Background: 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.
Objectives: To determine the effects (both benefits and harms) of Shengmai plus usual treatment versus usual treatment alone for heart failure.
Search strategy: We searched CENTRAL and DARE on The Cochrane Library (Issue 3, 2008), MEDLINE (1966 to August 2008), EMBASE (1984 to August 2008), AMED (1985 to August 2008) and BIOSIS (1997 to August 2008) and CBM (1978 to August 2008). We added two new Chinese databases for the update; VIP (1989 to September 2008) and CNKI (1979 to September 2008). We also handsearched Chinese journals. No language restrictions were applied.
Selection criteria: Randomized controlled trials (RCTs) of Shengmai plus usual treatment versus usual treatment alone or Shengmai versus placebo for heart failure, irrespective of blinding status, were included. More stringent inclusion criteria were applied in this update and only studies that have a clear description of randomisation methods are classed as true RCTs and hence included.
Data collection and analysis: Two authors independently selected trials, assessed methodological quality and extracted data. Dichotomous and continuous data were calculated as relative risk (RR), and mean differences (MD) or standardized mean difference (SMD). Random-effect model and fixed-effect model were used to perform meta-analysis for with and without heterogeneity respectively.
Main results: Only six RCTs with a total of 440 patients were included in this updated review. Compared to usual treatment alone, Shengmai plus usual treatment in five trials indicated an improvement in NYHA classification (RR 0.37; 95% CI 0.25 to 0.54). Other benefits were observed, but were limited to low patient numbers and significant heterogeneity: ejection fraction, cardiac output, stroke volume, exercise test and ratio of peak early to late diastolic filling velocity. Only one RCT with 40 patients compared Shengmai to placebo, and improvements were seen in stroke volume, Heath and Cardic index and myocardial contractility. Two studies reported mild adverse effects, but no patients were withdrawn or needed medication due to these adverse effects.
Authors' conclusions: Shengmai may be beneficial for heart failure compared to placebo or plus usual treatment compared to usual treatment alone. However, long-term and more high quality studies are needed to provide clear evidence for the future use of Shengmai.