Advances in Life Sciences and Health

Objective: To explore rhinitis treatment, with and without autoinflation of the middle ear, as therapy for otitis media with effusion Design: Prospective, randomised, double blind, placebo-controlled trial of long-term treatment with nasal corticosteroids in OME. Otovent auto-inflation device used when needed over 2 years, with either nasal corticosteroid or placebo, using a 2 ⇥ 2 factorial design Setting: Glue ear clinic at Royal National TNE Hospital, London, 1994-2003. Participants: 200 children with documented OME persisting over 3 months were randomised to receive in double blind fashion either fluticasone propionate aqueous nasal spray (FP) 100mcg daily or matching placebo administered over 2 years. Children with odd trial numbers also received the Otovent auto-inflation device with instructions to use this 3 times daily until hearing improved and to restart use 2 weeks after any upper respiratory tract infection Main outcome measures: The primary outcome measure was treatment failure defined as hearing loss of over 30dB in at least one ear or grommet insertion. Results: An unexpected interaction was apparent between FP and Otovent on time to hearing loss/grommet insertion. Therefore the only comparisons made are between FP and placebo and Otovent and placebo. The FP group had significantly improved disease-free survival compared with placebo (p=0.021). The Otovent group showed improved survival, but this did not reach statistical significance (p=0.140). Conclusion: FP alone decreases the need for grommet insertion or hearing loss When Otovent is used in addition to FP the effect is less than either treatment modality given alone.