Journal article
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
Headache, Vol.63(6), pp.805-812
06/2023
DOI: 10.1111/head.14474
PMCID: PMC10293029
PMID: 36757131
Abstract
To 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.
The 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.
CHAMP 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.
Results 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).
Regardless 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.
Details
- Title: Subtitle
- 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
- Creators
- Robert C Gibler - Cincinnati Children's Hospital Medical CenterJames L Peugh - Cincinnati Children's Hospital Medical CenterChristopher S Coffey - University of IowaLeigh Ann Chamberlin - Cincinnati Children's Hospital Medical CenterDixie Ecklund - University of IowaElizabeth Klingner - Department of Biostatistics, University of Iowa, Iowa, Iowa City, USAJon Yankey - University of IowaLeslie L KorbeeMarielle Kabbouche - Cincinnati Children's Hospital Medical CenterJoanne Kacperski - Cincinnati Children's Hospital Medical CenterLinda L Porter - National Institute of Neurological Disorders and StrokeBrooke L Reidy - Cincinnati Children's Hospital Medical CenterAndrew D Hershey - Cincinnati Children's Hospital Medical CenterScott W Powers - Cincinnati Children's Hospital Medical Center
- Resource Type
- Journal article
- Publication Details
- Headache, Vol.63(6), pp.805-812
- DOI
- 10.1111/head.14474
- PMID
- 36757131
- PMCID
- PMC10293029
- NLM abbreviation
- Headache
- eISSN
- 1526-4610
- Grant note
- T32DK063929 / NIDDK NIH HHS U01NSS076788 / NINDS NIH HHS U01NS077108 / National Institute of Child Health and Human Development
- Language
- English
- Electronic publication date
- 02/09/2023
- Date published
- 06/2023
- Academic Unit
- Biostatistics
- Record Identifier
- 9984366154902771
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