Adjunctive Tongxinluo capsule for patients with acute coronary syndromes undergoing percutaneous coronary intervention - a GRADE-assessed systematic review and meta-analysis of randomised controlled trials

Sep 29, 2026

Uploaded by McQueen

Tongxinluo capsule (TXL) is used in China alongside Western medical therapy for acute coronary syndromes after percutaneous coronary intervention (ACS-PCI), but its benefits and safety remain insufficiently synthesised. This GRADE-assessed systematic review and meta-analysis searched PubMed, Cochrane Library, CNKI, VIP and Wanfang through August 2024 and updated with a rapid search to November 2025 for randomised controlled trials. Eighteen RCTs (1800 participants) were included, with low-certainty evidence suggesting reduced restenosis, revascularisation, myocardial infarction, angina and other cardiovascular events, plus improved symptom and quality-of-life outcomes.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages14

Reading Time35 min

AccessFree to download

Abstract

Background

Methods

Results

Conclusion

Strengths and limitations of this study

Introduction

Open access Original research Adjunctive Tongxinluo capsule for patients with acute coronary syndromes undergoing percutaneous coronary intervention: a GRADE-assessed systematic review and meta-analysis of randomised controlled trials Shi-Bing Liang ,1,2,3 Yi-Fei Wang,1,2,4 Yu-Fei Li ,5 Wen-Jing Chen,4 Yu-Shuo Zhu,6 Zhen Hua,4 Hui-Min Zheng,1,2 Zhen-Chao Niu,3,7 Nicola Robinson,5,8 Jian-Ping Liu,5 Yun-Lun Li7,9,10 To cite: Liang S-B, Wang YF, Li Y-F, et al. Adjunctive Tongxinluo capsule for patients with acute coronary syndromes undergoing percutaneous coronary intervention: a GRADEassessed systematic review and meta-analysis of randomised controlled trials. BMJ Open 2025;15:e111565 . doi:10 . 1136/ bmjopen-2025-111565 ► Prepublication history and additional supplemental material for this paper are available online. To view these files, please visit the journal online ([https://doi.org/10.1136/](https://doi.org/10.1136/)[ ](https://doi.org/10.1136/)[bmjopen-2025-111565](bmjopen-2025-111565)) . Received 29 September 2025 Accepted 01 December 2025 © Author(s) (or their employer(s)) 2025. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ Group. For numbered affiliations see end of article. Correspondence to Dr Yun-Lun Li; [li.yunlun@163.com](li.yunlun@163.com) ABSTRACT Background Tongxinluo capsule (TXL) is widely used in China as an adjunctive therapy for patients with acute coronary syndromes (ACS) who underwent percutaneous coronary intervention (PCI), collectively referred to as ACSPCI. However, current evidence on its therapeutic effects and safety remains limited and insufficiently synthesised. This review aims to evaluate the therapeutic effects and safety of adding TXL to Western medical therapy (WM) in this population. Methods A systematic literature search was performed in PubMed, the Cochrane Library, CNKI, VIP and Wanfang from inception to August 2024; a rapid supplemental search was conducted up to November 2025, without language restrictions, to identify randomised controlled trials (RCTs) evaluating the therapeutic effects and safety of adding TXL to WM in patients with ACS-PCI. Dichotomous outcomes were summarised using risk ratios (RRs) with 95% CIs; absolute risk reductions (ARRs) were estimated as risk differences, and corresponding numbers needed to treat (NNTs) were calculated. Continuous outcomes were summarised using mean differences (MDs) STRENGTHS AND LIMITATIONS OF THIS STUDY ⇒ The review employed a systematic methodology adhering to Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, ensuring transparency and reproducibility. ⇒ Use of the Grading of Recommendations Assessment, Development and Evaluation framework to assess the certainty of evidence for each outcome strengthened the interpretability of findings and supported informed decision-making. ⇒ Calculations of absolute risk reductions and number needed to treat for dichotomous outcomes enhanced the clinical relevance and practical applicability of the results. ⇒ Involvement of both methodological experts and clinical specialists in cardiovascular disease contributed to methodological rigour and clinical validity. ⇒ The absence of an economic evaluation limits thereview’s utility for health policy decisions that require cost-effectiveness considerations. with 95% CIs. All meta-analyses were performed using a random-effects model. The included studies generally had limitations in methodological quality, heterogeneity across analyses was low to moderate and the potential for publication bias could not be excluded. The evidence certainty for each outcome was assessed using the Grading of Recommendations Assessment, Development and Evaluation approach. Results Eighteen RCTs involving 1800 participants were included. Low-certainty evidence indicated that adding TXL to WM may reduce the risks of restenosis (RR=0 .30, 95% CI 0.10

FAQs

What question does this systematic review address?

It evaluates the therapeutic effects and safety of adding Tongxinluo capsule (TXL) to Western medical therapy in patients with acute coronary syndromes undergoing percutaneous coronary intervention (ACS-PCI).

How was the evidence gathered and analysed?

The review searched major databases (PubMed, Cochrane Library, CNKI, VIP and Wanfang) through August 2024 and updated with a rapid search to November 2025 for randomised controlled trials. Dichotomous outcomes used risk ratios with 95% confidence intervals, and absolute effects were expressed as risk differences and NNTs; meta-analyses used random-effects models and each outcome’s certainty was assessed with GRADE.

What were the main benefits and what limitations affected confidence?

Low-certainty evidence suggested reductions in restenosis, revascularisation, myocardial infarction, angina, and other cardiovascular events, alongside improved symptom scores and quality of life. Limitations included general shortcomings in methodological quality of included studies and the potential for publication bias, and there was no economic evaluation.

Sep 29, 2026

Uploaded by McQueen