| OBJECTIVE: To investigate the clinical efficacy and safety of Yang He Tang with addition and subtraction in the treatment of metabolic-related fatty liver disease(MAFLD)with Yang deficiency and dampness obstruction,and to provide a new theory and method for the treatment of MAFLD with traditional Chinese medicine.METHODS: Sixty-eight patients who met the diagnostic criteria of MAFLD were included and randomly divided into control group and observation group.The control group was treated with silymarin capsules and the observation group was treated with Yang He Tang plus or minus.Both groups were observed for12 weeks in total..Relevant data(TCM symptoms,liver ultrasound,fat attenuation parameters,liver enzymology,blood glucose,blood lipids,uric acid,body weight,BMI)were collected from patients before and after treatment,to set up a model of database and to perform statistic analysis.So that we can systematically evaluate the clinical efficacy and safety of Yang He Tang plus reduction in the treatment of patients with Yang deficiency and dampness obstruction.Results: 1.Comparison of total scores of TCM syndromes and symptoms between the two groups: Yang He Tang plus and minus was more effective in treating MAFLD patients with Yang deficiency and dampness obstruction.The total effective rate in the observation group was 93.75%;the total effective rate in the control group was 70.00%.The efficacy of the observation group was more obvious,with significant differences(P < 0.01).After treatment,the TCM syndrome scores of both groups were lower than those before treatment,which was statistically significant(P < 0.01).The observation group was lower than that of control group.and the statistical difference between the two groups after treatment was significant(P < 0.01).2.Comparison of body weight and BMI: The observation group was better than the control group in terms of reducing body weight and BMI.After treatment,the weight and BMI of both groups decreased compared with those before treatment,and the difference between the two groups after treatment was statistically significant(P < 0.01).In comparison between groups,the weight and BMI of the observation group decreased more significantly than that of the control group,and the difference was statistically significant(P <0.05).、3.Comparison of serological efficacy: The observation group was significantly better than the control group in improving liver enzymology.The ALT,AST and GGT decreased in both groups before and after treatment,and the difference was statistically significant(P < 0.01).In comparison between groups,the ALT,AST,GGT of the observation group decreased more significantly than that of the control group,and the difference was statistically significant(P < 0.01 or P < 0.05).4.Comparison of blood lipids,blood glucose and uric acid: The abnormalities of blood lipids and uric acid in the observation group could be better improved.The differences of lipids(TG,TC,LDL-C)and uric acid in both groups after treatment were significant compared with those before treatment(P<0.01).In comparison between groups,both lipids and uric acid decreased more significantly in the observation group than in the control group,and the differences were statistically significant(P < 0.01 or P <0.05).Both groups showed no significant effect on lowering blood glucose.5.Comparison of the efficacy of color-Doppler and fat attenuation parameters: the degree of fatty liver was more severe in MAFLD patients with Yang deficiency and dampness obstruction after being treated with Yang He Tang plus reduction.After treatment,the color Doppler ultrasonography of both groups were reduced in some patients compared with those before treatment,and the total effective rate was 75.00% in the observation group and 46.67%in the control group.The difference in efficacy between the observation group and the control group was statistically significant(P < 0.05).The CAP values in both groups decreased after treatment compared with those before treatment,and the difference was highly significant(P < 0.01).Comparison between the groups showed that the CAP value of the observation group decreased more significantly than that of the control group after treatment,and the difference was highly significant(P < 0.01).Conclusion: Based on the theory of "Yang transforms Qi,Yin forms",Yang He Tang with addition and subtraction was used to treat Yang deficiency and dampness obstruction type of metabolism-related fatty liver disease,which has better efficacy in improving patients’ TCM symptoms,liver enzymology,liver ultrasound,fat attenuation parameters,blood lipids,uric acid,body weight and BMI,and is worthy of clinical application. |
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