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      Adverse Effects of Plant Food Supplements Self-Reported by Consumers in the PlantLIBRA Survey Involving Six European Countries

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          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.

          Objectives

          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.

          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.

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          Most cited references32

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          Beneficial effects of green tea: A literature review

          The health benefits of green tea for a wide variety of ailments, including different types of cancer, heart disease, and liver disease, were reported. Many of these beneficial effects of green tea are related to its catechin, particularly (-)-epigallocatechin-3-gallate, content. There is evidence from in vitro and animal studies on the underlying mechanisms of green tea catechins and their biological actions. There are also human studies on using green tea catechins to treat metabolic syndrome, such as obesity, type II diabetes, and cardiovascular risk factors. Long-term consumption of tea catechins could be beneficial against high-fat diet-induced obesity and type II diabetes and could reduce the risk of coronary disease. Further research that conforms to international standards should be performed to monitor the pharmacological and clinical effects of green tea and to elucidate its mechanisms of action.
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            Immunomodulatory and therapeutic properties of the Nigella sativa L. seed.

            Rany Salem (2005)
            A larger number of medicinal plants and their purified constituents have been shown beneficial therapeutic potentials. Seeds of Nigella sativa, a dicotyledon of the Ranunculaceae family, have been employed for thousands of years as a spice and food preservative. The oil and seed constituents, in particular thymoquinine (TQ), have shown potential medicinal properties in traditional medicine. In view of the recent literature, this article lists and discusses different immunomodulatory and immunotherapeutic potentials for the crude oil of N. sativa seeds and its active ingredients. The published findings provide clear evidence that both the oil and its active ingredients, in particular TQ, possess reproducible anti-oxidant effects through enhancing the oxidant scavenger system, which as a consequence lead to antitoxic effects induced by several insults. The oil and TQ have shown also potent anti-inflammatory effects on several inflammation-based models including experimental encephalomyelitis, colitis, peritonitis, oedama, and arthritis through suppression of the inflammatory mediators prostaglandins and leukotriens. The oil and certain active ingredients showed beneficial immunomodulatory properties, augmenting the T cell- and natural killer cell-mediated immune responses. Most importantly, both the oil and its active ingredients expressed anti-microbial and anti-tumor properties toward different microbes and cancers. Coupling these beneficial effects with its use in folk medicine, N. sativa seed is a promising source for active ingredients that would be with potential therapeutic modalities in different clinical settings. The efficacy of the active ingredients, however, should be measured by the nature of the disease. Given their potent immunomodulatory effects, further studies are urgently required to explore bystander effects of TQ on the professional antigen presenting cells, including macrophages and dendritic cells, as well as its modulatory effects upon Th1- and Th2-mediated inflammatory immune diseases. Ultimately, results emerging from such studies will substantially improve the immunotherapeutic application of TQ in clinical settings.
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              Valuable Nutrients and Functional Bioactives in Different Parts of Olive (Olea europaea L.)—A Review

              The Olive tree (Olea europaea L.), a native of the Mediterranean basin and parts of Asia, is now widely cultivated in many other parts of the world for production of olive oil and table olives. Olive is a rich source of valuable nutrients and bioactives of medicinal and therapeutic interest. Olive fruit contains appreciable concentration, 1–3% of fresh pulp weight, of hydrophilic (phenolic acids, phenolic alchohols, flavonoids and secoiridoids) and lipophilic (cresols) phenolic compounds that are known to possess multiple biological activities such as antioxidant, anticarcinogenic, antiinflammatory, antimicrobial, antihypertensive, antidyslipidemic, cardiotonic, laxative, and antiplatelet. Other important compounds present in olive fruit are pectin, organic acids, and pigments. Virgin olive oil (VOO), extracted mechanically from the fruit, is also very popular for its nutritive and health-promoting potential, especially against cardiovascular disorders due to the presence of high levels of monounsaturates and other valuable minor components such as phenolics, phytosterols, tocopherols, carotenoids, chlorophyll and squalene. The cultivar, area of production, harvest time, and the processing techniques employed are some of the factors shown to influence the composition of olive fruit and olive oil. This review focuses comprehensively on the nutrients and high-value bioactives profile as well as medicinal and functional aspects of different parts of olives and its byproducts. Various factors affecting the composition of this food commodity of medicinal value are also discussed.
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                Author and article information

                Contributors
                Role: Editor
                Journal
                PLoS One
                PLoS ONE
                plos
                plosone
                PLoS ONE
                Public Library of Science (San Francisco, CA USA )
                1932-6203
                29 February 2016
                2016
                : 11
                : 2
                : e0150089
                Affiliations
                [1 ]Dipartimento di Scienze Farmacologiche e Biomolecolari, Università degli Studi di Milano, Milano, Italy
                [2 ]Fundación para la Investigacion Nutricional, Barcelona Science Park, University of Barcelona, Barcelona, Spain
                [3 ]Transilvania University of Brasov, Brasov, Romania
                [4 ]National Poisons Center, Tox Info Suisse, Associated Institute of the University of Zurich, Zurich, Switzerland
                [5 ]Division of Clinical Pharmacology and Toxicology, Department of Internal Medicine, Ente Ospedaliero Cantonale, Lugano, Switzerland
                [6 ]Department of Clinical Pharmacology and Toxicology, University Hospital Zurich, Zurich, Switzerland
                [7 ]Food, Consumer Behaviour and Health Research Centre, University of Surrey, Guildford, Surrey, United Kingdom
                [8 ]Finnish Food Safety Authority Evira, Helsinki, Finland
                [9 ]Ciber Obn Fisiopatologıa de la Obesidad y la Nutrición, Instituto de Salud Carlos III, Madrid, Spain
                [10 ]Institute of Biomedical and Health Research of Las Palmas, University of Las Palmas de Gran Canaria, Las Palmas de Gran Canaria, Spain
                College of Tropical Agriculture and Human Resources, University of Hawaii, UNITED STATES
                Author notes

                Competing Interests: The authors have declared that no competing interests exist.

                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.

                Article
                PONE-D-15-45031
                10.1371/journal.pone.0150089
                4771165
                26928206
                f691d39d-486b-4d9d-9bec-e935313a2d3f
                © 2016 Restani et al

                This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

                History
                : 14 October 2015
                : 9 February 2016
                Page count
                Figures: 0, Tables: 6, Pages: 20
                Funding
                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 ( www.plantlibra.eu).
                Categories
                Research Article
                Medicine and Health Sciences
                Pharmacology
                Adverse Reactions
                Medicine and Health Sciences
                Vascular Medicine
                Blood Pressure
                Hypertension
                Biology and Life Sciences
                Plant Science
                Plant Physiology
                Plant Defenses
                Plant Disease Resistance
                Biology and Life Sciences
                Plant Science
                Plant Pathology
                Plant Disease Resistance
                Medicine and Health Sciences
                Pharmacology
                Drug Interactions
                Medicine and Health Sciences
                Clinical Medicine
                Clinical Immunology
                Allergies
                Biology and Life Sciences
                Immunology
                Clinical Immunology
                Allergies
                Medicine and Health Sciences
                Immunology
                Clinical Immunology
                Allergies
                Medicine and Health Sciences
                Pathology and Laboratory Medicine
                Signs and Symptoms
                Headaches
                Migraine
                Medicine and Health Sciences
                Neurology
                Sleep Disorders
                Dyssomnias
                Insomnia
                Medicine and Health Sciences
                Pain Management
                Myalgia
                Custom metadata
                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: lluis.serra@ 123456ulpgc.es ). All relevant data for the present paper are included in Table 3.

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