PMID- 27045864 OWN - NLM STAT- MEDLINE DCOM- 20170222 LR - 20220419 IS - 1872-7573 (Electronic) IS - 0378-8741 (Linking) VI - 186 DP - 2016 Jun 20 TI - A randomized, double-blind, multicenter, placebo-controlled clinical study on the efficacy and safety of Shenmai injection in patients with chronic heart failure. PG - 136-142 LID - S0378-8741(16)30189-1 [pii] LID - 10.1016/j.jep.2016.03.066 [doi] AB - 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 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. CI - Copyright (c) 2016 Elsevier Ireland Ltd. All rights reserved. FAU - Xian, Shaoxiang AU - Xian S AD - The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China. Electronic address: zhongfyy@126.com. FAU - Yang, Zhongqi AU - Yang Z AD - The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China. Electronic address: zqyang66@163.com. FAU - Lee, Jun AU - Lee J AD - The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, China. Electronic address: junlee008@126.com. FAU - Jiang, Zhiping AU - Jiang Z AD - Yuebei People's Hospital, Shaoguan, China. Electronic address: jzp7448@163.com. FAU - Ye, Xiaohan AU - Ye X AD - Dongguan Hospital of Traditional Chinese Medicine, Dongguan, China. Electronic address: xiaohanye666@126.com. FAU - Luo, Luyi AU - Luo L AD - Shenzhen Hospital of Traditional Chinese Medicine, Shenzhen, China. Electronic address: luoluyi8@126.com. FAU - Jin, Lili AU - Jin L AD - Guangdong second Traditional Chinese Medicine Hospital, Guangzhou, China. Electronic address: wondergirl2@yeah.net. FAU - Yang, Tianlun AU - Yang T AD - Xiangya Hospital, Central South University, Changsha, China. Electronic address: yangtl44@yeah.net. FAU - Ye, Suilin AU - Ye S AD - Guangzhou Hospital of Traditional Chinese Medicine, Guangzhou, China. Electronic address: suilinye52@163.com. FAU - Lu, Dongfeng AU - Lu D AD - The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China. Electronic address: ludf123@126.com. LA - eng PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial DEP - 20160401 PL - Ireland TA - J Ethnopharmacol JT - Journal of ethnopharmacology JID - 7903310 RN - 0 (Drug Combinations) RN - 0 (Drugs, Chinese Herbal) RN - 0 (fructus schizandrae, radix ginseng, radix ophiopogonis drug combination) SB - IM MH - Aged MH - Chronic Disease MH - Double-Blind Method MH - Drug Combinations MH - Drugs, Chinese Herbal/*therapeutic use MH - Female MH - Heart Failure/*drug therapy MH - Humans MH - Male MH - Middle Aged OTO - NOTNLM OT - Heart failure OT - Ophiopogon japonicas OT - Panax ginseng OT - Randomized controlled trial OT - Shenmai injection OT - Traditional Chinese medicines EDAT- 2016/04/06 06:00 MHDA- 2017/02/23 06:00 CRDT- 2016/04/06 06:00 PHST- 2015/11/19 00:00 [received] PHST- 2016/02/04 00:00 [revised] PHST- 2016/03/31 00:00 [accepted] PHST- 2016/04/06 06:00 [entrez] PHST- 2016/04/06 06:00 [pubmed] PHST- 2017/02/23 06:00 [medline] AID - S0378-8741(16)30189-1 [pii] AID - 10.1016/j.jep.2016.03.066 [doi] PST - ppublish SO - J Ethnopharmacol. 2016 Jun 20;186:136-142. doi: 10.1016/j.jep.2016.03.066. Epub 2016 Apr 1.