The methodology of symptom directing standardized intervention in therapeutic clinical trial design of traditional medicine / 国际中医中药杂志

ABSTRACT

Double-blind randomized controlled trial design is the most recognized scheme of therapeutic experimental design.On the assessment of the efficacy of traditional medicine, randomized controlled clinical trial design also has the same value.Only when using the research method towards epidemiology to perform the rigorous design on the clinical trial of traditional medicine and make the objective evaluation of its effect, can it get the real understanding and approval from modern medicine.When making the therapeutic clinical trial under the traditional medicine, due to the characteristics of the subject, therapeutic measures usually need to be changed so they cannot be standardized, and the modification may result in the share of multiple intervention components, which leads to the inaccurateness of results under the effect of confounding bias.According to the characteristics of traditional medicine, a new method was proposed for therapeutic clinical trial.Firstly do the randomization with the inclusion criteria made by the same symptom arise in a certain stage of disease, secondly adopt the standardized intervention measures for processing.Eventually confirm whether there is significant statistical difference.The symptom directing standardized interventions have provided the experimental design of the traditional medical clinical therapy with a feasible scheme, which can solve several problems existing in this design.