Xunjia Xu,1,2,* Shi Yin,1,2,* Huijuan Liu,3 Ruixia Zhao,4 Weifeng Cui,5 Mingyi Shao,6 Haibin Yu,7 Shuxun Yan,1 Yu Fu1,3 

1Department of Endocrinology, The First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou, Henan, 450000, People’s Republic of China; 2The First School of Clinical Medicine, Henan University of Chinese Medicine, Zhengzhou, Henan, 450046, People’s Republic of China; 3Department of Science Research, The First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou, Henan, 450000, People’s Republic of China; 4Center for Evidence-Based Medicine of Traditional Chinese Medicine, The First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou, Henan, 450000, People’s Republic of China; 5Center for Clinical Evaluation, Henan Integrative Medicine Hospital, Zhengzhou, Henan, 450003, People’s Republic of China; 6Department of Gastroenterology, The Third Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou, Henan, 450003, People’s Republic of China; 7Department of Cardiovascular, The First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou, Henan, 450000, People’s Republic of China

*These authors contributed equally to this work

Correspondence: Yu Fu, Email kybfuyu@126.com

Background: Chinese herbal medicines (CHMs) are used for type 2 diabetes mellitus combined with stable angina pectoris (T2DM-SAP), but their long-term effects lack real-world evidence.
Objective: To evaluate the effects of additional CHMs on angina readmission rates compared to standard treatment alone in patients with T2DM-SAP.
Methods: This retrospective cohort study included 704 patients with T2DM-SAP. Participants were stratified into two groups based on cumulative CHMs use (≥ 3 months). The CHMs group included 115 patients, while the non-CHMs group included 589 patients. A 1:1 propensity score matching (PSM) was used to balance differences between groups. The primary outcome was angina readmission. The secondary outcomes were SAP readmission and unstable angina pectoris (UA) readmission. Kaplan-Meier survival curves were plotted before and after matching. Sensitivity analysis was performed using Cox proportional hazards model. Baseline prescriptions were collected and herbal frequency and efficacy were counted.
Results: After matching, there were 106 patients in each of the two groups. Before matching, compared with the non-CHMs group, the adjusted hazard ratio (aHR) of angina readmission in the CHMs group was 0.49 [95% confidence interval (CI): 0.34, 0.71, P< 0.001]. After matching, the aHR was 0.37 [95% CI: 0.22, 0.60, P< 0.001]. The reliability of the results was confirmed by sensitivity analyses adjusted for different covariates. The CHMs group demonstrated a significantly longer median time to angina readmission compared to the non-CHMs group (55.66 vs 13.90 months, P< 0.001). Similar results were also shown after matching. 115 prescriptions involving 220 herbs were collected.
Conclusion: Additional CHMs treatment can significantly reduce the incidence of angina readmission and prolongs the interval to recurrent events in T2DM-SAP patients.

Keywords: type 2 diabetes mellitus, stable angina pectoris, angina readmission, Chinese herbal medicine, integrative therapy, retrospective cohort study