title: Effectiveness of nasal irrigation for chronic rhinosinusitis and fatigue in patients with Gulf War illness: protocol for a randomized controlled trial.
abstract: BACKGROUND
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  clinicaltrials.gov identifier NCT01700725.
authors.affiliation: 1100 Delaplaine Court, Madison, WI 53715, Department of Family Medicine, School of Medicine and Public Health, University of Wisconsin-Madison, United States.
authors.forename: Supriya D
authors.initials: SD
authors.lastname: Hayer
authors.affiliation: 1100 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.
authors.forename: David P
authors.initials: DP
authors.lastname: Rabago
authors.affiliation: 1100 Delaplaine Court, Madison, WI 53715, Department of Family Medicine, School of Medicine and Public Health, University of Wisconsin-Madison, United States.
authors.forename: Iliya P
authors.initials: IP
authors.lastname: Amaza
authors.affiliation: 600 Highland Avenue, Madison, WI 53792, Department of Surgery, Division of Otolaryngology, School of Medicine and Public Health, University of Wisconsin-Madison, United States.
authors.forename: Tony
authors.initials: T
authors.lastname: Kille
authors.affiliation: Department of Psychology, University of Wisconsin-Madison, United States.
authors.forename: Christopher L
authors.initials: CL
authors.lastname: Coe
authors.affiliation: 1100 Delaplaine Court, Madison, WI 53715, Department of Family Medicine, School of Medicine and Public Health, University of Wisconsin-Madison, United States.
authors.forename: Aleksandra
authors.initials: A
authors.lastname: Zgierska
authors.affiliation: 1100 Delaplaine Court, Madison, WI 53715, Department of Family Medicine, School of Medicine and Public Health, University of Wisconsin-Madison, United States.
authors.forename: Larissa
authors.initials: L
authors.lastname: Zakletskaia
authors.affiliation: 1100 Delaplaine Court, Madison, WI 53715, Department of Family Medicine, School of Medicine and Public Health, University of Wisconsin-Madison, United States.
authors.forename: Marlon P
authors.initials: MP
authors.lastname: Mundt
authors.affiliation: Department 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.
authors.forename: Dean
authors.initials: D
authors.lastname: Krahn
authors.affiliation: 1100 Delaplaine Court, Madison, WI 53715, Department of Family Medicine, School of Medicine and Public Health, University of Wisconsin-Madison, United States.
authors.forename: Chidi N
authors.initials: CN
authors.lastname: Obasi
authors.affiliation: Department 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.
authors.forename: Rachel C
authors.initials: RC
authors.lastname: Molander
mesh_terms: D000328:Adult; D000368:Aged; D002908:Chronic Disease; D016207:Cytokines / Q000276:immunology; D005221:Fatigue / Q000276:immunology / Q000628:therapy*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D055556:Nasal Lavage / Q000379:methods*; D009297:Nasal Mucosa / Q000276:immunology; D018923:Persian Gulf Syndrome / Q000276:immunology / Q000628:therapy*; D012220:Rhinitis / Q000000981:diagnostic imaging / Q000276:immunology / Q000628:therapy*; D012852:Sinusitis / Q000000981:diagnostic imaging / Q000276:immunology / Q000628:therapy*; D012965:Sodium Chloride / Q000627:therapeutic use*; D013549:Sweetening Agents / Q000627:therapeutic use*; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome; D014993:Xylitol / Q000627:therapeutic use*
chemical_list: D016207:Cytokines; D013549:Sweetening Agents; D012965:Sodium Chloride; D014993:Xylitol
keywords: Chronic rhinosinusitis; Fatigue; Gulf War Illness; Nasal irrigation; Veterans; Xylitol