Background: Otitis media with effusion is the persistent collection of fluid in the middle ear in the absence of active infection. It is a common diagnosis at primary care visits and may be the most common reason for surgery in children. Bilateral otitis media with effusion can lead to marked hearing loss and attendant difficulties with language development and behavior. Approximately 80 percent of children will have had at least one episode of otitis media with effusion by four years of age. Most cases resolve spontaneously within six to 10 weeks, although 10 percent will last at least one year.
No effective medical treatments, including antibiotics, decongestants, and antihistamines, have been identified, despite possible comorbid associations with atopy and allergic rhinitis. Topical intranasal corticosteroids have been used off-label with the goal of alleviating nasal and sinus inflammation that could contribute to eustachian tube dysfunction. However, large studies have not been conducted to compare intranasal steroids with watchful waiting. Williamson and colleagues conducted a double-blind, randomized, placebo-controlled trial to study the clinical effectiveness of nasal steroids for the resolution of otitis media with effusion.
The Study: The authors enrolled 217 children four to 11 years of age who had tympanometrically confirmed bilateral otitis media with effusion in a double-blind placebo controlled trial. Children with only unilateral effusion, those at high risk of recurrence (patients with Down syndrome, Kartagener syndrome, cleft palate, primary ciliary dyskinesia, and immunodeficiency disorders), and those already referred for ear surgery were excluded. Additionally, children who had taken systemic steroids within three months (or who might need them during the study period) and those with recurrent epistaxis were not eligible. Children younger than four years were not included because of the difficulty of using nasal steroids in this age group.
Baseline assessments involved audiometry and a functional health status measure that included respiratory symptoms, ear problems, and speech and hearing difficulties. Parents were given a prospective symptom diary to complete during the first month of participation. Children were randomized to receive mometasone furoate (Nasonex) 50-mcg spray in each nostril daily, or identical placebo, for three months. Parents and children were instructed on proper spray technique; compliance was assessed by weighing spray containers after one month. The primary outcome was tympanometric cure of bilateral effusions at one month. Secondary outcomes included tympanometric cure at three and nine months after treatment, and symptom-based assessments. Adverse effects were recorded at one and three months.
Results: The study reported no significant differences in outcomes between the treatment groups. At one month, 41 percent of children in the nasal steroid group had cleared effusion in at least one ear, and 45 percent in the placebo group had cleared effusion in at least one ear. By three months, 58 and 52 percent of the steroid and placebo groups had resolved in at least one ear. By nine months, 56 percent of the steroid group and 65 percent of the placebo group remained clear of bilateral effusions. Subgroup analyses detected no significant differences in outcome depending on age, presence of atopy, or clinical severity. Although not statistically significant, adverse effects, including cough, dry throat, epistaxis, and nasal stinging, were more common in the treatment group (48 reports) than in the placebo group (33 reports) by three months.
Conclusion: The authors conclude that topical intranasal steroids do not help resolve otitis media with effusion. Most effusions resolve within one to three months. Watchful waiting before referral to a subspecialist is recommended.