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Background. Otitis media with effusion (OME) is an ear disorder defined by the presence of fluid in the middle ear without signs or symptoms of acute infection. The aim of this randomised and controlled pilot study was to evaluate whether the treatment with a watery salso-bromo-iodine solution, administered by nasal douche, could induce ear healing better than isotonic saline in children with OME.Methods. The study was randomized, single-blind, and controlled. Study group (40 children) was treated with salso-bromo-iodine thermal water solution and Control group (40 children) was treated with isotonic saline; both compounds were administered by nasal nebulization with Rinowash nasal douche twice/day for 10 days a month for 3 consecutive months. Tympanogram and audiometry were performed at baseline and after treatment.Results. Salso-bromo-iodine therapy shows better and statistically significant trend after treatment when compared to control group both for tympanogram results with greater improvement (represented by type C tympanogram; p = 0.031) and healing (represented by type A tympanogram; p < 0.001) and audiometric results, with higher presence of patients with normal hearing (p = 0.029) and lower among patients with moderate hypoacusis (p = 0.014).Conclusions. The current randomized-controlled pilot study demonstrated that watery salso-bromo-iodine solution was effective in the treatment of children with OME

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