{ "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 ACS-PCI. 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) 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 to 0.91; ARR=0.056, NNT=18), revascularisation (RR=0.28, 95% CI 0.10 to 0.80; ARR=0.069, NNT=15), myocardial infarction (RR=0.44, 95% CI 0.20 to 0.98; ARR=0.033, NNT=31), angina (RR=0.32, 95% CI 0.17 to 0.61; ARR=0.076, NNT=14) and other cardiovascular events (RR=0.41, 95% CI 0.24 to 0.71; ARR=0.075, NNT=14). It also improved Seattle Angina Questionnaire scores (MD=8.82, 95% CI 6.58 to 11.05) and quality of life (qualitative synthesis). However, no statistically significant reductions were observed for sudden cardiac death (RR=0.39, 95% CI 0.12 to 1.27; ARR=0.022, NNT=45), or non-cardiovascular adverse events (RR=0.67, 95% CI 0.32 to 1.40; ARR=0.043, NNT=24) when TXL was added to WM.Conclusion Current evidence suggests that adjunctive TXL may reduce key cardiovascular events and improve symptoms and quality of life in patients with ACS-PCI, without increasing the risk of non-cardiovascular adverse events. However, all findings are based on low-certainty evidence. These results provide preliminary support for the use of TXL as an adjunctive therapy, but high-quality, multicentre RCTs are needed to confirm these effects and inform clinical guidelines.PROSPERO registration number CRD42024509453.", "authors": [ { "affiliations": [ "Clinical Study Center, Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan, China", "Centre for Evidence-Based Chinese Medicine, Shandong University of Traditional Chinese Medicine, Jinan, Shandong, China", "Postdoctoral Research Station, Shandong University of Traditional Chinese Medicine, Jinan, Shandong, China" ], "name": "Shi-Bing Liang" }, { "affiliations": [ "Clinical Study Center, Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan, China", "Centre for Evidence-Based Chinese Medicine, Shandong University of Traditional Chinese Medicine, Jinan, Shandong, China", "Cardiovascular Disease Center, Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan, Shandong, China" ], "name": "Yi-Fei Wang" }, { "affiliations": [ "Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, Beijing, China" ], "name": "Yu-Fei Li" }, { "affiliations": [ "Cardiovascular Disease Center, Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan, Shandong, China" ], "name": "Wen-Jing Chen" }, { "affiliations": [ "Department of Emergency Center, Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan, China" ], "name": "Yu-Shuo Zhu" }, { "affiliations": [ "Cardiovascular Disease Center, Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan, Shandong, China" ], "name": "Zhen Hua" }, { "affiliations": [ "Clinical Study Center, Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan, China", "Centre for Evidence-Based Chinese Medicine, Shandong University of Traditional Chinese Medicine, Jinan, Shandong, China" ], "name": "Hui-Min Zheng" }, { "affiliations": [ "Postdoctoral Research Station, Shandong University of Traditional Chinese Medicine, Jinan, Shandong, China", "Cardiovascular Disease Center, Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Tai’an, China" ], "name": "Zhen-Chao Niu" }, { "affiliations": [ "Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, Beijing, China", "Institute of Health and Social Care, London South Bank University, London, UK" ], "name": "Nicola Robinson" }, { "affiliations": [ "Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, Beijing, China" ], "name": "Jian-Ping Liu" }, { "affiliations": [ "Cardiovascular Disease Center, Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Tai’an, China", "The First School of Clinical Medicine, Shandong University of Traditional Chinese Medicine, Jinan, China", "Shandong Engineering Laboratory of Traditional Chinese Medicine Precision Therapy for Cardiovascular Diseases" ], "name": "Yun-Lun Li" } ], "title": "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", "uid": "cadc46c1-55fc-58f0-97eb-69a81a3d13ca" }