To evaluate the clinical efficacy of Lianhe Xiaozhi Ointment combined with semaglutide in treating metabolic associated fatty liver disease (MAFLD) combined with Type 2 Diabetes Mellitus (T2DM) characterized by the phlegm-heat interconnection syndrome.

METHODS A total of 80 patients were enrolled in this study. They were recruited from the Department of Endocrinology at the Affiliated Hospital of Nanjing University of Chinese Medicine between August 2022 and December 2023, with a diagnosis of both MAFLD and T2DM characterized by the phlegm-heat interconnection syndrome. Patients were randomized into a control group and an observation group (n=40 per group). The control group received lifestyle interventions combined with semaglutide. The observation group received oral Lianhe Xiaozhi Ointment in addition to the control regimen. The treatment course for both groups was 12 weeks. The following outcome measures were assessed before and after treatment: controlled attenuation parameter (CAP), liver stiffness measurement (LSM), anthropometric indicators body weight, body mass index (BMI), waist circumference (WC), visceral fat area (VFA), percentage of body fat (PBF), metabolism-related indicators fasting plasma glucose (FPG), glycated hemoglobin A1c (HbA1c), fasting insulin (FINS), fasting C-peptide (FC-P), homeostasis model assessment of insulin resistance index(HOMA-IR), total cholesterol (TC), triglycerides (TG), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), uric acid (UA), liver function-related indicators alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transferase (GGT), alkaline phosphatase (ALP), liver fibrosis-4 (FIB-4) index, traditional Chinese medicine (TCM) syndrome scores, and clinical efficacy.

RESULTS After treatment, both groups exhibited significant reductions in CAP, LSM, FIB-4 index, VFA, PBF, body weight, BMI, and WC (P < 0.05, P < 0.01), with the observation group showing significantly superior improvements compared to the control group (P < 0.05, P < 0.01). Levels of FPG, HbA1c, FC-P, FINS, HOMA-IR, TC, TG, LDL-C, ALT, AST, ALP, and GGT significantly decreased in both groups (P < 0.05, P < 0.01). Notably, the observation group outperformed the control group in improving FPG, HbA1c, FINS, HOMA-IR, TC, TG, ALT, AST, and GGT (P < 0.05, P < 0.01). Furthermore, TCM syndrome scores decreased significantly in both groups (P < 0.05), with greater reductions observed in the observation group (P < 0.05). The total clinical effective rate was significantly higher in the observation group than in the control group (P < 0.05).

CONCLUSION Combination therapy comprising Lianhe Xiaozhi Ointment and semaglutide demonstrates definitive efficacy in treating MAFLD with T2DM of phlegm-heat interconnection type. The regimen effectively reduces hepatic fat content, alleviates liver fibrosis, regulates metabolic disorders, and improves liver function with a favorable safety profile, suggesting significant clinical value.