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United States Pharmacopeia (USP) comprehensive review of the hepatotoxicity of green tea extracts.

ABSTRACT: As part of the United States Pharmacopeia's ongoing review of dietary supplement safety data, a new comprehensive systematic review on green tea extracts (GTE) has been completed. GTEs may contain hepatotoxic solvent residues, pesticide residues, pyrrolizidine alkaloids and elemental impurities, but no evidence of their involvement in GTE-induced liver injury was found during this review. GTE catechin profiles vary significantly with manufacturing processes. Animal and human data indicate that repeated oral administration of bolus doses of GTE during fasting significantly increases bioavailability of catechins, specifically EGCG, possibly involving saturation of first-pass elimination mechanisms. Toxicological studies show a hepatocellular pattern of liver injury. Published adverse event case reports associate hepatotoxicity with EGCG intake amounts from 140?mg to ?1000?mg/day and substantial inter-individual variability in susceptibility, possibly due to genetic factors. Based on these findings, USP included a cautionary labeling requirement in its Powdered Decaffeinated Green Tea Extract monograph that reads as follows: "Do not take on an empty stomach. Take with food. Do not use if you have a liver problem and discontinue use and consult a healthcare practitioner if you develop symptoms of liver trouble, such as abdominal pain, dark urine, or jaundice (yellowing of the skin or eyes)."

SUBMITTER: Oketch-Rabah HA

PROVIDER: S-EPMC7044683 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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United States Pharmacopeia (USP) comprehensive review of the hepatotoxicity of green tea extracts.

Oketch-Rabah Hellen A HA Roe Amy L AL Rider Cynthia V CV Bonkovsky Herbert L HL Giancaspro Gabriel I GI Navarro Victor V Paine Mary F MF Betz Joseph M JM Marles Robin J RJ Casper Steven S Gurley Bill B Jordan Scott A SA He Kan K Kapoor Mahendra P MP Rao Theertham P TP Sherker Averell H AH Fontana Robert J RJ Rossi Simona S Vuppalanchi Raj R Seeff Leonard B LB Stolz Andrew A Ahmad Jawad J Koh Christopher C Serrano Jose J Low Dog Tieraona T Ko Richard R

Toxicology reports 20200215

As part of the United States Pharmacopeia's ongoing review of dietary supplement safety data, a new comprehensive systematic review on green tea extracts (GTE) has been completed. GTEs may contain hepatotoxic solvent residues, pesticide residues, pyrrolizidine alkaloids and elemental impurities, but no evidence of their involvement in GTE-induced liver injury was found during this review. GTE catechin profiles vary significantly with manufacturing processes. Animal and human data indicate that r ...[more]

PMID: 32140423

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Project description:Trisomy of human chromosome 21 (Down syndrome, DS) alters development of multiple organ systems, including the face and underlying skeleton. Besides causing stigmata, these facial dysmorphologies can impair vital functions such as hearing, breathing, mastication, and health. To investigate the therapeutic potential of green tea extracts containing epigallocatechin-3-gallate (GTE-EGCG) for alleviating facial dysmorphologies associated with DS, we performed an experimental study with continued pre- and postnatal treatment with two doses of GTE-EGCG supplementation in a mouse model of DS, and an observational study of children with DS whose parents administered EGCG as a green tea supplement. We evaluated the effect of high (100 mg/kg/day) or low doses (30 mg/kg/day) of GTE-EGCG, administered from embryonic day 9 to post-natal day 29, on the facial skeletal development in the Ts65Dn mouse model. In a cross-sectional observational study, we assessed the facial shape in DS and evaluated the effects of self-medication with green tea extracts in children from 0 to 18 years old. The main outcomes are 3D quantitative morphometric measures of the face, acquired either with micro-computed tomography (animal study) or photogrammetry (human study). The lowest experimentally tested GTE-EGCG dose improved the facial skeleton morphology in a mouse model of DS. In humans, GTE-EGCG supplementation was associated with reduced facial dysmorphology in children with DS when treatment was administered during the first 3 years of life. However, higher GTE-EGCG dosing disrupted normal development and increased facial dysmorphology in both trisomic and euploid mice. We conclude that GTE-EGCG modulates facial development with dose-dependent effects. Considering the potentially detrimental effects observed in mice, the therapeutic relevance of controlled GTE-EGCG administration towards reducing facial dysmorphology in young children with Down syndrome has yet to be confirmed by clinical studies.

Project description:Background: Arab Americans are a historically understudied minority group in the United States and their health needs and risks have been poorly documented. We aim to provide an updated comprehensive review of the literature on Arab American physical and mental health and provide suggestions for future work in this field. Methods: A comprehensive review of the English language medical and public health literature published prior to 2017 identified through multiple database searches was conducted with search terms describing Arab Americans and health outcomes and behaviors. The literature was qualitatively summarized by health behavior (vaccination, tobacco use, drug and alcohol use, and physical activity), health outcome (diabetes, mental health, cardiovascular disease, cancer, women's, and child health), and populations at increased risk of poor health outcomes (adolescents and the elderly). Results: The majority of studies identified exploring Arab American health have been published since 2009 with an increase in the number of longitudinal and intervention studies done with this population. The majority of research is being undertaken among individuals living in ethnic enclaves due to the lack of an ethnic or racial identifier that may help identify Arab Americans from population-based studies. Studies highlight the conflicting evidence in the prevalence of diabetes and cardiovascular disease based on study sample, an increased understanding of cancer incidence and barriers to identification, and an increased level of knowledge regarding mental health and sexual health needs in the population. Information on health behaviors has also increased, with a better understanding of physical activity, alcohol and drug use, and vaccination. Conclusion: More research on Arab American health is needed to identify risks and needs of this marginalized population given the current social and political climate in the United States, especially with regard to acculturation status and immigrant generation status. We provide recommendations on approaches that may help improve our understanding of Arab American health.

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United States Pharmacopeia (USP) comprehensive review of the hepatotoxicity of green tea extracts.

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United States Pharmacopeia (USP) comprehensive review of the hepatotoxicity of green tea extracts.

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