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Herbal hepatotoxicity: challenges and pitfalls of causality assessment methods.
World J Gastroenterol 2013; 19(19):2864-82WJ

Abstract

The diagnosis of herbal hepatotoxicity or herb induced liver injury (HILI) represents a particular clinical and regulatory challenge with major pitfalls for the causality evaluation. At the day HILI is suspected in a patient, physicians should start assessing the quality of the used herbal product, optimizing the clinical data for completeness, and applying the Council for International Organizations of Medical Sciences (CIOMS) scale for initial causality assessment. This scale is structured, quantitative, liver specific, and validated for hepatotoxicity cases. Its items provide individual scores, which together yield causality levels of highly probable, probable, possible, unlikely, and excluded. After completion by additional information including raw data, this scale with all items should be reported to regulatory agencies and manufacturers for further evaluation. The CIOMS scale is preferred as tool for assessing causality in hepatotoxicity cases, compared to numerous other causality assessment methods, which are inferior on various grounds. Among these disputed methods are the Maria and Victorino scale, an insufficiently qualified, shortened version of the CIOMS scale, as well as various liver unspecific methods such as the ad hoc causality approach, the Naranjo scale, the World Health Organization (WHO) method, and the Karch and Lasagna method. An expert panel is required for the Drug Induced Liver Injury Network method, the WHO method, and other approaches based on expert opinion, which provide retrospective analyses with a long delay and thereby prevent a timely assessment of the illness in question by the physician. In conclusion, HILI causality assessment is challenging and is best achieved by the liver specific CIOMS scale, avoiding pitfalls commonly observed with other approaches.

Authors+Show Affiliations

Division of Gastroenterology and Hepatology, Department of Internal Medicine II, Klinikum Hanau, D-63450 Hanau, Germany. rolf.teschke@gmx.de

Pub Type(s)

Journal Article
Review

Language

eng

PubMed ID

23704820

Citation

Teschke, Rolf, et al. "Herbal Hepatotoxicity: Challenges and Pitfalls of Causality Assessment Methods." World Journal of Gastroenterology, vol. 19, no. 19, 2013, pp. 2864-82.
Teschke R, Frenzel C, Schulze J, et al. Herbal hepatotoxicity: challenges and pitfalls of causality assessment methods. World J Gastroenterol. 2013;19(19):2864-82.
Teschke, R., Frenzel, C., Schulze, J., & Eickhoff, A. (2013). Herbal hepatotoxicity: challenges and pitfalls of causality assessment methods. World Journal of Gastroenterology, 19(19), pp. 2864-82. doi:10.3748/wjg.v19.i19.2864.
Teschke R, et al. Herbal Hepatotoxicity: Challenges and Pitfalls of Causality Assessment Methods. World J Gastroenterol. 2013 May 21;19(19):2864-82. PubMed PMID: 23704820.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Herbal hepatotoxicity: challenges and pitfalls of causality assessment methods. AU - Teschke,Rolf, AU - Frenzel,Christian, AU - Schulze,Johannes, AU - Eickhoff,Axel, PY - 2013/02/21/received PY - 2013/04/11/revised PY - 2013/04/17/accepted PY - 2013/5/25/entrez PY - 2013/5/25/pubmed PY - 2014/1/1/medline KW - Causality assessment KW - Drug hepatotoxicity KW - Drug induced liver injury KW - Herb induced liver injury KW - Herbal hepatotoxicity KW - Herbs SP - 2864 EP - 82 JF - World journal of gastroenterology JO - World J. Gastroenterol. VL - 19 IS - 19 N2 - The diagnosis of herbal hepatotoxicity or herb induced liver injury (HILI) represents a particular clinical and regulatory challenge with major pitfalls for the causality evaluation. At the day HILI is suspected in a patient, physicians should start assessing the quality of the used herbal product, optimizing the clinical data for completeness, and applying the Council for International Organizations of Medical Sciences (CIOMS) scale for initial causality assessment. This scale is structured, quantitative, liver specific, and validated for hepatotoxicity cases. Its items provide individual scores, which together yield causality levels of highly probable, probable, possible, unlikely, and excluded. After completion by additional information including raw data, this scale with all items should be reported to regulatory agencies and manufacturers for further evaluation. The CIOMS scale is preferred as tool for assessing causality in hepatotoxicity cases, compared to numerous other causality assessment methods, which are inferior on various grounds. Among these disputed methods are the Maria and Victorino scale, an insufficiently qualified, shortened version of the CIOMS scale, as well as various liver unspecific methods such as the ad hoc causality approach, the Naranjo scale, the World Health Organization (WHO) method, and the Karch and Lasagna method. An expert panel is required for the Drug Induced Liver Injury Network method, the WHO method, and other approaches based on expert opinion, which provide retrospective analyses with a long delay and thereby prevent a timely assessment of the illness in question by the physician. In conclusion, HILI causality assessment is challenging and is best achieved by the liver specific CIOMS scale, avoiding pitfalls commonly observed with other approaches. SN - 2219-2840 UR - https://www.unboundmedicine.com/medline/citation/23704820/Herbal_hepatotoxicity:_challenges_and_pitfalls_of_causality_assessment_methods_ L2 - http://www.wjgnet.com/1007-9327/full/v19/i19/2864.htm DB - PRIME DP - Unbound Medicine ER -