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 randomized trials of this intervention are inconclusive, in part because of control groups that did not permit adequate blinding of the patients. Contribution This study randomly 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. Cautions 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 randomized, 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). Randomized, controlled trials of acupuncture face many methodologic 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 randomized, 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 methodologic problems, we performed a randomized, 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 designed 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 prerandomization global pain score of 4 or greater on a visual analogue scale (0 = no pain, 10 = worst pain ever). Participants agreed to undergo randomization and kept use of any fibromyalgia-related pharmacologic and nonpharmacologic therapies constant throughout the study. At the baseline evaluation before randomization, 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). Randomization 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 randomly assigned them to 1 of 4 treatment groups by using a computer-generated, blocked random-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 designed 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 standard 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 standard 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 those