A randomized clinical trial of acupuncture compared with sham acupuncture in fibromyalgia

NP Assefi, KJ Sherman, C Jacobsen… - Annals of internal …, 2005 - acpjournals.org
NP Assefi, KJ Sherman, C Jacobsen, J Goldberg, WR Smith, D Buchwald
Annals of internal medicine, 2005acpjournals.org
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 …
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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