A randomized trial of the standardized extract Legalon 140, itself an approved prescription product for hepatic disorders in parts of Europe and Asia, gave 154 patients with chronic hepatitis C unresponsive to interferon-based therapy 420 mg or 700 mg silymarin, or placebo, three times daily for 24 weeks. Neither dose (3 to 5 times the customary amount) significantly improved the prespecified ALT endpoint versus placebo (about 4% of each group responded, P>=.99) or secondary HCV RNA and quality-of-life outcomes. It does not support presenting milk thistle as established protection against steroid-induced liver injury, a different disease and indication.[1]
- Chronic hepatitis C, not drug/steroid-induced liver injury; findings are specific to the standardized Legalon 140 product at above-customary doses, not to unstandardized milk-thistle supplements generally.
- Full-text-checked; no qualified clinical review.
Inspection history
Clinical review: not reviewed by a qualified clinician.
· Independent source inspection; applicability narrowed and inherited assertions excluded where unsupported. No qualified clinical review.
· Reopened and read the full open-access PMC text (upgraded from abstract-checked to full-text); identified the specific branded product (Legalon 140) and confirmed both linked PubMed notices are editorial commentary (RefType=CommentIn), not retractions. Independent editorial review pending; no qualified clinical review.