ORIGINAL ARTICLE
Improvement in Fibromyalgia Symptoms With Acupuncture: Results of a Randomized Controlled Trial

https://doi.org/10.4065/81.6.749Get rights and content

OBJECTIVE

To test the hypothesis that acupuncture improves symptoms of fibromyalgia.

PATIENTS AND METHODS

We conducted a prospective, partially blinded, controlled, randomized clinical trial of patients receiving true acupuncture compared with a control group of patients who received simulated acupuncture. All patients met American College of Rheumatology criteria for fibromyalgia and had tried conservative symptomatic treatments other than acupuncture. We measured symptoms with the Fibromyalgia Impact Questionnaire (FIQ) and the Multidimensional Pain Inventory at baseline, immediately after treatment, and at 1 month and 7 months after treatment. The trial was conducted from May 28, 2002, to August 18, 2003.

RESULTS

Fifty patients participated in the study: 25 in the acupuncture group and 25 in the control group. Total fibromyalgia symptoms, as measured by the FIQ, were significantly improved in the acupuncture group compared with the control group during the study period (P=.01). The largest difference in mean FIQ total scores was observed at 1 month (42.2 vs 34.8 in the control and acupuncture groups, respectively; P=.007). Fatigue and anxiety were the most significantly improved symptoms during the follow-up period. However, activity and physical function levels did not change. Acupuncture was well tolerated, with minimal adverse effects.

CONCLUSION

This study paradigm allows for controlled and blinded clinical trials of acupuncture. We found that acupuncture significantly improved symptoms of fibromyalgia. Symptomatic improvement was not restricted to pain relief and was most significant for fatigue and anxiety.

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.

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