What is the clinical evidence from this study?

Study design: Cohort. Population: Heart failure (n=210). Intervention: Xinli Formula vs. Guideline-directed standard treatment. Primary outcome: Change in Left Ventricular Ejection Fraction (LVEF) (MD 2.1%, 95% CI 0.9-3.3, p=0.001).

What does this research mean for the field?

The Xinli Formula significantly improves cardiac function, exercise tolerance, and quality of life, while reducing inflammatory markers and NT-proBNP levels, in patients with heart failure. Novelty: ClaimNovelty.INCREMENTAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

November 17, 2025Frontiers in Pharmacology1 citationsOpen Access

Xinli formula’s efficacy in heart failure: analysis via Guangdong TCM hospital database

HCHaiming CaoGuangzhou University of Chinese Medicine JZJiongming ZhangUniversity of Science and Technology Beijing TZTong ZhangGuangzhou University of Chinese Medicine

Key Result

In patients with heart failure, the addition of Xinli Formula to standard care significantly improved left ventricular ejection fraction by an additional 2.1% compared to standard care alone over a 1-week period.

Study Design

Type

Cohort (n=210)

Multicenter

Structured PICO

Does the addition of Xinli Formula to guideline-directed medical therapy improve cardiac function, exercise tolerance, and biomarkers in patients with heart failure?

Population

210 patients with heart failure, characterized by reduced ejection fraction or enlarged left ventricle and elevated natriuretic peptides, evaluated over a 1-week treatment period.

Exposure

Xinli Formula (standardized 20 g granule containing Plantago asiatica, Curcuma zedoaria, Panax ginseng, Astragalus membranaceus, and Cornus officinalis) dissolved in warm water, oral twice daily for 1 week, added to guideline-directed standard treatment.

Comparator

Guideline-directed standard treatment alone (2021 ESC/2022 ACC/AHA HF protocols including intravenous loop diuretics, ACEI/ARB/ARNI, beta-blockers, MRA, and SGLT2 inhibitors).

Outcome

Cardiac function parameters (LVEF, LVESD, LVEDD), NT-proBNP levels, and 6-minute walk distance (6MWD) at 7 days.surrogate

Main Result

Mean Difference: 2.1 (95% CI 0.9–3.3)

Absolute Event Rate: 4% vs 2%

p-value: p=0.001

Limitations

Retrospective cohort design subject to residual confounding despite propensity score weighting
Short treatment and follow-up duration of only 1 week
Observed echocardiographic changes likely reflect short-term functional volume unloading rather than true pathological reverse remodeling
Single-center study

Abstract

Objective: To evaluate the efficacy of the "Xinli Formula" in improving cardiac function, symptoms, and quality of life in patients with heart failure using a hospital database. Methods: A retrospective study included 210 patients (2017-2022) divided into Xinli Formula group (n = 107) and non-Xinli Formula group (n = 103). Outcomes included cardiac function parameters, N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels, 6-min walk distance (6MWD), quality of life (Minnesota Living with Heart Failure Questionnaire, MLHFQ), and inflammatory markers. Data were analyzed using SPSS 26.0. Results: The Xinli Formula group showed significant improvements in Left Ventricular Ejection Fractions (LVEF) (38% → 42%), Left Ventricular End-Systolic Diameter (LVESD) (45 mm → 40 mm), Left Ventricular End-Diastolic Diameter (LVEDD) (60 mm → 55 mm), and 6MWD (350 m → 400 m). MLHFQ scores decreased from 45 to 30. Inflammatory markers and NT-proBNP levels also improved significantly. Conclusion: The Xinli Formula significantly improves cardiac function, exercise tolerance, and quality of life in patients with heart failure and may be an effective adjunctive therapy. Further studies are needed.

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