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 hours 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 failure patients.
Traditional Chinese Medicine Chronic Heart Failure Clinical Trial
Wang Xianliang Hou Yazhu Mao Jingyuan Zhao Yingqiang Niu Tianfu Yuan Ruyu Wang Yonggang Cui Jinrong Shi Le Jia Xiuli Fan Ruihong Lin Qian Zhang Yan Li Zhijun Shang Hongcai Wang Baohe Wang Hongwu Wang Henghe Cui Xiaolei Soh Shanbin Ruan Jishou Zhang Boli
Cardiovascular Department,the First Teaching Hospital of Tianjin University of Traditional Chinese M Cardiovascular Department,the Second Teaching Hospital of Tianjin University of Traditional Chinese Cardiovascular Department,Shanxi Traditional Chinese Medicine Institute,Shanxi Taiyuan 030012,China Cardiovascular Department,the Second Teaching Hospital of Tianjin Medical University,Tianjin 300211, Cardiovascular Department,the Second Teaching Hospital of Shanxi University of Traditional Chinese M Cardiovascular Department,the Integrated Hospitals of TCM and Western Medicine of Shanxi University Cardiovascular Department,Tianjin Beichen TCM Hospital,Tianjin 300400,China Cardiovascular Department,Tianjin Nankai TCM Hospital,Tianjin 300102,China Cardiovascular Department,Tianjin TCM Hospital,Tianjin 300020,China Cardiovascular Department,the Eastern Hospital of Beijing University of Traditional Chinese Medicine Evidence-based medicine center,Tianjin University of Traditional Chinese Medicine,Tianjin 300193,Chi Statistic Department,Tianjin University of Traditional Chinese Medicine,Tianjin 300193,China Graduate school,Tianjin University of Traditional Chinese Medicine,Tianjin 300193,China Department of Mathematics,Nankai University,Tianjin 300071,China Institute of traditional Chinese medicine,Tianjin University of Traditional Chinese Medicine,Tianjin