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


METHODS
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.


RESULTS
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).


CONCLUSIONS
Treatment outcomes for migraine do not differ between patients treated with sham acupuncture, verum acupuncture, or standard therapy.
Diener
Hans-Christoph
HC
Department of Neurology, University Essen, Essen, Germany. h.diener@uni-essen.de
Kronfeld
Kai
K
Boewing
Gabriele
G
Lungenhausen
Margitta
M
Maier
Christoph
C
Molsberger
Albrecht
A
Tegenthoff
Martin
M
Trampisch
Hans-Joachim
HJ
Zenz
Michael
M
Meinert
Rolf
R
D015670:Acupuncture Therapy / Q000379:methods*; D000293:Adolescent; D000328:Adult; D000368:Aged; D016001:Confidence Intervals; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D008881:Migraine Disorders / Q000517:prevention & control*; D016017:Odds Ratio; D011446:Prospective Studies; D012189:Retrospective Studies; D016896:Treatment Outcome