Evidence map›Paper›PMID 35546412›Full record

Trial reportTrials2022

Prevention of medication overuse and medication overuse headache in patients with migraine: a randomized, controlled, parallel, allocation-blinded, multicenter, prospective trial using a mobile software application.

Hans-Christoph Diener, Stephen Donoghue, Charly Gaul, Dagny Holle-Lee, Karl-Heinz Jöckel, Alec Mian, Bernadette Schröder, Tobias Kühl

Open access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
1.8field-weighted citation impact, top 15% 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

6 citing papers in PubMed, 12 citations in OpenAlex.

  1. Observational
  2. Article
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  6. Review
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

8 authors at 2 institutions in 1 country.

Hans-Christoph DienerInstitute for Medical Informatics, Biometry and Epidemiology, University of Duisburg-Essen, Essen, Germany. hans.diener@uk-essen.de.
Stephen DonoghueCurelator Inc., Cambridge, MA, 02139, USA.
Charly GaulHeadache Center Frankfurt, Frankfurt, Germany.
Dagny Holle-LeeDepartment of Neurology, Center for Translational Neuro- and Behavioral Sciences, University Medicine Essen, Essen, Germany.
Karl-Heinz JöckelInstitute for Medical Informatics, Biometry and Epidemiology, University of Duisburg-Essen, Essen, Germany.
Alec MianCurelator Inc., Cambridge, MA, 02139, USA.
Bernadette SchröderInstitute for Medical Informatics, Biometry and Epidemiology, University of Duisburg-Essen, Essen, Germany.
Tobias KühlInstitute for Medical Informatics, Biometry and Epidemiology, University of Duisburg-Essen, Essen, Germany.
University of Duisburg-Essen · DECardiovascular Center Frankfurt · DE

Funding

Deutsche Forschungsgemeinschaft 407181137
6 · The paper itself

Abstract

backgroundOverall, 55% of the German population suffers from primary episodic headaches according to recent studies. Inadequate management of headache disorders is a significant medical problem. The prevalence of medication overuse headache (MOH) is about 1% with an estimated number of 800,000 people in Germany. Medication overuse (MO) and MOH are usually managed through a complex process of medication withdrawal and initiating of prophylaxis. However, patients who were successfully treated for MO or MOH have a high relapse rate in the following 2 years. Previously, continued monitoring of self-reported medication intake demonstrated lower relapse rates. The prevalence and burden of MO and MOH are high, and effective strategies to prevent the development of a relapse into MOH or de novo MOH are still missing. Therefore, the MOH trial was designed to assess the effects of combining self-reported medication intake with daily monitoring of the entered data and a personalized patient-specific medication intake feedback system in an easy-accessible app-based platform in order to prevent the development and relapse of MO(H).

methodsThe MOH trial is a randomized, controlled, parallel, multicenter, prospective trial. A total of 624 migraine patients with frequent migraine attacks and 336 patients who underwent treatment for MO(H) will be randomly allocated to use either a customized app with or without individual feedback regarding their self-reported medication intake for 12 months. The primary outcome will be the proportion of patients developing MO or MOH for at least 3 consecutive months between baseline and end of study visits. DISCUSSION: This trial will assess the effects of providing patients with feedback regarding their self-reported use of migraine medications and migraine days using a mobile software on the development or prevention of MO(H). We hypothesize that the development of MO(H) in patients with frequent episodic migraine (EM) or chronic migraine (CM) and relapse after treatment of MO(H) can be reduced by a feedback system. If this trial proves that using an app with specific and unspecific messaging to the patient is successful, this method, which is now investigated mainly in specialized headache centers, could later be extended to primary care, thus providing benefits for a broader patient group.

trial registrationGerman Clinical Trials Register DRKS00025961 . Registered on 04 August 2021.

Indexed as

Headache Disorders, SecondaryMigraine DisordersMobile ApplicationsChronic DiseaseHeadacheHumansPrescription Drug OveruseProspective StudiesRecurrenceChronic migraineHeadacheMedication overuseMigraineMigraine app

Identifiers

PMID35546412
PMCPMC9092034
OpenAlexW4280602026

What OpenQuestion holds

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Registered trials

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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.