Evidence map›Paper›PMID 39853738›Full record

Trial reportHeadache2025

A randomized sequential cross-over trial evaluating five purportedly ICP-lowering drugs in idiopathic intracranial hypertension.

James L Mitchell, Hannah S Lyons, Jessica K Walker, Andreas Yiangou, Mark Thaller, Olivia Grech, Zerin Alimajstorovic, Georgios Tsermoulas, Kristian Brock, Susan P Mollan and 1 more

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Headache, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 2 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

8 citing papers in PubMed, 2 syntheses or guidelines pooled it.

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

11 authors.

James L MitchellTranslational Brain Science, Department of Metabolism and Systems Science, College of Medicine and Health, University of Birmingham, Birmingham, UK.ORCID 0000-0001-6785-9352
Hannah S LyonsTranslational Brain Science, Department of Metabolism and Systems Science, College of Medicine and Health, University of Birmingham, Birmingham, UK.ORCID 0000-0003-0105-1064
Jessica K WalkerTranslational Brain Science, Department of Metabolism and Systems Science, College of Medicine and Health, University of Birmingham, Birmingham, UK.ORCID 0000-0003-2586-7172
Andreas YiangouTranslational Brain Science, Department of Metabolism and Systems Science, College of Medicine and Health, University of Birmingham, Birmingham, UK.ORCID 0000-0001-8905-5734
Mark ThallerTranslational Brain Science, Department of Metabolism and Systems Science, College of Medicine and Health, University of Birmingham, Birmingham, UK.ORCID 0000-0001-7772-2157
Olivia GrechTranslational Brain Science, Department of Metabolism and Systems Science, College of Medicine and Health, University of Birmingham, Birmingham, UK.ORCID 0000-0001-5560-802X
Zerin AlimajstorovicTranslational Brain Science, Department of Metabolism and Systems Science, College of Medicine and Health, University of Birmingham, Birmingham, UK.ORCID 0000-0001-5622-8301
Georgios TsermoulasTranslational Brain Science, Department of Metabolism and Systems Science, College of Medicine and Health, University of Birmingham, Birmingham, UK.ORCID 0000-0001-5658-2335
Kristian BrockCancer Research Clinical Trials Unit, University of Birmingham, Birmingham, UK.ORCID 0000-0002-3921-0166
Susan P MollanTranslational Brain Science, Department of Metabolism and Systems Science, College of Medicine and Health, University of Birmingham, Birmingham, UK.ORCID 0000-0002-6314-4437
Alexandra J SinclairTranslational Brain Science, Department of Metabolism and Systems Science, College of Medicine and Health, University of Birmingham, Birmingham, UK.ORCID 0000-0003-2777-5132

Funding

Association of British Neurologists and Guarantors of the Brain FellowshipBrain Research UKInvex TherapeuticsMedical Research Council MR/K015184/1Ministry of Defence, UKNational Institute for Health and Care Research NIHR-CS-011-028University of Birmingham (Enterprising Birmingham)
6 · The paper itself

Abstract

objectiveTo gain initial insight into the efficacy to lower intracranial pressure (ICP), side effects, and effects on cognition of five drugs commonly used to treat idiopathic intracranial hypertension (IIH).

backgroundLimited clinical data exist for the treatment for IIH. Impaired cognition is recognized in IIH and can be exacerbated by medications.

methodsThis human experimental medicine study was a secondary analysis that focused on an unblinded randomized, sequential, cross-over extension of a previously completed randomized controlled trial. This study evaluated females with active IIH, recruited from University Hospital Birmingham, UK. Participants were treated, in randomized order, for 2 weeks with acetazolamide, amiloride, furosemide, spironolactone, and topiramate; assessment was at baseline and 2 weeks with a minimum 1-week drug washout between drugs. The primary outcome was change in ICP at 2 weeks post-drug administration. The cognitive evaluation was an exploratory study of the trial. ICP was recorded with telemetric, intraparenchymal ICP monitors (Raumedic, Hembrechts, Germany). Adverse events were recorded, and cognition was assessed utilizing the National Institutes of Health Toolbox Cognitive Battery.

resultsFourteen participants were recruited and evaluated by intention-to-treat analysis. Mean (standard deviation) body mass index was 37.3 (7.0) kg/m

conclusionsAcetazolamide, furosemide, spironolactone, and topiramate marginally reduced ICP. While their effects were not significant, this study was not powered to detect a difference between drugs. Participants reported significant side effects with acetazolamide and topiramate including cognitive decline. Cognitive measures were impaired by acetazolamide and topiramate. Therapeutics with greater efficacy and a favorable side effect profile are an unmet need in the treatment of IIH.

Indexed as

Intracranial PressurePseudotumor CerebriAcetazolamideAdultAmilorideCross-Over StudiesDiureticsFemaleFurosemideHumansMiddle AgedSpironolactoneTopiramateTreatment OutcomeYoung AdultAcetazolamideAmilorideDiureticsFurosemideSpironolactoneTopiramateadverse eventscerebrospinal fluidcognitionidiopathic intracranial hypertensionintracranial pressuretherapeutics

Identifiers

PMID39853738
PMCPMC11794974

What Socratic holds

Textmetadata
LicenceCC BY
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 Socratic graph.