Efficacy of acupuncture for the prophylaxis of migraine: a multicentre randomised controlled clinical trial
Item
Title
Efficacy of acupuncture for the prophylaxis of migraine: a multicentre randomised controlled clinical trial
Author(s)
Journal Publication
Date
2006
volume
5(4)
pages
310-316
Research Type
RCT
Keywords
Abstract
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
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
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has health condition studied
Headache Disorders
plan
>1/WK
has study population number
960
has duration
6 Weeks