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Acupuncture for patients with migraine: a randomized controlled trial
Linde K, Streng A, Jurgens S, Hoppe A, Brinkhaus B, Witt C, Wagenpfeil S, Pfaffenrath V, Hammes MG, Weidenhammer W, Willich SN, Melchart D
JAMA 2005 May 4;293(17):2118-2125
clinical trial
6/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

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 to 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 = 0.96) while there was a difference between the acupuncture group compared with the waiting list group (1.4 days; 95% confidence interval 0.8 to 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.

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