Objective To evaluate quality of current literature on Chinese medical cohort studies in China

and to provide methodological reference for further high-quality cohort study design. Methods Literature on effect evaluation of Chinese medicine by cohort study was systematically searched from China National Knowledge Infrastructure

Wan Fang Data

VIP Data and Chinese Biological Medical Literature Database on disc from the date of database inception until December 31

2015. Two researchers screened the papers independently and extracted data. General conditions

classification of diseases and treatment methods were described. The methodological quality of included papers was evaluated with Newcastle-Ottawa Scale（ NOS）. The reported methodological key points of cohort studies were analyzed. The research types were reclassified according to contents of included papers. Results Totally 113 papers on Chinese medicine cohort study were included in this research. NOS scores of most papers were 4- 7（ 103 papers

91. 15%）

and（ 5. 12 ± 1. 19） on average. After the research design was evaluated and papers were reclassified

only 41 papers（ 36. 28%） were completely in line with the principles of cohort study. Five papers（ 4. 42%）mentioned both "cohort study " and "randomization "

which should be randomized controlled trials. Sixty-seven papers（ 59. 29%） were not in accord with the design principles of observational cohort study

which should be clinical controlled trials. Conclusion The methodological quality of cohort study on Chinese medicine clinical effect evaluation in China was poor. There were many problems in study design and methodology. It was easy to confuse cohort study with other clinical trial design. The methodological training for researchers should be enhanced. Thus

Chinese medicine effect might be evaluated by cohort study reasonably and scientifically.