Construction of a clinical efficacy evaluation framework for traditional Chinese medicine treatment of metabolic dysfunction-associated fatty liver disease

Based on a review of clinical trial assessment indices for metabolic dysfunction-associated fatty liver disease （MAFLD） and the current status of traditional Chinese medicine （TCM） research， this article proposes a multi-dimensional， stratified， and operable clinical efficacy evaluation framework for TCM with reference to the features of MAFLD and the therapeutic effect of TCM. This system encompasses eight dimensions of liver histology， radiology， biochemical indicators， metabolic markers， anthropometry， TCM syndromes， patient-reported outcomes， and safety indicators， which are stratified according to research objectives and disease stages. This study further explores the implementation pathways for the standardization of syndrome evaluation， research design norms， and quality control， in order to provide methodological support for conducting high-quality TCM clinical research and promote the transition of TCM efficacy evaluation from “single indicators” to “multi-dimensional composite indicators”.