Because of its widespread use for liver health in the form of milk thistle extract, toxicity due to silibinin's consumption has never been a serious issue. This might be the reason for lack of studies/reports about its acute or chronic toxicity even in preclinical animal models. With the development of more bioavailable forms such as siliphos, silipide, and legalon, studies have been conducted in animals and humans to evaluate the health beneficial effects.
Various traditional toxicological tests have proven the nontoxic nature of siliphos, and it was reported safe for rats and monkeys at oral doses up to 2,000 rug/kg/day, after 13-week subacute toxicity studies. In 26-week chronic toxicity studies, oral doses up to 1,000 rug/kg/day were well tolerated in dogs and rats. In another 26-week oral toxicity study, rats were fed a daily 2,000 mg/kg dose of siliphos, which is equivalent to 160 g daily for a 176-pound human.
In this study, body weight, liver weight, and enzyme indicators of liver damage (AST, ALT) remained within the normal healthy range of the untreated control rats, confirming the nontoxic nature of this compound. Even in patients with liver conditions, treatment with 240 mg or 360 mg daily dose of siliphos for the period of 4 months did not cause any severe adverse effects except in 5.2% of total patients enrolled in the study, who reported nausea, heartburn, dyspepsia, or transient headaches.
In our in vivo studies we have reported that silymarin and silibinin are well tolerated and have no toxicity in terms of body weight gain, diet consumption, and animal behavior. In our phase I clinical trials we have reported that 13 g/day of silibinin in the form of phytosome, in three divided doses was well tolerated in patients with advanced prostate cancer.
The asymptomatic liver toxicity at higher doses was the most commonly seen adverse effect in this study. Studies conducted with silibinin in the form of a new pharmacological complex (silybin-vitamin E-phospholipids, sold under the trade name as RealSIL-Bi by Lorenzi Pharmaceuticals, Italy) in patients with nonalcoholic fatty liver disease with or without hepatitis C virus-related chronic hepatitis demonstrated some therapeutic effects, such as improvement in insulin resistance and hepatic fibrosis, and did not report any adverse effects. Patients enrolled in this study were treated with 4 pieces/day of complex, where each piece contained 94 mg of silibinin, 194 mg of phosphotidylcholine, and 90 mg of vitamin E.
In another long term, 12-month, open-controlled study with silymarin in two well-matched groups of insulin-treated diabetics with alcoholic cirrhosis, administration of 600 mg silymarin per day along with standard therapy did not show any toxicity in patients, though it reduced insulin resistance, endogenous insulin overproduction, and the need for exogenous insulin. Overall, reports of adverse effects of silibinin or silymarin are rare; however, cases of nausea, epigastric discomfort, arthralgia, pruritus, headache, urticaria, and mild laxative effect have been reported.
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