Objective:The randomized controlled clinical trial was conducted to observe the clinical efficacy of Chaihu-jia-Longgu-Muli-Decoction in the treatment of type 2 diabetes mellitus with depression and its effect on intestinal microbiota,evaluate its clinical value and safety,and explore its possible anti-depression mechanism.Methods:In this randomized,parallel controlled trial,60 patients with type 2 diabetes mellitus complicated with depression were randomly divided into observation group(n = 30)and control group(n = 30).The control group was given basic hypoglycemic treatment,and the observation group was given Chaihu-jia-Longgu-Muli-Decoction orally on the basis of the control group.The intervention course was 4 weeks.The changes of TCM syndrome score,HAMD-17 score,SDS score and glucolipid metabolism indexes in 2 groups were observed and recorded before and after treatment.Feces samples of patients were collected for 16 S r DNA sequencing,and the changes of intestinal microflora structure characteristics before and after treatment were analyzed.Results:1.There were no significant differences in general data,glucose and lipid metabolism index,safety index,HAMD-17 score,SDS score and TCM syndrome score between the observation group and the control group before treatment(P<0.05).After treatment,Hamd-17 score,SDS score and TCM syndrome score were significantly decreased in both groups(P<0.05),but the improvement degree of observation group was significantly better than that of control group(P<0.05).Compared with before treatment,BMI,FPG,2h PG,FIns and GA values of observation group were significantly decreased after treatment(P<0.05),the difference was statistically significant;FPG,2h PG and GA in control group were significantly decreased after treatment(P<0.05),but there were no significant changes in BMI and FIns(P<0.05).2.The clustering results showed that the 10 differences in OTU were mainly attributed to Firmicutes(21/42,50.00%),Bacteroidetes(15/42,35.71%),Proteobacteria(4/42,9.52%)and Actinomycetes(2/42,4.76%).Alpha diversity analysis showed that Shannon index,Chao index and Ace index in the observation group were significantly increased after 4 weeks of intervention compared with before treatment(P<0.05),Simpson index significantly decreased(P<0.05);The Chao index and Ace index in control group decreased significantly(P<0.05),while there was no significant difference between Shannon index and Simpson index(P>0.05).Beta diversity analysis showed that the distance between samples in the observation group was relatively small and the distribution was more concentrated,while the distance between samples in the control group was larger and the distribution was more dispersed.Lef Se analysis showed that when the LDA threshold was 2.0,the relative abundance of 9 bacterial communities in the observation group was significantly reduced after 4 weeks of intervention compared with before treatment.Clostridia,Clostridiales,Phascolarctobacterium,Prevotellaceae,Bacteroidetes,Streptococcaceae,Streptococcus,Oteobacteria and Rhizobiales;The relative abundance of 13 microflora increased significantly,they are Acidaminococcaceae,Negativicutes,Proteobacteria,Firmicutes,Clostridiales,Bifidobacterial,Anaerostipes,Porphyromonadaceae,Allisonella,Christensenellaceae,Rikenellaceae,Butyricicoccus and Bacteroidia.Conclusion:1.Chaihu-jia-Longgu-Muli-Decoction can effectively reduce HAMD-17 score,SDS score,TCM syndrome score,and BMI,FPG,2h PG,FIns and GA values in type 2diabetes patients with depression.2.Chaihu-jia-Longgu-Muli-Decoction can effectively improve the intestinal microbiota structural characteristics of type 2 diabetes patients with depression,reduce the abundance of opportunistic pathogens,and increase the abundance of probiotics. |