| Objective:To observe the clinical efficacy of Lianchen Decoction in treating obese T2DM patients with phlegm-dampness internal obstruction and its effect on intestinal flora diversity and species abundance,to explore its possible mechanism of action,and to provide more adequate evidence to support the clinical use of Lianchen Decoction in treating obese T2DM.Methods:Sixty-four patients with obese T2DM with phlegm-damp internal obstruction who met the inclusion criteria and attended the outpatient clinic of the Department of Endocrinology,The First Affiliated Hospital of Heilongjiang University of Traditional Chinese Medicine from February 2022 to October 2022 were randomly divided into 3 2 patients in the control group and 32 patients in the treatment group.Patients in both groups were given basic treatment such as diabetes education,diet and exercise,and metformin hydrochloride tablets were given to the control group,while patients in the treatment group were given Lianchen Decoction and metformin hydrochloride tablets for a 12-week treatment period.The clinical efficacy and safety of Lianchen Decoction combined with metformin were evaluated by comparing the changes of TCM evidence scores,glucose metabolism indexes(FBG,2hPG,HbA1c),obesity-related indexes(BMI,waist circumference),insulin-related indexes(FINS,HOMA-IR)and lipid metabolism indexes(TG,TC,LDL-C)before and after treatment in the two groups.The intestinal flora was detected by 16S rDNA technique before and after treatment in the two groups,and the differences in intestinal flora before and after treatment were analyzed from the Alpha diversity,Beta diversity and species abundance of intestinal flora in the two groups.Results:1.Number of patient cases completed:64 cases of obese T2DM patients with phlegm-damp internal obstruction were enrolled,among which 2 cases in the control group and 1 case in the treatment group withdrew during the trial and were regarded as detached cases,and the final statistically treated patients were 61 cases.2.General data:There was no significant difference between the two groups in terms of gender,age,and duration of disease by statistical analysis(P>0.05),and they were comparable.3.Chinese medicine evidence points:The TCM evidence scores were comparable between the two groups of patients before treatment(P>0.05);after treatment,the Chinese medicine evidence points of patients in both groups were lower than before(P<0.01);the treatment group improved significantly better than the control group(P<0.0 1).4.Glucose metabolism indexes:FBG,2hPG and HbA1c were comparable between the two groups before treatment(P>0.05);after treatment,FBG,2hPG and HbA1c decreased in both groups compared with those before treatment(P<0.01),and the improvement in the treatment group was better than that in the control group(P<0.05).5.Obesity-related indexes:BMI and waist circumference of patients in both groups were comparable before treatment(P>0.05);after treatment,BMI and waist circumference of patients in both groups decreased compared with those before treatment(P<0.01),the improvement in the treatment group was better than that in the control group(P<0.05).6.Insulin-related indexes:FINS and HOMA-IR were comparable between the two groups before treatment(P>0.05);after treatment,FINS and HOMA-IR decreased in both groups compared with those before treatment(P<0.01),and the treatment group improved better than the control group(P<0.05).7.Lipid metabolism indexes:TG,TC and LDL-C were comparable between the two groups before treatment(P>0.05);after treatment,TG,TC and LDL-C were lower in both groups than before treatment(P<0.05),and the treatment group improved better than the control group(P<0.05).8.Comparison of efficacy:①Chinese medicine efficacy:the total effective rate of Chinese medicine efficacy in the treatment group was 90.32%,and the total effective rate of Chinese medicine efficacy in the control group was 63.33%,the efficacy of Chinese medicine efficacy in the treatment group was significantly better than that in the control group,and the difference was statistically significant(P<0.0 1).②Western medicine efficacy:the total effective rate of western medicine efficacy in the treatment group was 87.09%,and the effective rate of western medicine efficacy in the control group was 73.33%,the western medicine efficacy in the treatment group was better than that in the control group,and the difference was statistically significant(P<0.05).9.Intestinal flora:①Alpha diversity:the differences between the indices of the two groups of patients before treatment were not statistically significant(P>0.05)and were comparable.After treatment,Chaol index and Ace index increased in both groups compared with those before treatment,but the differences were not statistically significant within and between groups(P>0.05).After treatment,the Shannon index and Simpson index increased in patients in the treatment group,and the Shannon index increased and the Simpson index did not change significantly in the control group.The changes were statistically significant in the treatment group(P<0.05)and not in the control group(P>0.05).②Beta diversity:There were differences in intestinal flora structure between the two groups after treatment.③Species abundance change:After treatment,the abundance of species at the gate,family and genus levels was changed to different degrees in the two groups.At the phylum level,there was an increase in the abundance of the phylum Synechococcus in the treatment group,and the difference was statistically significant(P<0.05),while none of the changes in the control group were statistically significant(P>0.05).At the family level,the abundance of Enterobacteriaceae decreased and that of Tannerella increased in the treatment group,with statistically significant differences(P<0.05),while none of the changes in the control group were statistically significant(P>0.05).At the genus level,the abundance of Escherichia spp.decreased in the treatment group,and the difference was statistically significant(P<0.05),while none of the changes in the control group were statistically significant(P>0.05).10.Safety:The four maj or vital signs of the patients in both groups were stable during the treatment,and no abnormalities were found in blood,urine and stool routine,liver and kidney function tests,and no significant adverse reactions were observed in either group.Conclusion:1.Lianchen Decoction combined with metformin was more effective than metformin alone in treating obese T2DM patients with phlegm-damp internal obstruction.2.Lianchen Decoction significantly improves the TCM symptoms,regulates the level of glucose and lipid metabolism,reduces body weight and increases insulin sensitivity in obese T2DM patients with phlegm-damp internal obstruction.3.Lianchen Decoction significantly increases the diversity and uniformity of intestinal flora in obese T2DM patients with phlegm-damp internal obstruction,up-regulates the abundance of beneficial flora and down-regulates the abundance of harmful flora at the level of phylum,family and genus,and corrects the intestinal imbalance.4.Lianchen Decoction is safe and reliable in treating obese T2DM patients with phlegm-damp internal obstruction and has no toxic side effects. |
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