Restani Patrizia, Di Lorenzo Chiara, Garcia-Alvarez Alicia, Badea Mihaela, Ceschi Alessandro, Egan Bernadette, Dima Lorena, Lüde Saskia, Maggi Franco M, Marculescu Angela, Milà-Villarroel Raimon, Raats Monique M, Ribas-Barba Lourdes, Uusitalo Liisa, Serra-Majem Lluís
Dipartimento di Scienze Farmacologiche e Biomolecolari, Università degli Studi di Milano, Milano, Italy.
Fundación para la Investigacion Nutricional, Barcelona Science Park, University of Barcelona, Barcelona, Spain.
PLoS One. 2016 Feb 29;11(2):e0150089. doi: 10.1371/journal.pone.0150089. eCollection 2016.
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.
SUBJECTS/SETTING: 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 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.
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.
含植物成分的食品补充剂在欧洲市场的使用正在增加。尽管其旨在维持健康状况，但已有数例关于植物性食品补充剂（PFS）不良反应的报道。
描述在2011 - 2012年欧洲PlantLIBRA PFS消费者调查中收集到的自我报告的不良反应，并使用文献数据和PlantLIBRA毒物中心的调查数据对所报告症状的合理性进行批判性评估。
对象/背景：在参与消费者调查的2359名消费者的总样本中，82名受试者报告了因总共87种PFS导致的不良反应。
这些病例是自我报告的，因此因果关系并非基于临床证据分类，而是根据科学论文中描述的不良反应的频率/强度来分类：87例中有52例被定义为可能（59.8%），4例为很可能（4.6%）。考虑到最常被提及的植物成分，8例不良反应由缬草引起；7例由茶树引起；6例由银杏和瓜拉那引起。大多数不良事件与胃肠道、神经和心血管系统有关。
将本研究的数据与科学论文中发表的数据以及PlantLIBRA毒物中心的调查数据进行比较，可以得出一些重要结论：PFS的严重不良反应相当罕见，尽管可能存在轻度或中度不良症状。本文报告的数据可帮助卫生专业人员（尤其是家庭医生）了解与含植物成分的食品补充剂使用增加相关的可能新问题。
