Background

Surgical intervention is the most common strategy used to manage persistent hearing loss due to otitis media with effusion among children. A cheap and effective medical treatment that would enhance treatment options is needed. The short-term benefits of oral steroids have been demonstrated only through underpowered, poor-quality studies.

Aim

The OSTRICH (Oral steroids for resolution of otitis media with effusion in children) study aimed at determining whether a short course of oral steroids would achieve acceptable hearing in children with persistent otitis media with effusion and hearing loss.

Patient Profile

• Children (age; 2-8 years, n=389) with symptoms attributable to otitis media with effusion for at least 3 months and having confirmed bilateral hearing loss.

Methods

Study Design

• Multi-centre, randomized, parallel, double-blinded, placebo-controlled trial

Treatment Strategy

Follow-up

• Five weeks

Outcomes

Primary Outcome

• Audiometry-confirmed acceptable hearing at 5 weeks (defined as less than or equal to 20 dB HL averaged within the frequencies of 0.5 kHz, 1 kHz, 2 kHz, and 4 kHz in at least one ear in children assessed by pure tone audiometry, ear-specific insert VRA, or ear-specific play audiometry, and less than or equal to 25 dB HL averaged within the frequencies of 0.5 kHz, 1 kHz, 2 kHz, and 4 KHz in children assessed by sound-field VRA or sound-field performance/play audiometry).

Secondary Outcomes

• The Impact of the intervention on acceptable hearing (defined through audiometry) at 6 months and 12 months
• Adverse events and symptoms

Results

• The assessment for hearing conducted at 5 weeks included 183 children in the oral steroid group and 180 children in the placebo group.
• Acceptable hearing was observed in 40% (n=73) vs. 33% (n=59) children treated with oral steroids and placebo respectively (absolute difference 7% [95% CI –3 to 17], number needed to treat 14; adjusted odds ratio 1·36 [95% CI 0·88–2·11]; p=0·16) (Figure 1).
• Acceptable hearing increased significantly from 5 weeks to 6 months and 12 months (p=0.0001) in both study groups.

• The improvement in hearing remained constant although non-significantly better by 7–8% in the oral steroid group vs. placebo group.
• Adverse events or quality-of-life measures did not differ between the two study groups.

Conclusions

• There was a high rate of spontaneous resolution for otitis media with effusion in children with documented hearing loss and having symptoms attributable for at least 3 months. A short –treatment course of oral prednisolone was not effective for most children aged 2–8 years with persistent otitis media with effusion, though it was well tolerated.
• One in 14 children might achieve improved hearing but not quality of life.

Lancet 2018; 392: 557–68.