Quality Of Reporting And Systematic Evaluation Of The Effect Of External Treatment Of Traditional Chinese Medicine (TCM)Mainly On Candidiasis In Randomized Controlled Tr-ials

Object ivesTo assess the quality of reporting of external TCM treatment mainly on candidiasis diseases in RCT and to evaluate effectiveness and safety of external TCM treatment mainly for relief of candidiasis diseases.MethodsAccording to the CONSORT statement and Jadad score scale, methods of randomization, assessment of sample content, comparability of baseline, methods of bl inding, therapeutic methods, statistical methods, fol lowing-up, drop-out, etc. in clinical studies were evaluated. According to Conchrane standards, Meta analysis would be used for evaluating the research which had high Jadad score, or qualitative analysis would be used for some researches which had large difference between each other.Result60RCT were identified meeting the criteria. Frequency was found to increase over time:from4(6.67%) in2005to13(21.67%) in2011. There were fewer papers in this field having high quality while41(68.33%) in domestic non-core journals and18(30.0%) in domestic core journals. Only1(1.67%) of the included trials adequately discussed informed consent. All of included literatures had no description of the sample size estimation process. Twenty-six (43.33%)1iteratures had more detai l ed descript ion of baseline data, one (1.67%) literature is accompanied by a list of description. Three studies (5.00%) are deemed to have authentic randomization and no paper provided some information about blinding of either participants or investigators. In one (1.67%) of papers, there was some information about the length of time for which participants were followed. Only5(8.33%) literatures simply described treatment adverse reaction. Conc l us ionThe quality of reporting and the research methods of external treatment of TCM mainly on candidiasis in RCT need to be improved and should be consistent with the standards of evidence-based medicine (EBM). Due to the low quality of included trials and publication bias, the conclusions can not be very convincing. We need to carry out RCT with rational design, strict implementation and multi-center sample.