Evidence map›Paper›PMID 19015839›Full record

Trial reportEuropean journal of clinical pharmacology2009

St John's wort extract (Ze 117) does not alter the pharmacokinetics of a low-dose oral contraceptive.

Liane Will-Shahab, Steffen Bauer, Ullrich Kunter, Ivar Roots, Axel Brattström

Erratum issuedOpen access · hybridAbstract readClinical Trial
PubMed Publisher
In one paragraph

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.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 3 pooled it
6.1field-weighted citation impact, top 4% 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

12 citing papers in PubMed, 3 syntheses or guidelines pooled it, 48 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Review
  6. Documentary Analysis ofPharmaceuticals (Basel, Switzerland) · 2024
    Review
  7. Review
  8. Article
  9. Review
  10. Drug interactions with herbal medicines.Clinical pharmacokinetics · 2012
    Review
  11. Review
  12. Review
4 · The record

Corrections and comments

  • Erratum issued
5 · Who and what money

Authors and funding

5 authors at 3 institutions in 3 countries.

Liane Will-ShahabBIOPHARM, Bitterfelder Str. 19, 12681 Berlin, Germany.
Steffen Bauer
Ullrich Kunter
Ivar Roots
Axel Brattström
Charité - Universitätsmedizin Berlin · DEBIOPHARM (Czechia) · CZMax Zeller Söhne (Switzerland) · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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.

Indexed as

Administration, OralAdultArea Under CurveContraceptives, Oral, CombinedDesogestrelEthinyl EstradiolFemaleHerb-Drug InteractionsHumansHypericumPlant ExtractsTabletsContraceptives, Oral, CombinedDesogestrelEthinyl EstradioletonogestrelPlant ExtractsTabletsZE 117

Identifiers

PMID19015839
OpenAlexW1980293674

What OpenQuestion holds

Textmetadata
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.