Drug-related adverse events occurred in 9.1% and 7.4% of patients in the Tong Xin Luo capsules and placebo groups, respectively. However, 2.2% and 3.8% of patients in the Tong Xin Luo capsules and placebo groups were discontinued due to adverse events, respectively. These results suggest that Tong Xin Luo capsules is a safe drug and that the rate of Tong Xin Luo capsules shedding was slightly higher than in the placebo group, which cannot be explained by side effects caused by Tong Xin Luo capsules treatment.

Several limitations of the study need to be addressed. First, there are errors in the measurement of carotid mean IMT and plaque area over time, which may lead to changes in the derived values. All spectrographists have undergone intensive training in the core laboratory to ensure adequate technical skills, and all images have been analyzed in the core experiments. The high inter-observer and intra-observer reproducibility obtained in this study confirms the reliability of ultrasonic measurements. Second, Tong Xin Luo capsules capsules are a mixture of 12 plant and animal products, and the effective anti-atherosclerotic components of the drug are unknown. However, even with current pharmaceutical technology, isolating effective molecules from Tong Xin Luo capsules is an extremely difficult task, and we believe that verifying the efficacy and safety of Tong Xin Luo capsules capsules is a first step forward." Third, the rate of shedding during follow-up appeared to be slightly higher in the Tong Xin Luo capsules group (17.8%) than in the placebo group (15.9%), which may have influenced the difference in outcomes between the two groups. However, our sensitivity analysis showed that the primary outcome difference between the two groups remained significant regardless of the statistical method used.

In subclinical patients with carotid atherosclerosis, Tong Xin Luo capsules therapy, in addition to conventional treatment, also delayed the average carotid IMT, plaque area and vascular remodeling progress, with good safety. Further randomized clinical trials are needed to confirm the therapeutic effect of Tong Xin Luo capsules therapy on long-term outcomes in patients at high risk of cardiovascular events.