| ObjectiveTo explore the clinical efficacy and safety of modified xiaochaihu decoction in treating metabolic dysfunction-associated fatty liver(MAFLD)of liver stagnation and spleen deficiency from the perspective of intestinal microflora,and analyze its effect of on intestinal microflora to explain its preliminary mechanism.MethodsAccording to the principle of randomized controlled trials,72 patients with MAFLD of liver stagnation and spleen deficiency were divided into a treatment group and a control group,with 36 patients in each group.Patients in both groups were treated with lifestyle interventions,in addition the treatment group was treated with modified xiaochaihu decoction in treating while the control group was treated with polyene-phosphatidylcholine capsules for 12 weeks.The efficacy indexes included the TCM syndrome score,the degree of fatty liver on liver ultrasound B,liver function indexes(ALT,AST,γ-GGT),and lipid levels(TC,TG,HDL-C,LDL-C)were recorded before and after treatment in both groups.The diversity and differences of intestinal microflora were detected using 16 S r DNA highthroughput sequencing before and after treatment,and the structure and abundance of flora at the phylum level and genus level were analyzed.ResultsA total of 72 patients were included in this study,and 11 cases were shed,resulting in the inclusion of 61 cases,including 31 cases in the treatment group and 30 cases in the control group.There were no statistically significant differences between the two groups in terms of baseline information such as gender,age,disease duration,BMI,TCM syndrome score,degree of liver ultrasound disease,liver enzymes as well as lipid levels before treatment,which were comparable.In terms of improvement of clinical symptoms,the total effective rate after treatment was 90.3% in the treatment group and 70.0% in the control group.The TCM clinical efficacy of the treatment group was better than that of the control group,and the difference was statistically significant(P < 0.05).The total TCM syndrome score of both groups decreased significantly after treatment compared with those before treatment(P <0.05),but the total TCM syndrome score of the experimental group were lower than those of the control group,and the difference was statistically significant(P < 0.05).In terms of improving liver function,the levels of ALT,AST and γ-GGT decreased in both groups after treatment compared with those before treatment,and the difference was statistically significant(P < 0.05).The levels of ALT and AST in the treatment group were significantly lower than those in the control group after treatment,and the difference was statistically significant(P < 0.05),while there was no significant difference with the control group in improving γ-GGT levels(P > 0.05).In terms of improving lipid levels,the levels of TC,TG and LDL-C decreased in both groups after treatment compared with those before treatment(P < 0.05),while HDL-C levels increased compared with those before treatment(P < 0.05).The decreasing levels of TC,TG and LDL-C in the treatment group were significantly better than those in the control group after treatment,and the difference was statistically significant(P < 0.05).The HDL-C levels in the treatment group were significantly higher than those in the control group,and the difference was statistically significant(P < 0.05).In terms of improving the degree of fatty liver on liver ultrasound B,the total efficacy of liver ultrasound in the treatment group was 77.4%,compared with 53.3% in the control group,and the efficacy of liver ultrasound in the treatment group was better than that in the control group,and the difference was statistically significant(P < 0.05).Regarding the effect on intestinal microflora,the structure and abundance of flora in the two groups changed to different degrees after treatment.At the phylum level,the abundance of Firmicutes increased significantly in the treatment group compared with the control group(P < 0.05),while the abundance of Bacteroidetes decreased significantly compared with the control group(P < 0.05),while the changes in the abundance of the Proteobacteria,Actinobacteria and Fusobacteria did not differ significantly between the two groups(P > 0.05).At the genus level,the relative abundance of Lactobacillus and Bifidobacterium was significantly higher in the treatment group compared with the control group after treatment(P < 0.05),and the abundance of Bacteroides decreased significantly compared with the control group(P < 0.05),while the changes in the abundance of Ruminococcus and Coprococcus have no significant difference between the two groups(P > 0.05).No adverse reactions occurred in both groups during the observation process,and there were no significant abnormalities in the safety indexes before and after treatment.ConclusionThe clinical efficacy of modified xiaochaihu decoction in treating MAFLD of liver stagnation and spleen deficiency is significant,and can effectively improve the TCM syndrome in MAFLD patients.It has significant advantages in reducing the TCM syndrom,improving liver function,lowering blood lipid levels,and improving liver ultrasound B signs with safety.Meanwhile,the modified xiaochaihu decoction can adjust the intestinal microflora structure of MAFLD patients,increase the abundance of beneficial flora and decrease the abundance of harmful flora.The regulation of intestinal microflora may be the mechanism of the effect of modified xiaochaihu decoction in the treatment of MAFLD. |