Objective

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To analyze the current status and existing problems of research on traditional Chinese medicine （TCM） syndrome diagnostic scales， and to provide references and suggestions for the standardization of TCM syndrome research.

Methods

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Literature related to the development and evaluation of TCM syndrome diagnostic scales published up to April 22， 2025， was retrieved from CNKI， Wanfang Database， VIP Database， and Chinese Biomedical Literature Database. Statistical analysis was conducted on scale names， disease names， research models， syndrome types， item pool construction methods， item screening methods， item weighting methods， diagnostic threshold determination methods， scale evaluation methods， and syndrome severity grading.

Results

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A total of 207 articles were included， involving 164 TCM syndrome diagnostic scales. Among them， 138 were disease-based syndrome scales， including 8 combined TCM disease-syndrome scales （covering 3 diseases） and 130 Western medicine disease-TCM syndrome scales （covering 77 diseases）， with hypertension-related scales being the most numerous （18）. There were 26 syndrome-based disease scales involving 20 syndromes. In total， 91 scales focused on common or compound syndrome diagnosis， 73 on basic syndrome or syndrome element diagnosis， and 3 on animal syndrome diagnosis. Macroscopic syndrome differentiation scales numbered 154， while macroscopic-microscopic combined differentiation scales numbered 10. Scale dimensions fell into three categories： （1） subjective symptoms， objective signs， and laboratory indicators； （2） basic syndromes of compound syndromes and tongue-pulse diagnosis； （3） syndrome elements and tongue-pulse diagnosis. Tongue-pulse indicators were included in 84 scales. Item pool construction was mainly based on modern literature research （61.99%， 106/171）. Item screening was often based on clinical surveys （33.22%， 102/307）， expert consultation （30.29%， 95/307）， and literature review （26.71%， 83/307）， using over 20 methods such as mean， frequency， dispersion trend， and correlation coefficient methods. Of the scales， 53.05% （87/164） had completed item weighting， 40.85% （67/164） had determined diagnostic thresholds， and 73.78% （121/164） had undergone scale evaluation， all using expert syndrome differentiation as the "gold standard". Among these， 32.93% （54/164） only evaluated psychometric properties such as reliability， 16.46% （27/164） only performed diagnostic test evaluations， and 21.34% （35/164） evaluated both psychometric properties and diagnostic tests. A total of 14.02% （23/164） explored syndrome severity grading， all using the quartile method.

Conclusion

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Research on TCM syndrome diagnostic scales has made certain progress， but remains weak in aspects such as research models， syndrome types， microscopic indicators， scale dimensions and items， and development methodology.