{"title":"天枢胶囊治疗偏头痛:一项多中心、双盲、随机、安慰剂对照临床试验。","authors":"Shengyuan Yu, Ye Ran, Wei Xiao, Wenjing Tang, Jianjun Zhao, Wei Chen, Huikui Zhuang, Cun Ouyang, Hai Lin, Dequan Liu, Tongjun Chen, Hui Huang, Baoshen Wang, Yanlei Hao, Zhongrui Yan, Shike Zhao, Yanling Wang, Jinjun Ni, Chaodong Wang, Wentao Ding, Guoqian Li, Jianhua Cao, Shujuan Tian","doi":"10.1186/s12906-019-2775-2","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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).</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>TSC is an effective, well-tolerated medicine for prophylactic treatment of migraine, and still have prophylactic effect after medicine discontinuation.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov Identifier: NCT02035111; Data of registration: 2014-01-10.</p>","PeriodicalId":9132,"journal":{"name":"BMC Complementary and Alternative Medicine","volume":" ","pages":"370"},"PeriodicalIF":0.0000,"publicationDate":"2019-12-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1186/s12906-019-2775-2","citationCount":"6","resultStr":"{\"title\":\"Treatment of migraines with Tianshu capsule: a multi-center, double-blind, randomized, placebo-controlled clinical trial.\",\"authors\":\"Shengyuan Yu, Ye Ran, Wei Xiao, Wenjing Tang, Jianjun Zhao, Wei Chen, Huikui Zhuang, Cun Ouyang, Hai Lin, Dequan Liu, Tongjun Chen, Hui Huang, Baoshen Wang, Yanlei Hao, Zhongrui Yan, Shike Zhao, Yanling Wang, Jinjun Ni, Chaodong Wang, Wentao Ding, Guoqian Li, Jianhua Cao, Shujuan Tian\",\"doi\":\"10.1186/s12906-019-2775-2\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>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).</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>TSC is an effective, well-tolerated medicine for prophylactic treatment of migraine, and still have prophylactic effect after medicine discontinuation.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov Identifier: NCT02035111; Data of registration: 2014-01-10.</p>\",\"PeriodicalId\":9132,\"journal\":{\"name\":\"BMC Complementary and Alternative Medicine\",\"volume\":\" \",\"pages\":\"370\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2019-12-16\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://sci-hub-pdf.com/10.1186/s12906-019-2775-2\",\"citationCount\":\"6\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"BMC Complementary and Alternative Medicine\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1186/s12906-019-2775-2\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"Medicine\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"BMC Complementary and Alternative Medicine","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1186/s12906-019-2775-2","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"Medicine","Score":null,"Total":0}
Treatment of migraines with Tianshu capsule: a multi-center, double-blind, randomized, placebo-controlled clinical trial.
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.
期刊介绍：
BMC Complementary Medicine and Therapies is an open access journal publishing original peer-reviewed research articles on interventions and resources that complement or replace conventional therapies, with a specific emphasis on research that explores the biological mechanisms of action, as well as their efficacy, safety, costs, patterns of use and/or implementation.
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