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1.
BMC Complement Altern Med ; 18(1): 22, 2018 Jan 22.
Artículo en Inglés | MEDLINE | ID: mdl-29357859

RESUMEN

BACKGROUND: Numerous health benefits have been attributed to the Ginkgo biloba leaf extract (GBLE), one of the most extensively used phytopharmaceutical drugs worldwide. Recently, concerns of the safety of the extract have been raised after a report from US National Toxicology Program (NTP) claimed high doses of GBLE increased liver and thyroid cancer incidence in mice and rats. A safety study has been designed to assess, in a population of elderly residents in nursing homes, clinical and genomic risks associated to GBLE treatment. METHODS: GiBiEx is a multicentre randomized clinical trial, placebo controlled, double blinded, which compared subjects randomized to twice-daily doses of either 120-mg of IDN 5933 (also known as Ginkgoselect®Plus) or to placebo for a 6-months period. IDN 5933 is extracted from dried leaves and contains 24.3% flavone glycosides and 6.1% of terpene lactones (2.9% bilobalide, 1.38% ginkgolide A, 0.66% ginkgolide B, 1.12% ginkgolide C) as determined by HPLC. The study was completed by 47 subjects, 20 in the placebo group and 27 in the treatment group. Clinical (adverse clinical effect and liver injury) and genomic (micronucleus frequency, comet assay, c-myc, p53, and ctnnb1 expression profile in lymphocytes) endpoints were assessed at the start and at the end of the study. RESULTS: No adverse clinical effects or increase of liver injury markers were reported in the treatment group. The frequency of micronuclei [Mean Ratio (MR) = 1.01, 95% Confidence Intervals (95% CI) 0.86-1.18), and DNA breaks (comet assay) (MR = 0.91; 95% CI 0.58-1.43), did not differ in the two study groups. No significant difference was found in the expression profile of the three genes investigated. CONCLUSIONS: None of the markers investigated revealed a higher risk in the treatment group, supporting the safety of IDN 5933 at doses prescribed and for duration of six months. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03004508 , December 20, 2016. Trial retrospectively registered.


Asunto(s)
Daño del ADN/efectos de los fármacos , Ginkgo biloba/química , Extractos Vegetales , Hojas de la Planta/química , Anciano , Anciano de 80 o más Años , Femenino , Genoma/efectos de los fármacos , Humanos , Hígado/efectos de los fármacos , Pruebas de Función Hepática , Masculino , Pruebas de Micronúcleos , Extractos Vegetales/administración & dosificación , Extractos Vegetales/efectos adversos , Extractos Vegetales/farmacología
2.
Food Chem Toxicol ; 109(Pt 1): 486-496, 2017 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-28943387

RESUMEN

The use of Ginkgo biloba leaf extract as nutraceutical is becoming increasingly common. As a consequence, the definition of a reliable toxicological profile is a priority for its safe utilization. Recently, contrasting data have been reported on the carcinogenic potential of Ginkgo biloba extract in rodent liver. We measured viability, Reactive Oxygen Species (ROS), apoptosis, colony-forming efficiency, genotoxicity by comet assay, and gene expression changes associated with hepato-carcinogenicity in human cells of hepatic origin (HepG2 and THLE-2) treated with different concentrations (0.0005-1.2 mg/mL) of Ginkgoselect®Plus. Our analyses highlighted a decrease of cell viability, not due to apoptosis, after treatment with high doses of the extract, which was likely due to ROS generation by a chemical reaction between extract polyphenols and some components of the culture medium. Comet assay did not detect genotoxic effect at any extract concentration. Finally, the array analysis detected a slight decrease in the expression of only one gene (IGFBP3) in Ginkgo-treated THLE-2 cells as opposed to changes in 28 genes in Aflatoxin B1 treated-cells. In conclusion, our results did not detect any significant genotoxic or biologically relevant cytotoxic effects and gross changes in gene expression using the Ginkgo extract in the hepatic cells tested.


Asunto(s)
Daño del ADN/efectos de los fármacos , Expresión Génica/efectos de los fármacos , Ginkgo biloba/toxicidad , Hepatocitos/efectos de los fármacos , Extractos Vegetales/toxicidad , Línea Celular , Supervivencia Celular/efectos de los fármacos , Ensayo Cometa , Ginkgo biloba/química , Hepatocitos/citología , Hepatocitos/metabolismo , Humanos , Proteína 3 de Unión a Factor de Crecimiento Similar a la Insulina/genética , Proteína 3 de Unión a Factor de Crecimiento Similar a la Insulina/metabolismo , Extractos Vegetales/química , Hojas de la Planta/química , Especies Reactivas de Oxígeno/metabolismo
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