Effects of Traditional Chinese Medicine Shensong Yangxin Capsules on Heart Rhythm and Function in Congestive Heart Failure Patients with Frequent Ventricular Premature Complexes：A Randomized, Double-blind, Multicenter Clinical Trial

• Published in: Chinese medical journal Vol. 130; no. 14; pp. 1639 - 1647
• Main Authors: Wang, Xi, Hu, Dan, Dang, Song, Huang, He, Huang, Cong-Xin, Yuan, Ming-Jie, Tang, Yan-Hong, Zheng, Qing-Shan, Yin, Fang, Zhang, Shu, Zhang, Bo-Li, Gao, Run-Lin
• Format: Journal Article
• Language: English
• Published: China Medknow Publications and Media Pvt. Ltd 20.07.2017; Lippincott Williams & Wilkins Ovid Technologies; Department of Experimental Cardiology, Masonic Medical Research Laboratory, Utica, NY 13501, USA%Center for Drug Clinical Research, Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China%National Center for Cardiovascular Disease, Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100037, China%State Key Laboratory of Modern Chinese Medicine, College of Traditional Chinese Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China; Department of Cardiology, Cardiovascular Research Institute, Renmin Hospital of Wuhan University, Wuhan University, Wuhan, Hubei 430060, China%Department of Cardiology, Cardiovascular Research Institute, Renmin Hospital of Wuhan University, Wuhan University, Wuhan, Hubei 430060, China; Medknow Publications & Media Pvt Ltd; Wolters Kluwer
• Subjects: Adolescent; Adult; Aged; Analysis; Atherosclerosis; Blood diseases; Cardiac arrhythmia; Cardiology; Cardiovascular disease; Care and treatment; Chinese medicine; Clinical trials; Congestive heart failure; Congestive Heart Failure; Randomized Controlled Trial; Shensong Yangxin Capsules; Ventricular Premature Complexes; Double-Blind Method; Double-blind studies; Drug dosages; Drugs, Chinese Herbal - therapeutic use; Electrocardiography; FDA approval; Female; Heart failure; Heart Failure - drug therapy; Heart Failure - metabolism; Heart function tests; Heart rate; Heart Rate - drug effects; Hospitals; Humans; Laboratories; Male; Medicine, Chinese Traditional - methods; Middle Aged; Original; Patients; Potassium; Research centers; Traditional Chinese medicine; Ventricular ectopic beats; Ventricular Function, Left - drug effects; Ventricular Premature Complexes - drug therapy; Ventricular Premature Complexes - metabolism; Young Adult; 充血性心力衰竭; 室性; 心脏节律; 患者; 松; 胶囊; 试验; 随机; China; Ventricular Premature Complexes; Congestive Heart Failure; Randomized Controlled Trial; Shensong Yangxin Capsules
• ISSN: 0366-6999; 2542-5641
• DOI: 10.4103/0366-6999.209906

Background：Pharmacological therapy for congestive heart failure （CHF） with ventricular arrhythmia is limited.In the study,our aim was to evaluate the effects of Chinese traditional medicine Shensong Yangxin capsules （SSYX） on heart rhythm and function in CHF patients with frequent ventricular premature complexes （VPCs）.Methods：This double-blind,placebo-controlled,multicenter study randomized 465 CHF patients with frequent VPCs to the SSYX （n =232） and placebo groups （n =233） for 12 weeks of treatment.The primary endpoint was the VPCs monitored by a 24-h ambulatory electrocardiogram.The secondary endpoints included the left ventricular ejection fraction （LVEF）,left ventricular end-diastolic diameter,N-terminal pro-brain natriuretic peptide （NT-proBNP）,New York Heart Association （NYHA） classification,6-min walking distance （6MWD）,Minnesota Living with Heart Failure Questionnaire （MLHFQ） scores,and composite cardiac events （CCEs）.Results：The clinical characteristics were similar at baseline.SSYX caused a significantly greater decline in the total number of VPCs than the placebo did （-2145 ± 2848 vs.-841 ± 3411,P 〈 0.05）.The secondary endpoints of the LVEE NYHA classification,NT-proBNP,6MWD,and MLHFQ scores showed a greater improvements in the SSYX group than in the placebo group （ALVEF at 12th week：4.75 ± 7.13 vs.3.30 ± 6.53;NYHA improvement rate at the 8th and 12th week：32.6% vs.21.8%,40.5% vs.25.7%;mean level of NT-proBNP in patients with NT-proBNP 〉125 pg/ml at 12th week：-122 [Q1,Q3：-524,0] vs.-75 [Q1,Q3：-245,0];A6MWD at 12th week：35.1 ± 38.6 vs.17.2 ± 45.6;AMLHFQ at the 4th,8th,and 12th week：-4.24 ± 6.15 vs.-2.31 ± 6.96,-8.l 9 ± 8.41 vs.-3.25 ± 9.40,10.60 ± 9.41 vs.-4.83 ± 11.23,all P 〈 0.05）.CCEs were not different between the groups during the study period.Conclusions：In this 12-week pilot study,SSYX was demonstrated to have the benefits of VPCs suppression and cardiac function improvement with good compliance on a background of standard treatment for CHF.