[Evaluation methods of clinical efficacy of traditional Chinese medicine].

Clinical efficacy is the basis for the development of traditional Chinese medicine(TCM), and the evaluation of clinical efficacy of TCM has always been the focus of attention. The technical and methodological difficulties in the evaluation process often restrict the generation of high-level evidence. Therefore, methodological research should be deepened and innovative practice should be carried out to study the application of scientific research methods in the evaluation of the advantages of TCM. After more than ten years of development, the clinical efficacy evaluation of TCM, on the basis of the initially classic placebo randomized controlled trials, has successively carried out a series of meaningful attempts and explorations in N-of-1 trials, cohort studies, case-control studies, cross-sectional studies, real world studies, narrative medicine studies, systematic evaluation, and other aspects, laying the foundation for the transformation of TCM from "experience" to "evidence". This paper focused on the clinical efficacy evaluation of TCM, summarized the main connotation and development status of efficacy evaluation indicators, standards, and methods, and put forward corresponding countermeasures and suggestions for the problems of indicator selection, standard formulation, and methodology optimization in the research process. It is clear that scientific and objective evaluation of the efficacy of TCM is an urgent problem to be solved at present.

[Problems and thoughts in clinical safety evaluation of traditional Chinese medicine].

Amid the modernization and internationalization of traditional Chinese medicine(TCM), the safety of TCM has attracted much attention. At the moment, the government, scientific research teams, and pharmaceutical enterprises have made great efforts to explore methods and techniques for clinical safety evaluation of TCM. Although considerable achievements have been made, there are still many problems, such as the non-standard terms of adverse reactions of TCM, unclear evaluation indicators, unreasonable judgment methods, lack of evaluation models, out-of-date evaluation standards, and unsound reporting systems. Therefore, it is urgent to further deepen the research mode and method of clinical safety evaluation of TCM. Based on the current national requirements for the life-cycle management of drugs, this study focused on the problems in the five dimensions of clinical safety evaluation of TCM, including normative terms, evaluation modes, judgment methods, evaluation standards, and reporting systems, and proposed suggestions on the development of a life-cycle clinical safety evaluation method that conformed to the characteristics of TCM, hoping to provide a reference for future research.

Efficacy and safety of zhibitai in the treatment of hyperlipidemia: A systematic review and meta-analysis.

Objective: To evaluate the efficacy and safety of Zhibitai (ZBT) in the treatment of patients with hyperlipidemia (HLP). Methods: A search of 8 electronic databases was conducted to find randomized controlled trials (RCTs), to evaluate the efficacy and safety of ZBT for the treatment of HLP. The risk of bias in randomized controlled trials was assessed by using the Cochrane Collaboration Risk of Bias tool for randomized controlled trials 2.0 (RoB 2.0). The primary outcomes were the levels of triglyceride (TG), total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C). The total effective rate served as the secondary outcome. The incidence of adverse events was considered the safety outcome. Review Manager 5.4 was used to conduct meta-analyses. Data were pooled by random-effects or fixed-effects model to obtain the mean difference (MD), risk ratio (RR), odds ratio (OR), and 95% confidence interval (CI). Results: There were 28 eligible RCTs with a total of 2,952 participants. Overall, we verified that ZBT plus conventional therapy (CT) was superior to CT for the treatment of HLP [TC: MD = -0.50, 95% CI (-0.80, -0.19); TG: MD = -0.38, 95% CI (-0.49, -0.27); LDL-C: MD = -0.50, 95% CI (-0.69, -0.31); HDL-C: MD = 0.17, 95% CI (0.11, 0.24); total effective rate: OR = 4.26, 95% CI (2.28, 7.95)]. There were no significant differences in the primary outcomes between ZBT alone vs. CT (p > 0.05). For safety, the ZBT group (with CT or alone) outperformed the CT group [ZBT alone: RR = 0.51, 95% CI (0.32, 0.81); ZBT plus CT: RR = 0.51, 95% CI (0.30, 0.89)]. For each outcome, the subgroups and the sensitivity analysis matched the overall results. Conclusion: ZBT may be safe and beneficial to HLP patients, especially for serum lipid management. ZBT can be used along with CT for the treatment of HLP. However, it is necessary to conduct more rigorous RCTs to confirm these findings. Systematic Review Registration: [https://www.crd.york.ac.uk/PROSPERO/], identifier [CRD42022316251].

Meta-Analysis of the Effect of Honghua Injection in the Treatment of Coronary Heart Disease Angina Pectoris.

Objective: To evaluate the effectiveness of honghua injection combined with western medicine in the treatment of coronary heart disease angina pectoris. Methods: Computer extensively searched PubMed, Cochrane Library, Embase, China Biomedical Archives (SinoMed), China Knowledge Network (CNKI), Chinese Journal Full-text Database (VIP), Wanfang Data Knowledge Service Platform (Wanfang), and collected randomized controlled trials (RCTs) of honghua injection combined with western medicine in the treatment of coronary heart disease angina pectoris. Use Review Manager5.3 software for meta-analysis. Results: 21 RCTs were included, involving 1894 participants. Meta-analysis shows that honghua injection combined with western medicine can significantly improve the clinical efficacy (OR = 4.03, 95% CI[2.96,5.49]), electrocardiographic efficacy (OR = 3.39, 95%CI[2.44, 4.70]), can significantly reduce total cholesterol (TC) levels (MD = -0.39, 95% CI[-0.47, -0.31]), triacylglycerol (TG) levels (MD = -0.45, 95% CI[-0.51, -0.39]), increase high-density lipoprotein cholesterol (HDL-C) levels (MD = 0.29,95%CI[0.26,0.32]), reduce low-density lipoprotein Cholesterol (LDL-C) levels (MD = -0.59, 95%CI[-0.79, -0.38]). Five articles reported adverse reactions. Conclusion: Honghua injection combined with western medicine is more effective than western medicine alone in patients with coronary heart disease angina pectoris. More multicenter, large sample, high-quality RCTs are needed to provide evidence.