Abstract

Correlating Chinese Medicine Syndromes with Heart Failure Severity and Qiliqiangxin Effectiveness in a Randomized Trial

Background: Heart failure (HF) remains a global health burden with high mortality and rehospitalization rates despite guideline-directed therapies. Traditional Chinese medicine (TCM) is increasingly used as an adjunct therapy, whose strategies are guided by syndrome differentiation. Whether TCM syndrome patterns correlate with clinical parameters or influence HF outcomes remains unclear.

Purpose: To investigate whether TCM syndrome patterns are associated with HF severity and modulate efficacy of Qiliqiangxin (QLQX), a standardized TCM formula.

Study Design: Randomized controlled trial on 2,845 participants with heart failure with reduced ejection fraction (HFrEF) enrolled across 133 Chinese hospitals.

Methods: Primary composite endpoint was cardiovascular death or HF rehospitalization; secondary endpoints included all-cause mortality and HF-related adverse events.

Results: TCM syndrome patterns correlated significantly with New York Heart Association (NYHA) class and NT-proBNP levels, reflecting HF severity. QLQX reduced primary endpoint overall (hazard ratio [HR], 0.77 [95% CI, 0.67 to 0.89]), with consistent effects across subgroups adjusted for age, sex, and BMI (P for interaction = 0.76). In the largest subgroup, Qi Deficiency pattern, QLQX yielded a robust HR of 0.75 (CI, 0.63 to 0.89). Exploratory analyses revealed delayed treatment benefits in the Yang-Qi Deficiency pattern after 9 months (HR, 0.41 [CI, 0.19 to 0.90]) and Qi-Yin Deficiency pattern after 15 months (HR, 0.10 [CI, 0.01 to 0.73]).

Conclusion: This study provides evidence supporting biological relevance of TCM syndrome differentiation. While QLQX confers broad benefits in HFrEF, the timing and magnitude of effects vary across syndrome-based subtypes, underscoring personalized TCM-integrated strategies.