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

Assefi, Nassim P. MD
Sherman, Karen J. PhD
Jacobsen, Clemma MS
Goldberg, Jack PhD
Smith, Wayne R. PhD
Buchwald, Dedra MD

From the University of Washington and The Group Health Cooperative Center for Health Studies, Seattle, Washington.

For author affiliations, see end of text.

Acknowledgments: The authors thank the research staff at the University of Washington (Roxanne Geller, Leigh Kochan, and Jovine Umali) and at the Clinical Monitoring Unit at the Group Health Cooperative Center for Health Studies (Rene Talenti, John Ewing, and Christel Kratohvil), the acupuncturists, and the study participants.

Grant Support: By grant RO1AT00003 from the National Center for Complementary and Alternative Medicine.

Potential Financial Conflicts of Interest:Grants received: N.P. Assefi, J. Goldberg, W.R. Smith, D. Buchwald (National Center for Complementary and Alternative Medicine).

Corresponding Author: Dedra Buchwald, MD, Box 359780, 1730 Minor Avenue, Suite 1760, Seattle, WA 98101.

Current author addresses and author contributions are available at www.annals.org.

Current Author Addresses: Dr. Assefi: Management Sciences for Health, House 24, Darulaman Road, Ayub Khan Mina, Kabul, Afghanistan.

Drs. Buchwald, Goldberg, and Smith and Ms. Jacobsen: Box 359780, 17360 Minor Avenue, Suite 1700, Seattle, WA 98101.

Dr. Sherman: 1730 Minor Avenue, Suite 1600, Seattle, WA 98101.

Author Contributions: Conception and design: K.J. Sherman, D. Buchwald.

Analysis and interpretation of the data: N.P. Assefi, K.J. Sherman, C. Jacobsen, J. Goldberg, W.R. Smith, D. Buchwald.

Drafting of the article: N.P. Assefi, K.J. Sherman, C. Jacobsen.

Critical revision of the article for important intellectual content: N.P. Assefi, K.J. Sherman, C. Jacobsen, J. Goldberg, W.R. Smith, D. Buchwald.

Final approval of the article: N.P. Assefi, K.J. Sherman, C. Jacobsen, J. Goldberg, W.R. Smith, D. Buchwald.

Provision of study materials or patients: D. Buchwald.

Statistical expertise: C. Jacobsen, J. Goldberg, W.R. Smith.

Administrative, technical, or logistic support: N.P. Assefi, K.J. Sherman, W.R. Smith.

Collection and assembly of data: N.P. Assefi, K.J. Sherman, C. Jacobsen, W.R. Smith.

Annals of Internal Medicine 143(1):p 10-19, July 5, 2005.

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.