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 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 .
A Randomized Clinical Trial of Acupuncture Compared with Sham Acupuncture in Fibromyalgia
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
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 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 .