[Effects of a new pharmacological complex (silybin + vitamin-E + phospholipids) on some markers of the metabolic syndrome and of liver fibrosis in patients with hepatic steatosis. Preliminary study].
OBJECTIVE
This open preliminary pilot study was aimed to evaluate the effect of a new pharmaceutical complex (silybin+vitamin E+phospholipids - RealSIL-IBI-Lorenzini Pharmaceutical, Italy) on some parameters of metabolic syndrome and of liver fibrosis in patients with non alcoholic fatty liver disease (NAFLD) with or without the contemporaneous presence of hepatitis C virus (HCV)-related chronic hepatitis.


METHODS
Eighty five patients were consecutively enrolled in the study and divided in 2 groups; the first group was represented by 59 patients affected by NAFLD, negative for other known causes of chronic liver damage (M/F= 39/20; median age and range: 44 years, 22-76, group A); the second group was represented by 26 patients (M/F=19/7; median age and range 51 years, 20-75, group B) with HCV-related chronic hepatitis associated to NAFLD. Adverse events and drop-outs were absent in all group and compliance at the study was absolute.


RESULTS
This open preliminary study shows that the new compound silybin+vitamin E+ phospholipids is active, in vivo, and produces some therapeutic effects in patients with different forms of chronic liver damage. In particular, it improves insulin resistance and plasma levels of markers of liver fibrosis in patients in whom these parameters are particularly altered.


CONCLUSIONS
Our data have a role of suggestion to further evaluate, through a controlled trial, a possible therapeutic use of this new compound in the management of patients with NAFLD.
Interuniversity Research Center on Foods Nutrition and Gastrointestinal Tract (CIRANAD),Unit of Gastroenterology, 2nd University of Naples, Naples, Italy.
M
M
Trappoliere
A
A
Federico
C
C
Tuccillo
I
I
de Sio
A
A
Di Leva
M
M
Niosi
M
M
D'Auria
C
C
Loguercio
D000328:Adult; D000368:Aged; D015415:Biomarkers / Q000097:blood*; D004338:Drug Combinations; D005234:Fatty Liver / Q000097:blood / Q000188:drug therapy* / Q000821:virology; D005260:Female; D019698:Hepatitis C, Chronic / Q000150:complications; D006801:Humans; D007333:Insulin Resistance; D008103:Liver Cirrhosis / Q000097:blood / Q000188:drug therapy* / Q000821:virology; D008297:Male; D024821:Metabolic Syndrome / Q000097:blood / Q000188:drug therapy*; D008875:Middle Aged; D010743:Phospholipids / Q000494:pharmacology* / Q000627:therapeutic use; D010865:Pilot Projects; D000077385:Silybin; D012838:Silymarin / Q000494:pharmacology / Q000627:therapeutic use; D014810:Vitamin E / Q000494:pharmacology* / Q000627:therapeutic use
D015415:Biomarkers; D004338:Drug Combinations; D010743:Phospholipids; D012838:Silymarin; D014810:Vitamin E; D000077385:Silybin