| ObjectiveTo evaluate the clinical efficacy and safety indexs of the clinical efficacy of TCM symptoms,Hamilton Depression Scale(HAMD),glucose metabolism and Serm Brain-Derived Neurotrophic Factor(BDNF)level in patients complicated diabetic mellitus with depression with stagnate fire inside the shaoyang channel treated with the Chaihu-jia-Longgu-Muli-Decoction(CLM),and to Search for the mechanism as well.MethodsUsing prospective and randomized controlled trials,patients complicated diabetic mellitus with depression with stagnate fire inside the shaoyang channel were randomly selected according to the inclusion and exclusion criteriam,and 75 cases were randomly divided into control group or test group,with 35 cases in each group.Both groups were treated with routine treatments such as the control of hypoglycemic,lipid regulation and blood pressure,but the test group was given CLM for 12 weeks extra.The changes of the clinical efficacy of TCM symptoms;,HAMD,glucose metabolism indexs,HOMA-IR,BDNF level and adverse reactions before and after treatment were compared between two groups.SPSS 24.0 was used for statistical analysis.Results1.The general information,glucose metabolism indexs,HAMD,BDNF level,total scores of TCM and safety indexs showed no signiificant difference between two groups before treatment(P>0.05).2.HAMD:the sorces of the HAMD of both group descend constrast with before treatment signiificantly(P<0.01),and for the test group,its reduction of the total scores is lager than the other(P<0.01),preceding that the test group is better than the control group when they compare with HAMD.Comparison of clinical efficacy:the total effective rate of the control group was 40.00%while the test group was 86.67%,which showed the total effective rate of the test group was higher than the other(P<0.01).3.Comparison of total scores of TCM symptoms:Compared with that before treatment,the total score of the two groups were descended after treatment(P<0.05),revealing that the two groups can improve the TCM synptoms,but the decrease degree of the test group is greater than the other group(P<0.01),so the test group is remarably better.Comparison of clinical efficacy of TCM symptoms:the total effective rate of the control group was 43.33%while the test group was 90.00%,suggesting that the total effective rate of the test group was higher than the other(P<0.01).4.Comparison of glucose metabolism indexes:Compareing before and after treatment,FPG of the control group changing with no significant difference distinguish the test group significantly decreased,while the 2hPG、HbA1c decline remarkably both in two groups(P<0.05),howerver the test group decline more than the other(P<0.05),presenting greater advantage to drop down the blood glucose.5.HOMA-IR:Paralleling the control group with no significant decline,the test group indicated remarkably descend(P<0.01)preceding superiorly ameliorate insulin resistance(P<0.01).5.BDNF level:The test group which taking the CLM ascend the level of BDNF in a lager range(P<0.01),the difference between two groups was statistically significant(P<0.05).6.The correlation of BDNF,HOMA-IR and HAMD:The result assessed by the Pearson correlation coefficients revealed that BDNF was negatively correlated with HAMD,while was positive correlation wtih HOMA-IR(P<0.01).Patients in the test group taking the CLM can raise BDNF level and decline HOMA-IR and HAMD,suggesting the mechanism of the CLM to treat diabetic mellitus with depression with stagnate fire inside the shaoyang channel was to raise BDNF level.7.Comparison of security:During the treatment,no significant adverse reactions were observed in both groups.ConclusionThe CLM application in the treatment of diabetic mellitus with depression with stagnate fire inside the shaoyang channel has a definite clinical effect,related to the rise of BDNF level,and has high safety. |
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