Adverse Effects of Plant Food Supplements Self-Reported by Consumers in the PlantLIBRA Survey Involving Six European Countries
Identifieur interne : 000376 ( Pmc/Curation ); précédent : 000375; suivant : 000377Adverse Effects of Plant Food Supplements Self-Reported by Consumers in the PlantLIBRA Survey Involving Six European Countries
Auteurs : Patrizia Restani [Italie] ; Chiara Di Lorenzo [Italie] ; Alicia Garcia-Alvarez [Espagne] ; Mihaela Badea [Roumanie] ; Alessandro Ceschi [Suisse] ; Bernadette Egan [Royaume-Uni] ; Lorena Dima [Roumanie] ; Saskia Lüde [Suisse] ; Franco M. Maggi [Italie] ; Angela Marculescu [Roumanie] ; Raimon Milà-Villarroel [Espagne] ; Monique M. Raats [Royaume-Uni] ; Lourdes Ribas-Barba [Espagne] ; Liisa Uusitalo [Finlande] ; Lluís Serra-Majem [Espagne]Source :
- PLoS ONE [ 1932-6203 ] ; 2016.
Abstract
The use of food supplements containing botanicals is increasing in European markets. Although intended to maintain the health status, several cases of adverse effects to Plant Food Supplements (PFS) have been described.
To describe the self-reported adverse effects collected during the European PlantLIBRA PFS Consumer Survey 2011–2012, with a critical evaluation of the plausibility of the symptomatology reported using data from the literature and from the PlantLIBRA Poisons Centers' survey.
From the total sample of 2359 consumers involved in the consumers' survey, 82 subjects reported adverse effects due to a total of 87 PFS.
Cases were self-reported, therefore causality was not classified on the basis of clinical evidence, but by using the frequency/strength of adverse effects described in scientific papers: 52 out of 87 cases were defined as possible (59.8%) and 4 as probable (4.6%). Considering the most frequently cited botanicals, eight cases were due to
Comparing the data from this study with those published in scientific papers and obtained by the PlantLIBRA Poisons Centers' survey, some important conclusions can be drawn: severe adverse effects to PFS are quite rare, although mild or moderate adverse symptoms can be present. Data reported in this paper can help health professionals (and in particular family doctors) to become aware of possible new problems associated with the increasing use of food supplements containing botanicals.
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DOI: 10.1371/journal.pone.0150089
PubMed: 26928206
PubMed Central: 4771165
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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Adverse Effects of Plant Food Supplements Self-Reported by Consumers in the PlantLIBRA Survey Involving Six European Countries</title><author><name sortKey="Restani, Patrizia" sort="Restani, Patrizia" uniqKey="Restani P" first="Patrizia" last="Restani">Patrizia Restani</name><affiliation wicri:level="1"><nlm:aff id="aff001"><addr-line>Dipartimento di Scienze Farmacologiche e Biomolecolari, Università degli Studi di Milano, Milano, Italy</addr-line></nlm:aff><country xml:lang="fr">Italie</country><wicri:regionArea>Dipartimento di Scienze Farmacologiche e Biomolecolari, Università degli Studi di Milano, Milano</wicri:regionArea></affiliation></author><author><name sortKey="Di Lorenzo, Chiara" sort="Di Lorenzo, Chiara" uniqKey="Di Lorenzo C" first="Chiara" last="Di Lorenzo">Chiara Di Lorenzo</name><affiliation wicri:level="1"><nlm:aff id="aff001"><addr-line>Dipartimento di Scienze Farmacologiche e Biomolecolari, Università degli Studi di Milano, Milano, Italy</addr-line></nlm:aff><country xml:lang="fr">Italie</country><wicri:regionArea>Dipartimento di Scienze Farmacologiche e Biomolecolari, Università degli Studi di Milano, Milano</wicri:regionArea></affiliation></author><author><name sortKey="Garcia Alvarez, Alicia" sort="Garcia Alvarez, Alicia" uniqKey="Garcia Alvarez A" first="Alicia" last="Garcia-Alvarez">Alicia Garcia-Alvarez</name><affiliation wicri:level="1"><nlm:aff id="aff002"><addr-line>Fundación para la Investigacion Nutricional, Barcelona Science Park, University of Barcelona, Barcelona, Spain</addr-line></nlm:aff><country xml:lang="fr">Espagne</country><wicri:regionArea>Fundación para la Investigacion Nutricional, Barcelona Science Park, University of Barcelona, Barcelona</wicri:regionArea></affiliation></author><author><name sortKey="Badea, Mihaela" sort="Badea, Mihaela" uniqKey="Badea M" first="Mihaela" last="Badea">Mihaela Badea</name><affiliation wicri:level="1"><nlm:aff 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xml:lang="fr">Suisse</country><wicri:regionArea>Division of Clinical Pharmacology and Toxicology, Department of Internal Medicine, Ente Ospedaliero Cantonale, Lugano</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="aff006"><addr-line>Department of Clinical Pharmacology and Toxicology, University Hospital Zurich, Zurich, Switzerland</addr-line></nlm:aff><country xml:lang="fr">Suisse</country><wicri:regionArea>Department of Clinical Pharmacology and Toxicology, University Hospital Zurich, Zurich</wicri:regionArea></affiliation></author><author><name sortKey="Egan, Bernadette" sort="Egan, Bernadette" uniqKey="Egan B" first="Bernadette" last="Egan">Bernadette Egan</name><affiliation wicri:level="1"><nlm:aff id="aff007"><addr-line>Food, Consumer Behaviour and Health Research Centre, University of Surrey, Guildford, Surrey, United Kingdom</addr-line></nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Food, Consumer Behaviour and Health Research Centre, University of Surrey, Guildford, Surrey</wicri:regionArea></affiliation></author><author><name sortKey="Dima, Lorena" sort="Dima, Lorena" uniqKey="Dima L" first="Lorena" last="Dima">Lorena Dima</name><affiliation wicri:level="1"><nlm:aff id="aff003"><addr-line>Transilvania University of Brasov, Brasov, Romania</addr-line></nlm:aff><country xml:lang="fr">Roumanie</country><wicri:regionArea>Transilvania University of Brasov, Brasov</wicri:regionArea></affiliation></author><author><name sortKey="Lude, Saskia" sort="Lude, Saskia" uniqKey="Lude S" first="Saskia" last="Lüde">Saskia Lüde</name><affiliation wicri:level="1"><nlm:aff id="aff004"><addr-line>National Poisons Center, Tox Info Suisse, Associated Institute of the University of Zurich, Zurich, Switzerland</addr-line></nlm:aff><country xml:lang="fr">Suisse</country><wicri:regionArea>National Poisons Center, Tox Info Suisse, Associated Institute of the University of Zurich, Zurich</wicri:regionArea></affiliation></author><author><name sortKey="Maggi, Franco M" sort="Maggi, Franco M" uniqKey="Maggi F" first="Franco M." last="Maggi">Franco M. Maggi</name><affiliation wicri:level="1"><nlm:aff id="aff001"><addr-line>Dipartimento di Scienze Farmacologiche e Biomolecolari, Università degli Studi di Milano, Milano, Italy</addr-line></nlm:aff><country xml:lang="fr">Italie</country><wicri:regionArea>Dipartimento di Scienze Farmacologiche e Biomolecolari, Università degli Studi di Milano, Milano</wicri:regionArea></affiliation></author><author><name sortKey="Marculescu, Angela" sort="Marculescu, Angela" uniqKey="Marculescu A" first="Angela" last="Marculescu">Angela Marculescu</name><affiliation wicri:level="1"><nlm:aff id="aff003"><addr-line>Transilvania University of Brasov, Brasov, Romania</addr-line></nlm:aff><country xml:lang="fr">Roumanie</country><wicri:regionArea>Transilvania University of Brasov, Brasov</wicri:regionArea></affiliation></author><author><name sortKey="Mila Villarroel, Raimon" sort="Mila Villarroel, Raimon" uniqKey="Mila Villarroel R" first="Raimon" last="Milà-Villarroel">Raimon Milà-Villarroel</name><affiliation wicri:level="1"><nlm:aff id="aff002"><addr-line>Fundación para la Investigacion Nutricional, Barcelona Science Park, University of Barcelona, Barcelona, Spain</addr-line></nlm:aff><country xml:lang="fr">Espagne</country><wicri:regionArea>Fundación para la Investigacion Nutricional, Barcelona Science Park, University of Barcelona, Barcelona</wicri:regionArea></affiliation></author><author><name sortKey="Raats, Monique M" sort="Raats, Monique M" uniqKey="Raats M" first="Monique M." last="Raats">Monique M. Raats</name><affiliation wicri:level="1"><nlm:aff id="aff007"><addr-line>Food, Consumer Behaviour and Health Research Centre, University of Surrey, Guildford, Surrey, United Kingdom</addr-line></nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Food, Consumer Behaviour and Health Research Centre, University of Surrey, Guildford, Surrey</wicri:regionArea></affiliation></author><author><name sortKey="Ribas Barba, Lourdes" sort="Ribas Barba, Lourdes" uniqKey="Ribas Barba L" first="Lourdes" last="Ribas-Barba">Lourdes Ribas-Barba</name><affiliation wicri:level="1"><nlm:aff id="aff002"><addr-line>Fundación para la Investigacion Nutricional, Barcelona Science Park, University of Barcelona, Barcelona, Spain</addr-line></nlm:aff><country xml:lang="fr">Espagne</country><wicri:regionArea>Fundación para la Investigacion Nutricional, Barcelona Science Park, University of Barcelona, Barcelona</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="aff009"><addr-line>Ciber Obn Fisiopatologıa de la Obesidad y la Nutrición, Instituto de Salud Carlos III, Madrid, Spain</addr-line></nlm:aff><country xml:lang="fr">Espagne</country><wicri:regionArea>Ciber Obn Fisiopatologıa de la Obesidad y la Nutrición, Instituto de Salud Carlos III, Madrid</wicri:regionArea></affiliation></author><author><name sortKey="Uusitalo, Liisa" sort="Uusitalo, Liisa" uniqKey="Uusitalo L" first="Liisa" last="Uusitalo">Liisa Uusitalo</name><affiliation wicri:level="1"><nlm:aff id="aff008"><addr-line>Finnish Food Safety Authority Evira, Helsinki, Finland</addr-line></nlm:aff><country xml:lang="fr">Finlande</country><wicri:regionArea>Finnish Food Safety Authority Evira, Helsinki</wicri:regionArea></affiliation></author><author><name sortKey="Serra Majem, Lluis" sort="Serra Majem, Lluis" uniqKey="Serra Majem L" first="Lluís" last="Serra-Majem">Lluís Serra-Majem</name><affiliation wicri:level="1"><nlm:aff id="aff002"><addr-line>Fundación para la Investigacion Nutricional, Barcelona Science Park, University of Barcelona, Barcelona, Spain</addr-line></nlm:aff><country xml:lang="fr">Espagne</country><wicri:regionArea>Fundación para la Investigacion Nutricional, Barcelona Science Park, University of Barcelona, Barcelona</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="aff009"><addr-line>Ciber Obn Fisiopatologıa de la Obesidad y la Nutrición, Instituto de Salud Carlos III, Madrid, Spain</addr-line></nlm:aff><country xml:lang="fr">Espagne</country><wicri:regionArea>Ciber Obn Fisiopatologıa de la Obesidad y la Nutrición, Instituto de Salud Carlos III, Madrid</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="aff010"><addr-line>Institute of Biomedical and Health Research of Las Palmas, University of Las Palmas de Gran Canaria, Las Palmas de Gran Canaria, Spain</addr-line></nlm:aff><country xml:lang="fr">Espagne</country><wicri:regionArea>Institute of Biomedical and Health Research of Las Palmas, University of Las Palmas de Gran Canaria, Las Palmas de Gran Canaria</wicri:regionArea></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">26928206</idno><idno type="pmc">4771165</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4771165</idno><idno type="RBID">PMC:4771165</idno><idno type="doi">10.1371/journal.pone.0150089</idno><date when="2016">2016</date><idno type="wicri:Area/Pmc/Corpus">000377</idno><idno type="wicri:Area/Pmc/Curation">000376</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Adverse Effects of Plant Food Supplements Self-Reported by Consumers in the PlantLIBRA Survey Involving Six European Countries</title><author><name sortKey="Restani, Patrizia" sort="Restani, Patrizia" uniqKey="Restani P" first="Patrizia" last="Restani">Patrizia Restani</name><affiliation wicri:level="1"><nlm:aff id="aff001"><addr-line>Dipartimento di Scienze Farmacologiche e Biomolecolari, Università degli Studi di Milano, Milano, Italy</addr-line></nlm:aff><country xml:lang="fr">Italie</country><wicri:regionArea>Dipartimento di Scienze Farmacologiche e Biomolecolari, Università degli Studi di Milano, Milano</wicri:regionArea></affiliation></author><author><name sortKey="Di Lorenzo, Chiara" sort="Di Lorenzo, Chiara" uniqKey="Di Lorenzo C" first="Chiara" last="Di Lorenzo">Chiara Di Lorenzo</name><affiliation wicri:level="1"><nlm:aff id="aff001"><addr-line>Dipartimento di Scienze Farmacologiche e Biomolecolari, Università degli Studi di Milano, Milano, Italy</addr-line></nlm:aff><country xml:lang="fr">Italie</country><wicri:regionArea>Dipartimento di Scienze Farmacologiche e Biomolecolari, Università degli Studi di Milano, Milano</wicri:regionArea></affiliation></author><author><name sortKey="Garcia Alvarez, Alicia" sort="Garcia Alvarez, Alicia" uniqKey="Garcia Alvarez A" first="Alicia" last="Garcia-Alvarez">Alicia Garcia-Alvarez</name><affiliation wicri:level="1"><nlm:aff id="aff002"><addr-line>Fundación para la Investigacion Nutricional, Barcelona Science Park, University of Barcelona, Barcelona, Spain</addr-line></nlm:aff><country xml:lang="fr">Espagne</country><wicri:regionArea>Fundación para la Investigacion Nutricional, Barcelona Science Park, University of Barcelona, Barcelona</wicri:regionArea></affiliation></author><author><name sortKey="Badea, Mihaela" sort="Badea, Mihaela" uniqKey="Badea M" first="Mihaela" last="Badea">Mihaela Badea</name><affiliation wicri:level="1"><nlm:aff id="aff003"><addr-line>Transilvania University of Brasov, Brasov, Romania</addr-line></nlm:aff><country xml:lang="fr">Roumanie</country><wicri:regionArea>Transilvania University of Brasov, Brasov</wicri:regionArea></affiliation></author><author><name sortKey="Ceschi, Alessandro" sort="Ceschi, Alessandro" uniqKey="Ceschi A" first="Alessandro" last="Ceschi">Alessandro Ceschi</name><affiliation wicri:level="1"><nlm:aff id="aff004"><addr-line>National Poisons Center, Tox Info Suisse, Associated Institute of the University of Zurich, Zurich, Switzerland</addr-line></nlm:aff><country xml:lang="fr">Suisse</country><wicri:regionArea>National Poisons Center, Tox Info Suisse, Associated Institute of the University of Zurich, Zurich</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="aff005"><addr-line>Division of Clinical Pharmacology and Toxicology, Department of Internal Medicine, Ente Ospedaliero Cantonale, Lugano, Switzerland</addr-line></nlm:aff><country xml:lang="fr">Suisse</country><wicri:regionArea>Division of Clinical Pharmacology and Toxicology, Department of Internal Medicine, Ente Ospedaliero Cantonale, Lugano</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="aff006"><addr-line>Department of Clinical Pharmacology and Toxicology, University Hospital Zurich, Zurich, Switzerland</addr-line></nlm:aff><country xml:lang="fr">Suisse</country><wicri:regionArea>Department of Clinical Pharmacology and Toxicology, University Hospital Zurich, Zurich</wicri:regionArea></affiliation></author><author><name sortKey="Egan, Bernadette" sort="Egan, Bernadette" uniqKey="Egan B" first="Bernadette" last="Egan">Bernadette Egan</name><affiliation wicri:level="1"><nlm:aff id="aff007"><addr-line>Food, Consumer Behaviour and Health Research Centre, University of Surrey, Guildford, Surrey, United Kingdom</addr-line></nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Food, Consumer Behaviour and Health Research Centre, University of Surrey, Guildford, Surrey</wicri:regionArea></affiliation></author><author><name sortKey="Dima, Lorena" sort="Dima, Lorena" uniqKey="Dima L" first="Lorena" last="Dima">Lorena Dima</name><affiliation wicri:level="1"><nlm:aff id="aff003"><addr-line>Transilvania University of Brasov, Brasov, Romania</addr-line></nlm:aff><country xml:lang="fr">Roumanie</country><wicri:regionArea>Transilvania University of Brasov, Brasov</wicri:regionArea></affiliation></author><author><name sortKey="Lude, Saskia" sort="Lude, Saskia" uniqKey="Lude S" first="Saskia" last="Lüde">Saskia Lüde</name><affiliation wicri:level="1"><nlm:aff id="aff004"><addr-line>National Poisons Center, Tox Info Suisse, Associated Institute of the University of Zurich, Zurich, Switzerland</addr-line></nlm:aff><country xml:lang="fr">Suisse</country><wicri:regionArea>National Poisons Center, Tox Info Suisse, Associated Institute of the University of Zurich, Zurich</wicri:regionArea></affiliation></author><author><name sortKey="Maggi, Franco M" sort="Maggi, Franco M" uniqKey="Maggi F" first="Franco M." last="Maggi">Franco M. Maggi</name><affiliation wicri:level="1"><nlm:aff id="aff001"><addr-line>Dipartimento di Scienze Farmacologiche e Biomolecolari, Università degli Studi di Milano, Milano, Italy</addr-line></nlm:aff><country xml:lang="fr">Italie</country><wicri:regionArea>Dipartimento di Scienze Farmacologiche e Biomolecolari, Università degli Studi di Milano, Milano</wicri:regionArea></affiliation></author><author><name sortKey="Marculescu, Angela" sort="Marculescu, Angela" uniqKey="Marculescu A" first="Angela" last="Marculescu">Angela Marculescu</name><affiliation wicri:level="1"><nlm:aff id="aff003"><addr-line>Transilvania University of Brasov, Brasov, Romania</addr-line></nlm:aff><country xml:lang="fr">Roumanie</country><wicri:regionArea>Transilvania University of Brasov, Brasov</wicri:regionArea></affiliation></author><author><name sortKey="Mila Villarroel, Raimon" sort="Mila Villarroel, Raimon" uniqKey="Mila Villarroel R" first="Raimon" last="Milà-Villarroel">Raimon Milà-Villarroel</name><affiliation wicri:level="1"><nlm:aff id="aff002"><addr-line>Fundación para la Investigacion Nutricional, Barcelona Science Park, University of Barcelona, Barcelona, Spain</addr-line></nlm:aff><country xml:lang="fr">Espagne</country><wicri:regionArea>Fundación para la Investigacion Nutricional, Barcelona Science Park, University of Barcelona, Barcelona</wicri:regionArea></affiliation></author><author><name sortKey="Raats, Monique M" sort="Raats, Monique M" uniqKey="Raats M" first="Monique M." last="Raats">Monique M. Raats</name><affiliation wicri:level="1"><nlm:aff id="aff007"><addr-line>Food, Consumer Behaviour and Health Research Centre, University of Surrey, Guildford, Surrey, United Kingdom</addr-line></nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Food, Consumer Behaviour and Health Research Centre, University of Surrey, Guildford, Surrey</wicri:regionArea></affiliation></author><author><name sortKey="Ribas Barba, Lourdes" sort="Ribas Barba, Lourdes" uniqKey="Ribas Barba L" first="Lourdes" last="Ribas-Barba">Lourdes Ribas-Barba</name><affiliation wicri:level="1"><nlm:aff id="aff002"><addr-line>Fundación para la Investigacion Nutricional, Barcelona Science Park, University of Barcelona, Barcelona, Spain</addr-line></nlm:aff><country xml:lang="fr">Espagne</country><wicri:regionArea>Fundación para la Investigacion Nutricional, Barcelona Science Park, University of Barcelona, Barcelona</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="aff009"><addr-line>Ciber Obn Fisiopatologıa de la Obesidad y la Nutrición, Instituto de Salud Carlos III, Madrid, Spain</addr-line></nlm:aff><country xml:lang="fr">Espagne</country><wicri:regionArea>Ciber Obn Fisiopatologıa de la Obesidad y la Nutrición, Instituto de Salud Carlos III, Madrid</wicri:regionArea></affiliation></author><author><name sortKey="Uusitalo, Liisa" sort="Uusitalo, Liisa" uniqKey="Uusitalo L" first="Liisa" last="Uusitalo">Liisa Uusitalo</name><affiliation wicri:level="1"><nlm:aff id="aff008"><addr-line>Finnish Food Safety Authority Evira, Helsinki, Finland</addr-line></nlm:aff><country xml:lang="fr">Finlande</country><wicri:regionArea>Finnish Food Safety Authority Evira, Helsinki</wicri:regionArea></affiliation></author><author><name sortKey="Serra Majem, Lluis" sort="Serra Majem, Lluis" uniqKey="Serra Majem L" first="Lluís" last="Serra-Majem">Lluís Serra-Majem</name><affiliation wicri:level="1"><nlm:aff id="aff002"><addr-line>Fundación para la Investigacion Nutricional, Barcelona Science Park, University of Barcelona, Barcelona, Spain</addr-line></nlm:aff><country xml:lang="fr">Espagne</country><wicri:regionArea>Fundación para la Investigacion Nutricional, Barcelona Science Park, University of Barcelona, Barcelona</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="aff009"><addr-line>Ciber Obn Fisiopatologıa de la Obesidad y la Nutrición, Instituto de Salud Carlos III, Madrid, Spain</addr-line></nlm:aff><country xml:lang="fr">Espagne</country><wicri:regionArea>Ciber Obn Fisiopatologıa de la Obesidad y la Nutrición, Instituto de Salud Carlos III, Madrid</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="aff010"><addr-line>Institute of Biomedical and Health Research of Las Palmas, University of Las Palmas de Gran Canaria, Las Palmas de Gran Canaria, Spain</addr-line></nlm:aff><country xml:lang="fr">Espagne</country><wicri:regionArea>Institute of Biomedical and Health Research of Las Palmas, University of Las Palmas de Gran Canaria, Las Palmas de Gran Canaria</wicri:regionArea></affiliation></author></analytic><series><title level="j">PLoS ONE</title><idno type="eISSN">1932-6203</idno><imprint><date when="2016">2016</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec id="sec001"><title>Background</title><p>The use of food supplements containing botanicals is increasing in European markets. Although intended to maintain the health status, several cases of adverse effects to Plant Food Supplements (PFS) have been described.</p></sec><sec id="sec002"><title>Objectives</title><p>To describe the self-reported adverse effects collected during the European PlantLIBRA PFS Consumer Survey 2011–2012, with a critical evaluation of the plausibility of the symptomatology reported using data from the literature and from the PlantLIBRA Poisons Centers' survey.</p></sec><sec id="sec003"><title>Subjects/Setting</title><p>From the total sample of 2359 consumers involved in the consumers' survey, 82 subjects reported adverse effects due to a total of 87 PFS.</p></sec><sec id="sec004"><title>Results</title><p>Cases were self-reported, therefore causality was not classified on the basis of clinical evidence, but by using the frequency/strength of adverse effects described in scientific papers: 52 out of 87 cases were defined as possible (59.8%) and 4 as probable (4.6%). Considering the most frequently cited botanicals, eight cases were due to <italic>Valeriana officinalis</italic> (garden valerian); seven to <italic>Camellia sinensis</italic> (tea); six to <italic>Ginkgo biloba</italic> (Maidenhair tree) and <italic>Paullinia cupana</italic> (guarana). Most adverse events related to the gastrointestinal tract, nervous and cardiovascular systems.</p></sec><sec id="sec005"><title>Conclusions</title><p>Comparing the data from this study with those published in scientific papers and obtained by the PlantLIBRA Poisons Centers' survey, some important conclusions can be drawn: severe adverse effects to PFS are quite rare, although mild or moderate adverse symptoms can be present. Data reported in this paper can help health professionals (and in particular family doctors) to become aware of possible new problems associated with the increasing use of food supplements containing botanicals.</p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct></biblStruct><biblStruct><analytic><author><name sortKey="Silano, V" uniqKey="Silano V">V Silano</name></author><author><name sortKey="Coppens, P" uniqKey="Coppens P">P Coppens</name></author><author><name sortKey="Larra Aga Guetaria, A" uniqKey="Larra Aga Guetaria A">A Larrañaga-Guetaria</name></author><author><name sortKey="Minghetti, P" uniqKey="Minghetti P">P Minghetti</name></author><author><name sortKey="Roth Ehrang, R" uniqKey="Roth Ehrang R">R Roth-Ehrang</name></author></analytic></biblStruct><biblStruct></biblStruct><biblStruct><analytic><author><name sortKey="Skeie, G" uniqKey="Skeie G">G Skeie</name></author><author><name sortKey="Braaten, T" uniqKey="Braaten T">T 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<front><journal-meta><journal-id journal-id-type="nlm-ta">PLoS One</journal-id><journal-id journal-id-type="iso-abbrev">PLoS ONE</journal-id><journal-id journal-id-type="publisher-id">plos</journal-id><journal-id journal-id-type="pmc">plosone</journal-id><journal-title-group><journal-title>PLoS ONE</journal-title></journal-title-group><issn pub-type="epub">1932-6203</issn><publisher><publisher-name>Public Library of Science</publisher-name><publisher-loc>San Francisco, CA USA</publisher-loc></publisher></journal-meta><article-meta><article-id pub-id-type="pmid">26928206</article-id><article-id pub-id-type="pmc">4771165</article-id><article-id pub-id-type="doi">10.1371/journal.pone.0150089</article-id><article-id pub-id-type="publisher-id">PONE-D-15-45031</article-id><article-categories><subj-group subj-group-type="heading"><subject>Research Article</subject></subj-group><subj-group subj-group-type="Discipline-v3"><subject>Medicine and Health Sciences</subject><subj-group><subject>Pharmacology</subject><subj-group><subject>Adverse Reactions</subject></subj-group></subj-group></subj-group><subj-group subj-group-type="Discipline-v3"><subject>Medicine and Health Sciences</subject><subj-group><subject>Vascular Medicine</subject><subj-group><subject>Blood Pressure</subject><subj-group><subject>Hypertension</subject></subj-group></subj-group></subj-group></subj-group><subj-group subj-group-type="Discipline-v3"><subject>Biology and Life Sciences</subject><subj-group><subject>Plant Science</subject><subj-group><subject>Plant Physiology</subject><subj-group><subject>Plant Defenses</subject><subj-group><subject>Plant Disease Resistance</subject></subj-group></subj-group></subj-group></subj-group></subj-group><subj-group subj-group-type="Discipline-v3"><subject>Biology and Life Sciences</subject><subj-group><subject>Plant Science</subject><subj-group><subject>Plant Pathology</subject><subj-group><subject>Plant Disease Resistance</subject></subj-group></subj-group></subj-group></subj-group><subj-group subj-group-type="Discipline-v3"><subject>Medicine and Health Sciences</subject><subj-group><subject>Pharmacology</subject><subj-group><subject>Drug Interactions</subject></subj-group></subj-group></subj-group><subj-group subj-group-type="Discipline-v3"><subject>Medicine and Health Sciences</subject><subj-group><subject>Clinical Medicine</subject><subj-group><subject>Clinical Immunology</subject><subj-group><subject>Allergies</subject></subj-group></subj-group></subj-group></subj-group><subj-group subj-group-type="Discipline-v3"><subject>Biology and Life Sciences</subject><subj-group><subject>Immunology</subject><subj-group><subject>Clinical Immunology</subject><subj-group><subject>Allergies</subject></subj-group></subj-group></subj-group></subj-group><subj-group subj-group-type="Discipline-v3"><subject>Medicine and Health Sciences</subject><subj-group><subject>Immunology</subject><subj-group><subject>Clinical Immunology</subject><subj-group><subject>Allergies</subject></subj-group></subj-group></subj-group></subj-group><subj-group subj-group-type="Discipline-v3"><subject>Medicine and Health Sciences</subject><subj-group><subject>Pathology and Laboratory Medicine</subject><subj-group><subject>Signs and Symptoms</subject><subj-group><subject>Headaches</subject><subj-group><subject>Migraine</subject></subj-group></subj-group></subj-group></subj-group></subj-group><subj-group subj-group-type="Discipline-v3"><subject>Medicine and Health Sciences</subject><subj-group><subject>Neurology</subject><subj-group><subject>Sleep Disorders</subject><subj-group><subject>Dyssomnias</subject><subj-group><subject>Insomnia</subject></subj-group></subj-group></subj-group></subj-group></subj-group><subj-group subj-group-type="Discipline-v3"><subject>Medicine and Health Sciences</subject><subj-group><subject>Pain Management</subject><subj-group><subject>Myalgia</subject></subj-group></subj-group></subj-group></article-categories><title-group><article-title>Adverse Effects of Plant Food Supplements Self-Reported by Consumers in the PlantLIBRA Survey Involving Six European Countries</article-title><alt-title alt-title-type="running-head">Adverse Effects Reported in the PlantLIBRA Survey</alt-title></title-group><contrib-group><contrib contrib-type="author"><name><surname>Restani</surname><given-names>Patrizia</given-names></name><xref ref-type="aff" rid="aff001"><sup>1</sup></xref><xref ref-type="corresp" rid="cor001">*</xref></contrib><contrib contrib-type="author"><name><surname>Di Lorenzo</surname><given-names>Chiara</given-names></name><xref ref-type="aff" rid="aff001"><sup>1</sup></xref></contrib><contrib contrib-type="author"><name><surname>Garcia-Alvarez</surname><given-names>Alicia</given-names></name><xref ref-type="aff" rid="aff002"><sup>2</sup></xref></contrib><contrib contrib-type="author"><name><surname>Badea</surname><given-names>Mihaela</given-names></name><xref ref-type="aff" rid="aff003"><sup>3</sup></xref></contrib><contrib contrib-type="author"><name><surname>Ceschi</surname><given-names>Alessandro</given-names></name><xref ref-type="aff" rid="aff004"><sup>4</sup></xref><xref ref-type="aff" rid="aff005"><sup>5</sup></xref><xref ref-type="aff" rid="aff006"><sup>6</sup></xref></contrib><contrib contrib-type="author"><name><surname>Egan</surname><given-names>Bernadette</given-names></name><xref ref-type="aff" rid="aff007"><sup>7</sup></xref></contrib><contrib contrib-type="author"><name><surname>Dima</surname><given-names>Lorena</given-names></name><xref ref-type="aff" rid="aff003"><sup>3</sup></xref></contrib><contrib contrib-type="author"><name><surname>Lüde</surname><given-names>Saskia</given-names></name><xref ref-type="aff" rid="aff004"><sup>4</sup></xref></contrib><contrib contrib-type="author"><name><surname>Maggi</surname><given-names>Franco M.</given-names></name><xref ref-type="aff" rid="aff001"><sup>1</sup></xref></contrib><contrib contrib-type="author"><name><surname>Marculescu</surname><given-names>Angela</given-names></name><xref ref-type="aff" rid="aff003"><sup>3</sup></xref></contrib><contrib contrib-type="author"><name><surname>Milà-Villarroel</surname><given-names>Raimon</given-names></name><xref ref-type="aff" rid="aff002"><sup>2</sup></xref></contrib><contrib contrib-type="author"><name><surname>Raats</surname><given-names>Monique M.</given-names></name><xref ref-type="aff" rid="aff007"><sup>7</sup></xref></contrib><contrib contrib-type="author"><name><surname>Ribas-Barba</surname><given-names>Lourdes</given-names></name><xref ref-type="aff" rid="aff002"><sup>2</sup></xref><xref ref-type="aff" rid="aff009"><sup>9</sup></xref></contrib><contrib contrib-type="author"><name><surname>Uusitalo</surname><given-names>Liisa</given-names></name><xref ref-type="aff" rid="aff008"><sup>8</sup></xref></contrib><contrib contrib-type="author"><name><surname>Serra-Majem</surname><given-names>Lluís</given-names></name><xref ref-type="aff" rid="aff002"><sup>2</sup></xref><xref ref-type="aff" rid="aff009"><sup>9</sup></xref><xref ref-type="aff" rid="aff010"><sup>10</sup></xref></contrib></contrib-group><aff id="aff001"><label>1</label><addr-line>Dipartimento di Scienze Farmacologiche e Biomolecolari, Università degli Studi di Milano, Milano, Italy</addr-line></aff><aff id="aff002"><label>2</label><addr-line>Fundación para la Investigacion Nutricional, Barcelona Science Park, University of Barcelona, Barcelona, Spain</addr-line></aff><aff id="aff003"><label>3</label><addr-line>Transilvania University of Brasov, Brasov, Romania</addr-line></aff><aff id="aff004"><label>4</label><addr-line>National Poisons Center, Tox Info Suisse, Associated Institute of the University of Zurich, Zurich, Switzerland</addr-line></aff><aff id="aff005"><label>5</label><addr-line>Division of Clinical Pharmacology and Toxicology, Department of Internal Medicine, Ente Ospedaliero Cantonale, Lugano, Switzerland</addr-line></aff><aff id="aff006"><label>6</label><addr-line>Department of Clinical Pharmacology and Toxicology, University Hospital Zurich, Zurich, Switzerland</addr-line></aff><aff id="aff007"><label>7</label><addr-line>Food, Consumer Behaviour and Health Research Centre, University of Surrey, Guildford, Surrey, United Kingdom</addr-line></aff><aff id="aff008"><label>8</label><addr-line>Finnish Food Safety Authority Evira, Helsinki, Finland</addr-line></aff><aff id="aff009"><label>9</label><addr-line>Ciber Obn Fisiopatologıa de la Obesidad y la Nutrición, Instituto de Salud Carlos III, Madrid, Spain</addr-line></aff><aff id="aff010"><label>10</label><addr-line>Institute of Biomedical and Health Research of Las Palmas, University of Las Palmas de Gran Canaria, Las Palmas de Gran Canaria, Spain</addr-line></aff><contrib-group><contrib contrib-type="editor"><name><surname>Nerurkar</surname><given-names>Pratibha V.</given-names></name><role>Editor</role><xref ref-type="aff" rid="edit1"></xref></contrib></contrib-group><aff id="edit1"><addr-line>College of Tropical Agriculture and Human Resources, University of Hawaii, UNITED STATES</addr-line></aff><author-notes><fn fn-type="conflict" id="coi001"><p><bold>Competing Interests: </bold>The authors have declared that no competing interests exist.</p></fn><fn fn-type="con" id="contrib001"><p>Conceived and designed the experiments: LSM LRB AGA BE LD FMM MMR MB. Analyzed the data: PR CDL RMV LRB AGA. Wrote the paper: PR CDL. Responsible for the survey: LSM. Coordination of the survey: AGA. Material elaboration: AGA BE LD FMM LRB MMR MB. Data reviewing/handling/cleaning: AGA BE LD FMM LRB MB FB MS AM LU. Data analysis strategy: LRB LSM AGA RMV BE MMR LD FMM MB AM LU PR CDL AC SL. Drafts reviews: AC SL AGA LRB LD FMM BE MMR MB AM LU LSM. Manuscript coordination: PR.</p></fn><corresp id="cor001">* E-mail: <email>patrizia.restani@unimi.it</email></corresp></author-notes><pub-date pub-type="epub"><day>29</day><month>2</month><year>2016</year></pub-date><pub-date pub-type="collection"><year>2016</year></pub-date><volume>11</volume><issue>2</issue><elocation-id>e0150089</elocation-id><history><date date-type="received"><day>14</day><month>10</month><year>2015</year></date><date date-type="accepted"><day>9</day><month>2</month><year>2016</year></date></history><permissions><copyright-statement>© 2016 Restani et al</copyright-statement><copyright-year>2016</copyright-year><copyright-holder>Restani et al</copyright-holder><license xlink:href="http://creativecommons.org/licenses/by/4.0/"><license-p>This is an open access article distributed under the terms of the <ext-link ext-link-type="uri" xlink:href="http://creativecommons.org/licenses/by/4.0/">Creative Commons Attribution License</ext-link>, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.</license-p></license></permissions><self-uri content-type="pdf" xlink:type="simple" xlink:href="pone.0150089.pdf"></self-uri><abstract><sec id="sec001"><title>Background</title><p>The use of food supplements containing botanicals is increasing in European markets. Although intended to maintain the health status, several cases of adverse effects to Plant Food Supplements (PFS) have been described.</p></sec><sec id="sec002"><title>Objectives</title><p>To describe the self-reported adverse effects collected during the European PlantLIBRA PFS Consumer Survey 2011–2012, with a critical evaluation of the plausibility of the symptomatology reported using data from the literature and from the PlantLIBRA Poisons Centers' survey.</p></sec><sec id="sec003"><title>Subjects/Setting</title><p>From the total sample of 2359 consumers involved in the consumers' survey, 82 subjects reported adverse effects due to a total of 87 PFS.</p></sec><sec id="sec004"><title>Results</title><p>Cases were self-reported, therefore causality was not classified on the basis of clinical evidence, but by using the frequency/strength of adverse effects described in scientific papers: 52 out of 87 cases were defined as possible (59.8%) and 4 as probable (4.6%). Considering the most frequently cited botanicals, eight cases were due to <italic>Valeriana officinalis</italic> (garden valerian); seven to <italic>Camellia sinensis</italic> (tea); six to <italic>Ginkgo biloba</italic> (Maidenhair tree) and <italic>Paullinia cupana</italic> (guarana). Most adverse events related to the gastrointestinal tract, nervous and cardiovascular systems.</p></sec><sec id="sec005"><title>Conclusions</title><p>Comparing the data from this study with those published in scientific papers and obtained by the PlantLIBRA Poisons Centers' survey, some important conclusions can be drawn: severe adverse effects to PFS are quite rare, although mild or moderate adverse symptoms can be present. Data reported in this paper can help health professionals (and in particular family doctors) to become aware of possible new problems associated with the increasing use of food supplements containing botanicals.</p></sec></abstract><funding-group><funding-statement>The research leading to these results has received funding from the European Community’s Seventh Framework Programme (FP7/2007–2013) under grant agreement n. 245199. It has been carried out within the PlantLIBRA project (<ext-link ext-link-type="uri" xlink:href="http://www.plantlibra.eu">www.plantlibra.eu</ext-link>).</funding-statement></funding-group><counts><fig-count count="0"></fig-count><table-count count="6"></table-count><page-count count="20"></page-count></counts><custom-meta-group><custom-meta id="data-availability"><meta-name>Data Availability</meta-name><meta-value>The authors confirm that data of the WHOLE SURVEY are available upon request from: Lluis Sierra Majem, Fundación para la Investigacion Nutriciònal, Barcelona Science Park, University of Barcelona, Barcelona, Spain (Email: <email>lluis.serra@ulpgc.es</email>). All relevant data for the present paper are included in <xref ref-type="table" rid="pone.0150089.t003">Table 3</xref>.</meta-value></custom-meta></custom-meta-group></article-meta><notes><title>Data Availability</title><p>The authors confirm that data of the WHOLE SURVEY are available upon request from: Lluis Sierra Majem, Fundación para la Investigacion Nutriciònal, Barcelona Science Park, University of Barcelona, Barcelona, Spain (Email: <email>lluis.serra@ulpgc.es</email>). All relevant data for the present paper are included in <xref ref-type="table" rid="pone.0150089.t003">Table 3</xref>.</p></notes></front></pmc></record>Pour manipuler ce document sous Unix (Dilib)
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