Siliphos® Reduces Liver Toxicity

NEW YORKResults of a new study published in Cancer showed silybin, the major active constituent of silymarin, can reduce liver toxicity in children receiving chemotherapy treatment for acute lymphoblastic leukemia (ALL) when administered in a more bioavailable complex (2010 Jan 15;116(2):506-13). In a double blind study, children with ALL and hepatic toxicity were randomized to milk thistle (MT; as Siliphos®, from Indena) or placebo orally for 28 days.

Fifty children were enrolled. No significant differences in frequency of side effects, incidence and severity of toxicities, or infections were observed between groups. There were no significant changes in mean amino alanine transferase (ALT), aspartate amino transferase (AST) or total bilirubin (TB) at day 28. At Day 56, the MT group had a significantly lower AST (P=0.05) and a trend toward a significantly lower ALT (P=0.07). Although not significantly different, chemotherapy doses were reduced in 61 percent of the MT group compared with 72 percent of the placebo group. In vitro experiments revealed no antagonistic interactions between MT and vincristine or L-asparaginase in CCRF-CEM cells. A modest synergistic effect with vincristine was observed.

Researchers concluded in children with ALL and liver toxicity, MT was associated with a trend toward significant reductions in liver toxicity. MT did not antagonize the effects of chemotherapy agents used for the treatment of ALL. However, a future study is needed to determine the most effective dose and duration of MT and its effect on hepatotoxicity and leukemia-free survival.

Indena is excited about the positive results of Siliphos on chemotherapy-associated liver toxicity in children with leukemia, said Antonella Riva, senior research scientist at Indena . Siliphos has been extensively used and investigated for maintaining healthy liver function, and these preliminary results indicate another potential benefit for Siliphos to preserve liver function, even under severe hepatotoxic challenge.