Efficacy and safety of Qiliqiangxin capsule for heart failure with reduced ejection fraction: a systematic review and meta-analysis

Background and purpose: Heart failure (HF) is a global chronic disease that significantly impacts patients’ quality of life and imposes substantial health burdens. Therapeutic strategies for HF with reduced ejection fraction (HFrEF) have advanced rapidly. However, conventional pharmacological treatments remain limited by clinical drawbacks. Traditional Chinese medicine, particularly Qiliqiangxin capsule (QLQX), has emerged as a promising complementary approach in China. To date, a comprehensive and updated systematic review and meta-analysis evaluating the efficacy and safety of QLQX for HFrEF is lacking. Therefore, we conducted this systematic review and meta-analysis to assess the effectiveness and safety of QLQX in treating patients with HFrEF. Methods: A systematic literature search was conducted in PubMed, the Cochrane Library, Web of Science, Wanfang Database, Chinese Biomedical Literature Database, China Science and Technology Journal Database, and China National Knowledge Infrastructure from inception to the latest available date. Two reviewers independently performed study selection, data extraction, and risk-of-bias assessment. Meta-analyses were performed using Review Manager Software 5.4 and Stata 16.0. Results: A total of 40 studies involving 7,367 patients were included. Compared with conventional Western medicine (CWM) alone, QLQX combined with CWM significantly improved New York Heart Association (NYHA) functional class (risk ratio [RR]: 1.22, 95% confidence interval [95% CI]: 1.16–1.29; P < 0.05) and 6-minute walking distance (mean differences [MD]: 58.40, 95% CI: 45.52–71.28; P < 0.05). Additionally, QLQX significantly reduced rehospitalization rates (RR: 0.78, 95% CI: 0.67–0.90; P < 0.05) and N-terminal Pro-B-type natriuretic peptide (NT-proBNP) levels (MD: −276.04, 95% CI: −348.49 to −203.59; P < 0.05). Moderate to high heterogeneity was observed in some outcomes. Subgroup and meta-regression analyses identified treatment duration and sex differences as potential sources of heterogeneity. Conclusions: QLQX combined with CWM appears to be an effective and safe adjunctive therapy for improving clinical outcomes in patients with HFrEF. Although these findings provide supportive evidence, further large-scale, high-quality randomized controlled trials are needed to confirm these results and inform clinical practice.