Clinical Briefs
Clinical Briefs
With Comments from Russell H. Greenfield, MD
Dr. Greenfield is Medical Director, Carolinas Integrative Health, Carolinas HealthCare System, Charlotte, NC, and Clinical Assistant Professor, School of Medicine, University of North Carolina, Chapel Hill, NC.
On Pains and Needles (Acupuncture for Fibromyalgia)
Source: Asseffi NP, et al. A randomized clinical trial of acupuncture compared with sham acupuncture in fibromyalgia. Ann Intern Med 2005;143:10-19.
Goal: To assess the effectiveness of directed acupuncture for relieving symptoms associated with fibromyalgia.
Study design: Twelve-week randomized, controlled trial including three different sham acupuncture treatments.
Subjects: Ninety-six people > age 18 years (mainly Caucasian women) diagnosed with fibromyalgia and with a pain score > 4 on a visual analog scale who had never previously experienced acupuncture.
Methods: Subjects were randomly assigned to one of four treatment groups: 1) directed acupuncture according to a practice of traditional Chinese medicine (TCM); 2) stimulation of points used for a condition unrelated to fibromyalgia (control for acupoint specificity); 3) sham needling using false acupoints (another control for acupoint specificity); and 4) non-insertive simulated acupuncture using a toothpick in a needle guide-tube. Treatment was offered twice weekly for 12 weeks with needles remaining in place for 30 minutes at a time (in group four, simulated needle withdrawal occurred at 30 minutes). One investigator instructed eight other U.S.-trained acupuncturists in the provision of all four treatments and also monitored protocol compliance. Subjects were assigned to a particular acupuncturist according to schedule and geography. Outcome measures included subjective pain, fatigue, sleep quality, and overall well-being, and data were collected at baseline and at weeks 1, 4, 8, 12, 24, and 36.
Results: There were no significant differences in study outcomes noted between the directed acupuncture and sham acupuncture groups. Some benefit was noted within all four treatment groups immediately after beginning the intervention, but the beneficial effects waned over the course of the treatment and subsequent follow-up.
Conclusion: True acupuncture is no better than sham acupuncture for the treatment of fibromyalgia.
Study strengths: Use of three separate sham acupuncture treatments; degree of blinding; follow-up; use of standard outcome measures.
Study weaknesses: Acupuncture therapy was provided in prescriptive form (fixed points stimulated), rather than in an individualized nature as is usually the case in TCM; small subject pool; some of the eight acupuncturists treated many more patients than did others (range, 4-33 subjects); missing data; no usual care comparison group.
Of note: Prior to randomization subjects were evaluated for tender points to confirm the diagnosis of fibromyalgia per the 1990 American College of Rheumatology criteria; subjects were permitted to use other therapies to help relieve discomfort during the trial provided use remained consistent; not all of the acupuncture treatments were offered to subjects by their same practitioner; acupoints and sham points were chosen by a single experienced practitioner and approved by three senior acupuncturists; subjects in the directed acupuncture group had slightly higher levels of pain and fatigue, slightly lower levels of sleep quality and overall well-being, than those in the control groups; all three sham acupuncture groups were combined for the purpose of analysis; the main side effects noted were discomfort at the site of needle insertion and bruising.
We knew that: Fibromyalgia affects 2-4% of the U.S. population, making it (after osteoarthritis) the second most common rheumatologic disorder; use of complementary and alternative medicine (CAM) is common among people with fibromyalgia, as most conventional medical interventions have not shown sustained benefit; a 1992 controlled trial of electroacupuncture for fibromyalgia suggested significant benefits during three weeks of treatment; the toothpick sham technique was shown to be indistinguishable from true acupuncture in one study of acupuncture-naïve patients with back pain; challenges to the performance of acupuncture research include blinding of both practitioners and participants.
Comments: A significant number of trials of acupuncture for painful conditions has been published, many with positive outcomes. Clinical experience would also strongly suggest that acupuncture can benefit patients with fibromyalgia, yet this intriguing study (funded by the National Center for Complementary and Alternative Medicine) detailed no significant benefit from a course of fixed-point acupuncture. As the authors readily point out, however, there is no "gold standard" for the selection of acupoints for treating people with fibromyalgia. Many practitioners espouse the belief that individualized acupuncture for any ailment is significantly more effective than fixed-point treatments. This perspective has never been adequately tested in a clinical trial, and that is exactly what is needed—a methodologically sound comparison of fixed-point acupuncture and individualized TCM treatment in the setting of fibromyalgia. Good trials of CAM therapies for fibromyalgia are still relatively hard to find, so this paper is one to hold on to, both to further the discussion of appropriate treatment and for the creative manner in which control and blinding were accomplished.
What to do with this article: Keep a hard copy in your file cabinet.
Greenfield RH. On pains and needles (acupuncture for fibromyalgia). Altern Med Alert 2005;8(8):96.Subscribe Now for Access
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