Objective To analyze and summarize the status of clinical trial outcome indexes of Chinese medicine treating diabetic retinopathy（ DR） and to put forward setting advice referring to DR outcome index in international field. Methods Clinical trials registry library was reviewed in Chinese Biological Medical Literature Database on disc

China National Knowledge Infrastructure

VIP Data

Wan Fang Data

Pub Med and Cochrane Library. Clinical randomized controlled trials of Chinese medicine treating DR were included from the databases were built to December of 2015. Meanwhile

published systematic reviews of various intervention measures treating DR were reviewed in Cochrane collaboration until December of 2015. Outcome indexes of reviewed results were extracted and made comparative analysis. Results Totally

93 randomized controlled trials of Chinese medicine treating DR and 5 systematic reviews were included. Ninety-three randomized controlled trials did not design main and secondary outcome indexes. Outcome indexes were mainly composite outcome indexes（ 68 /93）

vision（ 35 /93）

fundus（ 24 /93）

blood rheology（18 /93）

etc. Outcome indexes in 5 systematic reviews all were divided into main and secondary outcome indexes. Main outcome indexes included DR progression of disease（3 /5）

terminal event of causing blindness（2 /5） and disease onset（1 /5）. Secondary outcome indexes included progression of disease

terminal event

vision

disease onset

adverse event

life quality

expense and fundus. Conclusion There was a big gap between outcome indexes of clinical research reports of Chinese medicine treating DR and outcome indexes reported in systematic reviews in international field. The authors advised that

progression of disease and terminal event should be concerned when carrying out relating clinical researches hereafter. Rectifications should be made referring to indexes concerned internationally. Main and secondary outcome indexes should be reported respectively.