Evidence map›Paper›PMID 25625809›Full record

Trial reportContemporary clinical trials2015

Effectiveness of nasal irrigation for chronic rhinosinusitis and fatigue in patients with Gulf War illness: protocol for a randomized controlled trial.

Supriya D Hayer, David P Rabago, Iliya P Amaza, Tony Kille, Christopher L Coe, Aleksandra Zgierska, Larissa Zakletskaia, Marlon P Mundt, Dean Krahn, Chidi N Obasi and 1 more

Registry-linked trialOpen access · greenAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Contemporary clinical trials, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01700725 (Nasal Irrigation for Chronic Rhinosinusitis and Fatigue in Patients With Gulf War Illness), which is not on this map. Cited by 6 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 2 pooled it
0.5field-weighted citation impact, top 33% 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.

NCT01700725 phase2completednot on this map

Nasal Irrigation for Chronic Rhinosinusitis and Fatigue in Patients With Gulf War Illness

TypeinterventionalSponsorUniversity of Wisconsin, MadisonRan2012 to 2017Enrolled40ConditionsPersian Gulf Syndrome, Chronic Sinusitis, Fatigue, Acute SinusitisArmsNasal Irrigation - Saline, Nasal Irrigation - Xylitol
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 2 syntheses or guidelines pooled it, 6 citations in OpenAlex.

  1. Pooled it
  2. Saline irrigation for chronic rhinosinusitis.The Cochrane database of systematic reviews · 2016
    Pooled it
  3. A Detoxification Intervention for Gulf War Illness: A Pilot Randomized Controlled Trial.International journal of environmental research and public health · 2019
    Trial
  4. Review
  5. Article
  6. 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 at 2 institutions in 1 country.

Supriya D Hayer1100 Delaplaine Court, Madison, WI 53715, Department of Family Medicine, School of Medicine and Public Health, University of Wisconsin-Madison, United States.
David P Rabago1100 Delaplaine Court, Madison, WI 53715, Department of Family Medicine, School of Medicine and Public Health, University of Wisconsin-Madison, United States. Electronic address: David.rabago@fammed.wisc.edu.
Iliya P Amaza1100 Delaplaine Court, Madison, WI 53715, Department of Family Medicine, School of Medicine and Public Health, University of Wisconsin-Madison, United States.
Tony Kille600 Highland Avenue, Madison, WI 53792, Department of Surgery, Division of Otolaryngology, School of Medicine and Public Health, University of Wisconsin-Madison, United States.
Christopher L CoeDepartment of Psychology, University of Wisconsin-Madison, United States.
Aleksandra Zgierska1100 Delaplaine Court, Madison, WI 53715, Department of Family Medicine, School of Medicine and Public Health, University of Wisconsin-Madison, United States.
Larissa Zakletskaia1100 Delaplaine Court, Madison, WI 53715, Department of Family Medicine, School of Medicine and Public Health, University of Wisconsin-Madison, United States.
Marlon P Mundt1100 Delaplaine Court, Madison, WI 53715, Department of Family Medicine, School of Medicine and Public Health, University of Wisconsin-Madison, United States.
Dean KrahnDepartment of Psychiatry, Veterans Administration Hospital, 2500 Overlook Terrace, Madison, WI 53705, United States; Department of Psychiatry, School of Medicine and Public Health, University of Wisconsin-Madison, United States.
Chidi N Obasi1100 Delaplaine Court, Madison, WI 53715, Department of Family Medicine, School of Medicine and Public Health, University of Wisconsin-Madison, United States.
Rachel C MolanderDepartment of Psychiatry, Veterans Administration Hospital, 2500 Overlook Terrace, Madison, WI 53705, United States; Department of Psychiatry, School of Medicine and Public Health, University of Wisconsin-Madison, United States.
University of Wisconsin–Madison · USUnited States Department of Veterans Affairs · US

Funding

Institutional Clinical and Translational Science AwardUL1TR000427 · NCATS · UNIVERSITY OF WISCONSIN-MADISON · PI DREZNER, MARC KENNETH · 2012 to 2016
$32.2M
INSTITUTIONAL CTSA (UW-MADISON): CLINICAL TRIALSUL1RR025011 · NCRR · UNIVERSITY OF WISCONSIN-MADISON · PI DREZNER, MARC KENNETH · 2007 to 2011
$29.5M
Research Training in Complementary and Alternative MedicineT32AT006956 · NCCIH · UNIVERSITY OF WISCONSIN-MADISON · PI BARRETT, BRUCE P · 2011 to 2017
$1.5M
Mindfulness Meditation for Alcohol Relapse PreventionK23AA017508 · NIAAA · UNIVERSITY OF WISCONSIN-MADISON · PI ZGIERSKA, ALEKSANDRA EWA · 2009 to 2013
$918k
NCATS NIH HHS UL1 TR000427NCATS NIH HHS UL1TR000427NCCIH NIH HHS T32 AT006956NCCIH NIH HHS T32AT006956NCRR NIH HHS UL1 RR025011NIAAA NIH HHS K23 AA017508
6 · The paper itself

Abstract

introductionGulf War Illness (GWI) affects 1 in 7 returned Persian Gulf War veterans. Quality-of-life impact is large; there is no cure. Chronic sinus symptoms and fatigue are common. Nasal irrigation with saline (NI-S) or xylitol (NI-X) improve sinus symptoms and fatigue in the general population. This trial will assess the effect of NI-S and NI-X on sinus and fatigue symptoms, economic outcomes and pro-inflammatory milieu among participants with GWI.

methods75 participants (age 35 to 65 years, 25 in each of three arms) with GWI will be recruited from the Veteran's Administration and the community. They will use routine care for sinus symptoms and fatigue and be randomized to continued usual care alone or additional therapy with NI-S or NI-X. Participants will be able to adjust specific elements of the NI procedure. The primary outcome (Sinonasal Outcome Test, SNOT-20) and other self-reported assessments will occur at baseline, 8 and 26 weeks; lab assessment of pro-inflammatory cellular and cytokine profiles will occur at baseline and 26 weeks. Other outcomes will include fatigue-specific and overall health-related quality of life, pro-inflammatory cellular and cytokine profiles, cost-effectiveness and participant satisfaction.

resultsBaseline demographic and clinical data from the first 10 participants show effective participant recruitment, enrollment, randomization, retention and data collection.

conclusionEarly study conduct suggests that our participant-oriented approach will yield high rates of participant adherence and data capture, facilitating robust analysis. Results of this study will clarify the value of NI for chronic sinus symptoms and fatigue among patients with GWI. CLINICAL

trial registrationclinicaltrials.gov identifier NCT01700725.

Indexed as

AdultAgedChronic DiseaseCytokinesFatigueFemaleHumansMaleMiddle AgedNasal LavageNasal MucosaPersian Gulf SyndromeRhinitisSinusitisSodium ChlorideSweetening AgentsCytokinesSodium ChlorideSweetening AgentsXylitolChronic rhinosinusitisFatigueGulf War IllnessNasal irrigationVeteransXylitol

Identifiers

PMID25625809
PMCPMC4387129
OpenAlexW2023626877

What OpenQuestion holds

Textmetadata
LicenceTDM
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 OpenQuestion graph.