Trial reportBMC complementary and alternative medicine2018
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].
Trial report in BMC complementary and alternative medicine, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03004508 (Antioxidant Effect of Treatment With Ginkgo Biloba L. Leaf Extract), which is not on this map. Cited by 10 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Antioxidant Effect of Treatment With Ginkgo Biloba L. Leaf Extract (IDN 5933) on DNA Cell Maintenance and Genomic Stability: A Randomised Study Versus Placebo
Who cites it
10 citing papers in PubMed, 1 synthesis or guideline pooled it, 28 citations in OpenAlex.
- Ginkgo biloba as a Promising Candidate for Traumatic Brain Injury: Insights From Preclinical and Clinical Studies.Chemistry & biodiversity · 2026Pooled it
- Review
- The Potential ofMolecules (Basel, Switzerland) · 2023Review
- The Quest for Neurodegenerative Disease Treatment-Focusing on Alzheimer's Disease Personalised Diets.Current issues in molecular biology · 2023Review
- A Mixture ofOxidative medicine and cellular longevity · 2022Article
- Mild Cognitive Impairment and Mild Dementia: The Role ofPharmaceuticals (Basel, Switzerland) · 2021Review
- The Influence of Hemp Extract in Combination with Ginger on the Metabolic Activity of Metastatic Cells and Microorganisms.Molecules (Basel, Switzerland) · 2020Article
- Herbal Medicine for Cardiovascular Diseases: Efficacy, Mechanisms, and Safety.Frontiers in pharmacology · 2020Review
- Ginkgo biloba extract protects human melanocytes from HJournal of cellular and molecular medicine · 2019Article
- Protective Effect ofOxidative medicine and cellular longevity · 2018Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
16 authors at 5 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
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.
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