Jie Chen1, Yu Yao, Haining Chen, Joey S W Kwong, Jin Chen. 1. Department of Evidence-Based Medicine and Clinical Epidemiology, West China Hospital, Sichuan University, Chengdu, China. ebm_chenjin@126.com
Abstract
BACKGROUND: This systemic review is an update of a review previously published in 2011. 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 assess the effects (both benefits and harms) of Shengmai for heart failure. SEARCH METHODS: We searched CENTRAL and DARE on The Cochrane Library (2011, Issue 1), MEDLINE (1948 to March 2011), EMBASE (1980 to March 2011), AMED (1985 to August 2008) (AMED was not searched for the update as it is no longer available to the person conducting the searches), BIOSIS (1969 to March 2011), CBM (1978 to April 2011), VIP (1989 to April 2011) and CNKI (1979 to April 2011). 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 in treating heart failure, irrespective of blinding status, were included. More stringent inclusion criteria were applied in this update and only studies with a clear description of randomization methods and classified as true RCTs were 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 difference (MD) or standardized mean difference (SMD), respectively. A random-effects model and fixed-effect model were used to perform meta-analysis with and without heterogeneity, respectively. MAIN RESULTS: Nine RCTs (600 patients) with seven comparing Shengmai plus usual treatment with usual treatment alone and three comparing Shengmai with placebo (one RCT contained three arms) were included in this updated review. Based upon the seven RCTs (494 patients), improvement of the New York Heart Association (NYHA) functional classification was more common in patients taking Shengmai plus usual treatment than in those receiving usual treatment alone (risk ratio 0.33, 95% confidence interval 0.23 to 0.47). Beneficial effects of Shengmai in treating heart failure were also observed on other outcomes, including an exercise test, ejection fraction, cardiac output, cardiac index and left ventricular end-systolic volume. The three RCTs (106 patients) which compared Shengmai with placebo reported an improvement in NYHA functional classification, ejection fraction, stroke volume, cardiac index and myocardial contractility. Three out of the nine RCTs reported mild adverse effects, and two patients were withdrawn due to the adverse effects. The results of this review should be interpreted with caution. This is due to the studies being of low quality, their small sample size, and the significant heterogeneity for certain outcomes including ejection fraction and cardiac output. AUTHORS' CONCLUSIONS: Shengmai may be beneficial in treating heart failure, especially in terms of improving the NYHA functional classification with Shengmai plus usual treatment. However, the evidence for its effects on mortality and hospitalisation are not available yet. Therefore more studies, of higher quality and long-term follow-up, are needed to provide more evidence for the future use of Shengmai.
BACKGROUND: This systemic review is an update of a review previously published in 2011. 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 assess the effects (both benefits and harms) of Shengmai for heart failure. SEARCH METHODS: We searched CENTRAL and DARE on The Cochrane Library (2011, Issue 1), MEDLINE (1948 to March 2011), EMBASE (1980 to March 2011), AMED (1985 to August 2008) (AMED was not searched for the update as it is no longer available to the person conducting the searches), BIOSIS (1969 to March 2011), CBM (1978 to April 2011), VIP (1989 to April 2011) and CNKI (1979 to April 2011). 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 in treating heart failure, irrespective of blinding status, were included. More stringent inclusion criteria were applied in this update and only studies with a clear description of randomization methods and classified as true RCTs were 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 difference (MD) or standardized mean difference (SMD), respectively. A random-effects model and fixed-effect model were used to perform meta-analysis with and without heterogeneity, respectively. MAIN RESULTS: Nine RCTs (600 patients) with seven comparing Shengmai plus usual treatment with usual treatment alone and three comparing Shengmai with placebo (one RCT contained three arms) were included in this updated review. Based upon the seven RCTs (494 patients), improvement of the New York Heart Association (NYHA) functional classification was more common in patients taking Shengmai plus usual treatment than in those receiving usual treatment alone (risk ratio 0.33, 95% confidence interval 0.23 to 0.47). Beneficial effects of Shengmai in treating heart failure were also observed on other outcomes, including an exercise test, ejection fraction, cardiac output, cardiac index and left ventricular end-systolic volume. The three RCTs (106 patients) which compared Shengmai with placebo reported an improvement in NYHA functional classification, ejection fraction, stroke volume, cardiac index and myocardial contractility. Three out of the nine RCTs reported mild adverse effects, and two patients were withdrawn due to the adverse effects. The results of this review should be interpreted with caution. This is due to the studies being of low quality, their small sample size, and the significant heterogeneity for certain outcomes including ejection fraction and cardiac output. AUTHORS' CONCLUSIONS: Shengmai may be beneficial in treating heart failure, especially in terms of improving the NYHA functional classification with Shengmai plus usual treatment. However, the evidence for its effects on mortality and hospitalisation are not available yet. Therefore more studies, of higher quality and long-term follow-up, are needed to provide more evidence for the future use of Shengmai.