The methodology of symptom directed comprehensive intervention in therapeutic clinical trial design of traditional medicine for the complicated and critical deseases

Abstract

Due to the characteristics of the complicated and critical deseases, therapeutic measures in the TCM clinical trials need to be multiple rather than single indexes. It is the flexibility and principle reflection of treatment based on syndrome differentiation. The advantage is more suitable for severe and complex diseases, but the adverse effect is mis-understood by the confounding bias. According to the characteristics of traditional medicine, a new method was proposed for the complicated and critical deseases. Firstly, the randomization with the inclusion criteria was made by the same symptom in a certain stage of disease; and secondly, the comprehensive intervention measures were adopted of processing; Eventually, the statistical difference was calculated. The symptom directed comprehensive interventions have provided the experimental design of the TCM therapeutic clinical trials. Key words: Traditional medicine; Difficult complicated and critical deseases; Symptom; Comprehensive intervention; Therapeutic clinical trial; Method design