Weitere Migräne-Studie der Modellvorhaben veröffentlicht: Effektivität der Akupunktur zur Prophylaxe der Migräne: eine multizentrische, randomisierte, kontrollierte Studie

SummaryBackgroundOur 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.MethodsThis study was a prospective, randomised, multicentre, doubleblind, 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.FindingsOf 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 population and 443 in the perprotocol population. The primary outcome showed a mean reduction of 23 days (95 % CI 1·9–2·7) in the verum acupuncture group, 15 days (11–20) in the sham acupuncture group, and 21 days (15–27) 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).InterpretationTreatment outcomes for migraine do not differ between patients treated with sham acupuncture, verum acupuncture, or standard therapy.