In Vivo Efficacy Study of Milk Thistle Extract (ETHIS-094?) in STAM? Model of Nonalcoholic Steatohepatitis

摘要

Introduction A subcategory of nonalcoholic fatty liver disease (NAFLD), nonalcoholic steatohepatitis (NASH) is characterized by accumulation of fat accompanied by inflammatory infiltration and hepatocellular damage. The active complex of milk thistle is a lipophilic extract from its seeds, comprising three isomers, collectively known as silymarin. Silymarin has demonstrated antioxidant, anti-inflammatory, and antifibrotic properties, and has been extensively studied in the treatment of liver diseases. The majority of published clinical research on silymarin has used Legalon? (Rottapharm/Madaus), containing the patented extract of milk thistle ETHIS-094? (Euromed). The current study was undertaken to examine the effects of ETHIS-094? in the Stelic Animal Model (STAM?), a validated and widely used animal model for NASH. Methods After 4?h fasting from 4 to 8?weeks of age, 15 male mice in whom NASH had been induced were orally administered, once daily, either (1) vehicle (saline) at a volume of 10?mL/kg, (2) vehicle supplemented with milk thistle at a dose of 500?mg/kg, or (3) vehicle supplemented with milk thistle at a dose of 1,000?mg/kg. Results Mean liver weight and the liver-to-body weight ratio were significantly ( P Conclusion Milk thistle extract administration induced a decreasing trend in NAS compared with the vehicle group. Milk thistle induced a numerical decrease of the steatosis score compared with vehicle, and this was accompanied by a statistically significant decrease in liver weight and the liver-to-body weight ratio, implying a potential anti-steatosis effect of milk thistle.