OBJECTIVE:To evaluate the application of health assessment instruments in Chinese medicine. METHODS: According to a pre-defined search strategy, a comprehensive literature search for all articles published in China National Knowledge Infrastructure databases was conducted. The resulting articles that met the defined inclusion and exclusion criteria were used for analysis. RESULTS: A total of 97 instruments for health outcome assessment in Chinese medicine have been used in fundamental and theoretical research, and 14 of these were also used in 29 clinical trials that were randomized controlled trials, or descriptive or cross-sectional studies. In 2 152 Chinese medicine-based studies that used instruments in their methodology, more than 150 questionnaires were identified. Among the identified questionnaires, 51 were used in more than 10 articles (0.5%). Most of these instruments were developed in Western countries and few studies (4%) used the instrument as the primary evidence for their conclusions. CONCLUSION: Usage of instruments for health outcome assessment in Chinese medicine is increasing rapidly; however, current limitations include selection rationale, result interpretation and standardization, which must be addressed accordingly. KEYWORDS: treatment outcome; health-related quality of life; patient-reported outcome; personal satisfaction; questionnaires; instrumentation; medicine, Chinese traditional; outcome assessment (health care) DOI: 10.3736/jintegrmed2013023 Liu FB, Hou ZK, Yang YY, Li PW, Li QW, Xie N, Li JW, Zeng XJ. Literature review and analysis of the application of health outcome assessment instruments in Chinese medicine.