Abstract: Objective The aim of this study was to investigate oral bicyclol administration in patients with type 2 diabetes mellitus (T2DM) and non-alcoholic steatohepatitis (NASH). Methods A total of 102 patients with T2DM and nonalcoholic fatty liver disease (NAFLD) were enrolled in our hospital between January 2021 and October 2023, and out of them, NASH was diagnosed in 48 cases. Patients with NASH were randomly assigned to receive metformin in 24 cases (control) or receive metformin and bicyclol combination in another 24 cases (observation) for six months. Fasting blood glucose (FPG) and glycosylated hemoglobin (HbA1C) were routinely detected, fasting insulin (FINS) level was determined by radioimmunoassay, and homeostasis model assessment of insulin resistance index (HOMA-IR) was calculated. Results By end of six month treatment, serum AST and ALT levels in the observation group were (51.3±7.3)U/L and (49.6±9.4)U/L, both much lower than [(82.8±7.6)U/L and(98.7±11.1)U/L, respectively, P<0.05] in the control; serum total cholesterol, triacylglycerol, low-density lipoprotein cholesterol and high-density lipoprotein cholesterol levels in the observation were(5.5±0.7)mmol/L, (2.7±0.4)mmol/L, (3.2±0.4)mmol/L and (1.1±0.4)mmol/L, all not significantly different compared to [(5.5±0.6)mmol/L, (2.6±0.5)mmol/L, (3.2±0.5)mmol/L and (1.1±0.3)mmol/L] in the control (P>0.05); HbA1c, FPG, FINS and HOMA-IR were (6.9±0.8)%, (5.4±1.2)mmol/L, (5.4±0.7)μU/ml and (1.2±0.3), all not significantly different as compared to [(6.7±0.7)%, (5.2±1.1)mmol/L, (5.3±1.1)μU/ml and (1.2±0.5)] in the control group (P<0.05). Conclusion Oral bicyclol could short-termly reduce serum liver function test parameters in patients with NASH and underlying T2DM, which is worthy of further study.

Key words: Non-alcoholic steatohepatitis, Type 2 diabetes mellitus, Bicyclol, Metformin, Therapy