According to the results of a trial conducted in primary care in the UK, topical intranasal corticosteroids are unlikely to be an effective treatment for glue ear in this setting.

This trial, conducted as part of the NIHR Health Technology Assessment programme, sought to evaluate the clinical and cost-effectiveness of the topical nasal steroid mometasone in the treatment of children with otitis media with effusion (OME) in both ears.  The authors note that a recent review by NICE concluded there are no proven effective treatments for this condition; topical steroids delivered as a spray may be beneficial but there is not enough supporting research.

A total of 217 children aged 4-11 years meeting inclusion criteria were recruited into the study from 76 MRC General Practice Research Framework practices throughout the UK between the years 2004 and 2007.  In order to participate they had to present with confirmed OME on both sides, and have a history of one or more episodes of otitis media or ear-related problem in the previous 12 months.  The children were randomised to treatment with mometasone nasal spray (50mcg into each nostril) or placebo spray once daily for three months.  The primary outcome was the proportion of children free from OME at one month, as assessed by tympanometry.  Secondary outcomes included clearance at 3 months and 9 months; adverse events; OM8-30 scores (a functional health status responsive disease-specific measure); hearing loss; days with otalgia; cost-effectiveness; and health utilities.

The main results were as follows (taken from the abstract and executive summary):

• There was no difference between the groups in the rate of resolution at one month: 40.6% (39/96) of the mometasone group demonstrated tympanometric clearance in one or both ears, compared with 44.9% (44/98) of the placebo group (absolute risk reduction of –4.3%; 95% CI –18.05% to 9.26%; the odds ratio was 0.84 (95% CI 0.48 to 1.48))

• The authors say that based on these data (110/9.6), at least 11 children would require to be treated for 1 month with nasal steroids for one child to potentially benefit, and, using the average study value, the number needed to treat for one to benefit would actually be much greater than this.

• Four factors were pre-specified for inclusion in adjusting the analysis – age, season, allergy and severity of the glue ear – but only illness severity was found to affect the results. Even when an adjusted analysis was carried out, no statistically significant treatment effects were found at 1, 3 or 9 months after the start of treatment (the 95% confidence intervals of the adjusted odds ratios all crossed 1). 

• Adverse events (although relatively minor) occurred in 7–22% of children and included nasal stinging, epistaxis, dry throat and cough.

• The economic evaluation found the active treatment arm to be dominated by placebo, accruing slightly (but not significantly) higher costs and fewer quality-adjusted life-years (QALYs), with a 24.2% probability that topical steroids are a cost-effective use of NHS resources at a ceiling ratio of £20,000 per QALY gained.