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Clinical trials of Traditional Chinese medicine need core outcome sets

Date and Location




Monday 23 September 2013 - 10:30 - 12:00


Presenting author and contact person

Presenting author

Li Zhang

Contact person

Hongcai Shang
Abstract text
Background: Outcome measure is one of the most important factors about clinical trials. However, several problems with outcome measures (e.g. selective reporting bias, heterogeneity among studies, and insignificant for health decision making) were ignored. As a consequence, it is difficult for systematic reviewers to perform meta-analysis. Core outcome set (COS), which should be measured and reported in all clinical trials of a specific condition, was proposed to solve these issues. There are similar problems in clinical trials of Traditional Chinese medicine (TCM). Objectives: To clarify the basis and problems with outcome measures in clinical trials of TCM. Methods: Electronic databases in Chinese were searched to collect intervention reviews of TCM. Protocols and quality assessment papers were excluded. Information on outcome measures were extracted and summarized. Results: Problems with outcome measures in clinical trials of TCM were summarized as follows: (1) Outcome measures in clinical trials of the same condition varied greatly. (2) Measurement data was arbitrarily transformed into ranked data and reported by percentages. (3) Subjective outcome measures were in a dominant position; while objective outcome measures were less frequently adopted. (4) There were lack of standardized evaluation criteria for TCM-related outcomes (e.g. tongue and pulses). (5) Intermediate indicators not related to clinical practice and decision making, such as biochemical indicators, were widely adopted; while endpoint outcomes were rarely used. (6) Less attention has been paid to the adverse event associated with herbal medicines. Conclusions: It is necessary to use COS to improve the quality of clinical trials of TCM. Furthermore, the special characteristics of TCM should be concerned while developing COS for clinical trials of TCM.