title: Drug and herb induced liver injury: Council for International Organizations of Medical Sciences scale for causality assessment.
abstract: Causality assessment of suspected drug induced liver injury (DILI) and herb induced liver injury (HILI) is hampered by the lack of a standardized approach to be used by attending physicians and at various subsequent evaluating levels. The aim of this review was to analyze the suitability of the liver specific Council for International Organizations of Medical Sciences (CIOMS) scale as a standard tool for causality assessment in DILI and HILI cases. PubMed database was searched for the following terms: drug induced liver injury; herb induced liver injury; DILI causality assessment; and HILI causality assessment. The strength of the CIOMS lies in its potential as a standardized scale for DILI and HILI causality assessment. Other advantages include its liver specificity and its validation for hepatotoxicity with excellent sensitivity, specificity and predictive validity, based on cases with a positive reexposure test. This scale allows prospective collection of all relevant data required for a valid causality assessment. It does not require expert knowledge in hepatotoxicity and its results may subsequently be refined. Weaknesses of the CIOMS scale include the limited exclusion of alternative causes and qualitatively graded risk factors. In conclusion, CIOMS appears to be suitable as a standard scale for attending physicians, regulatory agencies, expert panels and other scientists to provide a standardized, reproducible causality assessment in suspected DILI and HILI cases, applicable primarily at all assessing levels involved.
authors.affiliation: Rolf Teschke, Alexander Schwarzenboeck, Axel Eickhoff, Department of Internal Medicine II, Klinikum Hanau, Academic Teaching Hospital of the Medical Faculty of the Goethe University of Frankfurt/Main, D-63450 Hanau, Germany.
authors.forename: Rolf
authors.initials: R
authors.lastname: Teschke
authors.affiliation: Rolf Teschke, Alexander Schwarzenboeck, Axel Eickhoff, Department of Internal Medicine II, Klinikum Hanau, Academic Teaching Hospital of the Medical Faculty of the Goethe University of Frankfurt/Main, D-63450 Hanau, Germany.
authors.forename: Albrecht
authors.initials: A
authors.lastname: Wolff
authors.affiliation: Rolf Teschke, Alexander Schwarzenboeck, Axel Eickhoff, Department of Internal Medicine II, Klinikum Hanau, Academic Teaching Hospital of the Medical Faculty of the Goethe University of Frankfurt/Main, D-63450 Hanau, Germany.
authors.forename: Christian
authors.initials: C
authors.lastname: Frenzel
authors.affiliation: Rolf Teschke, Alexander Schwarzenboeck, Axel Eickhoff, Department of Internal Medicine II, Klinikum Hanau, Academic Teaching Hospital of the Medical Faculty of the Goethe University of Frankfurt/Main, D-63450 Hanau, Germany.
authors.forename: Alexander
authors.initials: A
authors.lastname: Schwarzenboeck
authors.affiliation: Rolf Teschke, Alexander Schwarzenboeck, Axel Eickhoff, Department of Internal Medicine II, Klinikum Hanau, Academic Teaching Hospital of the Medical Faculty of the Goethe University of Frankfurt/Main, D-63450 Hanau, Germany.
authors.forename: Johannes
authors.initials: J
authors.lastname: Schulze
authors.affiliation: Rolf Teschke, Alexander Schwarzenboeck, Axel Eickhoff, Department of Internal Medicine II, Klinikum Hanau, Academic Teaching Hospital of the Medical Faculty of the Goethe University of Frankfurt/Main, D-63450 Hanau, Germany.
authors.forename: Axel
authors.initials: A
authors.lastname: Eickhoff
keywords: Causality assessment; Drug hepatotoxicity; Drug induced liver injury; Herb induced liver injury; Herbal hepatotoxicity