Analysis of Hepatobiliary Disorder Reports Associated With the Use of Herbal Medicines in the Global Suspected ADR Database Vigibase
Identifieur interne : 000626 ( Main/Exploration ); précédent : 000625; suivant : 000627Analysis of Hepatobiliary Disorder Reports Associated With the Use of Herbal Medicines in the Global Suspected ADR Database Vigibase
Auteurs : Florence Van Hunsel [Pays-Bas] ; Sonja Van De Koppel [Pays-Bas] ; Souad Skalli [Maroc] ; Andrea Kuemmerle [Suisse] ; Lida Teng [Japon] ; Jia-Bo Wang [République populaire de Chine] ; Joanne Barnes [Nouvelle-Zélande]Source :
- Frontiers in Pharmacology [ 1663-9812 ] ; 2019.
Abstract
Url:
DOI: 10.3389/fphar.2019.01326
PubMed: 31780942
PubMed Central: 6851844
Affiliations:
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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Analysis of Hepatobiliary Disorder Reports Associated With the Use of Herbal Medicines in the Global Suspected ADR Database Vigibase</title><author><name sortKey="Van Hunsel, Florence" sort="Van Hunsel, Florence" uniqKey="Van Hunsel F" first="Florence" last="Van Hunsel">Florence Van Hunsel</name><affiliation wicri:level="1"><nlm:aff id="aff1"><institution>The Netherlands Pharmacovigilance Centre Lareb</institution>,<addr-line>‘s-Hertogenbosch</addr-line>,<country>Netherlands</country></nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Van De Koppel, Sonja" sort="Van De Koppel, Sonja" uniqKey="Van De Koppel S" first="Sonja" last="Van De Koppel">Sonja Van De Koppel</name><affiliation wicri:level="1"><nlm:aff id="aff1"><institution>The Netherlands Pharmacovigilance Centre Lareb</institution>,<addr-line>‘s-Hertogenbosch</addr-line>,<country>Netherlands</country></nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Skalli, Souad" sort="Skalli, Souad" uniqKey="Skalli S" first="Souad" last="Skalli">Souad Skalli</name><affiliation wicri:level="1"><nlm:aff id="aff2"><institution>Microbiology and Molecular Biology Team, Center of Plant and Microbial Biotechnology, Biodiversity and Environment, Faculty of Sciences, Mohammed V University in Rabat</institution>,<addr-line>Rabat</addr-line>,<country>Morocco</country></nlm:aff><country xml:lang="fr">Maroc</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Kuemmerle, Andrea" sort="Kuemmerle, Andrea" uniqKey="Kuemmerle A" first="Andrea" last="Kuemmerle">Andrea Kuemmerle</name><affiliation wicri:level="1"><nlm:aff id="aff3"><institution>Department of Medicine, Swiss Tropical and Public Health Institute</institution>,<addr-line>Basel</addr-line>,<country>Switzerland</country></nlm:aff><country xml:lang="fr">Suisse</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="aff4"><institution>University of Basel</institution>,<addr-line>Basel</addr-line>,<country>Switzerland</country></nlm:aff><country xml:lang="fr">Suisse</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Teng, Lida" sort="Teng, Lida" uniqKey="Teng L" first="Lida" last="Teng">Lida Teng</name><affiliation wicri:level="1"><nlm:aff id="aff5"><institution>Department of Health Economics and Outcomes Research, Graduate School of Pharmaceutical Sciences</institution>,<addr-line>The University of Tokyo</addr-line>,<country>Tokyo, Japan</country></nlm:aff><country xml:lang="fr">Japon</country><wicri:regionArea></wicri:regionArea></affiliation></author><author><name sortKey="Wang, Jia Bo" sort="Wang, Jia Bo" uniqKey="Wang J" first="Jia-Bo" last="Wang">Jia-Bo Wang</name><affiliation wicri:level="1"><nlm:aff id="aff6"><institution>Institute of Chinese Herbal Medicine, Beijing Integrative Medical Center for Liver Diseases, Beijing 302 Hospital of China</institution>,<addr-line>Beijing</addr-line>,<country>China</country></nlm:aff><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Barnes, Joanne" sort="Barnes, Joanne" uniqKey="Barnes J" first="Joanne" last="Barnes">Joanne Barnes</name><affiliation wicri:level="1"><nlm:aff id="aff7"><institution>School of Pharmacy, The University of Auckland</institution>,<addr-line>Auckland</addr-line>,<country>New Zealand</country></nlm:aff><country xml:lang="fr">Nouvelle-Zélande</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">31780942</idno><idno type="pmc">6851844</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6851844</idno><idno type="RBID">PMC:6851844</idno><idno type="doi">10.3389/fphar.2019.01326</idno><date when="2019">2019</date><idno type="wicri:Area/Pmc/Corpus">000187</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">000187</idno><idno type="wicri:Area/Pmc/Curation">000187</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Curation">000187</idno><idno type="wicri:Area/Pmc/Checkpoint">000135</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Checkpoint">000135</idno><idno type="wicri:source">PubMed</idno><idno type="RBID">pubmed:31780942</idno><idno type="wicri:Area/PubMed/Corpus">000194</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">000194</idno><idno type="wicri:Area/PubMed/Curation">000193</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Curation">000193</idno><idno type="wicri:Area/PubMed/Checkpoint">000291</idno><idno type="wicri:explorRef" wicri:stream="Checkpoint" wicri:step="PubMed">000291</idno><idno type="wicri:Area/Main/Merge">000626</idno><idno type="wicri:Area/Main/Curation">000626</idno><idno type="wicri:Area/Main/Exploration">000626</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Analysis of Hepatobiliary Disorder Reports Associated With the Use of Herbal Medicines in the Global Suspected ADR Database Vigibase</title><author><name sortKey="Van Hunsel, Florence" sort="Van Hunsel, Florence" uniqKey="Van Hunsel F" first="Florence" last="Van Hunsel">Florence Van Hunsel</name><affiliation wicri:level="1"><nlm:aff id="aff1"><institution>The Netherlands Pharmacovigilance Centre Lareb</institution>,<addr-line>‘s-Hertogenbosch</addr-line>,<country>Netherlands</country></nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Van De Koppel, Sonja" sort="Van De Koppel, Sonja" uniqKey="Van De Koppel S" first="Sonja" last="Van De Koppel">Sonja Van De Koppel</name><affiliation wicri:level="1"><nlm:aff id="aff1"><institution>The Netherlands Pharmacovigilance Centre Lareb</institution>,<addr-line>‘s-Hertogenbosch</addr-line>,<country>Netherlands</country></nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Skalli, Souad" sort="Skalli, Souad" uniqKey="Skalli S" first="Souad" last="Skalli">Souad Skalli</name><affiliation wicri:level="1"><nlm:aff id="aff2"><institution>Microbiology and Molecular Biology Team, Center of Plant and Microbial Biotechnology, Biodiversity and Environment, Faculty of Sciences, Mohammed V University in Rabat</institution>,<addr-line>Rabat</addr-line>,<country>Morocco</country></nlm:aff><country xml:lang="fr">Maroc</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Kuemmerle, Andrea" sort="Kuemmerle, Andrea" uniqKey="Kuemmerle A" first="Andrea" last="Kuemmerle">Andrea Kuemmerle</name><affiliation wicri:level="1"><nlm:aff id="aff3"><institution>Department of Medicine, Swiss Tropical and Public Health Institute</institution>,<addr-line>Basel</addr-line>,<country>Switzerland</country></nlm:aff><country xml:lang="fr">Suisse</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="aff4"><institution>University of Basel</institution>,<addr-line>Basel</addr-line>,<country>Switzerland</country></nlm:aff><country xml:lang="fr">Suisse</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Teng, Lida" sort="Teng, Lida" uniqKey="Teng L" first="Lida" last="Teng">Lida Teng</name><affiliation wicri:level="1"><nlm:aff id="aff5"><institution>Department of Health Economics and Outcomes Research, Graduate School of Pharmaceutical Sciences</institution>,<addr-line>The University of Tokyo</addr-line>,<country>Tokyo, Japan</country></nlm:aff><country xml:lang="fr">Japon</country><wicri:regionArea></wicri:regionArea></affiliation></author><author><name sortKey="Wang, Jia Bo" sort="Wang, Jia Bo" uniqKey="Wang J" first="Jia-Bo" last="Wang">Jia-Bo Wang</name><affiliation wicri:level="1"><nlm:aff id="aff6"><institution>Institute of Chinese Herbal Medicine, Beijing Integrative Medical Center for Liver Diseases, Beijing 302 Hospital of China</institution>,<addr-line>Beijing</addr-line>,<country>China</country></nlm:aff><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Barnes, Joanne" sort="Barnes, Joanne" uniqKey="Barnes J" first="Joanne" last="Barnes">Joanne Barnes</name><affiliation wicri:level="1"><nlm:aff id="aff7"><institution>School of Pharmacy, The University of Auckland</institution>,<addr-line>Auckland</addr-line>,<country>New Zealand</country></nlm:aff><country xml:lang="fr">Nouvelle-Zélande</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author></analytic><series><title level="j">Frontiers in Pharmacology</title><idno type="eISSN">1663-9812</idno><imprint><date when="2019">2019</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p><bold>Introduction:</bold> Use of herbal medicines (HMs) is widespread across the world, with many people relying on HMs for their primary healthcare or using HMs in the context of a healthy life style. HMs originate from plant material and, as such, are often seen as “natural” and believed to be (relatively) safe by patients. Hepatobiliary disorders have been associated with numerous HMs.</p><p><bold>Aim:</bold> This paper aims to analyze reporting patterns for hepatobiliary disorders associated with HMs use from reports submitted to the WHO global database of individual case safety reports (ICSRs) VigiBase.</p><p><bold>Methods:</bold> A data extraction in VigiBase, the WHO international database of ICSR reports, was performed by the Uppsala Monitoring Centre on 2019-01-16. The dataset contained all ICSRs where an HM was identified with the UMC-assigned ATC code “V90: unspecified herbal and traditional medicine” and where the HM was classified as being either the suspected drug or an interacting drug, and containing at least one adverse reaction in the MedDRA<sup>®</sup> System Organ Class (SOC) Hepatobiliary Disorders (HBD). Descriptive analyses in Excel 2013<sup>®</sup> were used to determine general characteristics of the reports in the broad data set, including total number of reports, reporting country and patient characteristics. For single suspect herbal reports, reports categorized as “serious” according to CIOMS criteria (CIOMS), 2001) were extracted.</p><p><bold>Results:</bold> In total, 2,483 reports describing with at least one ADR in the SOC HBD were extracted from VigiBase. In total, 780 (31.4%) reports concern only one suspect HM. However, for 188 reports of these reports (24.1%), the single suspect herbal preparation contains more than one herbal ingredient. The 592 reports for single suspect herbal preparations described a total of 764 ADRs in the SOC HBD. Jaundice was the most reported ADR for these reports.</p><p><bold>Conclusion:</bold> Almost 2,500 reports for HMs and with at least one ADR coded to the MedDRA<sup>®</sup> SOC HBD were retrieved from VigiBase. Of the HBD SOC HM reports, around 25% concerned a single herbal species as the suspect “drug.” Substantial issues with coding of the suspect herbal drugs were found. In-depth causality assessment of the cases is needed to draw conclusions on the strength of the relationships.</p></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Agollo, M C" uniqKey="Agollo M">M. C. Agollo</name></author><author><name sortKey="Miszputen, S J" uniqKey="Miszputen S">S. J. Miszputen</name></author><author><name sortKey="Diament, J" uniqKey="Diament J">J. Diament</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Barnes, J" uniqKey="Barnes J">J. Barnes</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Barnes, J" uniqKey="Barnes J">J. Barnes</name></author><author><name sortKey="Abbot, N C" uniqKey="Abbot N">N. C. 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Chen</name></author></analytic></biblStruct></listBibl></div1></back></TEI><affiliations><list><country><li>Japon</li><li>Maroc</li><li>Nouvelle-Zélande</li><li>Pays-Bas</li><li>République populaire de Chine</li><li>Suisse</li></country></list><tree><country name="Pays-Bas"><noRegion><name sortKey="Van Hunsel, Florence" sort="Van Hunsel, Florence" uniqKey="Van Hunsel F" first="Florence" last="Van Hunsel">Florence Van Hunsel</name></noRegion><name sortKey="Van De Koppel, Sonja" sort="Van De Koppel, Sonja" uniqKey="Van De Koppel S" first="Sonja" last="Van De Koppel">Sonja Van De Koppel</name></country><country name="Maroc"><noRegion><name sortKey="Skalli, Souad" sort="Skalli, Souad" uniqKey="Skalli S" first="Souad" last="Skalli">Souad Skalli</name></noRegion></country><country name="Suisse"><noRegion><name sortKey="Kuemmerle, Andrea" sort="Kuemmerle, Andrea" uniqKey="Kuemmerle A" first="Andrea" last="Kuemmerle">Andrea Kuemmerle</name></noRegion><name sortKey="Kuemmerle, Andrea" sort="Kuemmerle, Andrea" uniqKey="Kuemmerle A" first="Andrea" last="Kuemmerle">Andrea Kuemmerle</name></country><country name="Japon"><noRegion><name sortKey="Teng, Lida" sort="Teng, Lida" uniqKey="Teng L" first="Lida" last="Teng">Lida Teng</name></noRegion></country><country name="République populaire de Chine"><noRegion><name sortKey="Wang, Jia Bo" sort="Wang, Jia Bo" uniqKey="Wang J" first="Jia-Bo" last="Wang">Jia-Bo Wang</name></noRegion></country><country name="Nouvelle-Zélande"><noRegion><name sortKey="Barnes, Joanne" sort="Barnes, Joanne" uniqKey="Barnes J" first="Joanne" last="Barnes">Joanne Barnes</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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