Objective To evaluate the randomized controlled trial (RCT) of clinical application of tongue imager, the methodology of case series study and the quality of report. METHODS: PubMed,CNKI, VIP, and WanFang databases were searched. The database was searched from December 2018, and RCT, case series, and case-control studies were performed using tongue images to observe clinical disease. Refer to Cochrane Manual 5.1. Version 0 of the Risk Assessment Tool and the CONSORT 2010 version of the statement, the methodological and reporting quality of the included RCT study was evaluated; and the methodological quality evaluation study of the methodology was conducted according to the fourth edition of the NICE and STROBE Statement.RESULTS:567 related literatures were initially detected and 59 were included, including 2 RCTs and 57 case series studies. 50% of the RCTs used Cochrane Bias Risk Tool to evaluate showed that the random allocation method was reasonable and did not use allocation concealment and blind method. Intentional Therapy (ITT) analysis was used, unfortunately, no missing interviews were reported, and there was no selective report in the study. The quality evaluation results of NICE case series studies: only 14.04% of the case series studies met the multi-center study; 59.64% of the studies included in the exclusion criteria were not clear; the data did not meet the expected set goals and did not carry out stratified analysis. The evaluation results of the 2010 edition of CONSORT statement showed that the included literature could not distinguish whether it was a randomized clinical trial or not, and the reporting rate of multiple items was 0. The results of evaluation with STROBE statement showed that all the included case series studies were not clearly identified as case series studies in the title, and the reporting rate of multiple items was 0. Conclusion The RCT and case series of clinical reports on tongue imaging are of low quality. It is recommended to refer to the CONSORT statement and the STROBE statement when designing and reporting clinical case-control and randomized controlled trials to correct the current methodological problems and further improve clinical research. Quality, enhance the intensity of clinical application of tongue imager in clinical efficacy, and promote the objectification and modernization of Chinese medicine.