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Medicines 2016, 3(3), 18; doi:10.3390/medicines3030018

Traditional Chinese Medicine (TCM) and Herbal Hepatotoxicity: RUCAM and the Role of Novel Diagnostic Biomarkers Such as MicroRNAs

1
Department of Internal Medicine II, Division of Gastroenterology and Hepatology, Klinikum Hanau, D-63450 Hanau, Teaching Hospital of the Medical Faculty of the Goethe University, Frankfurt/Main D-63450, Germany
2
Department of Liver and Transplantation—IRB-INSERM (Institut de Recherche Biologique-INstitut de la Santé Et de la Recherche Médicale) 1183, Saint Eloi Hospital, Montpellier University, 34295 Montpellier, France
3
Competence Centre for Complementary Medicine and Naturopathy (CoCoNat), Klinikum rechts der Isar, Technische Universität München, Munich D-80801, Germany
4
Institute for Complementary and Integrative Medicine, University Hospital Zurich and University of Zurich, Zurich CH-8091, Switzerland
5
Pharmacovigilance Consultancy, Paris 75020, France
*
Author to whom correspondence should be addressed.
Academic Editor: Gerhard Litscher
Received: 13 June 2016 / Revised: 4 July 2016 / Accepted: 6 July 2016 / Published: 19 July 2016
(This article belongs to the Special Issue Traditional Chinese Medicine (TCM) and Herbal Hepatotoxicity)
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Abstract

Background: Traditional Chinese Medicine (TCM) with its focus on herbal use is popular and appreciated worldwide with increased tendency, although its therapeutic efficacy is poorly established for most herbal TCM products. Treatment was perceived as fairly safe but discussions emerged more recently as to whether herb induced liver injury (HILI) from herbal TCM is a major issue; Methods: To analyze clinical and case characteristics of HILI caused by herbal TCM, we undertook a selective literature search in the PubMed database with the search items Traditional Chinese Medicine, TCM, alone and combined with the terms herbal hepatotoxicity or herb induced liver injury; Results: HILI caused by herbal TCM is rare and similarly to drugs can be caused by an unpredictable idiosyncratic or a predictable intrinsic reaction. Clinical features of liver injury from herbal TCM products are variable, and specific diagnostic biomarkers such as microsomal epoxide hydrolase, pyrrole-protein adducts, metabolomics, and microRNAs are available for only a few TCM herbs. The diagnosis is ascertained if alternative causes are validly excluded and causality levels of probable or highly probable are achieved applying the liver specific RUCAM (Roussel Uclaf Causality Assessment Method) as the most commonly used diagnostic tool worldwide. Case evaluation may be confounded by inappropriate or lacking causality assessment, poor herbal product quality, insufficiently documented cases, and failing to exclude alternative causes such as infections by hepatotropic viruses including hepatitis E virus infections; Conclusion: Suspected cases of liver injury from herbal TCM represent major challenges that deserve special clinical and regulatory attention to improve the quality of case evaluations and ascertain patients’ safety and benefit. View Full-Text
Keywords: Traditional Chinese Medicine; herbal TCM hepatotoxicity; diagnostic biomarkers; RUCAM; pyrrolizidine alkaloids; HLA; microsomal epoxide hydrolase; pyrrole-protein adducts; metabolomics; microRNA Traditional Chinese Medicine; herbal TCM hepatotoxicity; diagnostic biomarkers; RUCAM; pyrrolizidine alkaloids; HLA; microsomal epoxide hydrolase; pyrrole-protein adducts; metabolomics; microRNA
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This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. (CC BY 4.0).

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Teschke, R.; Larrey, D.; Melchart, D.; Danan, G. Traditional Chinese Medicine (TCM) and Herbal Hepatotoxicity: RUCAM and the Role of Novel Diagnostic Biomarkers Such as MicroRNAs. Medicines 2016, 3, 18.

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