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A randomized clinical trial of acupuncture compared with sham acupuncture in fibromyalgia [with consumer summary]
Assefi NP, Sherman KJ, Jacobsen C, Goldberg J, Smith WR, Buchwald D
Annals of Internal Medicine 2005 Jul 5;143(1):10-19
clinical trial
6/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: Yes; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: No; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: No. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

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.

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