Efficacy of Acupuncture in the Treatment of Fibromyalgia

Fibromyalgia (FM), one of the most common rheumatic conditions, is a condition of unknown etiology characterized by widespread muscle pain and stiffness. Treatment is generally unsatisfactory and most randomized, controlled treatment trials have been unable to demonstrate a sustained effective intervention. A single, brief trial of electroacupuncture demonstrated remarkable improvement among patients with FM, although lasting effects were not evaluated. Nonetheless, the recently published National Institutes of Health Consensus Development Statement on Acupuncture says "musculoskeletal conditions such as fibromyalgia, myofascial pain ....are conditions for which acupuncture may be beneficial". Thus, 96 patients will be recruited from a referral clinic for fatigue for a 12 week (24 treatments) trial. These patients will be randomized into 3 control groups and 1 "true" acupuncture group. The control groups will consist of a group receiving acupuncture treatment for an unrelated condition (morning sickness), a group receiving needle insertion at non-channel, non-point locations, and a "true" placebo group. This latter group will have acupuncture needle guides tapped on the skin, then needles tapped. Thus, the specific aims of this study are to 1) evaluate the short and long term efficacy and side effects of a 12 week randomized, controlled trial of bi-weekly acupuncture in the treatment of FM; 2) establish the most useful and scientifically sound control group for studies of acupuncture using FM as a model for conditions characterized by chronic pain; 3) use both subjective and objective measures of overall health and pain to determine the optimal time length of treatment; and 4) examine the concordance of allopathic and acupuncture-based measures of outcome. For the purposes of this study, subjects will be asked to complete a unique set of study measures at enrollment, at 4, 8, and 12 weeks, and then again at 1 and 6 months post-treatment. Our primary outcomes will be