[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.