Journal Article

Efficacy of acupuncture for the prophylaxis of migraine: a multicentre randomised controlled clinical trial

Kronfeld, Kai, Lungenhausen, Margitta, Maier, Christoph, Molsberger, Albrecht, Tegenthoff, Martin, Meinert, Rolf, Trampisch, Hans-Joachim, Zenz, Michael, Diener, Hans-Christoph, Boewing, Gabriele

2006

Overview

Our aim was to assess the efficacy of a part-standardised verum acupuncture procedure, in accordance with the rules of traditional Chinese medicine, compared with that of part-standardised sham acupuncture and standard migraine prophylaxis with beta blockers, calcium-channel blockers, or antiepileptic drugs in the reduction of migraine days 26 weeks after the start of treatment. This study was a prospective, randomised, multicentre, double-blind, parallel-group, controlled, clinical trial, undertaken between April 2002 and July 2005. Patients who had two to six migraine attacks per month were randomly assigned verum acupuncture (n=313), sham acupuncture (n=339), or standard therapy (n=308). Patients received ten sessions of acupuncture treatment in 6 weeks or continuous prophylaxis with drugs. Primary outcome was the difference in migraine days between 4 weeks before randomisation and weeks 23–26 after randomisation. This study is registered as an International Standard Randomised Controlled Trial, number ISRCTN52683557. Of 1295 patients screened, 960 were randomly assigned to a treatment group. Immediately after randomisation, 125 patients (106 from the standard group) withdrew their consent to study participation. 794 patients were analysed in the intention-to-treat popoulation and 443 in the per-protocol population. The primary outcome showed a mean reduction of 2 ·3 days (95% CI 1·9–2·7) in the verum acupuncture group, 1·5 days (1·1–2·0) in the sham acupuncture group, and 2·1 days (1·5–2·7) in the standard therapy group. These differences were statistically significant compared with baseline (p<0·0001), but not across the treatment groups (p=0·09). The proportion of responders, defined as patients with a reduction of migraine days by at least 50%, 26 weeks after randomisation, was 47% in the verum group, 39% in the sham acupuncture group, and 40% in the standard group (p=0·133). Treatment outcomes for migraine do not differ between patients treated with sham acupuncture, verum acupuncture, or standard therapy.

• Publisher: Elsevier Ltd,Elsevier Limited
• Subject: Acupuncture Therapy - methods / Adolescent / Adult / Aged / Confidence Intervals / Double-Blind Method / Female / Humans / Male / Middle Aged / Migraine Disorders - prevention & control / Odds Ratio / Prospective Studies / Retrospective Studies / Treatment Outcome