Efficacy and safety of Shenxiong-Xinmaikang Decoction in patients with stable angina pectoris: a real-world prospective observational study

TL;DR

A study found that adding Shenxiong-Xinmaikang Decoction to standard treatment for stable angina improved symptoms and biomarkers safely in real-world patients.

Contribution

This study provides real-world evidence supporting the safety and efficacy of Shenxiong-Xinmaikang Decoction as an adjunct treatment for stable angina.

Findings

The CTCM group showed significant improvements in angina symptoms, ECG readings, and LVEF compared to standard care.

The CTCM group had lower levels of LDL-C, CK, hs-CRP, and cTnI, indicating better biochemical outcomes.

The addition of SXXMKD was associated with a reduced incidence of cardiovascular events, though not statistically significant.

Abstract

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.

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.

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.

https://www.chictr.org.cn/, identifier: ChiCTR2100052872.

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