Efficacy of seawater for the treatment of allergic rhinitis : a randomized clinical trial

ABSTRACT: To evaluate the efficacy of diluted seawater (SW) nasal lavage and ingestion in the treatment of symptoms of allergic rhinitis, including nasal discharge, in children (2-6 years) compared with physiological “normal” saline solution (NS) as a control. Methods: Controlled, triple-blind, randomized clinical trial of 164 children with allergic rhinitis, drawn from schools and health centers located in areas with low socioeconomic status. Children were divided into two treatment groups: SW and NS. Clinical variables were evaluated at the beginning of the trial and at weeks 2 and 12. At the beginning and the end of the study an anthropometric growth check was performed. Results: 16 of the 164 children left the study early. There were 83 subject in the SW arm and 81 in the NS arm. In weeks 2 and 12, both groups achieved significant reductions in rhinorrhea (p<0.001) compared to baseline values (NS: Δ 36.3% (95% CI: 33.0 to 39.7) in week 2 and Δ 55.7% (95% CI: 52.3 to 59.0) in week 12; SW: Δ 32.0% (95% CI: 25.0 to 39.1) in week 2 and Δ 55.3% (95% CI: 42.2 to 62.3) in week 12). In both groups, instances of sneezing, itching and discharge were reduced (p<0.001). The SW group achieved larger reductions than the physiological NS group in dry cough, loss of appetite, nasal breathing and sleep quality at week 12; these differences were not significant. 14 cases of adverse effects were recorded. Between weeks 0 and 12 there were significant increases in height, weight and sitting height in both groups (p<0.001), and a slight reduction in BMI that was significant only in the SW group (p