Evidence map›Paper›PMID 37319244›Full record

Trial reportPloS one2023

Gulf war illness inflammation reduction trial: A phase 2 randomized controlled trial of low-dose prednisone chronotherapy, effects on health-related quality of life.

Ronald R Bach, Rebecca R Rudquist

Retracted Registry-linked trialOpen access · goldAbstract readRandomized Controlled TrialClinical Trial, Phase IIRetracted Publication
In one paragraph

Trial report in PloS one, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It has been retracted, and should not be counted. It is linked to trial NCT02506192 (Gulf War Illness Inflammation Reduction Trial), which is not on this map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
1.1field-weighted citation impact, top 24% 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.

NCT02506192 phase2completednot on this map

Gulf War Illness Inflammation Reduction Trial

TypeinterventionalSponsorMinneapolis Veterans Affairs Medical CenterRan2015 to 2023Enrolled83ConditionsChronic Inflammation, Chronic Pain, Fatigue, Cognitive ImpairmentArmsModified-Release Prednisone, Placebo
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 5 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

2 authors at 1 institution in 1 country.

Ronald R BachMinneapolis Veterans Affairs Health Care System, Minneapolis, Minnesota, United States of America.ORCID 0000-0002-6401-4327
Rebecca R RudquistMinneapolis Veterans Affairs Health Care System, Minneapolis, Minnesota, United States of America.
Minneapolis VA Health Care System · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundGulf War illness (GWI) is a deployment-related chronic multisymptom illness impacting the health-related quality of life (HRQOL) of many U.S. Military Veterans of the 1990-91 Gulf War. A proinflammatory blood biomarker fingerprint was discovered in our initial study of GWI. This led to the hypothesis that chronic inflammation is a component of GWI pathophysiology.

objectivesThe GWI inflammation hypothesis was tested in this Phase 2 randomized controlled trial (RCT) by measuring the effects of an anti-inflammatory drug and placebo on the HRQOL of Veterans with GWI. The trial is registered at ClinicalTrials.gov, Identifier: NCT02506192. RCT DESIGN AND

methodsGulf War Veterans meeting the Kansas case definition for GWI were randomized to receive either 10 mg modified-release prednisone or matching placebo. The Veterans RAND 36-Item Health Survey was used to assess HRQOL. The primary outcome was a change from baseline in the physical component summary (PCS) score, a measure of physical functioning and symptoms. A PCS increase indicates improved physical HRQOL.

resultsFor subjects with a baseline PCS <40, there was a 15.2% increase in the mean PCS score from 32.9±6.0 at baseline to 37.9±9.0 after 8 weeks on modified-release prednisone. Paired t-test analysis determined the change was statistically significant (p = 0.004). Eight weeks after cessation of the treatment, the mean PCS score declined to 32.7±5.8.

conclusionsThe prednisone-associated improvement in physical HRQOL supports the GWI inflammation hypothesis. Determining the efficacy of prednisone as a treatment for GWI will require a Phase 3 RCT.

Indexed as

Persian Gulf SyndromeVeteransChronotherapyGulf WarHumansInflammationPrednisonePrednisone

Identifiers

PMID37319244
PMCPMC10270619
OpenAlexW4380852789

What OpenQuestion holds

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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 OpenQuestion graph.