The Methodological Quality assessment of Current Traditional Chinese Medicine’s Clinical Trials

Abstract

Objective: To figure out the current development of the TCM clinical trials in 2016 and to analyze the main problems of the TCM clinical trials. Method: The keywords traditional Chinese medicine, TCM, clinical trials and clinical study were used in CNKI and PubMed to search the clinical trials on TCM, published from January 1st to December 31st in 2016. The meta-analyses and the systematic reviews got excluded. The quality assessment was conducted according to the CONSORT statement. IBM SPSS Statistics 22 was used for the statistical analyses. Result: Of 210 TCM clinical trials identified, 158 RCTs were included, 42 from CNKI and 116 from PubMed. On average, 77.85% of the items on the checklist were provided for all the trials included. Item participants, item interventions, item objectives, item outcomes were fully met while item randomization sequence generation, item implementation and item statistical methods remained partially met. In particular, item sample size, item allocation concealment and item blinding/masking showed in an unfavorite situation. Conclusion: The proportion and the quality of TCM RCTs still needs to be improved, especially item sample size, item allocation concealment and item blinding/masking. The quality of RCTs from PubMed was much higher than those from CNKI and the quality of RCTs on drug was higher than those on non-drugs.