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Acupuncture in Migraine Prevention: A Randomized Sham Controlled Study With 6-months Posttreatment Follow-up

Alecrim-Andrade, Jerusa MD, MSc* †; Maciel-Júnior, Jayme Antunes MD, PhD† ‡; Carnè, Xavier MD, PhD§; Severino Vasconcelos, Geraldo Magela BSc; Correa-Filho, Heleno Rodrigues MD† ∥

doi: 10.1097/AJP.0b013e3181590d66
Original Articles

Objective: To assess the efficacy of acupuncture in migraine prophylaxis.

Methods: Thirty-seven patients with migraine were enrolled in a randomized control trial at the Headache clinic located in a University Hospital. Real and sham acupuncture groups received 16 acupuncture sessions over 3 months. Treatment was individualized in the real acupuncture group and minimal acupuncture was used in the sham group. The primary end point was the percentage of patients with a ≥50% reduction in their migraine attack frequency in the second, third, fourth, fifth, and sixth (months) compared with the first one (baseline period). Primary and secondary end points were measured comparing headache diaries.

Results: Real acupuncture group showed improvement with significant differences compared with the sham acupuncture group in the primary efficacy end point (P=0.021) at the second month of the treatment. Differences also appeared in 2 secondary end points: number of days with migraine per month (P=0.007) in the second month and the percentage of patients with ≥40% reduction in migraine attack frequency in the first (P=0.044) and second months (P=0.004) of the treatment. These differences disappeared in the third (last) month of the treatment as a consequence of the high improvement of the sham acupuncture group. Comparisons within each group showed that several migraine parameters evaluated improved significantly in both groups.

Conclusions: Individualized treatment based on traditional Chinese medicine plays a role in preventing migraine attacks. Nevertheless, sham acupuncture had similar effects. Major conclusions were limited by the small sample sizes however the observed trends may contribute to design future trials.

*Department of Medicine, Autonomous University of Barcelona

§Clinical Pharmacology Unit, Hospital Clinic, Barcelona, Catalunya, Spain

Department of Neurology, Headache Clinic, School of Medical Sciences

Epidemiology Faculty, Department of Social and Preventive Medicine, School of Medical Sciences

State University of Campinas, Campinas, Brazil

Supported by a grant from the State of São Paulo Research Foundation (FAPESP, grant no. 00/09985-0). ISRCTN 93327878. Competing interests: None.

Reprints: Jerusa Alecrim-Andrade, MD, MSc, Rua Otávio Machado, 225 apto/33 Campinas-SP 13.076-160, Brazil (e-mail: jalecrim@uol.com.br).

Received for publication April 8, 2007; revised June 15, 2007; accepted August 17, 2007

© 2008 Lippincott Williams & Wilkins, Inc.