Treatment of migraines with Tianshu capsule: a multi-center, double-blind, randomized, placebo-controlled clinical trial
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. T...
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| Format: | Article |
| Language: | English |
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BMC
2019-12-01
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| Series: | BMC Complementary and Alternative Medicine |
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| Online Access: | https://doi.org/10.1186/s12906-019-2775-2 |
| _version_ | 1818386491267612672 |
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| author | 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 |
| author_facet | 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 |
| author_sort | Shengyuan Yu |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-12-14T03:54:54Z |
| format | Article |
| id | doaj.art-3f897ba2b71246d2a6b5d9f25aa6958d |
| institution | Directory Open Access Journal |
| issn | 1472-6882 |
| language | English |
| last_indexed | 2024-12-14T03:54:54Z |
| publishDate | 2019-12-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Complementary and Alternative Medicine |
| spelling | doaj.art-3f897ba2b71246d2a6b5d9f25aa6958d2022-12-21T23:18:07ZengBMCBMC Complementary and Alternative Medicine1472-68822019-12-011911910.1186/s12906-019-2775-2Treatment of migraines with Tianshu capsule: a multi-center, double-blind, randomized, placebo-controlled clinical trialShengyuan Yu0Ye Ran1Wei Xiao2Wenjing Tang3Jianjun Zhao4Wei Chen5Huikui Zhuang6Cun Ouyang7Hai Lin8Dequan Liu9Tongjun Chen10Hui Huang11Baoshen Wang12Yanlei Hao13Zhongrui Yan14Shike Zhao15Yanling Wang16Jinjun Ni17Chaodong Wang18Wentao Ding19Guoqian Li20Jianhua Cao21Shujuan Tian22Department of Neurology, Chinese PLA General HospitalDepartment of Neurology, Chinese PLA General HospitalState Key Laboratory of New-tech for Chinese Medicine Pharmaceutical ProcessDepartment of Neurology, Chinese PLA General HospitalAffiliated Hospital of Changchun University of Tradition Chinese MedicineBrain Hospital of Jilin provinceSecond Affiliated Hospital of Shandong University of Tradition Chinese MedicineWuhan Sixth HospitalXi’an Hospital of Tradition Chinese MedicineLangfang Tradition Chinese Medicine HospitalTangshan Tradition Chinese Medicine HospitalHuaibei People’s HospitalLuohe Hospital of Chinese MedicineAffiliation Hospital of Jining Medical UniversityJining No.1 People’s HospitalJi’nan Municipal Hospital of Traditional Chinese MedicineCangzhou People’s HospitalKaifeng Hospital of Tradition Chinese MedicineSanming First HospitalGuang’anmen Hospital, China Academy of Chinese Medical SciencesQuanzhou First HospitalYiyang Central HospitalThe 260th Hospital of PLAAbstract 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.https://doi.org/10.1186/s12906-019-2775-2Tianshu capsuleMigraineHerbal medicineMulticenterRandomized controlled trial |
| spellingShingle | 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 Treatment of migraines with Tianshu capsule: a multi-center, double-blind, randomized, placebo-controlled clinical trial BMC Complementary and Alternative Medicine Tianshu capsule Migraine Herbal medicine Multicenter Randomized controlled trial |
| title | Treatment of migraines with Tianshu capsule: a multi-center, double-blind, randomized, placebo-controlled clinical trial |
| title_full | Treatment of migraines with Tianshu capsule: a multi-center, double-blind, randomized, placebo-controlled clinical trial |
| title_fullStr | Treatment of migraines with Tianshu capsule: a multi-center, double-blind, randomized, placebo-controlled clinical trial |
| title_full_unstemmed | Treatment of migraines with Tianshu capsule: a multi-center, double-blind, randomized, placebo-controlled clinical trial |
| title_short | Treatment of migraines with Tianshu capsule: a multi-center, double-blind, randomized, placebo-controlled clinical trial |
| title_sort | treatment of migraines with tianshu capsule a multi center double blind randomized placebo controlled clinical trial |
| topic | Tianshu capsule Migraine Herbal medicine Multicenter Randomized controlled trial |
| url | https://doi.org/10.1186/s12906-019-2775-2 |
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