Evidence map›Paper›PMID 36757131›Full record

Trial reportHeadache2023

Impact of preventive pill-based treatment on migraine days: A secondary outcome study of the Childhood and Adolescent Migraine Prevention (CHAMP) trial and a comparison of self-report to nosology-derived assessments.

Robert C Gibler, James L Peugh, Christopher S Coffey, Leigh Ann Chamberlin, Dixie Ecklund, Elizabeth Klingner, Jon Yankey, Leslie L Korbee, Marielle Kabbouche, Joanne Kacperski and 4 more

Open access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Headache, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.9field-weighted citation impact, top 28% 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

3 citing papers in PubMed, 4 citations in OpenAlex.

  1. Article
  2. Article
  3. 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

14 authors at 4 institutions in 2 countries.

Robert C GiblerBehavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.ORCID 0000-0002-1532-7044
James L PeughBehavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.
Christopher S CoffeyDepartment of Biostatistics, University of Iowa, Iowa, Iowa City, USA.
Leigh Ann ChamberlinBehavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.
Dixie EcklundDepartment of Biostatistics, University of Iowa, Iowa, Iowa City, USA.
Elizabeth KlingnerDepartment of Biostatistics, University of Iowa, Iowa, Iowa City, USA.
Jon YankeyDepartment of Biostatistics, University of Iowa, Iowa, Iowa City, USA.
Leslie L KorbeeAcademic Regulatory & Monitoring Services, LLC, Cincinnati, Ohio, USA.
Marielle KabboucheDivision of Neurology, Cincinnati Children's Hospital Medical Center, Ohio, Cincinnati, USA.
Joanne KacperskiHeadache Center, Cincinnati Children's Hospital Medical Center, Ohio, Cincinnati, USA.
Linda L PorterNational Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, Maryland, USA.
Brooke L ReidyBehavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.
Andrew D HersheyHeadache Center, Cincinnati Children's Hospital Medical Center, Ohio, Cincinnati, USA.ORCID 0000-0002-1598-7536
Scott W PowersBehavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.ORCID 0000-0002-5348-9650
Cincinnati Children's Hospital Medical Center · USUniversity of Iowa · USCentre for Innovation in Regulatory Science · GBNational Institutes of Health · US

Funding

Amitriptyline and Topiramate in the Prevention of Childhood MigraineU01NS076788 · NINDS · CINCINNATI CHILDRENS HOSP MED CTR · PI HERSHEY, ANDREW D, POWERS, SCOTT W · 2011 to 2014
$9.3M
Research Training in Child Behavior and NutritionT32DK063929 · NIDDK · CINCINNATI CHILDRENS HOSP MED CTR · PI SCOTT W POWERS, MARGARET H ZELLER · 2003 to 2026
$6.0M
Amitriptyline and Topiramate in the Prevention of Childhood Migraine: DCCU01NS077108 · NINDS · UNIVERSITY OF IOWA · PI COFFEY, CHRISTOPHER S. · 2011 to 2014
$4.5M
NIDDK NIH HHS T32 DK063929NIDDK NIH HHS T32DK063929NINDS NIH HHS U01 NS077108NINDS NIH HHS U01NSS076788
6 · The paper itself

Abstract

objectiveTo examine group differences in self-reported migraine days among youth who completed the Childhood and Adolescent Migraine Prevention (CHAMP) trial prior to its closure and explore the relationship between self-reported and "nosology-derived" (i.e., International Classification of Headache Disorders, 3rd edition [ICHD-3]) migraine days.

backgroundThe CHAMP trial compared amitriptyline and topiramate to placebo for migraine prevention in youth and proposed to analyze change in migraine days as a secondary outcome. There is considerable variability in the field regarding what constitutes a "migraine day," how this is determined and reported in trials, and how consistent these measures are with diagnostic nosology.

methodsCHAMP trial completers (N = 175) were randomized to receive amitriptyline (n = 77), topiramate (n = 63), or placebo (n = 35). Participants maintained daily headache diaries where they reported each day with headache and if they considered that headache to be a migraine. For each headache day, participants completed a symptom record and reported about symptoms such as pain location(s) and presence of nausea/vomiting or photophobia and phonophobia. We examined group differences in self-reported migraine days at trial completion (summed from trial weeks 20-24) compared to baseline. We also used an algorithm to determine whether participants' symptom reports met ICHD-3 criteria for migraine without aura, and examined the association between self-reported and "nosology-derived" migraine days.

resultsResults showed no significant differences between groups in self-reported migraine days over the course of the trial. Self-reported and "nosology-derived" migraine days during the baseline and treatment phases were strongly associated (r's = 0.73 and 0.83, respectively; p's < 0.001).

conclusionRegardless of treatment, CHAMP trial completers showed clinically important reductions in self-reported migraine days over the course of the trial (about 3.8 days less). The strong association between self-reported and "nosology-derived" migraine days suggests youth with migraine can recognize a day with migraine and reliably report their headache features and symptoms. Greater rigor and transparency in the calculation and reporting of migraine days in trials is needed.

Indexed as

Headache DisordersMigraine DisordersAdolescentAmitriptylineChildDouble-Blind MethodFructoseHeadacheHumansOutcome Assessment, Health CareSelf ReportTopiramateTreatment OutcomeAmitriptylineFructoseTopiramateclinical trialmigrainemigraine daypediatricprevention

Identifiers

PMID36757131
PMCPMC10293029
OpenAlexW4319655739

What OpenQuestion holds

Textmetadata
LicenceTDM
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.