Quality evaluation and design protocol of randomized controlled trial of TCM gongfu intervention for gastrointestinal diseases

Background Traditional Chinese medicine (TCM) gongfu is a long-established non-drug therapy that has been increasingly used in the treatment and rehabilitation of gastrointestinal diseases in recent years. A growing number of randomized controlled trials (RCTs) related to TCM gongfu interventions in gastrointestinal diseases have been published. But the lack of uniformity in the design of gongfu intervention trials has limited the generation of high-quality, evidence-based medical evidence. Objective The aim of this study was to identify the current weakest components of reporting. Another aim was to promote the development of high-quality research by proposing ideas and identifying problems in study design elements we sorted out. Methods The international and Chinese databases were searched from January 2000 to October 2022. Two researchers independently screened the literature, extracted key study elements, evaluated the risk of bias of each study according to Cochrane, evaluated the quality of RCT reports using CONSORT (2010), and used qualitative analysis to describe the key design elements of the included studies. Result 51 RCTs were included. Cochrane: overall risk of bias was low, with the highest risk of implementation bias, low risk of reporting bias, low risk of follow-up bias, and uncertain risk of selection bias and measurement bias in some studies. CONSORT Statement: Average reporting rate of 44.48% for all items in the Chinese papers and 76.21% for all items in the English papers. Conclusion The risk of bias in the implementation of RCTs of TCM gongfu interventions for gastrointestinal diseases is high, the CONSORT Statement rate of most studies is low, and the completeness, rigor, and authenticity aspects of reporting need to be standardized. The design protocol needs to be optimized for study subjects, interventions, control group settings and outcome indicators. Promote the generation of high-quality, evidence-based medicine results.