CLINICAL TRIAL article
Front. Pharmacol.
Sec. Ethnopharmacology
Volume 16 - 2025 | doi: 10.3389/fphar.2025.1591959
Efficacy and Safety of Shenxiong-Xinmaikang Decoction in Patients with Stable Angina Pectoris: A Real-World Prospective Observational Study
Provisionally accepted
- 1Third Affiliated Hospital, Southern Medical University, Guangzhou, Guangdong Province, China
- 2Huizhou Central People's Hospital, Huizhou, Guangdong Province, China
- 3Zhujiang Hospital, Southern Medical University, Guangzhou, Guangdong Province, China
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Background: Shenxiong-Xinmaikang Decoction (SXXMKD), a modified traditional Chinese herbal formula, is widely used in clinical practice for stable angina pectoris (SAP). However, robust clinical evidence supporting its efficacy and safety is lacking. This study aimed to evaluate the real-world effectiveness and safety of SXXMKD as an adjunct to standard therapy for SAP.Methods: This was a prospective, single-center, real-world observational study conducted between 2019 and 2023, enrolling 219 SAP patients (Registry: ChiCTR2100052872). Patients received either standard care alone (standard biomedical treatment group, SBMT group; n = 101) or SXXMKD combined with standard care (combined Traditional Chinese Medicine, CTCM group; n = 118). To minimize selection bias and balance baseline covariates, we applied inverse probability of treatment weighting (IPTW). Clinical outcomes were assessed at short-and long-term follow-up.Results: After IPTW adjustment, baseline characteristics were well-balanced between the groups. Compared to the SBMT group, the CTCM group demonstrated significant improvements in angina symptom scores, electrocardiogram readings, and left ventricular ejection fraction (LVEF). Furthermore, the CTCM group showed lower levels of low-density lipoprotein cholesterol (LDL-C), creatine kinase (CK), high-sensitivity C-reactive protein (hs-CRP), and cardiac troponin I (cTnI). While the incidence of cardiovascular events was reduced in the CTCM group, the difference in cardiovascular event-free survival did not reach statistical significance.In a real-world setting, the addition of SXXMKD to standard biomedical treatment for SAP was safe and associated with improved symptomatic, functional, and biochemical outcomes. These findings suggest that SXXMKD is a promising adjunctive treatment for improving clinical outcomes in patients with stable angina.
Keywords: Shenxiong-Xinmaikang Decoction, Stable angina pectoris, Traditional Chinese Medicine, inverse probability treatment weighting, efficacy
Received: 11 Mar 2025; Accepted: 23 Jun 2025.
Copyright: © 2025 Dong, Zeng, Liang, Xie and Liang. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Donghui Liang, Zhujiang Hospital, Southern Medical University, Guangzhou, Guangdong Province, China
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