Clinical experience of using bicyclol in steatohepatitis of metabolic and metabolic-alcoholic genesis

Objective — to evaluate the clinical effectiveness of bicyclol in steatohepatitis of metabolic and metabolic‑alcoholic genesis based on the data of laboratory and instrumental studies. Materials and methods. 60 European outpatients participated in an open comparative study; among them, 38 men and 22 women, with an average age of 49.5±8.1 years. The patients were divided into groups. The first group included 34 patients with a diagnosis of metabolically associated steatotic liver disease, the second group — 26 patients with metabolic alcohol‑associated liver disease. The groups were matched by gender and age. Diagnoses were established according to modern regulatory recommendations. The patients in both groups received bicyclol orally at a dose of 25 mg (1 tablet) three times a day, 2 hours after meals, for 12 weeks. The dynamics of laboratory‑instrumental indicators were evaluated before the start of treatment and at the end of observation. Statistical processing of the obtained results was carried out using the methods of variational statistics using the Microsoft Excel program. Results. The use of bicyclol showed positive dynamics in both groups. Elimination of the cytolytic syndrome was observed in the form of a decrease in the activity of liver transferases (p <0.01 and p <0.05 in the 1st and 2nd groups, respectively); decrease in intrahepatic cholestasis; absence of pigment metabolism disorders; stabilization of cholesterol, triglyceride and glucose levels. Bicyclol therapy contributed to the reduction of the initially elevated ferritin level in patients with metabolically associated steatotic liver disease by almost 2 times (p <0.01), in patients with metabolic‑alcohol‑associated liver disease — by 1.5 times (p <0.01). In both groups, there was a decrease in the size of the liver and positive changes in indicators of steatosis and liver fibrosis. Conclusions. Due to its complex mechanism of action, Bicyclol is suitable for use in steatohepatitis of metabolic and metabolic‑alcoholic genesis. Bicyclol helps to improve laboratory‑instrumental indicators, in particular, it reduces the activity of cytolytic and cholestatic processes in the liver, stabilizes lipid and carbohydrate metabolism, significantly reduces the manifestations of ferroptosis, and has a positive effect on sonographic indicators that reflect the severity of steatosis and liver fibrosis. The drug demonstrates a favorable tolerability and safety profile.