Abstract
Objective: To assess the efficacy of saline nasal irrigation (S-NI) and xylitol nasal irrigation (X-NI) for chronic rhinosinusitis in participants with Gulf War illness (GWI).
Methods: This 26 week, 3-arm (1:1:1) randomized controlled trial examined veterans meeting criteria for GWI with moderate-to-severe chronic rhinosinusitis and fatigue symptoms. All participants received standard of care for chronic rhinosinusitis (CRS); additionally, S-NI or X-NI participants added twice-daily NI using 2% saline or 5% xylitol solutions. Outcomes included disease-specific quality of life (primary; sino-nasal outcome test [SNOT-20]; 0-100 points), overall quality of life (Short-Form 36), and fatigue (Multidimensional Fatigue Index). Outcome assessors were blind to allocation group. Intention-to-treat analysis used repeated measures modeling; statistical significance was evaluated at the two-sided α level of .05.
Results: Randomization (N = 40) produced three similar groups regarding sex (male, 80%), age (53.8 ± 7.8 years), duration (19.8 ± 7.7 years), and illness severity (48.5 ± 12.7 SNOT-20 points). Age- and gender-adjusted between-group comparison showed that X-NI participants, compared with control, reported improved SNOT-20 scores at 8 weeks (13.5 points, 95% confidence interval [CI] -27.9 to 0.9) and at 26 weeks (15.4 points, 95% CI -30.1 to -0.6). S-NI participants improved by 13.4 points (95% CI -28.8, 2.1) at 26 weeks compared with control.The improvement in both NI groups approached minimal clinical important difference compared to control for the SNOT-20 in the general population. Secondary outcomes were not different between groups. Satisfaction in both irrigation groups was high.
Conclusions: This randomized controlled trial suggests that NI with saline or xylitol improves chronic sinus symptoms among participants with GWI with improvement scores similar to those in the general population.
Methods: This 26 week, 3-arm (1:1:1) randomized controlled trial examined veterans meeting criteria for GWI with moderate-to-severe chronic rhinosinusitis and fatigue symptoms. All participants received standard of care for chronic rhinosinusitis (CRS); additionally, S-NI or X-NI participants added twice-daily NI using 2% saline or 5% xylitol solutions. Outcomes included disease-specific quality of life (primary; sino-nasal outcome test [SNOT-20]; 0-100 points), overall quality of life (Short-Form 36), and fatigue (Multidimensional Fatigue Index). Outcome assessors were blind to allocation group. Intention-to-treat analysis used repeated measures modeling; statistical significance was evaluated at the two-sided α level of .05.
Results: Randomization (N = 40) produced three similar groups regarding sex (male, 80%), age (53.8 ± 7.8 years), duration (19.8 ± 7.7 years), and illness severity (48.5 ± 12.7 SNOT-20 points). Age- and gender-adjusted between-group comparison showed that X-NI participants, compared with control, reported improved SNOT-20 scores at 8 weeks (13.5 points, 95% confidence interval [CI] -27.9 to 0.9) and at 26 weeks (15.4 points, 95% CI -30.1 to -0.6). S-NI participants improved by 13.4 points (95% CI -28.8, 2.1) at 26 weeks compared with control.The improvement in both NI groups approached minimal clinical important difference compared to control for the SNOT-20 in the general population. Secondary outcomes were not different between groups. Satisfaction in both irrigation groups was high.
Conclusions: This randomized controlled trial suggests that NI with saline or xylitol improves chronic sinus symptoms among participants with GWI with improvement scores similar to those in the general population.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 613-620 |
| Journal | Laryngoscope investigative otolaryngology |
| Volume | 5 |
| Issue number | 4 |
| State | Published - Jul 7 2020 |