ORIGINAL ARTICLEImprovement in Fibromyalgia Symptoms With Acupuncture: Results of a Randomized Controlled Trial
Section snippets
PATIENTS AND METHODS
The protocol was approved by the Mayo Foundation Institutional Review Board, and written consent was obtained from all participants before treatment. Our study population was recruited from patients who were referred to the Mayo Fibromyalgia Treatment Program in Rochester, Minn, by their physician, usually after a trial of conservative management. This program includes confirmation of the diagnosis of fibromyalgia by a rheumatologist and 1.5 days of education, counseling, and group discussion
RESULTS
Figure 5 illustrates patient enrollment and allotment to study groups. Sixty patients were enrolled in the study on completion of the Fibromyalgia Treatment Program. Ten of these patients withdrew from the study during the 4-week period of stabilization before treatments started and before randomization. Eight of those patients had difficulty in scheduling the 6 treatment sessions. One patient had received acupuncture in the past but had forgotten this during the initial screening process. The
DISCUSSION
In this controlled, randomized, and blinded assessment of acupuncture, our study patients were unable to determine in which group they had participated. Such blinding is necessary for quality research in acupuncture because the control group displayed the expected placebo response that is typical of pain studies.11 An alternative choice for control treatments in studying acupuncture is to place needles at incorrect or “sham” points. Although it would have been easier to use this as a control,
CONCLUSION
This study represents a prospective, blinded, randomized trial of acupuncture for patients with fibromyalgia. Acupuncture was well tolerated with minimal adverse effects. Symptoms of fibromyalgia improved in the acupuncture group to a greater extent than in the control group. Specific symptoms that showed the most significant improvements included fatigue and anxiety. The improvement was both clinically and statistically significant. Therefore, acupuncture may have a role in the symptomatic
Acknowledgments
We thank Gregory A. Wilson for study coordination and patient recruitment; Heidi L. Schmitz, Carolyn J. Nereson, Victoria L. Rud, Donna J. Fritsch, and Evelyn K. Perry for help with patient scheduling and appointment flow; and Yuko F. Voss, BA, Megan M. O'Byrne, MA, and Cyndy O. Townsend, PhD, for help with data analysis.
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This work was supported by Mayo Foundation and the Mayo Anesthesia Clinical Research Unit. Dr Martin is supported in part by a Research Starter Grant from the Foundation for Anesthesia Education and Research.