Abstract
BackgroundNumerous 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.MethodsGiBiEx 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.ResultsNo 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.ConclusionsNone 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 registrationClinicalTrials.gov Identifier: NCT03004508, December 20, 2016. Trial retrospectively registered.
Highlights
Numerous health benefits have been attributed to the Ginkgo biloba leaf extract (GBLE), one of the most extensively used phytopharmaceutical drugs worldwide
Modern use of Ginkgo biloba extract is centered on leaf-based preparations and numerous health benefits have been attributed to its use
GBLE is one of the most commercialized medicinal plants: in Europe it is principally regulated as herbal medicine, while in the US it is used as a dietary supplement, available in stores and online
Summary
Numerous health benefits have been attributed to the Ginkgo biloba leaf extract (GBLE), one of the most extensively used phytopharmaceutical drugs worldwide. Modern use of Ginkgo biloba extract is centered on leaf-based preparations and numerous health benefits have been attributed to its use. Ginkgo biloba leaf extract (GBLE) are commonly standardized to contain 24% of ginkgo flavone glycosides and 6% terpene lactones [2, 9]. The main use of the GBLE is to improve cognitive functions in elderly showing memory loss, the extract has been used to treat cardiovascular disease, idiopathic sudden sensorineural hearing loss, cerebral ischemia, and to decrease chemotherapy-associated toxicity [3, 6, 15,16,17]
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