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The Long-term Effect of Acupuncture for Migraine ProphylaxisA Randomized Clinical Trial

Educational Objective
To investigate the long-term effects of true acupuncture (TA) compared with sham acupuncture (SA) and being placed in a waiting-list control group for migraine prophylaxis in patients with migraine without aura.
1 Credit CME
Key Points

Question  What is the long-term efficacy of acupuncture for prophylaxis of migraine?

Findings  In this 24-week, randomized clinical trial that included 249 patients with migraine without aura, we found that true acupuncture significantly reduced the frequency of migraine attacks, compared with sham acupuncture and being placed on a waiting list for treatment.

Meaning  Among patients with migraine without aura, true acupuncture may be associated with long-term reduction in migraine recurrence compared with sham acupuncture or waiting list.

Abstract

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  clinicaltrials.gov Identifier: NCT01687660

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Article Information

Corresponding Author: Fanrong Liang, MD, Acupuncture and Tuina School, Chengdu University of Traditional Chinese Medicine, No. 37 Shi’er Qiao Rd, Chengdu, Sichuan 610075, China (acuresearch@126.com).

Accepted for Publication: November 30, 2016.

Published Online: February 20, 2017. doi:10.1001/jamainternmed.2016.9378

Author Contributions: Drs Liang and Zhao had full access to all study data and take full responsibility for data integrity and accuracy of the data analysis. Ling Zhao and Jiao Chen contributed equally to this manuscript.

Concept and design: Zhao, Y. Li, Zheng, Liang.

Acquisition, analysis, or interpretation of data: Zhao, Chen, Sun, Chang, Zheng, Gong, Huang, Yang, Wu, X. Li.

Drafting of the manuscript: Zhao, Chen, Zheng, Yang.

Critical revision of the manuscript for important intellectual content: Zhao, Y. Li, Sun, Chang, Zheng, Gong, Huang, Wu, X. Li, Liang.

Statistical analysis: Zheng.

Obtained funding: Zhao, Zheng, Liang.

Administrative, technical, or material support: Zhao, Chang, Gong, Huang, Yang, X. Li.

Supervision: Wu, Liang.

Conflict of Interest Disclosures: None reported.

Funding/Support: This trial was supported by grants from the State Key Program for Basic Research of China (2012CB518501), the National Natural Science Foundation of China (81473603, 81590951), and the Project of Youth Fund of Sichuan Province (2016JQ0013).

Role of the Funder/Sponsor: The funding sources had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

Additional Contributions: We thank Dongtao Lin, BA, of Sichuan University for copyediting the manuscript. She was not compensated for her assistance.

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