| Objective: Useing meta-analysis method to systematically evaluate the efficacy and safety of TCM combined with metformin in the T2DM-IR.Methods: Collect the RCT published in CNKI,Wanfang,VIP,Cochrane Library and Peb Med databases on the treatment of T2DM-IR with TCM combined with metformin.The intervention measures of the treatment group were TCM decoction combined with metformin,while the control group was intervened with metformin alone.The retrieval time was from the establishment of each database to December 2020.According to the inclusion and exclusion criteria,the final included documents were obtained,the basic information and data of the documents were extracted,and the quality evaluation and statistical analysis of the documents were carried out by Revmen5.4 software.Results:1.A total of 14 papers were included in this study,including 5 degree papers and 9 journal papers.A total of 1109 patients with T2DM-IR were included,including 579 patients in the treatment group and 530 patients in the control group.2.Efficacy analysis:(1)In improving the total effective rate: the total effective rate was reported in 14 included literatures,and the analysis results showed that RR=1.32,95%CI[1.24,1.41],Z=8.36,P<0.01,the difference was statistically significant,and the treatment group was superior to the control group.(2)In improving IR: eight literatures reported on HOMA-IR,and the analysis results showed that SMD=-1.35,95%CI[-1.71,-0.98],Z=7.25,P<0.01,the difference was statistically significant.Eleven papers reported ISI,and the results showed that SMD=1.40,95%CI[0.87,1.92],Z=5.23,P<0.01,the difference was statistically significant,and the increase of ISI in treatment group was better than that in control group.There are three papers reported on HOMA-β,and the results show that SMD =-0.05,95%CI[-1.64,1.54],Z=0.06,P=0.95>0.05,with no significant difference.(3)In reducing insulin level: FINS was reported in 14 articles,and the results showed that SMD=-0.62,95%CI[-0.89,-0.36],Z=4.62,P<0.01,the difference was statistically significant,and the treatment group was better than the control group in reducing FINS level.Two papers reported insulin2 h INS,and the results showed that SMD=-0.98,95%CI[-3.42,1.46],Z=0.79,P=0.43>0.05,with no significant difference.(4)In the aspect of lowering blood sugar: all the 14 included literatures reported FPG,and the analysis results showed that MD=-1.09,95%CI[-1.34,-0.84],Z=8.52,P<0.01,the difference was statistically significant,and the treatment group reduced FPG level better than the control group.There are 13 papers reported on 2h PG,and the analysis results show that MD=-1.14,95%CI[-1.50,-0.77],Z=6.06,P<0.01,the difference is statistically significant,and the treatment group is better than the control group in reducing 2h PG level.Eight papers have reported Hb A1 c,and the analysis results show that MD=-0.75,95%CI[-1.22,-0.28],Z=3.12,P=0.002<0.01,the difference is statistically significant,and the treatment group is better than the control group in reducing Hb A1 c level.(5)In regulating blood lipid: there are 10 literatures about TG,and the analysis results show that MD=-0.37,95%CI[-0.45,-0.28],Z=8.01,P<0.01,the difference is statistically significant,and the treatment group is better than the control group in reducing TG level.TC was reported in 10 literatures,and the analysis results showed that MD=-0.57,95%CI[-0.80,-0.34],Z=4.78,P<0.01,the difference was statistically significant,and the treatment group was superior to the control group in reducing TC level.Eight papers have reported LDL-C.The analysis results show that MD=-0.51,95%CI[-0.75,-0.27],Z=4.21,P<0.01.The difference is statistically significant.The treatment group is better than the control group in reducing LDL-C level.There are 9 literatures about HDL-C,and the analysis results show that MD=0.21,95%CI[0.10,0.33],Z=3.67,P=0.0002<0.01,the difference is statistically significant,and the treatment group is superior to the control group in increasing HDL-C level.(6)In the aspect of reducing BMI: there are 4 reports on BMI,and the analysis results show that MD=-0.92,95%CI[-1.53,-0.30],Z=2.90,P=0.004<0.01,the difference is statistically significant,and the treatment group is superior to the control group.3.Safety analysis: 8 papers have been monitored for safety.Among them,2 literatures reported adverse reactions.No adverse reactions occurred in the other 6 articles.The analysis results showed that RR=0.26,95%CI [0.07,1.00],Z=1.95,P=0.05,and there was no significant difference between the treatment group and the control group in reducing the incidence of adverse reactions.Conclusion:1.1.Compared with metformin alone,TCM combined with metformin in the treatment of T2DM-IR has obvious advantages in improving the total effective rate,ISI,HDL-C and reducing HOMA-IR,FINS,FPG,2h PG,Hb A1 c,TG,TC,LDL-C and BMI,but there is no obvious difference in improving HOMA-β and reducing 2h INS.2.There is no significant difference in adverse reactions between TCM combined with metformin and metformin alone in the treatment of T2DM-IR. |
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