A Literature Quality Assessment System for Randomized Controlled Trial Literature in Traditional Chinese Medicine (Preprint)

BACKGROUND In previous studies, researchers only evaluated the scores and grades of TCM clinical randomized controlled works of literature from an overall level, which gave us a general understanding of the overall literature level. OBJECTIVE This study aims to establish a literature quality assessment system specialized for randomized controlled trial (RCT) literature in traditional Chinese medicine (TCM). METHODS We combined the general international standard and characteristics of TCM to form a checklist of literature content to be evaluated in terms of basic method information and intervention operations. Then, we established a literature information rating system to classify the focused contents into four categories in terms of varied degree of completeness and accuracy. RESULTS Based on this system, we systematically assessed the quality of 2,776 RCTs in six categories of diseases in TCM. For the basic method information in these RCTs, “outcome indicators” and “participants’ medical sources” were mentioned in most of cases, but they might be described in a vague way, with accurate rates of 60.73% and 74.52% among the cases mentioned these information; “TCM diagnosis and diagnostic basis”, “TCM syndromes”, “randomization methods”, and “blinding” were often missing, with missing rates ranging from 68.58% to 97.48%. For the intervention information in these RCTs, the complete and accurate information for the “treatment group intervention” was higher at 97.83%, compared to 82.68% for the “control group intervention”. Most of the inaccurate information occurred when only the name of an intervention operation or drug was given, but the operation’s specific contents or drug’s composition were not clearly expressed. CONCLUSIONS Our results suggested a serious concern that TCM-related concepts were often missing in trail designs for TCM RCTs, which might impede the development of TCM theories. Also, inaccurate trail designs and intervention descriptions indicated in this study can serve as negative examples for future RCT protocols or reports in TCM to avoid.