Along with the changes of disease spectrum, medical models and health concept, people pay more and more attention to the diagnostic and therapeutic approaches of traditional Chinese medicine (TCM). With the effect assessment being changed from disease-based model to patient-based model, how to scientifically and objectively explain the validity of TCM has become the premise for further development of TCM and dissemination of it throughout the world. In this article, the authors analyzed the status quo and problems of the effect assessment of TCM, and proposed some general methods for clinical effect assessment of TCM, including formulating criteria for syndrome differentiation under the guidance of TCM theories, paying attention to quality of life, proper selection of indexes for outcome assessment, application of modern clinical study methods, such as the methods of evidence-based medicine and clinical epidemiology, designing randomized controlled trials, multi-subject co-operation, strict supervision of the quality of researches, and establishment of organizations for professional training.

Key words: Traditional Chinese medicine, Outcome assessment, Method