Context: Acupuncture is widely used to prevent migraine attacks, but the available evidence of its benefit is scarce.

Objective:  To investigate the effectiveness of acupuncture compared with sham acupuncture and with no acupuncture in patients with migraine.

Design, setting, and patients: Three-group, randomized, controlled trial (April 2002-January 2003) involving 302 patients (88% women), mean (SD) age of 43 (11) years, with migraine headaches, based on International Headache Society criteria. Patients were treated at 18 outpatient centers in Germany.

Interventions: Acupuncture, sham acupuncture, or waiting list control. Acupuncture and sham acupuncture were administered by specialized physicians and consisted of 12 sessions per patient over 8 weeks. Patients completed headache diaries from 4 weeks before to 12 weeks after randomization and from week 21 to 24 after randomization.

Main outcome measures: Difference in headache days of moderate or severe intensity between the 4 weeks before and weeks 9 to 12 after randomization.

Results: Between baseline and weeks 9 to 12, the mean (SD) number of days with headache of moderate or severe intensity decreased by 2.2 (2.7) days from a baseline of 5.2 (2.5) days in the acupuncture group compared with a decrease to 2.2 (2.7) days from a baseline of 5.0 (2.4) days in the sham acupuncture group, and by 0.8 (2.0) days from a baseline if 5.4 (3.0) days in the waiting list group. No difference was detected between the acupuncture and the sham acupuncture groups (0.0 days, 95% confidence interval, -0.7 to 0.7 days; P = .96) while there was a difference between the acupuncture group compared with the waiting list group (1.4 days; 95% confidence interval; 0.8-2.1 days; P<.001). The proportion of responders (reduction in headache days by at least 50%) was 51% in the acupuncture group, 53% in the sham acupuncture group, and 15% in the waiting list group.

Conclusion: Acupuncture was no more effective than sham acupuncture in reducing migraine headaches although both interventions were more effective than a waiting list control.

Publication:

Linde K, Streng A, Jürgens S, Hoppe A, Brinkhaus B, Witt C, Wagenpfeil S, Pfaffenrath V, Hammes MG, Weidenhammer W, Willich SN, Melchart D. Acupuncture for patients with migraine: a randomized controlled trial. JAMA. 2005 May 4;293(17):2118-25.

Principle investigator:
Willich, MD, MPH, MBA
Witt, MD, MBA

Research associate:
Brinkhaus, MD

Statistics:
Wagenfeil, PhD

Coorperation:
Zentrum für naturheilkundliche Forschung, TU München

Data management:
Weber
Icke

Study nurse:
Cree
Bartsch

Project duration:
2001-2005

Project status:
completed

Funding:
Techniker Krankenkasse (statutory health insurance)