[Evaluating the Body of Evidence on Postmarketing Clinical Safety of Chinese Herbs].

Abstract

The traditional evidence evaluating hierarchy developed at the early stage in evidence-based medicine (EBM) , founded on an efficacy evaluation model of intervention, is generalized to whole medical research and clinical practice. However, such a hierarchy system were increasingly abused and misunderstood, which has become an obstacle for clinical decision making process. The hierarchical model is valid for limited questions of efficacy and inadequate for the evaluation of interventions in real world, especially safety evidence for postmarketing Chinese medicines. There are very few studies reporting the evidence grading and classification of postmarketing herbs' safety at home and abroad. Therefore, systematical collection and evaluation of evidence of postmarketing herbs' safety are of important significance. By referring to successful experiences in evidence grading and classification of drug effec- tiveness in EBM, authors studied the establishment of standards for evaluation, classification and grad- ing of safety evidence of postmarketing Chinese herbs, and the formation of basic frameworks of safety evidence evaluation, and comprehensively analyzed different sources of evidence from the perspectives of point, line, and surface, thus establishing the evidence body for safety evaluation of postmarketing Chinese herbs, and providing methodology and technical supports for future studies on evidence system in this field.