OBJECTIVETo assess the clinical effects and safety of Shencao Tongmai Granule (STG) in treatment of patients with chronic heart failure (CHF) (NYHA functional class II - III) of qi deficiency blood stasis and water retention syndrome (QDBSWRS).

METHODSThis was a multi-centered, double blinded, randomized, and placebo parallel controlled study. A total of 280 CHF patients of QDBSWRS were randomly assigned to the trial group and the control group in the ratio of 1:1. All patients received Western medicine (WM) treatment such as ACEI, diuretics, Digoxin Elixirs, and so on. Additionally, patients in the trial group took STG while those in the control group took the placebo. The therapeutic course for all was twelve weeks. The NYHA functional classification, Chinese medicine (CM) syndrome integral, and left ventricular ejection fraction (LVEF) were compared between the two groups. The safety assessment was also carried out.

RESULTSTotally 265 patients completed this trial (138 cases in the trial group and 127 cases in the control group). The effective rate of NYHA functional classification and CM syndrome integral were obviously higher in the trial group than in the control group (94.20% vs 55.90%, 97.83% vs 70.08% respectively), showing statistical difference (P < 0.01). There was no statistical difference in LVEF between the two groups before treatment (P > 0.05). The LVEF both increased in the two groups when compared with before treatment (P < 0.05). The post-treatment increment of LVEF was obviously higher in the trial group than in the control group (6.55% +/- 6.23% vs 3.14% +/- 4.99%, P < 0.05). The rate of adverse reaction was 0.71% in the two groups (1/140).

CONCLUSIONSTG showed good therapeutic effectiveness and safety in treating CHF patients of QDBSWRS.