| Purpose:Using the method of meta-analysis to evaluate the therapeutic effect of invigorating the spleen and removing dampness in the treatment of type 2 diabetes,and to provide further evidence-based medicine evidence for the treatment of type 2 diabetes by traditional Chinese medicine.Method:To formulate strict inclusion and exclusion criteria,use manual retrieval and electronic retrieval methods,take"invigorating the spleen","removing dampness","removing dampness","promoting dampness","type 2diabetes","traditional Chinese medicine","random"and"traditional Chinese medicine"as the subject words or keywords,search the published literature in Pubmed,Datebase,CNKI,Wanfang database,Chinese Science and Technology Journal Full-text Database,Chinese Biomedical Database and other database.The retrieval time is from January 1,2009 to December 31,2019.Two researchers judge independently whether the retrieved documents meet the inclusion criteria,then discuss or seek help of a third person in case of disagreement.Using Excel to extract general data.The bias evaluation table of Cochrane collaborative network was used to evaluate the quality,including random assignment method,assignment concealment scheme,using of blind method,data integrity of results,selective report of results and other bias sources.The outcome of the study included total clinical effective rate,TCM syndrome score,Hemoglobin a1c(Hb A1c),Fasting plasma glucose(FPG),2-hour postprandial plasma glucose(2h PG),Fasting insulin level(FINS),Insulin resistance level(HOMA-IR)and the incidence of adverse reactions.Revman 5.3 software was used to make statistical analysis on the test results,in which RR was used to analyze the two categories of variables,and MD or SMD was used to analyze the continuity variables.Both of them were shown in 95%confidence interval(CI).If P>0.1,I2<50%,the results of each study are considered to be homogenous.FE(fixed effect model)is used for combined analysis of statistics;if P≤0.1,I~2≥50%,which indicates that there is heterogeneity between the results of each study.To find the factors that cause heterogeneity as much as possible.The statistics of heterogeneity can be calculated by subgroup analysis.If there is no factor that causes clinical or methodological differences,or the type of results still have heterogeneity after subgroup analysis,we use the random effect model(RE).The combination statistics need to use the hypothesis test method for Z-test,P≤0.05 can be considered that the combination statistics have statistical significance.The results of meta-analysis were shown by forest chart.The bias degree of meta-analysis was shown by funnel chart,Grading the evidence with the GRADE scale.Results:A total of 1184 cases were included in 15 randomized controlled trials,including 594 cases in the experimental group and 590 cases in the control group.The results of meta-analysis show that:(1)12 studies reported the total clinical effective rate,RR=1.37,95%CI(1.27-1.47),P<0.00001,the difference between the two groups was statistically significant,and the improvement of the clinical effective rate of type 2diabetes patients with invigorating the spleen and removing dampness method was better than that of the control group;(2)8 studies reported TCM syndrome score,MD=-3.32,95%CI(-4.84,-1.81),P<0.00001,the difference between the two groups was statistically significant,the use of invigorating the spleen and removing dampness method on the reduction of TCM syndrome score in patients with type 2 diabetes was better than that in the control group;(3)14 studies reported glycosylated hemoglobin,MD=-0.73,95%CI(-1.03,-1.42),P<0.00001,the difference between the two groups was statistically significant,the use of invigorating the spleen and removing dampness method on the decrease of glycosylated hemoglobin in patients with type 2 diabetes mellitus was better than that of the control group;(4)15 studies reported fasting blood glucose,MD=-0.73,95%CI(-0.93,-0.53),P<0.00001,the difference between the two groups was statistically significant,the use of invigorating the spleen and removing dampness method on the reduction of fasting blood glucose in patients with type 2 diabetes was better than that in the control group;(5)15 studies reported 2 postprandial blood glucose,MD=-1.22,95%CI(-1.57,-0.86),P<0.00001,the difference between the two groups was statistically significant,and the effect of invigorating the spleen and removing dampness method on postprandial2-hour blood glucose in patients with type 2 diabetes mellitus was better than that in the control group;(6)fasting insulin level was reported in 11 studies,SMD=-0.78,95%CI(-1.09,0.-47),P<0.00001,the difference between the two groups was statistically significant,the use of invigorating the spleen and removing dampness method on the reduction of fasting insulin level in patients with type 2 diabetes mellitus was better than that in the control group;(7)nine studies reported insulin resistance index,SMD=-1.12,95%CI(-1.46,-0.77),P<0.00001,the difference between the two groups was statistically significant,the use of invigorating the spleen and removing dampness method on the reduction of insulin resistance in patients with type 2diabetes mellitus was better than that of the control group;(8)10 studies reported the occurrence of adverse reactions,RR=0.29,95%CI 0.11-0.76,P=0.01<0.05,the difference between the two groups was statistically significant,it can be considered that the use of 95%CI为0.11-0.76,P=0.01<0.05 can make patients bad The incidence of the reaction was significantly reduced.The inverted funnel plot of clinical total effective rate did not show a typical inverted funnel distribution,which indicated that the included studies had certain publication bias or other bias;the funnel diagram of fasting blood glucose and 2-hour postprandial blood glucose was more symmetrical,indicating that the included articles had less bias.Grade grading evaluation showed that TCM syndrome score,fasting blood glucose,postprandial 2-hour blood glucose,fasting insulin level,insulin resistance level,were low-level evidence,clinical total effective rate,glycosylated hemoglobin,incidence of adverse reactions were intermediate evidence.Conclusion:1.The curative effect of Jianpi Qushi traditional Chinese medicine in the treatment of type 2 diabetes mellitus with spleen deficiency and dampness is better than that of Western medicine alone.2.Invigorating the spleen and eliminating dampness can reduce the incidence of adverse reactions in patients with type 2 diabetes mellitus of spleen deficiency and dampness excess,which is a relatively safe clinical treatment method. |
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