Heart failure is a major public health issue worldwide. Despite advances in treatment, many people are affected and hundreds of thousand of people die each year. Shengmai is a traditional Chinese herbal medicine and is a mixture extracted from three herbs: Panax ginseng, Ophiopogon japonicus and Schisandra chinensis. In China it has been used to treat heart failure and ischemiac heart disease.
In this Cochrane Review update, we included 14 trials which compared Shengmai plus usual treatment with usual treatment alone, or compared Shengmai with placebo. Shengmai may be beneficial in improving heart function (low quality evidence) and in most trials, people who took Shengmai had few unwanted side effects. However, many of the included trials were of poor quality and included a small number of people. More high quality, large trials of Shengmai of treatment heart failure are needed.
Shengmai may exert a positive effect on heart failure, especially for improving NYHA functional classification when Shengmai plus usual treatment is used. The review results should be interpreted with caution due to the high risk of bias of the included studies (particularly regarding allocation concealment and blinding), the small sample size of these studies, and the significant heterogeneity in outcomes such as ejection function, cardiac output and stroke volume. There was no evidence available concerning the effect of Shengmai on mortality, and more high quality studies with long-term follow-up are warranted.
Heart failure is a major public health problem worldwide. Shengmai, a traditional Chinese herbal medicine, has long been used as a complementary treatment for heart failure in China. This is an update of a Cochrane Review published in 2012.
To determine the effect (both benefits and harms) of Shengmai in treatment of people with heart failure.
We searched CENTRAL on The Cochrane Library (Issue 5 of 12, April 2013); DARE on The Cochrane Library (Issue 2 of 4, April 2013); MEDLINE (1948 to June Week 1 2013); EMBASE (1980 to 2013 Week 23); AMED (1985 to August 2008); BIOSIS (1969 to 7 June 2013); CBM (1978 to June 2013); VIP (1989 to June 2013); and CNKI (1979 to June 2013). We also handsearched Chinese journals and did not apply any language restrictions.
We included randomised controlled trials (RCTs) of Shengmai plus usual treatment for heart failure versus usual treatment alone, or Shengmai versus placebo, irrespective of blinding status. In this update we only included studies with a clear description of randomisation methods and classified as true RCTs.
Two authors independently selected trials, assessed methodological quality and extracted data. We calculated dichotomous data as risk ratios (RRs) and continuous data as mean differences (MDs) or standardized mean differences (SMDs) with corresponding 95% confidence intervals (CIs). We used a fixed-effect model to perform meta-analysis for outcomes without heterogeneity; and a random-effects model to perform meta-analysis for outcomes with heterogeneity.
We included a total of 14 RCTs (858 patients) in this review update, four of which were new trials. Of these 14 RCTs, 11 trials compared Shengmai plus usual treatment with usual treatment alone, and three trials compared Shengmai with placebo. Improvement of NYHA functional classification was more common in patients taking Shengmai plus usual treatment than in those receiving usual treatment alone (RR 0.37; 95% CI 0.26 to 0.51; 10 trials, 672 participants; low quality evidence). Beneficial effects of Shengmai in treating heart failure were also observed in other outcomes, including exercise test, ejection fraction and cardiac output. The three RCTs (106 patients) comparing Shengmai with placebo reported improvement in NYHA functional classification and in stroke volume. Three of the 14 RCTs reported a total of six patients with mild adverse effects and two were withdrawn due to the adverse effects. The adverse events rate was 1.21%.