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Kava hepatotoxicity: regulatory data selection and causality assessment.
Dig Liver Dis. 2009 Dec; 41(12):891-901.DL

Abstract

BACKGROUND

Kava hepatotoxicity in 20 patients from Germany has been debated worldwide following a regulatory ad hoc causality assessment and ban of kava, an anxiolytic herbal remedy obtained from the rhizome of Piper methysticum Forster.

AIMS

We assessed causality with a quantitative structured causality analysis in all 20 cases of patients with liver disease, presented by the German regulatory agency that assumed a causal relationship with the use of kava extracts.

METHODS

The quantitative scale of CIOMS (Council for International Organizations of Medical Sciences) in its updated form was employed for causality assessment and quality evaluation of the regulatory data presentation.

RESULTS

The regulatory information is scattered and selective, and items essential for causality assessment, such as exclusion of kava independent causes, were not, or only marginally, considered by the regulator. Quantitative causality assessment for kava was possible (n=2), unlikely (n=12), or excluded (n=6), showing no concordance with the regulatory ad hoc causality evaluation.

CONCLUSION

The regulatory data regarding kava hepatotoxicity is selective and of low quality, not supportive of the regulatory proposed causality; but instead, is an explanation of the overall causality discussions of kava hepatotoxicity. We are proposing that the regulatory agency reports data in full length and reevaluates causality.

Authors+Show Affiliations

Department 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.deNo affiliation info available

Pub Type(s)

Journal Article

Language

eng

PubMed ID

19477698

Citation

Teschke, R, and A Wolff. "Kava Hepatotoxicity: Regulatory Data Selection and Causality Assessment." Digestive and Liver Disease : Official Journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver, vol. 41, no. 12, 2009, pp. 891-901.
Teschke R, Wolff A. Kava hepatotoxicity: regulatory data selection and causality assessment. Dig Liver Dis. 2009;41(12):891-901.
Teschke, R., & Wolff, A. (2009). Kava hepatotoxicity: regulatory data selection and causality assessment. Digestive and Liver Disease : Official Journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver, 41(12), 891-901. https://doi.org/10.1016/j.dld.2009.04.003
Teschke R, Wolff A. Kava Hepatotoxicity: Regulatory Data Selection and Causality Assessment. Dig Liver Dis. 2009;41(12):891-901. PubMed PMID: 19477698.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Kava hepatotoxicity: regulatory data selection and causality assessment. AU - Teschke,R, AU - Wolff,A, Y1 - 2009/05/27/ PY - 2008/10/01/received PY - 2009/01/04/revised PY - 2009/04/07/accepted PY - 2009/5/30/entrez PY - 2009/5/30/pubmed PY - 2010/1/27/medline SP - 891 EP - 901 JF - Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver JO - Dig Liver Dis VL - 41 IS - 12 N2 - BACKGROUND: Kava hepatotoxicity in 20 patients from Germany has been debated worldwide following a regulatory ad hoc causality assessment and ban of kava, an anxiolytic herbal remedy obtained from the rhizome of Piper methysticum Forster. AIMS: We assessed causality with a quantitative structured causality analysis in all 20 cases of patients with liver disease, presented by the German regulatory agency that assumed a causal relationship with the use of kava extracts. METHODS: The quantitative scale of CIOMS (Council for International Organizations of Medical Sciences) in its updated form was employed for causality assessment and quality evaluation of the regulatory data presentation. RESULTS: The regulatory information is scattered and selective, and items essential for causality assessment, such as exclusion of kava independent causes, were not, or only marginally, considered by the regulator. Quantitative causality assessment for kava was possible (n=2), unlikely (n=12), or excluded (n=6), showing no concordance with the regulatory ad hoc causality evaluation. CONCLUSION: The regulatory data regarding kava hepatotoxicity is selective and of low quality, not supportive of the regulatory proposed causality; but instead, is an explanation of the overall causality discussions of kava hepatotoxicity. We are proposing that the regulatory agency reports data in full length and reevaluates causality. SN - 1878-3562 UR - https://www.unboundmedicine.com/medline/citation/19477698/Kava_hepatotoxicity:_regulatory_data_selection_and_causality_assessment_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1590-8658(09)00175-3 DB - PRIME DP - Unbound Medicine ER -