Efficacy and Safety of Bicyclol Treatment for Non-Alcoholic Fatty Liver Disease: Results of a Cohort Study

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....

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Main Authors: I. Yu. Pirogova, S. V. Yakovleva, T. V. Neuymina, S. P. Sinitsyn, V. S. Chulkov, T. N. Shamaeva
Format: Article
Language:Russian
Published: Gastro LLC 2018-09-01
Series:Российский журнал гастроэнтерологии, гепатологии, колопроктологии
Subjects:
Online Access:https://www.gastro-j.ru/jour/article/view/253
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author I. Yu. Pirogova
S. V. Yakovleva
T. V. Neuymina
S. P. Sinitsyn
V. S. Chulkov
T. N. Shamaeva
author_facet I. Yu. Pirogova
S. V. Yakovleva
T. V. Neuymina
S. P. Sinitsyn
V. S. Chulkov
T. N. Shamaeva
author_sort I. Yu. Pirogova
collection DOAJ
description 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.
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spelling doaj.art-f18d2cc011e547789b98ff7b5a76c6712024-03-25T16:53:08ZrusGastro LLCРоссийский журнал гастроэнтерологии, гепатологии, колопроктологии1382-43762658-66732018-09-01284667510.22416/1382-4376-2018-28-4-66-75253Efficacy and Safety of Bicyclol Treatment for Non-Alcoholic Fatty Liver Disease: Results of a Cohort StudyI. Yu. Pirogova0S. V. Yakovleva1T. V. Neuymina2S. P. Sinitsyn3V. S. Chulkov4T. N. Shamaeva5«Lotos» Medical Centre; South Ural State Medical University, Ministry of Healthcare of the Russian Federation«Lotos» Medical Centre«Lotos» Medical CentreSouth Ural State Medical University, Ministry of Healthcare of the Russian FederationSouth Ural State Medical University, Ministry of Healthcare of the Russian FederationSouth Ural State Medical University, Ministry of Healthcare of the Russian FederationAim. 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.https://www.gastro-j.ru/jour/article/view/253nonalcoholic fatty liver diseaseliver fibrosisliver steatosisbicyclol
spellingShingle I. Yu. Pirogova
S. V. Yakovleva
T. V. Neuymina
S. P. Sinitsyn
V. S. Chulkov
T. N. Shamaeva
Efficacy and Safety of Bicyclol Treatment for Non-Alcoholic Fatty Liver Disease: Results of a Cohort Study
Российский журнал гастроэнтерологии, гепатологии, колопроктологии
nonalcoholic fatty liver disease
liver fibrosis
liver steatosis
bicyclol
title Efficacy and Safety of Bicyclol Treatment for Non-Alcoholic Fatty Liver Disease: Results of a Cohort Study
title_full Efficacy and Safety of Bicyclol Treatment for Non-Alcoholic Fatty Liver Disease: Results of a Cohort Study
title_fullStr Efficacy and Safety of Bicyclol Treatment for Non-Alcoholic Fatty Liver Disease: Results of a Cohort Study
title_full_unstemmed Efficacy and Safety of Bicyclol Treatment for Non-Alcoholic Fatty Liver Disease: Results of a Cohort Study
title_short Efficacy and Safety of Bicyclol Treatment for Non-Alcoholic Fatty Liver Disease: Results of a Cohort Study
title_sort efficacy and safety of bicyclol treatment for non alcoholic fatty liver disease results of a cohort study
topic nonalcoholic fatty liver disease
liver fibrosis
liver steatosis
bicyclol
url https://www.gastro-j.ru/jour/article/view/253
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AT tvneuymina efficacyandsafetyofbicycloltreatmentfornonalcoholicfattyliverdiseaseresultsofacohortstudy
AT spsinitsyn efficacyandsafetyofbicycloltreatmentfornonalcoholicfattyliverdiseaseresultsofacohortstudy
AT vschulkov efficacyandsafetyofbicycloltreatmentfornonalcoholicfattyliverdiseaseresultsofacohortstudy
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