Evaluation on quality of randomized controlled trials on domestic traditional Chinese medicine decoction for oral care

doi:10.3969/j.issn.1009-6493.2016.13.012

Abstract：Objective:To evaluate the quality of reports on randomized controlled trials domestic traditional Chi-nese medicine decoction for oral care,and to understand study results of clinical trials in this field,and to provide scientific evidences for clinical nursing decision.Methods:Published clinical randomized controlled trials on tradi-tional Chinese medicine decoction for oral care in China academic j ournal full text database,Wanfang Data Re-source System,VIP Chinese science and technology periodical system and Chinese biomedical literature database were searched by computer.Time limit was up to June 2015,Language was Chinese.Quality evaluation was con-ducted by adopting Chinese medicine clinical randomized controlled trials reporting standard(CONSORT FOR TCM)in 2007,supplementary indicators and modified Jadad Rating Scale.Results:A total of 2 094 papers were preliminary selected,and 3 9 articles met the criteria were selected;sample size basis were not introduced in 3 9 literatures,inclusion and exclusion criteria were introduced in 15 literatures(38.5%);method of random group-ing was referred in 10 literatures(25.6%),but did not describe the distribution of hidden and implementation;blind method was referred in 3 papers(7.7%),but did not describe the implementation method;all studies were positive,but no effect quantity and precision were introduced;the adverse reactions were introdeuced in 6 papers (15.4%);ethical principles were considered in 3 papers(7.7%),and 3 papers (7.7%)were in TCM syndrome differentiation;score of 39 articles in modified Jadad scale≤2.Conclusion:Results of randomized controlled trials of oral care in Chinese traditional medicine could not provide reliable evidence for clinical nursing,and quality of the report needs to be improved.