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Human Liver Microphysiological System for Assessing Drug-Induced Liver Toxicity In Vitro

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Published on: January 31, 2022

Kava hepatotoxicity: regulatory data selection and causality assessment.

R Teschke¹, A Wolff

¹Department of Internal Medicine II, Division of Gastroenterology and Hepatology, Klinikum Hanau, Teaching Hospital of the Johann Wolfgang Goethe-University, Frankfurt/Main, Hanau, Germany. rolf_teschke@klinikum-hanau.de

Digestive and Liver Disease : Official Journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver

|May 30, 2009

Summary

Regulatory data on kava hepatotoxicity was found to be selective and of low quality. Quantitative causality analysis showed no concordance with the regulatory assessment, suggesting a need for reevaluation.

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Area of Science:

Pharmacology
Hepatology
Herbal Medicine Safety

Background:

Kava (Piper methysticum) is an herbal anxiolytic remedy.
Kava hepatotoxicity has been debated globally following German regulatory actions.
Twenty patient cases from Germany formed the basis of the regulatory assessment.

Purpose of the Study:

To quantitatively assess causality between kava use and liver disease in 20 reported cases.
To evaluate the quality of data presented by the German regulatory agency.
To compare quantitative causality assessment with the regulatory ad hoc evaluation.

Main Methods:

Utilized the updated Council for International Organizations of Medical Sciences (CIOMS) scale for causality assessment.
Performed a quantitative structured causality analysis on all 20 patient cases.
Evaluated the quality and completeness of the regulatory data presentation.

Main Results:

Regulatory data was scattered, selective, and lacked essential information like exclusion of independent causes.
Quantitative causality assessment classified kava's role as possible (n=2), unlikely (n=12), or excluded (n=6).
Results showed no concordance with the German regulatory agency's ad hoc causality evaluation.

Conclusions:

The regulatory data on kava hepatotoxicity is of low quality and selective, not supporting the proposed causality.
The findings suggest the regulatory data may explain broader discussions on kava hepatotoxicity.
Recommended the regulatory agency to report data in full and reevaluate causality.