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Journal of Traditional Chinese Medicine ›› 2017, Vol. 37 ›› Issue (06): 756-766.

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Western medication plus Traditional Chinese Medicine preparations in patients with chronic heart failure: a prospective, single-blind,randomized, controlled, and multicenter 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   

  1. Cardiovascular Department, the First Teaching Hospital of Tianjin University of Traditional Chinese Medicine;Cardiovascular Department, the Second Teaching Hospital of Tianjin University of Traditional Chinese Medicine;Cardiovascular Department, Shanxi Traditional Chinese Medicine Institute;Cardiovascular Department, the Second Teaching Hospital of Tianjin Medical University;Cardiovascular Department, the Second Teaching Hospital of Shanxi University of Traditional Chinese Medicine;Cardiovascular Department, the Integrated Hospitals of TCM and Western Medicine of Shanxi University of Traditional Chinese Medicine;Cardiovascular Department, Tianjin Beichen Traditional Chinese Medicine Hospital;Cardiovascular Department, Tianjin Nankai Traditional Chinese Medicine Hospital;Cardiovascular Department, Tianjin Traditional Chinese Medicine Hospital;Cardiovascular Department, the Eastern Hospital of Beijing University of Traditional Chinese Medicine;Evidence-based medicine center, Tianjin University of Traditional Chinese Medicine;Statistic Department, Tianjin University of Traditional Chinese Medicine;Graduate school, Tianjin University of Traditional Chinese Medicine;Department of Mathematics, Nankai University;Institute of Traditional Chinese Medicine, Tianjin University of Traditional Chinese Medicine;
  • Accepted:2017-12-15 Online:2017-12-15 Published:2022-04-04
  • Supported by:
    Supported by National Key Technology R&D Programs in the 11th Five-Year Plan of China:Study on Comprehensive Evaluation Method of Integral Effect of Traditional Chinese Medicine Treatment for Heart Failure(No.2006BAI08B02-01), Ministry of Education of People's Republic of China"Program for Innovative Research Team in University"–Research on TCM for the Prevention and Treatment of Cardiovascular Diseases(No.IRT_16R54), Tianjin Science and Technology Program:Tianjin TCM Clinical Medicine Research Center(No.15ZXLCSY00020)

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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(6 MWT), 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 6 MWT(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.

Key words: Heart failure, Medicine,Chinese traditional, Walk test, Randomized controlled trail

Cite this article

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. Western medication plus Traditional Chinese Medicine preparations in patients with chronic heart failure: a prospective, single-blind,randomized, controlled, and multicenter clinical trial[J]. Journal of Traditional Chinese Medicine, 2017, 37(06): 756-766.