Acupuncture for Patients With Migraine: A Randomized Controlled Trial

Klaus Linde, MD, Andrea Streng, PhD, Susanne Jürgens, MSc, Andrea Hoppe, MD, Benno Brinkhaus, MD, Claudia Witt, MD, Stephan Wagenpfeil, PhD, Volker Pfaffenrath, MD, Michael G. Hammes, MD, Wolfgang Weidenhammer, PhD, Stefan N. Willich, MD, MPH, Dieter Melchart, MD

Acupuncture is widely used to prevent migraine attacks, but the available evidence of its benefit is scarce. The objective of the study was to investigate the effectiveness of acupuncture compared with sham acupuncture and with no acupuncture in patients with migraine.

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.

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.

Difference in headache days of moderate or severe intensity between the 4 weeks before and weeks 9 to 12 after randomization.

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. 

Acupuncture was no more effective than sham acupuncture in reducing migraine headaches although both interventions were more effective than a waiting list control. 

Since both treatments were significantly effective in decreasing pain and medication use over those patient on a waiting list (natural history).  It must be questioned what component of the needling was the effective component of the treatment.  The success of non-specific needling should bring into question the necessity of traditional protocols more so than the efficacy of dry-needling and acupuncture in general.  The fact that both procedures were significantly efficacious should help lead future research and clinical practice to further define how and why treatments are beneficial since both protocols demonstrated in this large trial that the treatment is beneficial to significant levels.