ObjectiveTo evaluate the quality of randomized controlled trials (RCTs) on traditional Chinese medicine (TCM) compound formulations conducted under the "Pattern Dominating Disease" model. MethodsRCTs on "Syndrome Dominating Disease" published in the CBM, CNKI, WanFang Data, VIP, PubMed, Cochrane Library, Embase, and Web of Science databases were collected from inception to November 1, 2025. Two researchers independently screened the literature, extracted data, and assessed the quality of the included studies using the CONSORT extension for TCM formulas checklist and the Cochrane Collaboration's Risk of Bias tool. ResultsA total of 14 RCTs were included, primarily involving three types: basic syndrome patterns, common syndrome patterns, and compound syndrome patterns. Among the 25 items of the CONSORT extension for TCM formulas checklist, the reporting compliance rates for items 6b, 13a, and 16 were 100% across all studies. Items 3b, 10, 12b, 18, 23, and 24 were not reported in any study. The reporting compliance for the remaining items varied. The risk of bias assessment indicated that all studies were judged to have an "unclear risk" concerning blinding of outcome assessors, selective reporting bias, and other biases. ConclusionRCTs investigating the "Pattern Dominating Disease" model show notable deficiencies in both reporting quality and methodological quality. It is recommended that, based on existing tools, dedicated evaluation and reporting instruments be developed to enhance the quality of such RCTs.
