Objective To analyze the researches on traditional Chinese medicine（TCM） syndrome diagnosis

and to explore the methodology for its normative development. Methods We searched PubMed

Web of Science

CNKI

SinoMed

Wanfang database and VIP database for the relevant researches on TCM syndrome diagnosis. Data such as research publication time

type

mode

elements

common key techniques

and results were extracted and analyzed

to provide development condition of TCM syndrome diagnosis as well as research methodology. Results Totally 1001 articles were included

of which 949 were diagnosis studies based on the diagnostic model combining disease and syndrome

while the other 52 were solely syndrome differentiation studies

reviews

clinical investigations

or expert′s consultation. The research elements mainly included three parts: syndrome elements

syndromes

and symptoms/signs. Descriptive analysis

multivariate statistical methods

and/or data mining techniques were mainly used methods. The results of few researches have been published. Conclusion To normatively develop the TCM syndrome diagnosis

the mode combing Western medicine disease and TCM syndrome should be adopted; the methods of clinical epidemiological investigation

data mining and expert′s questionnaire should be combined to make a draft; and clinical validation should be adopted.