Abstract: According to concept and characteristics of adverse drug reaction of the interaction between Chinese herbs and western drug, and targeting for existing research about adverse drug reaction of herb and drug interaction, this article explored the judgment of causality relationship, judgment and analysis of herb and drug interaction, using evidence -based pharmacology methodology and explain how to design clinical study protocol in order to improve scientific nature, standardization and practicability in interaction clinical study. At the same time, the research can also offer high quality research evidence for adverse drug reaction evaluation study in order to realize guiding reasonable clinical drug use and improve safety of Chinese herbs and western drug for simultaneous use.

Key words: Chinese herbs, western drug, interaction effect, adverse drug reaction(ADR), clinical methodology