Xianliang Wang1, Yazhu Hou1, Jingyuan Mao1, Yan Zhang1, Zhijun Li1, Yingqiang Zhao2, Tianfu Niu3, Ruyu Yuan4, Yonggang Wang5, Jinrong Cui6, Le Shi7, Xiuli Jia8, Ruihong Fan9, Qian Lin10, Hongcai Shang11, Baohe Wang11, Hongwu Wang12, Boli Zhang13, Xiaolei Cui14, Shanbin Soh14, Jishou Ruan15. 1. Cardiovascular Department, the First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China. 2. Cardiovascular Department, the Second Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300150, China. 3. Cardiovascular Department, Shanxi Traditional Chinese Medicine Institute, Taiyuan 030012, China. 4. Cardiovascular Department, the Second Teaching Hospital of Tianjin Medical University, Tianjin 300211, China. 5. Cardiovascular Department, the Second Teaching Hospital of Shanxi University of Traditional Chinese Medicine, Xianyang 712000, China. 6. Cardiovascular Department, the Integrated Hospitals of TCM and Western Medicine of Shanxi University of Traditional Chinese Medicine, Taiyuan 030001, China. 7. Cardiovascular Department, Tianjin Beichen Traditional Chinese Medicine Hospital, Tianjin 300400, China. 8. Cardiovascular Department, Tianjin Nankai Traditional Chinese Medicine Hospital, Tianjin 300102, China. 9. Cardiovascular Department, Tianjin Traditional Chinese Medicine Hospital, Tianjin 300020, China. 10. Cardiovascular Department, the Eastern Hospital of Beijing University of Traditional Chinese Medicine, Beijing 100078, China. 11. Evidence-based medicine center, Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China. 12. Statistic Department, Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China. 13. Institute of Traditional Chinese Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China. 14. Graduate school, Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China. 15. Department of Mathematics, Nankai University, Tianjin 300071, China.
Abstract
OBJECTIVE: To assess the efficacy and safety in patients with chronic heart failure (CHF) of Western medication plus Traditional Chinese Medicine (TCM) preparations. METHODS: This prospective, single-blind, randomized, controlled, and multicenter clinical trial began on September 17, 2008, and was completed on June 25, 2011. A total of 340 inpatients, aged 40-79 years, with exacerbating CHF from 10 hospitals were enrolled and randomly allocated within 24 h of admission. The trial included three intervention periods. During hospitalization, the control group received western medication for CHF and the treatment group received Danhong injection with Shenfu injection or Shenmai injection. After discharge, all patients were treated with Qiliqiangxin capsules and Buyiqiangxin tablets or a placebo for 6 months. After the 6-month intervention, both groups received only continuous western medication. The primary endpoint was all-cause mortality. The efficacy assessments were as follows: B-type natriuretic peptide (BNP), Lee's HF score, the 6-minute walking test (6MWT), left ventricular ejection fraction (LVEF), and the Minnesota Living with Heart Failure Questionnaire (MLHFQ). The safety assessments were as follows: blood and urine routine examination, hepatic and renal function, electrolytes in blood and adverse events. RESULTS: Compared with the control group, the treatment group showed a 30.99% reduction in all-cause mortality and an improved survival rate. The treatment group showed greater improvement in 6MWT (P = 0.02) than the control group on discharge, after 12-month follow-up, there was a time-group interaction for MLHFQ (P = 0.03). Incidence rate of adverse events and other relevant safety indexes were not statistically significant between the two groups. CONCLUSION:Western medication plus TCM treatment can increase 6-minute walking distance (improve exercise tolerance) and quality of lifewith heart failure patients.
RCT Entities:
OBJECTIVE: To assess the efficacy and safety in patients with chronic heart failure (CHF) of Western medication plus Traditional Chinese Medicine (TCM) preparations. METHODS: This prospective, single-blind, randomized, controlled, and multicenter clinical trial began on September 17, 2008, and was completed on June 25, 2011. A total of 340 inpatients, aged 40-79 years, with exacerbating CHF from 10 hospitals were enrolled and randomly allocated within 24 h of admission. The trial included three intervention periods. During hospitalization, the control group received western medication for CHF and the treatment group received Danhong injection with Shenfu injection or Shenmai injection. After discharge, all patients were treated with Qiliqiangxin capsules and Buyiqiangxin tablets or a placebo for 6 months. After the 6-month intervention, both groups received only continuous western medication. The primary endpoint was all-cause mortality. The efficacy assessments were as follows: B-type natriuretic peptide (BNP), Lee's HF score, the 6-minute walking test (6MWT), left ventricular ejection fraction (LVEF), and the Minnesota Living with Heart Failure Questionnaire (MLHFQ). The safety assessments were as follows: blood and urine routine examination, hepatic and renal function, electrolytes in blood and adverse events. RESULTS: Compared with the control group, the treatment group showed a 30.99% reduction in all-cause mortality and an improved survival rate. The treatment group showed greater improvement in 6MWT (P = 0.02) than the control group on discharge, after 12-month follow-up, there was a time-group interaction for MLHFQ (P = 0.03). Incidence rate of adverse events and other relevant safety indexes were not statistically significant between the two groups. CONCLUSION: Western medication plus TCM treatment can increase 6-minute walking distance (improve exercise tolerance) and quality of life with heart failurepatients.
Entities:
Keywords:
Heart failure; Medicine, Chinese traditional; Randomized controlled trail; Walk test