The Effect of a Silybin-Vitamin E-Phospholipid Complex on Nonalcoholic Fatty Liver Disease: A Pilot Study

Loguercio, C.; Federico, Alessandro; Trappoliere, M.; Tuccillo, Concetta; Sio, Ilario de; Leva, A Di; Niosi, Marco; D’Auria, M.V.; Capasso, R; Blanco, C. Del Vecchio

doi:10.1007/s10620-006-9703-2

Cited by 96 publications

(79 citation statements)

References 63 publications

(60 reference statements)

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“…These results are in agreement those obtained by other authors [46] . A pilot study performed in patients with NAFLD confirmed an improvement in liver enzymes and insulin resistance when a complex of silybin, vitamin E and phospholipid was given [47] . The effects of silybum marianum and vitamin E on some biochemical indices of atherosclerotic progression must be confirmed by other experiences performed on a wide range, even though these metabolic data may be reported, not only for atherosclerosis, but also for MS alone.…”

Section: Discussionmentioning

confidence: 90%

Silymarin in non alcoholic fatty liver disease

Cacciapuoti

Scognamiglio²,

Palumbo³

et al. 2013

WJH

105

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AIM:This study was undertaken to evaluate the hepatic effects of silybum marianum on non alcoholic fatty liver disease (NAFLD). METHODS:In 72 patients affected by NAFLD, main metabolic, hepatic and anti-inflammatory parameters were assayed after 3 mo of a restricted diet and before silymarin treatment (twice a day orally). The brightness of liver echography texture (hepatorenal ratio brightness) was also defined at same time. These evaluations were repeated after 6 mo of treatment. RESULTS:Serum levels of some metabolic and anti-inflammatory data nonsignificantly lowered after 6 mo of silymarin. On the contrary, Steato test, alanine aminotransferase (ALT), aspartate aminotransferase (AST) and gamma-glutamyl transpeptidase were significantly (P < 0.001) reduced. Instead, the AST/ALT ratio unchanged. Finally, the hepatorenal brightness ratio, as an index of hepatic steatosis, significantly (P < 0.05) dropped. CONCLUSION:The obtained results indicate that silymarin appears to be effective to reduce the biochemical, inflammatory and ultrasonic indices of hepatic steatosis. Some parameters indicative of early stage of atherosclerosis were also lowered.

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Section: Discussionmentioning

confidence: 90%

Silymarin in non alcoholic fatty liver disease

Cacciapuoti

Scognamiglio²,

Palumbo³

et al. 2013

WJH

105

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“…Although the use of herbal products is increasing worldwide, their effects may not be exclusively beneficial [33]. Preliminary in vitro and in vivo studies of silybin showed an acceptable safety profile at doses exceeding 10 g/day [29,30,34,35]. This is important because NAFLD patients are generally younger than those with other hepatic conditions [36] and may require long-term treatment.…”

Section: Discussionmentioning

confidence: 99%

“…We acknowledge that numerous endpoints were used and that conclusive therapeutic effects were not always demonstrated. The latter may relate to sample size; additional data obtained after this trial began suggested that the sample size assumptions were incorrect [29,30].…”

Section: Discussionmentioning

confidence: 99%

“…Sample size assumptions incorporated preliminary data [29,30], showing 23-25% efficacy with RA versus 6-10% with P. Additional assumptions included improvement in clinical condition, normalization of biochemical index, planned accrual period of 1 year, and minimum 6-month treatment period. Estimated sample size (two-tailed α error of 5%, β potency of 90%) was 90 patients per group plus an estimated lost-to-follow up rate of 10% (200 patients in total).…”

Section: Statistical Analysesmentioning

confidence: 99%

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Silybin combined with phosphatidylcholine and vitamin E in patients with nonalcoholic fatty liver disease: A randomized controlled trial

Loguercio

Andreone

Brisc

et al. 2012

Free Radical Biology and Medicine

Self Cite

204

140

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The only currently recommended treatment for nonalcoholic fatty liver disease (NAFLD) is lifestyle modification. Preliminary studies of silybin showed beneficial effects on liver function. Realsil (RA) comprises the silybin phytosome complex (silybin plus phosphatidylcholine) coformulated with vitamin E. We report on a multicenter, phase III, double-blind clinical trial to assess RA in patients with histologically documented NAFLD. Patients were randomized 1:1 to RA or placebo (P) orally twice daily for 12 months. Prespecified primary outcomes were improvement over time in clinical condition, normalization of liver enzyme plasma levels, and improvement of ultrasonographic liver steatosis, homeostatic model assessment (HOMA), and quality of life. Secondary outcomes were improvement in liver histologic score and/or decrease in NAFLD score without worsening of fibrosis and plasma changes in cytokines, ferritin, and liver fibrosis markers. We treated 179 patients with NAFLD; 36 were also HCV positive. Forty-one patients were prematurely withdrawn and 138 patients analyzed per protocol (69 per group). Baseline patient characteristics were generally well balanced between groups, except for steatosis, portal infiltration, and fibrosis. Adverse events (AEs) were generally transient and included diarrhea, dysgeusia, and pruritus; no serious AEs were recorded. Patients receiving RA but not P showed significant improvements in liver enzyme plasma levels, HOMA, and liver histology. Body mass index normalized in 15% of RA patients (2.1% with P). HCV-positive patients in the RA but not the P group showed improvements in fibrogenesis markers. This is the first study to systematically assess silybin in NAFLD patients. Treatment with RA but not P for 12 months was associated with Free

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“…So, as a TNF-a blocker, pentoxifylline improves both steatosis and inflammation in patients with NAFLD and NASH (64)(65)(66). Antioxidants showed modest improvement in steatosis and lobular inflammation, with no effect on body weight, waist circumference, LDL-cholesterol, and fibrosis (48,67).…”

Section: Therapy Of Nafld and Nashmentioning

confidence: 99%

Nonalcoholic fatty liver disease: Diagnosis, pathogenesis, and management

Başaranoğlu

Örmeci²

2014

Turk J Gastroenterol

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Nonalcoholic fatty liver disease (NAFLD) is an umbrella term that covers both a relatively benign condition, which is simple steatosis, and nonalcoholic steatohepatitis (NASH). NASH is characterized by a chronic and progressive liver pathology that may progress to cirrhosis, end-stage liver disease, hepatocellular carcinoma, and liver transplantation. Despite the growing body of evidence, one of the important and unresolved problems is the pathogenesis of NASH. It might be a metabolic disturbance as a primary abnormality in NAFLD. Insulin resistance is at the center of these metabolic abnormalities. Then, hepatocyte injury might be induced by oxidative stress. This ongoing process progresses to NASH, even to cirrhosis in some patients. In addition to oxidative stress, possibilities for the next hit are lipid peroxidation, reactive metabolites, adipose tissue products, transforming growth factor-b 1 , Fas ligand, mitochondrial dysfunction, respiratory chain deficiency, and intestinal microbiota. Currently, there is no well-established and approved therapy. Recommendations are to improve existing co-morbidities, such as obesity, hyperlipidemia, or type 2 diabetes, and lifestyle modification with weight loss and exercise.

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The Effect of a Silybin-Vitamin E-Phospholipid Complex on Nonalcoholic Fatty Liver Disease: A Pilot Study

Cited by 96 publications

References 63 publications

Silymarin in non alcoholic fatty liver disease

Silymarin in non alcoholic fatty liver disease

Silybin combined with phosphatidylcholine and vitamin E in patients with nonalcoholic fatty liver disease: A randomized controlled trial

Nonalcoholic fatty liver disease: Diagnosis, pathogenesis, and management

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