An open-label, controlled trial of the efficacy and safety of Laennec to improve liver function in patients with non-alcoholic fatty liver disease

Abstract

Aim. Evaluation of the efficacy and safety of human placenta hydrolyzate (HPH) Laennec in the treatment of non-alcoholic fatty liver disease (NAFLD) in an experimental and clinical study. Material and methods. An experimental study was carried out on NAFLD models reproducible by administering various doses of CCl4 to rats. The clinical study involved patients with NAFLD (n=60, mean age 47±9 years) who were on a standard diet of the military hospital of the Republic of Vietnam. Half of the patients (n=30) received Laennec (2 ml/day IM, 4 weeks), while the other half were in the control group. The collected results were analyzed by standard methods of mathematical statistics. Results. Studies in a preclinical model of NAFLD in rats showed a significant reduction in the progression of liver fibrosis against the background of improved lipid metabolism. No negative effects of HPH on the nervous, cardiovascular and respiratory systems of animals have been established. In a clinical study, the mean levels of liver dysfunction markers (AST, ALT, GGT) of patients with NAFLD at the time of treatment initiation in both groups were significantly higher than the normal range (AST - 111±12 U/l, ALT - 103±8 U/l, GGT - 462±60 IU/l). The use of Laennec led to a significant decrease in the incidence of NAFLD symptoms (fatigue, a feeling of bloating in the abdominal cavity, anorexia) and a decrease in the levels of AST, ALT, GGT after a day of the therapy week. After 2 weeks of HLP therapy, there was a significant decrease in the levels of AST (53±4 U/l, control: 99±14 U/l, P<0.001), ALT (71±6 U/l, control: 92±7 U/l, P<0.001) and GGT (260±21 IU/l, control: 384±74 U/l, P<0.001). After 4 weeks of treatment, the parameters significantly decreased towards the lower limit of the normal interval: AST - 45±4 U/l, ALT - 52±5 U/l, GGT - 191±19 IU/l (all P<0.05 compared with the values at 2nd week) against the background of the absence of positive dynamics in the levels of AST, ALT, GGT in the control group. The use of the drug did not cause statistically significant changes in the parameters of clinical or laboratory hematological examination, urinalysis results, levels of other liver enzymes, as well as vital signs. Multivariate analysis showed that the effects of HPH are practically independent of age, gender, medical history, initial levels of AST, ALT, GGT, and other parameters of the biochemical blood test of patients. Conclusion. HPH Laennec is an effective and safe monotherapy for NAFLD.