A sham-controlled trial of acupuncture as an adjunct in migraine prophylaxis.

ABSTRACT

BACKGROUND: Migraine is one of the most common types of headache, with significant socioeconomic effects. Prophylactic drugs are used to prevent migraine headaches but are unpromising. OBJECTIVE: To assess the effects of adding acupuncture to conventional migraine prophylaxis. METHODS: One hundred patients with migraine (41 male, 59 female), in whom prophylactic drugs had not produced a fall of at least 50% in the number of attacks, entered the study. The patients were randomised into two groups, sham and true acupuncture. The patients in both groups continued their prophylactic treatment and received 12 sessions of either true or sham acupuncture. Each session was 30 min and was repeated three times a week. The number of headaches in the two groups was compared at baseline, and at the end of four successive months. RESULTS: There was no significant difference in the frequency of attacks between the two groups before intervention. After 1 month, the frequency of attacks each month decreased from 5.1 (0.8) to 3.4 (1.2) in the true acupuncture group, and from 5.0 (0.8) to 4.4 (1.1) in the sham acupuncture group (a significant difference, p<0.001). The frequency continued to decrease in month 2 but increased in months 3 and 4; however, it was still significantly lower than baseline, and the difference remained significant after month 4. CONCLUSIONS: Acupuncture is applicable as an adjunct to prophylactic drugs in migraineurs in whom the number of attacks does not fall with prophylactic medication.