -based data , we sought to determine the risk for all-cause mortality in older adults with dementia who received atypical antipsychotics , conventional antipsychotics , or no antipsychotic . Because important baseline differences exist among these groups , we used propensity score matching to improve their comparability . We also evaluated the effect of duration of treatment with antipsychotics on the risk for death . Methods Data Sources Ontario is Canada 's most populous province . During our study , Ontario had a population of approximately 12 million people , of whom 1.4 million were 65 years of age or older . A universally funded health program covers nearly all physician services , medications , and hospital services for patients 65 years of age or older in Ontario . Information from 4 administrative health care data bases was linked to develop the study cohort : pharmacy records from the Ontario Drug Benefit program , hospitalization records from the Canadian Institute for Health Information Discharge Abstract Data base , physician billing information for inpatient and outpatient services from the Ontario Health Insurance Plan , and basic demographic information and vital statistics from the Registered Persons Data base . We used encrypted unique identifiers that are common among data bases to link anonymous information on demographic characteristics and health services utilization for patients in our study . Little basic information on patients is missing in these data bases . For example , the coding accuracy of drug cl aims in the Ontario Drug Benefit program data base is excellent , with an error rate of only 0.7 % ( 20 ) . The study was approved by the ethics review board of Sunnybrook and Women 's College Health Sciences Centre , Toronto , Ontario , Canada . Dementia Cohort We identified a cohort of all Ontario residents 66 years of age or older with a diagnosis of dementia ( in the Ontario Health Insurance Plan or Discharge Abstract Data base ) between 1 April 1997 and 31 March 2002 . To focus on antipsychotic drug treatment for behavioral and psychological symptoms of dementia , we excluded patients who had evidence of other psychotic disorders ( such as schizophrenia ) or were receiving palliative care services . To reduce the potential for selection bias , we studied only new users of antipsychotics and excluded those who had received antipsychotics in the year before cohort entry ( 21 ) . Exposure to Antipsychotics We identified new use of antipsychotics if any agent available through the Ontario Drug Benefit program was dispensed after cohort entry . Cohort entry ( that is , the index date ) was defined as the date of the first dispensed antipsychotic drug . Available atypical drugs included olanzapine , quetiapine , and risperidone , and available conventional drugs included chlorpromazine , flupenthixol , fluphenazine , haloperidol , loxapine , pericyazine , perphenazine , pimozide , thioridazine , and trifluoperazine . Clozapine was rarely used in Ontario during the study period , and we therefore excluded patients who were receiving this medication . Other atypical antipsychotics ( such as aripiprazole and ziprasidone ) are not licensed for use in Canada . We decided that exposure to an antipsychotic was discontinued ( and we censored follow-up ) if the patient did not refill his or her antipsychotic prescription within an interval composed of the days of drug supply plus a grace period of 20 % . For example , we censored follow-up for a patient who did not refill his or her 60-day antipsychotic prescription within 72 days . We also censored follow-up for patients who switched from atypical to conventional antipsychotics ( or vice versa ) . However , we continued follow-up for patients who switched from 1 atypical antipsychotic to another , because data suggest no statistically significant difference in the risk for death associated with individual drugs in this class ( 13 , 14 , 16 ) . We applied the same rules to conventional antipsychotics . All-Cause Mortality The primary outcome was all-cause mortality , as recorded in the Registered Persons Data base ( for patients who were not hospitalized at the time of death ) or the Discharge Abstract Data base ( for patients who died while hospitalized ) . To assess the influence of the duration of antipsychotic exposure on the outcome , we evaluated the risk for death at 30 , 60 , 120 , and 180 days after the initial dispensing of antipsychotic medication . Cohort Matching We stratified the dementia cohort to support separate analyses among persons living in the community and those residing in long-term care at cohort entry . Studies have demonstrated that rates of antipsychotic prescribing are substantial among older adults newly admitted to long-term care facilities ( 4 ) . Furthermore , long-term care residents typically carry a greater burden of comorbid disease and are more vulnerable to adverse drug events than are their counterparts in the community ( 22 , 23 ) . Our first objective was to determine the risk for death among older adults with dementia who received atypical antipsychotics compared with those who were not exposed to any antipsychotic . Because antipsychotic use was not r and omly assigned in the study cohorts , we addressed potential confounding and selection biases by developing a propensity score for antipsychotic use . We then applied this score to match users of atypical antipsychotics with nonusers in the dementia cohort . The rationale and methods underlying the use of a propensity score for a proposed causal exposure variable are described elsewhere ( 24 ) . Recent studies provide guidance on the selection of variables to include in the propensity score ( 25 , 26 ) . We developed a logistic regression model by using 42 covariates describing patient characteristics . Tables 1 and 2 list many of the characteristics included in the propensity score . After a structured and iterative assessment of the balance of measured covariates OBJECTIVE To evaluate the efficacy and safety of aripiprazole treatment for psychotic symptoms associated with Alzheimer disease ( AD ) . METHODS In this parallel group , r and omized , double-blind , placebo-controlled , flexible-dose trial , institutionalized subjects with AD and psychotic symptoms were r and omized to aripiprazole ( n = 131 ) or placebo ( n = 125 ) for 10 weeks . The aripiprazole starting dose was 2 mg/day , and could be titrated to higher doses ( 5 , 10 , and 15 mg/day ) based on efficacy and tolerability . RESULTS No significant differences in mean change [ 2 x SD ] from baseline between aripiprazole ( mean dose approximately 9 mg/day at endpoint ; range = 0.7 - 15.0 mg ) and placebo were detected in the co primary efficacy endpoints of Neuropsychiatric Inventory-Nursing Home Version ( NPI-NH ) Psychosis score ( aripiprazole , -4.53 [ 9.23 ] ; placebo , -4.62 [ 9.56 ] ; F = 0.02 , df = 1 , 222 , p = 0.883 [ ANCOVA ] ) and Clinical Global Impression (CGI)-Severity score ( aripiprazole , -0.57 [ 1.63 ] ; placebo , -0.43 [ 1.65 ] ; F = 1.67 , df = 1 , 220 , p = 0.198 [ ANCOVA ] ) at endpoint . However , improvements in several secondary efficacy measures ( NPI-NH Total , Brief Psychiatric Rating Scale Total , CGI - improvement , Cohen-Mansfield Agitation Inventory and Cornell Depression Scale scores ) indicated that aripiprazole may confer clinical benefits beyond the primary outcome measures . Treatment-emergent adverse events ( AEs ) were similar in both groups , except for somnolence ( aripiprazole , 14 % ; placebo , 4 % ) . Somnolence with aripiprazole was of mild or moderate intensity , and not associated with accidental injury . Incidence of AEs related to extrapyramidal symptoms was low with aripiprazole ( 5 % ) and placebo ( 4 % ) . CONCLUSIONS In nursing home residents with AD and psychosis , aripiprazole did not confer specific benefits for the treatment of psychotic symptoms ; but psychological and behavioral symptoms , including agitation , anxiety , and depression , were improved with aripiprazole , with a low risk of AEs The efficacy and tolerability of extended-release quetiapine fumarate ( quetiapine XR ) once-daily monotherapy in generalized anxiety disorder ( GAD ) was assessed . This multicentre , double-blind , r and omized , placebo- and active-controlled , phase III trial consisted of a 1- to 4-wk enrolment/wash-out period and a 10-wk ( 8-wk active treatment , 2-wk post-treatment drug-discontinuation ) study period ; 873 patients were r and omized to 50 mg or 150 mg quetiapine XR , 20 mg paroxetine , or placebo . Primary endpoint was change from r and omization at week 8 in Hamilton Rating Scale for Anxiety ( HAMA ) total score . At week 8 , all active agents produced significant improvements in HAMA total and psychic subscale scores vs. placebo ; HAMA somatic subscale scores were significantly reduced only by 150 mg quetiapine XR . Significant separation from placebo ( -2.90 ) in HAMA total score was observed at day 4 for 50 mg quetiapine XR ( -4.43 , p<0.001 ) and 150 mg quetiapine XR ( -3.86 , p<0.05 ) , but not for paroxetine ( -2.69 ) . Remission ( HAMA total score 7 ) rates at week 8 were significantly higher for 150 mg quetiapine XR ( 42.6 % , p<0.01 ) and paroxetine ( 38.8 % , p<0.05 ) vs. placebo ( 27.2 % ) . The most common adverse events ( AEs ) were dry mouth , somnolence , fatigue , dizziness , and headache , for quetiapine XR , and nausea , headache , dizziness for paroxetine . A lower proportion of patients reported sexual dysfunction with quetiapine XR [ 0.9 % ( 50 mg ) , 1.8 % ( 150 mg ) ] than with placebo ( 2.3 % ) or paroxetine ( 7.4 % ) . The incidence of AEs potentially related to extrapyramidal symptoms was : quetiapine XR : 50 mg , 6.8 % , 150 mg , 5.0 % ; placebo , 1.8 % ; and paroxetine , 8.4 % . Once-daily quetiapine XR is an effective and generally well-tolerated treatment for patients with GAD , with symptom improvement seen as early as day 4 OBJECTIVE In this study we directly compared the efficacy and tolerability of the atypical antipsychotics quetiapine and risperidone in elderly patients with dementia and symptoms of disturbed perception , thought content , mood or behaviour ( behavioural and psychological symptoms of dementia-BPSD ) . METHODS We conducted an 8-week , rater-blinded , r and omised study of 72 out patients ( 55 - 85 years ) with BPSD ( assessed by NPI baseline score ) , who received flexibly-dosed quetiapine ( 50 - 400 mg/day ) or risperidone ( 0.5 - 2 mg/day ) . Primary efficacy measure : Neuropsychiatric Inventory ( NPI ) Parts 1 and 2 ; secondary efficacy measures : Clinical Global Impression ( CGI ) , Cohen-Mansfield Agitation Inventory ( CMAI ) , Mini-Mental State Examination ( MMSE ) , Age-adjusted concentration test ( AKT ) . Safety evaluations included the incidence of extrapyramidal symptoms ( EPS ) and adverse events ( AEs ) . RESULTS Sixty-nine of 72 patients were evaluable for efficacy ( 72 were evaluated for safety ) , 4 patients discontinued ( 3 due to AEs : quetiapine 2 , risperidone 1 ; 1 lost to follow-up ) . Sixty-five patients received quetiapine ( n=34 ; mean dose 77+/-40 mg/day ) or risperidone ( n=31 ; mean dose 0.9+/-0.3 mg/day ) . There was no significant difference between treatments on NPI scores ; within treatment groups , NPI scores decreased significantly from baseline to Week 8 ( P < or=0.05 vs. baseline ) . Most patients ( quetiapine arm 67.6 % , risperidone arm 71.0 % ) experienced clinical improvement ( CGI-Improvement scores ) ; both agents reduced agitation ( CMAI scores ) ; and there was no cognitive impairment ( MMSE and AKT scores ) . There were no significant differences between treatments in any safety measures , including EPS . Four patients experienced serious AEs ( quetiapine arm 3 ; risperidone arm 1 ) ; none were considered treatment-related by the study investigator . There were no cerebrovascular AEs or deaths . CONCLUSIONS Quetiapine or risperidone , at low doses , were equally effective and generally well tolerated ( including no cognitive impairment ) in the treatment of BPSD in elderly patients Abstract Objectives To determine the respective efficacy of quetiapine and rivastigmine for agitation in people with dementia in institutional care and to evaluate these treatments with respect to change in cognitive performance . Design R and omised double blind ( clinician , patient , outcomes assessor ) placebo controlled trial . Setting Care facilities in the north east of Engl and . Participants 93 patients with Alzheimer 's disease , dementia , and clinical ly significant agitation . Intervention Atypical antipsychotic ( quetiapine ) , cholinesterase inhibitor ( rivastigmine ) , or placebo ( double dummy ) . Main outcome measures Agitation ( Cohen-Mansfield agitation inventory ) and cognition ( severe impairment battery ) at baseline and at six weeks and 26 weeks . The primary outcome was agitation inventory at six weeks . Results 31 patients were r and omised to each group , and 80 ( 86 % ) started treatment ( 25 rivastigmine , 26 quetiapine , 29 placebo ) , of whom 71 ( 89 % ) tolerated the maximum protocol dose ( 22 rivastigmine , 23 quetiapine , 26 placebo ) . Compared with placebo , neither group showed significant differences in improvement on the agitation inventory either at six weeks or 26 weeks . Fifty six patients scored > 10 on the severe impairment battery at baseline , 46 ( 82 % ) of whom were included in the analysis at six week follow up ( 14 rivastigmine , 14 quetiapine , 18 placebo ) . For quetiapine the change in severe impairment battery score from baseline was estimated as an average of -14.6 points ( 95 % confidence interval -25.3 to -4.0 ) lower ( that is , worse ) than in the placebo group at six weeks ( P = 0.009 ) and -15.4 points ( -27.0 to -3.8 ) lower at 26 weeks ( P = 0.01 ) . The corresponding changes with rivastigmine were -3.5 points ( -13.1 to 6.2 ) lower at six weeks ( P = 0.5 ) and -7.5 points ( -21.0 to 6.0 ) lower at 26 weeks ( P = 0.3 ) . Conclusions Neither quetiapine nor rivastigmine are effective in the treatment of agitation in people with dementia in institutional care . Compared with placebo , quetiapine is associated with significantly greater cognitive decline OBJECTIVE The study measured the effects of atypical antipsychotics on psychiatric and behavioral symptoms in patients with Alzheimer 's disease and psychosis or agitated behavior . METHOD The Clinical Antipsychotic Trials of Intervention Effectiveness-Alzheimer 's Disease ( CATIE-AD ) Alzheimer 's disease effectiveness study included 421 out patients with Alzheimer 's disease and psychosis or agitated/aggressive behavior . Patients were assigned r and omly to masked , flexible-dose treatment with olanzapine , quetiapine , risperidone , or placebo for up to 36 weeks . Patients could be r and omly reassigned to a different medication at the clinician 's discretion , which ended phase 1 . Psychiatric and behavioral symptoms , functioning , cognition , care needs , and quality of life were measured at regular intervals . RESULTS In relation to placebo , the last observation in phase 1 showed greater improvement with olanzapine or risperidone on the Neuropsychiatric Inventory total score , risperidone on the Clinical Global Impression of Changes , olanzapine and risperidone on the Brief Psychiatric Rating Scale ( BPRS ) hostile suspiciousness factor , and risperidone on the BPRS psychosis factor . There was worsening with olanzapine on the BPRS withdrawn depression factor . Among patients continuing phase 1 treatment at 12 weeks , there were no significant differences between antipsychotics and placebo on cognition , functioning , care needs , or quality of life , except for worsened functioning with olanzapine compared to placebo . CONCLUSION In this descriptive analysis of out patients with Alzheimer 's disease in usual care setting s , some clinical symptoms improved with atypical antipsychotics . Antipsychotics may be more effective for particular symptoms , such as anger , aggression , and paranoid ideas . They do not appear to improve functioning , care needs , or quality of life OBJECTIVE The objective of this study was to evaluate efficacy and safety of low-dose risperidone for treating psychosis of Alzheimer disease ( AD ) . METHOD The authors conducted a r and omized , eight-week , double-blind , placebo-controlled , multicenter trial involving nursing home residents diagnosed with AD and psychosis . Four hundred seventy-three patients were r and omly assigned to placebo ( N = 238 ) or 1.0 to 1.5 mg risperidone per day ( N = 235 ) . Co primary efficacy end points were : changes in scores on the Behavioral pathology in Alzheimer 's Disease ( BEHAVE-AD ) Psychosis subscale and Clinical Global Impression of Change ( CGI-C ) . Protocol -specified subgroup analyses were performed by demographics and dementia severity . RESULTS Efficacy analysis included 416 patients . Both groups improved significantly on the BEHAVE-AD Psychosis subscale and CGI-C with no significant difference between groups . In the subgroups analyses , a statistically significant treatment by Mini-Mental Status Examination ( MMSE ) interaction on the CGI-C ( F([2,381 ] ) = 3.90 , p = 0.021 ) was observed with patients with more severe dementia ( MMSE < 10 ) showing significant differences at end point favoring risperidone treatment ( chi(2 ) ( [ 1 ] ) = 5.11 , p = 0.024 ) . Mean risperidone dose was 1.03 + /- 0.24 mg per day . All-cause discontinuation rates were 25 % for both risperidone and placebo . Treatment-emergent adverse events occurred in 74 % risperidone versus 64 % placebo patients , with somnolence occurring significantly more frequently with risperidone ( 16.2 % versus 4.6 % ) . Nine ( 3.8 % ) risperidone- and six ( 2.5 % ) placebo patients died during or within 30 days after treatment . CONCLUSION This trial did not confirm earlier findings in this population BACKGROUND This r and omized , double-blind , placebo-controlled trial examined the efficacy and safety of risperidone in the treatment of aggression , agitation , and psychosis in elderly nursing-home patients with dementia . METHOD Elderly patients with a DSM-IV diagnosis of dementia of the Alzheimer 's type , vascular dementia , or a combination of the 2 ( i.e. , mixed dementia ) and significant aggressive behaviors were r and omized to receive , for a period of 12 weeks , a flexible dose of either placebo or risperidone solution up to a maximum of 2 mg/day . Outcome measures were the Cohen-Mansfield Agitation Inventory ( CMAI ) , the Behavioral Pathology in Alzheimer 's Disease ( BEHAVE-AD ) rating scale , and the Clinical Global Impression of Severity ( CGI-S ) and of Change ( CGI-C ) scales . RESULTS A total of 345 patients were r and omized to treatment with risperidone or placebo , and 337 patients received at least one dose of study drug . The trial was completed by 67 % of patients in the placebo group and 73 % of patients in the risperidone group . The mean + /- SE dose of risperidone was 0.95 + /- 0.03 mg/day . The primary endpoint of the study , the difference from baseline to endpoint in CMAI total aggression score , showed a significant reduction in aggressive behavior for risperidone versus placebo ( p < .001 ) . A similar improvement was also seen for the CMAI total non-aggression subscale ( p < .002 ) and for the BEHAVE-AD total ( p < .001 ) and psychotic symptoms subscale ( p = .004 ) . At endpoint , the CGI-S and the CGI-C scores indicated a significantly greater improvement with risperidone compared with placebo ( p < .001 ) . Overall , 94 % and 92 % of the risperidone and placebo groups , respectively , reported at least 1 adverse event . Somnolence and urinary tract infection were more common with risperidone treatment , whereas agitation was more common with placebo . There was no significant difference in the number of patients who reported extrapyramidal symptoms between the risperidone ( 23 % ) and placebo ( 16 % ) groups . CONCLUSION Treatment with low-dose ( mean = 0.95 mg/day ) risperidone result ed in significant improvement in aggression , agitation , and psychosis associated with dementia OBJECTIVE The impact of the atypical antipsychotics olanzapine , quetiapine , and risperidone on cognition in patients with Alzheimer 's disease is unclear . The authors assessed the effects of time and treatment on neuropsychological functioning during the Clinical Antipsychotic Trials of Intervention Effectiveness-Alzheimer 's Disease study ( CATIE-AD ) . METHOD CATIE-AD included 421 out patients with Alzheimer 's disease and psychosis or agitated/aggressive behavior who were r and omly assigned to receive masked , flexible-dose olanzapine , quetiapine , risperidone , or placebo . Based on their clinicians ' judgment , patients could discontinue the originally assigned medication and receive another r and omly assigned medication . Patients were followed for 36 weeks , and cognitive assessment s were obtained at baseline and at 12 , 24 , and 36 weeks . Outcomes were compared for 357 patients for whom data were available for at least one cognitive measure at baseline and one follow-up assessment that took place after they had been on their prescribed medication or placebo for at least 2 weeks . RESULTS Overall , patients showed steady , significant declines over time in most cognitive areas , including in scores on the Mini-Mental State Examination ( MMSE ; -2.4 points over 36 weeks ) and the cognitive subscale of the Alzheimer 's Disease Assessment Scale ( -4.4 points ) . Cognitive function declined more in patients receiving antipsychotics than in those given placebo on multiple cognitive measures , including the MMSE , the cognitive subscale of the Brief Psychiatric Rating Scale , and a cognitive summary score summarizing change on 18 cognitive tests . CONCLUSIONS In CATIE-AD , atypical antipsychotics were associated with worsening cognitive function at a magnitude consistent with 1 year 's deterioration compared with placebo . Further cognitive impairment is an additional risk of treatment with atypical antipsychotics that should be considered when treating patients with Alzheimer 's disease The objectives of this r and omized clinical trial were to investigate the impact of the discontinuation of long-term antipsychotics in residents with dementia in chronic care institutions and to identify clinical predictors of safe discontinuation . Subjects included 34 residents with dementia who were on antipsychotics for more than 6 months and whose behavior was currently stable . Subjects were r and omized to either continue receiving their regular dosage of antipsychotics or to receive placebo for 6 months . Early withdrawal from the study was not statistically different between the groups ( relative risk [ RR ] = 1.57 , 95 % confidence interval [ CI ] 0.76 - 3.26 ) , and though not significantly different , subjects in the placebo group were more likely to be withdrawn from the study because of worsening behavior ( RR = 1.25 , 95 % Cl 0.33 - 4.76 ) . Three subjects in the placebo group were withdrawn from the study due to worsening of extrapyramidal symptoms . The active treatment group had more behavioral problems ( e.g. , physical aggression towards others , p < .05 ) compared to the placebo group . The placebo group developed more apathy , but balancing this outcome was a relative improvement in cognitive functioning . Baseline antipsychotic dose was predictive of behavioral worsening upon discontinuation of long-term antipsychotic drugs . The primary limitation of the study was the small sample size . In conclusion , a trial of discontinuation of antipsychotics should be considered in this population OBJECTIVE This was an exploratory study of olanzapine as potential treatment for improvement in cognition in patients with Alzheimer 's disease without prominent psychobehavioral symptoms . METHODS Non-psychotic/non-agitated patients ( n = 268 ) with Alzheimer 's disease , who had baseline Mini-Mental State Examination ( MMSE ) scores of 14 - 26 were r and omized to treatment with olanzapine ( 2.5 to 7.5 mg/d ) or placebo for 26 weeks . The primary objectives were to determine if treatment with olanzapine improved cognition as indexed by the Alzheimer 's disease Assessment Scale for Cognition ( ADAS-Cog ) and the Clinician 's Interview-Based Impression of Change ( CIBIC ) after 26 weeks of therapy . RESULTS Patients treated with olanzapine vs placebo experienced significant worsening ADAS-Cog scores at weeks 12 ( p = 0.03 ) and 26 ( p = 0.004 ) . Changes in CIBIC scores were not significantly different between treatment groups at either assessment . A post hoc analysis revealed that olanzapine-treated patients with more cognitive impairment at baseline ( MMSE scores of 14 - 18 ) ( n = 35 ) experienced significantly greater deterioration in ADAS-Cog performance than patients in the placebo group ( n = 24 ; p < 0.001 ) ; whereas in patients with less cognitive impairment ( n = 78 , baseline MMSE scores of 23 - 26 ) between-group ADAS-Cog changes were not significant . CONCLUSIONS In this 26-week study non-psychotic/non-agitated patients with Alzheimer 's disease treated with olanzapine experienced significant worsening of cognition as compared to placebo OBJECTIVE Quetiapine monotherapy shows efficacy in bipolar depression . The analyses in this multicenter , double-blind , r and omized , fixed-dose , placebo-controlled study evaluated effects of quetiapine monotherapy on anxiety symptoms in bipolar depression . METHOD Of 542 out patients r and omly assigned to treatment , 539 with bipolar I ( N = 358 ) or bipolar II ( N = 181 ) disorder experiencing a major depressive episode ( DSM-IV ) received 8 weeks of quetiapine monotherapy ( 600 or 300 mg/day ) or placebo between September 2002 and October 2003 . Anxiety assessment s included the Hamilton Rating Scale for Anxiety ( HAM-A ) and relevant items from the Montgomery-Asberg Depression Rating Scale ( MADRS ) and Hamilton Rating Scale for Depression ( HAM-D ) . Analyses evaluated the pooled dose groups versus placebo . RESULTS At week 8 , quetiapine 600 and 300 mg/day each demonstrated significant improvements in HAM-A total score versus placebo ( -10.8 and -9.9 vs. -6.7 , p < .001 ) . Quetiapine ( pooled doses ) significantly improved HAM-A total score from week 1 . In bipolar I depression , quetiapine showed significant improvement in HAM-A total score versus placebo ( -10.4 vs. -5.1 , p < .001 ) . In bipolar I depression , quetiapine also showed significant improvements versus placebo on the HAM-A anxious mood and tension items , HAM-A psychic and somatic subscales , MADRS inner tension item , and HAM-D psychic anxiety item ( all p < .001 ) , but not the HAM-D somatic anxiety item . In bipolar II depression , quetiapine reduced the HAM-A total score more than placebo , but the difference was not statistically significant ( -9.8 vs. -9.0 , p = .473 ) . In bipolar II depression , quetiapine showed significant improvement versus placebo on the HAM-A anxious mood , MADRS inner tension , and HAM-D psychic anxiety items ( all p < .01 ) . CONCLUSION Quetiapine monotherapy shows efficacy in treating anxiety symptoms in bipolar I depression ; however , the anxiolytic effects in bipolar II disorder require further investigation OBJECTIVE The authors compared efficacy of olanzapine versus placebo and risperidone as measured by the Neuropsychiatric Inventory and Clinical Global Impression-Severity of Psychosis scale in patients with dementia-related psychosis . METHODS Patients with moderate-to-severe psychotic symptoms associated with dementia were recruited from outpatient or residential setting s and r and omly assigned to 10-week , double-blind , flexible-dose treatment with olanzapine ( N=204 ; 2.5 mg-10 mg/day ; mean : 5.2 mg/day ) , risperidone ( N=196 ; 0.5 mg-2 mg/day ; mean : 1.0 mg/day ) or placebo ( N=94 ) . RESULTS Most measures of neuropsychiatric functioning improved in all treatment groups , including the placebo group , and no significant treatment differences occurred . Overall discontinuation was lowest in the placebo group , and the olanzapine group had a significantly higher incidence of discontinuation due to adverse events ( 16.2 % ) relative to placebo ( 3.2 % ) and risperidone ( 8.7 % ) groups . Treatment-emergent extrapyramidal symptoms were more numerous for risperidone- than placebo- or olanzapine-treated patients . Abnormally high prolactin levels occurred in 78.0 % of risperidone patients , compared with 16.7 % for olanzapine and 5.0 % for placebo . The incidence of weight gain greater than 7 % from baseline was higher in the olanzapine group relative to risperidone , but neither active-treatment group showed a statistical difference from placebo ( 1.1 % ) . No other statistically significant and clinical ly relevant differences were seen for any other vital sign , electrocardiographic measure , or laboratory hematology and chemistry , including glucose , except for cholesterol , which decreased from baseline to endpoint in both active-treatment groups . CONCLUSIONS Patients ' neuropsychiatric functioning improved with olanzapine , risperidone , and placebo treatment . There was a substantial response in the placebo group , and no significant differences emerged among treatments Objective : Although many patients with obsessive-compulsive disorder ( OCD ) benefit from treatment with serotonin reuptake inhibitors ( SRIs ) , it is estimated that 40 % to 60 % of them do not respond . The objective of the present study was to evaluate the efficacy of quetiapine added to baseline treatment with SRIs for the treatment of OCD in severely ill adult subjects . Method : Forty patients ( 21 men , 19 women ) with primary OCD according to Diagnostic and Statistical Manual of Mental Disorders , Fourth Edition criteria participated in a 12-week , double-blind , placebo-controlled trial . They were r and omly assigned to dosages of quetiapine titrated up to 400 mg/d ( n = 20 ) or to placebo ( n = 20 ) in addition to their SRI treatment . During the continuation phase ( weeks 6 - 12 ) , subjects received different dosages between 400 and 600 mg/d depending on clinical response . At entry , all patients were unresponsive to at least 1 course of at least 12 weeks of treatment with SRIs at defined doses . The total Yale-Brown Obsessive-Compulsive Scale score was the primary efficacy parameter . Results : Intention-to-treat , last-observation-carried-forward analysis demonstrated a mean ± SD decrease in Yale-Brown Obsessive-Compulsive Scale score of 5.2 ± 5.4 in the quetiapine group and 3.9 ± 4.9 in the placebo group . The analysis of treatment effects between the 2 groups showed no significant difference . There were no significant group differences in any of the other self-rating scales or clinician-administered rating scales . Conclusions : In this study , augmentation of SRI treatment with quetiapine in severe OCD had no additional effect Rationale More data are needed to guide “ next step ” strategies for patients with generalized anxiety disorder ( GAD ) remaining symptomatic despite initial pharmacotherapy . Objective This study prospect ively examined the relative efficacy of quetiapine versus placebo augmentation for individuals with GAD remaining symptomatic with initial paroxetine CR pharmacotherapy . Material s and methods Adult out patients with GAD were recruited from 2004 to 2007 at two academic centers . Phase 1 consisted of 10 weeks of open-label paroxetine CR flexibly dosed to a maximum of 62.5 mg/day . Those remaining symptomatic ( Hamilton Anxiety Scale [ HAM-A ] ≥ 7 ) at week 10 were r and omized to quetiapine or placebo augmentation flexibly dosed from 25 to 400 mg/day . Results For participants receiving paroxetine CR ( n = 50 ) , there was a significant reduction in HAM-A scores ( baseline mean ± SD = 22.4 ± 4.2 to endpoint mean ± SD = 11.2 ± 6.9 ; paired t = 12.1 , df = 49 , t < 0.0001 ) with 40 % ( n = 20 ) achieving remission . Counter to our hypothesis , we did not find significant benefit for quetiapine augmentation of continued paroxetine CR ( HAM-A reduction mean ± SD = 2.6 ± 5.8 points quetiapine , 0.3 ± 5.5 points placebo ; t = 0.98 , df = 20 , p = n.s . ) in the r and omized sample ( n = 22 ) with relatively minimal additional improvement overall in phase 2 . Conclusions Although conclusions are considered preliminary based on the relatively small sample size , our data do not support the addition of quetiapine to continued paroxetine CR for individuals with GAD who remain symptomatic after 10 weeks of prospect i ve antidepressant pharmacotherapy and suggest that further research examining strategies for GAD refractory to antidepressants is needed BACKGROUND Older individuals with dementia are highly sensitive to the effects of muscarinic receptor blockade . STUDY DESIGN This was a 6-week multisite , r and omized clinical trial . SUBJECTS Eighty-six patients with probable Alzheimer 's disease , vascular dementia , or mixed-etiology dementia ( DSM-IV criteria ) were r and omly assigned to treatment with olanzapine or risperidone . ASSESSMENT S Anticholinergic activity was measured with a radioreceptor assay , and plasma levels of antipsychotic medications were determined . Primary outcomes were assessed with the Udvalg for Kliniske Undersogelser ( UKU ) scale and somnolence adverse events ; secondary outcome measures included scores on the Neuropsychiatric Inventory ( NPI ) and other scales . RESULTS There were no between-treatment differences in the UKU scale or in somnolence adverse events . Statistically significant improvements ( p < .001 ) from baseline were found for the NPI measures , with no between-treatment group differences . Olanzapine was associated with significant increases from baseline in anticholinergic activity , while risperidone was not ; the between-treatment group differences were not statistically significant . Increase in anticholinergic activity was associated with an increase in anticholinergic side effects and slower performance on the Trail Making Test Part A. Higher endpoint anticholinergic activity was associated with higher endpoint scores on several items from the NPI , including delusions , anxiety , and aberrant motor behavior . IMPLICATION S Efficacious doses of olanzapine increased anticholinergic activity in older patients with dementia , while similarly efficacious doses of risperidone did not . Patients whose anticholinergic activity increased were more likely to experience anticholinergic side effects and to have worsening in certain cognitive domains . These data suggest that certain patients may be vulnerable to the anticholinergic activity associated with antipsychotic treatment BACKGROUND The purpose of this study was to explore the efficacy of adding an atypical antipsychotic , olanzapine , to a serotonin reuptake inhibitor ( SRI ) in treatment-refractory obsessive-compulsive disorder ( OCD ) . METHOD Twenty-six patients aged between 18 and 65 ( mean = 41.2 , SD = 11.9 ) years meeting DSM-IV criteria for OCD , who had not responded to SRIs , were treated for 6 weeks in a double-blind , placebo-controlled augmentation study with either olanzapine ( up to 20 mg/day ) or placebo . Severity of illness was assessed biweekly by the Yale-Brown Obsessive Compulsive Scale ( Y-BOCS ) . Analysis of covariance with baseline Y-BOCS score included as a covariate was used to compare improvement in Y-BOCS scores in the 2 groups . Response was defined as a 25 % or greater improvement in Y-BOCS score . Data were collected between April 2001 and May 2003 . RESULTS Outcome was assessed for all patients using the last observation carried forward . Subjects in the olanzapine group had a mean decrease of 4.2 ( SD = 7.9 ) in Y-BOCS score compared with a mean increase in score of 0.54 ( SD = 1.31 ) for subjects in the placebo group ( F = 4.85 , df = 2,23 ; p = .04 ) . Six ( 46 % ) of 13 subjects in the olanzapine group showed a 25 % or greater improvement in Y-BOCS score compared with none in the placebo group . The final mean dose of olanzapine was 11.2 ( SD = 6.5 ) mg/day . Medication was well tolerated . Only 2 ( 15 % ) of 13 subjects who received olanzapine discontinued because of side effects : sedation ( N = 1 ) or weight gain ( N = 1 ) . CONCLUSION These results provide preliminary evidence that adding olanzapine to SRIs is potentially efficacious and well tolerated in the short-term treatment of patients with refractory OCD . Controlled studies with larger sample sizes are necessary to more definitively address this treatment strategy OBJECTIVES Psychotic symptoms and behavioral disturbances are a concern in the care of elderly patients with Alzheimer 's dementia ( AD ) . This study was conducted to compare the efficacy of olanzapine versus placebo in patients with psychotic symptoms associated with AD in long-term or continuing-care setting s. METHODS Patients ( n = 652 ) with AD and delusions or hallucinations were r and omly assigned to 10 weeks of double-blind treatment with placebo or fixed-dose olanzapine ( 1.0 , 2.5 , 5.0 , 7.5 mg/day ) . RESULTS Mean age was 76.6+/-10.4 years . Repeated- measures analysis showed significant improvement from baseline in NPI/NH Psychosis Total scores ( sum of Delusions , Hallucinations items- primary efficacy measure ) in all five treatment groups ( p<0.001 ) , but no pairwise treatment differences were seen at the 10-week endpoint . However , under LOCF analysis , improvement in the 7.5 mg olanzapine group ( -6.2 + /- 4.9 ) was significantly greater than with placebo ( -5.0 + /- 6.1 , p = 0.008 ) , while endpoint CGI-C scores showed the greatest improvement in the Olz 2.5 olanzapine group ( 2.8 + /- 1.4 , p = 0.030 ) relative to placebo ( 3.2 + /- 1.4 ) . There were significant overall treatment-group differences in increased weight , anorexia , and urinary incontinence , with olanzapine showing numerically higher incidences . However , neither the incidence of any other individual events , including extrapyramidal symptoms , nor of total adverse events occurred with significantly higher frequency in any olanzapine group relative to placebo . No clinical ly relevant significant changes were seen across groups in cognition or any other vital sign or laboratory measure , including glucose , triglyceride , and cholesterol . CONCLUSIONS While 1.0 mg olanzapine did not show significant differences from placebo , the 2.5 mg dose was a reasonable starting dose . Olanzapine at 7.5 mg/day significantly decreased psychosis and overall behavioral disturbances ( NPI/NH , BPRS ) and was well tolerated According to previous data , the addition of risperidone in obsessive-compulsive patients refractory to serotonin reuptake inhibitors ( SRIs ) is shown to be a safe and effective treatment strategy . The aims of our study were to evaluate the efficacy of risperidone addition , in comparison to placebo , in fluvoxamine-refractory obsessive-compulsive patients and to investigate whether risperidone could boost the efficacy of fluvoxamine in fluvoxamine-responder patients . Subjects were 45 obsessive-compulsive in patients , consecutively recruited at the Department of Neurosciences at the San Raffaele Hospital , Milan . Thirty-nine patients completed the study . All patients received 12 weeks of a st and ardized open-label fluvoxamine monotherapy and then continued for 6 weeks with placebo or risperidone in a double-blind design . Results showed a significant effect of risperidone addition , at the end of the double-blind phase ( 18th week ) , only for fluvoxamine-refractory patients . Five patients on risperidone ( 50 % ) and two ( 20 % ) on placebo became responders , with a Yale-Brown Obsessive-Compulsive Scale ( Y-BOCS ) decrease > or = 35 % . Risperidone was generally well tolerated , except for a mild transient sedation and a mild increase in appetite . This preliminary study suggests that even very low ( 0.5 mg ) risperidone doses are effective in OC patients who were nonresponders to a st and ardized treatment with fluvoxamine The aim of the present pilot study was to investigate in a single-blind manner , over a period of 8 weeks , the comparative efficacy and tolerability of risperidone versus olanzapine addition in the treatment of OCD patients who did not show a > or=35 % decrease in the YBOCS score after 16-week SRI treatment ( defined as resistant ) . The study consisted of two different phases : a 16-week open-label prospect i ve phase to ascertain resistance to SRI treatment and an 8-week single-blind addition phase for resistant subjects only . Ninety-six subjects with DSM-IV OCD ( YBOCS > or=16 ) entered the open-label prospect i ve phase ; at the end of the 16-week period , 50 ( 52 % ) were judged to be resistant and were r and omized to receive risperidone ( 1 to 3 mg/d ) or olanzapine ( 2.5 to 10 mg/d ) addition for 8 weeks . Overall , patients in both groups responded significantly , without differences between the two treatment groups ; although no differences emerged for the proportion of patients reporting at least an adverse event , the profiles of adverse experiences differed significantly , being risperidone associated with amenorrhoea and olanzapine with weight gain OBJECTIVE Although atypical antipsychotic agents have been found effective in the augmentation of serotonin reuptake inhibitors ( SRIs ) for treatment-resistant obsessive-compulsive disorder ( OCD ) in short-term trials , there are few data on the effectiveness and safety of these agents in clinical setting s over the long term . METHOD Subjects ( N = 46 ) who responded to selective SRIs ( SSRIs ) in an initial 12-week trial were continued on SSRI monotherapy plus cognitive-behavioral therapy ( CBT ) for 1 year . Subjects ( N = 44 ) who failed to respond to SSRIs were r and omly assigned to 1 of 3 atypical antipsychotics -- olanzapine , quetiapine , or risperidone -- and were consecutively treated using SSRI + atypical antipsychotics combined with CBT for 1 year . This study was conducted from January 2006 to November 2007 at Osaka City University Graduate School of Medicine Hospital , Japan . RESULTS Augmentation with atypical antipsychotics reduced mean + /- SD Yale-Brown Obsessive Compulsive Scale ( YBOCS ) total scores in SSRI-refractory OCD patients ( at initial assessment = 29.3 + /- 9.9 , after 1 year = 19.3 + /- 6.8 ) . However , compared to SSRI responders ( at initial assessment = 25.8 + /- 11.4 , after 1 year = 13.7 + /- 4.6 ) , total YBOCS scores in those who required atypical antipsychotic augmentation were initially higher , and they remained at higher levels than those of SRI responders after 1 year of the treatments . CONCLUSIONS Our work does not sufficiently support the long-term effectiveness of the atypical antipsychotics in the augmentation of SSRIs for treatment-resistant OCD patients . Even though this approach seems useful for some types of OCD patients , such as those with symmetry/ordering and hoarding symptoms , these data emphasize the limitations of the current pharmacotherapeutic options in treatment-refractory OCD , and their chronic use raises a number of safety concerns . TRIAL REGISTRATION ( Clinical Trials.gov ) Identifier NCT00854919 BACKGROUND Patients with Alzheimer disease ( AD ) commonly exhibit psychosis and behavioral disturbances that impair patient functioning , create caregiver distress , and lead to institutionalization . This study was conducted to assess the efficacy and safety of olanzapine in treating psychosis and /or agitation/aggression in patients with AD . METHODS A multicenter , double-blind , placebo-controlled , 6-week study was conducted in 206 elderly US nursing home residents with AD who exhibited psychotic and /or behavioral symptoms . Patients were r and omly assigned to placebo or a fixed dose of 5 , 10 , or 15 mg/d of olanzapine . The primary efficacy measure was the sum of the Agitation/Aggression , Hallucinations , and Delusions items ( Core Total ) of the Neuropsychiatric Inventory-Nursing Home version . RESULTS Low-dose olanzapine ( 5 and 10 mg/d ) produced significant improvement compared with placebo on the Core Total ( -7.6 vs -3.7 [ P<.001 ] and -6.1 vs -3 . 7 [ P = .006 ] , respectively ) . Core Total improvement with olanzapine , 15 mg/d , was not significantly greater than placebo . The Occupational Disruptiveness score , reflecting the impact of patients ' psychosis and behavioral disturbances on the caregiver , was significantly reduced in the 5-mg/d olanzapine group compared with placebo ( -2.7 vs -1.5 ; P = .008 ) . Somnolence was significantly more common among patients receiving olanzapine ( 25.0%-35.8 % ) , and gait disturbance occurred in those receiving 5 or 15 mg/d ( 19.6 % and 17.0 % , respectively ) . No significant cognitive impairment , increase in extrapyramidal symptoms , or central anticholinergic effects were found at any olanzapine dose relative to placebo . CONCLUSION Low-dose olanzapine ( 5 and 10 mg/d ) was significantly superior to placebo and well tolerated in treating agitation/aggression and psychosis in this population of patients with AD Introduction : Behavioral disturbances are determining factors in h and ling patients with Alzheimer dementia . The current pharmacotherapy for behavioral symptoms associated with dementia is not satisfactory . Our goal was to compare a new anticonvulsant , topiramate , with a usually used medication , risperidone , for controlling behavioral disturbances of patients with Alzheimer dementia . Method : Elderly patients with a Diagnostic and Statistical Manual of Mental Disorders , Fourth Edition diagnosis of Alzheimer disease and significant behavioral disturbances were r and omized to receive , for a period of 8 weeks , a flexible dose of either topiramate ( 25 - 50 mg/d ) or risperidone ( 0.5 - 2 mg/d ) . Outcome measures were the Cohen-Mansfield Agitation Inventory , Neuropsychiatry Inventory parts 1 and 2 , and the Clinical Global Impression . Result : Forty-eight patients were r and omized to treatment with either topiramate or risperidone , and 41 patients ( 21 of 25 in topiramate group and 20 of 23 in risperidone group ) completed the trial . Both groups showed significant improvement in all outcome measures without important difference ( Neuropsychiatry Inventory total score P < 0.531 , Z = 0.62 ; Cohen-Mansfield Agitation Inventory P < 0.927 , Z = 0.09 ; Clinical Global Impression , P < 0.654 , Z = 0.48 ) . There were no significant changes in the cognitive status of patients ( assessed by Mini-Mental Status Examination ) taking topiramate or risperidone during the trial . Conclusion : Treatment with a low dose of topiramate ( 25 - 50 mg/d ) demonstrated a comparable efficacy with risperidone in controlling behavioral disturbances of patients with Alzheimer dementia This double-blind , placebo-controlled trial was performed to determine the efficacy and tolerability of 8 wk of risperidone augmentation of serotonin reuptake inhibitor ( SRI ) treatment in adult subjects with treatment-resistant obsessive-compulsive disorder ( OCD ) ( failure of at least two SRI trials ) . Sixteen adult treatment-resistant OCD patients were r and omly assigned to augmentation with 8 wk of either risperidone ( n=10 ) ( 0.5 - 3.0 mg/d ) or placebo ( n=6 ) following at least 12 wk of SRI treatment . Four patients on risperidone ( 40 % ) and none ( 0 % ) on placebo were responders with both a Clinical Global Impression - Improvement ( CGI-I ) score of 1 or 2 and a Yale-Brown Obsessive-Compulsive Scale ( Y-BOCS ) decrease > /=25 % . Risperidone was generally well tolerated : there were 3 dropouts , 1 on risperidone and 2 on placebo . Better Y-BOCS insight score at baseline significantly correlated with a greater CGI-I score at endpoint on risperidone augmentation . Risperidone may be an effective and well-tolerated augmentation strategy in treatment-resistant OCD subjects , but larger sample size studies are required to demonstrate this BACKGROUND Residual symptoms despite treatment are common in generalized anxiety disorders ( GAD ) . The Patient-Rated Troubling Symptoms for Anxiety ( PaRTS-A ) is a newly created and vali date d instrument that measures the symptoms most troublesome to each individual patient and was used to test the hypothesis that adjunctive risperidone improves residual GAD symptoms . METHODS Primary care and psychiatry clinicians enrolled adults ( n = 417 ) with GAD and a Clinical Global Impressions of Severity rating ≥ 4 despite ≥ 8 weeks of anxiolytic treatment . Subjects were r and omized to adjunctive risperidone or placebo . The primary endpoint was change from baseline to week 4 endpoint in PaRTS-A. RESULTS Improvement from baseline to week 4 endpoint in PaRTS-A total score ( mean + /-SE ) was similar between treatment groups ( -8.54 [ 0.63 ] and -7.61 [ 0.64 ] for adjunctive risperidone and placebo , respectively ; P = .265 ) . Patients in each treatment group exhibited significant improvements from baseline in nearly all patient- and clinician-rated measures . A post-hoc analysis of PaRTS-A symptoms of moderate to severe severity at baseline suggested greater improvement with risperidone than placebo ( P = .04 ) . Headache , weight increase , and increased appetite were the most frequently reported adverse events in both groups . CONCLUSIONS Residual GAD symptoms assessed by the PaRTS-A improved with either adjunctive risperidone or placebo . Alternative analyses or scoring approaches may improve the ability of the PaRTS-A to provide clinical ly meaningful information on patient-rated symptoms . Further exploration of the benefits of risperidone in patients with more severe GAD may be indicated OBJECTIVE To assess the efficacy of quetiapine addition to citalopram in treatment-naive or medication-free obsessive-compulsive disorder ( OCD ) patients . METHOD Seventy-six patients who met DSM-IV criteria for OCD and who were drug-free or drug-naive at entry were r and omly assigned in a 10-week , double-blind trial with citalopram ( 60 mg/day ) plus quetiapine ( 300 - 450 mg/day ) or placebo ; treatment-refractory OCD patients were excluded . Of the 76 eligible patients , 66 patients completed the trial-31 in the quetiapine and 35 in the placebo group . The change from baseline to endpoint on the total Yale-Brown Obsessive Compulsive Scale ( YBOCS ) and the response to treatment in the quetiapine addition compared with the placebo addition group were the primary outcome measures . Response was defined as a 35 % or greater reduction on the YBOCS and a Clinical Global Impressions-Improvement ( CGI-I ) score at endpoint of 1 or 2 . The study was conducted from November 2003 to June 2005 at the University Medical Centre Utrecht , The Netherl and s. RESULTS As measured by the mean reduction in YBOCS scores following an intent-to-treat , last-observation-carried-forward analysis , quetiapine addition ( 11.9 ) was significantly superior to placebo ( 7.8 ; p = .009 ) . Quetiapine addition was also significantly superior to placebo on the CGI-I scale , with a mean + /- SD CGI-I score of 2.1 + /- 1.3 versus 1.4 + /- 1.2 , respectively ( p = .023 ) . Quetiapine addition ( N = 22 , 69 % ) was also associated with a significantly greater number of patients responding to treatment compared with placebo addition ( N = 15 , 41 % ; p = .019 ) . More patients receiving quetiapine ( N = 8) than placebo ( N = 2 ; NS ) discontinued treatment due to adverse events . CONCLUSIONS The combination of quetiapine and citalopram was more effective than citalopram alone in reducing OCD symptoms in treatment-naive or medication-free OCD patients . TRIAL REGISTRATION www.trialregister.nl Identifier NTR116 OBJECTIVE To evaluate the efficacy and safety of low-dose risperidone in treating psychosis of Alzheimer 's disease ( AD ) and mixed dementia ( MD ) in a subset of nursing-home residents who had dementia and aggression and who were participating in a r and omized placebo-controlled trial of risperidone for aggression . METHOD This post-hoc analysis included only patients diagnosed with AD or MD with psychosis , defined by a score of > or= 2 on any item of the Behavioral Pathology of Alzheimer 's Disease ( BEHAVE-AD ) psychosis subscale at both screening and baseline . Co- primary efficacy endpoints were changes in scores on BEHAVE-AD psychosis subscale and Clinical Global Impression of Change ( CGI-C ) . RESULTS Overall , 93 patients ( 46 risperidone and 47 placebo ) fulfilled the psychosis of AD criteria . Mean change at endpoint in BEHAVE-AD psychosis subscale with risperidone was superior to placebo ( -5.2 vs -3.3 ; p = 0.039 ) . Distribution of CGI-C at endpoint also favoured risperidone ( p < 0.001 ) . The superior improvement with risperidone compared with placebo occurred as early as the first two weeks and persisted to the end of the treatment period . At endpoint , 59 % of risperidone-treated patients were responders ( i.e. were ' very much ' or ' much ' improved ) compared with 26 % of patients receiving placebo . The mean risperidone dose was 1.03 + /- 0.61 mg/day . Twelve weeks of treatment were completed by 37 patients treated with risperidone ( 80 % ) and 35 with placebo ( 74 % ) . A total of 46 ( 98 % ) placebo- and 44 ( 96 % ) risperidone-treated patients experienced at least one adverse event , with only somnolence occurring more frequently in the risperidone group . CONCLUSION Risperidone effectively reduces psychosis and improves global functioning in elderly patients with moderate-to-severe psychosis of AD and MD This study aim ed to determine the efficacy and tolerability of adding quetiapine to a serotonin reuptake inhibitor in treatment-resistant obsessive – compulsive disorder ( OCD ) . Twenty-one adult treatment-resistant OCD patients were r and omized to 16 weeks of augmentation with either quetiapine ( n=11 ) or placebo ( n=10 ) . Patients with significant comorbidities , including tic-spectrum disorders , were not included . The treatment was well tolerated , with only one premature dropout in each treatment-group . The primary analysis showed that individuals in the quetiapine-treated group showed a 14 % mean improvement in baseline Yale – Brown Obsessive – Compulsive Scale scores at study endpoint compared with a 6 % improvement in those treated with placebo , but this difference did not reach statistical significance ( F<1 ) . Three patients treated with quetiapine met criteria for clinical response , compared to one patient who was treated with placebo . Larger studies are needed to explore the efficacy of second generation antipsychotics , such as quetiapine , when used as adjunct treatment in resistant OCD BACKGROUND Although few placebo-controlled neuroleptic discontinuation studies have been conducted in people with dementia , such studies are essential to inform key clinical decisions . METHOD A 3-month , double-blind , placebo-controlled , neuroleptic discontinuation study ( June 2000 to June 2002 ) was completed in 100 care-facility residents with probable or possible Alzheimer 's disease ( according to National Institute of Neurological and Communicative Diseases and Stroke/Alzheimer 's Disease and Related Disorders Association criteria ) who had no severe behavioral disturbances and had been taking neuroleptics for longer than 3 months . The Neuropsychiatric Inventory ( NPI ) was used to measure changes in behavioral and psychiatric symptoms . Quality of life was evaluated using Dementia Care Mapping . RESULTS Eighty-two patients completed the 1-month assessment ( 36 placebo , 46 active ) . The number of participants withdrawing overall ( N = 14 [ 30 % ] placebo , N = 14 [ 26 % ] active treatment ) and because of exacerbation of behavioral symptoms ( N = 6 [ 13 % ] placebo , N = 5 [ 9 % ] active treatment ) was similar in the neuroleptic- and placebo-treated patients . As hypothesized , patients with baseline NPI scores at or below the median ( < or = 14 ) had a particularly good outcome , with a significantly greater reduction of agitation in the patients receiving placebo ( Mann-Whitney U test , z = 2.4 , p = .018 ) , while patients with higher baseline NPI scores were significantly more likely to develop marked behavioral problems if discontinued from neuroleptics ( chi(2 ) = 6.8 , p = .009 ) . There was no overall difference in the change of quality of life parameters between groups . DISCUSSION A st and ardized evaluation with an instrument such as the NPI may be a clinical indicator of which people with dementia are likely to benefit from discontinuation of neuroleptic treatment Objective : To compare effects of risperidone with placebo ( efficacy and tolerability ) and haloperidol ( tolerability ) for treating demented patients with aggression and other behavioral symptoms . Methods : A 13-week double-blind study involving 344 patients with dementia r and omly assigned to receive placebo or flexible doses ( 0.5 to 4 mg/d ) of risperidone or haloperidol . Behavioral symptoms were assessed by the Behavior Pathology in Alzheimer ’s Disease Rating Scale ( BEHAVE-AD ) , the Cohen-Mansfield Agitation Inventory ( CMAI ) , and the Clinical Global Impression ( CGI ) scale . Tolerability assessment s included the Extrapyramidal Symptom Rating Scale , sedation levels , Functional Assessment Staging , Mini-Mental State Examination , and incidence of adverse events . Results : The mean dose at endpoint was 1.1 mg/d of risperidone and 1.2 mg/d of haloperidol . Although not significant , a higher percentage of patients receiving risperidone than those receiving placebo showed clinical improvement ( ≥30 % reduction from baseline to endpoint in BEHAVE-AD total score ) at endpoint and week 12 . Reductions in the BEHAVE-AD total score were significantly greater with risperidone than with placebo at week 12 . In a further analysis of aggression , the most dominant symptom in these patients , BEHAVE-AD and CMAI aggression cluster scores were significantly reduced compared with placebo at endpoint and week 12 . CGI scores were also significantly reduced at endpoint and week 12 . Severity of extrapyramidal symptoms with risperidone did not differ significantly from that of placebo and was less than that of haloperidol . A post hoc analysis showed significantly greater reductions in the BEHAVE-AD aggressiveness score with risperidone than haloperidol at week 12 . Conclusion : Low-dose risperidone ( mean 1.1 mg/d ) was well tolerated and associated with reductions in the severity and frequency of behavioral symptoms , particularly aggression , in elderly patients with dementia BACKGROUND There has been little systematic study of " next-step " interventions for patients with generalized anxiety disorder ( GAD ) who remain symptomatic despite initial pharmacotherapy . We present one of the first r and omized controlled trials for refractory GAD , comprising double blind augmentation with olanzapine or placebo for patients remaining symptomatic on fluoxetine . METHODS Patients remaining symptomatic after 6 weeks of fluoxetine ( 20 mg/day ) were r and omized to 6 weeks of olanzapine ( mean dose 8.7 + /- 7.1 mg/day ) or placebo augmentation . RESULTS Twenty-four of 46 fluoxetine-treated patients were r and omized . Olanzapine result ed in a greater proportion of treatment responders based on a Clinical Global Impression-Severity Scale ( CGI-S ) end point score of 1 or 2 ( Fisher 's exact test [ FET ] p < .05 ) or a 50 % reduction in Hamilton Anxiety Scale ( HAMA-A ) score ( FET p < .05 ) . There were no other statistically significant differences for olanzapine compared with placebo augmentation in outcome measures , though rates of remission ( HAM-A < or= 7 ) on olanzapine were higher at the level of a trend ( FET , p = .1 ) . Average weight gain for completers was greater with olanzapine than placebo augmentation ( 11.0 + /- 5.1 vs. -0.7 + /- 2.4 pounds : t = 6.32 , p < .001 ) . CONCLUSIONS Olanzapine may have a salutary effect on anxiety for some GAD patients remaining symptomatic despite initial serotonin selective reuptake inhibitor ( SSRI ) therapy , but the emergence of significant weight gain represents an important clinical consideration OBJECTIVE Although significant advances have been made in recent years in the treatment of generalized anxiety disorder ( GAD ) , many patients remain symptomatic despite ongoing treatment , underscoring the need for adjunctive new treatments to help improve response . METHOD Forty patients with a primary diagnosis of DSM-IV GAD , who continued to experience GAD symptoms despite current anxiolytic treatment of at least 4 weeks ' duration , as evidence d by Hamilton Rating Scale for Anxiety ( HAM-A ) total score > or = 18 and Clinical Global Impressions-Severity of Illness scale score of moderate or greater , completed a 1-week screening phase and were then r and omly assigned to 5 weeks of double-blind adjunctive treatment with placebo or risperidone at flexible doses of 0.5 to 1.5 mg/day . Patients continued to take their anxiolytics throughout the study . The study was conducted from June 2001 through March 2003 . RESULTS Adjunctive risperidone was associated with statistically significant improvements in core anxiety symptoms , as demonstrated by greater reductions in HAM-A total scores ( p = .034 ) and HAM-A psychic anxiety factor scores ( p = .047 ) compared with placebo . Although change scores on other outcome variables , including response rates , were higher in the risperidone group , differences did not achieve statistical significance . CONCLUSION Study findings suggest that risperidone at low doses may represent a useful tool in the management of symptomatic GAD patients OBJECTIVE To assess the efficacy and safety of aripiprazole for psychosis associated with Alzheimer dementia ( AD ) . METHODS In this double-blind , multicenter study , 487 institutionalized patients with psychosis associated with AD were r and omized to placebo or aripiprazole , 2 , 5 or 10 mg/day . Primary efficacy assessment was the mean change from baseline to week 10 on the Neuropsychiatric Inventory-Nursing Home ( NPI-NH ) version Psychosis Subscale score . Secondary measures included NPI-NH Total , Clinical Global Impression-Severity of Illness ( CGI-S ) , Brief Psychiatric Rating Scale ( BPRS ) Core and Total , and the Cohen-Mansfield Agitation Inventory ( CMAI ) scores . RESULTS Aripiprazole 10 mg/day showed significantly greater improvements ( mean change [ 2 x SD ] ) than placebo on the NPI-NH Psychosis Subscale ( -6.87 [ 8.6 ] versus -5.13 [ 10.0 ] ; F = 6.29 , df = 1 , 422 , p = 0.013 by analysis of covariance [ ANCOVA ] ) ; CGI-S ( -0.72 [ 1.8 ] versus -0.46 [ 1.6 ] ; F = 4.68 , df = 1 , 419 , p = 0.031 [ ANCOVA ] ) ; BPRS Total ( -7.12 [ 18.4 ] versus -4.17 [ 21.6 ] ; F = 4.72 , df = 1 , 399 , p = 0.030 [ ANCOVA ] ) ; BPRS Core ( -3.07 [ 6.9 ] versus -1.74 [ 7.8 ] ; F = 7.30 , df = 1 , 407 , p = 0.007 [ ANCOVA ] ) ; CMAI ( -10.96 [ 22.6 ] versus -6.64 [ 28.6 ] ; F = 5.23 , df = 1 , 410 , p = 0.023 [ ANCOVA ] ) , and NPI-NH Psychosis response rate ( 65 versus 50 % ; chi(2 ) = 5.52 , df = 1 , p = 0.019 [ CMH ] ) . Aripiprazole 5 mg/day showed significant improvements versus placebo on BPRS and CMAI scores . Aripiprazole 2 mg/day was not efficacious . Cerebrovascular adverse events were reported : aripiprazole 2 mg/day , N = 1 ; 5 mg/day , N = 2 ; 10 mg/day , N = 4 ; placebo , N = 0 . No deaths in any group ( aripiprazole 2 mg/day , 3 % ; 5 mg/day , 2 % ; 10 mg/day , 7 % ; placebo , 3 % ) were considered to be treatment-related . CONCLUSION Aripiprazole 10 mg/day was efficacious and safe for psychosis associated with AD , significantly improving psychotic symptoms , agitation , and clinical global impression . However , clinicians should be aware of the safety considerations of atypical antipsychotic uses in this population This 5-wk , open-label , comparative study investigated the effects of quetiapine and haloperidol on behavioural , cognitive and circadian rest-activity cycle disturbances in patients with Alzheimer 's disease ( AD ) . Out of a total of 30 patients enrolled in the study , there were 22 completers , 11 in the quetiapine group ( mean age 81.9+/-1.8 yr , mean baseline MMSE 19.9+/-1.3 , mean dose 125 mg ) and 11 in the haloperidol group ( mean age 82.3+/-2.5 yr , mean baseline MMSE 18.1+/-1.3 , mean dose 1.9 mg ) . As shown in the Neuropsychiatric Inventory , both medications reduced delusion and agitation , whereas quetiapine additionally improved depression and anxiety . Haloperidol worsened aberrant motor behaviour and caused extrapyramidal symptoms . In the Consortium to Establish a Registry for Alzheimer 's Disease ( CERAD ) neuropsychological test battery which assessed cognitive parameters , quetiapine improved word recall ; significant interaction terms revealed differences between quetiapine and haloperidol in word-list memory and constructional praxis . According to the Nurses ' Observation Scale for Geriatric Patients ( NOSGER ) quetiapine improved instrumental activities of daily living . Actimetry documented the circadian rest-activity cycle before and after treatment . Sleep analysis revealed that patients receiving quetiapine had shorter wake bouts during the night , whereas patients receiving haloperidol had fewer though longer immobile phases . The study provides evidence that quetiapine at a moderate dose may be efficacious in treating behavioural disturbances in AD , with better tolerability than haloperidol This double-blind study evaluated the efficacy and safety of risperidone or olanzapine vs. promazine in the treatment of behavioral and psychological symptoms in dementia(BPSD ) . Patients were required to be 65 years or older , to have DSM-IV diagnoses of Alzheimer 's disease ( AD ) , vascular dementia ( VD ) or a combination of both . A brain computerized tomography ( CT ) was performed for all the patients ; 60 demented patients , 27 men ( 45 % ) and 33 women ( 55 % ) were selected for this study . The University of California Los Angeles neuropsychiatric inventory ( NPI ) was administered at baseline , then after 4 and 8 weeks . Patients had at least a score of 24 or more . The Hoehn and Yahr scale was used for evaluating parkinsonism . The scales were administered by an examinator who was not aware of the kind of treatment of the patients . After a wash-out period of 10 days,20 patients , 9 men and 11 women , mean age 76.6 + /- 6.0 years , were r and omly assigned torisperidone 1 mg daily in divided doses ( morning and bedtime ) ( Group A ) ; 20 patients , 9 men and 11 women , mean age 82.5 + /- 9.3 years were r and omly assigned to olanzapine 5 mg at bedtime ( Group B ) , and 20 patients , 9 men and 11 women , mean age 77.6 + /- 4.6 years , were r and omly assigned to promazine 50 mg daily ( morning and bedtime ) ( Group C ) . In case of lack of clinical response , after 4 weeks , the dose could be increased to 2 mg/day of risperidone , 10 mg/day of olanzapine , and to 100 mg/day of promazine in the respective groups . Repeated measures ANOVA was used for the statistical analysis of rating scales over time ( baseline , 4 and 8 weeks ) . At the end of the 8th week , a global improvement was obtained in 80 % of patients treated with risperidone and olanzapine , vs. 65 % of patients treated with promazine ( p < 0.01 ) . The results show that risperidone in doses of 1 - 2 mg/day and olanzapine in doses of 5 - 10 mg/day are effective and safe in the treatment of BPSD . Risperidone presents a major and dose-dependent antidopaminergic action and seems to be preferable when hallucinations and delusions are prevailing symptoms , even if it gives good results on aggression and w and ering . Olanzapine seems to be faster in its sedative effect , probably for H1 receptor blockade . Moreover , 5-HT6 antagonism may favor acetylcholine release and this explains why these patients have not presented a cognitive worsening . However , both drugs are comparable or even superior to promazine , with significantly fewer side effects of both anticholinergic and extrapyramidal character Generalized anxiety disorder ( GAD ) is a chronic and disabling condition . The aim of this study was to evaluate the effectiveness of low-dose augmentative quetiapine ( mean dose=50 mg/day ) in patients with GAD and partial/no response to selective serotonin reuptake inhibitors ( SSRIs ) . Twenty patients with GAD and partial/no response to SSRIs were r and omized to quetiapine ( n=10 ) or placebo ( n=10 ) for 8 weeks , continuing their treatment with SSRIs . Analyses of variance with repeated measures on Hamilton Anxiety Rating Scale ( HAM-A ) and Clinical Global Impression ( CGIs ; severity of illness ) were carried out at baseline and after 8 weeks and the number of responders/remitters was computed and compared between the groups . HAM-A scores at baseline were 15.60 ( ±4.48 ) in the placebo group and 18.50 ( ±6.59 ) in the quetiapine group , and at the end-point , HAM-A scores in the placebo group were 10.40 ( ±4.88 ) and 9.20 ( ±5.86 ) in the quetiapine group . A significant time-by-treatment effect was found on the HAM-A ( F=5.19 , P=0.035 ) and CGIs scores ( F=19.60 , P<0.001 ) in favor of the quetiapine group . The number of responders was numerically superior in the quetiapine group ( 60 vs. 30 % ) without reaching statistical significance ( & khgr;2=1.82 , degree of freedom=1 , P=0.37 , & phgr;=0.30 ) . Remitters were 40 % for the quetiapine group versus 20 % for the placebo group ( & khgr;2=0.95 , degree of freedom=1 , P=0.63 , & phgr;=0.22 ) . Low-dose augmentative quetiapine may be an useful treatment option for patients with GAD and partial/no response to SSRIs . The lack of double-blind conditions and the limited sample size may limit the confidence in the reported results . Larger r and omized controlled trials are warranted to confirm these data In this 10-week , double-blind , fixed-dose study , elderly institutionalized patients with dementia and agitation were r and omized ( 3:3:2 ) to quetiapine 200mg/day , 100mg/day , or placebo . The primary endpoint was change in Positive and Negative Syndrome Scale (PANSS)-Excitement Component ( EC ) scores at endpoint , analysed using last observation carried forward ( LOCF ) and observed cases ( OC ) approaches . Other efficacy measures were the Clinical Global Impression of Change ( CGI-C ) , and response rates ( percentage with > or = 40 % reduction [ PANSS-EC ] ; " much " or " very much improved " [ CGI-C ] ) , Neuropsychiatric Inventory-Nursing Home version ( NPI-NH ) , and Cohen-Mansfield Agitation Inventory ( CMAI ) . The key safety measure was incidence of adverse events ; change in Mini-Mental State Examination ( MMSE ) was also assessed . Baseline characteristics of 333 participants ( quetiapine 200mg/day , n=117 ; quetiapine 100mg/day , n=124 ; placebo , n=92 ) and completion rates ( 63 - 65 % ) were comparable among groups . Compared with placebo , quetiapine 200mg/day was associated with clinical ly greater improvements in PANSS-EC ( LOCF , p=0.065 ; OC , p=0.014 [ ANCOVA ] ) , CGI-C ( LOCF , p=0.017 ; OC , p=0.002 [ ANOVA ] ) , and CGI-C response rates ( LOCF , p=0.002 ; OC , p<0.001 [ Chi-square test ] ) . Quetiapine 100mg/day did not differentiate from placebo on these measures . There were no between-group differences in NPI-NH or CMAI . Incidences of cerebrovascular adverse events , postural hypotension , and falls were similar among groups . MMSE did not change in any group . Mortality was numerically higher in the quetiapine groups ; rates were not statistically different from placebo . The results of this study suggest that quetiapine 200mg/day was effective and well-tolerated for treating agitation associated with dementia . However , caution should be exercised given the concerns regarding increased mortality with atypical antipsychotics in this vulnerable patient population Recently , atypical antipsychotics have been used for the management of the patients with refractory obsessive – compulsive disorder ( OCD ) . The aim of the present study was to evaluate the results of quetiapine augmentation to a serotonin reuptake inhibitor ( SRI ) in the patients with refractory OCD . Fifty-two patients with OCD according to DSM-IV entered 3 months of an open-label phase treatment with a SRI with or without concomitant adjunctive treatment regimen . Of them , 27 patients were refractory OCD . These patients were r and omly divided into two groups , SRI plus quetiapine and SRI plus placebo , for an 8-week single-blind phase . The course of OCD was evaluated by Yale – Brown Obsession – Compulsion ( Y-BOCS ) and Clinical Global Impression – Severity of Illness and Improvement ( CGI-SI and I ) Scales every other week for 8 weeks . Of the 14 patients in group I , nine ( 64.4 % ) showed significant improvement with 60 % or greater improvement on the Y-BOCS and one ( 7.1 % ) partial improvement with 30 % or greater improvement on the Y-BOCS , whereas no improvement was observed in group II . The addition of quetiapine to ongoing SRI therapy has been found to be effective and well-tolerated approach in patients with refractory OCD This 8-week , r and omized , double-blind , placebo-controlled , flexible-dose trial assessed the efficacy , safety , and tolerability of ziprasidone in adults with treatment-resistant generalized anxiety disorder ( GAD ) . Seventy-three subjects with treatment-resistant GAD were recruited , and 62 were r and omized to either ziprasidone or placebo treatment at a ratio of 2:1 using a flexible dosing strategy ( 20 - 80 mg daily ) . R and omization was stratified into 2 subtypes of patients , those in whom the study drug was used as augmentation and those who have stopped their ineffective medications before entering the present trial ( nonaugmented group ) . The subjects ' clinical status was monitored weekly throughout the course of the study and included the Hamilton Anxiety Scale ( primary outcome measure ) , the Clinical Global Impression Improvement and Severity of Illness scales , the Hamilton Depression Scale , the Sheehan Disability Scale , the Hospital Anxiety and Depression Scale , and the Abnormal Involuntary Movements Scale . Sixty-two patients were r and omized to ziprasidone ( n = 41 ) or placebo ( n = 21 ) . The dropout rate was 24 % , consisting of 2 placebo patients and 13 ziprasidone patients . There was no statistically significant difference in the Hamilton Anxiety Scale score reduction between the drug and placebo groups . However , statistical trends were observed for an augmentation- study medication interaction effect , with ziprasidone patients producing more improvement in the nonaugmented than in the augmented group . This study provides pilot data for an augmentation- study medication interaction effect with ziprasidone patients producing more improvement in the nonaugmented than in the augmented group . Based on the data obtained in this trial and the subsequent power analyses , a future double-blind placebo-controlled trial should include at least 150 treatment-resistant GAD nonaugmented patients r and omized to ziprasidone and placebo in a 1:1 ratio OBJECTIVES To evaluate the tolerability of intramuscular ( IM ) aripiprazole in patients with agitation associated with dementia . DESIGN A 24-hour , double-blind , placebo-controlled , r and omized study . SETTING Sixteen healthcare facilities in the United States . PARTICIPANTS A total of 129 patients with acute agitation associated with Alzheimer 's , vascular or mixed dementia in healthcare facilities . INTERVENTION Patients were r and omized to IM aripiprazole ( 5 mg , 10 mg , or 15 mg ) or IM placebo administered in divided doses 2 hours apart . MEASUREMENTS Safety assessment s included adverse event ( AE ) reporting , vital signs , and electrocardiograms . Preliminary efficacy analyses used the Positive and Negative Syndrome Scale-Excited Component ( PEC ) scores and Agitation-Calmness Evaluation Scale ( ACES ) . RESULTS There was greater incidence of AEs with IM aripiprazole ( 50 % to 60 % ) than IM placebo ( 32.0 % ) , but over 90 % were mild or moderate in severity . The incidence of oversedation was low . PEC scores showed greater improvements in agitation with IM aripiprazole 10 mg and 15 mg compared with IM placebo . CONCLUSION A total of 10 mg or 15 mg of IM aripiprazole administered in divided doses was safe and well tolerated for treatment of agitation associated with Alzheimer 's , vascular , or mixed dementia in long-term care . Preliminary analysis showed greater efficacy compared with IM placebo BACKGROUND The treatment of bipolar disorder is often complicated by the presence of a co-occuring anxiety disorder . Although second generation antipsychotics are being used with increasing frequency in bipolar patients , their anxiolytic effects have not been well studied in this population . METHODS The anxiolytic effect of risperidone 0.5 - 4 mg/day was tested in an 8-week , double-blind , placebo-controlled , r and omized clinical trial in 111 patients with bipolar disorder and a co-occuring panic disorder or generalized anxiety disorder ( GAD ) . The primary outcome measure was the Clinician Global Improvement-21 Anxiety scale ( CGI-21 Anxiety ) . Secondary measures included the Hamilton Anxiety Scale ( HAM-A ) and the Sheehan Panic Disorder Scale . RESULTS On the last-observation-carried forward analysis of repeated measures analysis of variance ( ANOVA ) , risperidone was not more effective than placebo for the CGI-21 Anxiety score or the other anxiety outcome measures . Risperidone was well tolerated , with only two patients withdrawing because of adverse events . LIMITATIONS The risperidone treated group had more patients with mixed states and lifetime panic disorder at r and omization than the placebo group . The study was limited to 8 weeks and to individuals with bipolar and comorbid panic disorder or GAD . The results may not be applicable to risperidone as an add-on treatment to mood stabilizers , or to bipolar disorder comorbid with anxiety disorders other than panic disorder or GAD . CONCLUSIONS Risperidone monotherapy was not an effective anxiolytic for bipolar patients with comorbid panic disorder or GAD in doses of 0.5 - 4 mg/day over 8 weeks of treatment . The efficacy of other second generation antipsychotics and mood stabilizers on anxiety in patients with bipolar disorder and a co-occuring anxiety disorder should be investigated in double-blind , placebo-controlled studies |
11,593 | 23,451,110 | RESULT CTX is safe and efficacious against malaria .
CONCLUSION CTX is safe and still efficacious for the treatment of P.falciparum malaria in non-pregnant adults and children irrespective of HIV status and antifolate resistance profiles .
CTX prophylaxis in HIV infected individuals protects against malaria and CTX may have a role for malaria prophylaxis in specific HIV negative target groups | INTRODUCTION Cotrimoxazole ( CTX ) has been used for half a century .
It is inexpensive hence the reason for its almost universal availability and wide clinical spectrum of use .
In the last decade , CTX was used for prophylaxis of opportunistic infections in HIV infected people .
It also had an impact on the malaria risk in this specific group .
OBJECTIVE We performed a systematic review to explore the efficacy and safety of CTX used for P.falciparum malaria treatment and prophylaxis . | Background Presumptive treatment of malaria is common practice in malaria endemic re source -limited setting s. With the changing epidemiology of malaria and the introduction of artemisinin-based combination therapy ( ACT ) , there is increasing need for parasite-based malaria case management to prevent unnecessary use of anti-malarial medicines , improve patient care in parasite-positive patients and identify parasite-negative patients in whom another diagnosis must be sought . Although parasitological confirmation by microscopy or alternatively by malaria rapid diagnostic tests ( RDTs ) is recommended in all patients suspected of malaria before treatment , gaps remain in the implementation of this policy in re source -limited setting s. There is need to evaluate the use of RDTs among highly active anti-retroviral therapy (HAART)-treated people living with HIV ( PLHIV ) . Methods Within an urban prospect i ve observational research cohort of 559 PLHIV initiated on HAART and cotrimoxazole prophylaxis between April , 2004 and April , 2005 , 128 patients with sustained HIV-RNA viral load < 400 copies/ml for four years were evaluated , in a cross-sectional study , for asymptomatic malaria infection using a histidine-rich protein-2 ( HRP-2 ) RDT to detect Plasmodium falciparum antigen in peripheral blood . Patients with positive RDT results had microscopy performed to determine the parasite densities and were followed for clinical signs and symptoms during the subsequent six months . Results Of the 128 asymptomatic patients screened , only 5 ( 4 % ) had asymptomatic P. falciparum antigenaemia . All the patients with positive HRP2 RDT results showed malaria parasites on thick film with parasite densities ranging from 02 - 15 malaria parasites per high power field . None of the patients with positive RDT results reported signs and symptoms of malaria infection during the subsequent six months . Conclusions In an urban area of low to moderate stable malaria transmission , there was low HRP2 P. falciparum antigenaemia among PLHIV after long-term HAART and cotrimoxazole prophylaxis . Parasite-based malaria diagnosis ( PMD ) is recommended among PLHIV that are on long-term anti-retroviral therapy . RDTs should be utilized to exp and PMD in similar setting s where microscopy is unavailable The purpose of this prospect i ve cohort study was to assess the effect of cotrimoxazole prophylaxis taken by human immunodeficiency virus (HIV)-infected persons on the selection of sulfadoxine-pyrimethamine (SP)-resistant malaria parasites among HIV-uninfected household members . A total of 2,567 HIV-uninfected persons from 605 households were followed and blood specimens were collected each time an episode of Plasmodium falciparum malaria was diagnosed . Study participants were living in households where HIV-infected persons were either taking ( exposed ) or not taking ( unexposed ) cotrimoxazole prophylaxis . From all malaria episodes diagnosed , 50 % of the specimens were r and omly selected and tested for the presence of five key mutations known to mediate resistance to SP ( dihydrofolate reductase [ dhfr ] Asn-108 , Ile-51 , and Arg-59 , and dihydropteroate synthase [ dhps ] Gly-437 and Glu-540 ) . Plasmodium falciparum isolates were recovered from 163 specimens in the exposed households and 113 specimens in the unexposed households , with similar proportions containing the dhfr triple mutant ( 37 % versus 45 % ; P = 0.18 ) , the dhps double mutant ( 64 % versus 62 % ; P = 0.81 ) , and the dhfr/dhps quintuple mutant ( 30 % versus 32 % ; P = 0.74 ) . The HIV-uninfected persons living with HIV-infected household members taking cotrimoxazole prophylaxis had a lower incidence of malaria ( incidence rate ratio [ IRR ] = 0.64 , 95 % confidence interval [ CI ] = 0.50 - 0.83 , P = 0.001 ) and fewer malaria episodes due to parasites containing the dhfr/dhps quintuple mutant ( IRR = 0.61 , 95 % CI = 0.41 - 0.91 , P = 0.014 ) . Cotrimoxazole prophylaxis taken by HIV-infected persons did not select for SP-resistant malaria parasites among HIV-uninfected household members , and was associated with a lower overall incidence of SP-resistant malaria among household members Background : The effect of cotrimoxazole prophylaxis taken by persons with HIV on community health and antimicrobial resistance is unknown . Objective : To assess the effect of cotrimoxazole prophylaxis taken by persons with HIV on morbidity , mortality , and antimicrobial resistance of diarrheal pathogens infecting their HIV-negative family members . Design : Prospect i ve cohort in rural Ug and a. Methods : A total of 879 persons with HIV and 2771 HIV-negative family members received weekly home-visits . After 5 months , persons with HIV received daily cotrimoxazole prophylaxis and households were followed for an average of 17 additional months . Findings : During the study , 224 participants with HIV ( 25 % ) and 29 household members ( 1 % ) died . Mortality among HIV-negative family members < 10 years old was 63 % less during the cotrimoxazole period than before [ hazard ratio , 0.37 ; 95 % confidence interval ( CI ) , 0.14–0.95 ; P = 0.04 ] . Malaria among family members was less common during cotrimoxazole treatment [ incidence rate ratio ( IRR ) , 0.62 ; CI , 0.53–0.74 ; P < 0.0001 ] , as were diarrhea ( IRR , 0.59 ; CI , 0.45–0.76 ; P = 0.0001 ) , and hospitalizations ( IRR , 0.57 ; CI , 0.36–0.92 ; P = 0.02 ) . Death of a parent with HIV was associated with a threefold increase in mortality among HIV-negative children < 10 years old ( hazard ratio , 2.9 ; CI , 1.1–8.1 ; P = 0.04 ) . Of 134 bacterial isolates from family members before cotrimoxazole treatment , 89 ( 66 % ) were resistant to cotrimoxazole ; of 75 recovered during cotrimoxazole treatment , 54 ( 72 % ) were resistant ( P = 0.41 ) . Interpretation : Cotrimoxazole prophylaxis taken by persons with HIV was associated with decreased morbidity and mortality among family members . Antimicrobial resistance among diarrheal pathogens infecting family members did not increase . Concerns regarding the spread of bacterial resistance should not impede implementation of cotrimoxazole programs Objective To evaluate the proposed WHO/UNAIDS criteria for initiating co-trimoxazole prophylaxis in adult HIV-infected patients in Africa [ WHO clinical stages 2–4 or CD4 count < 500 × 106 /l or total lymphocyte count ( TLC ) equivalent ] . Design Observational cohort study of 5-year follow-up . Setting Adult HIV clinics , University of Cape Town , South Africa . Methods Effect of prophylactic low dose co-trimoxazole ( 480 mg per day or 960 mg three times per week ) on survival and morbidity was assessed in patients stratified by WHO clinical stage , CD4 T-lymphocyte count or TLC . Patients receiving antiretroviral therapy were excluded . Results Co-trimoxazole reduced mortality [ adjusted hazard ratio ( AHR ) , 0.56 ; 95 % confidence interval ( CI ) , 0.33–0.85;P > 0.001 ] and the incidence of severe HIV-related illnesses ( AHR , 0.52 ; 95 % CI , 0.38–0.68;P < 0.001 ) in patients with evidence of advanced immune suppression on clinical ( WHO stages 3 and 4 ) or laboratory assessment ( TLC < 1250 × 106/l or CD4 count < 200 × 106/l ) . No significant evidence of efficacy was found in patients with WHO stage 2 or CD4 count 200–500 × 106/l/TLC 1250–2000 × 106/l . If we had applied the WHO/UNAIDS recommendations 88.3 % of our patients would have received co-trimoxazole prophylaxis at their initial clinic visit . Conclusion Co-trimoxazole in HIV-infected adults from an area in which Pneumocystis carinii pneumonia is uncommon demonstrated a survival benefit consistent with previous r and omized trials . Further studies are needed to assess the optimal time of commencement of prophylaxis , as widespread co-trimoxazole use will lead to increasing antimicrobial resistance to other major pathogens in Africa Treatment of malaria with sulfadoxine/pyrimethamine and of presumed bacterial infections with trimethoprim/sulfamethoxazole ( cotrimoxazole ) was assessed to see if either increases the carriage of cotrimoxazole-resistant Streptococcus pneumoniae in Malawian children . Children < 5 years old treated with sulfadoxine/pyrimethamine , cotrimoxazole , or no antimicrobial agent were enrolled in a prospect i ve observational study . Nasopharyngeal swabs were taken before treatment and 1 and 4 weeks later . Pneumococci were tested for antibiotic susceptibility by broth microdilution . In sulfadoxine/pyrimethamine-treated children , the proportion colonized with cotrimoxazole-nonsusceptible pneumococci increased from 38.1 % at the initial visit to 44.1 % at the 4-week follow-up visit ( P=.048 ) . For cotrimoxazole-treated children , the proportion colonized with cotrimoxazole-nonsusceptible pneumococci increased from 41.5 % at the initial visit to 52 % at the 1-week follow-up visit ( P=.0017 ) and returned to 41.7 % at the 4-week follow-up . Exp and ing use of sulfadoxine/pyrimethamine to treat chloroquine-resistant malaria may have implication s for national pneumonia programs in developing countries where cotrimoxazole is widely used BACKGROUND Patients with human immunodeficiency virus ( HIV ) infection are at increased risk for bacterial pneumonia in addition to opportunistic infection . However , the risk factors for bacterial pneumonia and its incidence in this population are not well defined . METHODS In a multicenter , prospect i ve , observational study , we monitored 1130 HIV-positive and 167 HIV-negative participating adults for up to 64 months for pulmonary disease . The HIV-positive group comprised 814 homosexual or bisexual men , 261 injection-drug users , and 55 female partners of HIV-infected men . RESULTS There were 237 episodes of bacterial pneumonia among the HIV-positive participants ( rate , 5.5 per 100 person-years ) , as compared with 6 episodes among the HIV-negative participants ( rate , 0.9 per 100 person-years ; P < 0.001 ) . The rate of bacterial pneumonia increased with decreasing CD4 lymphocyte counts ( 2.3 , 6.8 , and 10.8 episodes per 100 person-years in the strata with more than 500 , 200 to 500 , and fewer than 200 cells per cubic millimeter , respectively ; P < or = 0.022 for each comparison ) . Injection-drug users had a higher rate of bacterial pneumonia than did homosexual or bisexual men or female partners . In the stratum with the fewest CD4 lymphocytes , cigarette smoking was associated with an increased rate of pneumonia . Mortality was almost four times higher among participants with an episode of pneumonia than among the others . Prophylaxis with trimethoprim-sulfamethoxazole was associated with a 67 percent reduction in confirmed episodes of bacterial pneumonia ( P = 0.007 ) . CONCLUSIONS Bacterial pneumonia is more frequent in HIV-positive persons than in seronegative controls , and the risk is highest among those with CD4 lymphocyte counts below 200 per cubic millimeter and among injection-drug users Objective To evaluate the protective efficacy of co-trimoxazole prophylaxis against malaria in HIV exposed children ( uninfected children born to HIV infected mothers ) in Africa . Design Non-blinded r and omised control trial Setting Tororo district , rural Ug and a , an area of high malaria transmission intensity Participants 203 breastfeeding HIV exposed infants enrolled between 6 weeks and 9 months of age Intervention Co-trimoxazole prophylaxis from enrolment until cessation of breast feeding and confirmation of negative HIV status . All children who remained HIV uninfected ( n=185 ) were then r and omised to stop co-trimoxazole prophylaxis immediately or continue co-trimoxazole until 2 years old . Main outcome measure Incidence of malaria , calculated as the number of antimalarial treatments per person year . Results The incidence of malaria and prevalence of genotypic mutations associated with antifolate resistance were high throughout the study . Among the 98 infants r and omised to continue co-trimoxazole , 299 malaria cases occurred in 92.28 person years ( incidence 3.24 cases/person year ) . Among the 87 infants r and omised to stop co-trimoxazole , 400 malaria cases occurred in 71.81 person years ( 5.57 cases/person year ) . Co-trimoxazole prophylaxis yielded a 39 % reduction in malaria incidence , after adjustment for age at r and omisation ( incidence rate ratio 0.61 ( 95 % CI 0.46 to 0.81 ) , P=0.001 ) . There were no significant differences in the incidence of complicated malaria , diarrhoea , pneumonia , hospitalisations , or deaths between the two treatment arms . Conclusions Co-trimoxazole prophylaxis was moderately protective against malaria in HIV exposed infants when continued beyond the period of HIV exposure despite the high prevalence of Plasmodium genotypes associated with antifolate resistance . Trial registration Clinical Trials Summary Background Co-trimoxazole prophylaxis can reduce mortality from untreated HIV infection in Africa ; whether benefits occur alongside combination antiretroviral therapy ( ART ) is unclear . We estimated the effect of prophylaxis after ART initiation in adults . Methods Participants in our observational analysis were from the DART r and omised trial of management strategies in HIV-infected , symptomatic , previously untreated African adults starting triple-drug ART with CD4 counts lower than 200 cells per μL. Co-trimoxazole prophylaxis was not routinely used or r and omly allocated , but was variably prescribed by clinicians . We estimated effects on clinical outcomes , CD4 cell count , and body-mass index ( BMI ) using marginal structural models to adjust for time-dependent confounding by indication . DART was registered , number IS RCT N13968779 . Findings 3179 participants contributed 14 214 years of follow-up ( 8128 [ 57 % ] person-years on co-trimoxazole ) . Time-dependent predictors of co-trimoxazole use were current CD4 cell count , haemoglobin concentration , BMI , and previous WHO stage 3 or 4 events on ART . Present prophylaxis significantly reduced mortality ( odds ratio 0·65 , 95 % CI 0·50–0·85 ; p=0·001 ) . Mortality risk reduction on ART was substantial to 12 weeks ( 0·41 , 0·27–0·65 ) , sustained from 12–72 weeks ( 0·56 , 0·37–0·86 ) , but not evident subsequently ( 0·96 , 0·63–1·45 ; heterogeneity p=0·02 ) . Variation in mortality reduction was not accounted for by time on co-trimoxazole or current CD4 cell count . Prophylaxis reduced frequency of malaria ( 0·74 , 0·63–0·88 ; p=0·0005 ) , an effect that was maintained with time , but we observed no effect on new WHO stage 4 events ( 0·86 , 0·69–1·07 ; p=0·17 ) , CD4 cell count ( difference vs non-users , −3 cells per μL [ −12 to 6 ] ; p=0·50 ) , or BMI ( difference vs non-users , −0·04 kg/m2 [ −0·20 to 0·13 ) ; p=0·68 ] . Interpretation Our results reinforce WHO guidelines and provide strong motivation for provision of co-trimoxazole prophylaxis for at least 72 weeks for all adults starting combination ART in Africa . Funding UK Medical Research Council , the UK Department for International Development , the Rockefeller Foundation , GlaxoSmithKline , Gilead Sciences , Boehringer-Ingelheim , and Abbott Laboratories A hospital-based prospect i ve study of 99 patients with community-acquired pneumonia ( CAP ) was carried out in Kampala , Ug and a. We evaluated microbiological etiologies , clinical features and effectiveness of short-term parenteral ampicillin followed by oral amoxicillin for these patients in relation to HIV-status . We demonstrated a very high prevalence ( 75 % ) of HIV-1 infection . No significant difference was observed with respect to age , gender , prior antibiotic usage , symptoms , laboratory data or bacterial etiology between HIV-1-infected and HIV-uninfected CAP patients . Most strains of Streptococcus pneumoniae ( n = 19 ) and Haemophilus influenzae ( n = 8) isolated from HIV-1-infected patients were penicillin-resistant ( 95 % ) and beta-lactamase producing ( 75 % ) strains , respectively . A high percentage of good clinical response was found in both HIV-1-infected ( 81 % ) and HIV-uninfected ( 86 % ) among 39 patients with CAP due to a defined bacterial pathogen . These data support the use of short-term parenteral ampicillin for patients with bacterial CAP irrespective of HIV-status BACKGROUND Cotrimoxazole prophylaxis is recommended for subgroups of human immunodeficiency virus (HIV)-infected adults and children to reduce all-cause morbidity and mortality . We investigated whether antenatal cotrimoxazole prophylaxis begun during pregnancy for HIV-infected pregnant women with low CD4 cell counts would affect birth outcomes . METHODS Cotrimoxazole prophylaxis was introduced as a routine component of antenatal care for HIV-infected women with CD4 cell counts < 200 cells/ micro L during the course of a trial of mother-to-child HIV transmission in Lusaka , Zambia . Rates of preterm delivery , low birth weight , and neonatal mortality were compared for women with low CD4 cell counts before and after its introduction . RESULTS Among 255 women with CD4 cell counts < 200 cells/ micro L , the percentage of preterm births ( < or = 34 weeks of gestation ) was lower ( odds ratio [ OR ] , 0.49 [ 95 % confidence interval { CI } , 0.24 - 0.98 ] ) after cotrimoxazole prophylaxis was introduced than before ; there was a significant decrease in neonatal mortality ( 9 % to 0 % ; P=.01 ) and a trend toward increased birth weight ( beta = 114 g [ 95 % CI , -42 to 271 g ] ) . In contrast , there were no significant changes in these parameters over the same time interval among women with CD4 cell counts > or = 200 cells/ micro L. Conclusion . Antenatal provision of cotrimoxazole for HIV-infected pregnant women with low CD4 cell counts may have indirect benefits for neonatal health Background Malaria in pregnancy is serious , and drug resistance in Africa is spreading . Drugs have greater risks in pregnancy and determining the safety and efficacy of drugs in pregnancy is therefore a priority . This study set out to determine the efficacy and safety of several antimalarial drugs and combinations in pregnant women with uncomplicated malaria . Methods Pregnant women with non-severe , slide proven , falciparum malaria were r and omised to one of 4 regimes : sulfadoxine-pyrimethamine [ SP ] ; chlorproguanil-dapsone [ CD ] ; SP+amodiaquine [ SP+AQ ] or amodiaquine+artesunate [ AQ+AS ] . R and omisation was on a 1∶2∶2∶2 ratio . Women were admitted for treatment , and followed at days 7 , 14 , 21 , 28 after the start of treatment , at delivery and 6 weeks after delivery to determine adverse events , clinical and parasitological outcomes . Primary outcome was parasitological failure by day 28 . Results 1433 pregnant women were screened , of whom 272 met entry criteria and were r and omised ; 28 to SP , 81 to CD , 80 to SP+AQ and 83 to AQ+AS . Follow-up to day 28 post treatment was 251/272 ( 92 % ) , and to 6 weeks following delivery 91 % . By day 28 parasitological failure rates were 4/26 ( 15 % , 95%CI 4–35 ) in the SP , 18/77 ( 23 % , 95%CI 14–34 ) in the CD , 1/73 ( 1 % 95%CI 7–0.001 ) in the SP+AQ and 7/75 ( 9 % 95%CI 4–18 ) in the AQ+AS arms respectively . After correction by molecular markers for reinfection the parasitological failure rates at day 28 were 18 % for CD , 1 % for SP+AQ and 4.5 % for AQ+AS . There were two maternal deaths during the trial . There was no apparent excess of stillbirths or adverse birth outcomes in any arm . Parasitological responses were strikingly better in pregnant women than in children treated with the same drugs at this site . Conclusions Failure rates with monotherapy were unacceptably high . The two combinations tested were efficacious and appeared safe . It should not be assumed that efficacy in pregnancy is the same as in children . Trial Registration Clinical Trials.gov 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 The safety and efficacy of amodiaquine ( AQ ) , sulfadoxine-pyrimethamine ( SP ) , and coadministered AQ+SP was assessed in 351 Tanzanian children ( age range , 6 - 59 months ) with uncomplicated Plasmodium falciparum malaria . This open , r and omized study followed the 28-day World Health Organization ( WHO ) protocol and evaluated safety using clinical and laboratory parameters . Children receiving SP were more likely to vomit during follow-up ( 32 % vs. 17 % : P = 0.03 ) , and SP alone result ed in prolonged fever clearance times . Although Day 7 and Day 14 clinical and parasitological cure rates were similar , by Day 28 45 % of children treated with AQ demonstrated R1 resistance and 27.5 % were clinical failures compared with 25 % and 6.3 % , respectively , for SP alone . Coadministered AQ+SP was safe , combined the greater clinical ( 96.2 % ) and parasitological ( 64.2 % ) efficacy of SP with the more rapid symptom resolution of AQ , and reduced the incidence of gametocytemia during follow-up ( AQ+SP 12.6 % vs. SP 29.9 % ; P = 0.001 ) . The level of R1 resistance to SP may herald a rapid decline in its efficacy as SP drug pressure increases . Coadministration of AQ+SP may delay this In Malawi , trimethoprim-sulfamethoxazole ( TS ) is the recommended first-line treatment for children with Integrated Management of Childhood Illness dual classifications of malaria and pneumonia , and sulfadoxine-pyrimethyamine ( SP ) plus five days of treatment with erythromycin ( SP plus E ) is the recommended second-line treatment . Using a 14-day , modified World Health Organization protocol , children with dual IMCI classifications of malaria and pneumonia with Plasmodium falciparum parasitemia were r and omized to receive TS or SP plus E. Clinical and parasitologic responses and gametocytemia prevalence were obtained . A total of 87.2 % of children receiving TS and 80.0 % receiving SP plus E reached adequate clinical and parasitologic responses ( ACPRs ) ( P = 0.19 ) . Severely malnourished children were less likely to achieve ACPRs than those better nourished ( relative risk = 3.34 , P = 0.03 ) . Day 7 gametocyte prevalence was 55 % and 64 % among children receiving TS and SP plus E , respectively ( P = 0.19 ) . Thus , TS and SP plus E remain efficacious treatment of P. falciparum malaria in this setting . However , patient adherence and effectiveness of five days of treatment with TS is unknown BACKGROUND Prophylaxis with co-trimoxazole ( trimethoprim-sulphamethoxazole ) is recommended for people with HIV infection or AIDS but is rarely used in Africa . We assessed the effect of such prophylaxis on morbidity , mortality , CD4-cell count , and viral load among people with HIV infection living in rural Ug and a , an area with high rates of bacterial resistance to co-trimoxazole . METHODS Between April , 2001 , and March , 2003 , we enrolled , and followed up with weekly home visits , 509 individuals with HIV-1 infection and their 1522 HIV-negative household members . After 5 months of follow-up , HIV-positive participants were offered daily co-trimoxazole prophylaxis ( 800 mg trimethoprim , 160 mg sulphamethoxazole ) and followed up for a further 1.5 years . We assessed rates of malaria , diarrhoea , hospital admission , and death . FINDINGS Co-trimoxazole was well tolerated with rare ( < 2 % per person-year ) adverse reactions . Even though rates of resistance in diarrhoeal pathogens were high ( 76 % ) , co-trimoxazole prophylaxis was associated with a 46 % reduction in mortality ( hazard ratio 0.54 [ 95 % CI 0.35 - 0.84 ] , p=0.006 ) and lower rates of malaria ( multivariate incidence rate ratio 0.28 [ 0.19 - 0.40 ] , p<0.0001 ) , diarrhoea ( 0.65 [ 0.53 - 0.81 ] , p<0.0001 ) , and hospital admission ( 0.69 [ 0.48 - 0.98 ] , p=0.04 ) . The annual rate of decline in CD4-cell count was less during prophylaxis than before ( 77 vs 203 cells per microL , p<0.0001 ) , and the annual rate of increase in viral load was lower ( 0.08 vs 0.90 log(10 ) copies per mL , p=0.01 ) . INTERPRETATION Daily co-trimoxazole prophylaxis was associated with reduced morbidity and mortality and had beneficial effects on CD4-cell count and viral load . Co-trimoxazole prophylaxis is a readily available , effective intervention for people with HIV infection in Africa BACKGROUND HIV contributes substantially to child mortality , but factors underlying these deaths are inadequately described . With individual data from seven r and omised mother-to-child transmission ( MTCT ) intervention trials , we estimate mortality in African children born to HIV-infected mothers and analyse selected risk factors . METHODS Early HIV infection was defined as a positive HIV-PCR test before 4 weeks of age ; and late infection by a negative PCR test at or after 4 weeks of age , followed by a positive test . Mortality rate was expressed per 1000 child-years . We investigated the effect of maternal health , infant HIV infection , feeding practice s , and age at acquisition of infection on mortality assessed with Cox proportional hazards models , and allowed for r and om effects for trials grouped geographically . FINDINGS 378 ( 11 % ) of 3468 children died . By age 1 year , an estimated 35.2 % infected and 4.9 % uninfected children will have died ; by 2 years of age , 52.5 % and 7.6 % will have died , respectively . Mortality varied by geographical region , and was associated with maternal death ( adjusted odds ratio 2.27 , 95 % CI 1.62 - 3.19 ) , CD4 + cell counts < 200 per microL ( 1.91 , 1.39 - 2.62 ) , and infant HIV infection ( 8.16 , 6.43 - 10.33 ) . Mortality was not associated with either ever breastfeeding and never breastfeeding in either infected or uninfected children . In infected children , mortality was significantly lower for those with late infection than those with early infection ( 0.52 , 0.39 - 0.70 ) . This effect was also seen in analyses of survival from the age at infection ( 0.74 , 0.55 - 0.99 ) . INTERPRETATION These findings highlight the necessity for timely antiretroviral care , for support for HIV-infected women and children in developing countries , and for assessment of prophylactic programmes to prevent MTCT , including child mortality and infection averted A prospect i ve cohort design was used to measure the association between daily cotrimoxazole-prophylaxis and infection with Plasmodium falciparum containing mutations associated with antifolate resistance among persons infected with human immunodeficiency virus ( HIV ) in Tororo and Busia District , in eastern Ug and a. Of 149 cases of P. falciparum parasitemia diagnosed , 147 ( 99 % ) ( smears from participants taking prophylaxis = 91 and smears from those not taking cotrimoxazole prophylaxis = 56 ) were successfully assessed for mutations in the dihydrofolate reductase ( dhfr ) and dihydropteroate synthase ( dhps ) mutations associated with antifolate resistance . Prevalences of the dhfr pure triple mutant ( 74 % and 70 % ; P = 0.71 ) , the dhps pure double mutant ( 95 % and 88 % ; P = 0.21 ) , and the dhfr/dhps pure quintuple mutant ( 73 % and 64 % ; P = 0.36 ) , were not significantly different between those taking and those not taking cotrimoxazole-prophylaxis , respectively . The overall prevalence of the pure quintuple mutant in this study was 69 % , which is among the highest in Africa . Although resistance rates of P. falciparum to antifolate drugs are high , cotrimoxazole-prophylaxis in HIV-infected persons was not associated with a higher prevalence of mutations associated with antifolate resistance Surveillance of molecular markers for key mutations in Plasmodium falciparum dihydrofolate reductase ( DHFR ) and dihydropteroate synthetase ( DHPS ) has been proposed as a means of predicting sulfadoxine/ pyrimethamine ( SP ) treatment outcomes in Africa . This study assessed the association between DHFR and DHPS mutations and st and ardized clinical outcomes in children treated with SP for uncomplicated malaria in Kampala , Ug and a. Two mutations ( DHFR Asn-108 and Ile-51 ) were too common to be useful predictors . Three other mutations ( DHFR Arg-59 , DHPS Gly-437 , and DHPS Glu-540 ) were associated with clinical treatment failure after 14 days , although associations were not significant . When follow-up was extended to 28 days and genotyping was used to distinguish recrudescence from new infections , associations were significantly strengthened . The presence of both the DHFR Arg-59 and DHPS Glu-540 mutations had the strongest association with clinical treatment failure ( odds ratio = 10.7 , P = 0.009 ) . These results support a previously proposed method of predicting clinical outcomes based on the prevalence of these two mutations Trimethoprim is inhibitory for a wide range of bacteria , and when used in combination with a sulphonamide marked synergy has been reported . In order to test its value in the treatment of urinary infections 154 hospital patients with infections of varying severity and due to a wide range of organisms were treated with combinations of sulphamethoxazole and trimethoprim . Combinations of these substances in two different ratios ( 2:1 and 10:1 ) were used in 113 patients , and one week after the end of treatment about three-quarters were cured by both combinations . In a second study 106 patients were treated with a sulphamethoxazole-trimethoprim combination ( 5:1 ) , ampicillin , or sulphadimidine . The cure rate with the 5:1 combination was higher than that found with ampicillin or sulphadimidine both one week after finishing treatment ( sulphamethoxazole-trimethoprim 85 % , ampicillin 70 % , sulphadimidine 40 % ) and at the fourth- to fifth-week follow-up ( sulphamethoxazole-trimethoprim 67 % , ampicillin 52 % , sulphadimidine 15 % ) . The results obtained with the various sulphamethoxazole – trimethoprim combinations did not indicate that a particular ratio was superior for treating urinary infections in general or for those caused by any particular species of organism . Laboratory studies showed that many bacteria causing urinary infections in hospital were sensitive to trimethoprim , and the therapeutic results could have been largely predicted from a knowledge of the in-vitro sensitivity tests to trimethoprim alone . For example , sulphamethoxazole – trimethoprim in the treatment of Proteus mirabilis infections was less successful than in those due to Escherichia coli , and this finding was clearly reflected in the higher minimal inhibitory concentrations for trimethoprim of Pr . mirabilis . The sulphamethoxazole – trimethoprim combination was simple to administer , free from side-effects , and gave satisfactory results in the treatment of urinary infections that occurred in hospital patients BACKGROUND In sub-Saharan Africa , various bacterial diseases occur before pneumocystosis or toxoplasmosis in the course of HIV-1 infection , and are major causes of morbidity and mortality . We did a r and omised , double blind , placebo-controlled clinical trial at community-health centres in Abidjan , Côte d'Ivoire , to assess the efficacy of trimethoprim-sulphamethoxazole ( co-trimoxazole ) chemoprophylaxis at early stages of HIV-1 infection . METHOD 843 HIV-infected patients were screened and 545 enrolled in the study . Eligible adults ( with HIV-1 or HIV-1 and HIV-2 dual seropositivity at stages 2 or 3 of the WHO staging system ) received co-trimoxazole chemoprophylaxis ( trimethoprim 160 mg , sulphamethoxazole 800 mg ) daily or a matching placebo . The primary outcome was the occurrence of severe clinical events , defined as death or hospital admission irrespective of the cause . Analyses were by intention to treat . FINDINGS Four of the r and omised patients were excluded ( positive for HIV-2 only ) . 120 severe events occurred among 271 patients in the co-trimoxazole group and 198 among 270 in the placebo group . Significantly fewer patients in the co-trimoxazole group than in the placebo group had at least one severe event ( 84 vs 124 ) ; the probability of remaining free of severe events was 63.7 % versus 45.8 % ( hazard ratio 0.57 [ 95 % CI 0.43 - 0.75 ] , p=0.0001 ) and the benefit was apparent in all subgroups of initial CD4-cell count . Survival did not differ between the groups ( 41 vs 46 deaths , p=0.51 ) . Co-trimoxazole was generally well tolerated though moderate neutropenia occurred in 62 patients ( vs 26 in the placebo group ) . INTERPRETATION Patients who might benefit from co-trimoxazole could be recruited on clinical criteria in community clinics without knowing the patients CD4-cell count . This affordable measure will enable quick public-health intervention , while monitoring bacterial susceptibility and haematological tolerance Information on the impact of insecticide (permethrin)-treated bed nets ( ITNs ) from r and omized controlled trials in areas of intense perennial malaria transmission is limited . As part of a large-scale , community-based , group-r and omized controlled trial of the effect of ITNs on childhood mortality in a holoendemic area in western Kenya , we conducted three cross-sectional surveys in 60 villages to assess the impact of ITNs on morbidity in 1,890 children less than three years old . Children in ITN and control villages were comparable pre-intervention , but after the introduction of ITNs , children in intervention villages were less likely to have recently experienced illness requiring treatment ( protective efficacy [ 95 % confidence intervals ] = 15 % [ 1 - 26 % ] ) , have an enlarged spleen ( 32 % [ 20 - 43 % ] ) , be parasitemic ( 19 % [ 11 - 27 % ] ) , have clinical malaria ( 44 % [ 6 - 66 % ] ) , have moderately severe anemia ( hemoglobin level < 7.0 g/dL ; 39 % [ 18 - 54 % ] ) , or have a pruritic body rash , presumably from reduced nuisance insect bites ( 38 % [ 24 - 50 % ] ) . Use of ITNs was also associated with significantly higher mean weight-for-age Z-scores and mid-upper arm circumferences . There was no evidence , however , that ITNs reduced the risk of helminth infections , diarrhea , or upper or lower respiratory tract infections . The ITNs substantially reduced malaria-associated morbidity and improved weight gain in young children in this area of intense perennial malaria transmission Molecular assays for monitoring sulfadoxine-pyrimethamine-resistant Plasmodium falciparum have not been implemented because of the genetic and statistical complexity of the parasite mutations that confer resistance and their relation to treatment outcomes . This study analyzed pretreatment dihydrofolate reductase ( DHFR ) and dihydropteroate synthase ( DHPS ) genotypes and treatment outcomes in a double-blind , placebo-controlled trial of sulfadoxine-pyrimethamine and chlorproguanil-dapsone treatment for uncomplicated P. falciparum malaria . Multiple logistic regression was used to identify mutations that were predictive of treatment failure and to identify interactions and confounding factors . Infections caused by parasites with 3 DHFR mutations and 2 DHPS mutations ( the " quintuple mutant " ) were associated with sulfadoxine-pyrimethamine treatment failure but not with chlorproguanil-dapsone treatment failure . The presence of a single DHFR mutation ( Arg-59 ) with a single DHPS mutation ( Glu-540 ) accurately predicted the presence of the quintuple mutant . If this model is vali date d in other population s , it will finally be possible to use molecular markers for surveillance of antifolate-resistant P. falciparum malaria in Africa BACKGROUND Intermittent preventive treatment during pregnancy ( IPTp ) with sulfadoxine-pyrimethamine ( SP ) decreases placental malaria parasitemia and associated maternal anemia , premature delivery , and low birth weight . However , the optimal regimen in the setting of a high prevalence of human immunodeficiency virus ( HIV ) infection remains unclear . METHODS In Malawi , where the efficacy of SP for the treatment of malaria in children is decreasing , we conducted a r and omized , nonblinded study to compare the efficacy of monthly SP IPTp with a 2-dose regimen for the prevention of placental parasitemia in HIV-positive and -negative primigravid and secundigravid women . RESULTS Of HIV-positive women , 7.8 % who received monthly SP had placental malaria , compared with 21.5 % of those who received 2-dose SP ( relative risk [ RR ] , 0.36 [ 95 % confidence interval { CI } , 0.17 - 0.79 ] ) . Of HIV-negative women , 2.3 % who received monthly SP and 6.3 % who received 2-dose SP had placental malaria ( RR , 0.37 [ 95 % CI , 0.11 - 1.19 ] ) . Less than 1 % of women reported adverse drug reactions , with no increase in HIV-positive women or those who received monthly SP . CONCLUSIONS In HIV-positive pregnant women , monthly SP IPTp is more efficacious than a 2-dose regimen in preventing placental malaria . The study also demonstrates the continued efficacy of SP for the prevention of placental malaria , even in the face of its decreasing efficacy for the treatment of malaria in children . In areas with intense transmission of falciparum malaria and a high prevalence of HIV infection , monthly SP IPTp should be adopted BACKGROUND There is a high incidence of opportunistic infection among HIV-1-infected patients with tuberculosis in Africa and , consequently , high mortality . We assessed the safety and efficacy of trimethoprim-sulphamethoxazole 800 mg/160 mg ( co-trimoxazole ) prophylaxis in prevention of such infections and in decrease of morbidity and mortality . METHODS Between October , 1995 , and April , 1998 , we enrolled 771 HIV-1 seropositive and HIV-1 and HIV-2 dually seroreactive patients who had sputum-smear-positive pulmonary tuberculosis ( median age 32 years [ range 18 - 64 ] , median CD4-cell count 317 cells/microL ) attending Abidjan 's four largest outpatient tuberculosis treatment centres . Patients were r and omly assigned one daily tablet of co-trimoxazole ( n=386 ) or placebo ( n=385 ) 1 month after the start of a st and ard 6-month tuberculosis regimen . We assessed adherence to study drug and tolerance monthly for 5 months and every 3 months thereafter , as well as rates of admission to hospital . FINDINGS Rates of laboratory and clinical adverse events were similar in the two groups . 51 patients in the co-trimoxazole group ( 13.8/100 person-years ) and 86 in the placebo group ( 25.4/100 person-years ) died ( decrease In risk 46 % [ 95 % CI 23 - 62 ] , p<0.001 ) . 29 patients on co-trimoxazole ( 8.2/100 person-years ) and 47 on placebo ( 15.0/100 person-years ) were admitted to hospital at least once after r and omisation ( decrease 43 % [ 10 - 64 ] ) , p=0.02 ) . There were significantly fewer admissions for septicaemia and enteritis in the co-trimoxazole group than in the placebo group . INTERPRETATION In HIV-1-infected patients with tuberculosis , daily co-trimoxazole prophylaxis was well tolerated and significantly decreased mortality and hospital admission rates . Our findings may have important implication s for improvement of clinical care for such patients in Africa Sulfadoxine-pyrimethamine ( SP ) and co-trimoxazole were both effective in reducing fever , clearing parasitaemia and improving anaemia in children aged < 5 years with uncomplicated malaria in 2 Kenyan endemic sites , Oyugis in the west and Tiwi on the coast . We compared the efficacy of these 2 regimens ( in May-July 1998 ) by evaluating clinical and parasitological responses over 14 days . The combined incidence of parasitological failure for the combined sites for co-trimoxazole was 14/123 ( 11 % ) and for SP 23/145 ( 16 % ) ( RR 0.72 , 95 % confidence interval [ CI ] 0.31 - 1.46 , P = 0.289 ) . The 14-day clinical failure rate for the combined sites for co-trimoxazole was 4/123 ( 3.3 % ) , and for SP 8/145 ( 5.5 % ) , ( RR 1.69 , 95 % CI 0.91 - 3.15 , P = 0.129 ) . The results indicate that the risk of treatment failure for the 2 regimens was similar . The antimalarial use of co-trimoxazole in uncomplicated malaria needs further investigation , since the 10 - 12-h elimination half-life of both components should reduce selective pressure for resistance . In addition , use of a 2-day high-dose course , tested previously , requires further study to demonstrate its efficacy Objective : To estimate 2-year mortality rates in HIV-1-infected and uninfected infants born to HIV+ and HIV− mothers . Methods : Data are from a prospect i ve study in rural Rakai District , Ug and a. Infant HIV status ( determined by polymerase chain reaction ) was evaluated at 1 to 6 weeks postpartum and during breast-feeding , and maternal HIV viral load and CD4 levels were measured at the postpartum visit . Multivariate Cox proportional hazards models and Kaplan-Meier survival analysis were used to assess survival of infants by maternal and infant HIV status and by quartiles of viral load . Log-rank tests were used to test the e quality of survival functions . Results : Of the 4604 pregnant women , 16.9 % were HIV+ , and the proportion of children infected was 20.9 % . Median survival of HIV-infected infants was 23 months . Two-year child mortality rates were 128 of 1000 children born to HIV− mothers , 165.5 of 1000 uninfected children born to HIV+ mothers , and 540.1 of 1000 HIV-infected children ( P < 0.0001 ) . Compared with children of HIV− mothers , the hazard of child mortality was 2.04 ( P < 0.001 ) if the mother was HIV+ and 3.78 ( P < 0.001 ) if the infant was also infected . In the adjusted model , the highest quartiles of log10 HIV viral load in infants and mothers were associated with significantly increased hazard of child mortality ( hazard ratio [ HR ] = 8.54 and HR = 2.50 , respectively ) . Maternal CD4 counts < 200 cells/mL were also significant predictors of child mortality ( HR = 2.61 ) . A total of 67.6 % of HIV-infected children with viral loads above the median died by the age of 2 years and are in need of early antiretroviral therapy ( ART ) . Conclusions : More than half of HIV-infected infants died at less than 2 years of age . Therefore , ART may need to be initiated earlier in HIV-infected African children BACKGROUND Trimethoprim-sulfamethoxazole ( TS ) prophylaxis is recommended for persons living with human immunodeficiency virus infection and acquired immunodeficiency syndrome in Africa . TS and the antimalarial combination sulfadoxine-pyrimethamine ( SP ) share mechanisms of action and resistance patterns , and concerns about the impact of TS resistance on SP efficacy have contributed to reluctance to implement TS prophylaxis in Africa . METHODS To determine whether TS prophylaxis impairs SP efficacy for treatment of uncomplicated falciparum malaria , we conducted a r and omized , controlled , open-label study of TS prophylaxis . Two hundred and forty children 5 - 15 years old were r and omized in a 2 : 1 fashion to receive either thrice-weekly TS for 12 weeks or no prophylaxis and were treated with SP for subsequent episodes of malaria . The incidence of malaria , SP efficacy , and the prevalence of parasite mutations that confer antifolate drug resistance were measured . RESULTS TS prophylaxis had a 99.5 % protective efficacy against episodes of clinical malaria , with 97 % efficacy against infection . Four SP treatment failures occurred in the control group , and none occurred in the TS group . No evidence was seen for selection by TS of antifolate resistance-conferring mutations in parasite dihydrofolate reductase or dihydropteroate synthase during sub clinical infections . CONCLUSIONS In this setting of low antifolate resistance , TS was highly effective in preventing falciparum malaria infection and disease and did not appear to select for SP-resistant parasites Two dosage schedules of co-trimoxazole , the st and ard antibacterial and a 2-day high-dose schedule , were compared with a st and ard course of chloroquine in the treatment of uncomplicated Plasmodium falciparum malaria . Parasites were cleared from the blood at similar rates , but pyrexia responded more slowly following the st and ard cotrimoxazole dose . No recrudescences were detected in those observed for up to 60 days after treatment BACKGROUND HIV-1 and malaria are common infections in Africa , and cause substantial morbidity and mortality . HIV infection has been associated with an increased incidence of malaria , and more severe disease . Our aim was to assess the effect of antiretroviral treatment ( ART ) on the frequency of clinical malaria in people with HIV , and to measure the additive effects of co-trimoxazole ( trimethoprim and sulfamethoxazole ) prophylaxis , ART , and insecticide-treated bednets . METHODS In 2001 , we enrolled 466 HIV-infected individuals aged 18 years or older in Ug and a in a prospect i ve cohort study that provided co-trimoxazole prophylaxis to 399 participants after 5 months of no intervention . In 2003 , we enrolled 138 survivors from the initial study , and 897 new participants from the same community , to take antiretroviral therapy ( ART ) in addition to co-trimoxazole prophylaxis . The ART was in most cases a combination of stavudine , lamivudine , and nevirapine or efavirenz . In 2004 , we also gave participants insecticide-treated bednets . Households were visited weekly by study staff to record fever , illness , or death in the preceding 7 days . In cases of reported fever in the previous 2 days , we took blood to test for malaria parasites . We compared the frequency of clinical malaria , adjusting for CD4-cell count , age , sex , and season . FINDINGS 1035 individuals were given co-trimoxazole and ART ( median age 38 years , 74 % female , and median CD4-cell count 124 cells/microL ) ; 985 of these , plus four new participants , received co-trimoxazole , ART , and bednets . There were 166 cases of clinical malaria in the study . Compared with a baseline malaria incidence of 50.8 episodes per 100 person-years , co-trimoxazole prophylaxis was associated with 9.0 episodes per 100 person-years ( adjusted incidence rate ratio [ IRR ] 0.24 , 95 % CI 0.15 - 0.38 ) ; ART and co-trimoxazole with 3.5 episodes per 100 person-years ( 0.08 , 0.04 - 0.17 ) ; and co-trimoxazole , ART , and bednets with 2.1 episodes per 100 person-years ( 0.05 , 0.03 - 0.08 ) . Malaria incidence was significantly lower during ART and co-trimoxazole than during co-trimoxazole alone ( IRR 0.36 [ 95 % CI 0.18 - 0.74 ] , p=0.0056 ) . INTERPRETATION A combination of co-trimoxazole , antiretroviral therapy , and insecticide-treated bednets substantially reduced the frequency of malaria in adults with HIV |
11,594 | 11,039,962 | When statin drugs were considered alone , no substantial differences in results were found .
Treatment with lipid lowering drugs lasting five to seven years reduces coronary heart disease events but not all cause mortality in people with no known cardiovascular disease | OBJECTIVE To summarise the effect of primary prevention with lipid lowering drugs on coronary heart disease events , coronary heart disease mortality , and all cause mortality . | OBJECTIVE To determine whether serum lipid intervention , in addition to conventional diabetes treatment , could alter cardiovascular outcomes in type 2 diabetes . RESEARCH DESIGN AND METHODS There were 164 type 2 diabetic subjects ( 117 men , 47 women ) without a history of clinical cardiovascular disease r and omized to receive either bezafibrate or placebo daily on a double-blind basis in addition to routine diabetes treatment and followed prospect ively for a minimum of 3 years . Serial biochemical and noninvasive vascular assessment s , carotid and femoral artery B-mode ultrasound measurements , and those pertaining to coronary heart disease (CHD)— clinical history , the World Health Organization ( WHO ) cardiovascular question naire , and resting and exercise electrocardiogram (ECG)—were recorded . RESULTS Bezafibrate treatment was associated with significantly greater reductions over 3 years in median serum triglyceride ( −32 vs. 4 % , P = 0.001 ) , total cholesterol ( −7 vs. −0.3 % , P = 0.004 ) , and total−to-HDL cholesterol ratio ( −12 vs. −0.0 % , P = 0.001 ) , and an increase in HDL cholesterol ( 6 vs. −2 % , P = 0.02 ) as compared with placebo . There was a trend toward a greater reduction of fibrinogen ( −18 vs. −6 % , P = 0.08 ) at 3 years . No significant differences between the two groups were found in the progress of ultrasonically measured arterial disease . In those treated with bezafibrate , there was a significant reduction ( P = 0.01 , log-rank test ) in the combined incidence of Minnesota-coded probable ischemic change on the resting ECG and of documented myocardial infa rct ion . CONCLUSIONS Improving dyslipidemia in type 2 diabetic subjects had no effect on the progress of ultrasonically measured arterial disease , although the lower rate of “ definite CHD events ” in the treated group suggests that this might result in a reduction in the incidence of coronary heart disease Few studies have evaluated the efficacy of cholesterol-lowering interventions in a community setting and have included a control or comparison group . As part of a preventive health demonstration project in rural Pennsylvania , Medicare beneficiaries underwent cholesterol screening to identify high-risk individuals with serum cholesterol levels > or = 240 mg/dL. These high-risk individuals were r and omized to a cholesterol-lowering intervention through either local hospitals or physicians ' offices or to a control group . Baseline and follow-up serum cholesterol levels collected two to three years later were compared according to service location ( hospital versus physician 's office ) , intervention attendance , degree of participation , baseline heart disease history , and cholesterol-lowering medication use at follow-up . Serum cholesterol levels decreased between 5.7 % and 6.6 % in the hospital-based and physician-based groups , as well as in a control group not offered the intervention . Participation rates did not differ between treatment groups , nor did participation affect serum cholesterol levels . Attendance level and heart disease history were not associated with a greater decrease in serum cholesterol levels . Individuals reporting cholesterol-lowering drug use at follow-up had significantly higher baseline serum cholesterol levels and a significantly greater decrease in total serum cholesterol ( P < .0001 ) than those not on medication . Both nonpharmacological ( diet ) and pharmacological ( drug ) interventions will reduce serum cholesterol levels and heart attack risk . The study results suggest that , at least for older individuals , the impact of nonpharmacological interventions on the community is minimal . We conclude that only very aggressive treatment will significantly loser serum cholesterol levels in older individuals at risk for heart attack Abstract Objective : To describe , and to test against trial data , a simple and flexible computer program for calculating cardiovascular risk in individual patients as an aid to managing risk factors and prescribing drugs to lower cholesterol concentration and blood pressure . Design : Descriptive comparison of actual cardiovascular risk in r and omised controlled trials of cholesterol reduction with risk predicted by a computer program based on the Framingham risk equation . Comparison of the program 's performance with that of tables and guidelines by means of hypothetical case examples . Main outcome measures : Average risk of coronary heart disease and myocardial infa rct ion . Results : The computer program accurately predicted baseline absolute risk in a UK population as well as the relative and absolute reduction in risk from cholesterol lowering for primary prevention of coronary heart disease . The program also allowed a more refined estimate of absolute risk of coronary heart disease than some existing tables and enabled the impact of prescribing decisions to be quantified and costed . Conclusions : This simple computer program to estimate individuals ' cardiovascular disease risk and display the benefits of intervention should help clinicians and patients decide on the most effective packages of risk reduction and identify those most likely to benefit from modulation of risk factors CONTEXT Although cholesterol-reducing treatment has been shown to reduce fatal and nonfatal coronary disease in patients with coronary heart disease ( CHD ) , it is unknown whether benefit from the reduction of low-density lipoprotein cholesterol ( LDL-C ) in patients without CHD extends to individuals with average serum cholesterol levels , women , and older persons . OBJECTIVE To compare lovastatin with placebo for prevention of the first acute major coronary event in men and women without clinical ly evident atherosclerotic cardiovascular disease with average total cholesterol ( TC ) and LDL-C levels and below-average high-density lipoprotein cholesterol ( HDL-C ) levels . DESIGN A r and omized , double-blind , placebo-controlled trial . SETTING Outpatient clinics in Texas . PARTICIPANTS A total of 5608 men and 997 women with average TC and LDL-C and below-average HDL-C ( as characterized by lipid percentiles for an age- and sex-matched cohort without cardiovascular disease from the National Health and Nutrition Examination Survey [ NHANES ] III ) . Mean ( SD ) TC level was 5.71 ( 0.54 ) mmol/L ( 221 [ 21 ] mg/dL ) ( 51 st percentile ) , mean ( SD ) LDL-C level was 3.89 ( 0.43 ) mmol/L ( 150 [ 17 ] mg/dL ) ( 60th percentile ) , mean ( SD ) HDL-C level was 0.94 ( 0.14 ) mmol/L ( 36 [ 5 ] mg/dL ) for men and 1.03 ( 0.14 ) mmol/L ( 40 [ 5 ] mg/dL ) for women ( 25th and 16th percentiles , respectively ) , and median ( SD ) triglyceride levels were 1.78 ( 0.86 ) mmol/L ( 158 [ 76 ] mg/dL ) ( 63rd percentile ) . INTERVENTION Lovastatin ( 20 - 40 mg daily ) or placebo in addition to a low-saturated fat , low-cholesterol diet . MAIN OUTCOME MEASURES First acute major coronary event defined as fatal or nonfatal myocardial infa rct ion , unstable angina , or sudden cardiac death . RESULTS After an average follow-up of 5.2 years , lovastatin reduced the incidence of first acute major coronary events ( 1 83 vs 116 first events ; relative risk [ RR ] , 0.63 ; 95 % confidence interval [ CI ] , 0.50 - 0.79 ; P<.001 ) , myocardial infa rct ion ( 95 vs 57 myocardial infa rct ions ; RR , 0.60 ; 95 % CI , 0.43 - 0.83 ; P=.002 ) , unstable angina ( 87 vs 60 first unstable angina events ; RR , 0.68 ; 95 % CI , 0.49 - 0.95 ; P=.02 ) , coronary revascularization procedures ( 157 vs 106 procedures ; RR , 0.67 ; 95 % CI , 0.52 - 0.85 ; P=.001 ) , coronary events ( 215 vs 163 coronary events ; RR , 0.75 ; 95 % CI , 0.61 - 0.92 ; P = .006 ) , and cardiovascular events ( 255 vs 194 cardiovascular events ; RR , 0.75 ; 95 % CI , 0.62 - 0.91 ; P = .003 ) . Lovastatin ( 20 - 40 mg daily ) reduced LDL-C by 25 % to 2.96 mmol/L ( 115 mg/dL ) and increased HDL-C by 6 % to 1.02 mmol/L ( 39 mg/dL ) . There were no clinical ly relevant differences in safety parameters between treatment groups . CONCLUSIONS Lovastatin reduces the risk for the first acute major coronary event in men and women with average TC and LDL-C levels and below-average HDL-C levels . These findings support the inclusion of HDL-C in risk-factor assessment , confirm the benefit of LDL-C reduction to a target goal , and suggest the need for re assessment of the National Cholesterol Education Program guidelines regarding pharmacological intervention BACKGROUND The atherosclerotic progression-reducing effect of LDL cholesterol ( LDL-C ) lowering has been established in subjects with severe atherosclerotic disease but not in persons with elevated LDL cholesterols without severe atherosclerosis . KAPS ( Kuopio Atherosclerosis Prevention Study ) is the first population -based trial in the primary prevention of carotid and femoral atherosclerosis . METHODS AND RESULTS The eligibility requirements were serum LDL-C > or = 4.0 mmol/L and total cholesterol < 7.5 mmol/L. Out of a geographically defined population , 447 men aged 44 to 65 years ( mean , 57 ) were r and omized to pravastatin ( 40 mg/d ) or placebo for 3 years . Less than 10 % of the subjects had prior myocardial infa rct ion . Thirty-nine men discontinued study medication ; however , efficacy data were available for 424 men . The primary outcome was the rate of carotid atherosclerotic progression , measured as the linear slope over annual ultrasound examinations in the average of the maximum carotid intima-media thickness ( IMT ) of the far wall of up to four arterial segments ( the right and left distal common carotid artery and the right and left carotid bulb ) . For the carotid arteries , at the overall mean baseline IMT of 1.66 mm , the rate of progression of carotid atherosclerosis was 45 % ( 95 % CI , 16 to 69 % ) less in the pravastatin ( 0.017 mm/y ) than the placebo ( 0.031 mm/y ) group ( P = .005 ) . In the common carotid artery there was a treatment effect of 66 % ( 95 % CI , 30 to 95 % ; pravastatin 0.010 mm/y ; placebo 0.029 mm/y ; P < .002 ) at the overall mean baseline IMT of 1.35 mm . A treatment effect of 30 % ( 95 % CI , -1 % to 54 % ) was found for the carotid bulb ( pravastatin , 0.028 ; placebo , 0.040 ; P = .056 ) at the overall mean baseline IMT of 2.0 mm . The treatment effect was larger in subjects with higher baseline IMT values , in smokers and in those with low plasma vitamin E levels . There was no significant treatment effect on atherosclerotic progression in the femoral arteries . CONCLUSIONS These data establish the antiatherogenic effect of LDL-C lowering by pravastatin in hypercholesterolemic men in a primary prevention setting and suggest a greater effect in smokers than in nonsmokers BACKGROUND Familial combined hyperlipidaemia ( FCH ) , characterized by elevated very-low-density lipoprotein ( VLDL ) and /or low-density lipoprotein ( LDL ) , is associated with an increased prevalence of premature cardiovascular disease . Therefore , lipid-lowering is frequently indicated . METHODS We evaluated in a parallel , double-blind r and omized fashion the effect of gemfibrozil ( 1200 mg/day ) ( n = 40 ) or simvastatin ( 20 mg/day ) ( n = 41 ) on lipids , apolipoprotein-B (apo-B)-containing lipoproteins , apo-CIII and lipoprotein(a ) [ Lp(a ) ] , in 81 well-defined FCH patients . RESULTS While both drugs lowered plasma cholesterol and triglyceride levels , gemfibrozil lowered plasma triglycerides more effectively by reduction of triglycerides in VLDL and LDL , whereas simvastatin was more effective in its reduction of total plasma cholesterol by exclusively decreasing LDL cholesterol . High-density lipoprotein ( HDL ) increased to an equal extent on both therapies . Total serum apo-B levels were reduced with both drugs ; however , gemfibrozil decreased apo-B only in VLDL + IDL , whereas simvastatin decreased apo-B in both VLDL + IDL and LDL . In keeping with a more effective reduction of VLDL particles , a more pronounced reduction of apo-CIII also was observed after gemfibrozil , which correlated with the reduction in plasma triglycerides . Baseline concentrations of Lp(a ) showed a wide range in both treatment groups . Median Lp(a ) levels increased after simvastatin , but were not affected by gemfibrozil . CONCLUSION Both therapies exhibited their specific effects , although none of the drugs alone completely normalized the lipid profiles of these patients with FCH . Therefore , the choice of treatment should be based on the most elevated lipoprotein fraction , and in some cases a combination of the two drugs may be indicated This report describes the design and baseline results of the Kyushu Lipid Intervention Study ( KLIS ) . The study aims to test the hypothesis that the long term reduction of serum total cholesterol by pravastatin will lead to a decrease in coronary heart disease ( CHD ) events . The trial was design ed to include a r and om 6,000 male patients aged 45 - 74 years with serum total cholesterol of 220 mg/dl ( 5.69 mmol/l ) or greater and without a history of myocardial infa rct ion , coronary surgery or angioplasty , to undertake either pravastatin or conventional treatment ( including hypolipidemic drugs other than HMG CoA reductase inhibitors , probucol and bezafibrate ) , and to follow up each patient for 5 years . Primary endpoints are fatal and nonfatal myocardial infa rct ion , coronary bypass surgery and angioplasty , cardiac death , and sudden and unexpected death . During the period from May 1990 to September 1993 , a total of 5,640 male patients aged 45 - 74 were recruited by 902 participating physicians throughout Kyushu . R and omization was , however , neglected by study physicians ; the numbers of patients enrolled were 3,061 in the pravastatin group and 2,579 in the conventional treatment group . Patients allocated to the pravastatin treatment were generally unfavorable regarding coronary risk factors . Baseline mean levels of serum total cholesterol were 259 mg/dl ( 6.70 mmol/l ) in the pravastatin group and 246 mg/dl ( 6.36 mmol/l ) in the conventional treatment group ( p < 0.001 ) . Although the trial was regarded as a prospect i ve observational study , the KLIS provides valuable quantitative data regarding cholesterol lowering and reduction in CHD events as well as safety data of the long-term use of a statin in Japanese men with hypercholesterolemia Abstract Objective : To estimate the economic efficiency of using pravastatin to prevent the transition from health to cardiovascular disease in men with hypercholesterolaemia . Design : Economic benefit analysis based on data from the West of Scotl and coronary prevention study . Treatment specific hazards of developing cardiovascular disease according to various definitions were estimated . Scottish record linkage data provided disease specific survival . Cost estimates were based on extracontractual tariffs and event specific average lengths of stay calculated from the West of Scotl and coronary prevention study . Subjects : Men with hypercholesterolaemia similar to the subjects in the West of Scotl and coronary prevention study . Main outcome : Cost consequences , the number of transitions from health to cardiovascular disease prevented , the number needed to start treatment , and cost per life year gained . Results : If 10 000 of these men started taking pravastatin , 318 of them would not make the transition from health to cardiovascular disease ( number needed to treat , 31.4 ) , at a net discounted cost of £ 20 m over 5 years . These benefits imply an undiscounted gain of 2460 years of life , and thus £ 8121 per life year gained , or £ 20 375 per life year gained if benefits are discounted . Restriction to the 40 % of men at highest risk reduces the number needed to treat to 22.5 ( £ 5601 per life year gained ( undiscounted ) and £ 13 995 per life year gained ( discounted ) ) . Conclusions : In subjects without evidence of prior myocardial infa rct ion but who have hypercholesterolaemia , the use of pravastatin yields substantial health benefits at a cost that is not prohibitive overall and can be quite efficient in selected high risk subgroups . Key messages The West of Scotl and coronary prevention study showed that pravastatin can prevent cardiovascular disease in men with hypercholesterolaemia So far , reports have deemed this prevention unjustified due to adverse economic implication s This analysis , based on data from the West of Scotl and coronary prevention study and extensive data from the Scottish record linkage system , shows that using pravastatin in this way is worth considering because of its substantial clinical benefit at a reasonable cost Practitioners must now consider using pravastatin to prevent cardiovascular disease in men with hypercholesterolaemia Increased economic efficiency may be obtained by restricting prevention to patients with additional risk A double-blind intervention trial was started in 1965 to test the hypothesis that the incidence of ischaemic heart disease in middle-aged men can be reduced by lowering raised serum cholesterol levels . It was carried out in 3 European centres-Edinburgh , Budapest , and Prague . Serum cholesterol was to be lowered by the drug clofibrate ( ethyl chlorophenoxyisobutyrate ) which was considered to be free from serious side effects . Studies were carried out on 15 745 males , aged 30 to 59 at entry , for an average of 5 - 3 years , accumulating 83 534 years of experience . The treatment group , of about 5000 , Group I , was a r and omly chosen half of the men in the upper third of the serum cholesterol distribution in some 30 000 volunteers . The comparable control group , Group II , comprised the other 5000 men of the upper third of the cholesterol distribution , and these were given a placebo . A further control group , Group III , of 5000 men , was selected r and omly from the lower third of the cholesterol distribution . These numbers were chosen in order to be 90 per cent certain of detecting a 30 per cent reduction in the incidence of ischaemic heart disease should this occur . Subjects with manifest heart or other major disease were excluded from the trial . No attempt was made to correct other ' risk factors ' for IHD , but their presence was monitored and considered in the analysis . Investigators and participants in the trial were unaware of the groups to which individual men belonged . A mean reduction of approximately 9 per cent of the initial serum cholesterol levels was achieved in the treatment group ( ranging from 7 to 11 % in the 3 centres ) ; this was less than the 15 per cent fall expected . In Edinburgh , during treatment , serum triglyceride concentrations in Group I resembled those naturally occurring in Group III . The incidence ofIHO was lower by 20 per cent in the clofibrate group compared with the high cholesterol controls ( P < 0.05 ) ; this fall was confined to non-fatal myocardial infa rcts which were reduced by 25 per cent . The incidence offatal heart attacks was similar in the 2 high cholesterol groups and there was no significant difference in the incidence of angina . Group III showed substantially lower rates of ischaemic heart disease . The reduction of myocardial infa rct ion in the clofibrate-treated group was greatest in men with the highest levels , and greatest reduction in serum cholesterol . Men with a substantial reduction of cholesterol concentration , who smoked , and also had above average blood pressure levels showed the most benefit . The numbers of deaths , and crude mortality rates from all causes in the clofibrate-treated group significantly exceeded those in the high cholesterol control group ( P < 0.05 ) , though the age-st and ardised mortality rates did not differ significantly between the 3 groups . The numbers of deaths from ' 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 The long-term efficacy and tolerability of simvastatin , a 3-hydroxy-3-methylglutaryl-co-enzyme A ( HMG-CoA ) reductase inhibitor , was assessed during a 24-month follow-up period in 168 elderly hypercholesterolemic patients . After completing a 4 week double blind dose ranging study with simvastatin , 47 males and 122 females over 62 years of age with type II hyperlipidemia , a total cholesterol level above 6.5 mmol/l and clinical ly manifest cardiovascular disease were included in this extended study . A total of 159 patients completed the 12-month follow-up period and 141 patients were monitored over the full 24 months . All patients were started on 10 mg simvastatin once daily and the dosage was increased until the target levels of low density lipoprotein ( LDL ) cholesterol between 2.3 mmol/l ( 90 mg/dl ) and 3.6 mmol/l ( 140 mg/dl ) were reached . Fifty percent of patients reached the targeted LDL cholesterol goal of < 3.6 mmol/l ( 140 mg/dl ) during the study . At study completion , 65 patients ( 39 % ) were taking 40 mg simvastatin per day , 56 patients ( 33 % ) 20 mg , 42 patients ( 25 % ) 10 mg and 5 patients ( 3 % ) only used 5 mg per day . Sixteen patients ( 9 % ) received concomitant lipid lowering therapy . Over 2 years , the mean decrease in LDL cholesterol ranged from 36 % to 38 % , the median decrease in triglycerides was 12 % to 19 % and the mean increase in high density lipoprotein ( HDL ) cholesterol ranged from 9 % to 10 % , respectively . Seven patients discontinued simvastatin because of adverse clinical or laboratory events , but only in two ( 1.1 % ) was this considered to be drug-related . Side-effects were mild and most frequently gastrointestinal in nature . Mean changes in asparate aminotransferase ( AST ) were not significantly different from zero and mean changes in alanine aminotransferase ( ALT ) and creatine phosphokinase ( CPK ) showed a small increase . We conclude that simvastatin is an efficacious and well-tolerated treatment for hypercholesterolemia in elderly individuals for extended periods Abstract Serum cholesterol-lowering ability and safety of colestipol hydrochloride were evaluated in a r and omized , placebo-controlled , multiclinic trial in 2278 hypercholesterolemic patients treated for up to 3 yr . After one month of treatment , serum cholesterol declined more ( P ≤ 0.001 ) in the colestipol group ( 32 mg/dl ) than in the placebo group ( 1 mg/dl ) . Serum cholesterol reduction over all observation periods averaged 37 mg/dl in the colestipol group and 7 mg/dl in the placebo group . Colestipol produced no serious side effects . The coronary heart disease ( CHD ) mortality rate was lower in the colestipol-treated men than in the placebo-treated men ( P ≤ 0.02 ) . The total mortality rate as well as the CHD mortality rate was significantly lower ( P ≤ 0.01 in both instances ) in colestipol-treated men with preexisting CHD than in placebo-treated men with preexisting CHD . Mortality rates in women did not differ significantly in the two treatment groups Probucol , a serum cholesterol-lowering agent , was studied in a double-blind , placebo-controlled trial for one year in 118 hypercholesterolemic men . The mean decrease in the level of serum cholesterol in the probucol group ( N = 88 ) from baseline for months 6 through 12 ranged from 16.2 % to 20.9 % . The mean decrease from baseline for the placebo-treated patients ( N = 30 ) ranged from 5.2 % to 12.7 % . The difference between the groups was highly significant . At the end of this one-year trial , 61 of the probucol-treated patients continued receiving therapy in an open trial for up to seven years . After the second year of probucol treatment , the reduction in serum cholesterol levels ranged from 23.1 % to 27.4 % and was subsequently maintained . The present report shows that probucol is safe and effective for the long-term lowering of serum cholesterol levels in patients with primary hypercholesterolemia This placebo-controlled , multinational study evaluated the use of pravastatin in 1,062 patients with hypercholesterolemia ( serum total cholesterol concentrations of 5.2 to 7.8 mmol/liter [ 200 to 300 mg/dl ] ) and > or = 2 additional risk factors for atherosclerotic coronary artery disease . Efficacy and safety analyses were performed on the initial 26-week , r and omized , double-blind , placebo-controlled period ; further safety analyses were conducted on the subsequent 52 weeks , which included an additional 26-week double-blind phase permitting other lipid-lowering agents and a final 26-week open-label period . At offweeks , pravastatin at a dose of 20 mg once daily at bedtime significantly lowered serum low-density lipoprotein cholesterol 26 % ( 4.7 to 3.5 mmol/liter [ 182 to 135 mg/dl ] ) , total cholesterol 19 % ( 6.8 to 5.6 mmol/liter [ 263 to 217 mg/dl ] ) and triglycerides 12 % ( 1.8 to 1.6 mmol/liter [ 159 to 142 mg/dl ] ) ( p < 0.001 compared with placebo ) and significantly raised serum high-density lipoprotein cholesterol 7 % ( 1.1 to 1.2 mmol/liter [ 43 to 46 mg/dl ] ) ( p < 0.001 compared with placebo ) . Efficacy of pravastatin was maintained at 26 weeks , and during this initial period there were significantly more serious cardiovascular adverse events in the placebo group ( 13 events , 2.4 % ) than in the pravastatin group ( 1 event , 0.2 % ) ( p < 0.001 ) . Six myocardial infa rct ions , 5 cases of unstable angina and 1 sudden cardiac death occurred in the placebo group , compared with none of these events in the pravastatin group . In this study , pravastatin produced beneficial effects on serum lipids and was associated with a reduction in the incidence of serious cardiovascular adverse events BACKGROUND Lowering the blood cholesterol level may reduce the risk of coronary heart disease . This double-blind study was design ed to determine whether the administration of pravastatin to men with hypercholesterolemia and no history of myocardial infa rct ion reduced the combined incidence of nonfatal myocardial infa rct ion and death from coronary heart disease . METHODS We r and omly assigned 6595 men , 45 to 64 years of age , with a mean ( + /- SD ) plasma cholesterol level of 272 + /- 23 mg per deciliter ( 7.0 + /- 0.6 mmol per liter ) to receive pravastatin ( 40 mg each evening ) or placebo . The average follow-up period was 4.9 years . Medical records , electrocardiographic recordings , and the national death registry were used to determine the clinical end points . RESULTS Pravastatin lowered plasma cholesterol levels by 20 percent and low-density-lipoprotein cholesterol levels by 26 percent , whereas there was no change with placebo . There were 248 definite coronary events ( specified as nonfatal myocardial infa rct ion or death from coronary heart disease ) in the placebo group , and 174 in the pravastatin group ( relative reduction in risk with pravastatin , 31 percent ; 95 percent confidence interval , 17 to 43 percent ; P < 0.001 ) . There were similar reductions in the risk of definite nonfatal myocardial infa rct ions ( 31 percent reduction , P < 0.001 ) , death from coronary heart disease ( definite cases alone : 28 percent reduction , P = 0.13 ; definite plus suspected cases : 33 percent reduction , P = 0.042 ) , and death from all cardiovascular causes ( 32 percent reduction , P = 0.033 ) . There was no excess of deaths from noncardiovascular causes in the pravastatin group . We observed a 22 percent reduction in the risk of death from any cause in the pravastatin group ( 95 percent confidence interval , 0 to 40 percent ; P = 0.051 ) . CONCLUSIONS Treatment with pravastatin significantly reduced the incidence of myocardial infa rct ion and death from cardiovascular causes without adversely affecting the risk of death from noncardiovascular causes in men with moderate hypercholesterolemia and no history of myocardial infa rct ion |
11,595 | 23,205,755 | According to the WHO Adherence Model domains , patient-related barriers were most commonly addressed , while condition , therapy , and socioeconomic barriers were underrepresented . | Multiple barriers can influence adherence to antihypertensive medications .
The aim of this systematic review was to determine what adherence barriers were included in each instrument and to describe the psychometric properties of the identified surveys . | OBJECTIVE Determine treatment adherence in patients with multiple chronic conditions ( MCC ) . METHODS A r and om patient sample ≥ 15 years , discharged from hospital with ≥1 chronic conditions ( CC ) was interviewed after 6 - 12 months . Analysis included variables in 5 dimensions ( WHO ) : socio-demographics , disease , treatment , patient and health system characteristics . Morisky-Green adherence question naire was used . High chronic treatment complexity was defined as : > 3 pills/day , > 6 inhalations/day , > 1 injection/day , pharmacological treatment plus diet or self-monitoring techniques . RESULTS 301 patients were interviewed ( 62 ± 15 years , 59 % males ) . Despite good treatment information perception ( 79 % ) , only 3 % followed the patient education programme . Poor adherents ( 82 % ) were older ( 64 ± 14 years vs. 55 ± 16 years ) , had more CC ( 3.25 ± 2.02 vs. 2.62 ± 2.72 ) , a higher frequency of hypertension ( 44 % vs. 15 % ) , ischaemic heart diseases : ( 21 % vs. 4 % ) , hyperlipidaemia ( 19 % vs. 6 % ) , more pills/day ( 5.78 ± 4.14 vs. 3.20 ± 4.70 ) and more complex treatments ( 95 % vs. 70 % ) ( p<0.05 ) . On multivariate analysis number of CC [ 3.68 ( 0.75 - 18.15 ) ] , pills/day [ 2.23 ( 1.02 - 4.84 ) ] , treatment complexity [ 4.00 ( 1.45 - 11.04 ) ] , and hypertension [ 2.57 ( 1.06 - 6.25 ) ] were predictive of poor adherence ( OR 95 % CI p<0.05 ) . CONCLUSION The WHO conceptual framework allows the construction of poor adherence risk profiles in patients with MCC after hospital discharge . PRACTICE IMPLICATION S Predictive variables of poor adherence could help clinicians detect patients with MCC most likely to present poor adherence Background The objective of this study was to develop and psychometrically evaluate a general measure of patients ' satisfaction with medication , the Treatment Satisfaction Question naire for Medication ( TSQM ) . Methods The content and format of 55 initial questions were based on a formal conceptual framework , an extensive literature review , and the input from three patient focus groups . Patient interviews were used to select the most relevant questions for further evaluation ( n = 31 ) . The psychometric performance of items and result ing TSQM scales were examined using eight diverse patient groups ( arthritis , asthma , major depression , type I diabetes , high cholesterol , hypertension , migraine , and psoriasis ) recruited from a national longitudinal panel study of chronic illness ( n = 567 ) . Participants were then r and omized to complete the test items using one of two alternate scaling methods ( Visual Analogue vs. Likert-type ) . Results A factor analysis ( principal component extraction with varimax rotation ) of specific items revealed three factors ( Eigenvalues > 1.7 ) explaining 75.6 % of the total variance ; namely Side effects ( 4 items , 28.4 % , Cronbach 's Alpha = .87 ) , Effectiveness ( 3 items , 24.1 % , Cronbach 's Alpha = .85 ) , and Convenience ( 3 items , 23.1 % , Cronbach 's Alpha = .87 ) . A second factor analysis of more generally worded items yielded a Global Satisfaction scale ( 3 items , Eigenvalue = 2.3 , 79.1 % , Cronbach 's Alpha = .85 ) . The final four scales possessed good psychometric properties , with the Likert-type scaling method performing better than the VAS approach . Significant differences were found on the TSQM by the route of medication administration ( oral , injectable , topical , inhalable ) , level of illness severity , and length of time on medication . Regression analyses using the TSQM scales accounted for 40–60 % of variation in patients ' ratings of their likelihood to persist with their current medication . Conclusion The TSQM is a psychometrically sound and valid measure of the major dimensions of patients ' satisfaction with medication . Preliminary evidence suggests that the TSQM may also be a good predictor of patients ' medication adherence across different types of medication and patient population Objectives Poor adherence is one of the biggest obstacles in therapeutic control of high blood pressure . The objectives of this study were ( i ) to measure adherence to antihypertensive therapy in a representative sample of the hypertensive Pakistani population and ( ii ) to investigate the factors associated with adherence in the studied population . Methods and Results A cross-sectional study was conducted on a simple r and om sample of 460 patients at the Aga Khan University Hospital ( AKUH ) and National Institute of Cardiovascular Diseases , Karachi , from September 2005–May 2006 . Adherence was assessed using the Morisky Medication Adherence Scale ( MMAS ) , with scores ranging from 0 ( non-adherent ) to 4 ( adherent ) . In addition to MMAS , patient self-reports about the number of pills taken over a prescribed period were used to estimate adherence as a percentage . AKU Anxiety and Depression Scale ( AKU-ADS ) was incorporated to find any association between depression and adherence . At a cut-off value of 80 % , 77 % of the cases were adherent . Upon univariate analyses , increasing age , better awareness and increasing number of pills prescribed significantly improved adherence , while depression showed no association . Significant associations , upon multivariate analyses , included number of drugs that a patient was taking ( P<0.02 ) and whether he/she was taking medication regularly or only for symptomatic relief ( P<0.00001 ) . Conclusions Similar to what has been reported worldwide , younger age , poor awareness , and symptomatic treatment adversely affected adherence to antihypertensive medication in our population . In contrast , monotherapy reduced adherence , whereas psychosocial factors such as depression showed no association . These findings may be used to identify the subset of population at risk of low adherence who should be targeted for interventions to achieve better blood pressure control and hence prevent complications Background Self-report scales are used to assess medication adherence . Data on how to discriminate change in self-reported adherence over time from r and om variability are limited . Objective : To determine the minimal detectable change for scores on the 8-item Morisky Medication Adherence Scale ( MMAS-8 ) . Methods : The MMAS-8 was administered twice , using a st and ard telephone script , with administration separated by 14 - 22 days , to 210 participants taking antihypertensive medication in the CoSMO ( Cohort Study of Medication Adherence among Older Adults ) . MMAS-8 scores were calculated and participants were grouped into previously defined categories ( < 6 , 6 to < 8 , and 8 for low , medium , and high adherence ) . Results : The mean ( SD ) age of participants was 78.1 ( 5.8 ) years , 43.8 % were black , and 68.1 % were women . Overall , 8.1 % ( 17/210 ) , 16.2 % ( 34/210 ) , and 51.0 % ( 107/210 ) of participants had low , medium , and high MMAS-8 scores , respectively , at both survey administrations ( overall agreement 75.2 % ; 158/210 ) . The weighted κ statistic was 0.63 ( 95 % CI 0.53 to 0.72 ) . The intraclass correlation coefficient was 0.78 . The within-person st and ard error of the mean for change in MMAS-8 scores was 0.81 , which equated to a minimal detectable change of 1.98 points . Only 4.3 % ( 9/210 ) of the participants had a change in MMAS-8 of 2 or more points between survey administrations . Conclusions : Within-person changes in MMAS-8 scores of 2 or more points over time may represent a real change in antihypertensive medication adherence Background The majority of patients using antihypertensive medications fail to achieve their recommended target blood pressure . Poor daily adherence with medication regimens and a lack of persistence with medication use are two of the major reasons for failure to reach target blood pressure . There is no single intervention to improve adherence with antihypertensives that is consistently effective . Community pharmacists are in an ideal position to promote adherence to chronic medications . This study aims to test a specific intervention package that could be integrated into the community pharmacy workflow to enable pharmacists to improve patient adherence and /or persistence with antihypertensive medications - Hypertension Adherence Program in Pharmacy ( HAPPY ) . Methods / Design The HAPPY trial is a multi-centre prospect i ve r and omised controlled trial . Fifty-six pharmacies have been recruited from three Australian states . To identify potential patients , a software application ( MedeMine CVD ) extracted data from a community pharmacy dispensing software system ( FRED Dispense ® ) . The pharmacies have been r and omised to either ' Pharmacist Care Group ' ( PCG ) or ' Usual Care Group ' ( UCG ) . To check for ' Hawthorne effect ' in the UCG , a third group of patients ' Hidden Control Group ' ( HCG ) will be identified in the UCG pharmacies , which will be made known to the pharmacists at the end of six months . Each study group requires 182 patients . Data will be collected at baseline , three and six months in the PCG and at baseline and six months in the UCG . Changes in patient adherence and persistence at the end of six months will be measured using the self-reported Morisky score , the Tool for Adherence Behaviour Screening and medication refill data . Discussion To our knowledge , this is the first research testing a comprehensive package of evidence -based interventions that could be integrated into the community pharmacy workflow to enable pharmacists to improve patient adherence and /or persistence with antihypertensive medications . The unique features of the HAPPY trial include the use of MedeMine CVD to identify patients who could potentially benefit from the service , control for the ' Hawthorne effect ' in the UCG and the offer of the intervention package at the end of six months to patients in the UCG , a strategy that is expected to improve retention . Trial Registration Australian New Zeal and Clinical Trial Registry Background Disparities in blood pressure ( BP ) control may be a function of disparities in treatment intensification ( TI ) . Objective To examine racial differences in TI , underst and modifiable factors that may mediate this relationship , and explore the relative effects of TI and race on blood pressure . Design Prospect i ve cohort study . Participants Participants were 819 black and white patients with hypertension from an urban , safety-net hospitalMain Measures We sequentially explored the effects of patient race , sociodemographic and clinical characteristics , beliefs about BP/medications , perceptions of provider/discrimination , sodium intake , medication adherence , and provider counseling on TI , performing a series of r and om effects analyses . To assess the effects of race and TI on BP , we performed linear regressions , using systolic BP ( SBP ) as the outcome .Key Results Unadjusted analyses and those including sociodemographic and clinical characteristics revealed that black patients had less TI than whites ( −0.31 vs.−0.24 , p < 0.001 ) , but adjustment for patient beliefs and experiences eliminated the effects of race ( β = −0.02 , p = 0.5 ) . Increased patient concerns about BP medications were related to lower TI , as was more provider counseling ( β = −0.06 , p = 0.02 and β = −0.01 , p = 0.001 , respectively ) . In the unadjusted analysis , black race was a significant predictor of SBP ( 134 mm/Hg for blacks vs. 131 mm/Hg for whites , p = 0.009 ) , but when both race and TI were included in the model , TI was a significant predictor of SBP ( final SBP 2.0 mm/Hg lower for each additional therapy increase per 10 visits , p < 0.001 ) , while race was not ( Blacks 1.6 mm/Hg higher than whites , p = 0.17 ) . Conclusions Improved patient – provider communication targeted towards addressing patient concerns about medications may have the potential to reduce racial disparities in TI and ultimately , BP control Background : Although hypertension is , in most cases , a controllable major risk factor in the development of cardiovascular disease , studies have demonstrated that hypertension remains poorly controlled in Portugal . Our aim was to evaluate the covariates associated with poor blood pressure ( BP ) control in a Portuguese hypertensive population . Patients and Results : We conducted a cross-sectional survey in a hospital hypertension outpatient clinic , located in the Eastern Central Region of Portugal . Patients attending the clinic from July to September 2009 were asked to participate in a structured interview including medication adherence and knowledge about hypertension . Eligible participants were all adults aged 18 or over with an established diagnosis of arterial hypertension and had been on antihypertensive drug treatment for at least 6 months . Exclusion criteria were dementia , pregnancy , and breastfeeding . Detailed clinical information was prospect ively obtained from medical records . A total of 197 patients meeting the inclusion criteria and consenting to participate completed the interview . Of these , only 33.0 % had their BP controlled according to the JNC 7 guidelines . Logistic regression analysis revealed three independent predictors of poor BP control : living alone ( OR = 5.3 , P = 0.004 ) , medication nonadherence ( OR = 4.8 , P < 0.001 ) , and diabetes ( OR = 4.4 , P = 0.011 ) . Predictors of medication nonadherence were : unawareness of target BP values ( OR = 3.7 , P < 0.001 ) , a report of drug side effects ( OR = 3.7 , P = 0.002 ) , lack of BP monitoring ( OR = 2.5 , P = 0.015 ) and unawareness of medication indications ( OR = 2.4 , P = 0.021 ) , and of hypertension risks ( OR = 2.1 , P = 0.026 ) . Conclusions : Poor medication adherence , lack of information about hypertension , and side effects should be considered as possible underlying causes of uncontrolled BP and must be addressed in any intervention aim ed to improve BP control OBJECTIVES To evaluate the efficacy of a healthcare education program for patients with hypertension . METHODS A multicenter , prospect i ve , cluster-r and omized trial was conducted . R and omization was by primary care center ; 18 of 36 urban primary care centers in Barcelona and its metropolitan area were r and omized to the intervention group ( IG ) and 18 to the control group ( CG ) . The study sample consisted of patients with hypertension ( n=996 ; 515 in the IG and 481 in the CG ) receiving outpatient treatment with antihypertensive drugs . The intervention consisted of personalized information by a trained nurse and written leaflets . Question naires on knowledge and awareness of hypertension and its medication , treatment adherence , healthy lifestyle habits , systolic and diastolic blood pressure , and body mass index were assessed at each visit , with a 12-month follow-up . An intention-to-treat analysis was applied . RESULTS Knowledge of hypertension increased by 27.8 % in the IG and by 18.5 % in the CG , while that of medication increased by 10.1 % in the IG and 5.5 % in the CG . Treatment adherence measured by the Morisky-Green test increased by 9.6 % ( 95 % CI : 5.5 - 13.6 ) in the IG and 8.8 % ( 95 % CI : 4.9 - 12.6 ) in the CG . There were no differences in adherence on the other tests used . No differences were observed between the IG and CG in clinical variables such as blood pressure or BMI at the end of the trial . CONCLUSIONS The educational intervention had no significant impact on patients ' adherence to the medication Objectives : To examine factors associated with oversupply and undersupply of antihypertensive medication , and examine evidence for medication acquisition as distinct from self-reported adherence . Research Design : Analysis of pharmacy refill records , medical charts , and in-person interviews . Subjects : Five hundred sixty-two male veterans with hypertension enrolled in a r and omized controlled trial to improve BP control . Measures : Patients were classified as having undersupply ( < 0.80 ) , appropriate supply ( ≥0.80 and ≤1.20 ) , or oversupply ( > 1.20 ) of antihypertensive medication in the 90 days before trial enrollment based on the ReComp algorithm . Determination of BP control was based on clinic measurements at enrollment . Demographic , clinical , psychosocial , and behavioral factors relevant to medication-taking behavior and BP were assessed at enrollment . Results : Twenty-three percent of the patients had undersupply , 47 % had appropriate supply , and 30 % had oversupply of antihypertensive medication . Multinomial logistic regression revealed that using fewer classes of antihypertensive medications and greater perceived adherence barriers were independently associated with greater likelihood of undersupply . Current employment was associated with decreased likelihood of oversupply , and greater comorbidity and being married were associated with increased likelihood of oversupply . Agreement between ReComp and self-reported adherence was poor ( & kgr ; = 0.19 , P < 0.001 ) . Undersupply , oversupply , and self-reported nonadherence were all independently associated with decreased likelihood of BP control after adjusting for each other and patient factors . Conclusions : Antihypertensive oversupply was common and may arise from different circumstances than undersupply . Measures of medication acquisition and self-reported adherence appear to provide distinct , complementary information about patients ' medication-taking behavior Premature morbidity and mortality from chronic diseases account for a major proportion of expenditures for health care cost in the United States . The purpose of this study was to measure the effects of a disease management program on physiological and behavioral health indicators for Medicaid patients in Florida . A two-year prospect i ve study of 15,275 patients with one or more chronic illnesses ( congestive heart failure , hypertension , diabetes , or asthma ) was undertaken . Control of hypertension improved from baseline to Year 1 ( adjusted odds ratio = 1.60 , p < .05 ) , with maintenance at Year 2 . Adjusted cholesterol declined by 6.41 mg/dl from baseline to Year 1 and by 12.41 mg/dl ( p < .01 ) from baseline to Year 2 . Adjusted average medication compliance increased by 0.19 points ( p < .01 ) in Year 1 and 0.29 points ( p < .01 ) in Year 2 . Patients in the disease management program benefited in terms of controlling hypertension , asthma symptoms , and cholesterol and blood glucose levels The problem of medication adherence is pronounced in hypertensive black men . However , factors influencing their adherence are not well understood . This secondary analysis of the ongoing Counseling African Americans to Control Hypertension ( CAATCH ) r and omized clinical trial investigated the patient , provider , and health care system factors associated with medication adherence among hypertensive black men . Participants ( N=253 ) were aged 56.6±11.6 years , earned < $ 20,000 yearly ( 72.7 % ) , and almost one half were on Medicaid ( 44 % ) . Mean systolic blood pressure was 148.7±15.8 mm Hg and mean diastolic blood pressure was 92.7±9.8 mm Hg . Over one half of participants ( 54.9 % ) were nonadherent . In a hierarchical regression analysis , the patient factors that predicted medication adherence were age , self-efficacy , and depression . The final model accounted for 32.1 % of the variance ( F=7.80 , df 10 , 165 , P<.001 ) . In conclusion , age , self-efficacy , and depression were associated with antihypertensive medication adherence in black men followed in Community/Migrant Health Centers . Age is a characteristic that may allow clinicians to predict who may be at risk for poor medication adherence . Depression can be screened for and treated . Self-efficacy is modifiable and its implication s for practice would be the development of interventions to increase self-efficacy in black men with hypertension BACKGROUND : Adherence to medication is a critical factor in the continued health and well-being of patients with hypertension . Patients ' acceptance of medical advice and information may be influenced by their subjective beliefs about their health condition ; therefore , it is essential that their beliefs be taken into account when giving health advice or medical treatment . OBJECTIVE : To determine whether a relationship exists between illness attribution , perceived control , and adherence to antihypertensive medications . METHODS : A prospect i ve , cross-sectional survey of hypertensive patients was conducted at the University of Michigan Medical Centers , Hypertension Clinic , Ann Arbor , MI . One hundred two patients with a goal to reduce their blood pressure were included in the study . Written and follow-up telephone survey questions assessing patients ' illness attributions , perceived control , and medication adherence were administered . Associations between these variables were analyzed using correlation analyses . RESULTS : The majority of patients ( 67.7 % ) were adherent with their hypertensive medications . Patients indicated that modifiable variables were the most common attribution believed to cause hypertension ; however , there was no significant relationship to medication adherence . A significant inverse relationship was found between perceived control over hypertension and medication adherence ( p < 0.01 ) . CONCLUSIONS : The findings suggest that patients ' greater perception of control over trying to reduce blood pressure may result in decreased reliance on medications and subsequent nonadherence to drug therapy . Implication s of these findings on pharmacy practice are discussed Many studies have documented the negative effects of depression on adherence to recommended treatment ; however , little is known about the mechanism underlying this relationship . Using the Kenny and Baron analytic framework of mediation , the authors assessed whether self-efficacy mediated the relationship between depression and medication adherence in 167 hypertensive African Americans followed in a primary care practice . Depressive symptoms are associated with poor medication adherence ( β = .013 , p = .036 ) and low self-efficacy ( β = —.008 , p = .023 ) . Self-efficacy is negatively associated with medication adherence at follow-up ( β = —.612 , p < .001 ) . The relationship between depressive symptoms and medication adherence becomes nonsignificant when controlling for self-efficacy ( β = .010 , p = .087 ) . Implication s for further examination into the mediating role of self-efficacy and the deleterious effect of depression on medication adherence are discussed The Hill-Bone Compliance to High Blood Pressure Therapy Scale assesses patient behaviors for three important behavioral domains of high blood pressure treatment : 1 ) reduced sodium intake ; 2 ) appointment keeping ; and 3 ) medication taking . This scale is comprised of 14 items in three subscales . Each item is a four point Likert type scale . The content validity of the scale was assessed by a relevant literature review and an expert panel , which focused on cultural sensitivity and appropriateness of the instrument for low literacy . Internal consistency reliability and predictive validity of the scale were evaluated using two community based sample s of hypertensive adults enrolled in clinical trials of high blood pressure care and control . The st and ardized alpha for the total scale were 0.74 and 0.84 , and the average interitem correlations of the 14 items were 0.18 and 0.28 , respectively . The construct and predictive validity of the scale was assessed by factor analysis and by testing of theoretically derived hypotheses regarding whether the scale demonstrated consistent and expected relationships with related variables . In this study , high compliance scale scores predicted significantly lower levels of blood pressure and blood pressure control . Moreover , high compliance scale scores at the baseline were significantly associated with blood pressure control at both baseline and at follow up in the two independent sample s. This brief instrument provides a simple method for clinicians in various setting s to use to assess patients ' self reported compliance levels and to plan appropriate interventions Intensive monitoring of adherence in patients with uncontrolled hypertension was evaluated over a 6-month period . After that period , only patients well characterized as having resistant hypertension were followed for 12 months . The goal of this study was to evaluate whether adherence to a drug regimen helps to identify patients with resistant hypertension . Forty-four hypertensive patients resistant to a 3-drug regimen ( average blood pressure [ BP ] mm Hg , mean + /- st and ard deviation ) were studied prospect ively . Each patient was followed for a 12-month period . Adherence to treatment was evaluated through self-report , applying Morisky 's question naire and the pill count method . Ambulatory BP monitoring and office BP measures were performed . By pill count , 63.6 % of the patients were adherent to treatment at the start of the survey and 94 % at the end , although 59 % of the patients still did not reach normal BP levels . We found that non-adherence was not associated with resistance to antihypertensive treatment . Therefore , after investigation , we concluded that patients who presented with uncontrolled arterial BP may be truly resistant hypertensive to treatment STUDY OBJECTIVES To determine characteristics associated with drug adherence and blood pressure control among patients with hypertension , and to assess agreement between self-reported and refill adherences . DESIGN Cross-sectional analysis of baseline data from an ongoing r and omized controlled trial . SETTING Primary care center at an urban , county health system in Indianapolis , Indiana . PATIENTS Four hundred ninety-two participants with hypertension and taking at least one antihypertensive drug . MEASUREMENTS AND MAIN RESULTS Social and demographic factors , comorbidity , self-reported drug adherence , prescription refill adherence , and systolic and diastolic blood pressures were recorded at baseline . Participants were aged 57 + /- 11 ( mean + /- SD ) years , were predominantly women ( 73 % ) and African-American ( 68 % ) , and took 2.4 + /- 1.1 antihypertensive drugs . Agreement between self-reported and refill adherences was poor to fair ( kappa = 0.21 ) . On multiple logistic regression analysis , increased age ( p < or = 0.002 ) and being married ( p=0.03 ) were independent predictors of improved self-reported and refill adherence , whereas depressed patients had low self-reported adherence ( p=0.005 ) , and African-Americans had low refill adherence ( p<0.001 ) . Compared with nonadherent patients , adherent patients had lower systolic ( -5.4 mm Hg by self-report and -5.0 mm Hg by refill ) and diastolic ( -2.7 mm Hg by self-report and -3.0 mm Hg by refill ) blood pressures ( p < or = 0.02 ) . Increased age was the only other variable strongly associated with systolic and diastolic blood pressure control in both measures of drug adherence ( p < or = 0.001 ) . The association of depression , race , and sex with blood pressure control was model dependent . CONCLUSION Age , sex , race and depression are associated with antihypertensive drug adherence and blood pressure control . Self-reported and refill adherences appear to provide complementary information and are associated with reductions in systolic and diastolic blood pressure of similar magnitude BACKGROUND Hypertension disproportionately affects African Americans compared to whites , and it is the single most common explanation for the disparity in mortality between African Americans and whites . Adherence with antihypertensive medications can help reduce risk of negative hypertension-related outcomes . Motivational interviewing is a promising patient-centered approach for improving adherence in patients with chronic diseases . In this paper we describe the rationale and design of an ongoing r and omized controlled trial testing the effectiveness of motivational interviewing versus usual care in improving medication adherence among 190 African American uncontrolled hypertensive patients , who receive care in a primary care setting . METHODS The usual care group receives st and ard medical care , while those in the intervention group receive st and ard care plus four sessions of motivational interviewing at 3-month intervals for a period of 1 year . This technique consists of brief , patient-driven counseling sessions to facilitate initiation and maintenance of behavior change . The primary outcome is adherence to prescribed antihypertensive medication , assessed with the electronic medication events monitoring system ( MEMS ) and the Morisky self-report adherence question naire . Secondary outcomes are within-patient changes in blood pressure , self-efficacy , and intrinsic motivation between baseline and 12 months . We report the baseline sociodemographic and clinical characteristics of the participants . CONCLUSIONS Despite the potential utility of motivational interviewing , little is known about its effectiveness in improving medication adherence among hypertensive patients , especially African Americans . In addition to the baseline data this study has generated , this trial should provide data with which we can assess the effectiveness of this approach as a behavioral intervention OBJECTIVE To determine whether pharmaceutical care provided by a pharmacist-managed hypertension clinic results in better treatment outcomes when compared with traditional health care from a primary care physician . DESIGN Prospect i ve , controlled study SETTING Veterans Affairs Medical Center , Philadelphia , Pennsylvania . PATIENTS Fifty six patients with essential hypertension ; 27 were r and omly assigned to the intervention group and 29 to the control group . INTERVENTION Patients in the intervention group were scheduled monthly to meet with a clinical pharmacist who made appropriate changes in prescribed drugs , adjusted dosages , and provided drug counseling in accordance with the hypertension guidelines in the sixth report of the Joint National Committee on the Detection , Evaluation , and Treatment of High Blood Pressure ( JNC VI ) . Patients in the control group received st and ard care from their physicians . The study period was 6 months . MEASUREMENTS AND MAIN RESULTS Treatment outcomes were measured by changes in compliance , blood pressure , and patient satisfaction . The Short Form-36 health survey and a patient satisfaction survey were used to measure changes in patient satisfaction , and a compliance evaluation survey measured compliance . Twenty-one ( 81 % ) patients in the intervention group attained their blood pressure goal of below 140/90 mm Hg at the completion of the study versus only eight ( 30 % ) in the control group ( p < 0.0001 ) . Of 11 patients with diabetes in the intervention group , 10 ( 91 % ) attained their blood pressure goal ( < 130/80 mm Hg ) versus only two ( 12 % ) of 16 patients with diabetes in the control group ( p < 0.0001 ) . No significant differences in patient satisfaction or compliance were reported between the intervention and control groups . CONCLUSIONS Pharmaceutical care improves blood pressure control and results in more patients with hypertension reaching their blood pressure goal OBJECTIVES A r and omized controlled trial involving a nurse administered patient-tailored intervention is being conducted to improve blood pressure ( BP ) control . METHODS Veterans with hypertension from an outpatient primary care clinic completed a baseline assessment and were r and omly allocated to either a nurse administered intervention or to usual care . In this ongoing study , intervention patients receive the tailored intervention bi-monthly for 2 years via telephone ; the goal of the intervention is to promote adherence with medication and improve health behaviors . Patient factors targeted for intervention include perceived risk of hypertension , memory , literacy , social support , patients ' relationship with their health care provider , side effects of therapy , pill refill , missed appointments , and health behaviors . RESULTS The sample r and omized to the nurse intervention consisted of 294 veterans with hypertension ( average age = 63 years ; 41 % African-American ) . A comparable sample of veterans was assigned to usual care ( n = 294 ) . We have maintained a 97 % retention rate for the first 12 months of the study . The average phone call has lasted 3.7 min ranging from less than 1 to 40 min . At 6-month post-enrollment , individuals receiving the nurse intervention had a greater increase in confidence with following hypertension treatment ( P < 0.007 ) than the usual care group . DISCUSSION The intervention is easily implemented and is design ed to enhance adherence with prescribed hypertension regimen . The study includes both general and patient-tailored information based upon need assessment . The study design ensures internal validity as well as the ability to generalize study findings to the clinic setting Objectives : To explore hypertensive patients ’ beliefs about their condition and its treatment and their adherence within the context of a clinical trial . To assess the degree of concordance between patients ’ beliefs about hypertension and the medical model of the condition . Methods : This was a question naire-based study , involving 230 patients participating in the Anglo-Sc and inavian Cardiac Outcomes Trial ( ASCOT ) , a r and omized controlled trial comparing two pharmaceutical approaches to the management of hypertension . A comparison group of 106 hypertensive patients who were screened for ASCOT but did not meet the entry criteria was also recruited . Outcome measures were beliefs about hypertension and antihypertensive medication , and adherence to medication ( self-report and tablet count ) . Results : Adherence to medication was higher than anticipated , with 45 % participants reporting complete adherence over the 18-month study and a further 40 % only rare non-adherence . Patients ’ beliefs about their condition and treatment were generally concordant with the medical model of hypertension . High concordance was associated with high medication adherence ( p<0.001 ) . Discussion : Clinical trial volunteers may have beliefs that are unusually concordant with the medical model of hypertension and may demonstrate atypically high adherence . This has implication s for the transferability of trial findings to the general hypertensive population |
11,596 | 18,049,172 | The analysis demonstrated that , with respect to sensitivity , specificity and accuracy , there was no statistically significant difference between EUS and MRCP for the detection of choledocholithiasis .
Our meta- analysis of prospect i ve comparison of MRCP and EUS for the detection of choledocholithiasis yielded statistically similar diagnostic values for both techniques | There is a lack of consensus on the optimal noninvasive strategy for patients with suspected choledocholithiasis after a negative transabdominal ultrasound and /or computed tomography .
A meta- analysis was conducted to compare the diagnostic ability of endoscopic ultrasound ( EUS ) and magnetic resonance cholangio-pancreatography ( MRCP ) in patients with suspected common bile duct ( CBD ) stones . | BACKGROUND Endoscopic ultrasonography ( EUS ) appears to be the best imaging method for the diagnosis of choledocholithiasis . The aim of this preliminary , prospect i ve , controlled study was to assess the accuracy of EUS and magnetic resonance cholangiopancreatography ( MRCP ) in the diagnosis of common bile duct stones . METHODS From December 1995 through April 1997 , all patients referred because of suspicion of the presence of common bile duct stones were included in the study . EUS and MRCP were performed . Each examination was performed by a different operator unaware of the result of the other procedure . The definitive diagnosis was established by means of endoscopic retro grade cholangiography with sphincterotomy or a surgical procedure . RESULTS Forty-three patients ( 18 men , 25 women ) with a mean age of 60.9 + /- 14.5 years ( range 25 to 81 years ) were included in the study . Eleven patients were excluded because of unavailability of magnetic resonance imaging(n = 5 ) or EUS ( n = 6 ) . Ten patients ( 31.2 % ) had choledocholithiasis . For this diagnosis , the sensitivity of EUS was 100 % , the specificity was 95.4 % , the positive predictive value was 90.9 % , and the negative predictive value was 100 % . The corresponding values for MRCP were 100 % , 72.7 % , 62.5 % , and 100 % , not significantly different from EUS results . The accuracy of EUS was 96.9 % , and that of MRCP was 82.2 % . CONCLUSION This preliminary study confirmed EUS as an accurate and noninvasive procedure for the diagnosis of common bile duct stones . MRCP , which had a high sensitivity and high negative predictive value , might be an accurate technique for patients with a contraindication to EUS This prospect i ve study compares repetitive thick-slab single-shot projection magnetic resonance cholangiopancreatography ( MRCP ) with endoscopic ultrasonography ( EUS ) for the detection of choledocholithiasis . Fifty-seven consecutive patients ( 36 women , mean age 61 ) referred for suspected choledocholithiasis underwent MRCP , followed by EUS . Each procedure was performed by different operators blinded to the results of the other investigation . MR technique included a turbo spin-echo T2-weighted axial sequence with selective fat saturation ( SPIR/TSE , TE=70 ms , TR=1,600 ms ) , followed by coronal dynamic MRCP . The same thick-slab slice was sequentially acquired 12 times as breath-hold single-shot projection imaging ( SSh , TE=900 ms , TE=8,000 ms ) centred on the common bile duct ( CBD ) . Two experienced radiologists independently and blindly evaluated MR images for the detection of CBD stones . Their inter-observer agreement kappa was determined . Secondly , the two observers read MR images in consensus again . CBD stones were demonstrated in 18 out of 57 patients ( 31.6 % ) and confirmed by endoscopic retro grade cholangiography ( ERCP , n=17 ) or intraoperative cholangiography ( n=1 ) . Clinical follow-up served as the “ gold st and ard ” in patients with negative results without following invasive procedure ( n=28 ) . Sensitivity , specificity , accuracy , positive and negative predictive value for MRCP result ing from consensus reading were 94.9 % , 94.4 % , 94.7 % , 97.4 % and 89.5 % , respectively . Corresponding values of EUS were 97.4 % , 94.4 % , 96.5 % , 97.4 % and 94.4 % . Inter-observer agreement kappa was 0.81 . Repetitive thick-slab single-shot projection MRCP is an accurate non-invasive imaging modality for suspected choledocholithiasis and should be increasingly used to select those patients who require a subsequent therapeutic procedure , namely ERCP Endoscopic ultrasonography ( EUS ) is a sensitive and specific modality for the detection of choledocholithiasis . In experienced h and s , it can be completely effective in almost all patients without significant risk . Prospect i ve studies have shown that the sensitivity and specificity of EUS for the detection of choledocholithiasis rival that of ERCP . The clinical roles for EUS in these setting s are currently evolving and will also likely be shaped by the continued forces to practice the most effective medicine BACKGROUND AND STUDY AIMS It is still unknown whether there is a difference in diagnostic accuracy and clinical impact between endoscopic ultrasonography ( EUS ) and magnetic resonance cholangiopancreatography ( MRCP ) . PATIENTS AND METHODS The test performance and potential clinical impact of EUS and MRCP , had each investigation been performed as the first examination method , were compared prospect ively in 163 patients admitted for and examined by endoscopic retro grade cholangiopancreatography ( ERCP ) . RESULTS The accuracies of EUS and MRCP were 0.93 and 0.91 , respectively ( no significant difference , P > 0.05 ) . Had EUS or MRCP been performed as the first investigation in the 75 patients who had a presumed high probability for needing therapeutic ERCP , only 15 and nine patients , respectively , would have avoided ERCP . In this group of patients , one patient needed other diagnostic investigations following EUS compared with 11 patients following MRCP ( P = 0.004 ) . For the 57 patients with an intermediate probability of needing endoscopic therapy , EUS and MRCP would have spared 37 and 38 patients , respectively , from the need to have an ERCP . In 31 patients with a presumed low risk of needing endoscopic therapy , 30 and 29 patients would have been spared from ERCP had EUS and MRCP , respectively , been performed initially . CONCLUSIONS There was no difference in the diagnostic accuracy and clinical impact between EUS and MRCP in the majority of the patients . The impact of EUS or MRCP on the ERCP workload was highly dependent on the presumed probability of needing endoscopic therapy Background Magnetic resonance cholangiography ( MRC ) is a new technique for non-invasive imaging of the biliary tract . Aim To assess the results of MRC in patients with suspected bile duct stones as compared with those obtained with reference imaging methods . Patients / Methods 70 patients ( 34 men and 36 women , mean ( SD ) age 71 ( 15.5 ) years ; median 75 ) with suspected bile duct stones were included ( cholangitis , 33 ; pancreatitis , three ; suspected post-cholecystectomy choledocholithiasis , nine ; cholestasis , six ; stones suspected on ultrasound or computed tomography scan , 19 ) . MR cholangiograms with two dimensional turbo spin echo sequences were acquired . Endoscopic retro grade cholangiography with or without sphincterotomy ( n = 63 ) , endosonography ( n = 5 ) , or intraoperative cho- langiography ( n = 2 ) were the reference imaging techniques used for the study and were performed within 12 hours of MRC . Radiologists were blinded to the results of endoscopic retro grade cholangiography and previous investigations . Results 49 patients ( 70 % ) had bile duct stones on reference imaging ( common bile duct , 44 , six of which impacted in the papilla ; intrahepatic , four ; cystic duct stump , one ) . Stone size ranged from 1 to 20 mm ( mean 6.1 , median 5.5 ) . Twenty seven patients ( 55 % ) had bile duct stones smaller than 6 mm . MRC diagnostic accuracy for bile duct lithiasis was : sensitivity , 57.1 % ; specificity , 100 % ; positive predictive value , 100 % ; negative predictive value , 50 % . Conclusions Stones smaller than 6 mm are still often missed by MRC when st and ard equipment is used . The general introduction of new technical improvements is needed before this method can be considered reliable for the diagnosis of bile duct stones BACKGROUND The management of possible common bile duct ( CBD ) stones in patients scheduled for laparoscopic cholecystectomy remains controversial . METHODS Prospect i ve evaluation of 609 patients who underwent laparoscopic cholecystectomy was carried out in relation to the use of selective preoperative ERCP for detection of common duct stones . Preoperative ERCP was performed if there is or has been ( 1 ) cholangitis , biliary pancreatitis , or jaundice ; ( 2 ) abnormal serum liver tests or ( 3 ) ultrasonogram showing a dilated CBD or ductal stones . RESULTS A total of 139 patients underwent preoperative ERCP , and cannulation of CBD was successful in 133 patients ( 96 % ) . CBD stones were found in 60 patients ( 45 % ) and extracted after sphincterotomy . High prevalence of CBD stones was noted in patients with acute cholangitis and CBD stones on ultrasonogram . There were six endoscopic sphincterotomy-related complications ( complication rate , 4.5 % ) : bleeding ( 2 ) , pancreatitis ( 3 ) , retroduodenal perforation ( 1 ) . No patient required surgery as the result of a complication . The prediction of the occurrence of ductal stones was further analyzed using stepwise logistic regression . Acute cholangitis and CBD stones on ultrasonogram were shown to be independent significant risk factors with odds ratios of 8.9 and 13.5 , respectively . CONCLUSIONS With selective preoperative ERCP , suspected CBD stones can be identified and removed prior to laparoscopic cholecystectomy OBJECTIVES New modalities , namely , endoscopic ultrasonography ( EUS ) , magnetic resonance cholangiopancreatography ( MRCP ) , and helical computed-tomographic cholangiography ( HCT-C ) , have been introduced recently for the detection of common bile duct ( CBD ) stones and shown improved detectability compared to conventional ultrasound or computed tomography . We conducted this study to compare the diagnostic ability of EUS , MRCP , and HCT-C in patients with suspected choledocholithiasis . METHODS Twenty-eight patients clinical ly suspected of having CBD stones were enrolled , excluding those with cholangitis or a definite history of choledocholithiasis . Each patient underwent EUS , MRCP , and HCT-C prior to endoscopic retro grade cholangio-pancreatography ( ERCP ) , the result of which served as the diagnostic gold st and ard . RESULTS CBD stones were detected in 24 ( 86 % ) of 28 patients by ERCP/IDUS . The sensitivity of EUS , MRCP , and HCT-C was 100 % , 88 % , and 88 % , respectively . False negative cases for MRCP and HCT-C had a CBD stone smaller than 5 mm in diameter . No serious complications occurred while one patient complained of itching in the eyelids after the infusion of contrast agent on HCT-C. CONCLUSIONS When examination can be scheduled , MRCP or HCT-C will be the first choice because they were less invasive than EUS . MRCP and HCT-C had similar detectability but the former may be preferable considering the possibility of allergic reaction in the latter . When MRCP is negative , EUS is recommended to check for small CBD stones OBJECTIVE Our purpose was to compare the accuracy of MR cholangiopancreatography and endoscopic sonography for the diagnosis of common bile duct stones in patients with a mild to moderate clinical suspicion of common bile duct stones . SUBJECTS AND METHODS Forty-seven patients were prospect ively enrolled . Inclusion criteria included acute pancreatitis , sub clinical jaundice , and clinical features of common bile duct stone migration . Radial endoscopic sonography and MR cholangiopancreatography with the single-shot fast spin-echo technique were performed a maximum of 48 hr apart . The gold-st and ard diagnosis was obtained with ERCP ( n = 20 ) or intraoperative cholangiography ( n = 14 ) if the results of endoscopic sonography or MR cholangiopancreatography were abnormal or if a cholecystectomy was performed , or by clinical and biochemical follow-up ( n = 11 ) if the results of endoscopic sonography and MR cholangiopancreatography were normal . RESULTS The final diagnosis was common bile duct stones in 16 patients , malignant obstructions in four , and another biliary disease in two ( lithiasis migration aspect with papillary edema ) ; 23 patients had no biliary disease . The sensitivity and specificity of MR cholangiopancreatography were , respectively , 90.5 % and 87.5 % for etiologic diagnosis and 87.5 % and 96.6 % for the detection of common bile duct stones . The corresponding values for endoscopic sonography were 86.4 % and 91.3 % for etiologic diagnosis and 93.8 % and 96.6 % for visualization of choledocholithiasis . Accuracy did not significantly differ between the techniques . CONCLUSION In cases of mild to moderate suspicion of choledocholithiasis , the accuracies of endoscopic sonography and MR cholangiopancreatography are similar . Because MR cholangiopancreatography is noninvasive , it may be preferred for this indication BACKGROUND AND STUDY AIMS The aim of this study was to compare prospect ively the diagnostic efficacy of magnetic resonance ( MR ) imaging and endoscopic ultrasonography ( EUS ) in extrahepatic biliary obstruction . PATIENTS AND METHODS A total of 50 patients with suspected benign or malignant extrahepatic biliary obstruction underwent MR imaging , including MR cholangiopancreatography , and EUS , within a median time delay of 1 day . The final diagnosis was established by endoscopic retro grade cholangiopancreatography in 37 cases , intraoperative cholangiography in nine cases , and clinical and biochemical follow-up in four cases . RESULTS In total , 33 patients had extrahepatic biliary obstruction , of benign origin in 21 cases and of malignant origin in 12 cases , whereas 17 had no evidence of obstruction . The sensitivity and specificity of MR imaging were 91 % and 94 % , respectively . There were one false-positive and three false-negative results , all related to choledochal sludge . The corresponding values for EUS were 97 % and 88 % . There were two false-positive results and one false-negative result . False-positive diagnoses were related to the presumed presence of biliary sludge and choledocholithiasis , whereas the false-negative diagnosis occurred in one patient with a final diagnosis of sludge . No significant difference in sensitivity and specificity was observed between the two imaging methods ( P>0.05 ) . CONCLUSION In our study MR imaging was as accurate as EUS in the diagnosis of extrahepatic biliary obstruction BACKGROUND & AIMS Magnetic resonance cholangiography ( MRC ) is a noninvasive diagnostic modality capable of producing high- quality images of the biliary tree . The purpose of this study was to determine in a prospect i ve , blinded fashion the sensitivity and specificity of three-dimensional fast spin-echo ( 3D FSE ) MRC for the evaluation of biliary tract abnormalities . METHODS Forty-six patients referred for elective direct cholangiography ( 45 endoscopic retro grade cholangiopancreatography and 1 percutaneous transhepatic cholangiography ) were studied prospect ively with 3D FSE MRC during a 1-year period . All images were interpreted blindly by two radiologists . The presence of dilatation , strictures , and intraductal abnormalities was recorded . Sensitivity and specificity of 3D FSE MRC were determined using findings on direct cholangiography as the gold st and ard . RESULTS MRC images of diagnostic quality were obtained in 44 ( 95.7 % ) of the patients . Sensitivity for the detection of bile duct dilatation ( n = 27 ) , biliary strictures ( n = 10 ) , and intraductal abnormalities ( n = 7 ) was 96.3 % , 90 % , and 100 % , respectively . In addition , the MRC showed 16 of 17 patients with normal bile ducts ( specificity , 94.1 % ) . CONCLUSIONS MRC has a very high sensitivity and specificity in the evaluation of the biliary tract . Based on these data , we believe that the efficacy of MRC using 3D FSE is sufficient to warrant its use in the routine diagnosis of biliary tract disease |
11,597 | 21,875,253 | New HPV vaccines will also help prevent HPV infection and the precancerous changes that lead to cervical cancer . | OBJECTIVE To give a clear picture with epidemiological evidence about the present scenario of cervical cancer control and HPV in India .
CONCLUSIONS AND RECOMMENDATIONS Cervical cancer is unique among cancers in that it can largely be prevented through screening and removal of precursor lesions .
It is the second most common cancer among women worldwide and is the most common malignancy in developing countries , particularly in India .
Nowadays , cervical screening for women is necessary because there are no signs and symptoms of cervical precancers .
But most women in India do not have access to effective screening programmes .
It has been estimated that in India , even with a major effort to exp and cytology services , it will not be possible to screen even one-fourth of the population once in a lifetime in the near future . | OBJECTIVE To determine the factors associated with participation in cervical cancer screening and follow-up treatment in the context of a r and omized controlled trial . The trial was initiated to evaluate the efficacy and cost effectiveness of visual inspection with acetic acid , cytological screening and testing for human papillomavirus in reducing the incidence of and mortality from cervical cancer in Maharashtra , India . METHODS Between October 1999 and November 2003 women aged 30 - 59 years were r and omized to receive one of the three tests or to a control group . Participation was analysed for all three intervention arms . The differences between those who were screened versus those who were not was analysed according to the sociodemographic characteristics of the 100,800 eligible women invited for screening . Those who were treated versus those who were not were analysed according to the sociodemographic characteristics of the 932 women diagnosed with high- grade lesions . Participation in screening and compliance with treatment were also analysed according to the type of test used . FINDINGS Compared with women who were not tested , screened women were younger ( aged 30 - 39 ) , better educated and had ever used contraception . A higher proportion of screened women were married and a lower proportion had never been pregnant . Of the 932 women diagnosed with high- grade lesions or invasive cancer , 85.3 % ( 795 ) received treatment . Women with higher levels of education , who had had fewer pregnancies and those who were married were more likely to comply with treatment . There were no differences in rates of screening or compliance with treatment when results were analysed by the test received . CONCLUSIONS Irrespective of the test being used , good participation levels for cervical cancer screening can be achieved in rural areas of developing countries by using appropriate strategies to deliver services . Communication methods and delivery strategies aim ed at encouraging older , less-educated women , who have less contact with reproductive services , are needed to further increase screening uptake BACKGROUND The proportion of women infected with human papillomavirus ( HPV ) varies greatly across population s , as might the distribution of HPV types . We aim ed to compare HPV-type distribution in representative sample s of women from different world regions . METHODS Women were r and omly selected from the general population of 13 areas from 11 countries ( Nigeria , India , Vietnam , Thail and , Korea , Colombia , Argentina , Chile , the Netherl and s , Italy , and Spain ) . A st and ardised protocol was used for cervical specimen collection . All HPV testing was by GP5+/6 + PCR-based EIA . The proportion of HPV-positive women infected with different HPV types was compared by study area and between pooled regions with age-adjusted odds ratios ( ORs ) with corresponding 95 % floating CIs . FINDINGS 15 613 women aged 15 - 74 years without cytological abnormalities were included in a pooled analysis . Age-st and ardised HPV prevalence varied nearly 20 times between population s , from 1.4 % ( 95 % CI 0.5 - 2.2 ) in Spain to 25.6 % ( 22.4 - 28.8 ) in Nigeria . Although both overall HPV prevalence and HPV16 prevalence were highest in sub-Saharan Africa , HPV-positive women in Europe were significantly more likely to be infected with HPV16 than were those in sub-Saharan Africa ( OR 2.64 , p=0.0002 ) , and were significantly less likely to be infected with high-risk HPV types other than HPV16 ( OR 0.57 , p=0.004 ) and /or low-risk HPV types ( OR 0.44 . p=0.0002 ) . Women from South America had HPV-type distribution in between those from sub-Saharan Africa and Europe . Heterogeneity between areas of Asia was significant . INTERPRETATION Heterogeneity in HPV type distribution among women from different population s should be taken into account when developing screening tests for the virus and predicting the effect of vaccines on the incidence of infection The objectives of this paper are to ( 1 ) underst and the nature of men ’s extramarital sexuality in three low income communities in Mumbai , India ; ( 2 ) explore the associations between marital relationships and extramarital sex ; and ( 3 ) assess the implication s of the research results for intervention . Results are based on survey data collected from 2,408 r and omly selected men from the three study communities and a matched subset of 260 r and omly selected men and their wives who responded to a female version of the men 's survey . These surveys produced a unique data set , which allows sociodemographic , attitudinal and behavioral variables from husb and and wife and variables that are the product of husb and and wife interaction to be utilized to predict men 's extramarital sex through multiple sequential logistic regression analysis . Results indicate that men 's extramarital sex is significantly associated with husb and 's and wife 's age , wife 's perception of domestic violence , husb and 's education and place of birth , husb and 's alcohol use , wife 's willingness to engage in marital sex , and types of marital sexual acts . These results confirm the need to move from the individual to the couple as the unit of research and the need for intervention to reduce the risk of HIV/STI transmission within marriage both in India and internationally The authors evaluated direct visual inspection of the cervix after the application of 5 % acetic acid ( DVI ) as a cervical cancer screening test for use in low‐re source setting We evaluated the feasibility and performance of visual inspection with acetic acid ( VIA ) and Lugol 's iodine ( VILI ) for cervical cancer screening in a primary health-care setting in Kinshasa , Congo . Women ( 1,528 ) aged > or = 30 years were screened independently by nurses and physicians by VIA and VILI and Pap cytology . Biopsy sample s were obtained from women with abnormal colposcopies and from 290 r and omly chosen women with normal colposcopy . Cytological and histological examinations were performed in Lyon and Montreal , respectively . The prevalence of cervical intraepithelial neoplasia ( CIN ) of grade s 1 , 2 and 3 was 4.5 , 1.3 and 4 % , respectively . Using biopsy as the reference , the sensitivity , specificity and negative predictive value ( NPV ) for > or = CIN 2 for VIA-nurse were 55.5 % ( 95 % CI : 34.7 - 76.2 ) , 64.6 % ( 95 % CI : 62.0 - 67.1 ) and 96.8 % ( 95 % CI : 93.5 - 98.7 ) , respectively . The corresponding values for VILI-nurse were 44.0 % ( 95 % CI : 24.2 - 63.8 ) , 74.6 % ( 95 % CI : 72.3 - 76.9 ) and 96.7 % ( 95 % CI : 93.7 - 98.6 ) . The equivalent parameters for physicians were 71.1 % ( 95 % CI : 46.7 - 95.5 ) , 71.3 % ( 95 % CI : 68.9 - 73.6 ) and 98.6 % ( 95 % CI : 96.0 - 99.7 ) for VIA and 68.3 % ( 95 % CI : 42.5 - 94.0 ) , 76.2 % ( 95 % CI : 74.0 - 78.4 ) and 97.2 % ( 95 % CI : 95.3 - 98.5 ) for VILI . The sensitivity of cytology ranged between 31 and 72 % , depending on the abnormality threshold used to define positivity , with a corresponding specificity range of 94 - 99 % and a NPV range of 97 - 99 % . Our results show that VIA and VILI performed by nurses and physicians are slightly more sensitive but less specific than Pap cytology across multiple combinations of test and lesion thresholds . Given their lower cost and easy deployment , visual inspection methods merit further assessment as cervical cancer screening methods for low-re source countries The efficacy of a single round of screening of visual inspection with acetic acid ( VIA ) on cervical cancer incidence and mortality is investigated in a cluster r and omized controlled trial in south India . Women aged 30 - 59 years in 113 clusters in Dindigul District were r and omized to VIA screening by nurses ( 57 clusters , 48,225 eligible women ) and to a control group ( 56 clusters , 30,167 women ) . 30,577 ( 63.4 % ) eligible women participated in screening . Younger , educated , married , multiparous , low-income women and those who have had tubal sterilization had a higher compliance with screening . Of the 2069 women diagnosed with CIN and invasive cancer , 1498 ( 72.4 % ) received treatment . Young women , those who practice d contraception and women with high- grade precursor lesions and invasive cancers were more likely to comply with treatment . In summary , our study indicates that women accept screening with VIA by nurses and a moderate level of compliance with screening and treatment can be reached through appropriate service delivery systems including health education activities , personal invitations , clinics in proximity to the target women , and testing and treatment in the same session . Our results imply that integration of screening activities with primary health services seems to have the potential to replicate most of these service delivery conditions in routine programs A prospect i ve study was undertaken to determine the sensitivity and specificity of acetic application to the cervix followed by naked eye visualization as a screening test for detection of cervical intraepithelial neoplasia . Three hundred and seventy two sexually active woman in the reproductive age group were studied . All the women underwent Papanicolaou test , acetic acid test and colposcopy . One hundred and seventy five woman were acetic acid test negative , 197 women were acetic acid test positive . The sensitivity of acetic acid test was 72.4 % , specificity 54 % and false negative rate 15.2 % , as compared to papanicolaou test which had a sensitivity of 13.2 % , specificity of 96.3 % and false negative rate of 24.4 % . The advantage of the acetic acid test lies in its easy technique , low cost and high sensitivity which are important factors for determining the efficacy of any screening programme in developing countries The impact of screening by visual inspection with acetic acid ( VIA ) , cytology or HPV testing on cervical cancer incidence and mortality is investigated in a cluster r and omized controlled trial in India . We report findings after the screening phase , when 52 clusters , with a total of 142,701 women aged 30 - 59 years in Osmanabad District , India , were r and omized into 4 arms for a single round of screening by trained midwives with either VIA , cytology or HPV testing as well as a control group . All laboratory tests were done locally . Test-positive women underwent investigations ( colposcopy/biopsy ) and treatment in the base hospital . Data on participation , test positivity , positive predictive value and detection rates of cervical neoplasia were analyzed using cluster design methodology . Of the eligible women , 72 - 74 % were screened . Test positivity rates were 14.0 % for VIA , 7.0 % for cytology and 10.3 % for HPV . The detection rate of high- grade lesions was similar in all intervention arms ( 0.7 % for VIA , 1.0 % for cytology and 0.9 % for HPV testing ) ( p = 0.06 , Mann-Whitney test ) . While the detection rate for VIA dropped to 0.5 % with declining test positivity during the course of the study , it remained constant for cytology and HPV testing . Over 85 % of women with high- grade lesions received treatment . Our results show that a high level of participation and good- quality cytology can be achieved in low-re source setting s. VIA is a useful alternative but requires careful monitoring . Detection rates obtained by HPV testing were similar to cytology , despite higher investments The impact of a single round of screening of visual inspection with acetic acid ( VIA ) on cervical cancer incidence and mortality was investigated in a cluster r and omized trial in south India . Women 30 - 59 years of age in 113 clusters in Dindigul District were r and omized to VIA screening ( 57 clusters , 48,225 women ) by nurses and to a control group ( 56 clusters , 30,167 women ) . 30,577 eligible women were screened between May 2000 and April 2003 ; 2,939 ( 9.6 % ) screen-positive women were investigated with colposcopy by nurses and 2,777 ( 9.1 % ) women had biopsy . CIN 1 was diagnosed in 1,778 women , CIN 2 - 3 lesions were found in 222 , and there were 69 screen detected invasive cervical cancers . The detection rates of lesions per 1,000 screened women were 58.2 for CIN 1 , 7.3 for CIN 2 - 3 , and 2.3 for invasive cancer . The detection rate of high- grade lesions in our study was 2 - 3-fold higher than those observed in repeatedly screened population s in developed countries . 71 % of women with CIN 1 and 80 % of those with CIN 2 - 3 lesions accepted cryotherapy provided by nurses and surgical treatment by mid-level clinicians . Overall , 97 and 34 incident cervical cancer cases were observed in the intervention and control arms , respectively . The intervention arm accrued 124,144 person years and the control arm accrued 90,172 during the study period . The age st and ardized cervical cancer incidence rates were 92.4/100,000 person-years in the intervention and 43.1/100,000 in the control arms . In the screened arm , 35.0 % of cases were in Stage I as opposed to none in the control arm . The preliminary findings from our study indicate that not only is a VIA-based screening programme feasible , safe and acceptable to a population in rural setting s , it also results in early detection of cervical neoplasia The cost and cost effectiveness of screening previously unscreened women by VIA , cytology or HPV testing was investigated within a large cluster r and omised trial involving 131,178 women in rural India . All re sources involved in implementation , training , management , recruitment , screening and diagnosis were identified and costed . We estimated the total costs and detection rates for each cluster and used these data to calculate an average cluster cost and detection rate for each screening approach . These estimates were combined to estimate a cost per case of cervical intraepithelial neoplasia grade 2/3 or invasive cancer ( CIN 2/3 + ) detected . The average total costs per 1,000 women eligible for screening were US dollar 3,917 , US dollar 6,609 and US dollar 11,779 with VIA , cytology and HPV respectively . The cost of detecting a case of CIN2/3 + using VIA was dollar 522 ( 95 % CI dollar 429- dollar 652 ) . Our results suggest that more CIN2/3 + cases would be detected in the same population if cytology were used instead of VIA and each additional case would cost US dollar 1065 ( 95 % CI dollar 713- dollar2175 ) . Delivering cervical cancer screening is potentially expensive in a low-income country although costs might be lower outside a trial setting . We found screening with VIA to be the least expensive option , but it also detected fewer cases of CIN2/3 + than other methods ; its long-term cost-effectiveness will depend on the long-term benefits of early detection . Cytology was more effective at detecting cases than VIA but was also more expensive . Our findings indicate that HPV may not be a cost effective screening strategy in India at current consumable prices BACKGROUND Cervical cancer is the most common cancer among women in developing countries . We assessed the effect of screening using visual inspection with 4 % acetic acid ( VIA ) on cervical cancer incidence and mortality in a cluster r and omised controlled trial in India . METHODS Of the 114 study clusters in Dindigul district , India , 57 were r and omised to one round of VIA by trained nurses , and 57 to a control group . Healthy women aged 30 to 59 years were eligible for the study . Screen-positive women had colposcopy , directed biopsies , and , where appropriate , cryotherapy by nurses during the screening visit . Those with larger precancerous lesions or invasive cancers were referred for appropriate investigations and treatment . Cervical cancer incidence and mortality in the study groups were analysed and compared using Cox regression taking the cluster design into account , and analysis was by intention to treat . The primary outcome measures were cervical cancer incidence and mortality . RESULTS Of the 49,311 eligible women in the intervention group , 31,343 ( 63.6 % ) were screened during 2000 - 03 ; 30,958 control women received the st and ard care . Of the 3088 ( 9.9 % ) screened positive , 3052 had colposcopy , and 2539 directed biopsy . Of the 1874 women with precancerous lesions in the intervention group , 72 % received treatment . In the intervention group , 274,430 person years , 167 cervical cancer cases , and 83 cervical cancer deaths were accrued compared with 178,781 person-years , 158 cases , and 92 deaths and in the control group during 2000 - 06 ( incidence hazard ratio 0.75 [ 95 % CI 0.55 - 0.95 ] and mortality hazard ratio 0.65 [ 0.47 - 0.89 ] ) . INTERPRETATION VIA screening , in the presence of good training and sustained quality assurance , is an effective method to prevent cervical cancer in developing countries |
11,598 | 30,123,008 | All studies assessed different aspects of QoL in PCOS women and found that PCOS had negative effects on QoL in this population .
Conclusion The PCOSQ and the SF-36 were used most frequently for the assessment of QoL in PCOS women .
Perhaps using either a specific question naire solely or a specific question naire in conjunction with a generic measure would be more appropriate when measuring QoL in PCOS women .
However , both question naires showed that they are able to capture different aspects of QoL in PCOS women and to identify areas that can help to improve QoL in these women | Introduction Polycystic ovary syndrome ( PCOS ) is associated with biochemical and hormonal disturbance and adverse cosmetic , reproductive , metabolic , and psychological consequences , result ing in reduced health-related quality of life ( HRQoL ) .
Various generic and specific question naires have been used for assessing different dimensions of HRQoL in PCOS women .
The purpose of this systematic review was to identify those general and specific instruments and to determine the factors that affect HRQoL in PCOS women . | Background Women with polycystic ovary syndrome ( PCOS ) have symptoms of depression and anxiety and impaired health related quality of life ( HRQoL ) . Here we test the post-hoc hypothesis that acupuncture and exercise improve depression and anxiety symptoms and HRQoL in PCOS women . Methods Seventy-two PCOS women were r and omly assigned to 16 weeks of 1 ) acupuncture ( n = 28 ) ; 2 ) exercise ( n = 29 ) ; or 3 ) no intervention ( control ) ( n = 15 ) . Outcome measures included : change in Montgomery Åsberg Depression Rating Scale ( MADRS-S ) , Brief Scale for Anxiety ( BSA-S ) , Swedish Short-Form 36 ( SF-36 ) , and PCOS Question naire ( PCOSQ ) scores from baseline to after 16-week intervention , and to 16-week post-intervention follow-up . Results A reduction in MADRS-S and BSA-S from baseline to 16-weeks post-intervention follow-up was observed for the acupuncture group . The SF-36 domains role physical , energy/vitality , general health perception and the mental component of summary scores improved in the acupuncture group after intervention and at follow-up . Within the exercise group the role physical decreased after treatment , while physical functioning and general health perception scores increased at follow-up . The emotion domain in the PCOSQ improved after 16-weeks of intervention within all three groups , and at follow-up in acupuncture and exercise groups . At follow-up , improvement in the infertility domain was observed within the exercise group . Conclusion There was a modest improvement in depression and anxiety scores in women treated with acupuncture , and improved HRQoL scores were noted in both intervention groups . While not a primary focus of the trial , these data suggest continued investigation of mental health outcomes in women treated for PCOS.Trial registration number Clinical Trials.gov Identifier : Abstract Polycystic ovary syndrome ( PCOS ) is a common endocrine disorder with a significant psychological burden throughout the life course of affected women . Thus , use of mindful awareness may be beneficial as an adjunct to conventional medical management of women with PCOS . A r and omized , controlled trial was conducted at the Evgenideion Hospital of the Athens University Medical School to explore the impact of an 8-week mindfulness stress management program on measures of depression , anxiety and stress as well as on the quality of life in reproductive age women with PCOS . The study was approved by the Research Ethics Committee . Twenty-three and 15 women with PCOS were r and omly allocated to the intervention or control group , respectively . All participants were administered DASS21 , PSS-14 , PCOSQ , Daily Life and General Life Satisfaction Question naires and provided three-timed daily sample s of salivary cortisol , before and after the intervention . Intervention group participants were provided with the Credibility/Expectancy Question naire at the day of enrolment , to check for possible placebo effect on the outcome . Post-intervention , between-group results revealed statistically significant reductions in stress , depressive and anxiety symptoms , as well as in salivary cortisol concentrations , along with an increase in Life Satisfaction and Quality of Life scores in the intervention group only . There was no significant “ placebo ” effect on the outcome measures . Mindfulness techniques seem promising in ameliorating stress , anxiety , depression and the quality of life in women with PCOS and could be used as an adjunct method to the conventional management of these women In most of South Asia , prevalences and phenotypes of polycystic ovary syndrome ( PCOS ) among women in the community are unknown . The authors aim ed to estimate prevalence and phenotype in a community setting in Sri Lanka and to test a valid , feasible screening approach to early diagnosis . A community-based , cross-sectional study was carried out in 2005 - 2006 . A r and om sample of 3,030 women aged 15 - 39 years was selected by cluster sampling proportionate to population size . An interviewer-administered question naire was utilized to screen for " probable cases " of PCOS based on menstrual history and clinical manifestations of hyper and rogenism . Selected " probable cases " underwent clinical , biochemical , and ovarian ultrasound assessment . The response rate was 96.2 % ( n = 2,915 ) . A total of 220 ( 7.5 % ) " probable cases " were identified : 209 women with oligo/amenorrhea ( 95 % ) and 11 women with hirsutism ( 5 % ) . Further evaluation of the 220 probable cases confirmed 164 newly diagnosed cases of PCOS based on the 2003 Rotterdam diagnostic criteria . With 19 previously diagnosed cases already present , total prevalence was 6.3 % ( 95 % confidence interval : 5.9 , 6.8 ) . Of the women with " oligo/amenorrhea and /or hirsutism , " 91.1 % were confirmed to have PCOS ; 99.4 % of women with " regular cycles in the absence of clinical hyper and rogenism " were confirmed as normal . The most common phenotypes of PCOS were oligo/amenorrhea and polycystic ovaries ( 91.4 % ) and oligo/amenorrhea and hirsutism ( 48.3 % ) CONTEXT Polycystic ovary syndrome ( PCOS ) is associated with reduced health-related quality of life ( HRQOL ) and increased prevalence of depressive and anxiety disorders . The impact of PCOS-specific treatments on these co-morbidities is unclear . OBJECTIVE To assess the impact of weight loss and decreasing hyper and rogenism on HRQOL and mood and anxiety disorders in women with PCOS . DESIGN / SETTING / PARTICIPANTS A secondary analysis of a r and omized controlled trial ( OWL-PCOS ) of preconception treatment conducted at two academic centers in women ( age , 18 - 40 years ; body mass index , 27 - 42 kg/m(2 ) ) with PCOS defined by Rotterdam criteria . INTERVENTION Continuous oral contraceptive pill ( OCP ) or intensive lifestyle intervention or the combination ( Combined ) for 16 weeks . MAIN OUTCOME MEASURE(S ) Changes in HRQOL assessed by PCOSQ and SF-36 and prevalence of depression and anxiety disorder assessed by PRIME-MD PHQ . RESULTS The lowest scores were noted on the general health domain of the SF-36 and the weight and infertility domains on the PCOSQ . All three interventions result ed in significant improvement in the general health score on the SF-36 . Both the OCP and Combined groups showed improvements in all domains of the PCOSQ ( P < .01 ) compared to baseline scores . The Combined group had significant improvements in the weight , body hair , and infertility domains compared to a single treatment group ( P < .05 ) . In a linear regression model , change in weight correlated with improvements in the weight domain ( P < .001 ) and physical well-being ( P < .02 ) , change in T correlated with improvements in the hair domain ( P < .001 ) , and change in both weight and T correlated with the infertility ( P < .001 ) and menstrual domains ( P < .05 ) . CONCLUSIONS Both weight loss and OCP use result in significant improvements in several physical and mental domains related to quality of life , depressive symptoms , and anxiety disorders , and combined therapies offer further benefits in overweight/obese women with PCOS Background Few studies have assessed whether the amelioration of the clinical signs of polycystic ovary syndrome ( PCOS ) achieved by treatment leads to improvement in the health-related quality of life ( HRQoL ) of patients . This study was aim ed to examine the HRQoL of ethnic Chinese women with PCOS who received metformin treatment . Methods This prospect i ve study was conducted at a medical center in Taiwan . Study participants aged 18–45 years were diagnosed as having PCOS according to the Rotterdam criteria , and all received metformin treatment . Their HRQoL was assessed using generic ( WHOQOL-Bref ) and PCOS-specific ( Chi-PCOSQ ) instruments . Mixed effect models were used to examine the effects of metformin on repeatedly measured HRQoL. Additional analyses using stratified patients characteristics ( overweight vs. normal ; hyper and rogenism vs. non-hyper and rogenism ) were done . Results We recruited 109 participants ( 56 % were overweight , 80 % had hyper and rogenism ) . Among the domain scores of WHOQOL-Bref , the psychological domain score was the lowest one ( 12.64 ± 2.2 , range 4–20 ) . Weight ( 3.25 ± 1.59 , range 1–7 ) and infertility ( 3.38 ± 1.93 , range 1–7 ) domain scores were relatively low among the domain scores of Chi-PCOSQ . Overweight and hyper and rogenic patients had significantly lower HRQoL as compared with those of normal weight and non-hyper and rogenic patients , respectively . Metformin significantly improved the physical domain of WHOQOL-Bref ( p = 0.01 ) , and the infertility ( p = 0.043 ) and acne and hair loss aspects ( p = 0.008 ) of PCOS-specific HRQoL. In the subgroup analysis , significantly improved HRQoL following metformin treatment appeared for only overweight and hyper and rogenism subgroups . Conclusions Metformin might improve health-related quality of life of polycystic ovary syndrome women by ameliorating psychological disturbances due to acne , hair loss and infertility problems , especially for overweight and hyper and rogenic patients BACKGROUND In polycystic ovary syndrome ( PCOS ) , changes in physical appearance , menstrual disturbances and infertility result in psychological distress and reduced quality -of-life . Metformin improves biochemical , clinical and reproductive parameters in PCOS women . In a prospect i ve , observational study , we analysed the effects of metformin treatment on health-related quality -of-life ( HRQL ) , emotional well-being and sexuality in PCOS . No placebo-treated control group was included . METHODS Before , during and after 6 months of treatment , changes in clinical and endocrine parameters , quality -of-life , psychological disturbances and sexuality were assessed in 64 PCOS patients using vali date d question naires ( SF-36 , SCL-90-R ) and visual analogue scales . Patients were also compared with published normative data for the vali date d question naires . RESULTS During treatment , HRQL , particularly the psychosocial aspects ( indicated by significant increases in SF-36 scales Vitality , Social Function , Emotional Role Function , Mental Health , Psychological Sum scale ) and emotional well-being ( reflected by significant lowering of SCL-90-R scales ) improved . These improvements in HRQL were significantly correlated with a reduction in body weight and significantly more pronounced in patients with normalized menstrual cycles . In addition , PCOS women were significantly more satisfied with their sex life and reported higher frequencies of sexual intercourse following treatment . CONCLUSION Treatment can improve the psychosocial , emotional and psychosexual situation of PCOS patients . Although at least some of these effects may be related to the reduction of individual clinical symptoms ( i.e. weight loss , normalization of menstrual disturbances , improvement of acne ) , this observational study does not allow us to clearly discern the role of symptom constellation and does not preclude non-specific and /or placebo effects . Nevertheless , emotional distress and reduced quality -of-life are clearly not an inevitable consequence of PCOS and should be considered as adjunct treatment goals in future studies BACKGROUND Ovulation induction with gonadotrophins is the st and ard treatment strategy for women with clomiphene citrate (CC)-resistant polycystic ovary syndrome ( PCOS ) . Laparoscopic electrocautery of the ovaries is an alternative treatment modality , leading to a comparable cumulative pregnancy rate . In deciding which treatment to opt for , women 's health-related quality of life ( HRQoL ) should be taken into account . METHODS A total of 168 CC-resistant women with PCOS were r and omly assigned to receive either the electrocautery strategy , entailing laparoscopic electrocautery of the ovaries followed by CC and recombinant FSH ( rFSH ) if anovulation persisted , or ovulation induction with rFSH . We assessed women 's HRQoL with the st and ard question naires Short Form-36 , Rotterdam Symptom Checklist and Center for Epidemiological Studies Depression Scale , administered before r and omization and 2 , 12 and 24 weeks thereafter . RESULTS The intention to treat analysis revealed no significant differences between the treatment groups on any of the scales at any point during follow-up . In women without an ongoing pregnancy , those treated with rFSH showed significantly more depressive symptoms than women allocated to the electrocautery strategy , with or without CC , although differences were small . CONCLUSIONS Overall , HRQoL was not affected in both groups . In women still under treatment , rFSH was slightly more burdensome for women 's HRQoL than electrocautery with or without CC OBJECTIVE This study was design ed to evaluate the reliability , validity , and responsiveness of a newly developed , health-related quality -of-life measure . STUDY DESIGN A total of 137 women ( 122 from a Phase III clinical trial and 15 from a private practice setting ) with endometriosis completed the question naire several times . RESULTS Reproducibility and internal-consistency reliability were acceptable with intraclass correlation coefficients ranging from 0.94 to 1.00 and Cronbach 's alpha coefficients ranging from 0.84 to 0.97 . Construct validity was demonstrated on the basis of correlations between items and scales . Health-related quality of life varied in a consistent manner according to clinician-rated measures of pelvic pain and dysmenorrhea and patient-reported levels of endometriosis pain , but no relationship emerged according to the revised American Fertility Society classification . In general , the question naire was moderately to highly responsive to change . CONCLUSION This is the first comprehensive health-related quality -of-life question naire available for use with endometriosis patients that has demonstrated reliability , validity , and responsiveness OBJECTIVE To determine the conversion risk and predictors for depression in women with polycystic ovary syndrome . DESIGN Prospect i ve longitudinal study . SETTING University practice . PATIENT(S ) Subjects with polycystic ovary syndrome who had participated in a previous study . INTERVENTION(S ) None . MAIN OUTCOME MEASURE(S ) The Primary Care Evaluation of Mental Disorders Patient Health Question naire was used to diagnose major depressive disorder and other depressive syndromes , anxiety syndromes , and binge eating disorder . Subjects completed a question naire on knowledge about polycystic ovary syndrome and treatment satisfaction . RESULT ( S ) A total of 60 of 103 subjects responded to the second survey . Mean time between the two surveys was 22 months ( range 12 - 26 months ) . The overall prevalence of depression was 40 % ( 24/60 ) . Of these , 10 women screened positive for major depressive disorder or other depressive syndromes and 14 were receiving antidepressant medications . There were 11 new cases identified in the second survey ( 19 % conversion ) . Total subjects with mood disorders in this study were 34/60 ( 56.6 % ) , including 11.6 % with anxiety syndromes and 23.3 % with binge eating disorder . Difficulties with menstrual function , fertility , and body image ( weight , hirsutism , acne ) were not significantly different in women with and without depression . CONCLUSION ( S ) There is a significant risk for mood disorders ( defined by the Diagnostic and Statistical Manual of Mental Disorders-IV ) in women with polycystic ovary syndrome . This finding together with a high conversion risk for depression over a 1- to 2-year period underscores the importance of routine screening and aggressive treatment of mental health disorders in this population Background Facial hirsutism is one of the characteristic features of polycystic ovary syndrome ( PCOS ) , and this can lead to high levels of depression and anxiety . OBJECTIVE To determine if the combination of lifestyle ( caloric restriction and exercise ) and metformin ( MET ) would be superior to lifestyle and placebo ( PBO ) in improving the polycystic ovary syndrome ( PCOS ) phenotype . DESIGN Double-blind r and omized 6-month trial of MET versus PBO . SETTING Two academic medical centers . PATIENT(S ) One hundred fourteen subjects with PCOS were r and omized to MET ( N = 55 ) or PBO ( N = 59 ) . INTERVENTION(S ) Subjects collected urine daily for ovulation monitoring , had monthly monitoring of hormones and weight and determination of body composition by dual-energy x-ray absorptiometry , glucose tolerance , and were evaluated for quality of life at baseline and completion . MAIN OUTCOME MEASURE(S ) Ovulation rates and testosterone levels . RESULT ( S ) Dropout rates were high . There was no significant difference in ovulation rates . Testosterone levels were significantly lower compared with baseline in the MET group at 3 mos but not at 6 mos . There were no differences in weight loss between groups , but MET showed a significant decline at 6 months compared with baseline ( -3.4 kg , 95 % confidence interval -5.3 to -1.5 kg ) . We noted divergent effects of MET versus PBO on oral glucose tolerance test indices of insulin sensitivity ( increased ) and secretion ( worsened ) . Total bone mineral density increased significantly in MET . There were no differences in quality of life measures between the groups . The MET group had increased diarrhea and headache , but fewer bladder infections and musculoskeletal complaints . CONCLUSION ( S ) The addition of metformin to lifestyle therapy produced little reproductive or glycemic benefit in women with PCOS , although our study had limited power owing to a high dropout rate . It is not possible at baseline to identify women likely to drop out Polycystic ovary syndrome ( PCOS ) , defined as the combination of oligoanovulation and hyper and rogenism , affects more than 5 % of women of reproductive age . Insulin resistance and hyperinsulinemia appear to play an important role in its pathogenesis . Here , we will present a characterization of a PCOS cohort from North Rhine-Westphalia in Germany . Clinical features , family history as well as endocrine and metabolic parameters were prospect ively recorded from 200 successive patients . All patients were evaluated for insulin resistance and beta-cell-function by oral glucose tolerance test . Patient data were compared with those of 98 age-matched control women . PCOS patients showed significantly higher BMI , body fat mass and and rogen levels as well as impaired glucose and insulin metabolism . A positive family history of PCOS and diabetes was more frequent in PCOS patients . Insulin resistance ( 71 % ) was the most common metabolic abnormality in PCOS patients followed by obesity ( 52 % ) and dyslipidemia ( 46.3 % ) , with an incidence of 31.5 % for the metabolic syndrome . C-reactive protein and other cardiovascular risk factors were frequently elevated even in young PCOS patients . While the clinical characteristics and endocrine parameters of this German PCOS cohort were heterogeneous , they were comparable to those from other Caucasian population OBJECTIVE To develop a self-administered question naire for measuring health-related quality of life ( HRQL ) in women with polycystic ovary syndrome ( PCOS ) . METHODS We identified a pool of 182 items potentially relevant to women with PCOS through semistructured interviews with PCOS patients , a survey of health professionals who worked closely with PCOS women , and a literature review . One hundred women with PCOS completed a question naire in which they told us whether the 182 items were relevant to them and , if so , how important the issue was in their daily lives . We included items endorsed by at least 50 % of women in the analysis plus additional items considered crucial by clinicians and an important subgroup of patients in a factor analysis . We chose items for the final question naire taking into account both item impact ( the frequency and importance of the items ) and the results of the factor analysis . RESULTS Over 50 % of the women with PCOS labelled 47 items as important to them . Clinicians chose 5 additional items from the infertility domain , 4 of which were identified as important by women who were younger , less educated , married , and African-American . The Cattell 's Scree plot from a factor analysis of these 51 items suggested 5 factors that made intuitive sense : emotions , body hair , weight , infertility , and menstrual problems . We chose the highest impact items from these 5 domains to construct a final question naire , the Polycystic Ovary Syndrome Question naire ( PCOSQ ) , which includes a total of 26 items and takes 10 - 15 minutes to complete . CONCLUSIONS We have used established principles to construct a question naire that promises to be useful in measuring health-related quality of life . The question naire should be tested prior to , or concurrent with , its use in r and omized trials of new treatment approaches OBJECTIVE We examined the measurement properties of a question naire ( PCOSQ ) measuring health-related quality of life ( HRQOL ) in women with the polycystic ovary syndrome ( PCOS ) . STUDY DESIGN This multicenter prospect i ve r and omized placebo-controlled blinded study enrolled 393 patients with PCOS at tertiary care sites . Participants were r and omized to placebo or troglitazone ( 150 mg/d , 300 mg/d , or 600 mg/d ) . At baseline ( n=393 ) and after 44 weeks of treatment ( n=284 ) the proportion of normal menstrual cycles , the free testosterone ( T ) level , four objective measures of facial hair growth ( hair density and hair growth rate by photography , and hair diameter and hair growth rate using plucked hairs ) , and a subjective assessment of the degree of hirsutism , the modified Ferriman-Gallwey ( F-G ) score , were determined . At both visits , patients also completed the PCOSQ . Since the trial was conducted , troglitazone has been removed from the market because of toxic effects . The PCOSQ includes 26 questions ( items ) that address five areas of concern ( domains ) , including emotions , body hair , body weight , fertility , and menstruation rated on a seven-point scales in which lower scores denote higher degrees of patient concern and a lower HRQOL . RESULTS Cronbach 's alpha was > 0.7 for four of five domains . Factor analysis provided moderate to strong support for the five-domain structure of the PCOSQ . Cross-sectional correlations were weak with all measures but the F-G score and hair growth ( r=-.46 , P < .01 ) . The change in the F-G score showed a statistically significant ( P < .01 ) correlation with changes in PCOSQ hair growth ( r=-.22 ) , weight ( r=-.17 ) , infertility ( r=-.20 ) , and menstruation ( r=-.20 ) . Changes in the proportion of normal menstrual cycles correlated with change in the infertility domain ( r=.14 , P < .03 ) and with the change in the menstruation domain ( r=.31 , P < .001 ) . The PCOSQ proved as responsive as the F-G , and more responsive than the objective measures of hair growth , to effects of troglitazone . CONCLUSIONS Our data provides some support for the discriminative and longitudinal validity , and appreciable support for the responsiveness , of the PCOSQ OBJECTIVE To assess the impact of adding exercise to dietary restriction on depressive symptoms and health-related quality of life ( HRQOL ) in women with polycystic ovary syndrome ( PCOS ) . DESIGN Analysis of depression and quality of life outcomes from a r and omized , controlled prospect i ve clinical intervention that evaluated the effects on a range of health outcomes in women with PCOS . SETTING Clinical research unit . PATIENT(S ) One hundred four overweight/obese PCOS women ( aged 29.3 ± 0.7 years ; body mass index [ BMI ] 36.1 ± 0.5 kg/m(2 ) ) . INTERVENTION(S ) R and omized to one of three 20-week lifestyle programs : diet only , diet and aerobic exercise , or diet and combined aerobic-resistance exercise . MAIN OUTCOME MEASURE(S ) Depression and PCOS-specific HRQOL . RESULT ( S ) Forty-nine women completed the intervention ( diet only = 14 , diet and aerobic exercise = 15 , diet and combined aerobic-resistance exercise = 20 ) . By week 20 all groups achieved weight loss and had improvements in depression and PCOS-specific HRQOL scores , except for body hair domain score . There was no difference between treatments for all outcomes . CONCLUSION ( S ) This study demonstrated that dietary restriction alone and combined with exercise had similar benefits for improving depression and HRQOL scores in overweight and obese women with PCOS |
11,599 | 30,759,311 | Based on short-term ( up to 12 months ) follow-up , the effect of Aquablation on urological symptoms is probably similar to that of TURP ( moderate-certainty evidence ) .
The effect on quality of life may also be similar ( low-certainty evidence ) . | BACKGROUND New , minimally invasive surgeries have emerged as alternatives to transurethral resection of the prostate ( TURP ) for the management of lower urinary tract symptoms ( LUTS ) in men with benign prostatic hyperplasia ( BPH ) .
Aquablation is a novel , minimally invasive , water-based therapy , combining image guidance and robotics for the removal of prostatic tissue .
OBJECTIVES To assess the effects of Aquablation for the treatment of lower urinary tract symptoms in men with benign prostatic hyperplasia . | To assess the safety and feasibility of aquablation in a first‐in‐man study . Aquablation is a novel minimally invasive water ablation therapy combining image guidance and robotics ( AquaBeam ® ) for the targeted and heat‐free removal of prostatic tissue in men with lower urinary tract symptoms ( LUTS ) secondary to benign prostatic hyperplasia ( BPH ) In recent years quality of life instruments have been featured as primary outcomes in many r and omized trials . One of the challenges facing the investigator using such measures is determining the significance of any differences observed , and communicating that significance to clinicians who will be applying the trial results . We have developed an approach to elucidating the significance of changes in score in quality of life instruments by comparing them to global ratings of change . Using this approach we have established a plausible range within which the minimal clinical ly important difference ( MCID ) falls . In three studies in which instruments measuring dyspnea , fatigue , and emotional function in patients with chronic heart and lung disease were applied the MCID was represented by mean change in score of approximately 0.5 per item , when responses were presented on a seven point Likert scale . Furthermore , we have established ranges for changes in question naire scores that correspond to moderate and large changes in the domains of interest . This information will be useful in interpreting question naire scores , both in individuals and in groups of patients participating in controlled trials , and in the planning of new trials Purpose : We compared the safety and efficacy of Aquablation and transurethral prostate resection for the treatment of lower urinary tract symptoms related to benign prostatic hyperplasia . Material s and Methods : In a double‐blind , multicenter , prospect i ve , r and omized , controlled trial 181 patients with moderate to severe lower urinary tract symptoms related to benign prostatic hyperplasia underwent transurethral prostate resection or Aquablation . The primary efficacy end point was the reduction in International Prostate Symptom Score at 6 months . The primary safety end point was the development of Clavien‐Dindo persistent grade 1 , or 2 or higher operative complications . Results : Mean total operative time was similar for Aquablation and transurethral prostate resection ( 33 vs 36 minutes , p = 0.2752 ) but resection time was lower for Aquablation ( 4 vs 27 minutes , p < 0.0001 ) . At month 6 patients treated with Aquablation and transurethral prostate resection experienced large I‐PSS improvements . The prespecified study noninferiority hypothesis was satisfied ( p < 0.0001 ) . Of the patients who underwent Aquablation and transurethral prostate resection 26 % and 42 % , respectively , experienced a primary safety end point , which met the study primary noninferiority safety hypothesis and subsequently demonstrated superiority ( p = 0.0149 ) . Among sexually active men the rate of anejaculation was lower in those treated with Aquablation ( 10 % vs 36 % , p = 0.0003 ) . Conclusions : Surgical prostate resection using Aquablation showed noninferior symptom relief compared to transurethral prostate resection but with a lower risk of sexual dysfunction . Larger prostates ( 50 to 80 ml ) demonstrated a more pronounced superior safety and efficacy benefit . Longer term followup would help assess the clinical value of Aquablation Purpose : We sought to establish the safety and effectiveness of aquablation , a novel , image guided , robotic assisted , water jet tissue ablation technology , for the treatment of benign prostatic hyperplasia . Material s and Methods : We performed a prospect i ve , single arm , multicenter trial at a total of 3 centers in Australia and New Zeal and with 1‐year followup . Participants were men 50 to 80 years old with moderate to severe lower urinary tract symptoms as determined by urodynamics . All patients underwent aquablation under image guidance . Primary end points included procedural and perioperative safety . The main clinical end point was the change from baseline in I‐PSS ( International Prostate Symptom Score ) . Other secondary end points included uroflow measures , prostate volume on transrectal ultrasound and detrusor pressure . Detrusor pressure at maximum flow was only measured at 6 months . Results : A total of 21 men underwent aquablation at a mean age of 69.7 years ( range 62 to 78 ) . Prostate volume was 57.2 ml ( range 30 to 102 ) . Procedural duration averaged 38 minutes with a mean aquablation treatment time of 5 minutes . All but 1 subject were catheterized for 1 day only and 19 of 21 were discharged home the day after the procedure . Detrusor pressure at maximum flow decreased from 65 cm H2O at baseline to 39 cm H2O at 6 months ( p < 0.0027 ) . Prostate volume decreased from 57 ml at baseline to 35 ml ( p < 0.0001 ) . Mean I‐PSS score improved from 23.0 at baseline to 6.8 at 12 months ( p < 0.0001 ) and maximum urinary flow increased from 8.7 to 18.3 ml per second ( p < 0.0001 ) . There were no important perioperative adverse events . No urinary incontinence developed and sexual function was preserved postoperatively . Conclusions : This phase II study provides early evidence to support the safety and effectiveness of aquablation for symptomatic benign prostatic hyperplasia Introduction TURB is the st and ard approach to bladder tumors but suffers from several disadvantages . Waterjet hydrodissection is a new technology for removing superficial tumors in the GI tract promising to preserve the histological structures of biopsy specimens with favorable long-term results as recent studies have shown . The aim of this study was to show the feasibility and applicability of waterjet hydrodissection for removing papillary superficial bladder tumors . Material s and methods In five patients diagnosed with superficial papillary bladder tumor , transurethral submucosal dissection was conducted using the T-type I-Jet HybridKnife ( Erbe , Tuebingen ) . The resection edges were labeled by means of electrical coagulation with the HybridKnife . Subsequently , a submucosal fluid cushion specific to the tissue layer was formed by the waterjet implementation function of the HybridKnife , thereby elevating the tumorous tissue . The tumor was endoscopically extracted with a retrieval bag . Biopsy specimens of the tumor edges and base were subsequently collected . Results All tumors could be resected en bloc , and the lamina propria was intact in all specimens , allowing the pathologist to distinguish between superficial and invasive tumors . Pathological analysis confirmed R0 resection in all sample s. Conclusion These initial results prove the feasibility of waterjet hydrodissection for removing bladder tumors . In contrast to conventional TURB , this new technique allows the pathologist to assess the entire lamina propria and the resection edges due to the en-bloc resection and to determine invasiveness as well as R0 versus R1 resection . These first results are promising , long-term oncological follow-up , and prospect i ve r and omized surveys investigating the recurrence rate have to be evaluated PURPOSE We analyzed data from the placebo arm of the MTOPS trial to determine clinical predictors of BPH progression . MATERIAL S AND METHODS A total of 3,047 patients with LUTS were r and omized to either placebo , doxazosin ( 4 to 8 mg ) , finasteride ( 5 mg ) , or a combination of doxazosin and finasteride . Average length of followup was 4.5 years . The primary outcome was time to overall clinical progression of BPH , defined as either a confirmed 4-point or greater increase in AUA SS , acute urinary retention , incontinence , renal insufficiency , or recurrent urinary tract infection . We analyzed BPH progression event data from the 737 men who were r and omized to placebo . RESULTS The rate of overall clinical progression of BPH events in the placebo group was 4.5 per 100 person-years , for a cumulative incidence ( among men who had at least 4 years of followup data ) of 17 % . The risk of BPH progression was significantly greater in patients on placebo with a baseline TPV of 31 ml or greater vs less than 31 ml ( p < 0.0001 ) , a baseline PSA of 1.6 ng/dl or greater vs PSA less than 1.6 ng/dl ( p = 0.0009 ) , a baseline Qmax of less than 10.6 ml per second vs 10.6 ml per second or greater ( p = 0.011 ) , a baseline PVR of 39 ml or greater vs less than 39 ml ( p = 0.0008 ) and baseline age 62 years or older vs younger than 62 years ( p = 0.0002 ) . CONCLUSIONS Among men in the placebo arm , baseline TPV , PSA , Qmax , PVR and age were important predictors of the risk of clinical progression of BPH To present early safety and feasibility data from a multicentre prospect i ve study ( WATER II ) of aquablation in the treatment of symptomatic men with large‐volume benign prostatic hyperplasia ( BPH ) Non-r and omised studies of the effects of interventions are critical to many areas of healthcare evaluation , but their results may be biased . It is therefore important to underst and and appraise their strengths and weaknesses . We developed ROBINS-I ( “ Risk Of Bias In Non-r and omised Studies - of Interventions ” ) , a new tool for evaluating risk of bias in estimates of the comparative effectiveness ( harm or benefit ) of interventions from studies that did not use r and omisation to allocate units ( individuals or clusters of individuals ) to comparison groups . The tool will be particularly useful to those undertaking systematic review s that include non-r and omised studies Background No study has compared the bothersomeness of all lower urinary tract symptoms ( LUTS ) using a population -based sample of adults . Despite this lack of evidence , investigators have often cited their LUTS of interest as the “ most bothersome ” or “ one of the most bothersome . ” Objective To compare the population - and individual-level burden of LUTS in men and women . Design , setting , and participants In this population -based cross-sectional study , question naires were mailed to 6000 individuals ( 18–79 yr of age ) r and omly identified from the Finnish Population Register . Outcome measurements and statistical analysis The vali date d Danish Prostatic Symptom Score question naire was used for assessment of bother of 12 different LUTS . The age-st and ardized prevalence of at least moderate bother was calculated for each symptom ( population -level burden ) . Among symptomatic individuals , the proportion of affected individuals with at least moderate bother was calculated for each symptom ( individual-level bother ) . Results and limitations A total of 3727 individuals ( 62.4 % ) participated ( 53.7 % female ) . The LUTS with the greatest population -level burden were urgency ( 7.9 % with at least moderate bother ) , stress urinary incontinence ( SUI ) ( 6.5 % ) , nocturia ( 6.0 % ) , postmicturition dribble ( 5.8 % ) , and urgency urinary incontinence ( UUI ) ( 5.0 % ) . Burden from incontinence symptoms was higher in women than men , and the opposite was true for voiding and postmicturition symptoms . At the individual level , UUI was the most bothersome for both genders . Although the response proportion was high , approximately a third did not participate . Conclusions Both men and women with UUI report moderate or major bother more frequently than individuals with other LUTS . At the population level , the most prevalent bothersome symptoms are urgency , SUI , and nocturia . Patient summary Urinary urgency was the most common troubling symptom in a large population -based study ; however , for individuals , urgency incontinence was the most likely to be rated as bothersome BACKGROUND Despite widespread adoption of the six-item erectile function ( EF ) domain of the International Index of Erectile Function ( IIEF ) as a clinical trial end point , there are currently no objective data on what constitutes a minimal clinical ly important difference ( MCID ) in the EF domain . OBJECTIVE Estimate the MCID for the IIEF EF domain . DESIGN , SETTING , AND PARTICIPANTS Anchor-based MCIDs were estimated using data from 17 r and omized , double-blind , placebo-controlled , parallel-group clinical trials of the phosphodiesterase type 5 inhibitor ( PDE5-I ) tadalafil for 3345 patients treated for 12 wk . MEASUREMENTS The anchor for the MCID is the minimal improvement measure calculated using change from baseline to 12 wk on IIEF question 7 : " Over the past 4 weeks , when you attempted sexual intercourse how often was it satisfactory for you ? " MCIDs were developed using analysis of variance (ANOVA)- and receiver operating characteristic (ROC)-based methods in a subset of studies ( n=11 ) by comparing patients with and without minimal improvement ( n=863 ) . MCIDs were vali date d in the remaining six studies ( n=377 ) . RESULTS AND LIMITATIONS The ROC-based MCID for the EF domain was 4 , with estimated sensitivity and specificity of 0.74 and 0.73 , respectively . MCIDs varied significantly ( p<0.0001 ) according to baseline ED severity ( mild : 2 ; moderate : 5 ; severe : 7 ) . MCIDs consistently distinguished between patients in the validation sample classified as no change or minimally improved overall and by geographic region , ED etiology , and age group . MCIDs did not differ by age group , geographic region , or ED etiology . Current analyses were based on 17 clinical trials of tadalafil . Results need to be replicated in studies using other PDE5-Is or in nonpharmacologic intervention studies . CONCLUSIONS The context ualization of treatment-related changes in terms of clinical ly relevant improvement is essential to underst and ing treatment efficacy , to interpreting results across studies , and to managing patients effectively . This analysis provides , for the first time , anchor-based estimates of MCIDs in the EF domain score of the IIEF PURPOSE Transurethral resection of the prostate has for decades been the st and ard surgical therapy for lower urinary tract symptoms secondary to benign prostatic hyperplasia , the most common benign neoplasm in men . To generate a contemporary reference for evolving medical and minimally invasive therapies we analyzed complications and immediate outcomes of transurethral prostate resection in a statewide multicenter study . MATERIAL S AND METHODS We prospect ively evaluated 10,654 patients undergoing transurethral prostate resection in the state of Bavaria , Germany from January 1 , 2002 until December 31 , 2003 . Case records containing 54 items concerning preoperative status , operation details , complications and immediate outcome , were recorded for each patient . RESULTS The mortality rate for transurethral prostate resection was 0.10 % . The cumulative short-term morbidity rate was 11.1 % . The most relevant complications were failure to void ( 5.8 % ) , surgical revision ( 5.6 % ) , significant urinary tract infection ( 3.6 % ) , bleeding requiring transfusions ( 2.9 % ) and transurethral resection syndrome ( 1.4 % ) . The resected tissue averaged 28.4 gm . Incidental carcinoma of the prostate was diagnosed by histological examination in 9.8 % of patients . Urinary peak flow rate increased significantly to 21.6 + /- 9.4 ml per second ( baseline 10.4 + /- 6.8 ml per second , 1 tail p < 0.0001 ) , while post-void residual decreased to 31.1 + /- 73.0 ml ( baseline 180.3 + /- 296.9 ml , 1-tail p < 0.0001 ) . CONCLUSIONS In a large scale evaluation comprising 44 mostly nonacademic urological departments in Bavaria , unique real-world data for transurethral prostate resection were prospect ively generated . This most contemporary information should be of use to potential patients and facilitate subsumption of emerging surgical and nonsurgical benign prostatic hyperplasia treatment options PURPOSE To revise the 2003 version of the American Urological Association 's ( AUA ) Guideline on the management of benign prostatic hyperplasia ( BPH ) . MATERIAL S AND METHODS From MEDLINE ® search es of English language publications ( January 1999 through February 2008 ) using relevant MeSH terms , articles concerning the management of the index patient , a male ≥45 years of age who is consulting a healthcare provider for lower urinary tract symptoms ( LUTS ) were identified . Qualitative analysis of the evidence was performed . Selected studies were stratified by design , comparator , follow-up interval , and intensity of intervention , and meta-analyses ( quantitative synthesis ) of outcomes of r and omized controlled trials were planned . Guideline statements were drafted by an appointed expert Panel based on the evidence . RESULTS The studies varied as to patient selection ; r and omization ; blinding mechanism ; run-in periods ; patient demographics , comorbidities , prostate characteristics and symptoms ; drug doses ; other intervention characteristics ; comparators ; rigor and intervals of follow-up ; trial duration and timing ; suspected lack of applicability to current US practice ; and techniques of outcomes measurement . These variations affected the quality of the evidence review ed making formal meta- analysis impractical or futile . Instead , the Panel and extractors review ed the data in a systematic fashion and without statistical rigor . Diagnosis and treatment algorithms were adopted from the 2005 International Consultation of Urologic Diseases . Guideline statements concerning pharmacotherapies , watchful waiting , surgical options and minimally invasive procedures were either up date d or newly drafted , peer review ed and approved by AUA Board of Directors . CONCLUSIONS New pharmacotherapies and technologies have emerged which have impacted treatment algorithms . The management of LUTS/BPH continues to evolve PURPOSE We evaluate the impact of GreenLight High-Performance System ( HPS ™ ) laser photoselective vaporization prostatectomy ( PVP ) on sexual function after treatment of lower urinary tract symptoms ( LUTS ) secondary to benign prostatic hyperplasia ( BPH ) . PATIENTS AND METHODS We prospect ively evaluated our initial single surgeon experience with GreenLight HPS ™ laser PVP . All patients had American Urological Association Symptom Score ( AUASS ) , Sexual Health Inventory for Men ( SHIM ) , maximum flow rate ( Qmax ) , and postvoid residual ( PVR ) determinations . Transurethral PVP was performed using a 120W GreenLight HPS ™ side-firing laser system . AUASS , SHIM , Qmax , and PVR were evaluated 1 , 4 , 12 , 24 , and 52 weeks postsurgery . Wilcoxon signed rank test and the Student t-test were used to assess the changes from baseline . RESULTS Seventy-two patients completed 52 weeks of follow-up , having a median age of 69 ( 45 - 89 ) years . The median prostate volume was 62 ( 21 - 263 ) mL. Median AUASS improved significantly from 23 to 8 , 6 , 5 , 5 , and 4 ( P < 0.05 ) at 1 , 4 , 12 , 24 , and 52 weeks , respectively . Median SHIM changed from 15 to 12 , 16 , 19 , 16 , and 17 during the follow-up period ( P = 0.032 , 0.427 , 0.074 , 0.081 , and 0.259 ) . Minimum change ( 0 ± 5 ) in SHIM occurred in 85.5 % , 90.5 % , 78.8 % , 77.5 % , and 73.7 % of patients ; 11.3 % , 6.3 % , 6.0 % , 4.8 % , and 7.0 % of patients had deterioration of erectile function ( SHIM reduction > 5 ) ; and 3.2 % , 3.2 % , 15.2 % , 17.7 % , and 19.3 % of patients had improvement of erectile function ( SHIM increase > 5 ) . Incidence of new-onset retro grade ejaculation was 30 % . CONCLUSION GreenLight HPS ™ laser PVP appears to not have a detrimental effect on erectile function The terms applicability , generalizability , external validity and transferability are related , sometimes used interchangeably and have in common that they lack a clear and consistent definition in the classic epidemiological literature . However , all of these terms generally describe one overarching theme : whether or not available research evidence can be directly utilized to answer the healthcare questions at h and , ideally supported by a judgment about the degree of confidence for this utilization . This concept has been called directness . The objectives of this paper were to delineate how non-r and omized studies ( NRS ) inform judgments in relation to directness and the concepts that it encompasses in the context of systematic review s. We will briefly review what is known and describe the theoretical and practical issues as well as offer guidance to those tackling the challenges of judging directness and using research evidence to answer healthcare questions with evidence from NRS . In particular , we suggest a framework in which authors can use NRS as a complement , sequence or replacement for r and omized controlled trials ( RCTs ) by focusing on judgments about the population , intervention , comparison and outcomes . Authors of systematic review s will use NRS to complement judgments about the inconsistencies , the rationale and credibility of subgroup analysis , the baseline risk estimates for the determination of absolute benefits and downsides , and the directness of surrogate outcomes . This evidence includes context ual or supplementary evidence . Authors of systematic review and other summaries of the evidence use NRS as sequential evidence to provide evidence when insufficient evidence is available for an outcome from RCTs , but NRS evidence is available ( e.g. , long-term harms ) . Use of evidence from NRS may also serve to replace RCT evidence when NRS provide equivalent ( or potentially higher ) confidence in the evidence ( i.e. quality ) compared to indirect evidence from RCTs . These judgments will be made in the context of other domains that influence the overall quality of the body of evidence , including the risk of bias , publication bias ( i.e. limitations in the detailed study design and execution ) , inconsistency , imprecision and factors that increase our confidence in effects . This article will support systematic review ers in their interaction with decision makers , that is , those who use the systematic review to develop guidelines , address health policy makers , and make clinical decisions , by making these judgments transparent . Copyright © 2013 John Wiley & Sons , INTRODUCTION The purpose of this analysis was to compare Aquablation to transurethral resection of the prostate ( TURP ) with respect to efficacy and safety at 1 year for the treatment of lower urinary tract symptoms related to benign prostatic hyperplasia ( BPH ) in the United States ( U.S. ) cohort from the Waterjet Ablation Therapy for Endoscopic Resection of prostate tissue ( WATER ) study . MATERIAL S AND METHODS WATER is a double-blinded , multicenter prospect i ve r and omized controlled trial for patients with moderate-to-severe lower urinary tract symptoms related to BPH . Men were r and omized to TURP or Aquablation . The efficacy and safety outcomes at 1 year were evaluated for the U.S. cohort . The efficacy objective was reduction in International Prostate Symptom Score ( IPSS ) . The safety objective was the occurrence of Clavien-Dindo persistent grade 1 or grade 2 or higher operative complications . RESULTS Ninety patients were r and omized and treated between December 2015 and December 2016 . Change in IPSS at 1 year between Aquablation and TURP was similar ( 14.5 versus 13.8 , respectively , p = 0.7117 ) . The number of subjects experiencing persistent Clavien-Dindo grade 1 or Clavien-Dindo grade 2 or higher adverse events was lower in the Aquablation group compared to the TURP group ( 20 % versus 47 % respectively , p = 0.0132 ) . Amongst sexually active subjects , the rate of anejaculation was lower in patients treated with Aquablation than TURP ( 9 % versus 45 % , respectively , p = .0006 ) . CONCLUSIONS Surgical prostate resection using Aquablation showed improvement in lower urinary tract symptoms at 1 year comparable to TURP , but with a lower risk of adverse events and ejaculatory dysfunction Purpose Ejaculatory dysfunction is the most common side effect related to surgical treatment of benign prostatic obstruction ( BPO ) . Nowadays , modified surgical techniques and non-ablative techniques have emerged with the aim of preserving ante grade ejaculation . Our objective was to conduce a systematic review of the literature regarding efficacy on ejaculatory preservation of modified endoscopic surgical techniques , and mini-invasive non-ablatives techniques for BPO management . Methods A systematic review of the literature was carried out on the PubMed data base using the following MESH terms : “ Prostatic Hyperplasia/surgery ” and “ Ejaculation ” , in combination with the following keywords : “ ejaculation preservation ” , “ photoselective vaporization of the prostate ” , “ photoselective vapo-enucleation of the prostate ” , “ holmium laser enucleation of the prostate ” , “ thulium laser ” , “ prostatic artery embolization ” , “ urolift ” , “ rezum ” , and “ aquablation ” . Results The ejaculation preservation rate of modified-TURP ranged from 66 to 91 % . The ejaculation preservation rate of modified-prostate photo-vaporization ranged from 87 to 96 % . The only high level of evidence studies available compared prostatic urethral lift ( PUL ) and aquablation versus regular TURP in prospect i ve r and omized-controlled trials . The ejaculation preservation rate of either PUL or aquablation compared to regular TURP was 100 and 90 versus 34 % , respectively . Conclusions Non-ablative therapies and modified endoscopic surgical techniques seemed to be reasonable options for patients eager to preserve their ejaculatory functions Purpose Aquablation of the prostate using the AquaBeam ™ system promises equivalent functional outcomes , reduced learning curve , and improved sexual function compared to transurethral prostate resection as shown in prospect i ve r and omized trials . This prospect i ve cohort study aims to evaluate if published results can be transferred into the clinical routine in a non-selected patient collective . Methods This study includes all patients treated between September 2017 and June 2018 with Aquablation of the prostate . Patients have been evaluated prospect ively for the perioperative course and early follow-up . Besides voiding parameter and symptom score , TRUS-volume change , ejaculatory function , and adverse events have been recorded . Results 118 consecutive patients have been treated in the given time . Aquablation could be carried out successfully in all patients . IPSS , QoL , Qmax , and PVR improved significantly after the procedure and continued to improve during 3-month follow-up . Mean OR time was 20 min , TRUS volume decreased by 65 % , and 73 % of the patients retained ante grade ejaculation . Thirteen adverse events ( > Clavien-Dindo I ) occurred in 10 patients . Conclusion The surgical ablation of the prostate using Aquablation achieved significant and immediate improvement of functional voiding parameters Qmax and PVR as well as symptomatic improvement of IPSS and QoL. Aquablation seems to be safe and effective with a low perioperative complication profile even in a non-selected group of patients INTRODUCTION Surgical management options for lower urinary tract symptoms/benign prostatic hyperplasia ( LUTS/BPH ) associated with prostates of small to moderate volume ( < 80 cc ) are numerous ; however , for men with enlarged prostates ( > 80 cc ) , many of these options are neither safe nor effective . Recently , Aquablation ( PROCEPT BioRobotics , Inc. , U.S. ) , a precise ultrasound-guided , robotically executed prostatic ablative procedure , has become available with U.S. Food and Drug Administration approval . Herein , we present three-month safety and efficacy data from the cohort of Canadian men included in the WATER II trial . METHODS WATER II is a prospect i ve clinical trial of the Aquablation system for the treatment of BPH in men with prostate volumes between 80 and 150 cc . Only patients from Canada were included for this analysis . At baseline , subjects completed International Prostate Symptom Score ( IPSS ) , as well as several vali date d question naires , uroflowmetry and post-void residual volume measurements , and underwent st and ard laboratory blood assessment . These were repeated at one and three months post-Aquablation . RESULTS A total of 19 subjects who met inclusion and exclusion criteria were enrolled at three Canadian academic sites . Mean pre- , one-month , and three-month post-treatment IPSS scores were 21.2±5.5 , 9.9±6.9 ( p<0.0001 ) , and 5.0±4.5 ( p<0.0001 ) , respectively . Mean pre- , one-month , and three-month post-treatment maximum urinary flow rates ( Qmax ) were 6.6±3.1 ml/s , 19.5±6.1 ml/s ( p<0.0001 ) , and 23.1±9.2 ml/s ( p<0.0001 ) , respectively . The Clavien-Dindo grade 2 or higher event rate at three months was 31.6 % ( six events ) . CONCLUSIONS In this short-term , three-month analysis of Canadian men , Aquablation appears to provide a strong surgical alternative in patients with LUTS/BPH due to larger prostate volumes , with impressive functional outcomes , relatively short operative time and length of hospital stay , and acceptable complication and low transfusion rates Introduction Surgical options for benign prostatic hyperplasia ( BPH ) become limited when treating large prostates due to steep learning curves and less effective treatment . Aquablation ( AquaBeam System , PROCEPT BioRobotics , Inc. , USA ) could remedy this . We compare the effectiveness of Aquablation in large prostates between 80 cc and 100 cc and very large prostates > 100 cc . Methods WATER II ( NCT03123250 ) is a prospect i ve , multicenter , international clinical trial of Aquablation for the surgical treatment of LUTS/BPH in men of age 45–80 years with prostates between 80 cc and 150 cc . Aquablation was performed using the AquaBeam System . The reported analysis compares the subgroup of patients with a baseline prostate size of < 100 cc versus those with a prostate size of > 100 cc . Students ’ t test was used for continuous variables and Fisher ’s test for ordinal/binary variables . Results Of 114 screened patients , 101 meeting eligibility criteria were enrolled at 13 US and 3 Canadian sites between September and December 2017 . Mean operative time was 31.2 ± 8 min in the < 100 cc subgroup and 41.7 ± 14.9 min in the > 100 cc subgroup . The average length of stay following the procedure for the < 100 cc subgroup was 1.5 ± 0.7 days versus 1.7 ± 1.1 days for the > 100 cc subgroup . Mean changes in International Prostate Symptom Score ( IPSS ) , IPSS quality of life , and IPSS voiding and storage subscores were substantial , occurring soon after treatment and averaging ( at 3 months ) 16.5 , 2.8 , 10.6 , and 5.8 points , respectively ( all p < 0.0001 ) . Conclusion Aquablation clinical ly normalizes outcomes between patients of the < 100 cc and > 100 cc prostate cohorts . It is safe and effective in patients with large prostate gl and s ( > 100 cc ) with a smoother learning curve OBJECTIVE To report 1-year safety and efficacy outcomes after either Aquablation or transurethral resection of the prostate ( TURP ) for the treatment of lower urinary tract symptoms related to benign prostatic hyperplasia ( BPH ) METHODS : This double-blinded , multicenter prospect i ve r and omized controlled trial assigned 181 patients with BPH-related moderate-to-severe lower urinary tract symptoms to either electrocautery-based prostate resection ( TURP ) or Aquablation . Efficacy endpoints included reduction in International Prostate Symptom Score and improvement in uroflow parameters . The primary safety endpoint was the occurrence of Clavien-Dindo persistent grade 1 or grade 2 or higher complications . RESULTS BPH symptom score improvements were similar across groups with 12-month reduction of 15.1 points after TURP or Aquablation . In both groups , mean maximum urinary flow rates increased markedly postoperatively , with mean improvements of 10.3 cc/s for Aquablation versus 10.6 cc/s for TURP ( P = .8632 ) . At 1 year , Prostate-specific antigen ( PSA ) was reduced significantly ( P < .01 ) in both groups by 1 point ; the reduction was similar across groups ( P = .9125 ) . Surgical retreatment for BPH rates for TURP were 1.5 % and Aquablation 2.6 % within 1 year from the study procedure ( P = not significant ( NS ) ) . The rate of late complications was low , with no procedure-related adverse events after month 6 . CONCLUSION The 1-year outcomes after TURP and Aquablation were similar and the rate of late procedure-related complications was low . ( Clinical Trials.gov number , NCT02505919 ) To present 6‐month safety and effectiveness data from a multicentre prospect i ve study of aquablation in men with lower urinary tract symptoms ( LUTS ) attributable to benign prostatic hyperplasia ( BPH ) with prostate volumes between 80 and 150 |
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