Construction of a new complex intervention mode of traditional Chinese medicine randomized controlled trial based on the complex and dynamic intervention characteristics of traditional Chinese medicine
According to the characteristics of interventions,the existing randomized controlled trial(RCT)design of traditional Chinese medicine(TCM)can be divided into two categories,the explanatory RCT design represented by a fixed prescription and the practical RCT design represented by dialectical medication.Both types of interventions have certain defects in realizing the organic combination of TCM characteristics and RCT.The strictly standardized design of explanatory RCTs guarantees the internal authenticity of the test at the expense of the therapeutic effects of some TCM,but the characteristics of dialectical treatment and personalized diagnosis and treatment of TCM are insufficient.The practical RCT design reflects the characteristics of TCM diagnosis and treatment,but reduces the degree of standardization of interventions,sacrificing the rigor of the design to promote the implementation of the solution.This paper proposes a new type of complex intervention model of TCM RCT with a view to providing ideas for clinical research of TCM.
Traditional Chinese medicineRandomized controlled trial(RCT)Trial designBody of evidenceComplex intervention