title: Improved clinical status in fibromyalgia patients treated with individualized homeopathic remedies versus placebo. Healthcare provided by a homeopath as an adjunct to usual care for Fibromyalgia (FMS): results of a pilot Randomised Controlled Trial. How Quickly Do Systematic Reviews Go Out of Date? A Survival Analysis AMSTAR is a reliable and valid measurement tool to assess the methodological quality of systematic reviews. The Effects of Nabilone on Sleep in Fibromyalgia: Results of a Randomized Controlled Trial Efficacy and Safety of Medicinal Plants or Related Natural Products for Fibromyalgia: A Systematic Review Improvement in fibromyalgia symptoms with acupuncture: results of a randomized controlled trial. Electroacupuncture in fibromyalgia: results of a controlled trial. Effects of acupuncture to treat fibromyalgia: A preliminary randomised controlled trial Short-term efficacy of topical capsaicin therapy in severely affected fibromyalgia patients Traditional Chinese acupuncture and placebo (sham) acupuncture are differentiated by their effects on μ-opioid receptors (MORs) A randomized clinical trial of fibromyalgia treatment with acupuncture compared with fluoxetine A randomized controlled trial of acupuncture added to usual treatment for fibromyalgia. Effect of homeopathic treatment on fibrositis (primary fibromyalgia) An Open, Pilot Study to Evaluate the Potential Benefits of Coenzyme Q10 Combined with Ginkgo Biloba Extract in Fibromyalgia Syndrome Effects of resistance training and chiropractic treatment in women with fibromyalgia. The effectiveness of chiropractic management of fibromyalgia patients: a pilot study. Effects of topical essential oil on exercise volume after a 12-week exercise program for women with fibromyalgia: a pilot study. A Randomized Clinical Trial of Acupuncture Compared with Sham Acupuncture in Fibromyalgia Treatment of fibromyalgia with formula acupuncture: investigation of needle placement, needle stimulation, and treatment frequency. Nabilone for the treatment of pain in fibromyalgia. Osteopathic manipulative treatment in conjunction with medication relieves pain associated with fibromyalgia syndrome: results of a randomized clinical pilot project. Effectiveness of acupuncture in the treatment of fibromyalgia.
abstract: OBJECTIVE To assess the efficacy of individualized classical homeopathy in the treatment of fibromyalgia . METHODS This study was a double-blind , r and omized , parallel-group , placebo-controlled trial of homeopathy .  Community-recruited persons ( N = 62 ) with physician-confirmed fibromyalgia ( mean age 49 yr , s.d . 10 yr , 94 % women ) were treated in a homeopathic private practice setting . Participants were r and omized to receive oral daily liquid LM ( 1/50,000 ) potencies with an individually chosen homeopathic remedy or an indistinguishable placebo . Homeopathic visits involved joint interviews and concurrence on remedy selection by two experienced homeopaths , at baseline , 2 months and 4 months ( prior to a subsequent optional crossover phase of the study which is reported elsewhere ) . Tender point count and tender point pain on examination by a medical assessor uninvolved in providing care , self-rating scales on fibromyalgia-related quality of life , pain , mood and global health at baseline and 3 months , were the primary clinical outcome measures for this report . RESULTS Fifty-three people completed the treatment protocol . Participants on active treatment showed significantly greater improvements in tender point count and tender point pain , quality of life , global health and a trend toward less depression compared with those on placebo . CONCLUSIONS This study replicates and extends a previous 1-month placebo-controlled crossover study in fibromyalgia that pre-screened for only one homeopathic remedy . Using a broad selection of remedies and the flexible LM dose ( 1/50,000 dilution factor ) series , the present study demonstrated that individualized homeopathy is significantly better than placebo in lessening tender point pain and improving the quality of life and global health of persons with fibromyalgia OBJECTIVES To assess the feasibility of a R and omised Controlled Trial ( RCT ) design of usual care compared with usual care plus adjunctive care by a homeopath for patients with Fibromyalgia syndrome ( FMS ) . METHODS In a pragmatic parallel group RCT design , adults with a diagnosis of FMS ( ACR criteria ) were r and omly allocated to usual care or usual care plus adjunctive care by a homeopath . Adjunctive care consisted of five in depth interviews and individualised homeopathic medicines . The primary outcome measure was the difference in Fibromyalgia Impact Question naire ( FIQ ) total score at 22 weeks . RESULTS 47 patients were recruited .  Drop out rate in the usual care group was higher than the homeopath care group ( 8/24 vs 3/23 ) . Adjusted for baseline , there was a significantly greater mean reduction in the FIQ total score ( function ) in the homeopath care group than the usual care group ( -7.62 vs 3.63 ) . There were significantly greater reductions in the homeopath care group in the McGill pain score , FIQ fatigue and tiredness upon waking scores . We found a small effect on pain score ( 0.21 , 95 % CI -1.42 to 1.84 ) ; but a large effect on function ( 0.81 , 95 % CI -8.17 to 9.79 ) . There were no reported adverse events . CONCLUSIONS Given the acceptability of the treatment and the clinical ly relevant effect on function , there is a need for a definitive study to assess the clinical and cost effectiveness of adjunctive healthcare by a homeopath for patients with FMS Context Clinicians rely on systematic review s for current , evidence -based information . Contribution This survival analysis of 100 meta-analyses indexed in ACP Journal Club from 1995 to 2005 found that new evidence that substantively changed conclusions about the effectiveness or harms of therapies arose frequently and within relatively short time periods . The median survival time without substantive new evidence for the meta-analyses was 5.5 years . Significant new evidence was already available for 7 % of the review s at the time of publication and became available for 23 % within 2 years . Implication Clinical ly important evidence that alters conclusions about the effectiveness and harms of treatments can accumulate rapidly . The Editors Systematic review s have become increasingly common in recent years ( 1 ) and are recommended by many as the best sources of evidence to guide both clinical decisions ( 2 ) and health care policy ( 3 ) . For systematic review s to fulfill these roles , their findings must remain relatively stable for at least several years or effective mechanisms must exist for alerting end users to important changes in evidence . Yet , surprisingly little research has assessed the extent to which systematic review s become out of date or the rate at which this occurs ( 47 ) . Some organizations , such as the Cochrane Collaboration , recommend updating systematic review s every 2 years , but few empirical data guide this or other recommendations about updating . We sought to determine how quickly systematic review s meet explicitly defined criteria for changes in evidence of sufficient importance to warrant updating . We also sought to identify predictors of survival time , the time to such important changes in evidence . Survival time might vary depending on many factors , including the type of question posed by the original review ( for example , therapeutic or diagnostic ) , the types of studies included ( for example , r and omized trials or observational studies ) , and whether the systematic review provided quantitative synthesis . To limit such variation , we focused on systematic review s of r and omized , controlled trials that evaluated therapeutic benefit or harm by providing quantitative synthesis ( meta- analysis ) for at least 1 outcome . Methods Study Design and Sample We used a quasi-r and om process ( alphabetical sort order by author ) to select 100 systematic review s that were indexed in ACP Journal Club with an accompanying commentary between January 1995 and December 2005 ( with a search date no later than 31 December 2004 to ensure at least 1 full year for new evidence to appear ) . We chose this sampling frame because ACP Journal Club selects systematic review s that meet explicit quality st and ards and are deemed directly relevant to clinical practice ( 8) . We regarded the sample size of 100 as sufficiently large to achieve suitably narrow confidence intervals and to permit evaluation of up to 5 potential predictors of survival . Eligibility Criteria Eligible review s evaluated the benefit or harm of a specific drug , class of drug , device , or procedure ( invasive procedure or surgery ) and included r and omized or quasi-r and omized , controlled trials . We excluded evaluations of alternative and complementary medicines because the stability of review s of such therapies might differ substantially from review s of conventional therapies . We required that review s provide a point estimate and 95 % confidence interval for at least 1 outcome in the form of a relative risk , odds ratio , or absolute risk difference for binary outcomes and weighted mean differences for continuous outcomes . We excluded meta-analyses of individual-patient data , meta-regressions , and indirect meta-analyses because of the difficulty of determining whether new data would alter previous quantitative results . Two team members independently assessed eligibility , with disagreements resolved by consensus involving a third review er . When more than 1 review on the same topic was identified , only the earliest was included . Search ing For each review , search es for new trials included identifying new systematic review s on the same topic , su bmi tting relevant content terms to the Clinical Queries function in Ovid , applying the Related Articles function in PubMed to the 3 largest and the 3 most recent trials in the original review ( up to 6 trials in total ) , and using Scopus ( www . scopus .com/ scopus /home.url ) to identify new r and omized trials that cited the original review . When these search strategies yielded no eligible new trials , we conducted more comprehensive electronic search es and review ed relevant chapters in such sources as Clinical Evidence and UpTo Date to ensure that we had not missed new trials . Team members who had background s in both medicine and clinical research screened citations retrieved by the preceding methods to identify trials that would have met the inclusion criteria in the original review . Retrieved articles were screened in chronological order to ascertain quantitative or qualitative signals for the need for updating . The review protocol stopped when any criteria for updating were met . Each systematic review was discussed in detail , with the final statussignal for updating was or was not detectedadjudicated by consensus ( Figure 1 ) . Figure 1 . Overall process for determining updating status . ACP Journal Club Signals for the Need to Up date Systematic Review s In design ing criteria for comparing new findings with those in a previous review , we adapted methods used by other investigators to address similar problems with comparing 2 sets of results relating to the same question ( 913 ) , such as r and omized and nonr and omized studies of the same intervention . These investigators identified conflicting findings among different publications using a combination of quantitative thresholds for differences in effect magnitude and qualitative judgments about the language used to describe the results . We have similarly conceptualized quantitative and qualitative signals of potential changes in evidence that are sufficiently important to warrant updating previous systematic review s. Quantitative Signals Quantitative signals consisted of a change in statistical significance or relative change in effect magnitude of at least 50 % . We restricted these changes to those involving 1 of the primary outcomes of the original review or any mortality outcome . We also ignored trivial changes in statistical significance when the original and up date d meta-analytic results both had P values between 0.04 and 0.06so that quantitative signals of changes in evidence would represent robust indicators of the need to up date previous review s. Quantitative signals were detected by combining data from eligible new trials with the previous results using a fixed-effects approach . Use of fixed-effect models allowed pooling of the new trials with the previous meta-analytic result , as opposed to having to obtain original data from all of the included trials in each of 100 systematic review s. Although r and om-effects models are usually preferred to avoid spurious precision in the face of heterogeneity , our goal was to detect potential changes in evidence that would warrant a formal up date , not produce exact estimates of the up date d results . Qualitative Signals Qualitative signals included new information about harm sufficient to affect clinical decision making , important caveats to the original results , emergence of a superior alternate therapy , and important changes in certainty or direction of effect . Qualitative signals were detected by using explicit criteria for comparing the language in the original review with descriptions of findings in new systematic review s that addressed the same topic , pivotal trials , clinical practice guidelines , or recent editions of major textbooks ( for example , UpTo Date ) . Pivotal trials were defined as trials that had a sample size at least 3 times larger than that of the previous largest trial or were published in 1 of the 5 highest-impact general medical journals ( The New Engl and Journal of Medicine , Lancet , Journal of the American Medical Association , Annals of Internal Medicine , and the British Medical Journal ) . We defined 2 levels of importance for qualitative signals : potentially invalidating changes in evidence , which would make one no longer want clinicians or policymakers to base decisions on the original findings ( such as a pivotal trial that characterized treatment effectiveness in terms opposite of those in the original systematic review ) , and major changes in evidence , which would affect clinical decision making in important ways without invalidating the previous results ( such as the identification of patient population s for whom treatment is more or less beneficial ) . Major changes also included differing characterizations of effectiveness that were less extreme than those for potentially invalidating signals but that would still affect clinical decision making ( for example , a change from possibly beneficial to definitely beneficial ) . Of importance , such characterizations as possibly effective , probably effective , and promising , were all categorized as possibly effective . Thus , qualitative signals for changes in evidence captured substantive differences in the characterization of treatment effects , not merely semantic differences . Full definitions for each of the specific signals can be found at www.ohri.ca/UpdatingSystRevs . Data Collection For each review , we characterized the clinical content area , eligibility criteria for included trials , definitions of reported outcomes , number of included trials and participants , meta-analytic result for each outcome , identification of statistical heterogeneity , and excerpted quotations of the authors ' characterizations of the main results . We also abstract ed whether a given outcome was explicitly identified as 1 of the primary or main outcomes . We discounted identification of more than 3 such outcomes as inconsistent with the OBJECTIVE Our purpose was to measure the agreement , reliability , construct validity , and feasibility of a measurement tool to assess  systematic review s ( AMSTAR ) . STUDY DESIGN AND SETTING We r and omly selected 30 systematic review s from a data base . Each was assessed by two review ers using : ( 1 ) the enhanced quality assessment question naire ( Overview of Quality Assessment Question naire [ OQAQ ] ) ; ( 2 ) Sacks ' instrument ; and ( 3 ) our newly developed measurement tool ( AMSTAR ) . We report on reliability ( interobserver kappas of the 11 AMSTAR items ) , intraclass correlation coefficients ( ICCs ) of the sum scores , construct validity ( ICCs of the sum scores of AMSTAR compared with those of other instruments ) , and completion times . RESULTS The interrater agreement of the individual items of AMSTAR was substantial with a mean kappa of 0.70 ( 95 % confidence interval [ CI ] : 0.57 , 0.83 ) ( range : 0.38 - 1.0 ) . Kappas recorded for the other instruments were 0.63 ( 95 % CI : 0.38 , 0.78 ) for enhanced OQAQ and 0.40 ( 95 % CI : 0.29 , 0.50 ) for the Sacks ' instrument . The ICC of the total score for AMSTAR was 0.84 ( 95 % CI : 0.65 , 0.92 ) compared with 0.91 ( 95 % CI : 0.82 , 0.96 ) for OQAQ and 0.86 ( 95 % CI : 0.71 , 0.94 ) for the Sacks ' instrument . AMSTAR proved easy to apply , each review taking about 15 minutes to complete . CONCLUSIONS AMSTAR has good agreement , reliability , construct validity , and feasibility . These findings need confirmation by a broader range of assessors and a more diverse range of review BACKGROUND : Sleep disorders affect many patients with chronic pain conditions . Cannabis has been reported by several patient population s to help sleep . We evaluated the safety and efficacy of nabilone , a synthetic cannabinoid , on sleep disturbance in fibromyalgia ( FM ) , a disease characterized by widespread chronic pain and insomnia . METHODS : We conducted a r and omized , double-blind , active-control , equivalency crossover trial to compare nabilone ( 0.5–1.0 mg before bedtime ) to amitriptyline ( 10–20 mg before bedtime ) in patients with FM with chronic insomnia . Subjects received each drug for 2 wk with a 2-wk washout period . The primary outcome was sleep quality , measured by the Insomnia Severity Index and the Leeds Sleep Evaluation Question naire . Secondary outcomes included pain , mood , quality of life , and adverse events ( AEs ) . RESULTS : Thirty-one subjects were enrolled and 29 completed the trial ( 26 women , mean age 49.5 yr ) . Although sleep was improved by both amitriptyline and nabilone , nabilone was superior to amitriptyline ( Insomnia Severity Index difference = 3.2 ; 95 % confidence interval = 1.2–5.3 ) . Nabilone was marginally better on the restfulness ( Leeds Sleep Evaluation Question naire difference = 0.5 [ 0.0–1.0 ] ) but not on wakefulness ( difference = 0.3 [ −0.2 to 0.8 ] ) . No effects on pain , mood , or quality of life were observed . AEs were mostly mild to moderate and were more frequent with nabilone . The most common AEs for nabilone were dizziness , nausea , and dry mouth . CONCLUSIONS : Nabilone is effective in improving sleep in patients with FM and is well tolerated . Low-dose nabilone given once daily at bedtime may be considered as an alternative to amitriptyline . Longer trials are needed to determine the duration of effect and to characterize long-term safety 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 To test the hypothesis that acupuncture improves symptoms of fibromyalgia .  PATIENTS AND METHODS We conducted a prospect i ve , partially blinded , controlled , r and omized clinical trial of patients receiving true acupuncture  compared with a control group of patients who received simulated acupuncture . All patients met American College of Rheumatology criteria for fibromyalgia and had tried conservative symptomatic treatments other than acupuncture .  We measured symptoms with the Fibromyalgia Impact Question naire ( FIQ ) and the Multidimensional Pain Inventory at baseline , immediately after treatment , and at 1 month and 7 months after treatment . The trial was conducted from May 28 , 2002 , to August 18 , 2003 . RESULTS Fifty patients participated in the study : 25 in the acupuncture group and 25 in the control group .  Total fibromyalgia symptoms , as measured by the FIQ , were significantly improved in the acupuncture group compared with the control group during the study period ( P = .01 ) . The largest difference in mean FIQ total scores was observed at 1 month ( 42.2 vs 34.8 in the control and acupuncture groups , respectively ; P = .007 ) . Fatigue and anxiety were the most significantly improved symptoms during the follow-up period . However , activity and physical function levels did not change . Acupuncture was well tolerated , with minimal adverse effects . CONCLUSION This study paradigm allows for controlled and blinded clinical trials of acupuncture . We found that acupuncture significantly improved symptoms of fibromyalgia . Symptomatic improvement was not restricted to pain relief and was most significant for fatigue and anxiety OBJECTIVE --To determine the efficacy of electroacupuncture in patients with fibromyalgia , a syndrome of unknown origin causing diffuse musculoskeletal pain . DESIGN --Three weeks ' r and omised study with blinded patients and evaluating physician . SETTING --University divisions of physical medicine and rehabilitation and rheumatology , Geneva . PATIENTS --70 patients ( 54 women ) referred to the division for fibromyalgia as defined by the American College of Rheumatology . INTERVENTIONS -- Patients were r and omised to electroacupuncture ( n = 36 ) or a sham procedure ( n = 34 ) by means of an electronic numbers generator . MAIN OUTCOME MEASURES --Pain threshold , number of analgesic tablets used , regional pain score , pain recorded on visual analogue scale , sleep quality , morning stiffness , and patient 's and evaluating physician 's appreciation . RESULTS --Seven of the eight outcome parameters showed a significant improvement in the active treatment group whereas none were improved in the sham treatment group . Differences between the groups were significant for five of the eight outcome measures after treatment . CONCLUSIONS --Electroacupuncture is effective in relieving symptoms of fibromyalgia . Its potential in long term management should now be studied Background Acupuncture is often used to treat fibromyalgia ( FM ) , but it remains unclear whether acupuncture is effective . This study aims to evaluate the effects of acupuncture on pain and quality of life ( QoL ) in FM patients . Methods Sixteen patients ( 13 women and 3 men aged 25 - 63 years ) suffering from FM were r and omised into two groups : group A ( n = 8) received five acupuncture treatments after the fifth week and group B received ten acupuncture treatments . Outcome measures used in this study were pain intensity ( visual analogue scale , VAS ) and the fibromyalgia impact question naire ( FIQ ) . Results After the fifth week , pain intensity ( U = 25.0 ; P = 0.022 ) in group B decreased and QoL ( U = 24.5 ; P = 0.026 ) improved compared to group A. Conclusion The present study suggests that acupuncture treatment is effective to relieve pain for FM patients in terms of QoL and FIQ The purpose of this study was to evaluate the short-term efficacy of topical capsaicin treatment in patients severely affected by fibromyalgia . One hundred and thirty fibromyalgia patients were r and omly divided into two groups . The  control group , 56 women and 4 men who continued their medical treatment , and the  capsaicin group , 70 women who apart from continuing their medical treatment , also underwent topical capsaicin 0.075 % 3 times daily for 6 weeks . At the beginning of the program , there were no significant differences between the two groups in any of the analyzed parameters . At the end of the treatment , there were significant improvements in the capsaicin group in the myalgic score ( 5.21 vs 3.8 , p = 0.02 ) and global subjective improvement ( 22.8 vs 5 % , p = 0.001 ) . Six weeks after the end of the treatment , the experimental group showed significant differences in Visual Analogue Scale of depression ( 5.63 vs 7.35 , p = 0.02 ) , Fibromyalgia Impact Question naire ( 67.89 vs 77.7 , p = 0.02 ) , role limitations due to emotional problems ( 36.17 vs 17.2 , p = 0.05 ) , Fatigue Severity Scale ( 6.2 vs 6.6 , p = 0.04 ) , myalgic score ( 3.94 vs 2.66 , p = 0.02 ) and pressure pain threshold ( 79.25 vs 56.71 , p = 0.004 ) . In conclusion , patients severely affected by fibromyalgia can obtain short-term improvements following topical capsaicin 0.075 % treatment three times daily for 6 weeks Controversy remains regarding the mechanisms of acupuncture analgesia . A prevailing theory , largely unproven in humans , is that it involves the activation of endogenous opioid antinociceptive systems and mu-opioid receptors ( MORs ) . This is also a neurotransmitter system that mediates the effects of placebo-induced analgesia . This overlap in potential mechanisms may explain the lack of differentiation between traditional acupuncture and either non-traditional or sham acupuncture in multiple controlled clinical trials . We compared both short- and long-term effects of traditional Chinese acupuncture ( TA ) versus sham acupuncture ( SA ) treatment on in vivo MOR binding availability in chronic pain patients diagnosed with fibromyalgia ( FM ) . Patients were r and omized to receive either TA or SA treatment over the course of 4 weeks .  Positron emission tomography ( PET ) with (11)C-carfentanil was performed once during the first treatment session and then repeated a month later following the eighth treatment . Acupuncture therapy evoked short-term increases in MOR binding potential , in multiple pain and sensory processing regions including the cingulate ( dorsal and subgenual ) , insula , cau date , thalamus , and amygdala . Acupuncture therapy also evoked long-term increases in MOR binding potential in some of the same structures including the cingulate ( dorsal and perigenual ) , cau date , and amygdala . These short- and long-term effects were absent in the sham group where small reductions were observed , an effect more consistent with previous placebo PET studies . Long-term increases in MOR BP following TA were also associated with greater reductions in clinical pain . These findings suggest that divergent MOR processes may mediate clinical ly relevant analgesic effects for acupuncture and sham acupuncture Background To evaluate the effectiveness of acupuncture and compare it with fluoxetine in treatment of fibromyalgia syndrome ( FMS ) . Methods We conducted a prospect i ve , r and omized clinical trial . Fifteen patients were treated with acupuncture  and compared with a  control group ( n=15 ) of patients who received fluoxetine .  Visual analogue scale , Fibromyalgia Impact Question naire ( FIQ ) and determined number of tender points were used as outcome measurements . Results After four weeks , the acupuncture group was significantly better than the control group in the number of tender points . Total fibromyalgia symptoms were significantly improved in the acupuncture group compared with the control group during the study period ( P= 0.01 ) . The largest difference in mean FIQ total scores was observed at 4 weeks ( 42.2 VS . 34.8 in the control and acupuncture groups , respectively ; P= 0.007 ) . At the end of one year of the follow up , patients who received acupuncture were significantly better than the control group in all measures . Fatigue and anxiety were the most significantly improved symptoms during the follow up period . Discussion Acupuncture significantly improved pain and symptoms of fibromyalgia . Also , we found that acupuncture did not have any side effect and was tolerable OBJECTIVE To evaluate the effectiveness of acupuncture for fibromyalgia . METHODS Fifty-eight women with fibromyalgia were allocated r and omly to receive either acupuncture together with tricyclic antidepressants and exercise ( n=34 ) , or tricyclic antidepressants and exercise only ( n=24 ) . Patients rated their pain on a visual analogue scale . A blinded assessor evaluated both the mean pressure pain threshold value over all 18 fibromyalgia points and quality of life using SF-36 . RESULTS At the end of 20 sessions , patients who received acupuncture were significantly better than the control group in all measures of pain and in 5 of the SF-36 subscales . After 6 months , the acupuncture group was significantly better than the control group in numbers of tender points , mean pressure pain threshold at the 18 tender points and 3 subscales of SF-36 . After one year , the acupuncture group showed significance in one subscale of the SF-36 ; at 2 years there were no significant differences in any outcome measures . CONCLUSION Addition of acupuncture to usual treatments for fibromyalgia may be beneficial for pain and quality of life for 3 months after the end of treatment . Future research is needed to evaluate the specific effects of acupuncture for fibromyalgia mens . Several treatments were required for each tumour , and injecting alcohol was often associated with considerable pain , whereas our patients did not report pain . These reports did not mention changes seen on ultrasound scans during or immediately after injection , which we found useful in laser treatment . The most important advantage of the laser is its precision . It is unlikely that it will ever be possible to predict the extent of necrosis around a site at which absolute alcohol has been injected with an accuracy comparable to that already possible with the laser technique . In conclusion , interstitial laser hyperthermia is feasible and seems to be safe . A multiple fibre system makes it feasible to treat tumours of clinical ly relevant size in the centre of solid organs . The real challenge for the future will be to develop diagnostic techniques that disclose exactly how far individual tumours extend in a wider range of organs ( unlike the well defined tumours treated in this pilot study ) and to establish the conditions of laser treatment that give complete tumour ablation with safe healing . This combination of technologies may be valuable for treating otherwise untreatable tumours in a range of solid organs and for the primary treatment of small neoplasms such as tumours of the prostate and adrenal gl and An open , uncontrolled study was undertaken to measure the subjective effects of coenzyme Q10 combined with a Ginkgo biloba extract in volunteer subjects with clinical ly diagnosed fibromyalgia syndrome . Anecdotal reports from patients with fibromyalgia syndrome have cl aim ed benefits from the use of these supplements . The aim of this study was to determine if these reports could be substantiated in a pilot clinical trial . Patient question ing had determined that poor quality of life was a major factor in the condition and a quality -of-life question naire was used to measure potential benefit . Subjects were given oral doses of 200 mg coenzyme Q10 and 200 mg Ginkgo biloba extract daily for 84 days . Quality of life was measured , using the well-vali date d Dartmouth Primary Care Cooperative Information Project/World Organization of Family Doctors ( COOP/WONCA ) question naire that measures seven different subjective responses , at 0- , 4- , 8- and 12-week intervals . The subjects were asked for an overall self-rating at the end of the study . A progressive improvement in the quality -of-life scores was observed over the study period and at the end , the scores showed a significant difference from those at the start . This was matched by an improvement in self-rating with 64 % cl aim ing to be better and only 9 % cl aim ing to feel worse . Adverse effects were minor . A controlled study is now planned OBJECTIVE The objective of this study was to evaluate resistance training ( RES ) and RES combined with chiropractic treatment ( RES-C ) on fibromyalgia ( FM ) impact and functionality in women with FM . DESIGN The design of the study was a r and omized control trial . SETTING Testing and training were completed at the university and chiropractic treatment was completed at chiropractic clinics . PARTICIPANTS Participants ( 48 + /- 9 years ; mean + /- st and ard deviation ) were r and omly assigned to RES ( n = 10 ) or RES-C ( n = 11 ) . INTERVENTION Both groups completed 16 weeks of RES consisting of 10 exercises performed two times per week . RES-C received RES plus chiropractic treatment two times per week . OUTCOME MEASURES Strength was assessed using one repetition maximum for the chest press and leg extension . FM impact was measured using the FM impact question naire , myalgic score , and the number of active tender points . Functionality was assessed using the 10-item Continuous Scale Physical Functional Performance test . Analyses of variance with repeated measures compared groups before and after the intervention . RESULTS Six ( 6 ) participants discontinued the study : 5 from  RES  and 1 from RES-C.  Adherence to training was significantly higher in RES-C ( 92.0 + /- 7.5 % ) than in RES ( 82.8 + /- 7.5 % ) . Both groups increased ( p < or = 0.05 ) upper and lower body strength . There were similar improvements in FM impact in both groups . There were no group interactions for the functionality measures . Both groups improved in the strength domains ; however , only RES-C significantly improved in the pre- to postfunctional domains of flexibility , balance and coordination , and endurance . CONCLUSIONS In women with FM , resistance training improves strength , FM impact , and strength domains of functionality . The addition of chiropractic treatment improved adherence and dropout rates to the resistance training and facilitated greater improvements in the domains of functionality OBJECTIVE To demonstrate the effectiveness of chiropractic management for fibromyalgia patients using reported pain levels , cervical and lumbar ranges of motion , strength , flexibility , tender points , myalgic score and perceived functional ability as outcome measures . DESIGN A. Preliminary r and omized control crossover trial . B. Before and after design . PATIENTS Twenty-one rheumatology patients ( 25 - 70 yr ) .  CHIROPRACTIC INTERVENTIONS : Treatment consisted of 4 wk of spinal manipulation , soft tissue therapy and passive stretching at the chiropractors ' discretion . CONTROL INTERVENTION : Chiropractic management withheld for 4 wk with continuation of prescribed medication . MAIN OUTCOME MEASURES Changes in scores on the Oswestry Pain Disability Index , Neck Disability Index , Visual Analogue Scale , straight leg raise and lumbar and cervical ranges of motion were observed . RESULTS Chiropractic management improved patients ' cervical and lumbar ranges of motion , straight leg raise and reported pain levels . These changes were judged to be clinical ly important within the confines of our sample only . CONCLUSIONS Further study with a sample size of 81 ( for 80 % power at alpha < or = .05 ) is recommended to determine if these findings are generalizable to the target population of fibromyalgia suffers OBJECTIVES We determined -- in women with fibromyalgia (FM)--effects of essential oils used with a 12-week exercise program on exercise volume , pain , physical performance , and physical function . DESIGN This was a r and omized clinical trial comparing 024 essential oil with sham oil combined with exercise . SETTING S SETTING S included community sites in southern California . SUBJECTS The study included 20 women r and omized to 024 oil , 23 to sham oil .  INTERVENTIONS Women were trained in oil application before exercise , at bedtime on exercise days ; the 12-week program included weekly group sessions with trained leaders guided by a prerecorded regimen ( allowing choice of program level ) plus 2 days of home exercise with the recorded regimen . OUTCOME MEASURES Primary : Exercise volume ( number of days exercised multiplied by exercise level -- intensity and duration ) . Secondary : Pain ( Brief Pain Inventory ) , measures of physical performance ( 30-second chair st and s , 6-minute walk , multidimensional balance ) , and self-reported physical function ( Composite Physical Function scale ) . RESULTS The average participant was 54 years old , had some college education , was married , Caucasian , and minimally/mildly depressed . There was no significant difference in exercise volume between women using 024 as compared with those using sham oil after 12 weeks ( depression as covariate ) . There were no significant group nor pre- to postexercise changes in pain intensity or interference . There were greater positive changes in 30-second chair st and s , 6-minute walk distance , and multidimensional balance scores in the 024 group than in the sham group , but these were not significant . The counterirritant 024 oil was not different from the sham oil in its effect on exercise volume ( frequency , exercise level -- intensity and duration ) for women with FM . It is unknown whether 024 actually decreases local pain when used with exercise . CONCLUSIONS Increases in physical function found , while not significant , may be attributable to the exercise regimen or to the interaction of the oils and exercise regimen Context A substantial number of patients use acupuncture to treat the symptoms of fibromyalgia , but previous r and omized trials of this intervention are inconclusive , in part because of control groups that did not permit adequate blinding of the patients . Contribution This study r and omly assigned 100 patients with fibromyalgia to 12 weeks of either true acupuncture treatment or one of 3 types of sham acupuncture . No differences in pain were identified between acupuncture and sham acupuncture . Caution s The study had too few patients to detect small differences between the groups . Patients could use other fibromyalgia therapies , so this study evaluates acupuncture as adjunctive treatment . The Editors Fibromyalgia is a condition of unknown cause that is characterized by chronic , diffuse pain and tenderness to palpation at specific musculoskeletal sites ( 1 ) . It is the second most common rheumatologic condition after osteoarthritis , afflicting 2 % to 4 % of the U.S. population ( 2 ) . Most r and omized , controlled trials of allopathic interventions have not demonstrated sustained benefit , and use of complementary and alternative medicine for fibromyalgia is common ( 3 ) . For example , 60 % to 90 % of patients with fibromyalgia report using 1 or more complementary or alternative treatments ( 4 , 5 ) , and 22 % of these patients have tried acupuncture ( 6 ) . Despite skepticism in western cultures , the literature suggests that acupuncture may alleviate chronic pain ( 7 ) . R and omized , controlled trials of acupuncture face many method ologic challenges , including the identification of appropriate treatment and control groups , blinding of study participants , and the inability to blind practitioners ( 8) . Needle placement and the extent to which needle insertion and stimulation is necessary are also controversial ( 7 - 9 ) . In the only rigorous r and omized , controlled trial of acupuncture for fibromyalgia , 7 of 8 outcome measures significantly improved after 3 weeks of treatment with electroacupuncture ( 10 ) . However , because blinding was not assessed and electroacupuncture involves perceptible current , these promising results could reflect a lack of blinding to treatment condition . Moreover , the study followed patients only during treatment . Because fibromyalgia is a chronic condition , longer-term outcomes should be examined . To address these method ologic problems , we performed a r and omized , controlled trial of acupuncture to treat fibromyalgia that included 3 sham acupuncture treatments to account for the effects of needle insertion and placement . The adequacy of participant blinding was carefully evaluated . We sought to determine whether directed acupuncture that is design ed to treat fibromyalgia relieves pain better than does sham acupuncture in adults with fibromyalgia . On the basis of the scant literature and our clinical experience , we hypothesized a priori that directed acupuncture would result in the greatest clinical improvement . Methods Participants Participants were recruited from the greater Seattle , Washington , metropolitan area between January 2001 and September 2002 . Recruitment strategies included dissemination of information on the study through newspapers , television , advertisements , signs posted at university-affiliated hospitals , and letters to local fibromyalgia support groups and health care providers with large caseloads of patients with fibromyalgia . Potential participants were told that they had an equal chance of being assigned to 1 of 4 acupuncture interventions , none of which have been proven but 1 of which was believed to have the most potential to improve the symptoms of fibromyalgia . The institutional review boards at the participating institutions approved the study , and participants provided written informed consent . Eligible participants were English-speaking adults 18 years of age or older in whom fibromyalgia was diagnosed by a physician and who had a prer and omization global pain score of 4 or greater on a visual analogue scale ( 0 = no pain , 10 = worst pain ever ) . Participants agreed to undergo r and omization and kept use of any fibromyalgia-related pharmacologic and nonpharmacologic therapies constant throughout the study . At the baseline evaluation before r and omization , a research coordinator trained in tender-point examination confirmed the diagnosis of fibromyalgia by using the 1990 criteria of the American College of Rheumatology ( 1 ) . Participants were excluded if they reported other pain-related medical conditions or potential contraindications to acupuncture treatment ( such as bleeding disorders or severe needle phobia ) , were pregnant or breastfeeding , used narcotics ( which could blunt the effects of acupuncture ) , were involved in litigation related to fibromyalgia ( which might reduce their incentive for improvement ) , or had previously received acupuncture ( to maximize blinding ) . R and omization Procedure A research coordinator screened and enrolled participants at an academic research center . After participants completed a baseline evaluation , another research coordinator who was uninvolved with data collection r and omly assigned them to 1 of 4 treatment groups by using a computer-generated , blocked r and om-allocation sequence with a block size of 4 . This research coordinator informed the acupuncture clinic of the treatment assignment . Intervention Eight U.S.-trained and licensed acupuncturists with a median of 10 years of experience ( range , 4 to 18 years ) provided study treatments in their private offices . One investigator trained the acupuncturists in the study procedures to increase their comfort with delivering all 4 treatments and monitored compliance with the protocol throughout the study . Participants were assigned an acupuncturist according to geographic convenience and schedule availability , and every effort was made to have them treated by the same acupuncturist for the entire 12 weeks . The primary acupuncturist was defined as the practitioner from whom a participant received the most treatments . In all groups , participants were asked to attend treatment sessions twice weekly for 12 weeks ( 24 treatments ) . We considered participants who attended 80 % or more ( 19 of 24 ) of acupuncture appointments to have completed a full course of treatment . Outcome measures were collected at regularly scheduled time points from participants who discontinued treatment . Participants received directed acupuncture design ed to treat fibromyalgia according to the practice of Traditional Chinese Medicine or 1 of 3 sham acupuncture treatments . One sham intervention , a control for acupoint specificity , involved acupuncture typically used to treat irregular menses or early menses due to Blood Heat ( an unrelated condition ) according to Traditional Chinese Medicine . Another sham intervention , which was also a control for acupoint specificity , used body locations not recognized as true acupoints or meridians for needling ( sham needling ) . The third sham treatment , a control for needle insertion , consisted of noninsertive simulated acupuncture at the same acupoints used in directed acupuncture ( simulated acupuncture ) . This technique , in which a toothpick in a needle guide-tube is used to mimic needle insertion and withdrawal , has been shown to be indistinguishable from true acupuncture in acupuncture-nave patients with back pain ( 9 ) . Simulated acupuncture more closely duplicates the needle insertion experience than do techniques using placebo needles that require placing adhesive or plastic foam on the skin ( 11 , 12 ) . Acupoints and sham points ( Appendix Figure ) were chosen by a study acupuncturist with 15 years of experience in treating fibromyalgia and were approved by 3 other senior acupuncturists . In all groups that underwent needle insertion , needles were retained at st and ard depths ( 13 ) for 30 minutes at each acupoint . Disposable Chinese , Japanese , or Korean needles ( 34 to 40 gauge ) were used , depending on the practitioner 's preference . In the simulated acupuncture group , participants remained on the table for 30 minutes after simulated insertion and then underwent simulated needle withdrawal . Efforts were made to imitate the sounds of opening needle packs and needle disposal . Acupuncturists were not blinded to the treatments they delivered . To maximize participant blinding , we included only acupuncture-nave persons who could not compare their treatment with previous experiences with acupuncture , limited contact among study participants , restricted conversation between acupuncturists and participants , and blindfolded participants during treatment . All research personnel who collected or analyzed data were unaware of treatment group . At the end of 12 weeks , we collected data to assess the adequacy of blinding . Outcome Measures Demographic measures collected at the baseline evaluation included age , sex , race , education , marital status , and duration of pain and diagnosis of fibromyalgia . Participants also listed the types of therapies they had previously tried for their pain . We grouped this information into manual therapies ( physical , ergonometric , chiropractic , or massage therapy ) , mental health therapies ( psychotherapy or cognitive behavioral therapy ) , dietary changes , or other therapies ( nerve blocks , hypnosis , or biofeedback ) . Outcome measures were collected at baseline ; after 1 , 4 , 8 , and 12 weeks of acupuncture treatment ; and 3 and 6 months after completion of treatment ( weeks 24 and 36 ) . The primary outcome was subjective pain , as measured by a st and ard 10-cm visual analogue scale ( 0 = no pain , 10 = worst pain ever ) . Other outcomes measured by using a visual analogue scale were intensity of fatigue ( 0 = none , 10 = worst ever ) , sleep quality ( 0 = worst ever , 10 = best ever ) , and overall well-being ( 0 = worst ever , 10 = best ever ) . We assessed physical and mental functioning by using the Medical Outcomes Study 36-item Short-Form Health Survey ( 14 ) , which has high reliability and validity in many patient groups , including OBJECTIVES The objective of this study was to investigate whether typical acupuncture methods such as needle placement , needle stimulation , and treatment frequency were important factors in fibromyalgia symptom improvement . DESIGN / SETTING S/SUBJECTS : A single-site , single-blind , r and omized trial of 114 participants diagnosed with fibromyalgia for at least 1 year was performed . INTERVENTION Participants were r and omized to one of four treatment groups : ( 1 ) T/S needles placed in traditional sites with manual needle stimulation ( n = 29 ) : ( 2 ) T/0 traditional needle location without stimulation ( n = 30 ) ; ( 3 ) N/S needles inserted in nontraditional locations that were not thought to be acupuncture sites , with stimulation ( n = 28 ) ; and ( 4 ) N/0 nontraditional needle location without stimulation ( n = 2 7 ) . All groups received treatment once weekly , followed by twice weekly , and finally three times weekly , for a total of 18 treatments . Each increase in frequency was separated by a 2-week washout period . OUTCOME MEASURES Pain was assessed by a numerical rating scale , fatigue by the Multi-dimensional Fatigue Inventory , and physical function by the Short Form-36 . RESULTS Overall pain improvement was noted with 25%-35 % of subjects having a clinical ly significant decrease in pain ; however this was not dependent upon " correct " needle stimulation ( t = 1.03 ; p = 0.307 ) or location ( t = 0.76 ; p = 0.450 ) . An overall dose effect of treatment was observed , with three sessions weekly providing more analgesia than sessions once weekly ( t = 2.10 ; p = 0.039 ) . Among treatment responders , improvements in pain , fatigue , and physical function were highly codependent ( all p < or = 0.002 ) . CONCLUSIONS Although needle insertion led to analgesia and improvement in other somatic symptoms , correct needle location and stimulation were not crucial UNLABELLED A r and omized , double-blind , placebo-controlled trial was conducted to determine the benefit of nabilone in pain management and quality of life improvement in 40 patients with fibromyalgia . After a baseline assessment , subjects were titrated up on nabilone , from 0.5 mg PO at bedtime to 1 mg BID over 4 weeks or received a corresponding placebo . At the 2- and 4-week visits , the primary outcome measure , visual analog scale ( VAS ) for pain , and the secondary outcome measures , number of tender points , the average tender point pain threshold , and the Fibromyalgia Impact Question naire ( FIQ ) , were evaluated . After a 4-week washout period , subjects returned for re assessment of the outcome measures . There were no significant differences in population demographics between groups at baseline . There were significant decreases in the VAS ( -2.04 , P < .02 ) , FIQ ( -12.07 , P < .02 ) , and anxiety ( -1.67 , P < .02 ) in the nabilone treated group at 4 weeks . There were no significant improvements in the placebo group . The treatment group experienced more side effects per person at 2 and 4 weeks ( 1.58 , P < .02 and 1.54 , P < .05 ) , respectively . Nabilone appears to be a beneficial , well-tolerated treatment option for fibromyalgia patients , with significant benefits in pain relief and functional improvement . PERSPECTIVE To our knowledge , this is the first r and omized , controlled trial to assess the benefit of nabilone , a synthetic cannabinoid , on pain reduction and quality of life improvement in patients with fibromyalgia . As nabilone improved symptoms and was well-tolerated , it may be a useful adjunct for pain management in fibromyalgia Osteopathic physicians caring for patients with fibromyalgia syndrome ( FM ) often use osteopathic manipulative treatment ( OMT ) in conjunction with other forms of st and ard medical care . Despite a growing body of evidence on the efficacy of manual therapy for the treatment of selected acute musculoskeletal conditions , the role of OMT in treating patients with chronic conditions such as FM remains largely unknown . Twenty-four female patients meeting American College of Rheumatology criteria for FM were r and omly assigned to one of four treatment groups : ( 1 ) manipulation group , ( 2 ) manipulation and teaching group , ( 3 ) moist heat group , and ( 4 ) control group , which received no additional treatment other than current medication . Participants ' pain perceptions were assessed by use of pain thresholds measured at each of 10 bilateral tender points using a 9-kg dolorimeter , the Chronic Pain Experience Inventory , and the Present Pain Intensity Rating Scale . Patients ' affective response to treatment was assessed using the Self-Evaluation Question naire . Activities of daily living were assessed using the Stanford Arthritis Center Disability and Discomfort Scales : Health Assessment Question naire . Depression was assessed using the Center for Epidemiological Studies Depression Scale . Significant findings between the four treatment groups on measures of pain threshold , perceived pain , attitude toward treatment , activities of daily living , and perceived functional ability were found . All of these findings favored use of OMT . This study found OMT combined with st and ard medical care was more efficacious in treating FM than st and ard care alone . These findings need to be replicated to determine if cost savings are incurred when treatments for FM incorporate nonpharmacologic approaches such as OMT CONTEXT Fibromyalgia syndrome ( FMS ) is a prevalent musculoskeletal disorder associated with pain , mood state alteration , and disability . A structured and effective treatment plan for palliative care has not been established . The genesis of FMS is not clear . FMS occurs primarily in adult women . DESIGN Using a quasi-experimental clinical design and following the criteria of the American College of Rheumatology ( ACR ) , for FMS , 21 participants completed the study . The mean age was 53.6 years . The data were collected at baseline and at 1 and 2 months . Acupuncture treatments included 17 points for FMS symptoms , and 8 outcome measures were collected . RESULTS The Fibromyalgia Impact Question naire ( FIQ ) showed significant differences at 1 and 2 months . For the SF-12 , 3 subscales showed significant differences between baseline and 2 months . Four of 6 items were significantly changed . The mean number of general health symptoms was significantly decreased by 2 months . For the Catastrophe Index , significant differences were found for baseline vs 2 months . Pain threshold scores were significantly different at end of treatment for 5 bilateral tender points . There was significant improvement in Beck Depression items for both 1- and 2-month periods . In a multivariate regression model , 5 covariates were included -- age , number of weeks in treatment , number of doctors treating , number of general symptoms , and baseline FIQ score . The results indicated significant age effect . This analysis showed that the higher the FIQ score , the more positive the change experienced by study participants . Number of weeks in treatment , number of doctors who treated , and total number of general health symptoms did not have a significant effect on outcomes . CONCLUSIONS Significant improvement was experienced by participants at 8 weeks of treatment . Acupuncture treatment as delivered was effective at reducing FMS symptoms in this outcome study
target: There was low- quality evidence that acupuncture  improves pain compared to no treatment or st and ard treatment , but good evidence that it is no better than sham acupuncture .
  The evidence for homoeopathy , spinal manipulation and herbal medicine was limited .
  No firm conclusions were drawn for efficacy of either spinal manipulation or homoeopathy for FM .
background: Background Fibromyalgia ( FM ) is a chronic , debilitating pain disorder .
  Dissatisfaction with conventional medicine can lead people with FM to turn to complementary and alternative medicine ( CAM ) .
  Two previous overviews of systematic review s of CAM for FM have been published , but they did not assessed for risk of bias in the review process .