Treatment of migraines with Tianshu capsule: a multi-center, double-blind, randomized, placebo-controlled clinical trial

BMC Complementary and Alternative Medicine

卷:19

Jianjun Zhao¹  Yanlei Hao²  Wei Chen³  Yanling Wang⁴  Ye Ran⁵  Shengyuan Yu⁵  Wenjing Tang⁵  Wentao Ding⁶  Hui Huang⁷  Zhongrui Yan⁸  Shike Zhao⁹  Jinjun Ni¹⁰  Dequan Liu¹¹  Baoshen Wang¹²  Guoqian Li¹³  Chaodong Wang¹⁴  Huikui Zhuang¹⁵  Wei Xiao¹⁶  Tongjun Chen¹⁷  Shujuan Tian¹⁸  Cun Ouyang¹⁹  Hai Lin²⁰  Jianhua Cao²¹ 

[1] Affiliated Hospital of Changchun University of Tradition Chinese Medicine;

[2] Affiliation Hospital of Jining Medical University;

[3] Brain Hospital of Jilin province;

[4] Cangzhou People’s Hospital;

[5] Department of Neurology, Chinese PLA General Hospital;

[6] Guang’anmen Hospital, China Academy of Chinese Medical Sciences;

[7] Huaibei People’s Hospital;

[8] Jining No.1 People’s Hospital;

[9] Ji’nan Municipal Hospital of Traditional Chinese Medicine;

[10] Kaifeng Hospital of Tradition Chinese Medicine;

[11] Langfang Tradition Chinese Medicine Hospital;

[12] Luohe Hospital of Chinese Medicine;

[13] Quanzhou First Hospital;

[14] Sanming First Hospital;

[15] Second Affiliated Hospital of Shandong University of Tradition Chinese Medicine;

[16] State Key Laboratory of New-tech for Chinese Medicine Pharmaceutical Process;

[17] Tangshan Tradition Chinese Medicine Hospital;

[18] The 260th Hospital of PLA;

[19] Wuhan Sixth Hospital;

[20] Xi’an Hospital of Tradition Chinese Medicine;

[21] Yiyang Central Hospital;

关键词: Tianshu capsule;    Migraine;    Herbal medicine;    Multicenter;    Randomized controlled trial;   

DOI  :  10.1186/s12906-019-2775-2

来源: DOAJ

【 摘 要 】

Abstract Background Tianshu capsule (TSC), a formula of traditional Chinese medicine, has been widely used in clinical practice for prophylactic treatment of headaches in China. However, former clinical trials of TSC were small, and lack of a standard set of diagnostic criteria to enroll patients. The study was conducted to re-evaluate the efficacy and safety of TSC post-marketing in an extending number of migraineurs who have diagnosed migraine with the International Classification of Headache Disorders, 3rd edition (beta version, ICHD-3β). Methods The study was a double-blind, randomized, placebo-controlled clinical trial that conducted at 20 clinical centers in China. At enrollment, patients between 18 and 65 years of age diagnosed with migraine were assigned to receive either TSC (4.08 g, three times daily) or a matched placebo according to a randomization protocol. The primary endpoint was a relative reduction of 50% or more in the frequency of headache attacks. The secondary outcomes included a reduction in the incidence of headache, the visual analogue scale of headache attacks, days of acute analgesic usage, and percentage of patients with a decrease of 50% or more in headache severity. Accompanying symptoms were also assessed. Results One thousand migraine patients were initially enrolled in the study, and 919 of them completed the trial. Following the 12-week treatment, significant improvement was observed in the TSC group concerning both primary and secondary outcomes. After therapy discontinuation, the gap between the TSC group and the placebo group in efficacy outcomes continued to increase. There were no severe adverse effects. Conclusions TSC is an effective, well-tolerated medicine for prophylactic treatment of migraine, and still have prophylactic effect after medicine discontinuation. Trial registration ClinicalTrials.gov Identifier: NCT02035111; Data of registration: 2014-01-10.

【 授权许可】

Unknown