Silybin combined with phosphatidylcholine and vitamin E in patients with nonalcoholic fatty liver disease: A randomized controlled trial (original) (raw)
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Oxidative Medicine and Cellular Longevity, 2019
Nowadays, the nonalcoholic fatty liver disease represents the main chronic liver disease in the Western countries, and the correct medical therapy remains a big question for the scientific community. The aim of our study was to evaluate the effect derived from the administration for six months of silybin with vitamin D and vitamin E (RealSIL 100D®) on metabolic markers, oxidative stress, endothelial dysfunction, and worsening of disease markers in nonalcoholic fatty liver disease patients. We enrolled 90 consecutive patients with histological diagnosis of nonalcoholic fatty liver disease and 60 patients with diagnosis of reflux disease (not in therapy) as healthy controls. The nonalcoholic fatty liver disease patients were randomized into two groups: treated (60 patients) and not treated (30 patients). We performed a nutritional assessment and evaluated clinical parameters, routine home tests, the homeostatic model assessment of insulin resistance, NAFLD fibrosis score and fibrosis-...
A placebo-controlled trial of silymarin in patients with nonalcoholic fatty liver disease
2009
Background and Aims: Nonalcoholic fatty liver disease (NAFLD) is a chronic liver condition that is characterized by significant hepatic lipid deposition with or without necroinflammation and fibrosis. Researchers have proposed that oxidative stress may play a role in pathogenesis of NAFLD, and there is challenging evidence for the efficacy of antioxidant agents in its treatment. Therefore, we tried silymarin as an antioxidant in a randomized controlled trial for a group of patients with NAFLD. Methods: During an 18-month period, a placebo-controlled study was conducted among patients with nonalcoholic steatohepatitis (NASH) referred to the Ahvaz Jundishapur University Hospital (AJSUH) and Hepatitis Clinic from 2007 to 2008. Based on sonography findings and elevated alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels or liver biopsy, we selected 100 NASH patients who were referred to our center for management of liver disease. Patients who had positive viral markers and other hepatic diseases and patients who had ingested ethanol or drugs known to produce fatty liver disease within the previous 6 months were excluded from the study. Patients were randomized to two groups: Group A received a placebo, and Group B received treatment with 280 mg of silymarin. Treatment was continued for 24 weeks, and cases were evaluated every 4 weeks in the outpatient clinic. Results: A total of 100 subjects who met the inclusion and exclusion criteria were included in the analysis. Group A (50 cases, 29 males and 21 females) and Group B (50 cases, 28 males and 22 females). The mean age was 39.0 ± 10.70 years for Group A and 39.28 ± 11.117 years for Group B. The age range for both groups was 20 to 50 years. The mean serum ALT levels in the silymarin group were 113.03 and 73.14 IU/mL before and after treatment, respectively (P = 0.001). ALT normalization (ALT < 40) was observed in 18% and 52% of patients in Groups A and B, respectively (P = 0.001). AST normalization (AST < 40) was observed in 20% of cases in the placebo group and 62% of cases in the silymarin-treated group (P = 0.0001). No significant side effects were reported in our cases. Conclusions: Silymarin treatment appears to be significantly effective in biochemical improvement and decreasing transaminases levels in patients with NAFLD.
Medicina
Background and Objectives: Non-Alcoholic Fatty Liver Disease (NAFLD) is an emerging cause of hepatopathy that is showing an increasing trend and where the recommendations of lifestyle modification are often not sufficient. The aim of this study is to evaluate the efficacy and tolerability profile of the association of silymarin, vitamin C, vitamin E, coenzyme Q10 and selenomethionine (Medronys epato®) by analyzing liver enzymes, along with the lipidic profile, as markers of liver function, and ultrasound results in NAFLD patients. Materials and Methods: This study enrolled 81 patients with mild to severe NAFLD, divided into two groups: Group A (N = 41) received two capsules a day of silymarin, vitamin C, vitamin E, coenzyme Q10 and selenomethionine (Medronys epato®), and Group B (N = 40) received only recommendations for lifestyle modification including hypocaloric diet, physical exercise and encouragement for weight loss. Patients have been evaluated at three timepoints: baseline (...
Digestive Diseases and Sciences, 2007
Oxidative stress leads to chronic liver damage. Silybin has been conjugated with vitamin E and phospholipids to improve its antioxidant activity. Eighty-five patients were divided into 2 groups: those affected by nonalcoholic fatty liver disease (group A) and those with HCV-related chronic hepatitis associated with nonalcoholic fatty liver disease (group B), nonresponders to treatment. The treatment consisted of silybin/vitamin E/phospholipids. After treatment, group A showed a significant reduction in ultrasonographic scores for liver steatosis. Liver enzyme levels, hyperinsulinemia, and indexes of liver fibrosis showed an improvement in treated individuals. A significant correlation among indexes of fibrosis, body mass index, insulinemia, plasma levels of transforming growth factor-β, tumor necrosis factor-α, degree of steatosis, and γ -glutamyl transpeptidase was observed. Our data suggest that silybin conjugated Other members of the Real Sud Group: L. Cimino, Federico II University, Naples;
Gastroenterology, 2010
levels were significantly decreased in UDCA group compared to control group. Microarray analysis revealed that gene expression of glutathione S-transferase (GST) is markedly increased in UDCA group compared to control group. Since Nrf2-activated genes such as glutamatecysteine ligase, catalytic subunit (Gclc), heme oxygenase 1 (HO-1) exert antioxidant effects, we next investigated mRNA expression levels of these genes by quantitative real-time PCR. Quantitative real-time PCR revealed the elevated expression of both Gclc and HO-1 in UDCA group. Conclusion : UDCA administration blocks progression of liver inflammation in NASH by inducing Nrf2-regulated antioxidant gene expression and reducing serum ROS levels.
European Journal of Gastroenterology & Hepatology, 2019
Introduction Nonalcoholic fatty liver disease (NAFLD) is the most common liver disease worldwide and is becoming the most frequent indication of liver transplantation. Cardiovascular disease is the main cause of death in these patients. There is no Food and Drug Association-approved medication for NAFLD patients. We aimed to provide more robust evidence on the use of medications that are inexpensive and available, namely, metformin, silymarin, pioglitazone, and vitamin E, for treating NAFLD. Materials and methods We conducted a randomized double-blinded, placebo-controlled trial on 150 consecutive patients with NAFLD who were assigned to five groups: lifestyle plus placebo, metformin 500 mg/day, silymarin 140 mg/day, pioglithasone 15 mg/day, and vitamin E 400 IU/day, all for 3 months. Anthropometric and biochemical variables were measured at baseline and 3 months later. Results The mean age of the patients was 47.0 ± 9.1 (range: 18-65) years and the sex distribution was 73 (48.7%) women and 77 (51.3%) men. Patients in all groups showed a significant improvement in anthropometric parameters such as waist circumference and BMI. There was no statistically significant difference in alanine transaminase and aspartate transaminase in the control group after treatment (P = 0.51, 0.18, respectively); however, both liver enzymes decreased significantly in the other groups. Discussion and conclusion This randomized double-blinded placebo-controlled clinical trial suggested a significant benefit of silymarin, pioglitazone, and vitamin E in improving liver aminotransferases in patients with NAFLD after only 3 months, without exerting any specific side effects.
Medicine Science | International Medical Journal, 2014
Hepatitis C virus is a major public health problem causing significant morbidity and mortality. Until recently, the standard treatment with peginterferon and ribavirin was far from being perfect due to its cost, poor tolerability and low sustained virological rates (SVR) rates. Although, the novel direct-acting antiviral agents (DAAs) telaprevir, and boceprevir has dramatically improved SVR rates; issues such as adverse reactions, frequent dosing, and drug interactions still represent a challenge. Even overcoming these challenges with the new revolutionary development of sofosbuvir, its high cost still needs to be addressed. Therefore, the popularity of alternative medicines in chronic hepatitis C (CHC) treatment such as silymarin and ursodeoxycholic acid (UDCA) has increased. The multiple hepatoprotective effects of these drugs have made them attractive for evaluation in patients with different liver diseases. The aim of this study is to compare the hepatoprotective effect of silymarin, UDCA, and a combination therapy of both in chronic hepatitis C patients. Forty CHC patients (32 males and 8 females) were recruited from hepatology clinic at Beni-Suef University. Patients were divided randomly into four equal groups of tens A, B, C and D, who received 420 mg/day silymarin capsules, 500 mg/day UDCA capsules, combined therapy of both, and a placebo treatment, respectively. Serum liver parameters were measured at baseline and repeated 12 weeks after therapy.A statistically significant improvement in mean serum levels of ALT, AST, and bilirubin was obtained with UDCA therapy either when administered alone or combined with silymarin. However, silymarin treatment failed to significantly affect liver function tests.
In Vivo
Aim: To compare levels of oxidative stress markers in patients' sera with non-alcoholic steatohepatitis (NASH) treated for 12 months (T 12) with silybin conjugated with phosphatidylcholine (Realsil ®) (R) or placebo (P) and investigate oxidative stress responses in human endothelial cells conditioned with patients' sera. Patients and Methods: We recruited twenty-seven patients with histological NASH. We measured thiobarbituric acid reactive substances (TBARS), superoxide dismutase (SOD) and catalase (CAT) activities in human endothelial cells conditioned with patients' sera exposed or not to H 2 O 2. Results: We found in decreased-TBARS patients' sera, at T 12 , a decrease of alanine aminotransferase (p=0.038), transforming growth factor-beta (p=0.009) and procollagen I (p=0.001). By dividing patients into two groups, increased (P-I/R-I) and decreased TBARS (P-II/R-II) at T 12 compared to T 0 , we found an increased CAT activity in conditioned endothelial cells at T12 in both groups (p=0.05 and p=0.001, respectively). Conclusion: Realsil ® may be effective against endothelial dysfunction by stimulating the cellular antioxidant defense. Non-alcoholic fatty liver disease (NAFLD) is the most common chronic liver disease worldwide (1). NAFLD is 609 This article is freely accessible online.
Egyptian Journal of …, 2011
Objectives: To measure the effectiveness of silybin-phosphatidylcholine complex (IdB1016) versus regular silymarin in improving clinical outcomes and quality of life (QoL) in chronic hepatitis C patients (CHC). Subjects and Methods: One hundred and ninety four CHC patients were randomly assigned to receive either silybin-phosphatidylcholine in the first group (68 patients), or silymarin in the second group (70 patients), or placebo capsules in the third group (56 patients). Participants had baseline and follow-up clinical, ultrasonography, blood tests and QoL assessments. Results: Sixty one patients in group I, 63 in the group II, and 55 in group III completed the 24 weeks treatment trial. Pruritis was the only improved clinical outcome that showed statistical significance when compared to the placebo group. The two treatment groups showed more improvement than the placebo group in pre-post percentage QoL scores and in mean percent changes of QoL scores. Statistical significance was found when these two groups were compared with the placebo group, but not when they were compared together, except for the impairment and health perception domains, where the percentage of improvement in pre-post percentage scores in the impairment domain, and the mean percent changes of both domains were significantly higher in group II. Group II showed more domains to be significantly affected than the other two groups.Conclusion: Silybinphosphatidylcholine complex appears to be no better than silymarin in improving clinical outcomes and quality of life in CHC patients. Further researches were needed for investigating the effectiveness of higher doses, prolonged administration and use in adjuvant with antiviral drugs on clinical and QoL outcomes; based on plasma and biliary silybin levels and using more than one QoL tool.
Lifestyle and silymarin: a fight against liver damage in NAFLD associated - prediabetic disease
Journal of Diabetes and Metabolic Disorders, 2020
Background Nonalcoholic fatty liver disease (NAFLD) is common in both prediabetic patients and healthy overweight individuals, yet it remains understudied. This study investigates the effects of hepatic steatosis on fibrosis and evaluates the major predictors of liver injury in prediabetes and whether this damage is reversible with Mediterranean diet and administration of the nutraceutical silymarin. Methods First, a case-control study was conducted in which 212 patients with prediabetes, not known to have NAFLD, and 126 healthy controls underwent clinical evaluation, transient elastography with measurement of liver stiffness (LS) and controlled attenuation parameter (CAP). Subsequently, the 212 prediabetic patients were enrolled into a prospective randomized interventional study: 104 were allocated to Mediterranean diet alone while 108 followed Mediterranean diet plus supplementation with silymarin (a flavonolignan complex isolated from Silybum marianum and Morus alba). The administered silymarin dose was 210 mg twice daily for 6 months. Clinical and instrumental evaluations were repeated at the end of the 6 month-study period. Prediabetics were genotyped for patatin like phospholipase domain containing 3 (PNPLA3). Results In the case-control study, 29% of prediabetic patients have significant fibrosis defined as LS ≥ 7.9 kPa vs only 3% of controls (p < 0.001). PNPLA3 genotype CG/GG are significantly associated with significant fibrosis LS ≥ 7.9 relative to CC genotype χ2(1) = 76.466, p < 0.001. Binomial regression analysis shows that increase in BMI, ALT and AST are significantly associated with increased likelihood of significant fibrosis (χ2(7) = 191.9, p < .001) prior to intervention. In the randomized interventional study, prediabetics following Mediterranean diet alone (group 1) experienced a significant regression of fibrosis and decrease in ALT, HbA1c, FBS after 6 months (p < 0.001); similar findings were observed in patients following Mediterranean diet plus silymarin regimen (group 2); group 2 had a significant decrease in HbA1c relative to group 1 (95% CI: 37.8-38.6 vs 39.5-40.3, p < 0.001). Conclusion PNPLA3 genotype CG/GG and elevated BMI are the major predictors of significant fibrosis in prediabetic patients prior to intervention in this study. Mediterranean diet either alone or with silymarin treatment for 6 months leads to significant regression of liver damage and improvement of the glycemic profile in prediabetic patients. Yet, as combination treatment of silymarin with Mediterranean diet shows significant reduction of HbA1c when compared to diet alone, this suggests that silymarin may exert an independent anti-glycemic action.