title: A randomized, double-blind, multicenter, placebo-controlled clinical study on the efficacy and safety of Shenmai injection in patients with chronic heart failure.
abstract: BACKGROUND
  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).
  
  
  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.affiliation: The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China. Electronic address: zhongfyy@126.com.
authors.forename: Shaoxiang
authors.initials: S
authors.lastname: Xian
authors.affiliation: The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China. Electronic address: zqyang66@163.com.
authors.forename: Zhongqi
authors.initials: Z
authors.lastname: Yang
authors.affiliation: The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, China. Electronic address: junlee008@126.com.
authors.forename: Jun
authors.initials: J
authors.lastname: Lee
authors.affiliation: Yuebei People's Hospital, Shaoguan, China. Electronic address: jzp7448@163.com.
authors.forename: Zhiping
authors.initials: Z
authors.lastname: Jiang
authors.affiliation: Dongguan Hospital of Traditional Chinese Medicine, Dongguan, China. Electronic address: xiaohanye666@126.com.
authors.forename: Xiaohan
authors.initials: X
authors.lastname: Ye
authors.affiliation: Shenzhen Hospital of Traditional Chinese Medicine, Shenzhen, China. Electronic address: luoluyi8@126.com.
authors.forename: Luyi
authors.initials: L
authors.lastname: Luo
authors.affiliation: Guangdong second Traditional Chinese Medicine Hospital, Guangzhou, China. Electronic address: wondergirl2@yeah.net.
authors.forename: Lili
authors.initials: L
authors.lastname: Jin
authors.affiliation: Xiangya Hospital, Central South University, Changsha, China. Electronic address: yangtl44@yeah.net.
authors.forename: Tianlun
authors.initials: T
authors.lastname: Yang
authors.affiliation: Guangzhou Hospital of Traditional Chinese Medicine, Guangzhou, China. Electronic address: suilinye52@163.com.
authors.forename: Suilin
authors.initials: S
authors.lastname: Ye
authors.affiliation: The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China. Electronic address: ludf123@126.com.
authors.forename: Dongfeng
authors.initials: D
authors.lastname: Lu
mesh_terms: D000368:Aged; D002908:Chronic Disease; D004311:Double-Blind Method; D004338:Drug Combinations; D004365:Drugs, Chinese Herbal / Q000627:therapeutic use*; D005260:Female; D006333:Heart Failure / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged
chemical_list: D004338:Drug Combinations; D004365:Drugs, Chinese Herbal; C009252:fructus schizandrae, radix ginseng, radix ophiopogonis drug combination
keywords: Heart failure; Ophiopogon japonicas; Panax ginseng; Randomized controlled trial; Shenmai injection; Traditional Chinese medicines