Manual acupuncture versus sham acupuncture and usual care for prophylaxis of episodic migraine without aura: multicentre, randomised clinical trialBMJ 2020; 368 doi: https://doi.org/10.1136/bmj.m697 (Published 25 March 2020) Cite this as: BMJ 2020;368:m697
- Shabei Xu, chief physician1,
- Lingling Yu, postdoctoral research fellow1,
- Xiang Luo, professor1,
- Minghuan Wang, associate professor1,
- Guohua Chen, professor2,
- Qing Zhang, masters student3,
- Wenhua Liu, assistant researcher4,
- Zhongyu Zhou, professor5,
- Jinhui Song, associate chief physician6,
- Huitao Jing, associate chief physician7,
- Guangying Huang, professor3,
- Fengxia Liang, professor8,
- Hua Wang, professor8,
- Wei Wang, professor1
- 1Department of Neurology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, Hubei, China
- 2Department of Neurology, Wuhan No.1 Hospital / Wuhan Hospital of Traditional Chinese and Western Medicine, Wuhan, Hubei, China
- 3Institute of Integrated Traditional Chinese and Western Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China
- 4Department of Scientific Research Management, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China
- 5Department of Acupuncture, Hubei Provincial Hospital of Traditional Chinese Medicine, Wuhan, Hubei, China
- 6Department of Neurology, Xiangyang No.1 People’s Hospital, Hubei University of Medicine, Xiangyang, Hubei, China
- 7Department of Rehabilitation Medicine, The Second Hospital of Huangshi, Huangshi, Hubei, China
- 8College of Acupuncture and Orthopedics, Hubei University of Chinese Medicine/Hubei Provincial Collaborative Innovation Center of Preventive Treatment by Acupuncture and Moxibustion, Wuhan 430065, Hubei, China
- Correspondence to: W Wang
- Accepted 6 February 2020
Objective To assess the efficacy of manual acupuncture as prophylactic treatment for acupuncture naive patients with episodic migraine without aura.
Design Multicentre, randomised, controlled clinical trial with blinded participants, outcome assessment, and statistician.
Setting Seven hospitals in China, 5 June 2016 to 15 November 2018.
Participants 150 acupuncture naive patients with episodic migraine without aura.
Interventions 20 sessions of manual acupuncture at true acupuncture points plus usual care, 20 sessions of non-penetrating sham acupuncture at heterosegmental non-acupuncture points plus usual care, or usual care alone over 8 weeks.
Main outcome measures Change in migraine days and migraine attacks per four weeks during weeks 1-20 after randomisation compared with baseline (four weeks before randomisation).
Results Among 150 randomised patients (mean age 36.5 (SD 11.4) years; 123 (82%) women), 147 were included in the full analysis set. Compared with sham acupuncture, manual acupuncture resulted in a significantly greater reduction in migraine days at weeks 13 to 20 and a significantly greater reduction in migraine attacks at weeks 17 to 20. The reduction in mean number of migraine days was 3.5 (SD 2.5) for manual versus 2.4 (3.4) for sham (adjusted difference −1.4, 95% confidence interval −2.4 to −0.3; P=0.005) at weeks 13 to 16 and 3.9 (3.0) for manual versus 2.2 (3.2) for sham (adjusted difference −2.1, −2.9 to −1.2; P<0.001) at weeks 17 to 20. At weeks 17 to 20, the reduction in mean number of attacks was 2.3 (1.7) for manual versus 1.6 (2.5) for sham (adjusted difference −1.0, −1.5 to −0.5; P<0.001). No severe adverse events were reported. No significant difference was seen in the proportion of patients perceiving needle penetration between manual acupuncture and sham acupuncture (79% v 75%; P=0.891).
Conclusions Twenty sessions of manual acupuncture was superior to sham acupuncture and usual care for the prophylaxis of episodic migraine without aura. These results support the use of manual acupuncture in patients who are reluctant to use prophylactic drugs or when prophylactic drugs are ineffective, and it should be considered in future guidelines.
Trial registration Clinicaltrials.gov NCT02765581.
Contributors: SX, LY, and XL contributed equally to the study. SX, LY, XL, HW, and WW conceived and designed the study. SX, LY, XL, HW, and WW had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. SX, LY, and XL drafted the manuscript. SX, LY, XL, MW, GC, QZ, ZZ, JS, HJ, HW, and WW contributed to the acquisition, analysis, and interpretation of data. All authors contributed to the critical revision of the manuscript for important intellectual content and gave final approval of the version to be published. WL did the statistical analysis. HW and WW obtained funding. GC, ZZ, JS, HJ, GH, FL, HW, and WW provided administrative, technical, or material support. The corresponding author attests that all listed authors meet authorship criteria and that no others meeting the criteria have been omitted. HW and WW supervised the study and are the guarantors.
Funding: This study was supported by a grant from the National Natural Science Foundation of China (61327902), and a project grant from Hubei University of Chinese Medicine/Hubei Provincial Collaborative Innovation Center of Preventive Treatment by Acupuncture and Moxibustion. Study sponsors were not involved in study design, data interpretation, writing the article, or the decision to submit the article for publication.
Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf and declare: funding for the submitted work as described above; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work.
Ethical approval: This study was approved by the Clinical Trial Ethics Committee of Tongji Medical College, Huazhong University of Science and Technology (2016S009), the Medical Ethics Committee of Wuhan No.1 Hospital (WuWeiYiYuanLunShen14), the Ethics Committee of Hubei Province Hospital of Traditional Chinese Medicine (HBZY2016-C25-01), the Ethics Committee of Xiangyang No.1 Hospital (YN20171220), the Ethics Committee of The Second Hospital of Huangshi (HEYLWJY1701), and the Ethics Committee of Hubei University of Chinese Medicine ( IEC No. 2). The trial was overseen by an independent trial steering committee and data monitoring and ethics committee. All patients gave written informed consent.
Data sharing: The raw trial data after de-identification can be shared on individual request to the corresponding author at firstname.lastname@example.org.
Transparency: The lead author affirms that this manuscript is an honest, accurate, and transparent account of the study being reported; that no important aspects of the study have been omitted; and that any discrepancies from the study as planned (and, if relevant, registered) have been explained.
Dissemination to participants and related patient and public communities: Participants will be informed of the results of the study by telephone. Dissemination to the public will be achieved through media outreach.
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