[Methodological thoughts about research of standardized clinical protocols of traditional Chinese medicine].

The treatment of traditional Chinese medicine (TCM) has been proved effective in clinical practice for thousands of years. To standardize the clinical protocols of TCM is absolutely necessary for enhancing the research quality of TCM and expanding the international influence of TCM. The standardization research on clinical protocols of TCM should be based on the basic theory of TCM and in the light of good clinical practice (GCP) principles. The clinical criteria for both diagnosis and efficacy evaluation of disease are also needed. To include all symptoms, tongue manifestations and pulse presentations into case report form, and to compare the differences in these clinical parameters between effective and non-effective cases by multivariate analysis may be helpful to find more specific indications for therapeutic protocol of TCM. Furthermore, It is suggested that two or more clinical trials on one therapeutic protocol are needed to identify its accurate indications.