Systematic review and meta-analysis of Tongxinluo capsules combined with statins in the treatment of carotid atherosclerosis

RELEVANCE: Carotid atherosclerosis affects more than one billion people, and the use of statins is sometimes limited by adverse effects. Tongxinluo (TXL) capsule, a standardized 12-herb formula, is widely used for cardiovascular conditions.

OBJECTIVES: This study aimed to systematically evaluate the efficacy, safety, and certainty of evidence for TXL added to statins in patients with carotid atherosclerosis, focusing on vascular remodeling and inflammatory modulation.

MATERIALS AND METHODS: A systematic search was performed across seven major databases for randomized controlled trials (RCTs) published from January 2000 to June 2025. We prespecified inclusion criteria and designated carotid intima-media thickness (IMT) as the primary outcome. Secondary outcomes included lipid profile parameters, Crouse plaque score, inflammatory biomarkers, and adverse events. All eligible articles were included for further analysis.

RESULTS: Forty-three RCTs involving 4175 participants were included. Compared with statins alone, TXL plus statin therapy significantly decreased IMT (moderate certainty) and lowered Crouse plaque scores (moderate certainty). The combination therapy also improved lipid profiles, by reducing total cholesterol (TC, moderate certainty), triglycerides (TG, moderate certainty), and low-density lipoprotein cholesterol (LDL-C, moderate certainty), alongside an increase in high-density lipoprotein cholesterol (HDL-C, moderate certainty). Furthermore, levels of interleukin-6 (IL-6, low certainty), tumor necrosis factor-alpha (TNF-α, low certainty), high-sensitivity C-reactive protein (hs-CRP, moderate certainty), and homocysteine (Hcy, low certainty) were significantly lowered. No statistically significant differences were observed in adverse event incidence (low certainty).

CONCLUSION: TXL combined with statins appears to improve lipid profiles, attenuate atherosclerotic burden, and enhance anti-inflammatory and antioxidant effects, without increasing adverse events. These findings support TXL as a potentially valuable adjunctive therapy for carotid atherosclerosis, which warrants further confirmation from high-quality, large-scale trials.