Efficacy of acupuncture for the prophylaxis of migraine: a multicentre randomised controlled clinical trial
Diener, H. C.
Kronfeld, K.
Boewing, G.
Lungenhausen, M.
Maier, C.
Molsberger, A.
Tegenthoff, M.
Trampisch, H. J.
Zenz, M.
Meinert, R.
The Lancet. Neurology
Acu Versus > 1 Control
Penetrating Sham
Superficial Needling Depth
Sham Acupoint Control
Headache Disorders
BACKGROUND: Our aim was to assess the efficacy of a part-standardized verum acupuncture procedure, in accordance with the rules of traditional Chinese medicine, compared with that of part-standardized 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, randomized, multicenter, 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 randomization and weeks 23-26 after randomization. This study is registered as an International Standard Randomized Controlled Trial, number ISRCTN52683557.
FINDINGS: Of 1295 patients screened, 960 were randomly assigned to a treatment group. Immediately after randomization, 125 patients (106 from the standard group) withdrew their consent to study participation. 794 patients were analyzed in the intention-to-treat population 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 randomization, was 47% in the verum group, 39% in the sham acupuncture group, and 40% in the standard group (p=0.133).
INTERPRETATION: Treatment outcomes for migraine do not differ between patients treated with sham acupuncture, verum acupuncture, or standard therapy