Context Acupuncture is widely used to prevent migraine attacks, but the available
evidence of its benefit is scarce.
Objective To investigate the effectiveness of acupuncture compared with sham acupuncture
and with no acupuncture in patients with migraine.
Design, Setting, and Patients Three-group, randomized, controlled trial (April 2002-January 2003)
involving 302 patients (88% women), mean (SD) age of 43 (11) years, with migraine
headaches, based on International Headache Society criteria. Patients were
treated at 18 outpatient centers in Germany.
Interventions Acupuncture, sham acupuncture, or waiting list control. Acupuncture
and sham acupuncture were administered by specialized physicians and consisted
of 12 sessions per patient over 8 weeks. Patients completed headache diaries
from 4 weeks before to 12 weeks after randomization and from week 21 to 24
after randomization.
Main Outcome Measures Difference in headache days of moderate or severe intensity between
the 4 weeks before and weeks 9 to 12 after randomization.
Results Between baseline and weeks 9 to 12, the mean (SD) number of days with
headache of moderate or severe intensity decreased by 2.2 (2.7) days from
a baseline of 5.2 (2.5) days in the acupuncture group compared with a decrease
to 2.2 (2.7) days from a baseline of 5.0 (2.4) days in the sham acupuncture
group, and by 0.8 (2.0) days from a baseline if 5.4 (3.0) days in the waiting
list group. No difference was detected between the acupuncture and the sham
acupuncture groups (0.0 days, 95% confidence interval, −0.7 to 0.7 days; P = .96) while there was a difference between
the acupuncture group compared with the waiting list group (1.4 days; 95%
confidence interval; 0.8-2.1 days; P<.001). The
proportion of responders (reduction in headache days by at least 50%) was
51% in the acupuncture group, 53% in the sham acupuncture group, and 15% in
the waiting list group.
Conclusion Acupuncture was no more effective than sham acupuncture in reducing
migraine headaches although both interventions were more effective than a
waiting list control.