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BMC Complementary Medicine and Therapies

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Open Access 01-12-2018 | Research article

Clinical and genomic safety of treatment with Ginkgo biloba L. leaf extract (IDN 5933/Ginkgoselect®Plus) in elderly: a randomised placebo-controlled clinical trial [GiBiEx]

Authors: Stefano Bonassi, Giulia Prinzi, Palma Lamonaca, Patrizia Russo, Irene Paximadas, Giuseppe Rasoni, Raffaella Rossi, Marzia Ruggi, Salvatore Malandrino, Maria Sánchez-Flores, Vanessa Valdiglesias, Barbara Benassi, Francesca Pacchierotti, Paola Villani, Martina Panatta, Eugenia Cordelli

Published in: BMC Complementary Medicine and Therapies | Issue 1/2018

Abstract

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.

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Title: Clinical and genomic safety of treatment with Ginkgo biloba L. leaf extract (IDN 5933/Ginkgoselect®Plus) in elderly: a randomised placebo-controlled clinical trial [GiBiEx]
Authors: Stefano Bonassi
Giulia Prinzi
Palma Lamonaca
Patrizia Russo
Irene Paximadas
Giuseppe Rasoni
Raffaella Rossi
Marzia Ruggi
Salvatore Malandrino
Maria Sánchez-Flores
Vanessa Valdiglesias
Barbara Benassi
Francesca Pacchierotti
Paola Villani
Martina Panatta
Eugenia Cordelli
Publication date: 01-12-2018
Publisher: BioMed Central
Published in: BMC Complementary Medicine and Therapies / Issue 1/2018
Electronic ISSN: 2662-7671
DOI: https://doi.org/10.1186/s12906-018-2080-5

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

Clinical and genomic safety of treatment with Ginkgo biloba L. leaf extract (IDN 5933/Ginkgoselect®Plus) in elderly: a randomised placebo-controlled clinical trial [GiBiEx]

Abstract

Background

Methods

Results

Conclusions

Trial registration

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

Abstract

Background

Methods

Results

Conclusions

Trial registration

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