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Drug- and Herb-Induced Liver Injury in Clinical and Translational Hepatology: Causality Assessment Methods, Quo Vadis?
J Clin Transl Hepatol 2013; 1(1):59-74JC

Abstract

Drug-induced liver injury (DILI) and herb-induced liver injury (HILI) are typical diseases of clinical and translational hepatology. Their diagnosis is complex and requires an experienced clinician to translate basic science into clinical judgment and identify a valid causality algorithm. To prospectively assess causality starting on the day DILI or HILI is suspected, the best approach for physicians is to use the Council for International Organizations of Medical Sciences (CIOMS) scale in its original or preferably its updated version. The CIOMS scale is validated, liver-specific, structured, and quantitative, providing final causality grades based on scores of specific items for individual patients. These items include latency period, decline in liver values after treatment cessation, risk factors, co-medication, alternative diagnoses, hepatotoxicity track record of the suspected product, and unintentional re-exposure. Provided causality is established as probable or highly probable, data of the CIOMS scale with all individual items, a short clinical report, and complete raw data should be transmitted to the regulatory agencies, manufacturers, expert panels, and possibly to the scientific community for further refinement of the causality evaluation in a setting of retrospective expert opinion. Good-quality case data combined with thorough CIOMS-based assessment as a standardized approach should avert subsequent necessity for other complex causality assessment methods that may have inter-rater problems because of poor-quality data. In the future, the CIOMS scale will continue to be the preferred tool to assess causality of DILI and HILI cases and should be used consistently, both prospectively by physicians, and retrospectively for subsequent expert opinion if needed. For comparability and international harmonization, all parties assessing causality in DILI and HILI cases should attempt this standardized approach using the updated CIOMS scale.

Authors+Show Affiliations

Department of Internal Medicine II, Division of Gastroenterology and Hepatology, Klinikum Hanau, Academic Teaching Hospital of the Medical Faculty, Goethe University Frankfurt/ Main, Germany.Department of Internal Medicine II, Division of Gastroenterology and Hepatology, Klinikum Hanau, Academic Teaching Hospital of the Medical Faculty, Goethe University Frankfurt/ Main, Germany.Institute of Industrial, Environmental and Social Medicine, Medical Faculty, Goethe University Frankfurt/Main, Germany.

Pub Type(s)

Journal Article
Review

Language

eng

PubMed ID

26357608

Citation

Teschke, Rolf, et al. "Drug- and Herb-Induced Liver Injury in Clinical and Translational Hepatology: Causality Assessment Methods, Quo Vadis?" Journal of Clinical and Translational Hepatology, vol. 1, no. 1, 2013, pp. 59-74.
Teschke R, Eickhoff A, Schulze J. Drug- and Herb-Induced Liver Injury in Clinical and Translational Hepatology: Causality Assessment Methods, Quo Vadis? J Clin Transl Hepatol. 2013;1(1):59-74.
Teschke, R., Eickhoff, A., & Schulze, J. (2013). Drug- and Herb-Induced Liver Injury in Clinical and Translational Hepatology: Causality Assessment Methods, Quo Vadis? Journal of Clinical and Translational Hepatology, 1(1), pp. 59-74. doi:10.14218/JCTH.2013.D002X.
Teschke R, Eickhoff A, Schulze J. Drug- and Herb-Induced Liver Injury in Clinical and Translational Hepatology: Causality Assessment Methods, Quo Vadis. J Clin Transl Hepatol. 2013;1(1):59-74. PubMed PMID: 26357608.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Drug- and Herb-Induced Liver Injury in Clinical and Translational Hepatology: Causality Assessment Methods, Quo Vadis? AU - Teschke,Rolf, AU - Eickhoff,Axel, AU - Schulze,Johannes, Y1 - 2013/09/15/ PY - 2013/04/04/received PY - 2013/05/30/revised PY - 2013/06/04/accepted PY - 2015/9/11/entrez PY - 2013/9/1/pubmed PY - 2013/9/1/medline KW - Causality assessment KW - Drug hepatotoxicity KW - Drug-induced liver injury KW - Herb-induced liver injury KW - Herbal hepatotoxicity SP - 59 EP - 74 JF - Journal of clinical and translational hepatology JO - J Clin Transl Hepatol VL - 1 IS - 1 N2 - Drug-induced liver injury (DILI) and herb-induced liver injury (HILI) are typical diseases of clinical and translational hepatology. Their diagnosis is complex and requires an experienced clinician to translate basic science into clinical judgment and identify a valid causality algorithm. To prospectively assess causality starting on the day DILI or HILI is suspected, the best approach for physicians is to use the Council for International Organizations of Medical Sciences (CIOMS) scale in its original or preferably its updated version. The CIOMS scale is validated, liver-specific, structured, and quantitative, providing final causality grades based on scores of specific items for individual patients. These items include latency period, decline in liver values after treatment cessation, risk factors, co-medication, alternative diagnoses, hepatotoxicity track record of the suspected product, and unintentional re-exposure. Provided causality is established as probable or highly probable, data of the CIOMS scale with all individual items, a short clinical report, and complete raw data should be transmitted to the regulatory agencies, manufacturers, expert panels, and possibly to the scientific community for further refinement of the causality evaluation in a setting of retrospective expert opinion. Good-quality case data combined with thorough CIOMS-based assessment as a standardized approach should avert subsequent necessity for other complex causality assessment methods that may have inter-rater problems because of poor-quality data. In the future, the CIOMS scale will continue to be the preferred tool to assess causality of DILI and HILI cases and should be used consistently, both prospectively by physicians, and retrospectively for subsequent expert opinion if needed. For comparability and international harmonization, all parties assessing causality in DILI and HILI cases should attempt this standardized approach using the updated CIOMS scale. SN - 2225-0719 UR - https://www.unboundmedicine.com/medline/citation/26357608/Drug__and_Herb_Induced_Liver_Injury_in_Clinical_and_Translational_Hepatology:_Causality_Assessment_Methods_Quo_Vadis L2 - https://dx.doi.org/10.14218/JCTH.2013.D002X DB - PRIME DP - Unbound Medicine ER -