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.


METHODS
Randomized, sham-controlled trial in which participants, data collection staff, and data analysts were blinded to treatment group.


METHODS
Private acupuncture offices in the greater Seattle, Washington, metropolitan area.


METHODS
100 adults with fibromyalgia.


METHODS
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.


METHODS
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.


CONCLUSIONS
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.


CONCLUSIONS
Acupuncture was no better than sham acupuncture at relieving pain in fibromyalgia.
The Group Health Cooperative Center for Health Studies, and University of Washington, Seattle, Washington, USA.
Nassim P
NP
Assefi
Karen J
KJ
Sherman
Clemma
C
Jacobsen
Jack
J
Goldberg
Wayne R
WR
Smith
Dedra
D
Buchwald
D015670:Acupuncture Therapy / Q000009:adverse effects; D000328:Adult; D003288:Contusions / Q000209:etiology; D005260:Female; D005356:Fibromyalgia / Q000628:therapy*; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000209:etiology; D016037:Single-Blind Method; D016896:Treatment Outcome