Efficacy and safety of Shengmai injection for chronic cor pulmonale: A systematic review with meta-analysis and trial sequential analysis of 31 randomized controlled trials

Abstract

Introduction

This study aimed to systematically evaluate the efficacy and safety of Shengmai injection (Radix ginseng, Radix ophiopogonis, and Fructus Schisandrae chinensis) as an adjunct to conventional medicine in the treatment of chronic cor pulmonale.

Methods

A search of ten databases was conducted up to March 27, 2023, to identify randomized controlled trials that assessed the efficacy of Shengmai injection plus conventional medicine versus conventional medicine alone in the treatment of chronic cor pulmonale. Meta-analysis was performed using RevMan version 5.4, with risk ratios (RRs), mean differences (MDs), and 95 % confidence intervals (CIs) used as effect measures. Trial sequential analyses were conducted to quantify the statistical reliability of the data in the studies.

Results

A total of 31 studies involving 3,036 patients were included in the meta-analysis. The results showed that Shengmai injection combined with conventional therapies significantly improved the response to treatment (RR 1.24, CIs 1.19 to 1.29) as well as heart function (e.g., left ventricular ejection fraction: MD 8.14 % [CIs 2.33 to 13.95]; right ventricular ejection fraction: MD 8.51 % [CIs 3.61 to 13.41], stroke volume: MD 12.38 mL [CIs 4.80 to 19.96], cardiac output: MD 0.35 L/min, [CIs 0.19 to 0.50], cardiac index: MD 0.45 L/min·m², [CIs 0.19 to 0.72]), blood gas indicators (SaO₂: MD 4.18 % [CIs 3.12 to 5.25], PaO₂: MD 5.63 mmHg [CIs 4.26 to 7.00]), and lung function (FEV₁: MD 0.40 L [CIs 0.26 to 0.53], FEV₁/FVC: MD 10.10 % [CIs 7.43 to 12.77]) in patients with cor pulmonale. Additionally, no significant improvement was observed in creatine kinase isoenzyme- myocardial band or plasma viscosity compared with the controls. Two cases (4 %) of mild adverse events (dry mouth) possibly related to Shengmai injection were reported, but no serious adverse events were observed.

Conclusions

Shengmai injection may be an effective supplemental therapy for chronic cor pulmonale, potentially improving treatment response, heart and lung functioning, blood gas analysis, and hemorheological indicators, with an acceptable safety profile. However, the risk of selection bias and high heterogeneity in some studies highlight the need for further multicenter, large-sample randomized controlled trials to validate these findings.