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

Teschke, Rolf, Larrey, Dominique, Melchart, Dieter, Danan, Gaby·2016·Medicines
DOI 10.3390/medicines3030018PMC PMC5456249
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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.

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  • Emodin was not considered the main hepatotoxin anymore, as opposed to previous studies.

    “It is noteworthy that emodin was not considered the main hepatotoxin anymore, as opposed to previous studies.88–90”

    From Herb-induced Liver Injury in Asia and Current Role of RUCAM for Causality Assessment in 11,160 Published Cases (2020) · cites this paper as [90]

  • Reports of 2016 presented case lists of HILI with TCM herbs and causality assessment by RUCAM or positive re-exposure tests, a country-wise case listing of HILI by herbal TCMs with exact numbers and references, and a large list of RUCAM-based injury cases by herbal TCMs, other herbs and drugs.

    “Reports of 2016 presented case lists of HILI with TCM herbs and causality assessment by RUCAM or positive re-exposure tests89 or a country-wise case listing of HILI by herbal TCMs with exact numbers and references,90 and a large list of RUCAM-based injury cases by herbal TCMs, other herbs and drugs, all listed within the publication of the updated RUCAM.15”

    From Herb-induced Liver Injury in Asia and Current Role of RUCAM for Causality Assessment in 11,160 Published Cases (2020) · cites this paper as [90]

  • Our group published initial lists of HILI by various herbal TCMs, with partially incomplete data regarding causality grading, RUCAM use, or quotation of respective reports.

    “For instance, our group published initial lists of HILI by various herbal TCMs, with partially incomplete data regarding causality grading, RUCAM use, or quotation of respective reports.15,89–95”

    From Herb-induced Liver Injury in Asia and Current Role of RUCAM for Causality Assessment in 11,160 Published Cases (2020) · cites this paper as [90]

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Metadata

Authors
Teschke, R., Larrey, D., Melchart, D., & Danan, G.
Affiliations
  • 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
  • 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
  • Competence Centre for Complementary Medicine and Naturopathy (CoCoNat), Klinikum rechts der Isar, Technische Universität München, Munich D-80801, Germany
  • Pharmacovigilance Consultancy, Paris 75020, France
ORCID
Danan, Gaby
Venue
Medicines
Publisher
MDPI AG
Published
2016-07-19
Volume
3
Issue
3
Pages
18
ISSN
2305-6320
DOI
10.3390/medicines3030018
PMC
PMC5456249
Cited by
69
References
5
Language
en
Licence
creativecommons.org/licenses/by/4.0/ (vor)
Funders
none (none)

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