Effectiveness of silymarin with lifestyle intervention in NAFLD and metabolic syndrome: a prospective single-arm study.

BACKGROUND

Non-alcoholic fatty liver disease (NAFLD) has now become a major global health concern. Lifestyle modifications are the first line of treatment; however, their effectiveness is often limited. Silymarin extracted from Silybum marianum is effective and well tolerated in patients with liver disorders. This study aimed to assess the effect of administration of silymarin along with lifestyle changes on lowering liver enzymes in patients with NAFLD and metabolic syndrome in a real-world setting.

METHODS

Patients enrolled in this observational study were prescribed standard of care (diet and physical exercise) and one capsule of 140 mg of silymarin thrice daily for 6 months. Laboratory tests, non-invasive tests, ultrasonography, quality of life questionnaire, lifestyle changes and safety were assessed at 3-month and 6-month visits.

RESULTS

Of 360 patients enrolled in the study, 315 (88%) completed the study. At baseline, aspartate transaminase (AST), alanine transaminase (ALT) and gamma-glutamyl transferase (GGT) levels were elevated in 45%, 90% and 47% of patients, respectively. By end of study, 45% (148/328) of patients achieved normalization in at least one enzyme (AST: 42%, ALT: 34%, GGT: 28%), and overall, 78% of patients showed reduction in levels for at least one liver enzyme. Enzyme levels including AST, ALT, and GGT, underwent a clinically relevant decrease (>30%) in 42%, 40%, and 34% of patients, respectively. Silymarin was well tolerated with no serious side-effects.

CONCLUSION

Silymarin combined with lifestyle modifications is a safe and effective treatment option for reducing and normalizing liver enzyme levels in patients with NAFLD and associated metabolic syndrome.

CLINICAL TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Identifier: NCT05051527.