Results of a RCT assessing saline and xylitol nasal irrigation for CRS and fatigue in Gulf War illness

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. LEVEL OF EVIDENCE: 1b, individual randomized controlled trial.