Quality evaluation and thinking of randomized controlled clinical trials reports of traditional Chinese medicine in the treatment of diabetes mellitus-induced erectile dysfunction
Objective To evaluate the quality of randomized controlled trials(RCTs)of traditional Chinese medicine(TCM)in the treatment of diabetes mellitus-induced erectile dysfunction(DMED),and to provide methodological reference for subsequent research in this field.Methods RCTs for TCM treatment of DMED included in CNKI,Wanfang,CBM,and VIP from the establishment of the databases to July 2023 were searched,and quality was evaluated based on the consolidated standards of reporting trials(CONSORT)-TCM compound edition and improved Jadad scale.Results A total of 26 RCTs were included,of which 19.23％were identified as RCTs through the title,76.92％described the experimental design and allocation proportion,15.38％described the algorithm for sample size,19.23％described the method of generating randomly assigned sequences,3.85％described the types of random methods,3.85％described allocation concealment mechanisms,3.85％used blind methods,11.54％used baseline data recorded in tables,46.15％mentioned adverse events,but the severity and outcomes were not recorded,15.38％indicating the estimated values and accuracy of outcome indicators,and 38.46％analyzing the limitations of the study.All literatures lacked appropriate keywords,subject flow charts,complete intervention records,access to research protocols,registration information,and funding sources.88.47％of the literatures were of low quality.Conclusions The number of RCTs used in the treatment of DMED with TCM in China is small,and the quality is low.Therefore,caution should be exercised when adopting and applying RCTs;subsequent researchers should refer to the CONSORT statement and the Jadad scale for experimental design,implementation,and reporting to improve the quality of RCT researches on TCM treatment of DMED.
万方数据
维普
