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.