Efficacy and Safety of a Fixed Combination of Glycyrrhizic Acid and Essential Phospholipids in Non-Alcoholic Fatty and Alcoholic Liver Disease: Results from Randomized Placebo-Controlled Trials

2021 ◽  
Vol 76 (6) ◽  
pp. 595-603
Author(s):  
Igor V. Maev ◽  
Alexey O. Bueverov ◽  
Artem V. Volnukhin
Keyword(s):  
Liver Disease ◽  
Fatty Liver ◽  
Alcoholic Liver Disease ◽  
Fatty Liver Disease ◽  
Glycyrrhizic Acid ◽  
Fixed Combination ◽  
Efficacy And Safety ◽  
Alcoholic Fatty Liver ◽  
Essential Phospholipids ◽  
Alcoholic Fatty Liver Disease

Background. Drug treatment of non-alcoholic fatty and alcoholic liver disease remains an urgent, unsolved problem. Due to the commonality of many pathogenetic mechanisms and predictors of progression, a universal approach to the search for a therapeutic agent can be considered. Aims pooled analysis of the results of two multicenter, randomized, double-blind, placebo-controlled studies of a fixed combination of glycyrrhizic acid and essential phospholipids in two dosage forms to study its efficacy and safety in non-alcoholic fatty and alcoholic liver disease, in the presence and absence of predictors of disease progression. Methods. The pooled analysis included 180 patients with non-alcoholic fatty liver disease (Gepard study) and 120 patients with alcoholic liver disease (Jaguar study). Patients of the main group received a fixed combination of 5.0 g intravenous jet 3 times a week for the first 2 weeks; then 2 capsules 3 times a day for the next 10 weeks. Patients in the control group received placebo according to the same scheme. The total duration of treatment was 12 weeks in the Gepard study (1 course of stepwise therapy) and 24 weeks in the Jaguar study (2 courses of stepwise therapy). A comparative analysis of the efficacy and safety of a fixed combination and a placebo was carried out, in the presence and absence of predictors of progression, separately for each nosology and in a mixed sample. Results. In patients with non-alcoholic fatty and alcoholic liver disease who received the fixed combination, in contrast to the placebo group, there was a statistically more significant decrease in the level of biochemical markers of inflammation alanine aminotransferase, aspartate aminotransferase, adiponectin, and the value of the AktiTest index. There was no negative trend in the NAFLD fibrosis score; more significant positive dynamics of FibroTest is shown. Predictors of disease progression hyperglycemia, hyperlipidemia, age did not have a negative impact on the results in the study group. The efficacy of the study drug was noted in patients with non-alcoholic fatty liver disease and normal body weight; data were obtained indicating its possible effectiveness with a high activity of the inflammatory process associated with alcoholic liver damage. The frequency of adverse events in the study and control groups was comparable. Conclusions. Based on a generalized analysis of the results of two studies, promising directions for the study and use of a fixed combination of glycyrrhizic acid and essential phospholipids were identified: non-alcoholic fatty liver disease without obesity, alcoholic steatohepatitis of high activity (as an adjuvant); steatohepatitis of non-alcoholic and alcoholic etiology, combined with hyperglycemia and hyperlipidemia.

scholarly journals Non-invasive diagnosis: non-alcoholic fatty liver disease and alcoholic liver disease

2020 ◽  
Vol 5 ◽  
pp. 31-31
Author(s):  
Jose Altamirano ◽  
Qiaochu Qi ◽  
Sabina Choudhry ◽  
Mohamed Abdallah ◽  
Ashwani K. Singal ◽  
...  
Keyword(s):  
Liver Disease ◽  
Fatty Liver ◽  
Alcoholic Liver Disease ◽  
Fatty Liver Disease ◽  
Alcoholic Fatty Liver ◽  
Non Invasive ◽  
Alcoholic Fatty Liver Disease

scholarly journals Hepatoprotective properties of glycyrrhizic acid

2020 ◽  
pp. 96-108
Author(s):  
S. V. Okovity ◽  
K. L. Raikhelson ◽  
A. V. Volnukhin ◽  
D. A. Kudlai
Keyword(s):  
Liver Disease ◽  
Fatty Liver ◽  
Intrahepatic Cholestasis ◽  
Fatty Liver Disease ◽  
Glycyrrhizic Acid ◽  
Evidence Base ◽  
Alcoholic Fatty Liver ◽  
Organ Systems ◽  
Wide Range ◽  
Alcoholic Fatty Liver Disease

The review is devoted to the problem of treatment of non-alcoholic fatty liver disease, which is the most common pathology of the hepato-biliary system worldwide and is characterized by an increasing frequency, including of more severe forms. A wide range of pathogenetic relationships of non-alcoholic fatty liver disease with diseases of other organ systems, primarily with diseases of the cardiovascular system, type 2 diabetes mellitus, chronic kidney disease and diseases of the biliary tract, is presented. The main mechanisms of comorbidity are insulin resistance, oxidative stress, inflammation, disorders of carbohydrate and fat metabolism. An approach to the therapy of this disease based on the concept of comorbidity has been substantiated. As a rational therapeutic choice, a molecule of glycyrrhizic acid is presented, which has pleiotropic effects, including anti-inflammatory, antioxidant, antifibrotic and immunomodulatory effects. The evidence base for glycyrrhizic acid is formed by a large array of clinical trials, including randomized placebo-controlled trials conducted both in Russia and abroad, in infectious and non-infectious liver diseases, including non-alcoholic fatty liver disease. Attention is focused on non-alcoholic fatty liver disease with intrahepatic cholestasis associated with a more severe course and high rates of disease progression. A theoretical justification for the use of a combination of glycyrrhizic acid and ursodeoxycholic acid in such patients is presented. The reason for this is the potential synergy of the two molecules, based on the induction of CYP3A4, and associated with the effect on inflammation, as a factor in the development of intrahepatic cholestasis and cholestasis itself.

scholarly journals Features of the therapy of non-alcoholic fatty liver disease in comorbid patients

2021 ◽  
pp. 136-143
Author(s):  
M. M. Maevskaya
Keyword(s):  
Liver Disease ◽  
Fatty Liver ◽  
Fatty Liver Disease ◽  
Liver Steatosis ◽  
Modern Society ◽  
Cardiovascular Complications ◽  
Efficacy And Safety ◽  
Alcoholic Fatty Liver ◽  
Positive Effect ◽  
Alcoholic Fatty Liver Disease

The problem of modern medicine and modern society is a comorbid patient with metabolic disorders. Hypothetical portrait of such a patient: over 40 years old, overweight, arterial hypertension, coronary atherosclerosis, impaired carbohydrate and lipid metabolism, liver steatosis or steato-hepatitis, often with changes in the function of the musculoskeletal system. Rational pharmacotherapy of this patient is of fundamental importance. The article analyzes, from the point of view of polypotency, efficacy and safety, the main drugs used in Russia for treatment of non-alcoholic fatty liver disease in comorbid patients. Attention is paid to vitamin E, glycyrrhizin, ursodeoxycholic acid. Domestic and foreign studies of these drugs are analyzed, and the scope of their rational use is shown: reducing the risk of cardiovascular complications, a positive effect on the lipid spectrum, reducing the activity of serum transaminases and other hepatotropic effects. Their side effects are also considered, which should be taken into account when choosing the treatment of a comorbid patient. We have analyzed the efficacy and safety of new molecules that are in clinical trials and/or have not yet been registered in our country, e.g. obeticholic acid, cenicriviroc, tropifexor, etc. The ability of some molecules to act as biological enhancers is also highlighted, which is important to consider when prescribing combination therapy. Doctors are recommended to carefully consider and take into account all the features of a comorbid patient and choose for this category of patients safe drugs of hepatotropic action with simultaneous positive effect on the cardiovascular system. Among other things, it will avoid polypragmasy.

scholarly journals Traditional Chinese medicine Lingguizhugan decoction treating non-alcoholic fatty liver disease with spleen-yang deficiency pattern: Study protocol for a multicenter randomized controlled trial

2020 ◽  
Author(s):  
Jing-juan Xu ◽  
Rui-rui Wang ◽  
Sheng-fu You ◽  
Lei Zhang ◽  
Pei-yong Zheng ◽  
...  
Keyword(s):  
Liver Disease ◽  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Liver Function ◽  
Fatty Liver ◽  
Fatty Liver Disease ◽  
Clinical Symptoms ◽  
Efficacy And Safety ◽  
Alcoholic Fatty Liver ◽  
Alcoholic Fatty Liver Disease

Abstract Background Nonalcoholic fatty liver disease (NAFLD) is a metabolic stress liver injury induced by excessive fat accumulation in liver, which is closely related to insulin resistance (IR). Traditional Chinese medicine (TCM) has showed good curative effects and unique advantages in the prevention and treatment of NADLD, particularly in improving IR, liver function and clinical symptoms. This study will examine the efficacy and safety of Lingguizhugan decoction (LGZG) in the treatment of non-alcoholic fatty liver disease with spleen-yang deficiency pattern, and assess the optimal dosage. Methods/design This study is a three-arm, dose-optimization, randomized, double-blinded, placebo-controlled clinical trial. A total of 243 NAFLD patients will be recruited and randomly assigned to standard dose Lingguizhugan decoction (SLGD) group, low dose Lingguizhugan decoction (LLGD) group, or the control group. The clinical indicator will be assessed during the 12-week intervention and follow-up 4 weeks. The primary outcome is the percentage of patients whose the decline of HOMA-IR reaches one standard unit. Secondary outcomes include body weight, body mass index, liver function, blood lipid metabolism, blood glucose metabolism, liver-kidney echo ratio, quantitative rating of clinical symptoms and signs, collecting sample(s) from participants, the medical outcomes study(MOS) item short from health survey(SF-36), Self-rating Depressive Scale(SAS), and Self-rating Anxiety Scale(SDS). Discussion This study will provide initial evidence regarding the efficacy and safety of LGZG in the treatment of NAFLD with spleen-yang deficiency pattern, meanwhile establish the demonstration technique, and promote its application in community healthcare center. In addition, potential mechanism will be explored based on research of oral and gut microbiota.

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