Efficacy and safety of Qiliqiangxin capsule as adjunctive therapy in heart failure with reduced ejection fraction: A systematic review and meta-analysis of randomized controlled trials

Clinical Snapshot

Key Findings

• P Value: P = 0.02 for CV death, P = 0.001 for HF hospitalization

• Effect Size: 18% reduction in cardiovascular death, 22% reduction in HF hospitalization

• Primary Outcome: Cardiovascular death reduced by 18% (RR = 0.82, 95% CI [0.69, 0.96])

• Nnt Or Sensitivity: NNT approximately 25-50 patients (estimated from 18% relative risk reduction)

• Confidence Interval: RR 0.82 (95% CI 0.69-0.96) for CV death; RR 0.78 (95% CI 0.67-0.91) for HF hospitalization

Clinical Application

Limited by availability outside China and integration with conventional cardiology practice Not TGA approved; would require special access scheme. Limited applicability given lack of multicultural validation and absence from Australian heart failure guidelines. RACGP would likely require stronger evidence base before recommendation. HFrEF patients on optimal conventional therapy, particularly those of Chinese ethnicity or familiar with traditional Chinese medicine

Abstract

ETHNOPHARMACOLOGICAL RELEVANCE: The Qiliqiangxin (QLQX) capsule is a prominent traditional Chinese medicine formulation developed based on the collateral disease theory, specifically for the treatment of heart failure (HF). Its composition includes 11 medicinal botanicals, such as Huang Qi, Ren Shen, and Dan Shen, and is designed to tonify qi, activate blood circulation, and promote diuresis. Supported by over 20 years of extensive clinical application, modern pharmacological research, and stringent quality control, QLQX has been incorporated into the national heart failure guidelines in China. AIM OF THE STUDY: This study evaluates the efficacy and safety of QLQX as adjunctive therapy for heart failure with reduced ejection fraction (HFrEF). METHODS: We systematically searched seven databases until February 24, 2025, for randomized controlled trials (RCTs) evaluating QLQX in patients with HFrEF. Two independent researchers screened trials, extracted data, and assessed the risk of bias using the Cochrane RoB 2.0 tool. Meta-analyses were conducted for efficacy and safety outcomes, with evidence quality evaluated through the GRADE framework. RESULTS: Twenty-four RCTs (n = 5580) were included. Compared with conventional treatments (CTs) alone, QLQX adjunctive therapy significantly reduced the risk of cardiovascular death (RR = 0.82, 95 %CI [0.69, 0.96], P = 0.02), hospitalization for HF (RR = 0.78, 95 %CI [0.67, 0.91], P = 0.001), and composite cardiovascular events by 18 % (RR = 0.82, 95 %CI [0.73, 0.92], P = 0.0005), with evidence quality rated as moderate. QLQX significantly improved cardiac function parameters compared to controls: increased left ventricular ejection fraction (MD = 7.14, 95 % CI [6.75, 7.54], P < 0.05), reduced left ventricular end-diastolic diameter (MD = -5.25, 95 % CI [-5.75, -4.75], P < 0.05), improved NYHA class (RR = 1.19, 95 %CI [1.14, 1.25]), decreased NT-proBNP (SMD = -2.01, 95 %CI [-2.26, -1.95], P < 0.05), and increased 6-min walking distance (MD = 44.80, 95 %CI [42.37, 47.22], P < 0.05). CONCLUSION: QLQX adjunct therapy effectively reduces cardiovascular death and HF hospitalization while improving cardiac function in HFrEF, with favorable safety. Large-scale multicenter RCTs with extended follow-up are required to confirm long-term benefits and address existing study limitations.

References

1. 1.Li, Y., Mao, T., Qu, X., Xie, L., Li, P., Cheng, B., Zhang, D., Li, S., Li, D., & Lin, Q. (2026). Efficacy and safety of Qiliqiangxin capsule as adjunctive therapy in heart failure with reduced ejection fraction: A systematic review and meta-analysis of randomized controlled trials. Journal of Ethnopharmacology, 121175. https://doi.org/10.1016/j.jep.2026.121175