Shaoxiang Xian1, Zhongqi Yang2, Jun Lee3, Zhiping Jiang4, Xiaohan Ye5, Luyi Luo6, Lili Jin7, Tianlun Yang8, Suilin Ye9, Dongfeng Lu10. 1. The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China. Electronic address: zhongfyy@126.com. 2. The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China. Electronic address: zqyang66@163.com. 3. The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, China. Electronic address: junlee008@126.com. 4. Yuebei People's Hospital, Shaoguan, China. Electronic address: jzp7448@163.com. 5. Dongguan Hospital of Traditional Chinese Medicine, Dongguan, China. Electronic address: xiaohanye666@126.com. 6. Shenzhen Hospital of Traditional Chinese Medicine, Shenzhen, China. Electronic address: luoluyi8@126.com. 7. Guangdong second Traditional Chinese Medicine Hospital, Guangzhou, China. Electronic address: wondergirl2@yeah.net. 8. Xiangya Hospital, Central South University, Changsha, China. Electronic address: yangtl44@yeah.net. 9. Guangzhou Hospital of Traditional Chinese Medicine, Guangzhou, China. Electronic address: suilinye52@163.com. 10. The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China. Electronic address: ludf123@126.com.
Abstract
ETHNOPHARMACOLOGICAL RELEVANCE: Shenmai injection (SMI) is a traditional Chinese herbal medicine extracted from Panax ginseng (Panax ginseng C.A. Mey, steamed and dry) and Ophiopogon japonicus (Ophiopogon japonicus (L.f.) Ker-Gawl, root). It has been widely used for the treatment of chronic heart failure (CHF) in China. However, the evidence supporting its effects remains unclear due to lack of high quality trials. The aim of this study was to investigate the efficacy and safety of SMI in CHF patients with coronary artery disease (CAD). MATERIALS AND METHODS: This double-blind, multicenter study randomized 240 eligible patients equally to receiveSMI or placebo (100ml/day) in addition to standard medicines for the treatment of CHF. The primary endpoint was the New York Heart Association (NYHA) functional classification. The secondary endpoints were 6-min walking distance (6MWD), short-form 36 (SF-36) hearth survey score, traditional Chinese medicines (TCM) syndrome score, left ventricular ejection fractions (LVEF) and B-type natriuretic peptide (BNP) level. RESULTS: During treatment of 1 week, the NYHA functional classification was gradually improved in both groups, but the SMI group demonstrated a significantly greater improvement compared with the placebo group (p=0.001). Moreover, the improvement in patients received SMI was superior to those in control group with respect to 6MWD, SF-36 score and TCM syndrome score. Treatment with SMI within 1 week was well tolerated with no apparent safety concerns. CONCLUSIONS: The integrative treatment with standard medicines plus SMI can further improve NYHA functional classification for patients with CHF and CAD. Therefore, SMI could be recommended in the combination therapy for CHF accompanied with CAD.
RCT Entities:
ETHNOPHARMACOLOGICAL RELEVANCE: Shenmai injection (SMI) is a traditional Chinese herbal medicine extracted from Panax ginseng (Panax ginseng C.A. Mey, steamed and dry) and Ophiopogon japonicus (Ophiopogon japonicus (L.f.) Ker-Gawl, root). It has been widely used for the treatment of chronic heart failure (CHF) in China. However, the evidence supporting its effects remains unclear due to lack of high quality trials. The aim of this study was to investigate the efficacy and safety of SMI in CHFpatients with coronary artery disease (CAD). MATERIALS AND METHODS: This double-blind, multicenter study randomized 240 eligible patients equally to receive SMI or placebo (100ml/day) in addition to standard medicines for the treatment of CHF. The primary endpoint was the New York Heart Association (NYHA) functional classification. The secondary endpoints were 6-min walking distance (6MWD), short-form 36 (SF-36) hearth survey score, traditional Chinese medicines (TCM) syndrome score, left ventricular ejection fractions (LVEF) and B-type natriuretic peptide (BNP) level. RESULTS: During treatment of 1 week, the NYHA functional classification was gradually improved in both groups, but the SMI group demonstrated a significantly greater improvement compared with the placebo group (p=0.001). Moreover, the improvement in patients received SMI was superior to those in control group with respect to 6MWD, SF-36 score and TCM syndrome score. Treatment with SMI within 1 week was well tolerated with no apparent safety concerns. CONCLUSIONS: The integrative treatment with standard medicines plus SMI can further improve NYHA functional classification for patients with CHF and CAD. Therefore, SMI could be recommended in the combination therapy for CHF accompanied with CAD.
Authors: Yuan Yu; Erica S Spatz; Qi Tan; Shuling Liu; Yuan Lu; Frederick A Masoudi; Wade L Schulz; Harlan M Krumholz; Jing Li Journal: J Am Heart Assoc Date: 2019-07-31 Impact factor: 5.501