A Real-World Retrospective Cohort Study on the Clinical Effect of Silymarin (Legalon) on Liver Damage and Diseases Using a Domestic Multicenter Common Data Model

Abstract

Background/Aims: Silymarin has been reported to be hepatoprotective and to improve liver function; however, its clinical effectiveness in specific liver diseases remains unclear. This study aimed to evaluate the impact of Legalon, which contains silymarin as its active ingredient, on changes in liver function test values and to assess its potential use as a practical treatment option for liver diseases. Methods: This multicenter retrospective cohort study used the Common Data Model. Data were collected from adult patients with liver disease who were first prescribed Legalon between January 1, 2013, and December31, 2022, across 10 medical institutions in South Korea. Changes in liver function test values at follow-up time points were compared with baseline values. Results: Patients who were prescribed Legalon for at least 6 months showed a statistically significant decrease in liver function test values (aspartate aminotransferase, alanine aminotransferase, and alkaline phosphatase) compared with baseline values. At 3 and 6 months, aspartate aminotransferase decreased by approximately 23.18% and 24.54%, alanine aminotransferase decreased by 20.24% and 25.12%, and alkaline phosphatase decreased by 3.02% and 5.90%, respectively. All three parameters showed a sustained decline. Conclusions: Our findings indicate that silymarin (Legalon) induces a significant reduction in liver function test values, thus suggesting that this drug exerts medium to long-term hepatoprotective benefits. Moreover, the synergistic effects of silymarin with standard treatments highlight its potential as a complementary therapy for liver diseases.