Evidence map›Paper›PMID 28766236›Full record

Trial reportThe journal of headache and pain2017

The impact of onabotulinumtoxinA on severe headache days: PREEMPT 56-week pooled analysis.

Manjit Matharu, Rashmi Halker, Patricia Pozo-Rosich, Ronald DeGryse, Aubrey Manack Adams, Sheena K Aurora

Abstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The journal of headache and pain, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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

23 citing papers in PubMed, 1 synthesis or guideline pooled it.

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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

6 authors.

Manjit MatharuUniversity College London (UCL) Institute of Neurology and The National Hospital for Neurology and Neurosurgery, Queen Square, London, WC1N3BG, UK. m.matharu@uclmail.net.
Rashmi HalkerMayo Clinic, Department of Neurology, 5777 East Mayo Blvd, Phoenix, AZ, 85054, USA.
Patricia Pozo-RosichHeadache and Pain Research Group, Institut de Recerca, Universitat Autònoma de Barcelona, Barcelona, Spain.
Ronald DeGryse, Allergan plc, 2525 Dupont Dr, Irvine, CA, USA.
Aubrey Manack Adams, Allergan plc, 2525 Dupont Dr, Irvine, CA, USA.
Sheena K AuroraFormerly of the Department of Neurology, Stanford University, 300 Pasteur Dr. Room A301 MC 5325, Stanford, CA, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundOnabotulinumtoxinA has been shown to reduce headache-days among patients with chronic migraine (CM). The objective of this analysis was to determine whether onabotulinumtoxinA has an impact on headache-day severity in patients with CM among those patients who were deemed non-responders based on reduction in the frequency of headache days alone.

methodsData from the Phase 3 REsearch Evaluating Migraine Prophylaxis Therapy (PREEMPT) clinical trial program (a 24-week, 2-treatment cycle, double-blind, randomized, placebo-controlled, parallel-group phase, followed by a 32-week, 3-treatment cycle, open-label phase) were pooled for analysis. Patients kept a daily diary to record headache severity on a 4-point scale (from none to severe), and a 6-domain Headache Impact Test (HIT-6) was used to determine the clinical impact of headaches. Analysis was undertaken to assess whether the subset of patients that were headache-day frequency non-responders at week 24 (patients with <50% reduction in headache-day frequency) experienced a reduction in headache severity whilst receiving onabotulinumtoxinA.

resultsFor headache-day frequency non-responders, significant reductions in the number of severe headache days, average daily headache severity, pooled percentage of severe headache days and headache severity score were observed at week 24 for patients who had received onabotulinumtoxinA compared with those who had received placebo. The between-group differences were reduced and non-significant at week 56. Similarly, headache-day frequency non-responders receiving onabotulinumtoxinA were found to have an improvement in the clinical impact of headaches using results from the HIT-6.

conclusionsThese results suggest that even those patients with CM who are deemed non-responders based on analysis of headache frequency alone experience clinically meaningful relief from headache intensity following treatment with onabotulinumtoxinA.

Indexed as

Outcome Assessment, Health CareAcetylcholine Release InhibitorsAdultBotulinum Toxins, Type AChronic DiseaseDouble-Blind MethodFemaleHumansMaleMiddle AgedMigraine DisordersSeverity of Illness IndexAcetylcholine Release InhibitorsBotulinum Toxins, Type AChronic migraineHeadache severityHit-6OnabotulinumtoxinAPREEMPT

Identifiers

PMID28766236
PMCPMC5539058

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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.