Application of pragmatic clinical trials in clinical evaluation of Chinese medicine / 中国中西医结合杂志

ABSTRACT

Since the evidence-based medicine (EBM) being evoked widely, to seek out the best evidence is becoming the pivotal step for the development of Chinese medicine (CM), and randomized controlled trial (RCT, at most times, it means explanatory clinical trial--ECT) has been accepted as the general golden standard for the evaluation of clinical intervention. However, it is noted that the traditional RCT (ECT) is unsuitable for the special characteristics of individual treatment in CM. The formation and development of CM theory is found on large amount of clinical experiences, and to evaluate its clinical efficacy and safety is the most primary task. Because the CM intervention measures are complex and individualized, the clinical effectiveness of CM is embodied as a complex system, which impacted greatly by the environment factors. It is deemed that the pragmatic clinical trial (PCT) has the character just fitting for the evaluation. The feasibility of PCT in CM clinical evaluation is discussed in this paper in order to raise a new issue for the evaluation of CM effectiveness.