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Randomized Controlled Trial
. 2015 Mar:41:219-26.
doi: 10.1016/j.cct.2015.01.008. Epub 2015 Jan 24.

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

Supriya D Hayer  1 , David P Rabago  2 , Iliya P Amaza  1 , Tony Kille  3 , Christopher L Coe  4 , Aleksandra Zgierska  1 , Larissa Zakletskaia  1 , Marlon P Mundt  1 , Dean Krahn  5 , Chidi N Obasi  1 , Rachel C Molander  5
Affiliations
Randomized Controlled Trial

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

Supriya D Hayer et al. Contemp Clin Trials. 2015 Mar.

Abstract

Introduction: Gulf 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.

Methods: 75 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.

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

Conclusion: Early 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 registration: clinicaltrials.gov identifier NCT01700725.

Keywords: Chronic rhinosinusitis; Fatigue; Gulf War Illness; Nasal irrigation; Veterans; Xylitol.

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Figures

Fig. 1
Fig. 1
[8] Recruitment/randomization flowchart. ICD-9, Internation Classification of Diseases-9 Code; NI-X, Nasal Irrigation-Xylitol; and NI-S, Nasal Irrigation-Saline.
See this image and copyright information in PMC

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