Efficacy and safety of Shenfu injection on bradyarrhythmia: A systematic review and meta-analysis

BACKGROUND: Bradyarrhythmia is a form of arrhythmia commonly seen in clinical settings. This study aims to investigate the efficacy and safety of the Shenfu injection (SFI) in the treatment of bradyarrhythmia. METHODS: A comprehensive search was conducted in seven databases for randomized controlled trials (RCTs) related to SFI and the treatment of bradyarrhythmia. Primary outcome in this meta-analysis included the overall response rate in clinical symptom improvement. The risk of bias was evaluated utilizing the Cochrane Collaboration's tool. RESULTS: A total of 28 studies, involving 2143 patients with bradyarrhythmia, were included. The meta-analysis results suggest that SFI treatment is superior to conventional medication alone. Further sensitivity analysis demonstrated that the total response rate in the SFI group was significantly higher than that in the conventional medication group (RR = 1.29; 95% CI: 1.22-1.37; P < .00001). Moreover, the improvement in heart rate in the SFI group was significantly better than that in the conventional medication group (MD = 5.17; 95% CI: 3.77-6.58; P < .00001). In terms of safety, the incidence of adverse events was lower in the SFI treatment group (5.25%, 19/362) compared to the conventional medication alone group (34.04%, 113/332) (RR = 0.20; 95% CI: 0.08-0.51; P < .001). CONCLUSION: SFI demonstrates significant improvement in the overall response rate and safety for patients with bradyarrhythmia compared to conventional basic therapy. However, due to the presence of potential bias in the included studies, well-designed RCT trials are needed to confirm the efficacy and safety of adjuvant SFI therapy for the treatment of bradyarrhythmia.