Evidence Map Analysis on Randomized Controlled Trials: Chinese Patent Medicines and Classic Traditional Chinese Medicine Prescriptions

OBJECTIVES: To evaluate the status and methodological quality of randomized controlled trials published in 2024 on Chinese patent medicines and Classic Traditional Chinese Medicine Prescriptions, providing evidence for clinical practice and policy. METHODS: We systematically searched multiple Chinese and English databases and trial registries for randomized controlled trials (RCTs) on Chinese patent medicines (CPMs) and Classic Traditional Chinese Medicine Prescriptions (CTCMPs) published in 2024. Two researchers independently screened studies, extracted data, and assessed methodological quality using the Cochrane RoB tool. Inter-rater reliability was evaluated using Kappa statistics and intraclass correlation coefficient. Spearman's correlation and Wilcoxon rank-sum tests were performed to analyze factors influencing methodological quality. RESULTS: In 2024, 1874 RCTs were included (1550 CPM, 324 CTCMP). Circulatory and digestive diseases predominated in CPM and CTCMP studies, respectively. Two-arm "Chinese medicine plus Western medicine" designs were mainstream. CPM RCTs favored physical/chemical outcomes, while CTCMP RCTs prioritized symptoms/signs outcomes; 169 patient-reported outcomes were identified. Most studies had small samples (100 cases) and were single-center. Methodological quality revealed adequate randomization but serious deficiencies in allocation concealment and blinding. Ethics approval (CPM≈68.5%, CTCMP≈61.1%) and trial registration (CPM≈3.8%, CTCMP≈0.9%) were suboptimal. Funding, higher journal IF, and multicenter design were positively associated with ROB scores. CONCLUSIONS: This evidence mapping reveals a significant disconnect between the quantity and quality of randomized controlled trials in Traditional Chinese Medicine. Persistent methodological weaknesses undermine evidence reliability. Future research should prioritize methodological rigor, adequate statistical power, and prospective trial registration. There is an urgent need to develop a dedicated evaluation framework that captures both methodological quality and clinical value.