Efficacy and Safety of Shengmai Injection for Chronic Heart Failure: A Systematic Review of Randomized Controlled Trials

Background: Shengmai injection (SMI) is made from purified ginseng, Radix Ophiopogonis, and Schisandra chinensis. It has cardiotonic effects and is clinically used for the adjuvant treatment of chronic heart failure (CHF). However, its efficacy and safety are uncertain. The purpose of this study was to systematically evaluate the existing efficacy and safety evidence in randomized controlled trials (RCTs) that studied SMI for the treatment of CHF.

Methods: PubMed, Embase, Cochrane Library, clinicaltrials.gov, CNKI, Wanfang, VIP, and CBM databases were searched up to September 10, 2019. RCTs that compared basic Western medicine treatment with SMI + basic Western medicine were included. The Cochrane Collaboration Risk of Bias Tool was used to assess the risk of bias in the RCTs. The meta-analysis used the random effects model; the mean difference (MD) and 95% confidence intervals (CIs) were combined using the inverse variance method, and the Mantel-Haenszel method was used to combine the relative risk (RR) and 95% CIs. Heterogeneity was assessed using I² and Q tests, and the source of heterogeneity was explored by analyzing three preset subgroup hypotheses.

Results: A total of 20 RCTs were included (n = 1562), with a moderate-to-high risk of bias. The meta-analysis showed that, compared with Western medicine alone, SMI adjuvant therapy significantly improved cardiac function indicators, including left ventricular ejection fraction (MD 6.8%, 95% CI 4.68 to 8.91), stroke volume (MD 9.81 ml, 95% CI 5.67 to 13.96), cardiac output (MD 0.96 L/min, 95% CI 0.66 to 1.25), and cardiac index (MD 0.53 L/min, 95% CI 0.36 to 0.70); heterogeneity was generally high among these outcomes. Compared with the controls, patients receiving SMI adjuvant therapy also had a higher response to treatment (RR 2.89, 95% CI 2.10 to 3.99; I² = 0%), a greater decrease in brain natriuretic peptide levels (MD -284.66 ng/l, 95% CI -353.73 to -215.59, I² = 0%), and a greater increase in six-minute walk test performance (MD 70.67 m, 95% CI 22.92 to 118.42; I² = 84%). Nine studies reported mild adverse events, such as gastrointestinal reactions, and no serious adverse events were reported.

Conclusion: Currently, available evidence indicates that SMI, as an adjuvant for basic Western medicine treatment, can improve the cardiac function of patients with CHF with good safety outcomes. Because of the high risk of bias among the included RCTs and the large heterogeneity of partial outcomes, the findings of this study must be verified by high-quality studies with large sample sizes.