A randomized, double-blind, multicenter, placebo-controlled clinical study on the efficacy and safety of Shenmai injection in patients with chronic heart failure

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). This double-blind, multicenter study randomized 240 eligible patients equally to receive SMI or placebo (100 ml/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. 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. 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.