| 1Research purposes①By the results of the system evaluation, it provides a comprehensive analysis of Jinqi jiangtang tablet clinical efficacy and safety of treating diabetes.②By the results of the system evaluation,it provides medical evidences for clinical practice.2 Research methodsAccording to the research methods of the Cochrane system evaluation,we retrieve all the Chinese electronic databases comprehensively and systematicly,that is CNKI,Wanfang Database,CBM and VIP,collecting data on the clinical efficacy of Jinqi jiangtang tablet randomized controlled trials.According to the inclusive or exclusive criteria for studys screening,we use the Cochrane Collaboration bias risk assessment tools to assess methodological quality of included studies.Extracting basic information of included studies,we use RevMan 5.3 software recommended by Cochrane systematic reviews to work out Meta-analysis,then explain and discuss the Meta-analysis results.3 Research results21 studies included in the system evaluation are all Jinqi jiangtang tablet combined with conventional Western medicine hypoglycemic agents efficacy comparing purely conventional Western medicine.Among the observed outcomes,the primary outcome measures are only clinical efficacy and adverse effects of the number of cases,and the secondary outcome measures were fasting and postprandial 2H glucose, fasting and postprandial 2H insulin, glycosylated hemoglobin,total cholesterol, triglycerides, insulin resistance index.The system evaluation make descriptive analysis of the above outcome indicators, and work on meta-analysis of the some results. The following is the results of the system evaluation:Clinical efficiency:analysis of individual clinical trials,5 studies have reported this outcome measure,3 of the studies showed that the combination of Jinqi jiangtang tablet and Western medicine treatment is better than that of the control group.On meta-analysis results,compared with the control group, there was no significant difference in clinical efficacy between the two groups.Reducing the effect of fasting blood glucose:analysis of individual clinical trials,21 studies have reported this outcome measure,15 of the studies showed that the combination of Jinqi jiangtang tablet and Western medicine treatment is better than that of the control group.On meta-analysis results,10 studies included in meta-analysis demonstrate Jinqi Jiangtang combined with western medicine treatment in reducing the effect of fasting blood glucose is superior to the control group using basic Western medicine treatment, the difference was statistically significant.Reducing the effect of postprandial 2H blood glucose:analysis of individual clinical trials,18 studies have reported this outcome measure,15 of the studies showed that the combination of Jinqi jiangtang tablet and Western medicine treatment is better than that of the control group.On meta-analysis results,9 studies included in meta-analysis demonstrate Jinqi Jiangtang combined with western medicine treatment in reducing the effect of postprandial 2H blood glucose is superior to the control group using basic Western medicine treatment, the difference was statistically significant.Reducing the effect of fasting insulin:analysis of individual clinical trials,10 studies have reported this outcome measure,5 of the studies showed that the combination of Jinqi jiangtang tablet and Western medicine treatment is better than that of the control group.On meta-analysis results,5 studies included in meta-analysis demonstrate Jinqi Jiangtang combined with western medicine treatment in reducing the effect of fasting insulin is superior to the control group using basic Western medicine treatment, the difference was statistically significant.Reducing the effect of postprandial 2h insulin:analysis of individual clinical trials,4 studies have reported this outcome measure,2 of the studies showed that the combination of Jinqi jiangtang tablet and Western medicine treatment is better than that of the control group.On meta-analysis results,2 studies included in meta-analysis demonstrate Jinqi Jiangtang combined with western medicine treatment in reducing the effect of postprandial 2h insulin is superior to the control group using basic Western medicine treatment, the difference was statistically significant.Reducing the effect of glycosylated hemoglobin:analysis of individual clinical trials,11 studies have reported this outcome measure,8 of the studies showed that the combination of Jinqi jiangtang tablet and Western medicine treatment is better than that of the control group.On meta-analysis results,2 studies included in meta-analysis demonstrate Jinqi Jiangtang combined with western medicine treatment in reducing the effect of glycosylated hemoglobin is superior to the control group using basic Western medicine treatment, the difference was statistically significant.Reducing the effect of total cholesterol:analysis of individual clinical trials,12 studies have reported this outcome measure,3 of the studies showed that the combination of Jinqi jiangtang tablet and Western medicine treatment is better than that of the control group.On meta-analysis results,4 studys are included meta-analysis and divided into two subgroups,one subgroup result demonstrates Jinqi Jiangtang combined with western medicine treatment in reducing the effect of total cholesterol is superior to the control group using basic Western medicine treatment, the difference was statistically significant.Reducing the effect of triglyceride:analysis of individual clinical trials,12 studies have reported this outcome measure,11 of the studies showed that the combination of Jinqi jiangtang tablet and Western medicine treatment is better than that of the control group.On meta-analysis results,4 studys are included meta-analysis and divided into two subgroups,one subgroup result demonstrates Jinqi Jiangtang combined with western medicine treatment in reducing the effect of triglyceride is superior to the control group using basic Western medicine treatment, the difference was statistically significant.Reducing the effect of insulin resistance:analysis of individual clinical trials,6 studies have reported this outcome measure,6 of the studies showed that the combination of Jinqi jiangtang tablet and Western medicine treatment is better than that of the control group.On meta-analysis results,2 studies included in meta-analysis demonstrate Jinqi Jiangtang combined with western medicine treatment in reducing the effect of insulin resistance is superior to the control group using basic Western medicine treatment, the difference was statistically significant.Safety evaluation:9 studies have reported adverse reaction conditions,4 of the studies showed that no adverse reactions occurred and the other 5 studies have reported adverse reactions,however,different intervention measures can not be carried out the results into meta-analysis. Analysis of individual clinical trials,the adverse reaction rate of Jinqi Jiangtang combined with western medicine treatmentwas was lower than that of the control group. Therefrom,we can boldly infer that Jinqi Jiangtang combined with western medicine treatment can reduce the incidence of adverse reactions.4 Research conclusionJinqi Jiangtang tablets combined with western medicine has a huge potential for clinical efficiency, egulating glucose and lipid metabolism,however, due to limitations of this systematic review, so we can not draw firm conclusions.In the future,there is necessary to continue working on large-scale multi-center, large sample randomized controlled clinical trials to verify the clinical efficacy and safety of it.Currently methodological quality of clinical trials of traditional Chinese medicine is generally low,so it is urgent to train TCM practitioners on designing and implementation methods of clinical trials.It is helpful for us in the future to carry out a large sample, multi-center clinical trial to improve the level of scientific research and evidence-based medicine to evaluate the clinical efficacy of traditional Chinese medicine.Due to the small number of trials included, it is necessary to continue to update the system evaluation about Jinqi Jiangtang Tablet combined with western medcine clinical efficacy.Chinese patent medicine treatment of diabetes should be based on Chinese medicine theory and based on syndrome differentiation as the core,consistent drug card, in order to have a significant clinical effect.And evaluation of clinical efficacy of traditional Chinese medicine should be based on the improvement of Syndrome, and pay attention to the improvement of the quality of life of patients. |
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