Trial reportEuropean journal of clinical pharmacology2009
St John's wort extract (Ze 117) does not alter the pharmacokinetics of a low-dose oral contraceptive.
Trial report in European journal of clinical pharmacology, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 12 papers, 3 of them syntheses that pooled it.
What it found
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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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
12 citing papers in PubMed, 3 syntheses or guidelines pooled it, 48 citations in OpenAlex.
- Co-administration of St. John's wort and hormonal contraceptives: a systematic review.Contraception · 2016Pooled it
- Interactions between herbal medicines and prescribed drugs: an updated systematic review.Drugs · 2009Pooled it
- The effect of St John's wort extracts on CYP3A: a systematic review of prospective clinical trials.British journal of clinical pharmacology · 2006Pooled it
- The pregnane X receptor agonist St John's Wort has no effects on the pharmacokinetics and pharmacodynamics of repaglinide.Clinical pharmacokinetics · 2011Trial
- St. John's Wort for Depression: From Neurotransmitters to Membrane Plasticity.International journal of molecular sciences · 2025Review
- Documentary Analysis ofPharmaceuticals (Basel, Switzerland) · 2024Review
- Clinical relevance of St. John's wort drug interactions revisited.British journal of pharmacology · 2020Review
- No Clinically Relevant Interactions of St. John's Wort Extract Ze 117 Low in Hyperforin With Cytochrome P450 Enzymes and P-glycoprotein.Clinical pharmacology and therapeutics · 2019Article
- Cytochrome P450 enzyme mediated herbal drug interactions (Part 1).EXCLI journal · 2014Review
- Drug interactions with herbal medicines.Clinical pharmacokinetics · 2012Review
- Concomitant use of prescription medications and dietary supplements in menopausal women: an approach to provider preparedness.Maturitas · 2011Review
- Herb-drug interactions with St John's wort (Hypericum perforatum): an update on clinical observations.The AAPS journal · 2009Review
Corrections and comments
- Erratum issued
Authors and funding
5 authors at 3 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeSt John's wort (Hypericum perforatum) is an herbal remedy that is widely used in the treatment of depression. Recent clinical data have demonstrated that St John's wort extracts interfere with the action of various drugs and possibly also with combined oral contraceptives. Therefore, we investigated the effects of a St John's wort extract (Ze 117) with low hyperforin content on the pharmacokinetics of ethinylestradiol and 3-ketodesogestrel.
methodSixteen healthy female volunteers, who had taken a low-dose oral contraceptive (Lovelle contains 0.02 mg ethinylestradiol + 0.15 mg desogestrel) for at least 3 months, participated in the study. Pharmacokinetic data (AUC, C(max), t(max)) were determined the day before (reference) and after (test) a 14-day period of Ze 117 intake (250 mg twice daily).
resultsBefore the co-administration of Ze 117 on day 7, the geometric mean (geometric coefficient of variation) for the AUC(0-24) of ethinylestradiol was 152.53 pg.h/ml (87.39%) and after co-administration on day 21 it was 196.57 pg.h/ml (78.14%). The respective values for ketodesogestrel were 36.37 pg.h/ml (34.18%) and 41.12 pg.h/ml (34.36%). The mean of individual ratios (reference-to-test) of log-transformed AUC values (90% confidence interval) were 0.951 (0.915-0.986) for ethinylestradiol and 0.968 (0.944-0.992) for ketodesogestrel indicating a small gain [corrected] in bioavilability, but bioequivalence nevertheless.
conclusionThese results indicate that the recommended dose of the hypericum extract Ze117, which has a low hyperforin content, does not interact with the pharmacokinetics of the hormonal components of the low-dose oral contraceptive.
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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.