Objective To evaluate Qishenyiqi Dripping Pills (QSYQ) on the efficacy of secondary prevention of myocardial infarction, improvement the evaluation system of coronary heart disease in traditional Chinese medicine (TCM), and to further establish the research methods and corresponding technical specifications of evidence-based medicine in TCM.
Method MISPS-TCM, (a multicenter, large sample, central randomised system, double-blinded, double dummy and positive drug) controlled parallel trials conducted at 18 centers and 88 hospitals in China, which enrolled patients aged 75 years or younger with a history of AMI between 28 days to 2 years, and complicated with syndromes of Qi-deficiency and blood-stasis. The sample size estimated to be 3600 patients were randomly divided into two groups according to the ratio of 1:1, the treatment group taking QSYQ and aspirin simulation, and the control group taking aspirin and QSYQ simulation for 18 months. The primary endpoint was non-fatal reinfarction or stroke, or cardiac death, combined with angina pectoris and TCM symptom scores and the Seattle Angina Questionnaire.
Results From November 20, 2005 to October 16, 2008, 3505 patients with AMI were entered into the study: 1746 were assigned to QSYQ, and 1759 were assigned to aspirin. Final follow-up visits were conducted on April 20, 2010. The study had 2451 men (69.9%). The mean age was 58.3 (SD: 9.0). The mean duration was 9.5 months (SD: 7.2). Disease history: 44% patients had hypertension, 39% had hyperlipidaemia, 13% had diabetes, 12% had gastritis and so on. Drug treatment history: 80% were taking anti-platelet drugs, 72% taking nitrates, withβ receptor blocking 45%, cholesterol lowering agents present in 41%, ACEI/ARB 38% and so on. The male ratio, height, smoking and drinking in QSYQ group were slightly lower than in aspirin, however, the other baseline characteristics bore no difference between the two groups, such as demographic information, diagnosis history, medication history, risk factors, angina and TCM symptom scores and the Seattle Angina Questionnaire.
Conclusion Baseline characteristics were well balanced between the two groups that for further analysis and evaluation.
- Qishenyiqi Dripping Pills (QSYQ)
- traditional Chinese medicine (TCM)