| Background:the gastroesophageal reflux disease(GERD) is a very common digestive disease. While treating it, the TCM therapy has contributed not only a large amount of effective experiences and fomulas, but also many clinical trial researches on it. However, it is because of the weakness of the methodologies and standardizations of these clinical trials that makes it difficult when trying to introduce the TCM therapy to and get confirmation from worldwide professional researchers. Systematic Review is a recognized methodology in the international field, it can be utilized to facilitate the research for medicine, methods, technologies, measures, etc. it can provide constructive comments and promote the development of TCM. Objective:in order to systematically find out the problems and evaluate the quality of these TCM clinical trials of GERD, To make the systematic review of the curative effect of the TCM treatment on GERD. Thus clinical treatment decision can be made based on objective and reliable conclusions.Methods:In the basis of the Principle and the method of DME, formulate the Systematic Review Table of the articles of TCM therapy for GERD, Then find out all the related articles during year 2001—2010 in database, and proceed the statistic analysis on several baselines. Such as randomization, the balance among groups, the inclusion and exclusion criteria, control patten, sample volumn, blinding-method, statistics methods, the curative effect judgement standardization and so on. Calculate the rations of each condition and evaluate their quality. Then utilize the RevMan software to proceed Meta analysis.Results:Among the 265 articles found in the database, only 25 of them can be in line with the inclusion criteria. (1). diagnosis standardization:14 articles (56.0%)have cited TCM syndrome diagnosis,23 articles(92.0%) have cited conventional medicine diagnosis. (2). the inclusion criteria and exclusion criteria:11 articles(44.0%) have cited clear and proper inclusion criteria,14 articles(56.0%) have set up clear and proper criteria to exclude factors which may affect the authenticity of the results. (3).curative effect judgement standard:all articles give clear curative effect judgement standard with 11 of them haven't mention the source. (4). sample volumn:The confirmation for sample volumn is not strict, only 2 (8.0%)of these articles have described the calculating method or did any estimate before study. (5). randomization:6 studies (24.0%)have used complete randomization,2 studies(8.0%)have used semi-randomization, the rest ones haven't mentioned any concrete randomization method. (6). uniformity among groups. All articles have described the basic conditions of each group(eg, average age, gender, disease course and stage, syndrome differention) and used statistic method to test the demography characteristics and varible quantities between treatment groups and control group and give the conclusion that P>0.05.2 articles(8.0%) have listed the result in forms. All the studies have used statistic method. (7). blinding method:None of these study have used blinding method. (8).safety datas:12 studies(48.0%) have described the safety datas(the blood, urine and stool routine test, liver and kidney function and EKG before and after) and observed no adverse reaction or event. We select 19 articles which are coincide with the including critieria of Meta analysis, and analyse them from three aspects:clinical efficacy, gastroesophgeal endoscopic efficacy, relapse ratio. The result shows that oral-taken Chinese medicine compound is suprior than acid suppressing medication or motility-acid suppressing combination in clinical efficacy, endoscopic efficacy and further clinical efficacy.Conclusion:at present, the quantity of RCTs of GERD treated by Chinese medicine is not large, and there are many defects in the project design. The Meta analysis shows that Chinese medicine is effective in curbing the clinical symptoms, esophageal mucosa lesion and the relapse ratio. However, due to the poor quality of the articles included in this study and their publication bias, the reliability and authenticity of the result is affected. We hope there will be more RCTs with high quality to provide much more convinced evidence of this study. |
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