title: Adverse Effects of Plant Food Supplements Self-Reported by Consumers in the PlantLIBRA Survey Involving Six European Countries.
abstract: BACKGROUND
  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.
  
  
  OBJECTIVE
  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.
  
  
  METHODS
  From the total sample of 2359 consumers involved in the consumers' survey, 82 subjects reported adverse effects due to a total of 87 PFS.
  
  
  RESULTS
  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 Valeriana officinalis (garden valerian); seven to Camellia sinensis (tea); six to Ginkgo biloba (Maidenhair tree) and Paullinia cupana (guarana). Most adverse events related to the gastrointestinal tract, nervous and cardiovascular systems.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Dipartimento di Scienze Farmacologiche e Biomolecolari, Università degli Studi di Milano, Milano, Italy.
authors.forename: Patrizia
authors.initials: P
authors.lastname: Restani
authors.affiliation: Dipartimento di Scienze Farmacologiche e Biomolecolari, Università degli Studi di Milano, Milano, Italy.
authors.forename: Chiara
authors.initials: C
authors.lastname: Di Lorenzo
authors.affiliation: Fundación para la Investigacion Nutricional, Barcelona Science Park, University of Barcelona, Barcelona, Spain.
authors.forename: Alicia
authors.initials: A
authors.lastname: Garcia-Alvarez
authors.affiliation: Transilvania University of Brasov, Brasov, Romania.
authors.forename: Mihaela
authors.initials: M
authors.lastname: Badea
authors.affiliation: National Poisons Center, Tox Info Suisse, Associated Institute of the University of Zurich, Zurich, Switzerland.|Division of Clinical Pharmacology and Toxicology, Department of Internal Medicine, Ente Ospedaliero Cantonale, Lugano, Switzerland.|Department of Clinical Pharmacology and Toxicology, University Hospital Zurich, Zurich, Switzerland.
authors.forename: Alessandro
authors.initials: A
authors.lastname: Ceschi
authors.affiliation: Food, Consumer Behaviour and Health Research Centre, University of Surrey, Guildford, Surrey, United Kingdom.
authors.forename: Bernadette
authors.initials: B
authors.lastname: Egan
authors.affiliation: Transilvania University of Brasov, Brasov, Romania.
authors.forename: Lorena
authors.initials: L
authors.lastname: Dima
authors.affiliation: National Poisons Center, Tox Info Suisse, Associated Institute of the University of Zurich, Zurich, Switzerland.
authors.forename: Saskia
authors.initials: S
authors.lastname: Lüde
authors.affiliation: Dipartimento di Scienze Farmacologiche e Biomolecolari, Università degli Studi di Milano, Milano, Italy.
authors.forename: Franco M
authors.initials: FM
authors.lastname: Maggi
authors.affiliation: Transilvania University of Brasov, Brasov, Romania.
authors.forename: Angela
authors.initials: A
authors.lastname: Marculescu
authors.affiliation: Fundación para la Investigacion Nutricional, Barcelona Science Park, University of Barcelona, Barcelona, Spain.
authors.forename: Raimon
authors.initials: R
authors.lastname: Milà-Villarroel
authors.affiliation: Food, Consumer Behaviour and Health Research Centre, University of Surrey, Guildford, Surrey, United Kingdom.
authors.forename: Monique M
authors.initials: MM
authors.lastname: Raats
authors.affiliation: Fundación para la Investigacion Nutricional, Barcelona Science Park, University of Barcelona, Barcelona, Spain.|Ciber Obn Fisiopatologıa de la Obesidad y la Nutrición, Instituto de Salud Carlos III, Madrid, Spain.
authors.forename: Lourdes
authors.initials: L
authors.lastname: Ribas-Barba
authors.affiliation: Finnish Food Safety Authority Evira, Helsinki, Finland.
authors.forename: Liisa
authors.initials: L
authors.lastname: Uusitalo
authors.affiliation: Fundación para la Investigacion Nutricional, Barcelona Science Park, University of Barcelona, Barcelona, Spain.|Ciber Obn Fisiopatologıa de la Obesidad y la Nutrición, Instituto de Salud Carlos III, Madrid, Spain.|Institute of Biomedical and Health Research of Las Palmas, University of Las Palmas de Gran Canaria, Las Palmas de Gran Canaria, Spain.
authors.forename: Lluís
authors.initials: L
authors.lastname: Serra-Majem
mesh_terms: D019587:Dietary Supplements / Q000009:adverse effects*; D005060:Europe; D005260:Female; D006801:Humans; D008297:Male; D028321:Plant Preparations / Q000009:adverse effects*; D057566:Self Report
chemical_list: D028321:Plant Preparations