Introduction Approximately 1.4%–2.2% of the global population suffers from chronic migraine. Acupuncture may serve as an alternative management for chronic migraine, where pharmacological prophylaxis is not suitable. However, the effects of acupuncture as migraine prophylaxis have not been confirmed. This study is designed as a single-blinded, double-dummy randomised controlled trial to evaluate the efficacy and safety of acupuncture compared with topiramate in patients with chronic migraine.
Methods and analysis A total of 60 participants will be randomly assigned to two different groups. Participants will receive verum acupuncture and placebo medicine in the treatment group, while participants in the control group will be treated with sham acupuncture and real medicine (topiramate). All participants will receive a 12-week treatment and then be followed up for another 12 weeks. The primary outcome is the reduction of monthly headache days, and the secondary outcomes include the reduction of the number of days with acute headache medications, and changes of Migraine Disability Assessment, Migraine-Specific Quality of Life Questionnaire, Headache Impact Test, State-Trait Anxiety Inventory-trait, and Beck Depression Inventory-II scores from baseline to endpoints.
Ethics and dissemination Ethical approval of this study was granted by the Research Ethical Committee of Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University (2017BL-045-01). Written informed consent will be obtained from all participants. Outcomes of the trial will be disseminated through peer-reviewed publications.
Trial registration number ISRCTN13563102; Pre-results.
- chronic migraine
- randomised controlled trial
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LL and L-Z contributed equally.
Contributors BL, XGJ, LL and LPZ conducted the study. LL and LPZ drafted the protocol. CSZ, KLW and JXZ participated in the design of the study and contributed to the revising the protocol manuscript. LZ was responsible for the statistical design of the study. LPW provided clinical advice and made critical revisions. BL is a principal investigator of the study and is responsible for making final decisions on the trial design and manuscript preparation. All authors approved the final manuscript.
Funding This study was supported by Beijing Municipal Science and Technology Commission (grant number Z171100001017033), China National Natural Science Foundation (grant number 81603683) , China Postdoctoral Science Foundation Funded Project (grant number 2018M630261) and National Basic Research Program of China (grant number 2014CB543203).
Competing interests None declared.
Patient consent Obtained.
Ethics approval Ethical approval was granted on 21 July 2017 by the Research Ethical Committee of Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University (Ethics Reference No: 2017BL-045-01).
Provenance and peer review Not commissioned; externally peer reviewed.