Frontiers in Pharmacology
7,922
Total views
45
Downloads
Sec. Gastrointestinal and Hepatic Pharmacology
Volume 15 - 2024 | doi: 10.3389/fphar.2024.1276313
SEVERE LIVER INJURY DUE TO THE PROPRIETARY HERBAL LIV.52® -CLINICAL OUTCOMES, TOXICOLOGY, AND CRITICAL REVIEW OF LITERATURE Provisionally accepted
Cyriac A. Philips Cyriac A. Philips *Arif H. Theruvath Arif H. TheruvathResmi Ravindran Resmi RavindranRizwan Ahamed Rizwan AhamedTharun T. Oomen Tharun T. OomenJinsha K. Abduljaleel Jinsha K. AbduljaleelSasidharan Rajesh Sasidharan RajeshAjit Tharakan Ajit TharakanPhilip Augustine Philip Augustine
Rajagiri Hospital, Kochi, India
Introduction
Liv.52® is a multi-herbal marketed on advertised claims for various liver diseases. However, there is a lack of high-quality clinical evidence supporting its use. A randomized trial in alcohol-related cirrhosis showed no benefits but increased death. We present the first series of liver injuries associated with Liv.52® and report on the clinical presentations, liver histopathology, possible mechanisms of injury, and detailed /toxicology of the herbal formulation retrieved from patients.
Methods
We identified 15 cases of herb-induced liver injury (HILI) linked to Liv.52® on a retrospective review of a prospectively maintained patient database between Jun 1, 2019, and Jun 15, 2023. All patients underwent a detailed diagnostic workup to exclude other competing causes for liver injury. Where possible, the implicated Liv.52® formulation was retrieved for analysis.
Results
We identified five patients with Liv.52®-induced HILI after reasonably excluding competing causes. Eighty percent were males, and all patients consumed the herbal supplement as per product label instructions. The median duration of herbal supplement intake was 57 days. Indications for use included "alcohol detox," reversal of fatty liver, and prevention of infectious hepatitis—patients presented with self-limiting acute hepatitis, acute severe liver injury, acute decompensation, and acute-on-chronic liver failure. Cholestatic pattern predominated. Lobular inflammation, hepatocellular necrosis and cholestasis were notable on liver biopsy. Supplements contained liver-damaging botanical ingredients and toxicology analysis revealed high levels of heavy metals and hepatotoxic organic/inorganic compounds due to poor manufacturing and adulteration.
Conclusion
The commonly used proprietary herbal supplement Liv.52® may cause severe liver injury which presents variably with a prolonged clinical course. Physicians and the public must be educated on the potential harms of consuming advertised and unscientific alternative medications.
Keywords: ACLF, DILI, Ayurveda, AYUSH, Himalaya
Received: 11 Sep 2023; Accepted: 15 Jan 2024.
Copyright: © 2024 Philips, Theruvath, Ravindran, Ahamed, Oomen, Abduljaleel, Rajesh, Tharakan and Augustine. 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.