中医药临床试验的方法学问题与挑战:循证医学的观点

运用循证医学观点分析了中医药临床试验及其评价的现状,论述了随机、对照、盲法在中医药临床试验及其疗效评价研究中的应用条件,并阐明了在中医药临床疗效评价研究中如何估算样本量、选择结局评价指标及临床试验依从性与意向性治疗分析。将循证医学应用于中医药临床试验,有助于提高中医药临床诊疗与研究水平、促进国际间的合作与交流。建立循证的中医药临床疗效评价体系,有利于客观、科学地评价中医药的有效性与安全性。

Methodological quality assessment of clinical trials in traditional Chinese medicine: the principles of evidence-based medicine

The quality of clinical trials in traditional Chinese medicine (TCM) was analyzed with respect to their methodology and outcome assessment according to the concepts of evidence-based medicine (EBM). It was suggested that the essential methodological principles of EBM should be applied in clinical trials of TCM, including randomization, control and blindness. The sample size estimation, optimal parameter selection for outcome assessment, compliance and intention-to-treat analysis are all important aspects of randomized controlled trials. To bring the benefits of EBM into clinical trials will improve the quality of research in TCM and also promote international co-operation and communications. It is necessary to establish an assessment system of clinical outcome for TCM on the basis of EBM in order to evaluate the efficacy and safety of TCM objectively and scientifically.