Qian-Yu Zhao1,2, Rong-Hua Tang3, Guo-Xiong Lu4, Xu-Zheng Cao5, Lu-Ran Liu6, Ji-Hua Zhang7, Jin-Tao Zhang8, Bin Xu9, Hong-Tao Wei10, Miao Yang11, Ling Wei12, Mei Zhang13, Wen-Zong Zhu14, Hong Wang15, Hong-Lin Li16, Li-Ping Ma17, Chi Zhong18, Yan-Jie Gao1, Na Zhang1, Shan Ren1, Lu Chen1, Yun-Hai Liu19, Zhi-Gang Chen20. 1. Department of Neurology, Dongfang Hospital Affiliated to Beijing University of Chinese Medicine, Beijing, 100078, China. 2. The Second School of Clinical Medicine, Beijing University of Chinese Medicine, Beijing, 100029, China. 3. Department of Neurology, Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology, Wuhan, 430030, China. 4. Department of Neurology, the Hospital Affiliated to Jiangxi University of Traditional Chinese Medicine, Nanchang, 330006, China. 5. Department of Neurology, the 211th Hospital of the People's Liberation Army, Harbin, 150000, China. 6. Department of Neurology, the Fourth Hospital Affiliated to Harbin Medical University, Harbin, 150000, China. 7. Department of Neurology, the First Hospital of Suihua, Suihua, Heilongjiang Province, 152053, China. 8. Department of Neurology, the 88th Hospital of the People's Liberation Army, Tai'an, Shandong Province, 271000, China. 9. Department of Neurology, Xinhua Hospital of Zhejiang Province, Hangzhou, 310005, China. 10. Department of Neurology, the Second Provincial People's Hospital of Gansu, Lanzhou, 730000, China. 11. Department of Neurology, People's Hospital of Bozhou, Bozhou, Anhui Province, 236800, China. 12. Department of Neurosurgery, the Third Hospital Affiliated to Shanxi University of Chinese Medicine, Taiyuan, 030000, China. 13. Department of Neurology, the First People's Hospital of Huainan, Huainan, Anhui Province, 232007, China. 14. Department of Neurology, Wenzhou Hospital of Traditional Chinese Medicine, Wenzhou, Zhejiang Province, 325000, China. 15. Department of Neurology, the First Hospital Affiliated to Medical College of Shihezi University, Shihezi, Xinjiang Uygur Autonomous Region, 832008, China. 16. Department of Rehabilitation, the Second Hospital Affiliated to Heilongjiang University of Traditional Chinese Medicine, Harbin, 150001, China. 17. Department of Neurology, People's Hospital of Xinzhou, Xinzhou, Shanxi Province, 034000, China. 18. Department of Neurology, People's Hospital of Weifang, Weifang, Shandong Province, 261000, China. 19. Department of Neurology, Xiangya Hospital Affiliated to Central South University, Changsha, 410013, China. 20. Department of Neurology, Dongfang Hospital Affiliated to Beijing University of Chinese Medicine, Beijing, 100078, China. chenzhigang64@126.com.
Abstract
OBJECTIVE: To evaluate whether the efficacy of Getong Tongluo Capsule (, GTC, consisted of total flavone of Radix Puerariae) on improving patients' quality of life and lowering blood pressure are superior to the extract of Ginkgo biloba (EGB) for patients with convalescent-phase ischemic stroke and primary hypertension. METHODS: This randomized, positive-drug- and placebo-controlled, double-blind trial was conducted from September 2015 to October 2017. Totally 477 eligible patients from 18 hospitals in China were randomly assigned in a 2:1:1 ratio to the following interventions, twice a day for 12 weeks: (1) GTC 250 mg plusEGB-matching placebo 40 mg (237 cases, GTC group), (2) EGB 40 mg plusGTC-matching placebo 250 mg (120 cases, EGB group) or (3) GTC-matching placebo 250 mg plus EGB-matching placebo 40 mg (120 cases, placebo group). Moreover, all patients were orally administered aspirin enteric-coated tablets 100 mg, once a day for 12 weeks. The primary outcome was the Barthel Index (BI). The secondary outcomes included the control rate of blood pressure and National Institutes of Health Stroke Scale (NIHSS) scores. The incidence and severity of adverse events (AEs) were calculated and assessed. RESULTS: The BI relative independence rates, the clinical recovery rates of NIHSS, and the total effective rates of NIHSS in the GTC and EGB groups were significantly higher than the placebo group at 12 weeks after treatment (P<0.05), and no statistical significance was found between the GTC and EGB groups (P>0.05). The control rate of blood pressure in the GTC group was significantly higher than the EGB and placebo groups at 12, 18 and 24 weeks after treatment (P<0.01). There were no statistically significant differences in the incidences of AEs, adverse drug reactions, or serious AEs among the 3 groups (P>0.05). CONCLUSION:GTC exhibited significant efficacy in improving patients' quality of life as well as neurological function and controlling hypertension. (Registration No. ChiCTR1800016667).
RCT Entities:
OBJECTIVE: To evaluate whether the efficacy of Getong Tongluo Capsule (, GTC, consisted of total flavone of Radix Puerariae) on improving patients' quality of life and lowering blood pressure are superior to the extract of Ginkgo biloba (EGB) for patients with convalescent-phase ischemic stroke and primary hypertension. METHODS: This randomized, positive-drug- and placebo-controlled, double-blind trial was conducted from September 2015 to October 2017. Totally 477 eligible patients from 18 hospitals in China were randomly assigned in a 2:1:1 ratio to the following interventions, twice a day for 12 weeks: (1) GTC 250 mg plus EGB-matching placebo 40 mg (237 cases, GTC group), (2) EGB 40 mg plus GTC-matching placebo 250 mg (120 cases, EGB group) or (3) GTC-matching placebo 250 mg plus EGB-matching placebo 40 mg (120 cases, placebo group). Moreover, all patients were orally administered aspirin enteric-coated tablets 100 mg, once a day for 12 weeks. The primary outcome was the Barthel Index (BI). The secondary outcomes included the control rate of blood pressure and National Institutes of Health Stroke Scale (NIHSS) scores. The incidence and severity of adverse events (AEs) were calculated and assessed. RESULTS: The BI relative independence rates, the clinical recovery rates of NIHSS, and the total effective rates of NIHSS in the GTC and EGB groups were significantly higher than the placebo group at 12 weeks after treatment (P<0.05), and no statistical significance was found between the GTC and EGB groups (P>0.05). The control rate of blood pressure in the GTC group was significantly higher than the EGB and placebo groups at 12, 18 and 24 weeks after treatment (P<0.01). There were no statistically significant differences in the incidences of AEs, adverse drug reactions, or serious AEs among the 3 groups (P>0.05). CONCLUSION:GTC exhibited significant efficacy in improving patients' quality of life as well as neurological function and controlling hypertension. (Registration No. ChiCTR1800016667).
Entities:
Keywords:
Chinese medicine; Getong Tongluo Capsule; convalescent-phase of ischemic stroke; primary hypertension; randomized controlled trial; total flavone of Radix Puerariae