Evidence map›Paper›PMID 22189672›Full record

Trial reportEuropean journal of clinical pharmacology2012

Effect of Ginkgo biloba special extract EGb 761® on human cytochrome P450 activity: a cocktail interaction study in healthy volunteers.

G Zadoyan, D Rokitta, S Klement, A Dienel, R Hoerr, T Gramatté, U Fuhr

Open access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in European journal of clinical pharmacology, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 33 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
33citing papers in PubMed, 1 pooled it
25.3field-weighted citation impact, top 1% of its field
1 · What the graph read from 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.

2 · The registry

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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

33 citing papers in PubMed, 1 synthesis or guideline pooled it, 83 citations in OpenAlex.

  1. Pooled it
  2. Dicloxacillin induces CYP2C19, CYP2C9 and CYP3A4 in vivo and in vitro.British journal of clinical pharmacology · 2018
    Trial
  3. Trial
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  6. Review
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  8. Article
  9. OptimizedJournal of pharmacy & pharmaceutical sciences : a publication of the Canadian Society for Pharmaceutical Sciences, Societe canadienne des sciences pharmaceutiques · 2025
    Article
  10. TiOAdvances in neurobiology · 2023
    Review
  11. Review
  12. Review
  13. Review
  14. Review
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  16. Article
  17. Article
  18. Review
  19. Effects ofPharmaceutical biology · 2019
    Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 2 institutions in 1 country.

G ZadoyanDepartment of Pharmacology Clinical Pharmacology Unit, University of Cologne, Gleueler Str. 24, 50931, Cologne, Germany.
D Rokitta
S Klement
A Dienel
R Hoerr
T Gramatté
U Fuhr
Dr Willmar Schwabe (Germany) · DEUniversity of Cologne · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeWe assessed the human in vivo metabolic drug interaction profile of Ginkgo biloba extract EGb 761® with respect to the activities of major cytochrome P450 (CYP) enzymes.

methodsA single-center, open-label, randomized, three-fold crossover, cocktail phenotyping design was applied. In random order, the following treatments were administered to 18 healthy men and women for 8 days each: placebo twice daily, EGb 761® 120 mg twice daily, and EGb 761® 240 mg in the morning and placebo in the evening. In the morning of day 8, administration was performed together with the orally administered phenotyping cocktail (enzyme, metric): 150 mg caffeine (CYP1A2, paraxanthine/caffeine plasma ratio 6-h postdose), 125 mg tolbutamide (CYP2C9, plasma concentration 24-h postdose), 20 mg omeprazole (CYP2C19, omeprazole/5-hydroxy omeprazole plasma ratio 3-h postdose), 30 mg dextromethorphan (CYP2D6, dextromethorphan/dextrorphan plasma ratio 3-h postdose), and 2 mg of midazolam (CYP3A, plasma concentration 6-h postdose). Formally, absence of a relevant interaction was assumed if the 90% confidence intervals (CIs) for EGb 761®/placebo ratios of the metrics were within the 0.70-1.43 range.

resultsEGb 761®/placebo ratios for phenotyping metrics were close to unity for all CYPs. Furthermore, respective CIs were within the specified margins for all ratios except CYP2C19 for EGb 761® 120 mg twice daily (90% CI 0.681-1.122) and for CYP2D6 for EGb 761® 240 mg once daily (90% CI 0.667-1.281). These findings were attributed to the intraindividual variability of the metrics used. All treatments were well tolerated.

conclusionEGb 761® has no relevant effect on the in vivo activity of the major CYP enzymes in humans and therefore has no relevant potential to cause respective metabolic drug-drug interactions.

Indexed as

Dietary SupplementsHerb-Drug InteractionsAdultBiotransformationCaffeineCross-Over StudiesCytochrome P-450 Enzyme InhibitorsCytochrome P-450 Enzyme SystemDose-Response Relationship, DrugDrug CombinationsEnzyme InductionEnzyme InhibitorsFemaleGinkgo bilobaGinkgo ExtractGinkgolidesCaffeineCytochrome P-450 Enzyme InhibitorsCytochrome P-450 Enzyme SystemDrug CombinationsEnzyme InhibitorsGinkgo biloba extractGinkgo ExtractGinkgolidesPlant Extracts

Identifiers

PMID22189672
PMCPMC3332346
OpenAlexW2135505944

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.