Acupuncture in migraine prevention: a randomized sham controlled study with 6-months posttreatment follow-up.

OBJECTIVE To assess the efficacy of acupuncture in migraine prophylaxis. METHODS Thirty-seven patients with migraine were enrolled in a randomized control trial at the Headache clinic located in a University Hospital. Real and sham acupuncture groups received 16 acupuncture sessions over 3 months. Treatment was individualized in the real acupuncture group and minimal acupuncture was used in the sham group. The primary end point was the percentage of patients with a >or=50% reduction in their migraine attack frequency in the second, third, fourth, fifth, and sixth (months) compared with the first one (baseline period). Primary and secondary end points were measured comparing headache diaries. RESULTS Real acupuncture group showed improvement with significant differences compared with the sham acupuncture group in the primary efficacy end point (P=0.021) at the second month of the treatment. Differences also appeared in 2 secondary end points: number of days with migraine per month (P=0.007) in the second month and the percentage of patients with >or=40% reduction in migraine attack frequency in the first (P=0.044) and second months (P=0.004) of the treatment. These differences disappeared in the third (last) month of the treatment as a consequence of the high improvement of the sham acupuncture group. Comparisons within each group showed that several migraine parameters evaluated improved significantly in both groups. CONCLUSIONS Individualized treatment based on traditional Chinese medicine plays a role in preventing migraine attacks. Nevertheless, sham acupuncture had similar effects. Major conclusions were limited by the small sample sizes however the observed trends may contribute to design future trials.