Efficacy and Safety of Bicyclol Treatment for Non-Alcoholic Fatty Liver Disease: Results of a Cohort Study
https://doi.org/10.22416/1382-4376-2018-28-4-66-75
Abstract
Aim. This study is aimed at evaluating the efficacy and safety of Bicyclol administration in patients suffering from non-alcoholic fatty liver disease (NAFLD) («ZIGUN» research) by monitoring laboratory data and non-invasive methods of diagnosis of liver fibrosis and steatosis.
Materials and methods. The study included 93 patients with NAFLD with the average age of 44 (38–49) years, having the stage of liver fibrosis and steatosis greater than the 1st according to FibroScan (FibroScan 502 TOUCH with CAP software). Patients were randomized into 2 groups: 1) the main group comprised 67 patients receiving 75 mg/day of Bicyclol for 24 weeks in combination with aerobic exercise and Mediterranean diet; 2) the comparison group (26 patients) prescribed of only aerobic exercise and Mediterranean diet for 24 weeks.
Results. During Bicyclol treatment, a decrease in the following indicators was observed: ALT, AST, GGT, CRP by 30 % or more, glycated hemoglobin (–10 %) and HOMA-index (–24 %), cholesterol (–12 %), LDL (–19 %), triglycerides (–31 %), atherogenic coefficient (–22 %). A decrease to the1st stage of fibrosis was observed in 30 patients (44 %), steatosis regression to the 1st stage was noted in 57 patients (85 %). Liver steatosis of the 4th stage was not revealed after treatment with Bicyclol. The number of patients with indolent steatosis (less than 2nd stage) increased 2 times (p < 0.001). No significant changes were found in the group without drug therapy.
Conclusions. Bicyclol therapy in NAFLD is accompanied by positive dynamics of inflammation activity markers, insulin resistance and lipid spectrum, which suggests a positive dynamics of the stages of liver fibrosis and steatosis.
About the Authors
I. Yu. Pirogova
«Lotos» Medical Centre;
South Ural State Medical University, Ministry of Healthcare of the Russian Federation
Russian Federation
Dr. Sci. (Med.), Associate Professor of the Department of Faculty Therapy, South Ural State Medical University, Ministry of Healthcare of the Russian Federation, Head of the Center for Gastroenterology and Hepatology of the «Lotos» Medical Centre
Russian Federation
Dr. Sci. (Med.), Associate Professor of the Department of Faculty Therapy, South Ural State Medical University, Ministry of Healthcare of the Russian Federation, Head of the Center for Gastroenterology and Hepatology of the «Lotos» Medical Centre
S. V. Yakovleva
«Lotos» Medical Centre
Russian Federation
Head of the Department of Therapy
Russian Federation
Head of the Department of Therapy
T. V. Neuymina
«Lotos» Medical Centre
Russian Federation
Gastroenterologist
Russian Federation
Gastroenterologist
S. P. Sinitsyn
South Ural State Medical University, Ministry of Healthcare of the Russian Federation
Russian Federation
Dr. Sci. (Med.), Professor, Head of the Department of Faculty Therapy
Russian Federation
Dr. Sci. (Med.), Professor, Head of the Department of Faculty Therapy
V. S. Chulkov
South Ural State Medical University, Ministry of Healthcare of the Russian Federation
Russian Federation
Dr. Sci. (Med.), Associate Professor of the Department of Faculty Therapy
Russian Federation
Dr. Sci. (Med.), Associate Professor of the Department of Faculty Therapy
T. N. Shamaeva
South Ural State Medical University, Ministry of Healthcare of the Russian Federation
Russian Federation
Associate Professor of the Department of Mathematics, Medical Informatics and Statistics
Russian Federation
Associate Professor of the Department of Mathematics, Medical Informatics and Statistics
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Review
For citations:
Pirogova I.Yu., Yakovleva S.V., Neuymina T.V., Sinitsyn S.P., Chulkov V.S., Shamaeva T.N. Efficacy and Safety of Bicyclol Treatment for Non-Alcoholic Fatty Liver Disease: Results of a Cohort Study. Russian Journal of Gastroenterology, Hepatology, Coloproctology. 2018;28(4):66-75. (In Russ.) https://doi.org/10.22416/1382-4376-2018-28-4-66-75
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