Abstract:To evaluate the literature quality of randomized controlled clinical trial related with the treatment of non-small cell lung cancer with traditional Chinese medicine integrated with western medicine (TCM-WM). Methods:The related studies were searched by computer and the references of the included studies by manual method in the database of Chinese Sci Tech Periodicals (VIP Database) during the period of 1989-2014. The quality of the literature of RCTs was evaluated in reference to 22-item checklist of the CONSORT Statement and other self-established criteria. Results:A total of 69 pieces of articles were included among the initial 225. There was only one article with the word “randomization” presenting in its title; 46 of them used a structured abstract. None of them mentioned the scientific background, the rational for the trial, the calculation of the sample size, blinding methods, participant flow, ITT analysis or ancillary analyses. Some haven’t described the statistical methods clearly or used incorrect methods. All 69 trials had positive outcomes, only 19 mentioned adverse effects. Only 9 had general interpretation of the trial’s results in the context of current evidences in their discussion section, and a few of them mentioned the limitations of the study, the clinical and research significance or the external validity of the results. Conclusion:The quality of literature on RCTs of TCM-WM for non-small cell lung cancer is generally poor. It is suggested that the clinical researchers strengthen the quality control throughout the process of RCTs, enhance the scientific preciseness of randomization, controlling and blinding, so that the quality of RCTs of traditional Chinese medicine literature can be improved.