Glenis Kathleen Scadding* , Allergy & Rhinology , University College London , United Kingdom
Yvonne Colette Darby , Allergy & Rhinology , Royal National TNE Hospital
Anna Jansz , Allergy & Rhinology , RNTNE Hospital, London
David Richards , Respiratory , *Glaxo Smith Kline, Stevenage.
Helen Tate , Statistics , MSD Hertford Rd, Hoddesdon, EN11 9BU
Simon Gane , ENT Surgery , University College London
Abstract
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.
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.
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