| Background data from the 8th edition of the global diabetes map released by the international diabetes federation(IDF)in 2017 show that the global prevalence of diabetes is currently 8.8%.The rate of adult diabetes in China is the highest in the world,and it continues to grow.The prevalence of diabetes in China was 10.9 percent in 2017,and the prevalence of diabetes poses a serious social and economic burden.Understanding of diabetes,modern medicine has clarified from multiple angles in the pathogenesis of diabetes may be associated with HLA susceptibility,insulin resistance.intestinal disorders and so on,and according to different mechanism developed on different targets for drugs,on behalf of the drug metformin,gliclazide and all kinds of insulin and so on,greatly improve the patient's blood sugar levels,slow down the progress of T2DM duration and complications.Diabetes is called "quenching thirst" in traditional Chinese medicine.Chinese medicine believes that the etiology of quenching thirst is mainly related to the deficiency of innate endowment and the inappropriate adjustment of acquired.Yin-deficiency and heat-drying are the basic pathogenesis of the disease.In recent years,a large number of clinical studies have shown that T2DM patients are mostly manifested as qi and Yin deficiency and blood stasis syndrome,with symptoms such as thirst,fatigue,hypoglottic vein cyanosis,etc.,indicating that the pathogenesis of this disease is closely related to kidney qi deficiency,Yin deficiency,fire flourishing and blood stasis.In clinical,qi and activating blood method in treating type 2 diabetes with the outcome,regardless of qi and activating blood on traditional Chinese medicine compound,or related acupuncture treatment and acupuncture thereof,has good clinical curative effect,the blood glucose level in patients with improved at the same time can effectively adjust the metabolism of blood lipid and further prevent diabetes heart,cerebrovascular complications,qi and activating blood method to treat diabetes clinical application prospect.However,the clinical efficacy and safety of qi-nourishing Yin and activating blood therapy for type 2 diabetes mellitus are still not supported by specific evidence-based medicine conclusions.There is no systematic conclusion on whether it can be used for a long time and how safe it is.The clinical efficacy and safety of qi-nourishing Yin and activating blood therapy are still unclear.Purpose through with teacher learning mentor qi and activating blood method in the treatment of type 2 diabetes clinical experience,qi and activating blood method)in recent 10 years clinical literature data,using the method of meta analysis system evaluation research of TCM treatment of qi and activating blood method for the efficacy and safety of type 2 diabetes,reference for clinical treatment.Systematic evaluation of the treatment of type 2 diabetes with traditional Chinese medicinemethods1 data sourcesMain Chinese databases:cnki,wanfang,etc.Foreign language databases:PubMed,Embase,etc.Retrieval period:January 2008 to January 2018.2 inclusion criteriaType of experiment:the experimental group included all clinical trials of traditional Chinese medicine compound therapy for T2DM including qi-nourishing Yin and activating blood circulation,and the experimental type was RCT.The control group was metformin.Subjects:the inclusion criteria were in l:ine with the diagnostic criteria for DM published by WHO in 1999.Outcome indexes:blood glucose and lipid,etc.3 quality evaluationThe quality evaluation criteria adopted in Cochrane systematic evaluation manual 5.1.0 were followed.4 data analysisMeta analysis and description were performed using the RevMan5.3 softwa re provided by the Cochrane collaboration,and the final results were presented as forest maps.OR value,RR value,WMD value and SMD value were selected to describe the effect size analysis,with 95%as the confidence interval.X2 test was used to test the heterogeneity of each test.Sensitivity analysis was also performed for each article.Meta analysis was performed when more than two literatures reported the same adverse reactions.Results1 Literature quality:17 literatures were eventually included,most of which were based on the randomization principle.17 literatures did not report allocation and hiding,and the use of blind method among patients,implementors and evaluators was not reported.The overall quality of the included literature was medium.2.Clinical efficacy:differences in clinical efficacy between the experimental group and the control group were reported in 12 literatures.One of the literatures reported the comparison between the treatment group and the two control groups,and the results showed that the differences were significant(P<0.05 or P<0.01).Two literatures showed the clinical efficacy of metformin in the pure Chinese medicine group,and the heterogeneity test 12=0.The results showed that the clinical efficacy of the patients was significantly improved after the traditional Chinese medicine compound therapy for nourishing qi,nourishing Yin and promoting blood circulation,and the difference was statistically significant[RR=1.37,95%ci(1.14,1.65),P<0.01].After the heterogeneity test of 9 literatures,I2=0,the results showed that the clinical efficacy of the patients was significantly improved after the traditional Chinese medicine compound therapy for nourishing qi,nourishing Yin and promoting blood circulation,and the difference was statistically significant[RR=1.29,95%ci(1.20,1.39),P<0.01].3.Fasting blood glucose:16 literatures reported the difference of fasting blood glucose between the experimental group and the control group after the treatment of traditional Chinese medicine compound for invigorating qi,nourishing Yin and promoting blood circulation.One study reported the comparison between the treatment group and the two control groups,and the results showed that there were significant differences between the experimental group 1 and the experimental group 2 and the control group(P<0.05).Two literatures reported the hypoglycemic effect of the pure Chinese medicine group compared with the western medicine metformin 500mg group.After the heterogeneity test,12=64%.Meta analysis was conducted using the random effect model,and the results showed that there was no significant difference between the two literatures control group and the control group[MD=-0.40,95%CI(-1.25,-0.45),P=0.36].5 articles were reported is qi and invigorate the circulation of Chinese traditional medicine compound joint metformin compared with western medicine comparison of 500 mg metformin group,the heterogeneity of the literature of 5 inspection,12=19%,hence the use of fixed effects model were analyzed,and the results show that the experimental group than the control group can significantly improve patients with fasting plasma glucose,the difference is statistically significant(MD=0.34,95%CI(0.64,0.05),P<0.05).In 6 references,the dose of metformin in the control group was 250mg,while in 2 references,the dose of metformin in the control group was not clear,but all of them showed that there was a significant difference between the two groups in fasting blood glucose(P<0.05 or P<0.01).4.Postprandial blood glucose:16 literatures reported the difference of postprandial blood glucose between the experimental group and the control group after the treatment of traditional Chinese medicine compound for invigorating qi,nourishing Yin and promoting blood circulation.One study reported the comparison between the treatment group and the two control groups,and the results showed that there were significant differences between the experimental group 1 and the experimental group 2 and the control group(P<0.05).Two literatures reported the hypoglycemic effect of the pure Chinese medicine group compared with the western medicine metformin 500mg group,and the heterogeneity test 12=51%.The results showed that there was no significant difference between the control group and the two literatures,[MD=-0.59,95%CI(-1.68,-0.51),P=0.29].Five literatures reported the control results of traditional Chinese medicine compound for invigorating qi,nourishing Yin and promoting blood circulation combined with metformin in comparison with western medicine metformin 500mg group.Heterogeneity test was conducted,12=0.The results showed that the experimental group could significantly improve the patients' fasting blood glucose compared with the control group,and the difference was statistically significant[MD=-0.64,95%CI(-1.03,-0.25),P<0.05].In 6 references,the dose of metformin in the control group was 250mg,while in 2 references,the dose of metformin in the control group was not clear,indicating that there were significant differences in postprandial blood glucose between the test group and the control group(P<0.05 or P<0.01).5.Glycosylated hemoglobin:10 literatures reported the differences of glycosylated hemoglobin between the experimental group and the control group after the treatment of traditional Chinese medicine compound for invigorating qi,nourishing Yin and promoting blood circulation.Two articles showed the improvement of hbalc in the pure Chinese medicine compound compared with the control group(500mg),and the heterogeneity test I2=0.The results showed that there was no significant difference between the test group and the control group in the two articles[MD=-0.17,95%ci(-0.73,-0.39),P=0.55].Five literatures reported the control results of traditional Chinese medicine compound prescription combined with metformin for invigorating qi,nourishing Yin and promoting blood circulation in comparison with western medicine metformin 500mg group,and the heterogeneity test,12=88,showed no significant difference between the test group and the control group in the five literatures,[MD=-0.64,95%CI(-1.27,-0.00),P=0.05]6.Adverse reactions:relevant adverse reactions were reported in 2 literatures.These included nausea in 3 cases and mild gastrointestinal discomfort in 4 cases.1 patient had mild hypoglycemia and 1 patient had mild nausea and vomiting.No serious adverse reactions occurred.Systematic evaluation of TCM external treatment for type 2 diabetes mellitus methods1 data sourcesMain Chinese databases:cnki,wanfang,etc.Foreign language databases:PubMed,Embase,etc.Retrieval period:January 2008 to January 2018.2inclusion criteriaExperimental type:the experimental group is a clinical trial study of all TCM external treatment for T2DM with the effect of invigorating qi,nourishing Yin and activating blood,and the experimental type is RCT.Subj ects:the inclusion criteria were in line with the diagnostic criteria for DM published by WHO in 1999Outcome indexes:blood glucose and lipid,etc3 quality evaluationThe quality evaluation criteria adopted in Cochrane systematic evaluation manual 5.1.0 were followed.4 data analysisMeta analysis and description were performed using the RevMan5.3 software provided by the Cochrane collaboration,and the final results were presented as forest maps.OR value,RR value,WMD value and SMD value were selected to describe the effect size analysis,with 95%as the confidence interval.X2 test was used to test the heterogeneity of each test Sensitivity analysis was also performed for each article.Meta analysis was performed when more than two literatures reported the same adverse reactions.Results1.Literature quality:5 literatures were eventually included,most of which were based on the random principle.1 literatures reported allocation hiding,1 literatures reported the use of blind method among patients,implementors and evaluators,5 literatures had complete outcome data,and no selective publication or other bias was found in all literatures.The overall quality of the included literature was medium2.Clinical effective rate:three literatures reported the difference of clinical efficacy between the experimental group and the control group after the treatment of traditional Chinese medicine compound prescription for invigorating qi,nourishing Yin and promoting blood circulation.The heterogeneity test,12=3%,showed that the clinical efficacy of the patients was significantly improved after the external treatment of TCM for nourishing qi,nourishing Yin and promoting blood circulation,and the difference was statistically significant[RR=-131,95%ci(1.11,1.53),P<0.011.3.Fasting blood glucose:5 literatures reported the difference of fasting blood glucose between the experimental group and the control group after the external treatment of TCM for invigorating qi,nourishing Yin and promoting blood circulation.One paper reported the comparison between the treatment group and the two control groups,and the results showed that there were significant differences between the experimental group 1 and the experimental group 2 and the control group(P<0.05).The control group was normal,and the fasting blood glucose in the experimental group decreased significantly after treatment(P<0.01),and the difference between the two groups was statistically significant(P<0.01).Heterogeneity test was performed in 3 articles,I2=40%.The results showed that the experimental group could significantly improve the patients'fasting blood glucose compared with the control group,and the difference was statistically significant[MD=-0.69,95%CI(-1.32,-0.07),P<0.05].4.Postprandial blood glucose:three literatures reported the difference of postprandial blood glucose between the experimental group and the control group after the external treatment of TCM for invigorating qi,nourishing Yin and promoting blood circulation.One paper reported the comparison between the treatment group and the two control groups,and the results showed that there were significant differences between the experimental group 1 and the experimental group 2 and the control group(P<0.05).Heterogeneity test was conducted on the two literatures,I2=0,and the results showed that external treatment of TCM for invigorating qi,nourishing Yin and promoting blood circulation could effectively reduce postprandial blood glucose of patients,and the difference was statistically significant[MD=-2.39,95%CI(-3.41,-1.36),P<0.01].5.Glycosylated hemoglobin:two literatures reported the differences of glycosylated hemoglobin between the experimental group and the control group after the treatment of traditional Chinese medicine compound for invigorating qi,nourishing Yin and promoting blood circulation.One paper reported the comparison between the treatment group and the two control groups,and the results showed that there were significant differences between the experimental group 1 and the experimental group 2 and the control group(P<0.05).The mean and standard deviation of hbalc before and after treatment in the experimental group and the control group were reported in one paper,and the results showed that the differences between the two groups were statistically significant(P<0.05).6.Adverse reactions:relevant adverse reactions were reported in 2 literatures.This included 11 cases of pruritus,7 cases of minor tingling in the eax,and mild hypoglycemia,as well as cyanosis and red spots at the local injection of insulin.No serious adverse reactions occurred.Conclusion1.TCM compound prescription and external treatment of TCM have certain clinical effects on type 2 diabetes.After treatment and intervention with traditional Chinese medicine and various external therapies,the clinical symptoms of the patients were significantly improved,and the levels of FBG,PBG,TC,TG,LDL and other indicators of the patients were significantly reduced,suggesting that the qi-nourishing and yin-activating therapy plays a unique role in the treatment of type 2 diabetes.The compound or external therapy combined with western medicine is obviously better than the western medicine alone.2.The incidence of adverse reactions in the treatment of type 2 diabetes with the method of invigorating qi,nourishing Yin and activating blood circulation is low 5 indicating that this kind of traditional Chinese medicine compound and external treatment have certain safety.However,due to the generally moderate quality of the included literature and the non-standard design of most trials,more high-quality and large-sample clinical studies are still needed. |
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