Since its inception in the 1990s in China,evidence-based medicine(EBM)has emerged as a significant guiding principle and practical tool in the realm of clinical disease diagnosis and pharmacotherapy.To effectively employ EBM within traditional Chinese medicine(TCM)clinical trials,a comprehensive understanding of the methodology and principles of EBM is imperative.Additionally,the initiation of these clinical trials should be predicated on thorough evidence from systematic review.A well-executed TCM clinical trial should involve several essential components,namely:the implementation of meticulous study design,adherence to the accurate and stringent methodological approach,preliminary exploratory investigation,focused breakthrough of critical and intricate aspects,establishment of a pragmatic regulatory framework,and conformity to international standards.As TCM progresses towards modernization and globalization,it is crucial to maintain its distinct characteristics,while simultaneously embracing interdisciplinary integration and showcasing the achievements of TCM clinical trials,all within the confines of international regulations.
关键词
中医临床试验/循证医学/方法学质量/问题挑战/对策
Key words
traditional Chinese medicine clinical trial/evidence-based medicine/methodological quality/questions and challenges/strategies