title: Effects of muscle strengthening versus aerobic exercise program in fibromyalgia A six-month double-blind, placebo-controlled, randomized clinical trial of duloxetine for the treatment of fibromyalgia A six-month randomized controlled trial of exercise and pyridostigmine in the treatment of fibromyalgia. Effect of gamma-hydroxybutyrate on pain, fatigue, and the alpha sleep anomaly in patients with fibromyalgia. Preliminary report. A Successful, Long-Term Exercise Program for Women With Fibromyalgia Syndrome and Chronic Fatigue and Immune Dysfunction Syndrome Double-blind, multicenter trial comparing acetyl l-carnitine with placebo in the treatment of fibromyalgia patients. Fibromyalgia: the role of sleep in affect and in negative event reactivity and recovery. Long-term Maintenance of Response Across Multiple Fibromyalgia Symptom Domains in a Randomized Withdrawal Study of Pregabalin Vulnerability to stress among women in chronic pain from fibromyalgia and osteoarthritis davis et al. stress vulnerability Effectiveness of high-frequency transcutaneous electrical nerve stimulation at tender points as adjuvant therapy for patients with fibromyalgia. Effects of Panax ginseng extract in patients with fibromyalgia: a 12-week, randomized, double-blind, placebo-controlled trial. Effectiveness of a Psychoeducational Treatment Program Implemented in General Practice for Fibromyalgia Patients: A Randomized Controlled Trial A double-blind, multicenter trial comparing duloxetine with placebo in the treatment of fibromyalgia patients with or without major depressive disorder. Safety and efficacy of esreboxetine in patients with fibromyalgia: a fourteen-week, randomized, double-blind, placebo-controlled, multicenter clinical trial. The Effect of Melatonin in Patients with Fibromyalgia: A Pilot Study The prevalence and characteristics of fibromyalgia in the general population. Pregabalin for the treatment of fibromyalgia syndrome: results of a randomized, double-blind, placebo-controlled trial. Effectiveness of multidisciplinary therapy on symptomatology and quality of life in women with fibromyalgia. Fibromyalgia syndrome improved using a mostly raw vegetarian diet: An observational study A randomized, double-blind, placebo-controlled, phase III trial of pregabalin in the treatment of patients with fibromyalgia. Longterm Therapeutic Response to Milnacipran Treatment for Fibromyalgia. A European 1-Year Extension Study Following a 3-Month Study Efficacy of Low Power Laser Therapy in Fibromyalgia: A Single-blind, Placebo-controlled Trial Impact of an occupation-based self-management programme on chronic disease management. Fibromyalgia: a randomised, controlled trial of a treatment programme based on self management A randomized placebo-controlled study of noninvasive cortical electrostimulation in the treatment of fibromyalgia patients. Aerobic exercise versus combined exercise therapy in women with fibromyalgia syndrome: a randomized controlled trial. Six weeks of whole-body vibration exercise improves pain and fatigue in women with fibromyalgia. Improvement in multiple dimensions of fatigue in patients with fibromyalgia treated with duloxetine: secondary analysis of a randomized, placebo-controlled trial Effects of unilateral repetitive transcranial magnetic stimulation of the motor cortex on chronic widespread pain in fibromyalgia. A randomized, double-blind, placebo-controlled trial of pramipexole, a dopamine agonist, in patients with fibromyalgia receiving concomitant medications. Reduction of fibromyalgia symptoms through intravenous nutrient therapy: results of a pilot clinical trial. A pilot randomized controlled trial of the Yoga of Awareness program in the management of fibromyalgia Modafinil treatment for fatigue associated with fibromyalgia. Efficacy of the "body movement and perception" method in the treatment of fibromyalgia syndrome: an open pilot study. A randomized controlled trial of dehydroepiandrosterone in postmenopausal women with fibromyalgia. A pilot study of external qigong therapy for patients with fibromyalgia. Efficacy of Raloxifen in treatment of fibromyalgia in menopausal women. Health status and disease severity in fibromyalgia: results of a six-center longitudinal study. Pool exercise combined with an education program for patients with fibromyalgia syndrome. A prospective, randomized study. The effect of combined therapy (ultrasound and interferential current) on pain and sleep in fibromyalgia Effects of low power laser and low dose amitriptyline therapy on clinical symptoms and quality of life in fibromyalgia: a single-blind, placebo-controlled trial Vegetarian diet in the treatment of fibromyalgia. Neurofeedback Intervention in Fibromyalgia Syndrome; a Randomized, Controlled, Rater Blind Clinical Trial A European Multicenter Randomized Double-blind Placebo-controlled Monotherapy Clinical Trial of Milnacipran in Treatment of Fibromyalgia Balneotherapy for fibromyalgia at the Dead Sea Can coenzyme q10 improve clinical and molecular parameters in fibromyalgia? Electroconvulsive therapy in patients with depression and fibromyalgia Milnacipran for the treatment of fibromyalgia in adults: a 15-week, multicenter, randomized, double-blind, placebo-controlled, multiple-dose clinical trial. Long-term maintenance of the analgesic effects of transcranial magnetic stimulation in fibromyalgia Effects of concurrent strength and endurance training on physical fitness and symptoms in postmenopausal women with fibromyalgia: a randomized controlled trial. Effects of Sodium Oxybate on Sleep Physiology and Sleep/Wake-related Symptoms in Patients with Fibromyalgia Syndrome: A Double-blind, Randomized, Placebo-controlled Study Efficacy of milnacipran in patients with fibromyalgia. A randomized, placebo-controlled, double-blind, flexible-dose study of fluoxetine in the treatment of women with fibromyalgia. The internet-based arthritis self-management program: a one-year randomized trial for patients with arthritis or fibromyalgia. Results of a multidisciplinary program for patients with fibromyalgia implemented in the primary care Investigation of the effects of pool-based exercise on fibromyalgia syndrome A double-blind placebo-controlled trial of milnacipran in the treatment of fibromyalgia. Efficacy and safety of milnacipran 100 mg/day in patients with fibromyalgia: results of a randomized, double-blind, placebo-controlled trial. The contribution of pain, reported sleep quality, and depressive symptoms to fatigue in fibromyalgia Content and Criterion Validity of the Preliminary Core Dataset for Clinical Trials in Fibromyalgia Syndrome Strength training induced adaptations in neuromuscular function of premenopausal women with fibromyalgia: comparison with healthy women The effects of sodium oxybate on clinical symptoms and sleep patterns in patients with fibromyalgia. Oral S-adenosylmethionine in primary fibromyalgia. Double-blind clinical evaluation. Open trial of mirtazapine in patients with fibromyalgia. Double-blind, placebo-controlled cross-over study of intravenous S-adenosyl-L-methionine in patients with fibromyalgia. Assessing fibromyalgia-related fatigue: content validity and psychometric performance of the Fatigue Visual Analog Scale in adult patients with fibromyalgia. SPA therapy in fibromyalgia: a randomised controlled clinic study The Efficacy and Safety of Milnacipran for Treatment of Fibromyalgia. A Randomized, Double-blind, Placebo-controlled Trial Fibromyalgia treatment with intravenous tropisetron administration. Safety and efficacy of esreboxetine in patients with fibromyalgia: An 8-week, multicenter, randomized, double-blind, placebo-controlled study. Measurement properties of the Medical Outcomes Study Sleep Scale in patients with fibromyalgia. Multidisciplinary treatment of fibromyalgia: does cognitive behavior therapy increase the response to treatment? An open-label study of quetiapine in the treatment of fibromyalgia Written Emotional Expression Produces Health Benefits in Fibromyalgia Patients Sodium oxybate reduces pain, fatigue, and sleep disturbance and improves functionality in fibromyalgia: Results from a 14-week, randomized, double-blind, placebo-controlled study Toward Development of a Fibromyalgia Responder Index and Disease Activity Score: OMERACT Module Update
abstract: The purpose of this study was to compare the effects of aerobic training with a muscle-strengthening program in patients with fibromyalgia . Thirty women with fibromyalgia were r and omized to either an aerobic exercise ( AE ) program or a strengthening exercise ( SE ) program for 8 weeks . Outcome measures included the intensity of fibromyalgia-related symptoms , tender point count , fitness ( 6-min walk distance ) , hospital anxiety and depression ( HAD ) scale , and short-form health survey ( SF-36 ) . There were significant improvements in both groups regarding pain , sleep , fatigue , tender point count , and fitness after treatment . HAD-depression scores improved significantly in both groups while no significant change occurred in HAD-anxiety scores . Bodily pain subscale of SF-36 and physical component summary improved significantly in the AE group , whereas seven subscales of SF-36 , physical component summary , and mental component summary improved significantly in the SE group . When the groups were compared after treatment , there were no significant differences in pain , sleep , fatigue , tender point count , fitness , HAD scores , and SF-36 scores . AE and SE are similarly effective at improving symptoms , tender point count , fitness , depression , and quality of life in fibromyalgia Objective : Assess the efficacy of  duloxetine 60/120 mg ( N = 162 ) once daily compared with  placebo ( N = 168 ) in the treatment of patients with fibromyalgia , during six months of treatment . Methods : This was a phase-III , r and omized , double-blind , placebo-controlled , parallel-group study assessing the efficacy and safety of duloxetine . Results : There were no significant differences between treatment groups on the co- primary efficacy outcome measures , change in the Brief Pain Inventory ( BPI ) average pain severity from baseline to endpoint ( P = 0.053 ) and the Patient ’s Global Impressions of Improvement ( PGI-I ) at endpoint ( P = 0.073 ) . Duloxetine-treated patients improved significantly more than placebo-treated patients on the Fibromyalgia Impact Question naire pain score , BPI least pain score and average interference score , Clinical Global Impressions of Severity scale , area under the curve of pain relief , Multidimensional Fatigue Inventory mental fatigue dimension , Beck Depression Inventory-II total score , and 36-item Short Form Health Survey mental component summary and mental health score . Nausea was the most common treatment-emergent adverse event in the duloxetine group . Overall discontinuation rates were similar between groups . Conclusions : Although duloxetine 60/120 mg/day failed to demonstrate significant improvement over placebo on the co- primary outcome measures , in this supportive study , duloxetine demonstrated significant improvement compared with placebo on numerous secondary measures OBJECTIVE A subset of fibromyalgia ( FM ) patients have a dysfunctional hypothalamic-pituitary-insulin-like growth factor 1 ( IGF-1 ) axis , as evidence d by low serum levels of IGF-1 and a reduced growth hormone ( GH ) response to physiologic stimuli . There is evidence that pyridostigmine ( PYD ) improves the acute response of GH to exercise in FM patients . The purpose of this study was to evaluate the clinical effectiveness of 6 months of PYD and group exercise on FM symptoms . METHODS FM patients were r and omized to 1 of the following 4 groups : PYD plus exercise , PYD plus diet recall but no exercise , placebo plus exercise , and placebo plus diet recall but no exercise . The primary outcome measures were the visual analog scale ( VAS ) score for pain , tender point count , and total myalgic score . Secondary outcome measures were the total score on the Fibromyalgia Impact Question naire ( FIQ ) and FIQ VAS scores for individual symptoms ( fatigue , poor sleep , stiffness , and anxiety ) , as well as quality of life ( QOL ) and physical fitness ( lower body strength/endurance , upper and lower body flexibility , balance , and time on the treadmill ) . RESULTS A total of 165 FM patients completed baseline measurements ; 154 ( 93.3 % ) completed the study . The combination of PYD and exercise did not improve pain scores .  PYD groups showed a significant improvement in sleep and anxiety in those who completed the study and in QOL in those who complied with the therapeutic regimen as compared with the placebo groups . Compared with the nonexercise groups , the 2 exercise groups demonstrated improvement in fatigue and fitness .  PYD was generally well tolerated . CONCLUSION Neither the combination of PYD plus supervised exercise nor either treatment alone yielded improvement in most FM symptoms . However , PYD did improve anxiety and sleep , and exercise improved fatigue and fitness . We speculate that PYD may have improved vagal tone , thus benefiting sleep and anxiety ; this notion warrants further study OBJECTIVE To evaluate the effects of using a gamma-hydroxybutyrate ( GHB ) administered in divided doses at night in 11 patients previously diagnosed with fibromyalgia ( FM ) . METHODS Subjects completed daily diaries assessing their pain and fatigue levels and slept in the sleep laboratory before and one month after initiating GHB treatment . Polysomnographic recordings were evaluated for sleep stages , sleep efficiency and the presence of the alpha anomaly in non-REM sleep . RESULTS There was a significant improvement in both fatigue and pain , with an increase in slow wave sleep and a decrease in the severity of the alpha anomaly . CONCLUSION Further controlled studies are needed to characterize the clinical improvement and the polysomnographic changes we observed This article describes an ongoing , long-term clinical exercise program for women with fibromyalgia syndrome ( FMS ) , some of whom also have chronic fatigue and immune dysfunction syndrome ( CFIDS ) . The recorded outcomes from the most recent year of the program also are reported . Participants engaged in sessions lasting 50 - 70 minutes , 5 days per week ; each session involved aerobic activity , resistance training , and other dynamic exercise . One group was in the program for 3 years and another group was in the program for 2 years . Program outcomes for the year ( comparing beginning and end-of-year results ) are presented for both groups on physical fitness , psychosocial , and FMS/CFIDS symptoms . The outcomes support that all of the women appear to have benefited from the program in numerous ways , suggesting that the program works . Also , those outcomes are in agreement with past research reported in this journal . Implication s for clinical nurse specialists working with FMS/CFIDS patients are discussed OBJECTIVE Fibromyalgia ( FMS ) is a chronic syndrome characterized by widespread pain , troubled sleep , disturbed mood , and fatigue . Several analgesic strategies have been evaluated but the results are moderate and inconsistent . Antidepressant agents are now considered the treatment of choice in most patients . It has been recently suggested that FMS may be associated with metabolic alterations including a deficit of carnitine . In this multicenter r and omized clinical trial we evaluated the efficacy of acetyl L-carnitine ( LAC ) in patients with overt FMS . METHODS One hundred and two patients meeting the American College of Rheumatology criteria for FMS were r and omized into the study . The treatment consisted of 2 capsules/day of 500 mg LAC or placebo plus one intramuscular ( i.m . ) injection of either 500 mg LAC or placebo for 2 weeks . During the following 8 weeks the patients took 3 capsules daily containing either 500 mg LAC or placebo . The patients were seen during treatment after 2 ( visit 3 ) , 6 ( visit 4 ) and 10 weeks ( visit 5 ) . The patients were also visited 4 weeks after treatment discontinuation ( follow-up visit ) . Outcome measures included the number of positive tender points , the sum of pain threshold ( kg/cm2 or " total myalgic score " ) , the Short Form 36 ( SF36 ) , a 100 mm visual analog scale ( VAS ) for self-perceived stiffness , fatigue , tiredness on awakening , sleep , work status , depression , and muscular-skeletal pain , and the Hamilton depression scale . RESULTS The " total myalgic score " and the number of positive tender points declined significantly and equally in both groups until the 6th week of treatment . At the 10th week both parameters remained unchanged in the placebo group but they continued to improve in the LAC group with a statistically significant between-group difference . Most VAS scores significantly improved in both groups . A statistically significant between-group difference was observed for depression and musculo-skeletal pain . Significantly larger improvements in SF36 question naire were observed in LAC than in placebo group for most parameters . Treatment was well-tolerated . CONCLUSION Although this experience deserves further studies , these results indicate that LAC may be of benefit in patients with FMS , providing improvement in pain as well as the general and mental health of these patients OBJECTIVE Fibromyalgia ( FM ) syndrome is a chronic pain condition characterized by diffuse muscle pain , increased negative mood , and sleep disturbance . Until recently , sleep disturbance in persons with FM has been modeled as the result of the disease process or its associated pain . The current study examined sleep disturbance ( i.e. , sleep duration and sleep quality ) as a predictor of daily affect , stress reactivity , and stress recovery . DESIGN AND MEASURES A hybrid of daily diary and ecological momentary assessment methodology was used to evaluate the psychosocial functioning of 89 women with FM . Participants recorded numeric ratings of pain , fatigue , and positive and negative affect 3 times throughout the day for 30 consecutive days . At the end of each day , participants completed daily diary records of positive and negative life events . In addition , participants reported on their sleep duration and sleep quality each morning . RESULTS After accounting for the effects of positive events , negative events , and pain on daily affect scores , it was found that sleep duration and quality were prospect ively related to affect and fatigue . Furthermore , the effects of inadequate sleep on negative affect were cumulative . In addition , an inadequate amount of sleep prevented affective recovery from days with a high number of negative events . CONCLUSIONS These results lend support to the hypothesis that sleep is a component of allostatic load and has an upstream role in daily functioning Objective : To determine the incidence and duration of response of clinical ly meaningful improvements with pregabalin across several key symptoms of fibromyalgia ( FM ) . Methods : This was a post hoc analysis of data from a multicenter , double-blind , placebo-controlled , r and omized , withdrawal study , originally design ed to evaluate the efficacy of pregabalin monotherapy for durability of effect on FM pain based on pain and Patient Global Impression of Change ( PGIC ) criteria . Responder criteria for Fibromyalgia Impact Question naire total score ( ≥16-point change ) , Medical Outcomes Study Sleep Scale Sleep Disturbance subscale ( ≥15.8-point change ) , and the 36-item Short-Form Health Survey Vitality scale ( ≥10-point change ) were used to evaluate the incidence and duration of improvements in function , sleep , and fatigue  for pregabalin versus placebo among pain and PGIC responders . A composite responder index consisting of pain , PGIC , function , and sleep endpoints was used to explore multidimensional response . Results : Approximately 80 % of patients meeting pain and PGIC improvement criteria at r and omization had clinical ly meaningful improvement in fatigue , sleep , or function . Higher proportions of patients in the pregabalin group maintained a clinical ly meaningful response , and pregabalin-treated patients had a significantly longer time to loss of therapeutic response  compared with the placebo group . Composite responder Kaplan-Meier analysis , performed with patients demonstrating clinical ly meaningful improvements in pain , PGIC , function , and sleep at r and omization showed a significantly longer median time to loss of therapeutic response for pregabalin-treated patients . Discussion : The results from this post hoc analysis indicate that pregabalin provides long-term effects across multiple domains of FM ( Clinical Trials.gov registry ID : NCT00151489 ) In two investigations , we studied vulnerability to the negative effects of stress among women in chronic pain from 2 types of musculoskeletal illnesses , fibromyalgia syndrome ( FMS ) and osteoarthritis ( OA ) . In Study 1 , there were 101 female participants 50 to 78 years old : 50 had FMS , 29 had OA knee pain and were scheduled for knee surgery , and 22 had OA but were not planning surgery . Cross-sectional analyses showed that the three groups were comparable on demographic variables , personality attributes , negative affect , active coping , and perceived social support . As expected , FMS  and  OA surgery women reported similar levels of bodily pain , and both groups scored higher than OA nonsurgery women . However , women with FMS reported poorer emotional and physical health , lower positive affect , a poorer quality social milieu , and more frequent use of avoidant coping with pain than did both groups of women with OA . Moreover , the perception and use of social support were closely tied to perceived social stress only among the FMS group . In Study 2 , we experimentally manipulated negative mood and stress in 41 women 37 to 74 years old : 20 women had FMS , and 21 women had OA . Participants from each group were r and omly assigned to either a negative mood induction or a neutral mood ( control ) condition , and then all participants discussed a stressful interpersonal event for 30 min . Stress-related increases in pain were exacerbated by negative mood induction among women with FMS but not women with OA , and pain during stress was associated with decreases in positive affect in women with FMS but not women with OA . These findings suggest that among women with chronic pain , those with FMS may be particularly vulnerable to the negative effects of social stress . They have fewer positive affective re sources , use less effective pain-coping strategies , and have more constrained social networks than their counterparts with OA , particularly those who experience similar levels of pain . They also seem to experience more prolonged stress-related increases in pain under certain circumstances , all of which may contribute to a lowering of positive affect and increased stress reactivity over time BACKGROUND Fibromyalgia is a chronic pain syndrome associated with sleep disorders , fatigue and psychological symptoms . Combinations therapies , such as electrotherapy and therapeutic exercises have been used in the clinical practice . AIM To assess the efficacy of high-frequency transcutaneous electrical nerve stimulation ( TENS ) as an adjuvant therapy to aerobic and stretching exercises , for the treatment of fibromyalgia . DESIGN Controlled clinical trial . SETTING Unit of rehabilitation of a public hospital . POPULATION Twenty-eight women aged 52.4±7.5 years , with fibromyalgia . METHODS A visual analogue scale measured pain intensity ; tender points pain threshold , by dolorimetry ; and quality of life , by the Fibromyalgia Impact Question naire . All subjects participated in an eight-week program consisting of aerobic exercises , followed by static stretching of muscle chains . In TENS group , high-frequency ( 150 Hz ) was applied on bilateral tender points of trapezium and supraspinatus . RESULTS TENS group had a greater pain reduction ( mean change score=-2.0±2.9 cm ) compared to Without TENS group ( -0.7±3.7 cm ) . There was a difference between mean change scores of each group for pain threshold ( right trapezium : 0.2±1 kg/cm² in TENS group and -0.2±1.2 kg/cm² in Without TENS group ) . In the evaluation of clinical ly important changes , patients receiving TENS had relevant improvement of pain , work performance , fatigue , stiffness , anxiety and depression compared to those not receiving TENS . CONCLUSION It has suggested that high-frequency TENS as an adjuvant therapy is effective in relieving pain , anxiety , fatigue , stiffness , and in improving ability to work of patients with fibromyalgia . CLINICAL REHABILITATION IMPACT High-frequency TENS may be used as a short-term complementary treatment of fibromyalgia The purpose of the study was to evaluate the efficacy of an extract of Panax ginseng in patients with fibromyalgia . A r and omized , double-blind , controlled clinical trial was carried out over 12 weeks to compare the effects of P. ginseng ( 100 mg/d ) with amitriptyline ( 25 mg/d ) and placebo in 38 patients with fibromyalgia : 13 in Group I ( amitriptyline ) , 13 in Group II ( placebo ) , and 12 in Group III ( P. ginseng ) . Ratings on the Visual Analogue Scale ( VAS ) revealed a reduction in pain in the P. ginseng group ( p < .0001 ) , an improvement in fatigue ( p < .0001 ) and an improvement in sleep ( p < .001 ) , with respect to baseline characteristics , but there were no differences between the three groups . With respect to anxiety , improvements occurred in the P. ginseng group compared to baseline ( p < .0001 ) ; however , amitriptyline treatment result ed in significantly greater improvements ( p < .05 ) . P. ginseng reduced the number of tender points and improved patients ' quality of life ( using the Fibromyalgia Impact Question naire - FIQ ) ; however , there were no differences between groups . The beneficial effects experienced by patients for all parameters suggest a need for further studies to be performed on the tolerability and efficacy of this phytotherapic as a complementary therapy for fibromyalgia Objectives A recent meta- analysis concluded that multicomponent treatments are effective for some fibromyalgia ( FM ) symptoms . The objective of this study was to examine whether a psychoeducational intervention implemented in primary care is more effective than usual care for improving the functional status of patients with FM . Methods This study was based on a r and omized controlled trial . The 484 patients with FM included in a data base of the Viladecans Hospital ( Barcelona , Spain ) were eligible for screening . Finally , 108 patients were r and omly assigned to the intervention and 108 patients were assigned to usual care . The intervention comprised nine 2-hour sessions ( 5 sessions of education and 4 sessions of autogenic relaxation ) . The patients were assessed before and after the intervention with a battery of instruments ( measuring sociodemographic data , medical comorbidities , functional status , trait anxiety , and social desirability ) . Results The posttreatment drop-out rate was 9.7 % ( intervention : 6.5 % ; control : 13 % ) . The intention-to-treat analyses showed significant differences between the groups at posttreatment : the intervention group improved in physical impairment , days not feeling well , pain , general fatigue , morning fatigue , stiffness , anxiety , and depression ( medium effect size in most cases ) . The patients who responded to the intervention reported less trait anxiety at baseline than nonresponders . The absolute risk reduction with the intervention was 36.1 % ( 95 % confidence interval : 23.3 - 48.8 ) and the number needed to treat was 3 ( 95 % confidence interval : 2.0 - 4.3 ) . Discussion A 2-month psychoeducational intervention improves the functional status of FM patients to a greater extent than usual care , at least in the short-term . The social desirability bias did not explain the reported outcomes . Trait anxiety was associated with response to treatment . Trial Registration NCT00550966 OBJECTIVE To assess the efficacy and safety of duloxetine , a serotonin and norepinephrine reuptake inhibitor , in subjects with primary fibromyalgia , with or without current major depressive disorder . METHODS This study was a r and omized , double-blind , placebo-controlled trial conducted in 18 outpatient research centers in the US . A total of 207 subjects meeting the American College of Rheumatology criteria for primary fibromyalgia were enrolled ( 89 % female , 87 % white , mean age 49 years , 38 % with current major depressive disorder ) . After single-blind placebo treatment for 1 week , subjects were r and omly assigned to receive duloxetine 60 mg twice a day ( n = 104 ) or placebo ( n = 103 ) for 12 weeks . Co- primary outcome measures were the Fibromyalgia Impact Question naire ( FIQ ) total score ( score range 0 - 80 , with 0 indicating no impact ) and FIQ pain score ( score range 0 - 10 ) . Secondary outcome measures included mean tender point pain threshold , number of tender points , FIQ fatigue , tiredness on awakening , and stiffness scores , Clinical Global Impression of Severity ( CGI-Severity ) scale , Patient Global Impression of Improvement ( PGI-Improvement ) scale , Brief Pain Inventory ( short form ) , Medical Outcomes Study Short Form 36 , Quality of Life in Depression Scale , and Sheehan Disability Scale . RESULTS Compared with placebo-treated subjects , duloxetine-treated subjects improved significantly more ( P = 0.027 ) on the FIQ total score , with a treatment difference of -5.53 ( 95 % confidence interval -10.43 , -0.63 ) , but not significantly more on the FIQ pain score ( P = 0.130 ) . Compared with placebo-treated subjects , duloxetine-treated subjects had significantly greater reductions in Brief Pain Inventory average pain severity score ( P = 0.008 ) , Brief Pain Inventory average interference from pain score ( P = 0.004 ) , number of tender points ( P = 0.002 ) , and FIQ stiffness score ( P = 0.048 ) , and had significantly greater improvement in mean tender point pain threshold ( P = 0.002 ) , CGI-Severity ( P = 0.048 ) , PGI-Improvement ( P = 0.033 ) , and several quality -of-life measures . Duloxetine treatment improved fibromyalgia symptoms and pain severity regardless of baseline status of major depressive disorder . Compared with placebo-treated female subjects ( n = 92 ) , duloxetine-treated female subjects ( n = 92 ) demonstrated significantly greater improvement on most efficacy measures , while duloxetine-treated male subjects ( n = 12 ) failed to improve significantly on any efficacy measure . The treatment effect on significant pain reduction in female subjects was independent of the effect on mood or anxiety . Duloxetine was safely administered and well tolerated . CONCLUSION In this r and omized , controlled , 12-week trial ( with a 1-week placebo lead-in phase ) , duloxetine was an effective and safe treatment for many of the symptoms associated with fibromyalgia in subjects with or without major depressive disorder , particularly for women , who had significant improvement across most outcome measures OBJECTIVE To evaluate the efficacy , tolerability , and safety of multiple fixed dosages of esreboxetine for the treatment of fibromyalgia . METHODS Patients meeting the American College of Rheumatology criteria for fibromyalgia were r and omized to receive esreboxetine at dosages of 4 mg/day ( n=277 ) , 8 mg/day ( n=284 ) , or 10 mg/day ( n=283 ) or matching placebo ( n=278 ) for 14 weeks . The primary efficacy outcomes were the weekly mean pain score and the Fibromyalgia Impact Question naire ( FIQ ) total score at week 14 . Secondary efficacy measures included scores for the Patient 's Global Impression of Change ( PGIC ) scale , the Global Fatigue Index ( GFI ) , and the 36-item Short-Form health survey ( SF-36 ; physical function scale only ) at week 14 . The safety profile of esreboxetine was evaluated based on adverse events and other safety measures . RESULTS Patients receiving all dosages of esreboxetine demonstrated statistically significant improvements in the pain score ( P≤0.025 ) , the FIQ score ( P≤0.023 ) , and the PGIC score ( P≤0.007 ) compared with patients in the placebo group . Additionally , patients receiving esreboxetine at dosages of 4 mg/day and 8 mg/day showed statistically significant improvements in the GFI score compared with those receiving placebo ( P=0.001 ) . No significant differences in SF-36 physical function scores were observed between patients receiving esreboxetine ( any dosage ) and those receiving placebo . Adverse events were mostly mild to moderate in severity ; insomnia , constipation , dry mouth , nausea , dizziness , hot flush , headache , hyperhidrosis , and palpitations were reported most frequently . CONCLUSION Esreboxetine was generally well tolerated and was associated with significant improvements in pain , FIQ , PGIC , and fatigue scores compared with placebo . The lack of a dose-response relationship in both the efficacy and safety analyses suggests that esreboxetine at a dosage of 4 mg/day would offer clinical benefit with the least risk of drug exposure Abstract : The aim of the study was to determine the possible effect of melatonin treatment on disturbed sleep , fatigue and pain symptoms observed in fibromyalgia ( FM ) patients . Twenty-one consecutive patients with FM were included in an open 4-week- duration pilot study . Before and after treatment with melatonin 3 mg at bedtime , patients were evaluated using tender point count by palpation of 18 classic anatomical regions , pain score in four pre design ated areas , pain severity on a 10 cm visual analogue scale ( VAS ) , sleep disturbances , fatigue , depression , anxiety , and patient and physician global assessment s , also by a VAS . Urine 6-sulphatoxymelatonin levels ( aMT-6S ) were measured in the patients and 20 age- and sex-matched controls . Nineteen patients completed the study . One patient withdrew because of migraine and another was lost to follow-up . At day 30 , median values for the tender point count and severity of pain at selected points , patient and physician global assessment s and VAS for sleep significantly improved with melatonin treatment . Other variables improved but did not reach statistical significance . Adverse events were mild and transient . Lower levels of aMT-6S were found in FM patients compared with normal median controls ( ±SD , 9.16 ± 7.9 μg/24 h vs 16.8 ± 12.8 μg/24 h ) ( p= 0.06 ) . Although this is an open study , our preliminary results suggest that melatonin can be an alternative and safe treatment for patients with FM . Double-blind placebo controlled studies are needed OBJECTIVE To determine the prevalence and characteristics of fibromyalgia in the general population . METHODS A r and om sample of 3,006 persons in Wichita , KS , were characterized according to the presence of no pain , non-widespread pain , and widespread pain . A sub sample of 391 persons , including 193 with widespread pain , were examined and interviewed in detail . RESULTS The prevalence of fibromyalgia was 2.0 % ( 95 % confidence interval [ 95 % CI ] 1.4 , 2.7 ) for both sexes , 3.4 % ( 95 % CI 2.3 , 4.6 ) for women , and 0.5 % ( 95 % CI 0.0 , 1.0 ) for men . The prevalence of the syndrome increased with age , with highest values attained between 60 and 79 years ( > 7.0 % in women ) . Demographic , psychological , dolorimetry , and symptom factors were associated with fibromyalgia . CONCLUSION Fibromyalgia is common in the population , and occurs often in older persons . Characteristic features of fibromyalgia -- pain threshold and symptoms -- are similar in community and clinic population s , but overall severity , pain , and functional disability are more severe in the clinic population OBJECTIVE Fibromyalgia syndrome ( FMS ) is characterized by widespread musculoskeletal pain and lowered pain threshold . Other prominent symptoms include disordered sleep and fatigue . FMS affects an estimated 2 % of the population , predominantly women . This trial was design ed to evaluate the efficacy and safety of pregabalin , a novel alpha(2)-delta lig and , for treatment of symptoms associated with FMS . METHODS This multicenter , double-blind , 8-week , r and omized clinical trial compared the effects of placebo with those of 150 , 300 , and 450 mg/day pregabalin on pain , sleep , fatigue , and health-related quality of life in 529 patients with FMS . The primary outcome variable was the comparison of end point mean pain scores , derived from daily diary ratings of pain intensity , between each of the pregabalin treatment groups and the placebo group . RESULTS Pregabalin at 450 mg/day significantly reduced the average severity of pain in the primary analysis compared with placebo ( -0.93 on a 0 - 10 scale ) ( P < /= 0.001 ) , and significantly more patients in this group had > /=50 % improvement in pain at the end point ( 29 % , versus 13 % in the placebo group ; P = 0.003 ) . Pregabalin at 300 and 450 mg/day was associated with significant improvements in sleep quality , fatigue , and global measures of change .  Pregabalin at 450 mg/day improved several domains of health-related quality of life . Dizziness and somnolence were the most frequent adverse events . Rates of discontinuation due to adverse events were similar across all 4 treatment groups . CONCLUSION Pregabalin at 450 mg/day was efficacious for the treatment of FMS , reducing symptoms of pain , disturbed sleep , and fatigue compared with placebo . Pregabalin was well tolerated and improved global measures and health-related quality of life OBJECTIVES To study the effects of a 3-month multidisciplinary intervention based on exercise and psychological therapy on symptomatology and quality of life in women with fibromyalgia . METHODS Seventy-five women with fibromyalgia volunteered to participate and were allocated to a 3-month ( 3-times/week ) multidisciplinary ( pool , l and -based and psychological session based on the Acceptance and Commitment Therapy ) intervention ( n=41 ) , or to a usual care group ( n=34 ) . Sixty-five women with fibromyalgia completed the study protocol ( n=33 multidisciplinary intervention , aged 51.4±7.4 years and n=32 usual care group , aged 50.0±7.3 years ) . The outcomes variables were Fibromyalgia Impact Question naire ( FIQ ) , Short Form Health Survey 36 ( SF-36 ) , Hospital Anxiety and Depression Scale , V and erbilt Pain Management Inventory and Rosenberg Self-Esteem Scale . RESULTS We observed a significant interaction effect ( group*time ) for the FIQ total score , the subscales fatigue , stiffness , anxiety and depression , and the subscales of SF-36 physical role , bodily pain , vitality and social functioning . Post-hoc analysis revealed significant improvements in total score of FIQ ( p<0.001 ) , fatigue ( p=0.001 ) , stiffness ( p<0.001 ) , anxiety ( p=0.011 ) , depression ( p=0.008 ) , physical role ( p=0.002 ) , bodily pain ( p<0.001 ) , vitality ( p<0.001 ) and social functioning ( p<0.001 ) in the intervention group , whereas in the control group , there was a significant worsening in the subscale depression ( p=0.006 ) and social functioning ( p=0.019 ) . CONCLUSIONS A 3-month low-moderate intensity multidisciplinary intervention improved fibromyalgia symptomatology and quality of life in women with fibromyalgia Background Fibromyalgia engulfs patients in a downward , reinforcing cycle of unrestorative sleep , chronic pain , fatigue , inactivity , and depression . In this study we tested whether a mostly raw vegetarian diet would significantly improve  fibromyalgia symptoms . Methods Thirty people participated in a dietary intervention using a mostly raw , pure vegetarian diet . The diet consisted of raw fruits , salads , carrot juice , tubers , grain products , nuts , seeds , and a dehydrated barley grass juice product . Outcomes measured were dietary intake , the fibromyalgia impact question naire ( FIQ ) , SF-36 health survey , a quality of life survey ( QOLS ) , and physical performance measurements . Results Twenty-six subjects returned dietary surveys at 2 months ; 20 subjects returned surveys at the beginning , end , and at either 2 or 4 months of intervention ; 3 subjects were lost to follow-up . The mean FIQ score ( n = 20 ) was reduced 46 % from 51 to 28 . Seven of the 8 SF-36 subscales , bodily pain being the exception , showed significant improvement ( n = 20 , all P for trend < 0.01 ) . The QOLS , scaled from 0 to 7 , rose from 3.9 initially to 4.9 at 7 months ( n = 20 , P for trend 0.000001 ) . Significant improvements ( n = 18 , P < 0.03 , paired t-test ) were seen in shoulder pain at rest and after motion , abduction range of motion of shoulder , flexibility , chair test , and 6-minute walk . 19 of 30 subjects were classified as responders , with significant improvement on all measured outcomes , compared to no improvement among non-responders . At 7 months responders ' SF-36 scores for all scales except bodily pain were no longer statistically different from norms for women ages 45–54 . Conclusion This dietary intervention shows that many fibromyalgia subjects can be helped by a mostly raw vegetarian diet OBJECTIVE To evaluate the efficacy and safety of pregabalin for symptomatic relief of pain  associated with fibromyalgia ( FM ) and for management of FM . METHODS This multicenter , double-blind , placebo-controlled trial r and omly assigned 748 patients with FM to receive placebo or pregabalin 300 , 450 , or 600 mg/day ( dosed twice daily ) for 13 weeks . The primary outcome variable for study objective 1 , symptomatic relief of pain associated with FM , was comparison of endpoint mean pain scores between each pregabalin group and placebo . The outcome variable for study objective 2 , management of FM , included endpoint mean pain scores , Patient Global Impression of Change ( PGIC ) , and Fibromyalgia Impact Question naire (FIQ)-Total Score . Secondary outcomes included assessment s of sleep , fatigue , and mood disturbance . RESULTS Patients in all pregabalin groups showed statistically significant improvement in endpoint mean pain score and in PGIC response compared with placebo . Improvements in FIQ-Total Score for the pregabalin groups were numerically but not significantly greater than those for the placebo group . Compared with placebo , all pregabalin treatment groups showed statistically significant improvement in assessment s of sleep and in patients ' impressions of their global improvement . Dizziness and somnolence were the most frequently reported adverse events . CONCLUSION Pregabalin at 300 , 450 , and 600 mg/day was efficacious and safe for treatment of pain associated with FM . Pregabalin monotherapy provides clinical ly meaningful benefit to patients with FM Objective . This double-blind , 1-year extension study investigated the longterm efficacy and safety of milnacipran 100 , 150 , and 200 mg/day in the treatment of fibromyalgia ( FM ) in completers of a 3-month European double-blind lead-in study of milnacipran 200 mg/day versus placebo . Methods . A total of 468 patients with FM successfully completing the lead-in study were either blindly maintained on milnacipran 200 mg/day ( MLN200:MLN200 , n = 198 ) or ( if previously receiving placebo ) rer and omized to milnacipran 100 mg/day ( PBO : MLN100 , n = 91 ) , 150 mg/day ( PBO : MLN150 , n = 92 ) , or 200 mg/day ( PBO : MLN200 , n = 87 ) for an additional 12 months ( including a 4-week dose escalation ) . The main efficacy endpoint was a 2-measure composite responder rate ( relative to lead-in study baseline ) incorporating the weekly-recall pain score recorded on a visual analog scale and the Patient Global Impression of Change score . A panel of other assessment s including the Fibromyalgia Impact Question naire explored the multidimensional aspects of FM . Descriptive analyses using the last observation carried forward approach were performed . Results . At the 1-year endpoint , the proportion of composite responders ( relative to the lead-in study baseline ) ranged from 27.5 % ( PBO : MLN100 ) to 35.9 % ( MLN200:MLN200 ) , and had increased from the extension study baseline by 15.2 % ( PBO : MLN150 ) to 20.7 % ( PBO : MLN200 and MLN200:MLN200 ) . At endpoint , an improvement from both baselines was shown in all groups on pain , fatigue , sleep , and quality of life measures . Up to 1 year , all doses of milnacipran were safe and well tolerated . The most common drug-related adverse events were hyperhidrosis and nausea . Conclusion . Over 1 year , milnacipran 100 , 150 , and 200 mg/day exhibited sustained and safe therapeutic effects on predominant symptoms of FM . Registered as trial no. NCT00757731 Low energy lasers are widely used to treat a variety of musculoskeletal conditions including fibromyalgia , despite the lack of scientific evidence to support its efficacy . A r and omised , single-blind , placebo-controlled study was conducted to evaluate the efficacy of low-energy laser therapy in 40 female patients with fibromyalgia . Patients with fibromyalgia were r and omly allocated to active ( Ga-As ) laser or placebo laser treatment daily for two weeks except weekends . Both the laser and placebo laser groups were evaluated for the improvement in pain , number of tender points , skinfold tenderness , stiffness , sleep disturbance , fatigue , and muscular spasm . In both groups , significant improvements were achieved in all parameters ( p<0.05 ) except sleep disturbance , fatigue and skinfold tenderness in the placebo laser group ( p>0.05 ) . It was found that there was no significant difference between the two groups with respect to all parameters before therapy whereas a significant difference was observed in parameters as pain , muscle spasm , morning stiffness and tender point numbers in favour of laser group after therapy ( p<0.05 ) . None of the participants reported any side effects . Our study suggests that laser therapy is effective on pain , muscle spasm , morning stiffness , and total tender point number in fibromyalgia and suggests that this therapy method is a safe and effective way of treatment in the cases with fibromyalgia INTRODUCTION There is a need for the development and evaluation of occupational therapy interventions enabling participation and contributing to self-management for individuals with multiple chronic conditions . This pilot study aim ed to assess the feasibility and potential impact of an occupation-based self-management programme for community living individuals with multiple chronic conditions . METHODS Sixteen participants completed a six-week programme . Assessment s were conducted at baseline , immediately post-intervention and at eight-week follow-up . Sixteen participants provided immediate follow-up data and 15 participants provided eight-week follow-up data . Outcome measures included participation in occupations ; perceptions of occupational performance and satisfaction ; self-efficacy ; depression , anxiety and quality of life . Focus groups explored participants ' perceptions of the programme . RESULTS The findings are promising and indicate that the programme delivery was feasible . Significant differences were found immediately post-intervention in frequency of activity participation ( P = 0.008 ) , including domestic ( P = 0.040 ) and work/leisure activities ( P = 0.015 ) , self-perceptions of occupational performance ( P = 0.017 ) and satisfaction with same ( P = 0.023 ) . At eight-week follow-up , significant differences continued to be found in frequency of activity participation ( P = 0.018 ) , including work/leisure activities ( P = 0.038 ) , perceptions of occupational performance ( P = 0.010 ) and satisfaction ( P = 0.008 ) and self-efficacy ( P = 0.050 ) . No differences were found in anxiety , depression or quality of life at follow-up periods . Focus group data supported the programme 's impact on activity participation and self-efficacy . CONCLUSION Despite the small sample in this pilot study there were significant improvements in occupational performance and the findings provide support for the programme . However , there is a need to test the intervention rigorously with a definitive r and omised trial in a primary care setting Objective : To evaluate the efficacy of a treatment programme for patients with fibromyalgia ( FM ) based on self management , using pool exercises and education . Methods : R and omised controlled trial with a 6 month follow up to evaluate an outpatient multidisciplinary programme ; 164 patients with FM were allocated to an immediate 6 week programme ( n = 84 ) or to a waiting list control group ( n = 80 ) . The main outcomes were changes in quality of life , functional consequences , patient satisfaction and pain , using a combination of patient question naires and clinical examinations . The question naires included the Fibromyalgia Impact Question naire ( FIQ ) , Psychological General Well-Being ( PGWB ) index , regional pain score diagrams , and patient satisfaction measures . Results : 61 participants in the treatment group and 68 controls completed the programme and 6 month follow up examinations . Six months after programme completion , significant improvements in quality of life and functional consequences of FM were seen in the treatment group as compared with the controls and as measured by scores on both the FIQ ( total score p = 0.025 ; fatigue p = 0.003 ; depression p = 0.031 ) and PGWB ( total score p = 0.032 ; anxiety p = 0.011 ; vitality p = 0.013 , ) . All four major areas of patient satisfaction showed greater improvement in the treatment than the control groups ; between-group differences were statistically significant for “ control of symptoms ” , “ psychosocial factors ” , and “ physical therapy ” No change in pain was seen . Conclusion : A 6 week self management based programme of pool exercises and education can improve the quality of life of patients with FM and their satisfaction with treatment . These improvements are sustained for at least 6 months after programme completion OBJECTIVE The aim of this multicenter study was to evaluate the efficacy , safety , and tolerability of noninvasive cortical electrostimulation in the management of fibromyalgia ( FM ) . DESIGN A prospect i ve , r and omized , double-blind , placebo-controlled design was used . Setting . Subjects received therapy at two different outpatient clinical locations . PATIENTS There were 77 subjects meeting the American College of Rheumatology 1990 classification criteria for FM . Intervention . Thirty-nine ( 39 ) active treatment ( AT ) FM patients and 38 placebo controls received 22 applications of either noninvasive cortical electrostimulation or a sham therapy over an 11-week period . OUTCOME MEASURES The primary outcome measures were the number of tender points ( TePs ) and pressure pain threshold ( PPT ) . Secondary outcome measures were responses to the Fibromyalgia Impact Question naire ( FIQ ) , Symptom Checklist-90 ( SCL-90 ) , Beck Depression Inventory-II , and a novel sleep question naire , all evaluated at baseline and at the end of treatment . RESULTS Intervention provided significant improvements in TeP measures : compared with placebo , the AT patients improved in the number of positive TePs ( -7.4 vs -0.2 , P<0.001 ) and the PPT ( 19.6 vs -3.2 , P<0.001 ) . Most secondary outcomes also improved more in the AT group : total FIQ score ( -15.5 vs -5.6 , P=0.03 ) , FIQ pain ( -2.0 vs -0.6 , P=0.03 ) , FIQ fatigue ( -2.0 vs -0.4 , P=0.02 ) , and FIQ refreshing sleep ( -2.1 vs -0.7 , P=0.02 ) ; and while FIQ function improved ( -1.0 vs -0.2 ) , the between-group change had a 14 % likelihood of occurring due to chance ( P=0.14 ) . There were no significant side effects observed . CONCLUSIONS Noninvasive cortical electrostimulation in FM patients provided modest improvements in pain , TeP measures , fatigue , and sleep ; and the treatment was well tolerated . This form of therapy could potentially provide worthwhile adjunctive symptom relief for FM patients OBJECTIVE To investigate the effects of supervised aerobic exercise ( AE ) and a combined program of supervised aerobic , muscle strengthening , and flexibility exercises ( combined exercise [ CE ] ) on important health outcomes in women with fibromyalgia syndrome ( FMS ) . DESIGN R and omized controlled trial . SETTING Community-based supervised intervention . PARTICIPANTS Women ( N=64 ) with a diagnosis of FMS according to the American College of Rheumatology criteria . INTERVENTION Participants were r and omly allocated to 1 of 3 groups : supervised AE , supervised CE , or usual-care control . Exercise sessions were performed twice weekly ( 45 - 60min/session ) for 24 weeks . MAIN OUTCOME MEASURES The primary outcome measure was the Fibromyalgia Impact Question naire ( FIQ ) . Exploratory outcome measures were the 36-Item Short-Form Health Survey , Beck Depression Inventory ( BDI ) , aerobic capacity ( 6-minute walk test ) , h and -grip strength , and range of motion in the shoulders and hips . RESULTS Compliance with both interventions was excellent , with women in the exercise groups attending more than 85 % of sessions . A 14 % to 15 % improvement from baseline in total FIQ score was observed in the exercise groups ( P≤.02 ) and was accompanied by decreases in BDI scores of 8.5 ( P<.001 ) and 6.4 ( P<.001 ) points in the AE and CE groups , respectively . Relative to nonexercising controls , CE evoked improvements in the SF-36 Physical Functioning ( P=.003 ) and Bodily Pain ( P=.003 ) domains and was more effective than AE for evoking improvements in the Vitality ( P=.002 ) and Mental Health ( P=.04 ) domains . Greater improvements also were observed in shoulder/hip range of motion and h and grip strength in the CE group . CONCLUSION Given the equivalent time commitment required for AE and CE , our results suggest that women with FMS can gain additional health benefits by engaging in a similar volume of CE OBJECTIVE The aim of this study was to investigate the effectiveness of a 6-week traditional exercise program with supplementary whole-body vibration ( WBV ) in improving health status , physical functioning , and main symptoms of fibromyalgia ( FM ) in women with FM . METHODS Thirty-six ( 36 ) women with FM ( mean + /- st and ard error of the mean age 55.97 + /- 1.55 ) were r and omized into 3 treatment groups : exercise and vibration ( EVG ) , exercise ( EG ) , and control ( CG ) . Exercise therapy , consisting of aerobic activities , stretching , and relaxation techniques , was performed twice a week ( 90 min/day ) . Following each exercise session , the EVG underwent a protocol with WBV , whereas the EG performed the same protocol without vibratory stimulus . The Fibromyalgia Impact Question naire ( FIQ ) was administered at baseline and 6 weeks following the initiation of the treatments . Estimates of pain , fatigue , stiffness , and depression were also reported using the visual analogue scale . RESULTS A significant 3 x 2 ( group x time)-repeated measures analysis of variance interaction was found for pain ( p = 0.018 ) and fatigue ( p = 0.002 ) but not for FIQ ( p = 0.069 ) , stiffness ( p = 0.142 ) , or depression ( p = 0.654 ) . Pain and fatigue scores were significantly reduced from baseline in the EVG , but not in the EG or CG . In addition , the EVG showed significantly lower pain and fatigue scores at week 6 compared to the CG , whereas no significant differences were found between the EG and CG ( p > 0.05 ) . CONCLUSION Results suggest that a 6-week traditional exercise program with supplementary WBV safely reduces pain and fatigue , whereas exercise alone fails to induce improvements Introduction Fatigue is one of the most disabling symptoms associated with fibromyalgia that greatly impacts quality of life . Fatigue was assessed as a secondary objective in a 2-phase , 24-week study in out patients with American College of Rheumatology-defined fibromyalgia . Methods Patients were r and omized to duloxetine 60 - 120 mg/d ( N = 263 ) or placebo ( N = 267 ) for the 12-week acute phase . At Week 12 , all placebo-treated patients were switched to double-blind treatment with duloxetine for the extension phase . Fatigue was assessed at baseline and every 4 weeks with the Multidimensional Fatigue Inventory ( MFI ) scales : General Fatigue , Physical Fatigue , Mental Fatigue , Reduced Activity , and Reduced Motivation . Other assessment s that may be associated with fatigue included Brief Pain Inventory ( BPI ) average pain , numerical scales to rate anxiety , depressed mood , bothered by sleep difficulties , and musculoskeletal stiffness . Treatment-emergent fatigue-related events were also assessed . Changes from baseline to Week 12 , and from Week 12 to Week 24 , were analyzed by mixed-effects model repeated measures analysis . Results At Week 12 , duloxetine versus placebo significantly ( all p < .05 ) reduced ratings on each MFI scale , BPI pain , anxiety , depressed mood , and stiffness . Improvement in ratings of being bothered by sleep difficulties was significant only at Weeks 4 and 8 . At Week 24 , mean changes in all measures indicated improvement was maintained for patients who received duloxetine for all 24 weeks ( n = 176 ) . Placebo-treated patients switched to duloxetine ( n = 187 ) had significant within-group improvement in Physical Fatigue ( Weeks 16 , 20 , and 24 ) ; General Fatigue ( Weeks 20 and 24 ) ; Mental Fatigue ( Week 20 ) ; and Reduced Activity ( Weeks 20 and 24 ) . These patients also experienced significant within-group improvement in BPI pain , anxiety , depressed mood , bothered by sleep difficulties , and stiffness . Overall , the most common ( > 5 % incidence ) fatigue-related treatment-emergent adverse events were fatigue , somnolence , and insomnia . Conclusions Treatment with duloxetine significantly improved multiple dimensions of fatigue in patients with fibromyalgia , and improvement was maintained for up to 24 weeks . Trial registration Clinical Trials.gov registry NCT00673452 Non-invasive unilateral repetitive transcranial magnetic stimulation ( rTMS ) of the motor cortex induces analgesic effects in focal chronic pain syndromes , probably by modifying central pain modulatory systems . Neuroimaging studies have shown bilateral activation of a large number of structures , including some of those involved in pain processing , suggesting that such stimulation may induce generalized analgesic effects . The goal of this study was to assess the effects of unilateral rTMS of the motor cortex on chronic widespread pain in patients with fibromyalgia . Thirty patients with fibromyalgia syndrome ( age : 52.6 + /- 7.9 ) were r and omly assigned , in a double-blind fashion , to two groups , one receiving active rTMS ( n = 15 ) and the other sham stimulation ( n = 15 ) , applied to the left primary motor cortex in 10 daily sessions . The primary outcome measure was self-reported average pain intensity over the last 24 h , measured at baseline , daily during the stimulation period and then 15 , 30 and 60 days after the first stimulation . Other outcome measures included : sensory and affective pain scores for the McGill pain Question naire , quality of life ( assessed with the pain interference items of the Brief Pain Inventory and the Fibromyalgia Impact Question naire ) , mood and anxiety ( assessed with the Hamilton Depression Rating Scale , the Beck Depression Inventory and the Hospital Anxiety and Depression Scale ) . We also assessed the effects of rTMS on the pressure pain threshold at tender points ipsi- and contralateral to stimulation . Follow-up data were obtained for all the patients on days 15 and 30 and for 26 patients ( 13 in each treatment group ) on day 60 . Active rTMS significantly reduced pain and improved several aspects of quality of life ( including fatigue , morning tiredness , general activity , walking and sleep ) for up to 2 weeks after treatment had ended . The analgesic effects were observed from the fifth stimulation onwards and were not related to changes in mood or anxiety . The effects of rTMS were more long-lasting for affective than for sensory pain , suggesting differential effects on brain structures involved in pain perception . Only few minor and transient side effects were reported during the stimulation period . Our data indicate that unilateral rTMS of the motor cortex induces a long-lasting decrease in chronic widespread pain and may therefore constitute an effective alternative analgesic treatment for fibromyalgia OBJECTIVE To assess the efficacy and safety of pramipexole , a dopamine 3 receptor agonist , in patients with fibromyalgia . METHODS In this 14-week , single-center , double-blind , placebo-controlled , parallel-group , escalating-dose trial , 60 patients with fibromyalgia were r and omized 2:1  ( pramipexole : placebo ) to receive 4.5 mg of pramipexole or placebo orally every evening . The primary outcome was improvement in the pain score ( 10-cm visual analog scale [ VAS ] ) at 14 weeks . Secondary outcome measures were the Fibromyalgia Impact Question naire ( FIQ ) , the Multidimensional Health Assessment Question naire ( MDHAQ ) , the pain improvement scale , the tender point score , the 17- question Hamilton Depression Inventory ( HAM-d ) , and the Beck Anxiety Index ( BAI ) .  Patients with comorbidities and disability were not excluded . Stable dosages of concomitant medications , including analgesics , were allowed . RESULTS Compared with the placebo group , patients receiving pramipexole experienced gradual and more significant improvement in measures of pain , fatigue , function , and global status . At 14 weeks , the VAS pain score decreased 36 % in the pramipexole arm and 9 % in the placebo arm ( treatment difference -1.77 cm ) . Forty-two percent of patients receiving pramipexole and 14 % of those receiving placebo achieved > or = 50 % decrease in pain . Secondary outcomes favoring pramipexole over placebo included the total FIQ score ( treatment difference -9.57 ) and the percentages of improvement in function ( 22 % versus 0 % ) , fatigue ( 29 % versus 7 % ) , and global ( 38 % versus 3 % ) scores on the MDHAQ . Compared with baseline , some outcomes showed a better trend for pramipexole treatment than for placebo , but failed to reach statistical significance , including improvement in the tender point score ( 51 % versus 36 % ) and decreases in the MDHAQ psychiatric score ( 37 % versus 28 % ) , the BAI score ( 39 % versus 27 % ) , and the HAM-d score ( 29 % versus 9 % ) . No end points showed a better trend for the placebo arm . The most common adverse events associated with pramipexole were transient anxiety and weight loss . No patient withdrew from the study because of inefficacy or an adverse event related to pramipexole . CONCLUSION In a subset of patients with fibromyalgia , approximately 50 % of whom required narcotic analgesia and /or were disabled , treatment with pramipexole improved scores on assessment s of pain , fatigue , function , and global status , and was safe and well-tolerated OBJECTIVE To evaluate the effectiveness of a modified Myers ' formula of intravenous nutrient therapy ( IVNT ) on the symptoms of fibromyalgia ( FM ) in therapy-resistant FM patients . METHODS In this pilot clinical trial , 7 participants with therapy resistant FM were given IVNT once per week for 8 weeks . Patient 's pain levels , fatigue , and activities of daily living were evaluated weekly . RESULTS All participants reported decreased pain levels , decreased fatigue , and increased activities of daily living . Participants noted increased energy levels within 24 - 48 hours of the initial infusion . At the end of the study , all participants reported increased energy and activities of daily living as well as a 60 % reduction in pain ( P=.005 ) and an 80 % decrease in fatigue ( P=-.005 ) . No participants , however , reported complete or lasting resolution of pain or fatigue . No side effects were reported . DISCUSSION Anecdotal reports have indicated benefit for IVNT for patients with chronic pain , including FM . However , except for 2 reports , the medical literature is devoid of any studies of IVNT for the treatment of FM . In this pilot study , 7 participants received  IVNT  once a week for 8 weeks . All participants had long-st and ing FM ( at least 8 years ) and had tried conventional therapies , such as antidepressants , nonsteroidal anti-inflammatory drugs , and exercise , without significant or lasting relief . All had improvement in symptoms and increases in their activities of daily living , although no participant reported complete resolution of symptoms .  IVNT appears to be safe to reduce FM symptoms & NA ; A mounting body of literature recommends that treatment for fibromyalgia ( FM ) encompass medications , exercise and improvement of coping skills . However , there is a significant gap in determining an effective counterpart to pharmacotherapy that incorporates both exercise and coping . The aim of this r and omized controlled trial was to evaluate the effects of a comprehensive yoga intervention on FM symptoms and coping . A sample of 53 female FM patients were r and omized to the 8‐week Yoga of Awareness program ( gentle poses , meditation , breathing exercises , yoga‐based coping instructions , group discussion s ) or to wait‐listed st and ard care . Data were analyzed by intention to treat . At post‐treatment , women assigned to the yoga program showed significantly greater improvements on st and ardized measures of FM symptoms and functioning , including pain , fatigue , and mood , and in pain catastrophizing , acceptance , and other coping strategies . This pilot study provides promising support for the potential benefits of a yoga program for women with FM Fatigue , which may occasionally be the chief manifestation , is present in more than 90 % of patients with fibromyalgia . It is a significant cause of morbidity and is quite disabling in its ability to disrupt quality of life . The cause of fatigue is complex , but disturbances in sleep architecture may have a role to play . Modafinil , a nonamphetamine wake-promoting agent and a popular treatment of narcolepsy , displays its antifatigue properties through a potentially central prohistaminergic interplay and may conceptually be postulated to lower fatigue in fibromylagia patients as well . Modafinil , unlike amphetamines , is well tolerated with less peripheral hemodynamic alterations combined with low abuse and tolerance sequelae . It also improves vigilance in sleep-deprived patients . Modafinil has been suggested as a possible treatment of fatigue in multiple sclerosis , parkinsonism , depression , primary biliary cirrhosis among other disorders with some demonstrable benefit . Since fatigue constitutes a significant proportion of the morbidity associated with fibromyalgia , we have conducted a retrospective chart review of 98 patients who have fibromyalgia , were being treated by a rheumatologist and 2 nurse practitioners in a private practice setting , and had been given a prescription for modafinil .  Patients were involved in this usual practice setting , and the clinicians documented patient encounters in a st and ard medical record format . The charts were review ed by 5 outside psychiatric clinicians from SUNY Upstate Medical University ’s Depression and Anxiety Disorders Research Program . The study team attempted to exclude charts where there may have been other medical comorbidities that may have induced fatigue and also excluded charts where the initiation of modafinil coincided with the initiation of any other off-label fibromyalgia treatment ( i.e. , duloxetine , amytriptyline , tramadol , etc ) . An analog rating scale was created for this chart review as notes had to be read by study clinicians and retrospective assessment s were made regarding any change in fatigue . This simple scale used a method of visual quantitation of subjective symptomatology change with regard to fatigue . This ranged from a level of 1 , indicative of low fatigue , to 10 , as a representative of the diametrically opposite extreme of marked symptom fatigue . The 5 clinician raters were calibrated to 0.8 accuracy to decrease inter-rater reliability bias . Progress notes were also scanned for reported side effects and for reasons why modafinil may have been discontinued . The average age of the patients was 47 years , and the average dose of modafinil was 162 mg/d , with an average duration of treatment spanning 2 years . The average number of concomitant medications was eight . The mean pre and postfatigue analog scale scores were analyzed and significant statistical difference was demonstrated whereby modafinil augmentation lowered patient fatigue levels from 7.2 0.13 ( severe fatigue ) to 4.4 0.18 ( low-moderate fatigue ( P 0.001 ) . The net mean improvement in fatigue as a target symptom was approximately 28 % . There is often little focus on the fatigue that is commonly reported by these patients . Our simple , retrospective study may be the first that focuses on the use of modafinil for alleviating this symptom . In our retrospective chart review , we found a majority of patients to be involved in both polypharmacy regimens and nonpharmacologic treatment ( i.e. , biofeedback ) as well . The timing of modafinil addition and fatigue amelioration suggests that this agent may be able to effectively treat the fatigue associated with fibromyalgia . It is also a well-tolerated drug with a minimum of side effects reported . These observations should encourage the development of prospect i ve controlled studies OBJECTIVES Group exercises may be useful in fibromyalgia syndrome ( FMS ) .  The ' Body movement and perception ' ( BMP ) method is based on low impact exercises , awareness of body perception and relaxation , aim ed at treating small groups of patients following the Resseguier method ( RM ) and integrating RM with exercises derived from soft gymnastics . We assessed the effects of BMP method on FMS . METHODS 40 women with FMS ( age and disease duration : 51.7±7.2 and 4.9±3.8 years ) participated in an open pilot study . BMP sessions were performer twice a week ( 50 minutes each ) for 8 weeks . Patients were assessed at enrolment ( T0 ) and at the end of the study ( T1 ) by a self-administered question naire ( temporal characteristics of pain , pain interference in working and recreational activities and in night-time rest , awareness of pain , fatigue , irritability , well-being , quality of movement , ability to focus on perception and to perceive whole body , postural selfcontrol , ability to relax ) and a clinical evaluation ( tender points , assumption of analgesics/NSAIDs , distribution of pain , pain in sitting and st and ing position , pain during postural passages and gait , postural body alignment , muscular contractures ) . RESULTS At T1 , FMS patients significantly improved with respect to T0 in pain , fatigue , irritability , well-being , quality of movement , postural self-control , ability to relax mind and body , movement perception , tender point scores , assumption of analgesic/NSAIDs , body alignment and muscle contractures ( p<0.05 for all the comparisons T1 versus T0 ) . CONCLUSIONS In FMS patients , rehabilitation with BMP  improves pain and well being , reduces the number of tender points and muscle contractures , thus it is useful in FMS management OBJECTIVE Patients with fibromyalgia ( FM ) consistently have adrenal hyporesponsiveness and low dehydroepi and rosterone ( DHEA ) levels . DHEA is promoted for and used by patients with FM . We tested the efficacy and safety of DHEA supplementation in ameliorating the symptoms of FM . METHODS In a double-blind crossover study , postmenopausal women with FM were r and omized to DHEA supplementation  ( 50 mg/day ) or placebo for 3 months , with a one-month washout period in between . Patients were assessed monthly for well-being and pain and by medical evaluations at the beginning and the end of each treatment period . The primary outcome was well being ; secondary outcomes were pain , fatigue , cognition , sexuality , functional impairment , depression , and anxiety . RESULTS A total of 52 patients were r and omized , 47 patients completed the  DHEA  treatment period , and 45 the placebo treatment period . After 3 months of treatment with 50 mg of DHEA , median DHEA sulfate blood levels had tripled , but there was no improvement in well-being , pain , fatigue , cognitive dysfunction , functional impairment , depression , or anxiety , nor in objective measurements made by physicians . And rogenic side effects ( greasy skin , acne , and increased growth of body hair ) were more common during the DHEA treatment period ( p = 0.02 ) . CONCLUSION DHEA does not improve quality of life , pain , fatigue , cognitive function , mood , or functional impairment in FM OBJECTIVES Although qigong is an important part of Traditional Chinese medicine ( TCM ) based on a philosophy similar to acupuncture , few studies of qigong exist in the Western medicine literature . To evaluate qigong therapy as a modality in treating chronic pain conditions such as fibromyalgia syndrome ( FMS ) , we report a pilot trial of 10 women with severe FMS who experienced significant improvement after external qigong therapy ( EQT ) .  DESIGN Ten patients with FMS completed five to seven sessions of EQT over 3 weeks with pre- and posttreatment assessment and a 3-month follow-up . Each treatment lasted approximately 40 minutes . OUTCOME MEASURES Tender point count ( TPC ) and Fibromyalgia Impact Question naire ( FIQ ) were the primary measures . McGill Pain Question naire ( MPQ ) , Beck Depression Inventory ( BDI ) , anxiety , and self-efficacy were the secondary outcomes . RESULTS Subjects demonstrated improvement in functioning , pain , and other symptoms . The mean TPC was reduced from 136.6 to 59.5 after EQT treatment ; mean MPQ decreased from 27.0 to 7.2 ; mean FIQ from 70.1 to 37.3 ; and mean BDI from 24.3 to 8.3 ( all p < 0.01 ) . Many subjects reported reductions in other FMS symptoms , and two reported they were completely symptom-free . Results from the 3-month follow-up indicated some slight rebound from the post-treatment measures , but still much better than those observed at baseline . CONCLUSIONS Treatment with EQT result ing in complete recovery for some FMS patients suggests that TCM may be very effective for treating pain and the multiplicity of symptoms associated with FMS . Larger controlled trials of this promising intervention are urgently needed BACKGROUND This study compared Raloxifen ( Evista ) with placebo in treatment of fibromyalgia . METHODS One hundred menopausal women with fibromyalgia enrolled in a double-blind r and omized study from Feb 2005 until Oct 2006 . We compared efficacy of Raloxifen , and placebo over 16 weeks of treatment . Fifty patients received Raloxifen 49 of which ( 98 % ) completed the study and 47 ( 94 % ) of 50 patients who received placebo completed the study . Raloxifen in 60 mg or identical placebo dose was given every other day over 16 weeks and patients were followed up . Improved recovery for a treatment group was assessed by a significantly higher mean score from baseline to the end of the treatment trial , compared with patients treated with placebo , on measures of Stanford Health Assessment Question naire ( HAQ ) ; Iranian version of Hospital Anxiety and Depression question naire ( IHAD ) ; sleep disturbance ; number of tender points ; reduction of pain and fatigue based on Visual Analogue Score ( VAS ) . RESULTS Raloxifen produced a significantly higher response rate than placebo in treating fibromyalgia by improving pain and fatigue , reducing of the tender point count , sleep disturbance and recovery of usual activities as measured by the Stanford Health Assessment Question naire ( HAQ ) . The significant effect of Raloxifen on HAD score among patients with fibromyalgia was not seen . CONCLUSION Raloxifen was superior to placebo in the treatment of menopausal patients with fibromyalgia OBJECTIVE To determine the intermediate and long-term outcomes of fibromyalgia in patients seen in rheumatology centers in which there is special interest in the syndrome . METHODS We conducted a longitudinal outcome study by mailed comprehensive Health Assessment Question naire administered every 6 months to 538 patients , from 6 rheumatology centers , whose median duration of disease at first assessment was 7.8 years . The final assessment took place after 7 years . In addition , there was study followup on 85 patients who had attended the Wichita center for > 10 years . RESULTS Although functional disability worsened slightly and health satisfaction improved slightly , measures of pain , global severity , fatigue , sleep disturbance , anxiety , depression , and health status were markedly abnormal at study initiation and were essentially unchanged over the study period . Correlations between first and last assessment values were as high as r = 0.82 . For some variables , abnormalities were 3 times greater at one center compared with another . CONCLUSION Patients with established fibromyalgia , seen in rheumatology centers in which there a special interest in the disease and followed up for as long as 7 years , have markedly abnormal scores for pain , functional disability , fatigue , sleep disturbance , and psychological status , and these values do not change substantially over time . Half the patients are dissatisfied with their health , and 59 % rate their health as fair or poor . There are marked differences in disease severity among the various centers , but < 14 % of the variance in outcomes can be explained by demographic or center factors . Values at the first assessment are predictive of final values OBJECTIVE To evaluate the effects of 6 months of pool exercise combined with a 6 session education program for patients with fibromyalgia syndrome ( FM ) . METHODS The study population comprised 58 patients , r and omized to a treatment or a control group . Patients were instructed to match the pool exercises to their threshold of pain and fatigue . The education focused on strategies for coping with symptoms and encouragement of physical activity . The primary outcome measurements were the total score of the Fibromyalgia Impact Question naire ( FIQ ) and the 6 min walk test , recorded at study start and after 6 mo . Several other tests and instruments assessing functional limitations , severity of symptoms , disabilities , and quality of life were also applied . RESULTS Significant differences between the treatment group and the control group were found for the FIQ total score ( p = 0.017 ) and the 6 min walk test ( p < 0.0001 ) . Significant differences were also found for physical function , grip strength , pain severity , social functioning , psychological distress , and quality of life . CONCLUSION The results suggest that a 6 month program of exercises in a temperate pool combined with education will improve the consequences of FM Multidisciplinary treatment has proven to be the best therapeutic option to fibromyalgia ( FM ) and physiotherapy has an important role in this approach . Considering the controversial results of electrotherapy in this condition , the aim of this study was to assess the effects of combined therapy with pulsed ultrasound and interferential current ( CTPI ) on pain and sleep in FM . Seventeen patients fulfilling FM criteria were divided into two groups , CTPI and SHAM , and su bmi tted to pain and sleep evaluations . Pain was evaluated by body map ( BM ) of the painful areas ; quantification of pain intensity by visual analog scale ( VAS ) ; tender point ( TP ) count and tenderness threshold ( TT ) . Sleep was assessed by inventory and polysomnography ( PSG ) . After 12 sessions of CTPI or SHAM procedure , patients were evaluated by the same initial protocol . After treatment , CTPI group showed , before and after sleep , subjective improvement of pain in terms of number ( BM ) and intensity ( VAS ) of painful areas ( P<0.001 , both ) ; as well as objective improvement , with decrease in TP count and increase in TT ( P<0.001 , both ) . Subjective sleep improvements observed after CTPI treatment included decrease in morning fatigue and in non‐refreshing sleep complaint ( P<0.001 , both ) . Objective ly , PSG in this group showed decrease in sleep latency ( P<0.001 ) and in the percentage of stage 1 ( P<0.001 ) , increase in the percentage of slow wave sleep ( P<0.001 ) and in sleep cycle count ( P<0.001 ) . Decrease in arousal index ( P<0.001 ) , number of sleep stage changes ( P<0.05 ) and wake time after sleep onset ( P<0.05 ) , were also observed and no difference regarding pain or sleep parameters were verified after SHAM procedure . This study shows that CTPI can be an effective therapeutic approach for pain and sleep manifestations in FM Abstract . The purpose of this study was to examine the effectiveness of low power laser ( LPL ) and low-dose amitriptyline therapy and to investigate effects of these therapy modalities on clinical symptoms and quality of life ( QOL ) in patients with fibromyalgia ( FM ) . Seventy-five patients with FM were r and omly allocated to active gallium-arsenide ( Ga-As ) laser ( 25 patients ) , placebo laser ( 25 patients ) , and amitriptyline therapy ( 25 patients ) . All groups were evaluated for the improvement in pain , number of tender points , skin fold tenderness , morning stiffness , sleep disturbance , muscular spasm , and fatigue . Depression was evaluated by a psychiatrist according to the Hamilton Depression Rate Scale and DSM IV criteria . Quality of life of the FM patients was assessed according to the Fibromyalgia Impact Question naire ( FIQ ) . In the laser group , patients were treated for 3 min at each tender point daily for 2 weeks , except weekends , at each point with approximately 2 J/cm2 using a Ga-As laser . The same unit was used for the placebo treatment , for which no laser beam was emitted . Patients in the amitriptyline group took 10 mg daily at bedtime throughout the 8 weeks . Significant improvements were indicated in all clinical parameters in the laser group ( P=0.001 ) and significant improvements were indicated in all clinical parameters except fatigue in the amitriptyline group ( P=0.000 ) , whereas significant improvements were indicated in pain ( P=0.000 ) , tender point number ( P=0.001 ) , muscle spasm ( P=0.000 ) , morning stiffness ( P=0.002 ) , and FIQ score ( P=0.042 ) in the placebo group . A significant difference was observed in clinical parameters such as pain intensity ( P=0.000 ) and fatigue ( P=0.000 ) in favor of the laser group over the other groups , and a significant difference was observed in morning stiffness ( P=0.001 ) , FIQ ( P=0.003 ) , and depression score ( P=0.000 ) after therapy . A significant difference was observed in morning stiffness ( P=0.001 ) , FIQ ( P=0.003 ) , and depression ( P=0.000 ) in the amitriptyline group compared to the placebo group after therapy . Additionally , a significant difference was observed in depression score ( P=0.000 ) in the amitriptyline group in comparison to the laser group after therapy . Our study suggests that both amitriptyline and laser therapies are effective on clinical symptoms and QOL in fibromyalgia and that Ga-As laser therapy is a safe and effective treatment in cases with FM . Additionally , the present study suggests that the Ga-As laser therapy can be used as a monotherapy or as a supplementary treatment to other therapeutic procedures in FM Brain tryptophan is low in fibromyalgia . Intake of protein rich in large neutral amino acids is reported to lower brain tryptophan . This study was undertaken to assess whether any reduction of such proteins by exclusion of animal protein from the diet reduced pain and morbidity in fibromyalgia patients . It was an open , r and omized controlled trial . 37 subjects with fibromyalgia were enrolled in the vegetarian diet and 41 in the amitriptyline groups .  The outcome was assessed with the help of frequencies of fatigue , insomnia & non-restorative sleep , pain score on a 10-point VAS and tender point count . Fatigue , insomnia and non-restorative sleep were present in 41 , 26 and 32 subjects before and in 3 , 0 and 0 subjects respectively at six weeks of treatment in the amitriptyline group . The pain score and tender point count were 6.2 + /- 1.9 & 16.1 + /- 2.3 before and 2.3 + /- 1.3 & 6.4 + /- 3.0 after treatment . All these differences were significant ( P < 0.001 ) . In the vegetarian diet group , fatigue , insomnia and non-restorative sleep were present in 36 , 24 and 27 subjects before and in 34 , 29 and 29 subjects at six weeks of treatment . The pain score and tender point count were 5.7 + /- 1.8 and 15.7 + /- 2.4 before and 5.0 + /- 1.8 & 14.7 + /- 3.6 after treatment . All these differences were insignificant except that in the pain score . The decrease in the pain score , though significant , was much smaller than that in the amitriptyline group . So , it may be concluded that vegetarian diet is a poor option in the treatment of fibromyalgia We design ed a r and omized , rater blind study to assess the efficacy of EEG Biofeedback ( Neurofeedback-NFB ) in patients with fibromyalgia syndrome ( FMS ) . Eighteen patients received twenty sessions of NFB-sensory motor rhythm ( SMR ) treatment ( NFB group ) during 4 weeks , and eighteen patients were given 10 mg per day escitalopram treatment ( control group ) for 8 weeks . Visual Analog Scales for pain and fatigue , Hamilton and Beck Depression and Anxiety Inventory Scales , Fibromyalgia Impact Question naire and Short Form 36 were used as outcome measures which were applied at baseline and 2nd , 4th , 8th , 16th , 24th weeks . Mean amplitudes of EEG rhythms ( delta , theta , alpha , SMR , beta1 and beta2 ) and theta/SMR ratio were also measured in NFB group . All post-treatment measurements showed significant improvements in both of the groups ( for all parameters p < 0.05 ) . NFB group displayed greater benefits than controls ( for all parameters p < 0.05 ) . Therapeutic efficacy of NFB was found to begin at 2nd week and reached to a maximum effect at 4th week . On the other h and , the improvements in SSRI treatment were also detected to begin at 2nd week but reached to a maximum effect at 8th week . No statistically significant changes were noted regarding mean amplitudes of EEG rhythms ( p > 0.05 for all ) . However , theta/SMR ratio showed a significant decrease at 4th week compared to baseline in the NFB group ( p < 0.05 ) . These data support the efficacy of NFB as a treatment for pain , psychological symptoms and impaired quality of life associated with fibromyalgia Objective . This r and omized , double-blind , placebo-controlled , multicenter study investigated the efficacy and safety of milnacipran in the treatment of fibromyalgia ( FM ) in a European population . Methods . Out patients diagnosed with FM according to 1990 American College of Rheumatology criteria ( N = 884 ) were r and omized to placebo ( n = 449 ) or milnacipran 200 mg/day ( n = 435 ) for 17 weeks ( 4-week dose escalation , 12-week stable dose , 9-day down-titration ) , followed by a 2-week posttreatment period . The primary efficacy criterion was a 2-measure composite responder analysis requiring patients to achieve simultaneous improvements in pain ( ≥ 30 % improvement from baseline in visual analog scale , 24-hour morning recall ) and a rating of “ very much ” or “ much ” improved on the Patient Global Impression of Change scale . If responder analysis was positive , Fibromyalgia Impact Question naire ( FIQ ) was included as an additional key primary efficacy measure . Results . At the end of the stable dose period ( Week 16 ) , milnacipran 200 mg/day showed significant improvements from baseline relative to placebo in the 2-measure composite responder criteria ( p = 0.0003 ) and FIQ total score ( p = 0.015 ) . Significant improvements were also observed in multiple secondary efficacy endpoints , including Short-Form 36 Health Survey ( SF-36 ) Physical Component Summary ( p = 0.025 ) , SF-36 Mental Component Summary ( p = 0.007 ) , Multidimensional Fatigue Inventory ( p = 0.006 ) , and Multiple Ability Self-Report Question naire  ( p = 0.041 ) . Milnacipran was safe and well tolerated ; nausea , hyperhidrosis , and headache were the most common adverse events . Conclusion . Milnacipran is an effective and safe treatment for pain and other predominant symptoms of FM . Registered as trial no. NCT00436033 Abstract . The aim of this study was to evaluate the effectiveness of balneotherapy on patients with fibromyalgia ( FM ) at the Dead Sea . Forty-eight patients with FM were r and omly assigned to a treatment group receiving sulfur baths and a control group .  All participants stayed for 10 days at a Dead Sea spa .  Physical functioning , FM-related symptoms , and tenderness measurements ( point count and dolorimetry ) were assessed at four time points : prior to arrival at the Dead Sea , after 10 days of treatment , and 1 and 3 months after leaving the spa . Physical functioning and tenderness moderately improved in both groups . With the exception of tenderness threshold , the improvement was especially notable in the treatment group and it persisted even after 3 months . Relief in the severity of FM-related symptoms ( pain , fatigue , stiffness , and anxiety ) and reduced frequency of symptoms ( headache , sleep problems , and subjective joint swelling ) were reported in both groups but lasted longer in the treatment group . In conclusion , treatment of FM at the Dead Sea is effective and safe and may become an additional therapeutic modality in FM . Future studies should address the outcome and possible mechanisms of this treatment in FM patients Fibromyalgia ( FM ) is a complex disorder that affects up to 5 % of the general population worldwide . Its pathophysiological mechanisms are difficult to identify and current drug therapies demonstrate limited effectiveness . Both mitochondrial dysfunction and coenzyme Q10 ( CoQ10 ) deficiency have been implicated in FM pathophysiology . We have investigated the effect of CoQ10 supplementation . We carried out a r and omized , double-blind , placebo-controlled trial to evaluate clinical and gene expression effects of forty days of CoQ10 supplementation ( 300 mg/day ) on 20 FM patients . This study was registered with controlled-trials.com ( IS RCT N 21164124 ) . An important clinical improvement was evident after CoQ10 versus placebo treatment showing a reduction of FIQ ( p<0.001 ) , and a most prominent reduction in pain ( p<0.001 ) , fatigue , and morning tiredness ( p<0.01 ) subscales from FIQ . Furthermore , we observed an important reduction in the pain visual scale ( p<0.01 ) and a reduction in tender points ( p<0.01 ) , including recovery of inflammation , antioxidant enzymes , mitochondrial biogenesis , and AMPK gene expression levels , associated with phosphorylation of the AMPK activity . These results lead to the hypothesis that CoQ10 have a potential therapeutic effect in FM , and indicate new potential molecular targets for the therapy of this disease . AMPK could be implicated in the pathophysiology of FM The effect of electroconvulsive therapy ( ECT ) on depression and other symptoms of fibromyalgia was studied in a prospect i ve 3‐month trial in 13 patients with fibromyalgia and concomitant depression . All the patients met the DSM‐IV diagnostic criteria for Major Depressive Disorder and fulfilled the American College of Rheumatology diagnostic criteria for fibromyalgia . The Montgomery and Åsberg Depression Rating Scale ( MADRS ) and the clinical global impression scale ( CGI ) were used to assess the severity of depression and the clinical change of the patients . The fibromyalgia impact question naire ( FIQ ) was used to evaluate the severity of the fibromyalgia symptoms . The intensity of pain was evaluated using a 6‐point scale ( 0=no pain , 5=very severe pain ) , and tender point palpation . All assessment s were performed at baseline and at follow‐up visits , which took place one week , one month and three months after ECT . There was a significant improvement in depression  after ECT  according to MADRS . Using CGI , six patients were much or very much improved , while four patients were minimally improved and three patients had no change . There was significant improvement in four out of ten FIQ item scores , “ feel good ” , “ fatigue ” , “ anxiety ” and “ depression ” . No significant change was found in the FIQ item scores “ physical function ” , “ pain ” , “ stiffness ” and “ morning tiredness ” or number of tender points and self‐reported pain . We conclude that ECT is a safe and effective treatment for depression in fibromyalgia patients , but has no effect on the pain or other physical symptoms of these patients BACKGROUND Pre clinical and clinical studies have suggested that milnacipran , a dual norepinephrine-serotonin reuptake inhibitor , may be efficacious in the treatment of fibromyalgia ( FM ) . OBJECTIVE This study was conducted to evaluate the efficacy and tolerability of milnacipran in treating the multiple domains of FM . METHODS This was a multicenter , double-blind , placebo-controlled trial . Adult patients ( age 18 - 70 years ) who met 1990 American College of Rheumatology criteria for FM were r and omized to receive milnacipran 100 mg/d , milnacipran 200 mg/d , or placebo for 15 weeks . Because this was a pivotal registration trial , the primary end points were chosen to investigate efficacy for 2 potential indications : the treatment of FM and the treatment of FM pain . Thus , the 2 primary efficacy end points were rates of FM composite responders and FM pain composite responders . FM composite responders were defined as patients concurrently experiencing clinical ly meaningful improvements in the following 3 domain criteria : pain ( > or = 30 % improvement , as recorded in an electronic diary ) ; patients ' global status ( a rating of very much improved or much improved on the Patient Global Impression of Change [ PGIC ] scale ) ; and physical function ( a > or = 6-point improvement on the 36-item Short-Form Health Survey [ SF-36 ] Physical Component Summary score ) . FM pain composite responders were defined as those who met the pain and PGIC criteria . Adverse events reported by patients or observed by investigators were recorded throughout the trial . RESULTS Of 2270 patients screened , 1196 were r and omized to receive milnacipran 100 mg/d ( n = 399 ) , milnacipran 200 mg/d ( n = 396 ) , or placebo ( n = 401 ) . The majority of patients were female ( 96.2 % ) and white ( 93.5 % ) . The population had a mean age of 50.2 years , a mean baseline weight of 180.8 pounds , and a mean baseline body mass index of 30.6 kg/m(2 ) . Compared with placebo , significantly greater proportions of milnacipran-treated patients were FM composite responders ( 100 mg/d : P = 0.01 ; 200 mg/d : P = 0.02 ) and FM pain composite responders ( 100 mg/d : P = 0.03 ; 200 mg/d : P = 0.004 ) . Milnacipran was associated with significant improvements in pain after 1 week of treatment ( 100 mg/d : P = 0.004 ; 200 mg/d : P = 0.04 ) , as well as significant improvements in multiple secondary efficacy end points , including global status ( PGIC : P<0.001 for both doses ) , physical function ( SF-36 physical functioning domain-100 mg/d : P < 0.001 ; 200 mg/d : P = 0.02 ) , and fatigue ( Multidimensional Fatigue Inventory- 100 mg/d : P = 0.04 ) . The most commonly reported adverse events with milnacipran were nausea ( 100 mg/d , 34.3 % ; 200 mg/d , 37.6 % ) , headache ( 18.0 % and 17.7 % , respectively ) , and constipation ( 14.3 % and 17.9 % ) . Adverse events result ed in premature study discontinuation in 19.5 % and 23.7 % of those who received milnacipran 100 and 200 mg/d , respectively , compared with 9.5 % of placebo recipients . CONCLUSION In these adult patients with FM , both doses of milnacipran ( 100 and 200 mg/d ) were associated with significant improvements in pain and other symptoms . Clinical Trials Identification Number : NCT00098124 & NA ; We assessed for the first time the long‐term maintenance of repetitive transcranial magnetic stimulation (rTMS)‐induced analgesia in patients with chronic widespread pain due to fibromyalgia . Forty consecutive patients were r and omly assigned , in a double‐blind fashion , to 2 groups : one receiving active rTMS ( n = 20 ) and the other , sham stimulation ( n = 20 ) , applied to the left primary motor cortex . The stimulation protocol consisted of 14 sessions : an “ induction phase ” of 5 daily sessions followed by a “ maintenance phase ” of 3 sessions a week apart , 3 sessions a fortnight apart , and 3 sessions a month apart . The primary outcome was average pain intensity over the last 24 hours , measured before each stimulation from day 1 to week 21 and at week 25 ( 1 month after the last stimulation ) . Other outcomes measured included quality of life , mood and anxiety , and several parameters of motor cortical excitability .  Thirty patients completed the study ( 14 in the sham stimulation group and 16 in the active stimulation group ) . Active rTMS significantly reduced pain intensity from day 5 to week 25 . These analgesic effects were associated with a long‐term improvement in items related to quality of life ( including fatigue , morning tiredness , general activity , walking , and sleep ) and were directly correlated with changes in intracortical inhibition . In conclusion , these results suggest that TMS may be a valuable and safe new therapeutic option in patients with fibromyalgia . The analgesic effects induced by repetitive transcranial magnetic stimulation of the motor cortex can be maintained over 6 months in patients with fibromyalgia , using monthly stimulation OBJECTIVE To examine the effectiveness of concurrent strength and endurance training on muscle strength , aerobic and functional performance , and symptoms in postmenopausal women with fibromyalgia ( FM ) . DESIGN R and omized controlled trial . SETTING Local gym and university research laboratory . PARTICIPANTS Twenty-six women with FM . INTERVENTION Progressive and supervised 21-week concurrent strength and endurance training . MAIN OUTCOME MEASURES Muscle strength of leg extensors , upper extremities , and trunk ; peak oxygen uptake ( Vo(2)peak ) , maximal workload ( Wmax ) , and work time ; 10-m walking and 10-step stair-climbing time and self-reported functional capacity ( Health Assessment Question naire ) ; and symptoms of FM . RESULTS After concurrent strength and endurance training , the groups differed significantly in Wmax ( P=.001 ) , work time ( P=.001 ) , concentric leg extension force ( P=.043 ) , walking ( P=.001 ) and stair-climbing ( P<.001 ) time , and fatigue ( P=.038 ) . The training led to an increase of 10 % ( P=.004 ) in Wmax and 13 % ( P=.004 ) in work time on the bicycle but no change in Vo(2)peak . CONCLUSIONS Concurrent strength and endurance training in low to moderate volume improves the muscle strength of leg extensors , Wmax , work time , and functional performance as well as perceived symptoms , fatigue in particular . Concurrent strength and endurance training is beneficial to postmenopausal women with FM without adversities , but more extensive studies are needed to confirm the results Objective . To determine the effects of sodium oxybate ( SXB ) on sleep physiology and sleep/wake-related symptoms in patients with fibromyalgia syndrome ( FM ) . Methods . Of 304 patients with FM ( American College of Rheumatology tender point criteria ) in the screened study population , 209 underwent polysomnography , 195 were r and omized , and 151 completed this 8-week , double-blind , placebo-controlled study of SXB 4.5 g and 6 g/night . We evaluated changes in objective sleep measures and subjective symptoms , including daytime sleepiness [ Epworth Sleepiness Scale ( ESS ) ] , fatigue visual analog scale ( FVAS ) , sleep [ Jenkins Scale for Sleep ( JSS ) ] , and daytime functioning [ Functional Outcome of Sleep Question naire ( FOSQ ) , SF-36 Vitality domain , and Fibromyalgia Impact Question naire ( FIQ ) general and morning tiredness ] . Results . Pretreatment screening revealed an elevated incidence of maximum alpha EEG-intrusion > 24 min/hour of sleep ( 66 % ) , periodic limb movements of sleep ( 20.1 % ≥ 5/hour ) , and moderate to severe obstructive sleep apnea disorder ( 15.3 % apnea-hypopnea index ≥ 15/hour ) . Compared with placebo , both doses of SXB achieved statistically significant improvements in ESS , morning FVAS , JSS , FOSQ , SF-36 Vitality , and FIQ general and morning tiredness ; both doses also demonstrated decreased rapid eye movement ( REM ) sleep ( all p ≤ 0.040 ) . SXB 6 g/night improved afternoon , evening and overall FVAS , reduced wakefulness after sleep onset , and increased Stage 2 , slow-wave , and total non-REM sleep ( all p ≤ 0.032 ) versus placebo . Moderate correlations ( ≥ 0.40 ) were noted between changes in subjective sleep and pain measures . Adverse events occurring significantly more frequently with SXB than placebo were nausea , pain in extremity , nervous system disorders , dizziness , restlessness , and renal/urinary disorders ( including urinary incontinence ) . Conclusion . This large cohort of patients with FM demonstrated that SXB treatment improved EEG sleep physiology and sleep-related FM symptoms OBJECTIVE Fibromyalgia ( FM ) is a common musculoskeletal condition characterized by widespread pain , tenderness , and a variety of other somatic symptoms . Current treatments are modestly effective . Arguably , the best studied and most effective compounds are tricyclic antidepressants ( TCA ) . Milnacipran , a nontricyclic compound that inhibits the reuptake of both serotonin and norepinephrine , may provide many of the beneficial effects of TCA with a superior side effect profile . METHODS One hundred twenty-five patients with FM were r and omly assigned in a 3:3:2 ratio to receive milnacipran twice daily , milnacipran once daily , or placebo for 3 months in a double-blind dose-escalation trial ; 92 % of twice-daily and 81 % of once-daily participants achieved dose escalation to the target milnacipran dose of 200 mg . RESULTS The primary endpoint was reduction of pain . Both the once- and twice-daily groups showed statistically significant improvements in pain , as well as improvements in global well being , fatigue , and other domains . Response rates for patients receiving milnacipran were equal in patients with and without comorbid depression , but placebo response rates were considerably higher in depressed patients , leading to significantly greater overall efficacy in the nondepressed group . CONCLUSION In this Phase II study , milnacipran led to statistically significant improvements in pain and other symptoms of FM . The effect sizes were equal to those previously found with TCA , and the drug was generally well tolerated PURPOSE To assess the efficacy of fluoxetine in the treatment of patients with fibromyalgia . SUBJECTS AND METHODS Sixty out patients ( all women , aged 21 - 71 years ) with fibromyalgia were r and omly assigned to receive fluoxetine ( 10 - 80 mg/d ) or placebo for 12 weeks in a double-blind , parallel-group , flexible-dose study . The primary outcome measures were the Fibromyalgia Impact Question naire total score ( score range , 0 [ no impact ] to 80 ) and pain score ( score range , 0 - 10 ) . Secondary measures included the McGill Pain Question naire , change in the number of tender points , and total myalgic score . RESULTS In the intent-to-treat analysis , women who received fluoxetine ( mean [ + /- SD ] dose , 45 + /- 25 mg/d ) had significant ( P = 0.005 ) improvement in the Fibromyalgia Impact Question naire total score compared with those who received placebo , with a difference of -12 ( 95 % confidence interval [ CI ] : -19 to -4 ) . They also had significant ( P = 0.002 ) improvement in the Fibromyalgia Impact Question naire pain score ( difference , -2.2 [ 95 % CI : -3.6 to -0.9 ] ) , as well as in the Fibromyalgia Impact Question naire fatigue ( P = 0.05 ) and depression ( P = 0.01 ) scores and the McGill Pain Question naire ( P = 0.01 ) , when compared with subjects who received placebo . Although counts for the number of tender points and total myalgic scores improved more in the fluoxetine group than in the placebo group , these differences were not statistically significant . CONCLUSIONS In a 12-week , flexible-dose , placebo-controlled trial , fluoxetine was found to be effective on most outcome measures and generally well tolerated in women with fibromyalgia OBJECTIVE To determine the efficacy of an Internet-based Arthritis Self-Management Program ( ASMP ) as a re source for arthritis patients unable or unwilling to attend small-group ASMPs , which have proven effective in changing health-related behaviors and improving health status measures . METHODS R and omized intervention participants were compared with usual care controls at 6 months and 1 year using repeated- measures analyses of variance . Patients with rheumatoid arthritis , osteoarthritis , or fibromyalgia and Internet and e-mail access ( n = 855 ) were r and omized to an intervention  ( n = 433 ) or  usual care control ( n = 422 ) group . Measures included 6 health status variables ( pain , fatigue , activity limitation , health distress , disability , and self-reported global health ) , 4 health behaviors ( aerobic exercise , stretching and strengthening exercise , practice of stress management , and communication with physicians ) , 5 utilization variables ( physician visits , emergency room visits , chiropractic visits , physical therapist visits , and nights in hospital ) , and self-efficacy . RESULTS At 1 year , the intervention group significantly improved in 4 of 6 health status measures and self-efficacy . No significant differences in health behaviors or health care utilization were found . CONCLUSION The Internet-based ASMP proved effective in improving health status measures at 1 year and is a viable alternative to the small-group ASMP Purpose . Fibromyalgia is a syndrome of unknown origin with a high prevalence . Multimodal approaches seem to be the treatment of choice in fibromyalgia . A multidisciplinary program was developed and implemented for patients with fibromyalgia in the primary care setting . The program included education ( seven sessions ) and physical therapy ( 25 sessions ) . Method . Patients were referred to the program by their general practitioner or by a medical specialist . A prospect i ve non-controlled treatment study was performed , patients were evaluated before , after and three months after the program ( single group time series design ) . The following measurements were performed : The Fibromyalgia Impact Question naire , R AND 36 , the Pain Coping and Cognition List , the Tampa scale for kinesiophobia , two physical tests and a qualitative evaluation .  Data of 65 patients with fibromyalgia were analysed , of whom 97 % were female . The mean age was 44 and the mean duration of pain was nine years . Results . Data of 65 patients with fibromyalgia were analysed , patients significantly improved on the domains feeling good , pain , fatigue , stiffness , quality of life , catastrophizing and on the physical tests . Conclusion . The multidisciplinary program fibromyalgia implemented in primary care seems feasible and the results are promising Objective The aim of this study was to compare pool-based exercise and balneotherapy in fibromyalgia syndrome ( FMS ) patients . Methods Fifty female patients diagnosed with FMS according to the American College of Rheumatism ( ACR ) criteria were r and omly assigned to two groups : group 1 ( n=25 ) with pool-based exercise , and in group 2 ( n=25 ) balneotherapy was applied in the same pool without any exercise for 35 min three times a week for 12 weeks . In both groups , pre- ( week 0 ) and post-treatment ( weeks 12 and 24 ) evaluation was performed by one of the authors , who was blind to the patient group . Evaluation parameters included pain , morning stiffness , sleep , tender points , global evaluation by the patient and the physician , fibromyalgia impact question naire , chair test , and Beck depression inventory . Statistical analysis was done on data collected from three evaluation stages . Results Twenty-four exercise and 22 balneotherapy patients completed the study . Pretreatment ( week 0 ) measurements did not show any difference between the groups . In group 1 , statistically significant improvement was observed in all parameters ( P<0.01 ) except for the chair test at both weeks 12 and 24 . In group 2 , week 12 measurements showed significant improvement in all parameters ( P<0.01 ) except for the chair test and Beck depression inventory . Week 24 evaluation results in group 2 showed significant improvements in pain and fatigue according to visual analogue scale ( VAS ) , 5-point scale , number of tender points , algometric and myalgic scores , and patient and physician global evaluation ( P<0.01 and P<0.05 , respectively ) , while improvements were nonsignificant in morning stiffness , sleep , fibromyalgia impact question naire ( FIQ ) , chair test , and Beck depression inventory parameters in this group . Comparison of the two groups based on the post-treatment ( weeks 12 and 24 ) percent changes and difference scores relative to pretreatment ( week 0 ) values failed to show a significant difference between the groups for any parameter except Beck depression inventory ( P<0.01 ) . Conclusion The results of our study showed that pool-based exercise had a longer-lasting effect on some of the FMS symptoms , but statistical analysis failed to show a significant superiority of pool-based exercise over balneotherapy without exercise . While we believe that exercise is a gold st and ard in FMS treatment , we also suggest in light of our results that balneotherapy is among the valid treatment options in FMS , and further research regarding the type and duration of the exercise programs is necessary Fibromyalgia syndrome is a systemic disorder of widespread pain which is thought to result from abnormal pain processing within the central nervous system . There are no currently approved treatments for this indication . Antidepressants appear , however , to be effective , especially those with an action on noradrenergic neurotransmission . The objective of the present study was to test the efficacy of the dual action noradrenaline and serotonin reuptake inhibitor antidepressant , milnacipran , in the treatment of fibromyalgia . The 125 patients , who were enrolled in a double-blind , placebo-controlled , flexible dose escalation trial , were r and omized to receive placebo or milnacipran for 4 weeks of dose escalation ( up to 200 mg/day ) , followed by 8 weeks at a constant dose . The study evaluated the efficacy and safety of milnacipran for the treatment of pain and associated symptoms such as fatigue , depressed mood and sleep . 75 % of milnacipran-treated patients reported overall improvement , compared with 38 % in the placebo group ( p < 0.01 ) . Furthermore , 37 % of twice daily milnacipran-treated patients reported at least 50 % reduction in pain intensity , compared with 14 % of placebo-treated patients ( p < 0.05 ) . 84 % of all milnacipran patients escalated to the highest dose ( 200 mg/day ) with no tolerability issues . Most adverse events were mild to moderate in intensity , and transient in duration . These results suggest that milnacipran may have the potential to relieve not only pain but several of the other symptoms associated with fibromyalgia OBJECTIVE To assess the efficacy and safety of milnacipran at a dosage of 100 mg/day ( 50 mg twice daily ) for monotherapy treatment of fibromyalgia . METHODS A double-blind , placebo-controlled trial was performed to assess 1,025 patients with fibromyalgia who were r and omized to receive milnacipran 100 mg/day ( n = 516 ) or placebo ( n = 509 ) . Patients underwent 4 - 6 weeks of flexible dose escalation followed by 12 weeks of stable-dose treatment . Two composite responder definitions were used as primary end points to classify the response to treatment . The 2-measure composite response required achievement of ≥30 % improvement from baseline in the pain score and a rating of " very much improved " or " much improved " on the Patient 's Global Impression of Change ( PGIC ) scale . The 3-measure composite response required satisfaction of these same 2 improvement criteria for pain and global status as well as improvement in physical function on the Short Form 36 ( SF-36 ) physical component summary ( PCS ) score . RESULTS After 12 weeks of stable-dose treatment , a significantly greater proportion of milnacipran-treated patients compared with placebo-treated patients showed clinical ly meaningful improvements , as evidence d by the proportion of patients meeting the 2-measure composite responder criteria ( P < 0.001 in the baseline observation carried forward [ BOCF ] analysis ) and 3-measure composite responder criteria ( P < 0.001 in the BOCF ) . Milnacipran-treated patients also demonstrated significantly greater improvements from baseline on multiple secondary outcomes , including 24-hour and weekly recall pain score , PGIC score , SF-36 PCS and mental component summary scores , average pain severity score on the Brief Pain Inventory , Fibromyalgia Impact Question naire total score ( all P < 0.001 versus placebo ) , and Multidimensional Fatigue Inventory total score ( P = 0.036 versus placebo ) . Milnacipran was well tolerated by most patients , with nausea being the most commonly reported adverse event ( placebo-adjusted rate of 15.8 % ) . CONCLUSION Milnacipran administered at a dosage of 100 mg/day improved pain , global status , fatigue , and physical and mental function in patients with fibromyalgia & NA ; The major objective of this research was to evaluate the predictors of fatigue in patients with fibromyalgia ( FM ) , using cross‐sectional and daily assessment method ologies . In the cross‐sectional phase of the research involving a sample of 105 FM patients , greater depression and lower sleep quality were concurrently associated with higher fatigue . While pain was correlated with fatigue , it did not independently contribute to fatigue in the regression equation . For a subset of patients from the cross‐sectional sample ( n=63 ) who participated in a week of prospect i ve daily assessment of their pain , sleep quality , and fatigue , multiple regression analysis of aggregated ( averaged ) daily scores revealed that previous day 's pain and sleep quality predicted next day 's fatigue . Depression from the cross‐sectional phase was not related to aggregated daily fatigue scores . A path analytic framework was tested with disaggregated ( removing between subjects variability ) data in which pain was predicted to contribute to lower sleep quality which , in turn , was predicted to lead to greater fatigue . The results revealed that poor sleep quality fully accounted for the positive relationship between pain and fatigue , thus substantiating the mediational role of sleep quality . The findings are indicative of a dysfunctional , cyclical pattern of heightened pain and non‐restful sleep underlying the experience of fatigue in FM Objective . Increasing research interest and emerging new therapies for treatment of fibromyalgia ( FM ) have led to a need to develop a consensus on a core set of outcome measures that should be assessed and reported in all clinical trials , to facilitate interpretation of the data and underst and ing of the disease . This aligns with the key objective of the Outcome Measures in Rheumatology ( OMERACT ) initiative to improve outcome measurement through a data driven , interactive consensus process . Methods . Through patient focus groups and Delphi processes , working groups at previous OMERACT meetings identified potential domains to be included in the core data set . A systematic review has shown that instruments measuring these domains are available and are at least moderately sensitive to change . Most instruments have been vali date d in multiple language s. This pooled analysis study aims to develop the core data set by analyzing data from 10 r and omized controlled trials ( RCT ) in FM . Results . Results from this study provide support for the inclusion of the following in the core data set : pain , tenderness , fatigue , sleep , patient global assessment , and multidimensional function/health related quality of life . Construct validity was demonstrated with outcome instruments showing convergent and divergent validity . Content and criterion validity were confirmed by multivariate analysis showing R square values between 0.4 and 0.6 . Low R square value is associated with studies in which one or more domains were not assessed . Conclusion . The core data set was supported by high consensus among attendees at OMERACT 9 . Establishing an international st and ard for RCT in FM should facilitate future metaanalyses and indirect comparisons OBJECTIVE To investigate the effects of 21 weeks ' progressive strength training on neuromuscular function and subjectively perceived symptoms in premenopausal women with fibromyalgia ( FM ) . METHODS Twenty one women with FM were r and omly assigned to experimental ( FMT ) or control ( FMC ) groups . Twelve healthy women served as training controls ( HT ) . The FMT and HT groups carried out progressive strength training twice a week for 21 weeks . The major outcome measures were muscle strength and electromyographic ( EMG ) recordings . Secondary outcome measures were pain , sleep , fatigue , physical function capacity ( Stanford Health Assessment Question naire ) , and mood ( short version of Beck 's depression index ) . RESULTS Female FMT subjects increased their maximal and explosive strength and EMG activity to the same extent as the HT group . Moreover , the progressive strength training showed immediate benefits on subjectively perceived fatigue , depression , and neck pain of training patients with FM . CONCLUSIONS The strength training data indicate comparable trainability of the neuromuscular system of women with FM and healthy women .  Progressive strength training can safely be used in the treatment of FM to decrease the impact of the syndrome on the neuromuscular system , perceived symptoms , and functional capacity . These results confirm the opinion that FM syndrome has a central rather than a peripheral or muscular basis OBJECTIVE Fibromyalgia ( FM ) is associated with the sleep phenomenon of alpha intrusion , and with low growth hormone secretion . Sodium oxybate has been shown to increase both slow-wave sleep and growth hormone levels . This double blind , r and omized , placebo controlled crossover trial was conducted to evaluate the effects of sodium oxybate on the subjective symptoms of pain , fatigue , and sleep quality and the objective polysomnographic ( PSG ) sleep variables of alpha intrusion , slow-wave ( stage 3/4 ) sleep , and sleep efficiency in patients with FM . METHODS Patients received either 6.0 g/day sodium oxybate or placebo for 1 month , with an intervening 2 week washout period . Efficacy measures included PSG evaluations , tender point index ( TPI ) , and subjective measurements from daily diary entries . Safety measures included clinical laboratory values , vital signs , and adverse events . RESULTS Twenty-four female patients were included in the study ; 18 completed the trial .  TPI was decreased from baseline by 8.5 , compared with an increase of 0.4 for placebo ( p = 0.0079 ) . Six of the 7 pain/fatigue scores ( overall pain , pain at rest , pain during movement , end of day fatigue , overall fatigue , and morning fatigue ) were relieved by 29 % to 33 % with sodium oxybate , compared with 6 % to 10 % relief with placebo ( p < 0.005 ) . Alpha intrusion , sleep latency , and rapid-eye-movement sleep were significantly decreased , while slow-wave ( stage 3/4 ) sleep was significantly increased , compared with placebo ( p < 0.005 ) . Two of the 5 subjective sleep related variables were significantly different from placebo :  morning alertness ( improved by 18 % with sodium oxybate , compared with 2 % for placebo ; p = 0.0033 ) and quality of sleep ( improved by 33 % and 10 % , respectively ; p = 0.0003 ) . CONCLUSION Sodium oxybate effectively reduced the symptoms of pain and fatigue in patients with FM , and dramatically reduced the sleep abnormalities ( alpha intrusion and decreased slow-wave sleep ) associated with the nonrestorative sleep characteristic of this disorder S-adenosylmethionine is a relatively new anti-inflammatory drug with analgesic and anti-depressant effects . Efficacy of 800 mg orally administered s-adenosylmethionine daily versus placebo for six weeks was investigated in 44 patients with primary fibromyalgia in double-blind setting s. Tender point score , isokinetic muscle strength , disease activity , subjective symptoms ( visual analog scale ) , mood parameters and side effects were evaluated . Improvements were seen for clinical disease activity ( P = 0.04 ) , pain experienced during the last week ( P = 0.002 ) , fatigue ( P = 0.02 ) , morning stiffness ( P = 0.03 ) and mood evaluated by Face Scale ( P = 0.006 ) in the actively treated group compared to placebo . The tender point score , isokinetic muscle strength , mood evaluated by Beck Depression Inventory and side effects did not differ in the two treatment groups . S-adenosylmethionine has some beneficial effects on primary fibromyalgia and could be an important option in the treatment hereof BACKGROUND Some positive therapeutic effects in fibromyalgia syndrome ( FS ) were reported with both tricyclic and new antidepressant drugs as well as serotonergic agents ( 5HT2 and 5HT3 receptor blockers ) . METHODS In the present study , a novel antidepressant drug mirtazapine , 15 - 30 mg/day , has been used in 29 patients with FS in an open trial . RESULTS Twenty-six patients completed the six-week study . Ten ( 38 % ) were considered responders on account of the reduction of > or = 40 % on pain , fatigue and sleep disturbances and remission of depressive symptoms at the end of study . Eighteen patients had at least moderate depression before mirtazapine treatment and 8 patients presented mild depressive symptoms .  Reduction on main symptoms of FS after 6 weeks of mirtazapine treatment significantly correlated with the reduction in depression . However , the percentage of responders and patients with > or = 40 % reduction on main symptoms of fibromyalgia was similar in high and low depression groups . CONCLUSIONS The results obtained suggest that mirtazapine may be promising method of FS treatment . Further double-blind placebo-controlled studies are required to confirm these results The objective of this study was to test the efficacy of intravenously administered S-adenosyl-L-methionine ( SAMe ) in patients with fibromyalgia ( FM ) . Thirty-four out- patients with fibromyalgia symptoms received SAMe 600 mg i.v . or placebo daily for 10 days in a cross-over trial . There was no significant difference in improvement in the primary outcome : tender point change between the two treatment groups . There was a tendency towards statistical significance in favour of SAMe on subjective perception of pain at rest ( p = 0.08 ) , pain on movement ( p = 0.11 ) , and overall well-being ( p = 0.17 ) and slight improvement only on fatigue , quality of sleep , morning stiffness , and on the Fibromyalgia Impact Question naire for pain . No effect could be observed on isokinetic muscle strength , Zerrsen self- assessment question naire , and the face scale . No effect of SAMe in patients with FM was found in this short term study OBJECTIVES To document 1 ) the content validity and 2 ) measure improvements in fatigue , using the  Fatigue Visual Analogue Scale ( VAS ) assessment tool in patients with fibromyalgia . METHODS The relevance and comprehensiveness of the Fatigue VAS were tested through a qualitative analysis of 20 subjects ' verbatim transcripts from semi-structured qualitative interviews . Data from two r and omised , controller trials in fibromyalgia ( n=1121 ) were used to conduct correlation analyses with the  Fatigue and Tiredness  items from the Fibromyalgia Impact Question naire ( FIQ ) and the Short Form-36 Vitality scale . Known-groups and cross classification analyses were conducted to demonstrate the ability to measure improvement in fatigue using the Fatigue VAS . RESULTS All subjects spontaneously reported that fatigue was an important symptom to capture in fibromyalgia . The Fatigue VAS was well understood by most subjects ( n=18/20 ) . High correlations ( Pearson r>0.75 ) and good agreement ( k>0.66 ) were found between the Fatigue VAS and the FIQ tiredness items no. 16 and 17 and SF-36 ™ Vitality scale . In both clinical trials there was a substantial separation of approximately 20 points on the mean change in the Fatigue VAS score between responders ( > 30 % improvement in pain VAS ) and non-responders . CONCLUSIONS Previous studies have confirmed that fatigue is a major component of the fibromyalgia experience . This current study reports that fibromyalgia patients spontaneously rated fatigue as a highly significant feature of their illness , and supports the use of the Fatigue VAS as a valid question naire in fibromyalgia clinical trials Objective : The aim of the present study is to evaluate the effectiveness of spa therapy in the management of  fibromyalgia .  Methods : Thirty women with fibromyalgia were r and omly assigned to either a spa therapy group or a control group . The spa therapy group ( n = 16 ) had spa treatment for 2 weeks in addition to their medical treatment . The control group ( n = 14 ) continued to have their medical treatment and /or daily exercises . An investigator who was blinded for the intervention assessed all the patients for 9 months . Improvements in Fibromyalgia Impact Question naire ( FIQ ) , pain and number of tender points were primary outcomes . Secondary outcome measures were improvement in sleep disturbance , fatigue , gastrointestinal symptoms , anxiety , Beck Depression Inventory and patient ’s global evaluation . Results : the spa group was found to be superior to the control group at the end of intervention in terms of FIQ , pain , tender point count , fatigue and patients ’ global assessment . This superiority remained for 6 months in FIQ , 1 month in pain and tender point count . Conclusion : It was concluded that the addition of spa therapy to medical therapy has both short- and long-term beneficial effects in female patients with fibromyalgia Objective . To evaluate the safety and efficacy of milnacipran , a dual norepinephrine and serotonin reuptake inhibitor , in the treatment of fibromyalgia ( FM ) . Methods . A 27-week , r and omized , double-blind , multicenter study compared milnacipran 100 and 200 mg/day with placebo in the treatment of 888 patients with FM . Two composite responder definitions were used to classify each patient ’s individual response to therapy . “ FM responders ” concurrently satisfied response criteria for improvements in pain ( visual analog scale 24-h morning recall ) , patient global impression of change ( PGIC ) , and physical functioning ( SF-36 Physical Component Summary ) ; while “ FM pain responders ” concurrently satisfied response criteria for improvements in pain and PGIC . Results . At the primary endpoint , after 3-month stable dose treatment , a significantly higher percentage of milnacipran-treated patients met criteria as FM responders versus placebo ( milnacipran 200 mg/day , p = 0.017 ; milnacipran 100 mg/day , p = 0.028 ) . A significantly higher percentage of patients treated with milnacipran 200 mg/day also met criteria as FM pain responders versus placebo ( p = 0.032 ) . Significant pain reductions were observed after Week 1 with both milnacipran doses . At 15 weeks , milnacipran 200 mg/day led to significant improvements over placebo in pain ( realtime , daily and weekly recall ; all measures , p < 0.05 ) , PGIC ( p < 0.001 ) , fatigue ( p = 0.016 ) , cognition ( p = 0.025 ) , and multiple SF-36 domains .  Milnacipran was safe and well tolerated by the majority of patients during 27 weeks of treatment ; nausea and headache were the most common adverse events . Conclusion . Milnacipran is safe and effective for the treatment of multiple symptoms of FM A prospect i ve , r and omized , placebo-controlled , multicenter , double-blind trial in fibromyalgia patients demonstrated that peroral daily treatment with 5 mg tropisetron for 10 days produced a significant reduction in pain and other symptoms . The aim of the present study was to determine whether intravenous administration of 2 mg tropisetron daily for a limited period of time would produce quicker and more favorable results . In the first cohort 18 fibromyalgia patients received a single intravenous injection of 2 mg tropisetron .  In the second cohort 24 fibromyalgia patients were treated with 2 mg intravenous tropisetron daily for 5 days . Pain intensity was measured with the visual analog scale and the pain score . Pain at tender and control points ( dolorimeter ) as well as 17 ancillary symptoms before and after treatment were evaluated . Pain intensity was followed-up by means of a patient diary until recurrence . Dolorimetry revealed that a single intravenous injection of 2 mg tropisetron significantly reduced pain and enhanced pain threshold . These effects , however , lasted for only a few days . Of 18 patients in the first cohort , only three showed no response to therapy . Of the 24 patients in the second cohort , 23 showed pain reduction when 2 mg tropisetron was administered daily for 5 days . Pain relief lasted for 2 weeks to 2 months in 20 of these patients . Two patients stopped filling in the pain diary . Twelve ancillary symptoms such as sleep disturbances , fatigue , morning stiffness were also significantly improved by the latter treatment . In the global assessment 16 out of 24 patients showed significant improvement and seven showed slight improvement . Only one patient experienced no improvement . Tolerability was good . In conclusion , intravenous injection of 2 mg of the 5-hydroxytryptamine3 receptor antagonist tropisetron once daily for 5 days produced a longer-lasting therapeutic effect on fibromyalgia symptoms than did peroral daily treatment with 5 mg of this drug . The results achieved are currently being evaluated in a r and omized , placebo-controlled , double-blind trial BACKGROUND Esreboxetine is an investigational , highly selective norepinephrine reuptake inhibitor that has been reported to have antinociceptive effects in pre clinical pain models . OBJECTIVE This study assessed the efficacy and safety profile of esreboxetine in the management of fibromyalgia . METHODS This was a multicenter , r and omized , double-blind , placebo-controlled trial in patients aged ≥18 years who met American College of Rheumatology criteria for fibromyalgia . Eligible patients were required to have a score ≥40 mm on the 100-mm visual analog scale of the Short-Form McGill Pain Question naire at screening and r and omization , and a mean score ≥4 on an 11-point pain rating scale ( from 0 = no pain to 10 = worst possible pain ) based on the weekly mean pain score in the week before r and omization . After a 1-week baseline period and a 2-week , single-blind , placebo run-in period , patients were r and omized to receive esreboxetine or placebo for 8 weeks , followed by a 1-week follow-up period . Esreboxetine dosing was started at 2 mg/d and was escalated by 2 mg/d every 2 weeks until attainment of a dose of 8 mg/d or the maximum tolerated dose . The primary efficacy outcome was the change from baseline to week 8 in weekly mean pain scores , as derived from patients ' daily pain ratings on the 11-point scale . Additional primary efficacy outcomes included changes in the Fibromyalgia Impact Question naire ( FIQ ) total score and the Patient Global Impression of Change ( PGIC ) . The safety profile was evaluated based on observed and spontaneously reported adverse events , laboratory tests , and other safety measures . RESULTS One hundred thirty-four patients were r and omized to each study group , but 1 patient in the placebo group did not receive treatment . Thus , the study population consisted of 267 patients ( 89.5 % female ; 88.4 % white ; mean age , ∼50 years [ range , 20 - 84 years ] ) . Twenty-seven patients in each group discontinued the study . Adverse events were the most common reason for discontinuation in the esreboxetine group ( 11 patients ) , compared with 3 discontinuing due to adverse events in the placebo group . Patient default ( withdrawal of consent and loss to follow-up ) was the most common reason for discontinuation in the placebo group ( 13 patients ) , compared with 10 in the esreboxetine group . The esreboxetine group had significantly greater improvement in the weekly mean pain score compared with the placebo group ( mean [ SE ] change from baseline : -1.55 [ 0.16 ] vs -0.99 [ 0.16 ] , respectively ; P = 0.006 ) . A significantly greater percentage of patients in the esreboxetine group reported a ≥30 % reduction in pain scores compared with the placebo group ( 37.6 % [ 50/133 ] vs 22.6 % [ 30/133 ] ; P = 0.004 ) . Esreboxetine was associated with significant improvement compared with placebo in the FIQ total score ( mean change from baseline : -15.63 [ 1.56 ] vs -8.07 [ 1.54 ] ; P < 0.001 ) . On the PGIC , significantly more patients in the esreboxetine group than in the placebo group reported their condition much or very much improved ( odds ratio = 2.42 ; 90 % CI , 1.549 - 3.786 ; P < 0.001 ) . Esreboxetine also was associated with significant improvements in secondary outcomes compared with placebo . These included fatigue , as reflected in scores on the Multidimensional Assessment of Fatigue ( mean [ SE ] change from baseline : -6.39 [ 0.75 ] vs -2.82 [ 0.75 ] , respectively ; P < 0.001 ) , and scores on measures of patient function and health-related quality of life , including the 36-item Short Form Health Survey ( SF-36 ) Physical Component Summary ( mean change from baseline : 4.36 [ 0.59 ] vs 1.86 [ 0.59 ] ; P = 0.002 ) , the SF-36 Mental Component Summary ( mean change from baseline : 4.25 [ 0.83 ] vs 1.81 [ 0.83 ] ; P = 0.019 ) , and the Sheehan Disability Scale total score ( mean change from baseline : -6.50 [ 0.64 ] vs -2.79 [ 0.61 ] ; P < 0.001 ) . Numerically more patients in the esreboxetine group than in the placebo group reported at least one adverse event ( 71.6 % vs 57.1 % ) , most commonly constipation ( 17.2 % vs 5.3 % ) , insomnia ( 15.7 % vs 3.0 % ) , dry mouth ( 15.7 % vs 2.3 % ) , and headache ( 10.4 % vs 2.3 % ) . CONCLUSIONS In this 8-week trial in patients with fibromyalgia , esreboxetine was associated with significant reductions in pain scores compared with placebo . It was also associated with improvements in outcomes relevant to fibromyalgia , including the PGIC , function , and fatigue . Clinical Trials.gov identifier : NCT00357825 OBJECTIVE Sleep problems are a common symptom of fibromyalgia ( FM ) . The objective of this study was to evaluate the Medical Outcomes Study ( MOS ) Sleep Scale as a measure of FM-related sleep problems . METHODS Analyses were based on data from the 1056 and 1077 studies , two r and omized , double-blind , placebo-controlled trials of pregabalin for adults with FM .  MOS Sleep Scale scores of study patients were compared with United States normative scores using a one- sample Z test . Subscale structure of the MOS was evaluated by confirmatory factor analyses , internal consistency was evaluated using Cronbach 's alpha reliability coefficients . Estimated clinical ly important differences ( CID ) in MOS Sleep Disturbance subscale scores were evaluated using mixed-effects models of change in subscale scores as a function of the Patient Global Impression of Change ( PGIC ) . RESULTS 1056 and 1077 included 748 and 745 patients , respectively . Most patients were female ( 1056 : 94.4 % , 1077 : 94.5 % ) and white ( 1056 : 90.2 % , 1077 : 91.0 % ) . Mean ages were 48.8 years ( 1056 ) and 50.1 years ( 1077 ) .  Baseline MOS Sleep Scale scores were statistically ( P<0.001 ) and substantially poorer than general population values . The MOS subscale structure was confirmed in both studies at each assessment except at baseline in the 1056 study . Cronbach 's alpha coefficients were acceptable , at least 0.70 , for all multi-item scales at baseline and end-of- study assessment s in both studies , with the exception of the Sleep Adequacy subscale at baseline . The estimated CID for the MOS Sleep Disturbance subscale was 7.9 . CONCLUSIONS The MOS Sleep Scale is an appropriate measure of FM-related sleep problems . These analyses provide the foundation for further use and evaluation of the MOS Sleep Scale in FM patients OBJECTIVE Multidisciplinary treatments ( MTs ) are usually recommended for reducing fibromyalgia ( FM ) symptoms and include physical exercise , drug management , education , and cognitive behavior therapy ( CBT ) . However , there is no evidence that CBT adds efficacy to the other therapeutic components . This r and omized controlled trial analyzed the response of FM patients to two MTs , with and without CBT , according to the presence of concurrent symptoms . METHODS Eighty-three women with FM were r and omly assigned to MT or combined MT and CBT . The MT included medical intervention , physical training , education , and discussion of the syndrome . The CBT focused on coping with stress , modifying lifestyles , and changing pain behaviors . Demographic and clinical data , information regarding tender points , and question naire responses about functional capability [ Fibromyalgia Impact Question naire ( FIQ ) ] , health status [ 36-item Short Form Health Survey ( SF-36 ) ] , and mental health [ Symptom Checklist-90-Revised ( SCL-90-R ) ] were obtained at the beginning , at the end of the 15-week treatment , and at 6-month follow-up . Subgroups are identified in relation to treatment response . RESULTS Sixty-six women ( 80 % ) completed treatment . Although the variance of the total sample had changed at posttreatment ( F=2.67 , P=.031 ) , there was no significant effect for the TimexTreatment interaction ( F=1.65 , P=.16 ) . Univariate tests detected a significant fall in the FIQ score . The subgroup of patients with fatigue showed a better response with MT+CBT than with MT . At 6-month follow-up , the statistical differences had been maintained . Intention-to-treat analysis ratified these results . CONCLUSIONS MT improves functional capability and reduces symptom impact . CBT increases mildly the effect of MT in patients with fatigue The aim of this exploratory study was to systematic ally assess the potential effectiveness and tolerability of quetiapine , an atypical antipsychotic , for the treatment of patients with fibromyalgia . This was a unicentre , open-label study conducted in thirty-five out patients , 18 years or older , who met the ACR criteria for fibromyalgia and who had not satisfactorily responded to their previous fibromyalgia treatment .  Quetiapine , flexibly dosed ( 25 - 100 mg/day ) , was added to their original treatment regimen for 12 weeks . The primary outcome measure was the mean change from baseline to endpoint in the Fibromyalgia Impact Question naire ( FIQ ) total score . Secondary efficacy measures included mean changes from baseline to endpoint in the scores of the Clinical Global Impression ( CGI ) of Severity scale , Pittsburgh Sleep Quality Index ( PSQI ) , Beck Depression Inventory ( BDI ) , State-Trait Anxiety Inventory ( STAI ) , 12-Item Short Form Health Survey ( SF-12 ) , and individual items of the FIQ .  Thirty ( 85.7 % ) patients ( mean age 47+/-7.9 , 93.3 % females ) had a postbaseline evaluation and constituted the intent-to-treat efficacy sample . Mean FIQ total score decreased significantly by 10.2 points from a baseline of 63.2 to 53.0 at study endpoint ( p<0.001 ) . A statistically significant reduction was observed in FIQ stiffness and FIQ fatigue subscores but not in FIQ pain subscore . Large effect sizes were observed for the FIQ total ( 1.04 ) , CGI-severity ( 1.00 ) and PSQI ( 1.07 ) , while moderate effect sizes ( i.e. > or = 0.50 ) were encountered in the FIQ fatigue , FIQ stiffness and SF-12 mental component summary .  Quetiapine was safely administered and well tolerated . Despite the lack of effect on pain , the significant and relevant improvement in overall efficacy measures and quality of life suggests that quetiapine may be a valuable drug for treatment of patients with fibromyalgia that should be further tested in double-blind , placebo-controlled trials Objective : Written expression of traumatic experiences , an intervention found to have health benefits in rheumatoid arthritis , asthma , and breast cancer , was tested in a r and omized , controlled trial with female fibromyalgia patients . It was hypothesized that relative to controls , patients engaging in the writing intervention would experience improved status on psychological well-being and physical health variables . Methods : Patients ( N = 92 ) were r and omized into a trauma writing group , a control writing group , or usual care control group .  The two writing groups wrote in the laboratory for 20 minutes on 3 days at 1-week intervals . Psychological well-being , pain , and fatigue were the primary outcome variables . Assessment s were made at pretreatment , posttreatment , 4-month follow-up , and 10-month follow-up . Results : The trauma writing group experienced significant reductions in pain ( effect size [ ES ] = 0.49 ) and fatigue ( ES = 0.62 ) and better psychological well-being ( ES = 0.47 ) at the 4-month follow-up relative to the control groups . Benefits were not maintained at the 10-month follow-up . Conclusion : Fibromyalgia patients experienced short-term benefits in psychological and health variables through emotional expression of personal traumatic experiences . ED = written emotional disclosure ; RA = rheumatoid arthritis ; QOL = Quality of Life Scale ; STAI-S = state version , State-Trait Anxiety Inventory ; BDI = Beck Depression Inventory ; MOS = Medical Outcome Study ; CLINHAQ = Clinical Health Assessment Question naire ; FIQ = Fibromyalgia Impact Question naire ; VAS = visual analogue scale ; NW = neutral writing group ; UC = usual-care control group ; ANOVA = analysis of variance ; ES = effect size & NA ; This 14‐week , phase 3 , double‐blind , r and omized , controlled trial evaluated sodium oxybate ( SXB ) 4.5 and 6 g per night versus placebo in patients with fibromyalgia ( FM ) .  SXB is the sodium salt of γ‐hydroxybutyrate ( GHB ) . GHB is an endogenous compound , synthesized from γ‐aminobutyric acid ( GABA ) and found broadly in the central nervous system and body . Among 548 r and omized patients , a ⩾30 % reduction in pain was experienced by 54.2 % and 58.5 % of patients treated with SXB 4.5 and 6 g , respectively , versus 35.2 % for placebo with a 100‐mm Visual Analog Scale ( VAS ) ( P < 0.001 for both comparisons ) . Relative to placebo , both SXB doses significantly reduced fatigue ( with a 100‐mm VAS ; P < 0.001 ) and sleep disturbance ( with the Jenkins Sleep Scale ; P < 0.001 ) , and result ed in significant improvements in function as measured by the FM Impact Question naire ( P = 0.003 and P = 0.001 for 4.5 and 6 g per night , respectively ) . On the Short‐Form 36 Health Survey , SXB‐related improvement was significant on the Physical , but not the Mental , Component Scale . The proportion of patients who reported a global improvement of “ much ” or “ very much ” better on the Patient Global Impression of Change was significantly greater in both SXB groups versus placebo ( P < 0.001 ) . Headache , nausea , dizziness , vomiting , diarrhea , anxiety , and sinusitis were the most commonly reported adverse events , with an incidence at least twice that of placebo . These results exp and the evidence from previous clinical trials suggesting that SXB is effective and safe in FM . This study exp and s evidence from previous trials that sodium oxybate provides safe , effective treatment for multiple symptoms experienced by patients with fibromyalgia Following development of the core domain set for fibromyalgia ( FM ) in Outcome Measures in Rheumatology Clinical Trials ( OMERACT ) meetings 7 to 9 , the FM working group has progressed toward the development of an FM responder index and a disease activity score based on these domains , utilizing outcome indices of these domains from archived r and omized clinical trials in FM . Possible clinical domains that could be included in a responder index and disease activity score include pain , fatigue , sleep disturbance , cognitive dysfunction , mood disturbance , tenderness , stiffness , and functional impairment . Outcome measures for these domains demonstrate good to adequate psychometric properties , although measures of cognitive dysfunction need to be further developed . The approach used in the development of responder indices and disease activity scores for rheumatoid arthritis and ankylosing spondylitis represents heuristic models for our work , but FM is challenging in that there is no clear algorithm of treatment that defines disease activity based on treatment decisions , nor are there objective markers that define thresholds of severity or response to treatment . The process of developing c and i date dichotomous responder definitions and continuous quantitative disease activity measures is described , along with participant discussion s from OMERACT 10 . Final results of this work will be published in a separate report pending completion of analyses
target: While no clinical trial to date has specifically targeted fatigue , r and omized controlled trials , systematic review s , and meta-analyses indicate that treatment modalities studied in the context of other fibromyalgia symptoms could also improve fatigue .
background: Fatigue is a disabling , multifaceted symptom that is highly prevalent and stubbornly persistent .
  Although fatigue is a frequent complaint among patients with fibromyalgia , it has not received the same attention as pain .
  Reasons for this include lack of st and ardized nomenclature to communicate about fatigue , lack of evidence -based guidelines for fatigue assessment , and a deficiency in effective treatment strategies .
  Fatigue does not occur in isolation ; rather , it is present concurrently in varying severity with other fibromyalgia symptoms such as chronic widespread pain , unrefreshing sleep , anxiety , depression , cognitive difficulties , and so on .
  Survey-based and preliminary mechanistic studies indicate that multiple symptoms feed into fatigue and it may be associated with a variety of physiological mechanisms .