Background: Consistency of diagnostic criteria and efficacy evaluation criteria, if undetected, could lead to inaccurate estimates of effect and hence undermine the validity of clinical practice. It has been greatly ignored. One of the main reasons is that most Chinese authors lack relative knowledge. Objective: To identify randomized controlled trials (RCTs) of traditional Chinese herbal medicine (TCM) to find out the gap of the diagnostic criteria and efficacy evaluation criteria; to study how to reduce the consistency of diagnostic criteria and efficacy of the evaluation criteria. Methods: Published RCTs of TCM were sought from Chinese Science Citation Database (1989 to September 2009).Chinese Scientific Journal Full-text Database and Chinese Journal Full-text Database were used to acquire full-text for included RCTs. Two reviewers independently extracted data and assessed relative data with disagreements resolved by consensus. Analysis of diagnostic criteria and efficacy evaluation criteria were carried out for each study, and results compared where there was consistency of outcome reporting. We classified the diagnostic criteria and efficacy evaluation criteria three groups, standard of TCM,Western Medicine (WM) and integrated TCM-WM. Results: The searches returned 1809 potentially relevant articles. After application of inclusion criteria, 765 studies were included. Table 1 showed that 403 studies diagnostic criteria and 547 studies efficacy of the evaluation criteria were WM,97 studies diagnostic criteria and 155 studies efficacy of the evaluation criteria were TCM,265 studies diagnostic criteria 63 studies efficacy of the evaluation criteria were integrated TCM-WM; Table 2 showed the organization for developing standard, standard of TCM were developed by Ministry of Public Health in China and State Administration of Traditional Chinese Medicine, standard of WM were developed by Chinese Medical Association, Books and Ministry of Public Health in China, but the diagnostic criteria and efficacy evaluation criteria were unclear in most studies. Conclusion: There were discrepancy between diagnostic criteria and efficacy evaluation criteria in RCTs. the researchers should adopt the consistency diagnostic criteria and efficacy evaluation criteria in RCTs of TCM in the future.