Components of effective randomized controlled trials of hydrotherapy programs for fibromyalgia syndrome: A systematic review Fitness and perceived exertion in patients with fibromyalgia syndrome. Randomised EORTC head and neck cooperative group trial of preoperative intra-arterial chemotherapy in oral cavity and oropharynx carcinoma. Hydrotherapy and conventional physiotherapy improve total sleep time and quality of life of fibromyalgia patients: randomized clinical trial. Efficacy and Safety of Medicinal Plants or Related Natural Products for Fibromyalgia: A Systematic Review Content and Criterion Validity of the Preliminary Core Dataset for Clinical Trials in Fibromyalgia Syndrome Clinical and Economic Characteristics of Patients With Fibromyalgia Syndrome Sexual and Physical Abuse in Women With Fibromyalgia Syndrome: A Test of the Trauma Hypothesis Elevated cerebrospinal fluid levels of substance P in patients with the fibromyalgia syndrome. Evidence for the Use of Hearing Assistive Technology by Adults: The Role of the FM System Phytothermotherapy: a possible complementary therapy for fibromyalgia patients. Exercise, fibromyalgia, and fibrofog: a pilot study. Internet-Delivered Acceptance and Values-Based Exposure Treatment for Fibromyalgia: A Pilot Study Comparison of patients with chronic fatigue syndrome, fibromyalgia, and multiple chemical sensitivities. Inaccuracy in the diagnosis of fibromyalgia syndrome: analysis of referrals. The London Fibromyalgia Epidemiology Study: the prevalence of fibromyalgia syndrome in London, Ontario. Meditation awareness training for the treatment of fibromyalgia syndrome: A randomized controlled trial Management of patients with fibromyalgia using biofeedback: a randomized control trial. Sodium oxybate relieves pain and improves function in fibromyalgia syndrome: a randomized, double-blind, placebo-controlled, multicenter clinical trial. Theory of Mind and Emotional Functioning in Fibromyalgia Syndrome: An Investigation of the Relationship between Social Cognition and Executive Function Reduction of Intraepidermal Nerve Fiber Density (IENFD) in the skin biopsies of patients with fibromyalgia: A controlled study Familial aggregation of depression in fibromyalgia: a community-based test of alternate hypotheses Efficacy of the "body movement and perception" method in the treatment of fibromyalgia syndrome: an open pilot study.
Aim Previous systematic review s have found hydrotherapy to be an effective management strategy for  fibromyalgia syndrome ( FMS ) .  The aim of this systematic review was to summarize the components of hydrotherapy programs used in r and omized controlled trials . Method A systematic review of r and omized controlled trials was conducted . Only trials that have reported significant FMS-related outcomes were included . Data relating to the components of hydrotherapy programs ( exercise type , duration , frequency and intensity , environmental factors , and service delivery ) were analyzed . Results Eleven r and omized controlled trials were included in this review . Overall , the quality of trials was good . Aerobic exercise featured in all 11 trials and the majority of hydrotherapy programs included either a strengthening or flexibility component . Great variability was noted in both the environmental components of hydrotherapy programs and service delivery . Conclusions Aerobic exercise , warm up and cool-down periods and relaxation exercises are common features of hydrotherapy programs that report significant FMS-related outcomes . Treatment duration of 60 minutes , frequency of three sessions per week and an intensity equivalent to 60%–80 % maximum heart rate were the most commonly reported exercise components . Exercise appears to be the most important component of an effective hydrotherapy program for FMS , particularly when considering mental health-related outcomes OBJECTIVE The aim of this study was to evaluate the cardiorespiratory fitness and perceived exertion of female patients with fibromyalgia syndrome ( FMS ) compared with that of healthy female subjects . DESIGN AND SUBJECTS This was design ed as a cross-sectional case-control study , with a consecutive sample of 30 female patients with FMS and an age-matched control group of 67 healthy female subjects . SETTING This study was conducted at the multidisciplinary pain center of a university hospital in a city of more than 1 million inhabitants . OUTCOME MEASURES A cardiorespiratory fitness index ( PWC65%/kg ) and an original perceived exertion index ( B65 % ) were obtained from the  heart rates and perceived exertions scored on a 10-point Borg scale during a submaximal cycle ergometer test .  Average indexes for the FMS patients and control subjects were compared . RESULTS The mean cardiorespiratory fitness index of the FMS patients was not significantly different from that of the controls . The mean perceived exertion index in the FMS patients was significantly greater than that of the controls , meaning that the FMS patients systematic ally reported higher ratings of perceived exertion during exercise . CONCLUSIONS Cardiorespiratory fitness , as expressed by a submaximal work capacity index , seems normal in female patients with FMS compared with age- and sex-matched healthy individuals . The fact that FMS patients overscore their perception of exertion may be due to a greater overlap of peripheral pain and perceived exertion perceptions during exercise . This observation should be noted when using perceived exertion scores to prescribe and monitor exercise in FMS patients Between February 1978 and January 1984 , 222 eligible patients were r and omised in a multicentre trial of preoperative intra-arterial chemotherapy in the treatment of oral cavity and oropharynx carcinoma . Patients were r and omised between either surgery or preoperative chemotherapy .  This latter group received vincristine and bleomycin for 12 days . Patients were stratified according to the primary site : floor of the mouth ( FM ) versus posterior oral cavity or oropharynx ( POC ) and institution . The FM group received postoperative radiotherapy depending upon quality of the margins and lymph-node pathological involvement , when it was systematic ally applied in the POC group . Tumour regression after chemotherapy either complete ( CR ) or partial ( PR greater than 50 % ) was observed in 48 % in the FM group and 41 % in the POC group , and lymph-node regression ( CR + PR ) was respectively 15 % and 23 % . Some discrepancies appeared between clinical regression and pathological response , and the number of cases without histological response was clearly higher than the number of cases without clinical response . The overall survival showed a statistically significant difference ( P = 0.048 ) between FM and POC groups . In the FM group , median survival in the chemotherapy arm was estimated at 7 years compared with 3 years in the surgery arm . In the POC group , median survival was estimated at 3 years in both treatment arms . Chemotherapy lowered the uncontrolled disease and local recurrence in the FM group . These differences do not exist in the POC group , which may be due to the systematic ally postoperative radiotherapy OBJECTIVE To compare hydrotherapy ( HT ) and conventional physiotherapy ( CP ) in the treatment of fibromyalgia ( FM ) , regarding quality of life ( QOL ) , total sleep time ( TST ) , and total nap time ( TNT ) . METHODS Fifty out patients , all female , 30 - 60 years old , diagnosed with FM , were r and omly assigned to two groups to carry out 3 weeks of treatment with HT or CP . In the beginning and in the end of treatment , patients were evaluated with the SF-36 question naire to measure QOL and the sleep diary for TST and TNT . Data analyses were blind . RESULTS All 24 HT patients increased 1h in TST compared to 19 CP patients . TNT decreased in the HT group . QOL improved for the two groups in all domains when pre- and post-intervention were compared , but there was no difference between groups . CONCLUSION HT is more effective than CP to improve TST and to decrease TNT in FM patients To assess the effects of medicinal plants ( MPs ) or related natural products ( RNPs ) on fibromyalgia ( FM ) patients , we evaluate the possible benefits and advantages of MP or RNP for the treatment of FM based on eight r and omized placebo-controlled trials ( RCTs ) involving 475 patients . The method ological quality of all studies included was determined according to JADAD and “ Risk of Bias ” with the criteria in the Cochrane H and book for Systematic Review s of Interventions 5.1.0 . Evidence suggests significant benefits of MP or RNP in sleep disruption , pain , depression , joint stiffness , anxiety , physical function , and quality of life . Our results demonstrated that MP or RNP had significant effects on improving the symptoms of FM compared to conventional drug or placebo ; longer tests are required to determine the duration of the treatment and characterize the long-term safety of using MP , thus suggesting effective alternative therapies in the treatment of pain with minimized side effects 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 Objectives Fibromyalgia syndrome ( FMS ) is a chronic disorder defined by widespread muscle pain and multiple tender points . The objectives of this study were to estimate prevalence of comorbidities , healthcare re sources utilization , and costs associated with FMS . Methods A retrospective cohort study was conducted using data from the Quebec provincial health plans ( RAMQ ) for a r and om sample of patients with diagnoses of FMS and a control cohort of patients without FMS , matched for age and gender . Prevalence of comorbidities was estimated . Healthcare re sources consumed by FMS and non-FMS patients were identified in terms of visits to physicians , physician 's interventions , pain-related medications , nonpain-related medications , and hospitalizations . Results A total of 16,010 patients with 2 diagnoses of FMS were identified , and control patients were r and omly selected with a ratio of 1:1 . Incidence of most comorbidities was significantly higher in the FMS group and the chronic disease score ( 3.8 vs. 2.8 ; ANOVA P < 0.001 ) . The proportion of patients with at least 1 comorbidity was 87.4 % in the FMS group and 60.1 % in the control group ( χ2P<0.001 ) . The annual number of visits to physician and physician 's interventions was 25.1 for FMS and 14.8 for non-FMS patients . The amount paid by the RAMQ was significantly higher for patients with FMS ( $ 4065 ) compared with patients without FMS ( $ 2766 ) ( ANOVA P<0.001 ) . Discussion Results of this analysis of the RAMQ data base illustrate the high prevalence of comorbidities among patients with a diagnosis of FMS and strongly indicate that the economic burden of FMS is substantial Objectives : According to the trauma hypothesis , women with fibromyalgia syndrome ( FMS ) are more likely to report a history of sexual and /or physical abuse than women without FMS . In this study , we rely on a community sample to test this hypothesis and the related prediction that women with FMS are more likely to have posttraumatic stress disorder than women without FMS . Methods : Eligibility for the present study was limited to an existing community sample in which FMS and major depressive disorder were prevalent . The unique composition of the original sample allowed us to recruit women with and without FMS from the community . A total of 52 female participants were enrolled in the present FMS group and 53 in the control ( no FMS ) group .  Sexual and physical abuse were assessed retrospectively using a st and ardized telephone interview . Results : Except for rape , sexual and physical abuse were reported equally often by women in the FMS and control groups . Women who reported rape were 3.1 times more likely to have FMS than women who did not report rape ( P < 0.05 ) . There was no evidence of increased childhood abuse in the FMS group . Women with FMS were more likely to have posttraumatic stress disorder symptoms ( intrusive thoughts and arousal ) as well as posttraumatic stress disorder diagnosis ( P < 0.01 ) . Discussion : With the exception of rape , no self-reported sexual or physical abuse event was associated with FMS in this community sample . In accord with the trauma hypothesis , however , posttraumatic stress disorder was more prevalent in the FMS group . Chronic stress in the form of posttraumatic stress disorder but not major depressive disorder may mediate the relationship between rape and FMS OBJECTIVE To measure , and seek clinical correlates with , levels of  substance P ( SP ) in the cerebrospinal fluid ( CSF ) of fibromyalgia syndrome ( FMS ) patients . METHODS CSF from 32 FMS patients and 30 normal control subjects was tested for SP by radioimmunoassay . Clinical measures included tender point examination and st and ardized question naires . RESULTS CSF SP levels were 3-fold higher in FMS patients than in normal controls ( P < 0.001 ) , but they correlated only weakly with tenderness found on examination . CONCLUSION SP is significantly elevated in FMS CSF , but other abnormalities must exist in FMS to more fully explain the symptoms Hearing assistive technologies include listening , alerting , and /or signaling devices that use auditory , visual , and /or tactile modalities to augment communication and /or facilitate awareness of environmental sounds . The importance of hearing assistive technologies in the management of adults with hearing loss was recently acknowledged in an evidence -based clinical practice guideline developed by the American Academy of Audiology . Most currently available evidence for hearing assistive technology use by adults focuses on frequency-modulated ( FM ) technology . Previous research is review ed that demonstrates the efficacy of FM devices for adults in terms of laboratory measures of speech underst and ing in noise . Also review ed are the outcomes from field trials of FM use by community-dwelling adults , which , to date , have been disappointing . Few to no individuals , in previous studies , elected to use FM devices at the end of the trial periods . Data are presented from a 1-group pretest-posttest study examining the role of extensive counseling , coaching , and instruction on FM use by adults . In addition , the potential influence of the cost of devices to the individual was eliminated by conducting the study with veterans who were eligible to receive FM systems through the Veterans Affairs National Hearing Aid Program . Positive outcomes were obtained at the end of a 6-week trial period and were found to remain 1 year after study completion . Implication s for increasing the evidence base for the use of FM devices by adults are discussed OBJECTIVE It is a traditional practice in the Alpine region of Trentino and Alto Adige ( Italy ) to use phytothermotherapeutic treatment with fermenting grass ( " hay baths " ) for rheumatic diseases . However , despite its long history and popularity , a clinical validation of the efficacy and tolerability of the treatment has yet to be found in current literature . Fibromyalgia syndrome ( FMS ) is characterised by generalised musculoskeletal pain , high tender point counts , sleep disturbance , fatigue , headaches , irritable bowel syndrome , frequent psychological distress and depressed mood . There is no st and ard therapy regime for FMS and the variety of medical treatments used have given limited benefits . The aim of this study was to assess the efficacy and tolerability of a cycle of phytothermotherapy through a single-blind , controlled , r and omised trial , in patients with primary FMS . METHODS Fifty-six patients with primary FMS according to the ACR criteria were r and omly allocated to two groups : 30 were su bmi tted to phytothermotherapy at the thermal resort of Garniga Terme ( Trento , Italy ) and the other 26 were considered as controls . All patients were evaluated by FIQ , Tender Points Count , HAQ and AIMS 1 at baseline , after 10 days , then after 12 and 24 weeks . RESULTS Patients su bmi tted to phytothermotherapy showed visible and significant improvement of all evaluation parameters at the end of the treatment , which persisted during the follow-up period . No significant difference was found in the control group . Regarding the tolerability , none of the patients presented side effects . CONCLUSIONS Our results suggest the efficacy and the tolerability of phytothermotherapy in patients with primary FMS BACKGROUND This pilot study was design ed to test the efficacy of a physical activity program for improving psychological variables and fibromyalgia syndrome ( FMS ) symptoms and to provide preliminary evidence regarding the effects on perceived cognitive symptoms and objective ly measured cognitive performance by FMS patients . METHODS Sixteen women diagnosed with FMS were r and omly assigned to an 18-week physical activity program or to a control condition .  Psychological measures , FMS symptoms , perceived cognitive function , objective measures of cognition , and walking capacity were assessed at baseline and posttest . RESULTS At posttest , there were significant differences in fatigue ( effect size , ES=1.86 ) , depression ( ES=1.27 ) , FMS symptoms ( ES=1.56 ) , self-reported cognitive symptoms ( ES=1.19 ) , and delayed recall performance ( ES=1.16 ) between the physically active group and the control group , indicating that the FMS patients benefited from physical activity . Beneficial effects were also observed for 6 of the 7 objective measures of cognition and ranged from small to large ( ESs=0.26 to 1.06 ) . CONCLUSIONS Given that all FMS patients do not respond well to conventional treatments , these beneficial effects of physical activity are important . Future studies with larger sample s are warranted to test the reliability of the findings for the objective measures of cognition Background : Acceptance and commitment therapy ( ACT ) is a promising treatment option for fibromyalgia ( FM ) . Studies have shown that many cognitive behavioral protocol s can be transferred to the Internet with sustained efficacy . However , no study has investigated the effect on an Internet-delivered ACT-based protocol for FM . This study evaluated the efficacy , acceptability , and the health economic effects of an Internet-delivered acceptance and values-based exposure treatment for FM . Methods : This open pilot trial included 41 self-referred women with a FM diagnosis . The 10-week Internet-delivered treatment included acceptance , mindfulness , work with life-values , and systematic exposure to FM symptoms and FM-related situations . Participants also had regular contact with an assigned online therapist . Assessment s were made at pretreatment , post-treatment , and 6-month follow-up . Results : The treatment was completed by 70 % of the participants . Attrition rates were low , with 98 % completing the post-treatment assessment and 90 % completing the 6-month follow-up assessment . Multiple imputations were used to replace missing values . Pre- to post-treatment within-group effect sizes were in the moderate to large range ( Cohen 's d = 0.62–1.56 ) on measures of FM symptoms and impact , disability , quality of life , depression , anxiety , fatigue , and psychological flexibility . All improvements were maintained at follow-up . Economical analyses revealed significant societal cost reductions that offset the treatment costs within 2 months of treatment completion . Conclusions : An Internet-delivered psychological treatment based on acceptance and exposure principles seems to be an efficacious , acceptable , and cost-effective treatment for FM . R and omized controlled trials are needed to confirm these results BACKGROUND Chronic fatigue syndrome ( CFS ) , fibromyalgia ( FM ) , and multiple chemical sensitivities ( MCS ) are conditions associated with fatigue and a variety of other symptoms that appear to share many clinical and demographic features . Our objectives were to describe the similarities and differences among patients with CFS , FM , and MCS . Additional objectives were to determine how frequently patients with MCS and FM met the criteria for CFS and if they differed in their health locus of control . METHODS  Demographic , clinical , and psychosocial measures were prospect ively collected in 90 patients , 30 each with CFS , FM , and MCS . Patients were recruited from a university-based referral clinic devoted to the evaluation and treatment of chronic fatigue and three private practice s. Variables included demographic features , symptoms characteristic of each condition , psychological complaints , a measure of health locus of control , and information on health care use .  RESULTS Overall , the three patient groups were remarkably similar in demographic characteristics and the presence of specific symptoms . Patients with CFS and FM frequently reported symptoms compatible with MCS .  Likewise , 70 % of patients with FM and 30 % of those with MCS met the criteria for CFS . Health care use was substantial among patients with CFS , FM , and MCS , with an average of 22.1 , 39.7 , and 23.3 visits , respectively , to a medical provider during the prior year . Health locus of control did not differ among the three population s. CONCLUSIONS In general , demographic and clinical factors and health locus of control do not clearly distinguish patients with CFS , FM , and MCS . Symptoms typical of each disorder are prevalent in the other two conditions OBJECTIVE To examine prospect ively the accuracy of an initial diagnosis for fibromyalgia ( FM ) . METHODS All patients newly referred for rheumatology consultation in a 6-month period were evaluated prospect ively for either a preceding , current or subsequent diagnosis of FM . Clinical characteristics , previous and subsequent management and health care utilization were assessed . The final diagnosis at 6 months was verified and accuracy regarding the diagnosis of FM was assessed . RESULTS Seventy six ( 12 % ) of all new patients were either referred with a question of FM or finally diagnosed with FM . At the final evaluation the accuracy of the diagnosis regarding FM by either the referring physician or by the rheumatologist at the time of the initial visit was correct in 34 % of patients . The FM group in comparison with those with some other rheumatological diagnosis had more tender points ( 12.5 vs 4 ) and were more fatigued . In contrast , prolonged early morning stiffness and limitation of lumbar spinal mobility in more than one plane was more common in the non-FM group . CONCLUSION There is a disturbing inaccuracy , mostly observed to be overdiagnosis , in the diagnosis of FM by referring physicians . This finding may help explain the current high reported rates of FM and caution physicians to consider other diagnostic possibilities when addressing diffuse musculoskeletal pain OBJECTIVE To estimate the point prevalence of fibromyalgia syndrome ( FM )  among noninstitutionalized Canadian adults ; and to assess the effect of demographic variables on the odds of having FM . METHODS A screening question naire was administered via telephone to a r and om community sample of 3395 noninstitutionalized adults residing in London , Ontario . Individuals screening positive were invited to be examined by a rheumatologist to confirm or exclude FM using the 1990 American College of Rheumatology classification criteria . RESULTS One hundred confirmed cases of FM were identified , of whom 86 were women . Mean age among FM cases was 49.2 years among women , 39.3 years among men ( p < 0.02 ) . FM affects an estimated 4.9 % ( 95 % CI 4.7 % , 5.1 % ) of adult women and 1.6 % ( 1.3 % , 1.9 % ) of adult men in London , for a female to male ratio of roughly 3 to one . In women , prevalence rises steadily with age from < 1 % in women aged 18 - 30 to almost 8 % in women 55 - 64 . Thereafter , it declines . The peak prevalence in men also appears to be in middle age ( 2.5 % ; 1.1 % , 5.7 % ) . FM affects 3.3 % ( 3.2 % , 3.4 % ) of noninstitutionalized adults in London . Female sex , middle age , less education , lower household income , being divorced , and being disabled are associated with increased odds of having FM . CONCLUSION FM is a common musculoskeletal disorder among Canadian adults , especially among women and persons of lower socioeconomic status OBJECTIVES The purpose of this study was to conduct the first r and omized controlled trial ( RCT ) to evaluate the effectiveness of a second-generation mindfulness-based intervention ( SG-MBI ) for treating fibromyalgia syndrome ( FMS ) . Compared to first-generation mindfulness-based interventions , SG-MBIs are more acknowledging of the spiritual aspect of mindfulness . DESIGN A RCT employing intent-to-treat analysis . METHODS Adults with FMS received an 8-week SG-MBI known as meditation awareness training ( MAT ; n = 74 ) or an  active control intervention known as cognitive behaviour theory for groups ( n = 74 ) . Assessment s were performed at pre- , post- , and 6-month follow-up phases . RESULTS Meditation awareness training participants demonstrated significant and sustained improvements over control group participants in FMS symptomatology , pain perception , sleep quality , psychological distress , non-attachment ( to self , symptoms , and environment ) , and civic engagement . A mediation analysis found that ( 1 ) civic engagement partially mediated treatment effects for all outcome variables , ( 2 ) non-attachment partially mediated treatment effects for psychological distress and sleep quality , and ( 3 ) non-attachment almost fully mediated treatment effects for FMS symptomatology and pain perception . Average daily time spent in meditation was found to be a significant predictor of changes in all outcome variables . CONCLUSIONS Meditation awareness training may be a suitable treatment for adults with FMS and appears to ameliorate FMS symptomatology and pain perception by reducing attachment to self . Statement of contribution What is already known on this subject ? Design ing interventions to treat fibromyalgia syndrome ( FMS ) continues to be a challenge . There is growing interest into the applications of mindfulness-based interventions for treating FMS . Second-generation mindfulness-based interventions ( SG-MBIs ) are a key new direction in mindfulness research . What does this study add ? Meditation awareness training - an SG-MBI - result ed in significant reductions in FMS symptomatology . SG-MBIs recognize the spiritual aspect of mindfulness and may have a role in the treatment of FMS OBJECTIVE Fibromyalgia syndrome ( FMS ) is a chronic rheumatological condition which could be characterized by generalized pain and fatigue . Cognitive and behavioral therapy has been found to be a suitable technique in the management of FMS . This study intends to evaluate the efficacy of electromyography ( EMG ) biofeedback to reduce pain in patients with FMS . MATERIAL S AND METHODS A r and omized controlled trial involving two groups of FMS patients , one receiving EMG biofeedback and the other a sham biofeedback  , was carried out . The assessment tools included in the study were fibromyalgia impact question naire ( FIQ ) , visual analogue scale ( VAS ) , six-minute walk test ( SMWT ) and number of tender points ; and tenderness of each tender point was done for both the groups . STATISTICS A Student 's ' t ' test was used to study the test for significance . RESULTS After using biofeedback , the mean VAS scores and the mean number of tender points were found to be 3 out of 10 and 6 out of 18 respectively . Subjective analysis from both groups showed improvement in physical and psychological realms . Statistical significance . CONCLUSION Biofeedback as a treatment modality reduces pain in patients with FMS , along with improvements in FIQ , SMWT and the number of tender points OBJECTIVE To evaluate the safety and efficacy of sodium oxybate for management of the symptoms of fibromyalgia syndrome ( FMS ) . METHODS Patients with FMS ( according to the American College of Rheumatology 1990 criteria ) were r and omized , after discontinuing their pre study medications for FMS , to receive 4.5 gm or 6 gm of sodium oxybate or matching placebo once per night for 8 weeks . The primary outcome variable ( POV ) was a composite score for changes from baseline in 3 co primary self-report measures : patient 's pain rating ( in daily electronic diaries ) on a visual analog scale ( PVAS ) , the Fibromyalgia Impact Question naire ( FIQ ) score , and the Patient Global Impression of Change ( PGI-C ) . A beneficial response rate for the POV composite score was defined as > or=20 % improvement in the PVAS and FIQ scores plus a rating of " much better " or " very much better " on the PGI-C. Secondary measures included subjective sleep outcomes ( on the Jenkins Scale for Sleep ) and quality -of-life measures . The analyses were based on an intent-to-treat ( ITT ) population . RESULTS The ITT population included 188 patients with FMS , 78 % of whom completed the trial . Significant benefit was observed with both dosages of sodium oxybate , according to changes in the POV and subjective sleep quality . Improvements in the PVAS score were significantly correlated with sleep outcomes . Sodium oxybate was well tolerated overall ; dose-related nausea ( < or=28 % of patients ) and dizziness ( < or=18 % of patients ) tended to resolve with continued therapy . CONCLUSION Sodium oxybate therapy was well tolerated and significantly improved the symptoms of FMS . Further study of sodium oxybate as a novel therapeutic option for FMS is warranted Background Fibromyalgia ( FM ) is a syndrome primarily characterised by chronic , widespread musculoskeletal pain . In the aetiology of this syndrome a crucial role is played by complex interactions among biological , genetic , psychological , and socio-cultural factors . Recently , research ers have started to explore emotional functioning in FM , with their attention focused on alexithymia , a personality construct that affects the regulation of a person ’s own emotions . On the other h and , the detection and experience of emotional signals from other people have only been sparsely investigated in FM syndrome and no studies have investigated the ability to represent other people ’s mental states ( i.e. Theory of Mind , ToM ) in these patients . Here we present the first study investigating a large set of social-cognitive abilities , and the possible relationships between these abilities and the performance on executive-function tasks , in a homogenous sample of patients with FM . Methodology Forty women with FM and forty-one healthy women matched for education and age were involved in the study .  Social cognition was assessed with a set of vali date d experimental tasks .  Measures of executive function were used to test the correlations between this dimension and the social-cognitive profile of patients with FM . Relationships between social-cognitive abilities and demographic , clinical and psychological variables were also investigated . Principal Findings Patients with FM have impairments both in the regulation of their own affect and in the recognition of other ’s emotions , as well as in representing other people ’s mental states . No significant correlations were found between social cognition tasks and the subcomponents of the executive function that were analysed . Conclusions The results show the presence of several impairments in social cognition skills in patients with FM , which are largely independent of both executive function deficits and symptoms of psychological distress . The impairments reported highlight the importance of adequately assessing ToM and emotional functioning in clinical practice OBJECTIVES Fibromyalgia ( FM ) is one of the most common chronic pain syndromes . Various pathogenetic mechanisms have been implicated but none is proven . Our scope was to determine if Intraepidermal Nerve Fiber Density ( IENFD ) is reduced in the skin of FM patients , as observed in patients with painful small fiber sensory neuropathy ( SFSN ) . DESIGN , SETTING AND PARTICIPANTS We prospect ively studied 46 FM patients ( 5 men and 41 women ) , aged 29 to 76 ( mean : 52.5 ) years , diagnosed according to the ACR 2010 criteria , and 34 controls ( 18 women and 16 men ) aged 19 to 84 ( mean : 31.7 ) years .  IENFD was measured using published guidelines and immune markers were sought immunocytochemically . In 30 FM patients , pain intensity was assessed with the Neuropathic Pain Symptom Inventory ( NPSI ) , a scale vali date d for neuropathic pain . RESULTS 15 of 46 ( 32.6 % ) FM patients had reduced IENFD [ range : 0.6 - 12.5 fibers/mm ( mean : 4.83 SD : 2.5 ) ] , compared to healthy controls [ 2.8 - 11.5 fibers/mm ( mean : 7.35 , SD : 1.85 ) ] ( p<0.0001 ) . No significant correlation was noticed between NPSI scores and IENFD . No difference in the Langerhans cells , the major Antigen Presenting Cells ( APCs ) in the epidermis , or in IL-6 staining , was noted between FM and controls . IENFD was equally reduced in a subset of FM patients who also had another autoimmune disease . CONCLUSION This is one of the largest series of FM patients demonstrating a significant reduction of IENFD in their skin biopsies . The findings indicate that in a subset of FM patients , the pain syndrome is , at least partially , of neuropathic origin . Skin biopsy may prove a useful tool and a potential biomarker in future studies of FM patients & NA ; Numerous studies report that fibromyalgia ( FM ) , a syndrome characterized by widespread pain and generalized tender points , is comorbid with major depressive disorder ( MDD ) . The current study tests two alternate explanations for their comorbidity using a family study methodology . The first is that FM is a depression spectrum disorder . The second is that depression is a consequence of living with FM . We recruited potential prob and s by initially screening by telephone for FM and MDD among women in the NY/NJ metropolitan area , r and omly selecting telephone numbers from a list of households with women . Eligible women were invited for second stage physical examinations for FM diagnosis and psychiatric interviews for MDD diagnosis . All available adult , first‐degree relatives received psychiatric interviews . Relatives of prob and s were divided into four groups on the basis of the prob and s ' FM and MDD diagnoses ( FM+/MDD+ ( n=156 ) , FM+/MDD− ( n=51 ) , FM−/MDD+ ( n=351 ) and FM−/MDD− ( n=101 ) ) . Results indicated that rates of MDD in the relatives of prob and s with FM but without personal histories of MDD were virtually identical to rates of MDD in relatives of prob and s with MDD themselves . This outcome is consistent with the hypothesis that FM is a depression spectrum disorder , in which FM and MDD are characterized by shared , familially mediated risk factors . The implication s of these findings for a stress‐vulnerability model of FM are discussed 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
There is moderate evidence that hydrotherapy has short-term beneficial effects on pain and HRQOL in FMS patients .
OBJECTIVE To systematic ally review the efficacy of hydrotherapy in FM syndrome ( FMS ) .