Safeguarding patient’s safety is important in clinical research and practice. At present, there are many problems in the clinical safety evaluation of traditional Chinese medicine. For instance, combination of Chinese and western medicines provides difficulty for definite reflection of clinical safety of Chinese medicine, lack of reliability of reporting of symptomatic adverse events/reactions, as well as discrepancy in safety outcomes reporting in similar clinical studies. Based on the application of adverse events/reactions term sets and core outcomes sets in clinical trials of western medicine, it is proposed that the concept of core outcome sets should be introduced to the clinical safety evaluation of integrated Chinese and western medicines in order to improve the clinical safety evaluation.
Citation： QIU Ruijin, ZHONG Changming, GUAN Manke, HU Jiayuan, ZHAO Chen, CHEN Zhao, LI Min, HAN Songjie, HE Tianmai, HUANG Ya, CHEN Jing, SHANG Hongcai. Core outcome set should be introduced to safety evaluation in clinical research of integrated traditional Chinese and western medicine. Chinese Journal of Evidence-Based Medicine, 2020, 20(5): 511-514. doi: 10.7507/1672-2531.201911068 Copy