Title | Qishen Yiqi dripping pills for chronic ischaemic heart failure: results of the CACT-IHF randomized clinical trial |
Authors | Mao, Jingyuan Zhang, Jian Lam, Carolyn S. P. Zhu, Mingjun Yao, Chen Chen, Shutao Liu, Zhongyong Wang, Fengrong Wang, Yonggang Dai, Xiaohua Niu, Tianfu An, Dongqing Miao, Yang Xu, Tao Dong, Bo Ma, Xiaofeng Zhang, Fengru Wang, Xiaolong Fan, Ruihong Zhao, Yingqiang Jiang, Tiemin Zhang, Yuhui Wang, Xianliang Hou, Yazhu Zhao, Zhiqiang Su, Quan Zhang, Junhua Wang, Baohe Zhang, Boli |
Affiliation | Tianjin Univ Tradit Chinese Med, Teaching Hosp 1, Tianjin, Peoples R China Chinese Acad Med Sci, Natl Ctr Cardiovasc Dis, Fuwai Hosp, Beijing, Peoples R China Natl Heart Ctr Singapore, Singapore, Singapore Duke Nat Univ Singapore, Singapore, Singapore Univ Med Ctr Groningen, Groningen, Netherlands George Inst Global Hlth, Sydney, NSW, Australia Henan Univ Tradit Chinese Med, Affiliated Hosp 1, Zhengzhou, Henan, Peoples R China Peking Univ, Clin Res Inst, Beijing, Peoples R China Tianjin Chest Hosp, Tianjin, Peoples R China Jiangxi Univ Tradit Chinese Med, Affiliated Hosp, Nanchang, Jiangxi, Peoples R China Liaoning Univ Tradit Chinese Med, Affiliated Hosp 1, Shenyang, Liaoning, Peoples R China Shaanxi Univ Chinese Med, Affiliated Hosp 2, Xianyang, Shaanxi, Peoples R China Anhui Univ Chinese Med, Affiliated Hosp 1, Hefei, Anhui, Peoples R China Shanxi Tradit Chinese Med Hosp, Xianyang, Shanxi, Peoples R China Tradit Chinese Med Hosp Xinjiang Uygur Autonomous, Xinjiang, Peoples R China China Acad Chinese Med Sci, Xiyuan Hosp, Beijing, Peoples R China Guiyang Coll Tradit Chinese Med, Affiliated Hosp 2, Guiyang, Guizhou, Peoples R China Liaoning Univ Tradit Chinese Med, Affiliated Hosp 2, Shenyang, Liaoning, Peoples R China Univ South China, Affiliated Nanhua Hosp, Hengyang, Hunan, Peoples R China Shanghai Jiao Tong Univ, Sch Med, Ruijin Hosp, Shanghai, Peoples R China Shanghai Univ Tradit Chinese Med, Shuguang Hosp, Shanghai, Peoples R China Tianjin Acad Tradit Chinese Med, Affiliated Hosp, Tianjin, Peoples R China Tianjin Univ Tradit Chinese Med, Teaching Hosp 2, Tianjin, Peoples R China Logist Univ Chinese Peoples Armed Police Force, Affiliated Hosp, Tianjin, Peoples R China Tianjin Univ Tradit Chinese Med, Tianjin, Peoples R China |
Keywords | CORONARY-ARTERY-DISEASE TRADITIONAL CHINESE MEDICINE DOUBLE-BLIND MULTICENTER PROTOCOL OUTCOMES |
Issue Date | Sep-2020 |
Publisher | ESC HEART FAILURE |
Abstract | Aims Qishen Yiqi dripping pills (QSYQ) may be beneficial in patients with ischaemic heart failure (IHF). We aimed to assess the efficacy and safety of QSYQ administered together with guideline-directed medical therapy in patients with IHF. Methods and results This prospective randomized, double-blind, multicentre placebo-controlled study enrolled 640 patients with IHF between March 2012 and August 2014. Patients were randomly assigned to receive 6 months of QSYQ or placebo in addition to standard treatment. The primary outcome was 6 min walking distance at 6 months. Among the 638 IHF patients (mean age 65 years, 72% men), the 6 min walking distance increased from 336.15 +/- 100.84 to 374.47 +/- 103.09 m at 6 months in the QSYQ group, compared with 334.40 +/- 100.27 to 340.71 +/- 104.57 m in the placebo group (mean change +38.32 vs. +6.31 m respectively;P < 0.001). The secondary outcomes in composite clinical events, including all-cause mortality and emergency treatment/hospitalization due to heart failure, were non-significantly lower at 6 months with QSYQ compared with placebo (13% vs. 17%;P = 0.45), and the change of brain natriuretic peptide was non-significantly greater with QSYQ compared with placebo (median change -14.55 vs. -12.30 pg/mL, respectively;P = 0.21). By contrast, the Minnesota Living with Heart Failure Questionnaire score significantly improved with QSYQ compared with placebo (-11.78 vs. -9.17;P = 0.004). Adverse events were minor and infrequent with QSYQ, similar to the placebo group. Conclusions Treatment with QSYQ for 6 months in addition to standard therapy improved exercise tolerance of IHF patients and was well tolerated. |
URI | http://hdl.handle.net/20.500.11897/607703 |
ISSN | 2055-5822 |
DOI | 10.1002/ehf2.12980 |
Indexed | SCI(E) |
Appears in Collections: | 医学部待认领 |