Traditional Chinese Medicine in the prevention and treatment of stable angina pectoris in patients with coronary heart disease based on the theory of "phlegm and blood stasis" under guidance of evidence-based medicine: a prospective cohort study.

OBJECTIVE: To ascertain whether continuous treatment with Traditional Chinese Medicine (TCM) combined with standardized drug therapy from Western Medicine can further reduce the incidence of cardiovascular events in patients with coronary heart disease and angina and reduce the incidence of angina pectoris in patients with coronary heart disease. METHODS: A multicenter, prospective cohort study of 1042 patients in 22 hospitals was conducted. A total of 423 patients with angina pectoris were treated with standardized Western Medicine alone (control group) and 619 with a combination of Chinese and Western Medicine (exposure group). The two groups underwent follow-up for 1 year to establish whether there was any improvement in the incidence of cardiovascular events or change in the curative effect. RESULTS: The incidence of primary endpoint events in the combined-exposure group decreased by 0.45% (P > 0.05) and the incidence of secondary terminal events decreased by 5.25% in comparison with the control group (P < 0.05). The total angina pectoris score clearly decreased in the Western Medicine group over the first 6 months, but the decline was more apparent in the combined-exposure group. CONCLUSION: Compared with treatment using standardized Western Medicine alone, providing TCM combined with Western medical treatment reduced the incidence of cardiovascular events in patients with stable angina pectoris (grade Ⅱ endpoint) and effectively improved the curative effect.

Clinical effectiveness and safety of salvia miltiorrhiza depside salt combined with aspirin in patients with stable angina pectoris: A multicenter, pragmatic, randomized controlled trial.

BACKGROUND: Salvia Miltiorrhiza Depside Salt (SMDS) was extracted from Salvia miltiorrhiza with high-quality control of active principles. In 2005, China's FDA approved the use of SMDS for stable angina pectoris (SAP), but the evidence of SMDS combined with aspirin remains unclear. PURPOSE: The aim of this study was to assess the clinical effectiveness and safety of SMDS combined with aspirin in patients with SAP. METHODS: A multicenter, pragmatic, three-armed parallel group and an individually randomized controlled superiority trial was designed. Participants aged 35 to 75 years old with SAP were recruited from four "Class Ⅲ Grade A" hospitals in China. Participants who were randomized into the SMDS group were treated with SMDS by intravenous drip. Participants in the control group received aspirin enteric-coated tablets (aspirin). Participants who were randomly assigned to the combination group received SMDS combined with aspirin. All participants received standard care from clinicians, without any restrictions. The primary outcome measure was thromboelastography (TEG). Secondary outcome measures included symptom score of the Seattle Angina Questionnaire (SAQ), visual analogue scale (VAS) score of traditional Chinese medicine (TCM) symptoms, platelet aggregation measured by light transmittance aggregometry (LTA), and fasting blood glucose. Effectiveness evaluation data were collected at baseline and ten days after treatment. Researchers followed up with participants for one month after treatment to determine whether adverse events (AEs) or adverse drug reactions (ADRs) such as bleeding tendency occurred. All statistical calculations were carried out with R 3.5.3 statistical analysis software. RESULTS: A total of 135 participants completed follow-up data on the primary outcome after ten days of treatment. Participants in the SMDS combined aspirin group had the highest improvement rate of sensitivity in AA% [p < 0.001, 95% CI (0.00-0.00)], from 30.6% before treatment to 81.6% after treatment. Participants with drug resistance (AA% < 20%) in the SMDS combined with aspirin group also had the highest sensitivity rate [p < 0.001, 95% CI (0.00-0.00)] after treatment (accounting for 81.0% of the combination group and 60.7% of the sensitive participants). The improvement of TCM symptoms in participants treated with SMDS combined with aspirin was significantly better than that of the aspirin group [MD = 1.71, 95% CI (0.15-3.27), p = 0.032]. There were no significant differences in other indexes (R, TPI, MA, K, CI, α value) of TEG, SAQ, platelet aggregation and fasting blood glucose among the three groups. No bleeding tendency or ADRs occurred in all participants. CONCLUSION: SMDS combined with aspirin is a clinically effective and safe intervention to treat adults aged 35 and older with SAP. This trial shows that SMDS combined with aspirin can significantly improve the sensitivity rate of AA% in TEG and the VAS score of TCM symptoms. Further large samples and high-quality research are needed to determine if certain participants might benefit more from SMDS combined with aspirin. The study protocol was registered in the Clinical Trials USA registry (registration No. NCT02694848).