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Randomized Controlled Trial
. 2019 Oct 15:2019:8742075.
doi: 10.1155/2019/8742075. eCollection 2019.

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  1 , Marcello Dallio  1 , Mario Masarone  2 , Antonietta Gerarda Gravina  1 , Rosa Di Sarno  1 , Concetta Tuccillo  1 , Valentina Cossiga  3 , Stefania Lama  1 , Paola Stiuso  1 , Filomena Morisco  3 , Marcello Persico  2 , Carmelina Loguercio  1
Affiliations
Randomized Controlled Trial

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 et al. Oxid Med Cell Longev. .

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.

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Conflict of interest statement

The authors declare no conflict of interest.

Figures

Figure 1
Figure 1
Study design flowchart. NAFLD: nonalcoholic fatty liver disease; HOMA-IR: homeostatic model assessment for insulin resistance; TNF-α: tumor necrosis factor-alpha; HMGB-1: high mobility group box 1; TBARS: thiobarbituric acid reactive substances; EGFR: epidermal growth factor receptor; CD: cluster of differentiation; IL: interleukin; IGF: insulin growth factor; TGF-β: transforming growth factor-beta; MMP-2: metalloproteinase 2; FIB-4: fibrosis 4 index; NFS: NAFLD fibrosis score.
Figure 2
Figure 2
Comparison between the two NAFLD group patients with improvement of aspartate/alanine aminotransferase and gamma glutamyl transpeptidase. NAFLD: nonalcoholic fatty liver disease; AST: aspartate aminotransferase; ALT: alanine aminotransferase; γGT: gamma glutamyl transpeptidase.
Figure 3
Figure 3
Comparison between the two NAFLD group patients with improvement of insulinemia, the homeostatic model assessment for insulin resistance, vitamin D, and controlled attenuation parameter. NAFLD: nonalcoholic fatty liver disease; HOMA-IR: homeostatic model assessment for insulin resistance; CAP: controlled attenuation parameter.
Figure 4
Figure 4
Comparison between the two NAFLD group patients with improvement of C reactive protein and tumor necrosis factor-alpha. NAFLD: nonalcoholic fatty liver disease; CRP: C reactive protein; TNF-α: tumor necrosis factor-alpha.
Figure 5
Figure 5
Comparison between the two NAFLD group patients with improvement of epidermal growth factor receptor, interleukin-18, insulin growth factor-II, transforming growth factor-beta, and matrix metalloproteinase-2. NAFLD: nonalcoholic fatty liver disease; EGFR: epidermal growth factor receptor; IL-18: interleukin-18; IGF-II: insulin growth factor-II; TGF-beta: transforming growth factor-beta; MMP-2: matrix metalloproteinase-2.
Figure 6
Figure 6
Comparison between the two NAFLD group patients with improvement of Endocan, high mobility group box-1, and thiobarbituric acid reactive substances. NAFLD: nonalcoholic fatty liver disease; HGMB-1: high mobility group box-1; TBARS: thiobarbituric acid reactive substances.
Figure 7
Figure 7
Fibrosis degree distribution in the two NAFLD groups with or without metabolic syndrome. NAFLD: nonalcoholic fatty liver disease; MS: metabolic syndrome.
Figure 8
Figure 8
Comparison between the two NAFLD group patients with metabolic syndrome which presented an improvement of insulinemia, the homeostatic model assessment for insulin resistance, vitamin D, C reactive protein, tumor necrosis factor-alpha, transforming growth factor-beta, Endocan, high mobility group box-1, and thiobarbituric acid reactive substances. NAFLD: nonalcoholic fatty liver disease; MS: metabolic syndrome; HOMA-IR: homeostatic model assessment for insulin resistance; CRP: C reactive protein; TNF-α: tumor necrosis factor-alpha; TGF-beta: transforming growth factor-beta; HGMB-1: high mobility group box-1; TBARS: thiobarbituric acid reactive substances.
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