Traditional Chinese medicine: extension guidelines for international clinical research reporting standards

With the continued advancement of evidence-based medicine, four major international clinical research reporting guidelines-standard protocol items: recommendations for interventional trials (SPIRIT), consolidated standards of reporting trials (CONSORT), preferred reporting items for systematic reviews and meta-analyses (PRISMA) and reporting items for practice guidelines in healthcare (RIGHT)-have formed a comprehensive framework covering the entire research process. However, the unique theoretical system and diagnostic and therapeutic modalities of traditional Chinese medicine (TCM) pose significant challenges for the direct application of these universal standards. In response, the field of TCM has developed a series of guidelines for extension based on international reporting frameworks. This article systematically reviews the core content of these TCM extension guidelines, identifies and summarises key adaptations for TCM characteristics by comparing them with the original international guidelines. Furthermore, from the perspective of evidence-based medicine, this study evaluates the applicability of these extension guidelines in terms of evidence validity, applicability and clinical importance. This review aims to provide a theoretical foundation and practical guidance for standardising TCM clinical research practices, thereby facilitating the generation of high-quality evidence and its translation into clinical practice.