| ObjectiveTo evaluate the clinical efficacy and safety of the combination of Pingwei Anshen Decoction and low-carbohydrate diet in the treatment of metabolic dysfunction-associated fatty liver disease,and to clarify its clinical efficacy characteristics.MethodsThis study was a prospective cohort study.Patients with metabolic dysfunction-associated fatty liver disease who attended the clinic of Director Du Hongbo of Dongzhimen Hospital of Beijing University of Traditional Chinese Medicine from September 2020 to March 2023 with evidence of liver depression,spleen deficiency,and phlegm-stasis interconnection were selected.The use of the treatment regimen of Pingwei Anshen Decoction during the treatment period was defined as an exposure factor based on the patient’s subjective willingness and tendency to choose the treatment regimen.Patients were divided into a treatment group(exposed group),which received only a low-carbohydrate diet regimen,and a control group(non-exposed group),which was treated with Pingwei Anshen Decoction in addition to the control group,depending on the treatment regimen used.Patients in both groups were informed of the same dietary management protocol and health education.The duration of the intervention was 2 weeks,the data of TCM syndrome score,liver controlled attenuation parameter(CAP),liver function-related indexes(ALT,AST,GGT,ALP),glucolipid metabolism-related indexes(FPG,C-P,FINS,HOMA-IR,TC,TG,HDL-C,LDL-C),BMI,and appetite VAS score were collected before and after the intervention,and the occurrence of adverse effects.It was used to evaluate the clinical efficacy and safety of the treatment regimen.SPSS 26.0 software was used to process the data for own pre-and post-control and inter-group comparison.Results145 patients with metabolic dysfunction-associated fatty with evidence of liver depression,spleen deficiency,and phlegm-stasis interconnection in the tutor’s clinic were screened.After screening by inclusion and exclusion criteria,67 patients voluntarily accepted the treatment protocol of this study,including 34 cases in the treatment group and 33 cases in the control group.After shedding and excluding some patients,a total of 50 cases were included in this study for analysis,including 27 cases in the treatment group and 23 cases in the control group.The baseline data levels of gender,age,CAP value,TCM syndrome score,liver function-related indexes,glycolipid metabolism-related indexes,BMI,and appetite VAS score were comparable between the two groups(P>0.05)(1)Clinical efficacy:①Regarding the main efficacy indexes:both the treatment group and the control group could reduce the TCM syndrome score(P<0.01);and the treatment group was better(P<0.05);the total effective rate of the treatment group was 81.48%(22/27)and the total effective rate of the control group was 39.13%(9/23),and the treatment group was significantly better than the control group(P<0.01).Based on the evaluation of liver CAP values,both treatment and control groups could effectively reduce CAP values(P<0.01),but there was no statistical difference between the two groups(P=0.319).②As for secondary efficacy indexes:after treatment,liver function indexes(ALT,AST,GGT,ALP),glucolipid metabolism-related indexes(FPG,C-P,FINS,HOMA-IR,TG),BMI,and appetite VAS score in the treatment group were significantly improved(P<0.05);only GGT and BMI in the control group were improved(P<0.05),and there was a tendency to increase appetite VAS scores.Compared with the control group,the treatment group could significantly reduce the appetite VAS score(P<0.01).Further comparing the changes of each index in the group before and after treatment,there was a statistical difference between the changes of AST,FPG,C-P,HOMA-IR and BMI before and after treatment in the treatment group and those in the control group(P<0.05).(2)Safety evaluation:There were no serious adverse events observed in both the treatment group and the control group,and although there were some negative effects,no special treatment was needed,and the safety evaluation was grade 2.Among them,①Clinical discomfort symptoms:Treatment group:1 case of fatigue and 1 case of constipation,with a total incidence rate of 7.41%(2/27).Control group:5 cases of obvious hunger,2 cases of palpitations and palpitations,and 1 case of constipation,with a total incidence rate of 34.78%(8/23).The discomfort symptoms of both groups of patients were relatively mild,and they were not interrupted or withdrawn from the study due to this,indicating good safety.The treatment group was superior to the control group(P=0.040).②Trends in dyslipidemia:the overall incidence of LDL-C elevation in the treatment group was 51.85%(14/27),with an increase of 3.61%to 79.64%,while the overall incidence in the control group was 47.63%(11/23),with an increase of 1.79%to 31.52%.There was no statistically significant increase in LDL-C in the two groups(P>0.05).The total incidence of HDL-C reduction in the treatment group was 44.44%(12/27),with a decrease of 1.10%to 45.00%;the total incidence in the control group was 56.52%(13/23),with a decrease of 0.85%to 19.73%.There was no statistically significant decrease in HDL-C in the two groups(P>0.05).Conclusion(1)Both the combination of Pingwei Anshen Decoction with low-carbohydrate diet and single low-carbohydrate diet can effectively improve the TCM clinical symptoms of patients with metabolic dysfunction-associated fatty liver disease with liver depression,spleen deficiency and phlegm-stasis interconnection,reduce liver CAP,improve liver function,and reduce BMI.The combined regimen can also improve disorders of glucolipid metabolism.(2)Pingwei Anshen Decoction can strengthen the therapeutic efficiency of single lowcarbohydrate diet intervention program and reduce the discomfort and hyper-appetite associated with low-carbohydrate diet intervention process,effectively improving the safety and sustainability of low-carbohydrate diet intervention process.(3)Elevating LDL-C and lowering HDL-C may be a potential risk for a low-carbohydrate diet. |
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