Abstract:The development of a scientific evaluation tool is a prerequisite to reflect the efficacy of traditional Chinese medicine (TCM). At present, separate analysis of each outcome is the most commonly used method in randomized controlled trials (RCTs) of TCM, while this method has been reported to have some limitations. Evaluation of multiple primary endpoints which include diseases and symptoms outcomes can reflect the effectiveness of TCM comprehensively and objectively. In recent years, despite the great development of multiple primary endpoints in the field of statistical methods, there are still some challenges in choosing methods, calculating sample size and employing statistical software. In this article, we introduced several multiple primary endpoints evaluation methods, in the expectation of appropriate use of those methods by TCM researchers as well as methodological support for comprehensive assessment of the characteristics and advantages of TCM.