Evaluation of the Effect Derived from Silybin with Vitamin D and Vitamin E Administration on Clinical, Metabolic, Endothelial Dysfunction, Oxidative Stress Parameters, and Serological Worsening Markers in Nonalcoholic Fatty Liver Disease Patients.

Alessandro Federico,Stefania Lama,Carmelina Loguercio,Marcello Persico,Concetta Tuccillo,Paola Stiuso,Filomena Morisco,Rosa Di Sarno,Antonietta Gerarda Gravina,Marcello Dallio,Valentina Cossiga,Mario Masarone

doi:10.1155/2019/8742075

Abstract

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-4, transient elastography and controlled attenuation parameter, thiobarbituric acid reactive substances, tumor necrosis factor α, transforming growth factor β, interleukin-18 and interleukin-22, matrix metalloproteinase 2, epidermal growth factor receptor, insulin growth factor-II, cluster of differentiation-44, high mobility group box-1, and Endocan. Compared to the healthy controls, the nonalcoholic fatty liver disease patients had statistically significant differences for almost all parameters evaluated at baseline (p < 0.05). Six months after the baseline, the proportion of nonalcoholic fatty liver disease patients treated that underwent a statistically significant improvement in metabolic markers, oxidative stress, endothelial dysfunction, and worsening of disease was greater than not treated nonalcoholic fatty liver disease patients (p < 0.05). Even more relevant results were obtained for the same parameters by analyzing patients with a concomitant diagnosis of metabolic syndrome (p < 0.001). The benefit that derives from the use of RealSIL 100D could derive from the action on more systems able to advance the pathology above all in that subset of patients suffering from concomitant metabolic syndrome.

Highlights

Nonalcoholic fatty liver disease (NAFLD) represents the major cause of chronic liver disease in the Western countries [1, 2]
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 of oxidative stress, endothelial dysfunction, and markers of the disease worsening in NAFLD patients
Compared to the population of healthy control patients, NAFLD patients had statistically significant differences (p < 0:05) for almost all the parameters evaluated at the baseline: body mass index (BMI), body weight, AST, ALT, insulin, homeostatic model assessment for insulin resistance (HOMA-IR), total cholesterol, triglycerides, vitamin D, CRP, TNF-α, epidermal growth factor receptor (EGFR), cluster of differentiation- (CD-)44, IL-18, insulin growth factor-II (IGF-II), IL-22, TGF-β, matrix metalloproteinase 2 (MMP-2), Endocan, high mobility group box 1 (HMGB-1), and thiobarbituric acid reactive substance (TBARS) (Table 1)

Summary

Introduction

Nonalcoholic fatty liver disease (NAFLD) represents the major cause of chronic liver disease in the Western countries [1, 2]. NAFLD is closely linked with cardiovascular pathology, representing an independent risk factor for the development of chronic and acute diseases [9, 10] This linkage is represented, precisely, by the endothelial dysfunction, which, in turn, is caused by the systemic “low-grade inflammation” that is supported both by the alteration of metabolic homeostasis and by the high production of reactive oxygen species in NAFLD patients [11]. It seems plausible that the administration of substances such as silybin and its association with vitamin D could positively influence the course of the disease by stopping or slowing the evolution of NASH in cirrhosis For these reasons, 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 of oxidative stress, endothelial dysfunction, and markers of the disease worsening in NAFLD patients

Objectives

Methods

Results

Discussion

Conclusion