Evaluation of randomized controlled trial literature in traditional Chinese medicine: a literature quality assessment system

Abstract Background Previous studies have evaluated traditional Chinese medicine (TCM) clinical randomized controlled trial (RCT) literature broadly, but they have provided limited depth in evaluating the specific aspects of trial quality. Objective This study aims to develop a specialized literature quality assessment system for TCM RCTs. Methods We integrated international standards with TCM characteristics to create a checklist for evaluating basic method information and intervention operations. A rating system was established to classify content into four categories based on completeness and accuracy. Results We assessed 2776 TCM RCTs across six disease categories. For basic method information, “outcome indicators” and “participants’ medical sources” were commonly mentioned but often vague, with accurate rates of 60.73% and 74.52%, respectively. Critical elements, including “TCM diagnosis and diagnostic basis,” “TCM syndromes (clinically defined patterns of symptoms that guide TCM therapy),” “randomization methods,” and “blinding” were frequently omitted, with omission rates ranging from 68.58% to 97.48%. For interventions, “treatment group intervention” had higher completeness (97.83%) than “control group intervention” (82.68%). Inaccurate reporting commonly stemmed from incomplete descriptions of interventions or unspecified drug compositions. Conclusion Our results suggested a serious concern that TCM–related concepts were often missing in trial designs for TCM RCTs, which might impede the development of TCM theories. Also, this study’s inaccurate trial designs and intervention descriptions can provide cautionary examples for future RCT protocols or reports in TCM to avoid.