Trials · 8 authors, 3 centres
This summary was generated by AI from a single paper. It has not been reviewed by a clinician and is not clinical advice. Verify against the source before acting on it.
This is a protocol for a randomized, double-blind, placebo-controlled trial investigating silymarin supplementation as an adjuvant treatment for adult patients with non-alcoholic fatty liver disease (NAFLD). The primary outcome is change in liver fat content measured by CT scan over 12 weeks. The study is a protocol and does not report results, so its efficacy and safety are not yet established.
Non-alcoholic fatty liver disease (NAFLD) is a highly prevalent global health concern with limited pharmacological treatment options. Silymarin, an herbal extract from Silybum marianum, is hypothesized to have hepatoprotective and anti-inflammatory properties that may benefit NAFLD patients. Methods: This is a protocol for a randomized, double-blind, placebo-controlled clinical trial. Adult NAFLD patients will be randomized to receive either silymarin (700mg) plus vitamin E and phosphatidylcholine, or a placebo (maltodextrin) plus the same vitamin E and phosphatidylcholine, for 12 weeks. The primary outcome is the change in liver fat content, measured by the difference in attenuation coefficient between liver and spleen on a non-contrast CT scan. Secondary outcomes include changes in body composition, glucose metabolism, and liver function biomarkers. The study plans to recruit approximately 132 participants. Key Results: As this is a study protocol, no results are reported. The paper outlines the planned methodology, including randomization, blinding, adherence monitoring, and statistical analysis. Limitations: The study is a protocol, so no efficacy or safety data are available. It is conducted at a single tertiary referral hospital in Brazil, which may limit generalizability. The primary outcome relies on CT imaging, which is a reference standard but involves radiation exposure. Implications: The trial aims to provide robust evidence on whether silymarin can serve as an effective adjuvant therapy for NAFLD. If successful, it could inform clinical practice and support further research into herbal supplements for liver disease management.
