Efficiency and safety of Hepato-complex of amino acids in patients with non-alcoholic fatty liver disease. The results of an open incomparable uncontrolled clinical trial

Abstract

Objective — to investigate the effectiveness and safety of the use of Hepato‑complex of amino acids in patients with non‑alcoholic fatty liver disease (NAFLD).
 Materials and methods. Examinations involved 20 patients with NAFLD, mean age (48.3 ± 10.1) years. The diagnosis of NAFLD was established in accordance with the international and national protocols and standards for its diagnosis. The randomized patients were prescribed Hepato‑complex of amino acids 2 capsules 3 times a day with meals daily for 8 weeks. The following examinations were performed to all patients: assessment of the dynamics of clinical symptoms, indicators of transaminases (alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma glutamine transpeptidase (GGTP), lipid profile (total cholesterol (TC), triglycerides), lipoproteins high, low and very high density (HDL, LDL and VLDL), atherogenic factor (AF)), glycosylated hemoglobin (HbA1c), degree of hepatic steatosis before (0 days), during (4 weeks) and after treatment (8 weeks). Standard methods of mathematical statistics were used to assess the certainty of the obtained results.
 Results. The following results were obtained against the background of the Hepato‑complex of amino acids’ administration in patients with NAFLD on the 28 — 30th day of therapy: significant positive dynamics in the clinical symptoms (probable regression of symptoms such as fatigue, emotional lability, sleep disturbances, heaviness in the right hypochondrium, nausea, bowel movements, decreased appetite (p < 0.001)), indicators of cytolysis (decrease in ALT (p < 0.001) and AST (p < 0.05)) and cholestasis (decrease in GGTP (p < 0.001)). These results were preserved at the long‑term evaluation on the 58 — 60th day of treatment compared to baseline (p < 0.001) of the indices of lipid profile (decrease in TC levels (p < 0.05), LDL (p < 0.05), HbA1c (p < 0.001)) and reduction of liver steatosis of the (p < 0.05). High patients’ compliance to the treatment and good tolerance have been established.
 Conclusions. The results of the use of the preparation “Hepato‑complex of amino acids” demonstrated its effectiveness and safety as a pathogenetic agent for the treatment of patients with non‑alcoholic fatty disease.