The therapy under scrutiny is Qili Qiangxin Capsule, a Chinese patent medicine that has been widely prescribed in China as an add-on treatment for heart failure. The review, conducted by researchers from Beijing University of Chinese Medicine, Shandong University of Traditional Chinese Medicine and collaborating institutions, focused specifically on patients whose heart failure developed after an acute myocardial infarction, a high-risk population in which roughly a quarter of patients with ST-segment elevation myocardial infarction go on to develop heart failure.

Heart failure following a heart attack remains a major cause of illness and death despite advances in conventional therapy. Epidemiological data cited in the review indicate that the rehospitalisation rate due to heart failure after myocardial infarction reaches 16.7 percent, and the risks of ventricular remodelling, recurrent hospitalisation and adverse cardiovascular events remain high even with guideline-directed medical therapy, coronary revascularisation and device-based interventions.

The researchers searched seven databases from their inception to January 2026 and included only randomised controlled trials comparing Qili Qiangxin plus conventional Western medicine against the same Western medicine alone. The primary outcome was N-terminal pro-B-type natriuretic peptide, or NT-proBNP, a widely used biomarker of heart failure severity and treatment response. Secondary outcomes spanned left ventricular ejection fraction, cardiac chamber dimensions, B-type natriuretic peptide, high-sensitivity C-reactive protein, quality of life, clinical response rate, all-cause mortality, heart failure-related hospitalisation and adverse events.

The pooled results suggested meaningful short-term gains. Compared with Western medicine alone, the combination therapy was associated with greater reductions in NT-proBNP, BNP, left ventricular end-diastolic diameter, left ventricular end-systolic diameter and hs-CRP, along with improvements in ejection fraction, quality of life and clinical response rate. Ejection fraction, a key measure of the heart’s pumping capacity, improved by an average of 6.04 percentage points in the combined-therapy group. No statistically significant differences emerged for left ventricular end-diastolic volume, all-cause mortality or adverse events, and not a single included study reported heart failure-related hospitalisation.

These apparent benefits align with plausible biological mechanisms. Experimental studies suggest Qili Qiangxin can attenuate myocardial fibrosis by suppressing remodelling-related factors such as TGF-β1 and MMP-9, protect cardiomyocytes from apoptosis through PI3K/Akt and ROS/AMPK/mTOR signalling, and dampen inflammation via the TMAO/NF-κB pathway, reducing pro-inflammatory cytokines including TNF-α, IL-6 and IL-1β. The review’s authors note these mechanisms are consistent with the observed reductions in natriuretic peptides and inflammatory markers.

The findings also echo results from the larger QUEST trial, a multicentre, double-blind, placebo-controlled study published in Nature Medicine, which found that Qili Qiangxin reduced the risk of heart failure hospitalisation or cardiovascular death in patients with reduced ejection fraction, with generally consistent effects in patients with an ischaemic aetiology. The review team deliberately excluded the ischaemic subgroup from QUEST, however, because an ischaemic aetiology does not necessarily mean heart failure developed secondary to a prior heart attack, and including it would have altered the predefined study population.

Despite the encouraging surrogate signals, the certainty of evidence for every outcome was rated as low or very low under the GRADE framework. None of the 16 trials reported allocation concealment or blinding, and seven did not adequately describe their randomisation process. Substantial heterogeneity plagued several outcomes, particularly the primary NT-proBNP endpoint, and subgroup analyses based on treatment duration failed to explain it. Funnel plot asymmetry also suggested potential publication bias. Because NT-proBNP was reported in different units across studies, the pooled effect was expressed as a standardised mean difference, which cannot be read as an absolute reduction in clinical units.

The limitations extend beyond methodology. All included trials were conducted in China, limiting generalisability to other populations and healthcare settings. Definitions of clinical response varied across studies and involved relatively subjective assessments. Most importantly, the statistically significant outcomes in the review, including NT-proBNP, ejection fraction and inflammatory markers, are surrogate or intermediate measures, and improvements in such measures cannot be assumed to translate into reduced mortality or rehospitalisation. Only one small trial reported all-cause mortality, finding no significant difference between groups.

The authors conclude that the current evidence is inadequate to determine whether Qili Qiangxin improves long-term clinical prognosis and should not be considered sufficient to inform changes in clinical practice or guideline recommendations. They call for large-scale, multicentre randomised trials with rigorous randomisation, allocation concealment and blinding, longer follow-up, standardised treatment protocols and clinically meaningful endpoints such as mortality and heart failure-related hospitalisation. Until such trials are completed, the capsule’s apparent short-term benefits remain hypothesis-generating rather than definitive proof of efficacy.

Subject of Research: Efficacy and safety of Qili Qiangxin Capsule as adjunctive therapy for heart failure after acute myocardial infarction

Article Title: Qili Qiangxin capsule as adjunctive therapy for heart failure after acute myocardial infarction: a GRADE-assessed systematic review and meta-analysis of randomised controlled trials

Article References: Yu, J.-H., Yu, H.-Y., Zhang, J.-C., Chen, Z.-Y., Wang, C., Wu, Y.-Q., Wang, Y.-F., Robinson, N., Liu, J.-P., Li, Y.-L., & Liang, S.-B. (2026). Qili Qiangxin capsule as adjunctive therapy for heart failure after acute myocardial infarction: a GRADE-assessed systematic review and meta-analysis of randomised controlled trials. Frontiers in Pharmacology, 17, Article 1959187. https://doi.org/10.3389/fphar.2026.1959187

Image Credits: AI Generated

DOI: 10.3389/fphar.2026.1959187

Keywords: Qili Qiangxin Capsule, heart failure, acute myocardial infarction, meta-analysis, systematic review, GRADE, traditional Chinese medicine, NT-proBNP, ventricular remodelling, randomised controlled trials, ejection fraction, evidence certainty