Shengyuan Yu1, Ye Ran1, Qi Wan2, Xiaosu Yang3, Huisheng Chen4, Hebo Wang5, Xueqiang Hu6, Shanping Mao7, Tingming Yu8, Guogang Luo9, Yangtai Guan10, Xuguang Gao11, Xin Li12, Muke Zhou13, Yu Li14. 1. Department of Neurology, Chinese PLA General Hospital, Beijing, P.R. China. 2. Department of Neurology, Jiangsu Province Hospital, Nanjing, P.R. China. 3. Department of Neurology, Xiangya Hospital Central South University, Changsha, P.R. China. 4. Department of Neurology, The General Hospital of Shenyang Military, Shenyang, P.R. China. 5. Department of Neurology, Hebei General Hospital, Shijiazhuang, P.R. China. 6. Department of Neurology, The Third Affiliated Hospital, Sun Yat-Sen University, Guangzhou, P.R. China. 7. Department of Neurology, Hubei General Hospital, Wuhan, P.R. China. 8. Department of Neurology, The Second Hospital of Jilin University, Changchun, P.R. China. 9. Department of Neurology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, P.R. China. 10. Department of Neurology, Changhai Hospital of Shanghai, Shanghai, P.R. China. 11. Department of Neurology, Peking University People's Hospital, Beijing, P.R. China. 12. Department of Neurology, The Second Hospital of Tianjin Medical University, Tianjin, P.R. China. 13. Department of Neurology, West China Hospital, Sichuan University, Chengdu, P.R. China. 14. Department of Neurology, Fuling Center Hospital of Chongqing City, Chongqing, P.R. China.
Abstract
Objective: Toutongning (TTN) capsule, a Chinese patent medicine, is used as a prophylactic treatment for migraine. The present study was conducted as a postmarketing evaluation of the efficacy and safety of TTN capsule. Design: A randomized, double-blind, placebo-controlled trial. Location: Patients recruited from 14 medical centers in China from May 2014 to August 2015. Subjects: Patients between 18 and 65 years of age with a diagnosis of migraine. Interventions: The patients were randomly assigned to receive either TTN (1200 mg, three times daily) or a matched placebo (1:1) for 4 weeks. Outcome measures: The primary outcome measured was a minimum 50% reduction in the frequency of headaches from the 4-week baseline period to the last 4 weeks of the 12-week trial. Secondary outcomes included duration, days, and visual analog score of headache attack, interval between headache attacks, usage of acute analgesics, and score on the Headache Impact Test-6. In addition, all patients were evaluated for adverse events (AEs). Results: This study initially enrolled 400 patients; a total of 378 participants completed the experiment while fulfilling all study requirements. TTN had a superior effect compared with the placebo on both the primary and secondary outcome measures without any serious AEs or unexpected side effects. Conclusion: TTN can effectively prevent the occurrence of migraine headaches and is well-tolerated and safe. TTN may exhibit a persistent therapeutic effect even after cessation of use. Trial Registration number: ChiCTR-IPR-15007058.
RCT Entities:
Objective: Toutongning (TTN) capsule, a Chinese patent medicine, is used as a prophylactic treatment for migraine. The present study was conducted as a postmarketing evaluation of the efficacy and safety of TTN capsule. Design: A randomized, double-blind, placebo-controlled trial. Location: Patients recruited from 14 medical centers in China from May 2014 to August 2015. Subjects: Patients between 18 and 65 years of age with a diagnosis of migraine. Interventions: The patients were randomly assigned to receive either TTN (1200 mg, three times daily) or a matched placebo (1:1) for 4 weeks. Outcome measures: The primary outcome measured was a minimum 50% reduction in the frequency of headaches from the 4-week baseline period to the last 4 weeks of the 12-week trial. Secondary outcomes included duration, days, and visual analog score of headache attack, interval between headache attacks, usage of acute analgesics, and score on the Headache Impact Test-6. In addition, all patients were evaluated for adverse events (AEs). Results: This study initially enrolled 400 patients; a total of 378 participants completed the experiment while fulfilling all study requirements. TTN had a superior effect compared with the placebo on both the primary and secondary outcome measures without any serious AEs or unexpected side effects. Conclusion: TTN can effectively prevent the occurrence of migraine headaches and is well-tolerated and safe. TTN may exhibit a persistent therapeutic effect even after cessation of use. Trial Registration number: ChiCTR-IPR-15007058.
Authors: Xia Du; Zhibiao Di; Yang Liu; Wenbing Zhi; Yuan Liu; Hong Zhang; Feng Liu Journal: Evid Based Complement Alternat Med Date: 2022-01-15 Impact factor: 2.629