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ORIGINAL RESEARCH article

Front. Pharmacol.
Sec. Pharmacoepidemiology
Volume 16 - 2025 | doi: 10.3389/fphar.2025.1498124

Exploring the Association Between Herbal Medicine Usage and Drug-Induced Liver Injury: Insights from a Nationwide Population-Based Cohort Study Using SCCS in South Korea

Provisionally accepted
Taehyun Yang Taehyun Yang 1Juhee Ahn Juhee Ahn 1Sungho Won Sungho Won 1Sanghun Lee Sanghun Lee 2*
  • 1 Seoul National University, Seoul, Republic of Korea
  • 2 Dankook University, Yongin, Republic of Korea

The final, formatted version of the article will be published soon.

    Drug-induced liver injury (DILI) is a significant health concern that often results from exposure to various pharmaceuticals, over-the-counter medications, herbal remedies, and dietary supplements. However, the extent to which prescribed herbal medicines contribute to DILI remains unknown. This study investigated the hepatotoxicity risk associated with traditional Korean medicines (TKMs) using nationwide health insurance claims data. A tailored cohort of patients diagnosed with DILI (K71, ICD-10) between January 2011 and December 2019 was provided by the Health Insurance Review and Assessment. After applying the inclusion and exclusion criteria, 672,411 patients were diagnosed with DILI. In a selfcontrolled case study (SCCS) design, hospital/clinic visits or medication prescription histories served as exposures within a 90-day window in three groups: outpatients, inpatients, and patients with liver disease. The relative incidences of DILI in outpatients 3-15 days after visiting Western hospitals/clinics or being prescribed commercial drugs were the highest (1.55 [95% confidence interval (CI): 1.55-1.56] and 2.44 [95% CI: 2.43-2.44], respectively) and gradually declined to 1.0. All the other groups showed similar results. Conversely, the DILI risks associated with TKM hospital/clinic visits and prescriptions for herbal medicine were minimal (1.01 [95%CI: 1.00-1.01] and 0.99 [95%CI: 0.99-0.99], respectively); only patients with liver disease had mildly elevated risk. This nationwide population-based cohort study suggests that herbal medicines prescribed by TKM doctors have a minimal impact on DILI risk, while also indicating an increased DILI susceptibility in patients with liver diseases.Distinguishing between unregulated herbal products and herbal medicines prescribed within medical institutions is crucial when considering hepatotoxicity.

    Keywords: Drug-Induced Liver Injury, herbal medicines, traditional Korean medicines, Herbal and dietary supplements, Pharmacovigilance, Hepatotoxicity, Self-controlled case series

    Received: 18 Sep 2024; Accepted: 10 Jan 2025.

    Copyright: © 2025 Yang, Ahn, Won and Lee. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

    * Correspondence: Sanghun Lee, Dankook University, Yongin, Republic of Korea

    Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.