Evidence map›Paper›PMID 38360739›Full record

ArticleTrials2024

Continuous combined oral contraceptive use versus vitamin E in the treatment of menstrual migraine: rationale and protocol of a randomized controlled trial (WHAT!).

Britt W H van der Arend, Daphne S van Casteren, Iris E Verhagen, Antoinette MaassenVanDenBrink, Gisela M Terwindt

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04007874 (Open-label Randomized Controlled Trial for the Effects of Continuous Ethinylestradiol/Levonorgestrel), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
1.2field-weighted citation impact, top 23% 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.

NCT04007874 phase3unknown statusnot on this map

Open-label Randomized Controlled Trial for the Effects of Continuous Ethinylestradiol/Levonorgestrel (30/150 μg/Day) Compared With Vitamin E (400 IU/Day) in the Treatment of Menstrually-related Migraine and Migraine During Perimenopause

TypeinterventionalSponsorLeiden University Medical CenterRan2019 to 2024Enrolled360ConditionsMigraine, Migraine, MenstrualArmsEthinylestradiol/levonorgestrel, Vitamin E
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 3 citations in OpenAlex.

  1. Review
  2. Article
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

5 authors at 2 institutions in 1 country.

Britt W H van der Arend *Department of Neurology, Leiden University Medical Center, PO Box 9600, Leiden, 2300 RC, The Netherlands.ORCID http://orcid.org/0000-0001-8999-0087
Daphne S van Casteren *Department of Neurology, Leiden University Medical Center, PO Box 9600, Leiden, 2300 RC, The Netherlands.
Iris E VerhagenDepartment of Neurology, Leiden University Medical Center, PO Box 9600, Leiden, 2300 RC, The Netherlands.
Antoinette MaassenVanDenBrink *Division of Vascular Medicine and Pharmacology, Department of Internal Medicine, Erasmus Medical Center, Rotterdam, The Netherlands.
Gisela M Terwindt *Department of Neurology, Leiden University Medical Center, PO Box 9600, Leiden, 2300 RC, The Netherlands. g.m.terwindt@lumc.nl.
Leiden University Medical Center · NLErasmus MC · NL

Funding

ZonMw 849200007
6 · The paper itself

Abstract

backgroundCurrently, there is no evidence-based hormonal treatment for migraine in women. Several small studies suggest a beneficial effect of combined oral contraceptives, but no large randomized controlled trial has been performed. As proof of efficacy is lacking and usage may be accompanied by potentially severe side effects, there is a great need for clarity on this topic.

methodsWomen with menstrual migraine (n = 180) are randomly assigned (1:1) to ethinylestradiol/levonorgestrel 30/150 μg or vitamin E 400 IU. Participants start with a baseline period of 4 weeks, which is followed by a 12-week treatment period. During the study period, a E-headache diary will be used, which is time-locked and includes an automated algorithm differentiating headache and migraine days.

resultsThe primary outcome will be change in monthly migraine days (MMD) from baseline (weeks - 4 to 0) to the last 4 weeks of treatment (weeks 9 to 12). Secondary outcomes will be change in monthly headache days (MHD) and 50% responder rates of MMD and MHD.

conclusionsThe WHAT! trial aims to investigate effectivity and safety of continuous combined oral contraceptive treatment for menstrual migraine. Immediate implementation of results in clinical practice is possible.

trial registrationClinical trials.gov NCT04007874 . Registered 28 June 2019.

Indexed as

Contraceptives, Oral, CombinedMigraine DisordersFemaleHeadacheHumansRandomized Controlled Trials as TopicContraceptives, Oral, CombinedCombined oral contraceptive pillHeadacheHormonesMigraineTreatment

Identifiers

PMID38360739
PMCPMC10870678
OpenAlexW4391844391

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

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.