The Long-term Effect of Acupuncture for Migraine Prophylaxis: A Randomized Clinical Trial.

Author: Zhao L1, Chen J1, Li Y1, Sun X2, Chang X3, Zheng H1, Gong B4, Huang Y5, Yang M1, Wu X1, Li X4, Liang F1
1Acupuncture and Tuina School, Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, China.
2The Chinese Cochrane Centre, West China Hospital, Sichuan University, Chengdu, Sichuan, China.
3Acupuncture and Tuina School, Hunan University of Traditional Chinese Medicine, Hunan, Changsha, China.
4Department of Traditional Chinese Medicine, Chongqing Medical University, Chongqing, China.
5Department of Traditional Chinese Medicine, Ningxia Medical University, Ningxia, Yinchuan, China.
Conference/Journal: JAMA Intern Med.
Date published: 2017 Feb 20
Other: Special Notes: doi: 10.1001/jamainternmed.2016.9378. [Epub ahead of print] , Word Count: 370

Importance: The long-term prophylactic effects of acupuncture for migraine are uncertain.

Objective: To investigate the long-term effects of true acupuncture compared with sham acupuncture and being placed in a waiting-list control group for migraine prophylaxis.

Design, Setting, and Participants: This was a 24-week randomized clinical trial (4 weeks of treatment followed by 20 weeks of follow-up). Participants were randomly assigned to true acupuncture, sham acupuncture, or a waiting-list control group. The trial was conducted from October 2012 to September 2014 in outpatient settings at 3 clinical sites in China. A total of 249 participants 18 to 65 years old with migraine without aura based on the criteria of the International Headache Society, with migraine occurring 2 to 8 times per month.

Interventions: Participants in the true acupuncture and sham acupuncture groups received treatment 5 days per week for 4 weeks for a total of 20 sessions. Participants in the waiting-list group did not receive acupuncture but were informed that 20 sessions of acupuncture would be provided free of charge at the end of the trial.

Main Outcomes and Measures: Participants used diaries to record migraine attacks. The primary outcome was the change in the frequency of migraine attacks from baseline to week 16. Secondary outcome measures included the migraine days, average headache severity, and medication intake every 4 weeks within 24 weeks.

Results: A total of 249 participants 18 to 65 years old were enrolled, and 245 were included in the intention-to-treat analyses. One hundred eighty-nine (77.1%) were women. Baseline characteristics were comparable across the 3 groups. The mean (SD) change in frequency of migraine attacks differed significantly among the 3 groups at 16 weeks after randomization (P < .001); the mean (SD) frequency of attacks decreased in the true acupuncture group by 3.2 (2.1), in the sham acupuncture group by 2.1 (2.5), and the waiting-list group by 1.4 (2.5); a greater reduction was observed in the true acupuncture than in the sham acupuncture group (difference of 1.1 attacks; 95% CI, 0.4-1.9; P = .002) and in the true acupuncture vs waiting-list group (difference of 1.8 attacks; 95% CI, 1.1-2.5; P < .001). Sham acupuncture was not statistically different from the waiting-list group (difference of 0.7 attacks; 95% CI, -0.1 to 1.4; P = .07).

Conclusions and Relevance: Among patients with migraine without aura, true acupuncture may be associated with long-term reduction in migraine recurrence compared with sham acupuncture or assigned to a waiting list.

Trial Registration: Identifier: NCT01687660.

PMID: 28241154 DOI: 10.1001/jamainternmed.2016.9378