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

Background: Fibromyalgia is a common chronic pain condition for which patients frequently use acupuncture. Objective: To determine whether acupuncture relieves pain in fibromyalgia. Design: Randomized, sham-controlled trial in which participants, data collection staff, and data analysts were blinded to treatment group. Setting: Private acupuncture offices in the greater Seattle, Washington, metropolitan area. Patients: 100 adults with fibromyalgia. Intervention: Twice-weekly treatment for 12 weeks with an acupuncture program that was specifically designed to treat fibromyalgia, or 1 of 3 sham acupuncture treatments: acupuncture for an unrelated condition, needle insertion at nonacupoint locations, or noninsertive simulated acupuncture. Measurements: The primary outcome was subjective pain as measured by a 10-cm visual analogue scale ranging from 0 (no pain) to 10 (worst pain ever). Measurements were obtained at baseline; 1, 4, 8, and 12 weeks of treatment; and 3 and 6 months after completion of treatment. Participant blinding and adverse effects were ascertained by self-report. The primary outcomes were evaluated by pooling the 3 sham-control groups and comparing them with the group that received acupuncture to treat fibromyalgia. Results: The mean subjective pain rating among patients who received acupuncture for fibromyalgia did not differ from that in the pooled sham acupuncture group (mean between-group difference, 0.5 cm [95% CI, −0.3 cm to 1.2 cm]). Participant blinding was adequate throughout the trial, and no serious adverse effects were noted. Limitations: A prescription of acupuncture at fixed points may differ from acupuncture administered in clinical settings, in which therapy is individualized and often combined with herbal supplementation and other adjunctive measures. A usual-care comparison group was not studied. Conclusion: Acupuncture was no better than sham acupuncture at relieving pain in fibromyalgia.