Abstract: Objective To assess the efficacy and safety of Danshen decoction (DSD) in treating coronary heart disease (CHD). Methods Cochrane, PubMed, Embase, Web of Science, and CNKI were searched for literature about RCTs related to the use of DSD in treating CHD that was published from the inception to August 1, 2023. The Cochrane Handbook 5.1 tool was used to evaluate the methodological quality of the included studies, Review Manager 5.3 was adopted to analyze the data, and GRADE was employed to assess the quality of evidence for indexes of outcomes. Results Sixteen studies involving 1,388 patients were included. Meta-analysis showed that DSD compared favorably with the controls in terms of the total efficacy [RR=1.31,95%CI(1.24,1.39), P<0.000 01], ECG improvements [RR=1.28, 95%CI(1.19,1.38), P<0.000 01], frequency of angina onsets[SMD=-1.27,95%CI(-2.12,-0.41), P=0.004], TCM symptom scores[SMD=-2.22, 95%CI(-2.62,-1.82), P<0.000 01], and adverse reactions [RR=0.25%, 95%CI (0.09,0.75), P=0.001]. Subgroup analysis found that 2 to 4 weeks of treatment with DSD were the most effective. GRADE assessment indicated that the evidence for efficacy and ECG improvement was of medium quality. Conclusion There is evidence to suggest that DSD combined with conventional medications is more effective and safer than conventional medications alone for CHD, and a 2-to 4-week course of treatment is recommended. However, more high-quality RCTs are needed to confirm these findings.

Key words: Danshen Decoction, Coronary Heart Disease, Systematic Review, Meta-Analysis, Efficacy, Safety, GRADE Assessment