Short-term effects of Pingwei Anshen Decoction combined with low-carbohydrate diet on metabolic dysfunction-associated fatty liver disease
Objective:Evaluation of the clinical efficacy and safety of Pingwei Anshen Decoction combined with a low-carbohydrate diet (LCD)in the treatment of metabolic-associated fatty liver disease (MAFLD).Methods:A prospective cohort study was conducted on 113 patients diagnosed with metabolic dysfunction-associated fatty liver disease (MAFLD)characterized by liver stagnation and spleen deficiency syndrome,as well as phlegm-stasis interaction syndrome.Based on patient preference,the participants were allocated into a treatment group (n=45)and a control group (n=38).Both groups underwent a low-carbohydrate diet (LCD)intervention,while the treatment group received additional therapy with Pingwei Anshen Decoction.The intervention lasted 2 weeks for both groups.Outcomes measured included liver controlled attenuation parameter (CAP)values,traditional Chinese medicine (TCM)syndrome scores,liver function indicators[alanine aminotransferase (ALT),aspartate aminotransferase (AST),gamma-glutamyl transferase (γ-GT),and alkaline phosphatase (ALP)],glycemic and lipid metabolism parameters[fasting plasma glucose (FPG),fasting serum C-peptide (C-P),fasting insulin (FINS),homeostasis model assessment of insulin resistance (HOMA-IR),total cholesterol (TC),triglycerides (TG),high-density lipoprotein cholesterol (HDL-C),and low-density lipoprotein cholesterol (LDL-C)],body mass index (BMI),appetite visual analog scale (VAS) scores,and safety profiles.Results:Both groups showed a significant decrease in CAP values.The total clinical effective rate of the treatment group was 57.78%(26/45),which was better than the control group's 31.58%(12/38),with a statistical difference (P<0.05).Both groups of TCM syndrome scores showed significant improvement,with a total effective rate of 84.44% in the treatment group,which was better than the control group's 36.84%(P<0.01 ).The treatment group showed significant improvements in liver function indexes (ALT,AST,GGT,ALP),glucose metabolism-related indexes (FPG,C-P,FINS,HOMA-IR),TG,BMI,and appetite VAS score indexes (P<0.01);There was a significant decrease in GGT and BMI within the control group (P<0.01),while the appetite VAS score showed an increasing trend (P<0.05).There were no serious adverse events in either group.Conclusion:The combination of Pingwei Anshen Decoction and LCD can safely and effectively improve the degree of liver steatosis and TCM syndromes in MAFLD patients,reduce liver enzymes,correct glucose and lipid metabolism disorders,and reduce weight.Suppressing excessive appetite and alleviating discomfort associated with LCD may be the core value of Pingwei Anshen Decoction in treating MAFLD.