Review
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World J Hepatol. Jan 27, 2014; 6(1): 17-32
Published online Jan 27, 2014. doi: 10.4254/wjh.v6.i1.17
Drug and herb induced liver injury: Council for International Organizations of Medical Sciences scale for causality assessment
Rolf Teschke, Albrecht Wolff, Christian Frenzel, Alexander Schwarzenboeck, Johannes Schulze, Axel Eickhoff
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
Albrecht Wolff, Department of Internal Medicine II, Division of Gastroenterology, Hepatology and Infectious Diseases, Friedrich Schiller University Jena, D-07743 Jena, Germany
Christian Frenzel, Department of Medicine I, University Medical Center Hamburg Eppendorf, 20246 Hamburg, Germany
Johannes Schulze, Institute of Industrial, Environmental and Social Medicine, Medical Faculty, Goethe University, 60590 Frankfurt/Main, Germany
Author contributions: Teschke R and Eickhoff A provided substantial contributions to the conception and design; Wolff A, Frenzel C and Schwarzenboeck A contributed to the literature search and acquisition of relevant literature; Teschke R, Schulze J and Eickhoff A contributed to analysis and interpretation of the data; Teschke R contributed to drafting the article; Wolff A, Frenzel C, Schwarzenboeck A, Schulze J and Eickhoff A contributed to revising it critically for important intellectual content; all the authors contributed to final approval of the version to be published.
Correspondence to: Rolf Teschke, MD, Professor of Medicine, Department of Internal Medicine II, Klinikum Hanau, Academic Teaching Hospital of the Medical Faculty of the Goethe University of Frankfurt/Main, Leimenstrasse 20, D-63450 Hanau, Germany. rolf.teschke@gmx.de
Telephone: +49-6181-21859 Fax: +49-6181-2964211
Received: August 2, 2013
Revised: November 11, 2013
Accepted: December 9, 2013
Published online: January 27, 2014
Processing time: 178 Days and 23.8 Hours
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.

Keywords: Drug induced liver injury; Drug hepatotoxicity; Herb induced liver injury; Herbal hepatotoxicity; Causality assessment

Core tip: We propose that the attending physicians caring for patients with assumed drug induced liver injury and herb induced liver injury should use the Council for International Organizations of Medical Sciences (CIOMS) scale for causality assessment. This approach includes the option of subsequent refinement of the CIOMS based results by expert panels and regulatory agencies. The use of the CIOMS scale as an identical tool for all involved parties will allow early and prospective collection of all relevant data required for a valid causality assessment in clinical hepatology.