Evidence map›Paper›PMID 32985341›Full record

Trial reportJournal of primary care & community health

Patient-Reported Outcomes from a 1-Year, Real-World, Head-to-Head Comparison of OnabotulinumtoxinA and Topiramate for Headache Prevention in Adults With Chronic Migraine.

Andrew M Blumenfeld, Atul T Patel, Ira M Turner, Kathleen B Mullin, Aubrey Manack Adams, John F Rothrock

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of primary care & community health. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02191579 (A Multicenter, Prospective, Randomized, Open-label Study to Compare the Efficacy, Safety, and Tolerability of BOTOX® and Topiramate for Headache Prophylaxis in Adults With Chronic Migraine), which is not on this map. Cited by 9 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 2 pooled it
2.4field-weighted citation impact, top 10% 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.

NCT02191579 phase4completednot on this map

A Multicenter, Prospective, Randomized, Open-label Study to Compare the Efficacy, Safety, and Tolerability of BOTOX® and Topiramate for Headache Prophylaxis in Adults With Chronic Migraine

TypeinterventionalSponsorAllerganRan2014 to 2017Enrolled282ConditionsMigraine DisordersArmsonabotulinumtoxinA, Topiramate
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 2 syntheses or guidelines pooled it, 26 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Article
  6. Article
  7. Review
  8. Article
  9. 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

6 authors at 4 institutions in 1 country.

Andrew M BlumenfeldHeadache Center of Southern California, The Neurology Center, Carlsbad, CA, USA.ORCID 0000-0003-0851-4914
Atul T PatelKansas City Bone and Joint Clinic, Overland Park, KS, USA.ORCID 0000-0003-2765-7953
Ira M TurnerThe Center for Headache Care and Research, Island Neurological Associates, Plainview, NY, USA.
Kathleen B MullinMontefiore Headache Center, Bronx, NY, USA.
Aubrey Manack AdamsAllergan, an AbbVie Company, Irvine, CA, USA.
John F RothrockGeorge Washington University School of Medicine, Washington, DC, USA.
AbbVie (United States) · USGeorge Washington University · USMontefiore Medical Center · USNeurology Center of Southern California · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

INTRODUCTION/

objectiveChronic migraine (CM) is associated with impaired health-related quality of life and substantial socioeconomic burden, but many people with CM are underdiagnosed and do not receive appropriate preventive treatment. OnabotulinumtoxinA and topiramate have demonstrated

methodsFORWARD was a prospective, multicenter, randomized, parallel-group, open-label, phase 4 study comparing onabotulinumtoxinA 155 U every 12 weeks with topiramate 50 to 100 mg/day for ≤36 weeks in people with CM. PROs measured included the Headache Impact Test (HIT-6), 9-item Patient Health Questionnaire Quick Depression Assessment (PHQ-9), Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI:SHP), and Functional Impact of Migraine Questionnaire (FIMQ).

resultsA total of 282 patients were randomized and treated with onabotulinumtoxinA (n = 140) or topiramate (n = 142). From baseline to week 30, mean HIT-6 test scores improved significantly in patients taking onabotulinumtoxinA compared with topiramate (

conclusionOnabotulinumtoxinA treatment had more favorable real-world effectiveness than topiramate on depression, headache impact, functioning and daily living, activity, and work productivity. The overall study results suggest that the beneficial effects on a range of PROs are the result of improved effectiveness when onabotulinumtoxinA is used as preventive treatment for CM.

trial registrationCLINICALTRIALS.GOV: NCT02191579; https://clinicaltrials.gov/ct2/show/NCT02191579.

Indexed as

Botulinum Toxins, Type AMigraine DisordersAdultChronic DiseaseHeadacheHumansPatient Reported Outcome MeasuresProspective StudiesQuality of LifeTopiramateTreatment OutcomeBotulinum Toxins, Type ATopiramateactivities of daily livinganxietydepressionheadachemigraine disordersonabotulinumtoxinApatient health questionnairepatient-reported outcome measuresquality of lifetopiramatetreatment outcome

Identifiers

PMID32985341
PMCPMC7536482
OpenAlexW3088054673

What Socratic holds

Textmetadata
LicenceCC BY-NC
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 Socratic graph.