A cross-sectional study of reporting guidelines for clinical studies in Traditional Chinese Medicine

Introduction: Reporting guidelines (RGs) provide the minimum information for inclusion to ensure that research reports can be understood by readers, reproduced or otherwise utilized by other researchers, or guide decisions by clinicians. The Reporting Guidelines for Clinical Studies in Traditional Chinese Medicine (RGCS-TCM) were established to guide the development of reporting standardization of clinical studies in Traditional Chinese Medicine (TCM). However, the characteristics and methodological quality of existing RGCS-TCM are yet to be investigated. We therefore performed a cross-sectional study to identify and evaluate the adequacy of RGCS-TCM and propose recommendations to optimize the development standards and future directions for RGCS-TCM. 

Methods: Seven databases including MEDLINE, Excerpta Medica Database (EMBASE), the Allied and Complementary Medicine Database (AMED), Chinese Biomedical Literature Service System (CBM), China National Knowledge Infrastructure (CNKI), Wanfang Data and VIP Chinese Medical Journal Database, the EQUATOR network website, tracking references to included studies, and Google Scholar were searched up to 20^th Oct 2023 for RGCS-TCM. The characteristics of included RGCS-TCM were summarized. The methodological quality of included RGCS-TCM were critically appraised. 

Results: Thirty published RGCS-TCM and six registered (under development) RGCS-TCM for different types of studies were included. Nine RGCS-TCM did not use a consensus method and lacked a consensus process, and fourteen RGCS-TCM failed to retrieve and use existing relevant evidence and lacked preliminary systematic reviews. Thirteen RGs had a relatively complete research and development process, which met the 3 basic criteria for determining high-quality RGs. Most RGCS-TCM reported the details of 1) rationale of TCM (10/15, 66.7 %), 2) reason for selected certain type of TCM intervention (9/15, 60.0 %), 3) diagnosis of TCM conditions (9/15, 60.0 %), 4) details about the intervention and its controls (13/15, 86.7 %), 5) dynamic changes of Pattern Differentiation and Treatment (2/15, 13.3 %), 6) outcome assessment specifically linked with TCM (8/15, 53.3 %), and 7) potential side effects related to TCM (4/15, 26.7 %). 

Conclusion: There are opportunities to rationalise and improve the quality of existing RGCS-TCM and reduce research waste. Further research is indicated to investigate the barriers and facilitators for optimizing the development and application of RGCS-TCM.