Oral steroids do not improve hearing, symptoms, or quality of life in children with glue ear. This NIHR-funded trial compared oral steroids with placebo for 389 children with glue ear, also called otitis media with effusion, and found no significant effect on those outcomes.
Glue ear is when the middle ear fills with fluid, often following an ear or respiratory infection. The fluid makes hearing more difficult. It usually resolves within three months without treatment, but if it lasts longer, the hearing loss may cause delayed language development or difficulties with communicating, for instance at school.
This study shows that many children will improve spontaneously, even after three months of glue ear and confirms that steroids are not useful, even though they are well tolerated. Surgery to place ventilation tubes known as grommets is an option for children with persistent glue ear in and hearing loss in both ears. This evidence supports more informed discussions with parents about watchful waiting and the surgical options available.
Why was this study needed?
Otitis media with effusion, glue ear, is a common problem in childhood that can need an operation. It would be very useful to families and the NHS if a drug could help children to improve without needing surgery.
A 2011 Cochrane review looked at steroids taken orally or by nasal spray for treating glue ear. Nasal steroids did not improve glue ear or hearing loss. Oral steroids with or without antibiotics reduced symptoms of glue ear one month after treatment but had no long-term effects or any effects on hearing loss. No other drug treatments are known to be effective for improving the condition.
Most previously identified studies were small and of poor quality. So this trial aimed to recruit a large number of children and to see if a well-designed trial could resolve the question of whether oral steroids could improve hearing outcomes for children who have lived with glue ear for at least three months and have documented hearing loss.
What did this study do?
The OSTRICH randomised controlled trial was conducted in 20 outpatient departments treating ear, nose and throat disorders in England and Wales. In all, 389 children aged two to eight with glue ear for three months and hearing loss participated. Two hundred were assigned to the soluble oral steroid prednisolone daily for seven days and 189 children were assigned to placebo. The dose of prednisolone was 20 mg daily for children aged two to five years and 30 mg daily for children aged six to eight years.
Randomisation was balanced by the age of the child and by trial site. Parents, children, clinicians and researchers were blinded to treatment allocation and this was a well-conducted trial, thus minimising bias.
What did it find?
- Overall, 40% (73/183) of children taking oral steroids and 33% (459/180) taking placebo had acceptable hearing four weeks after treatment. This represents an absolute difference of 7 percentage points that is statistically non-significant (95% confidence interval [CI] –3 to 17) and below the 15% difference that researchers thought would be clinically important. Acceptable hearing was defined as less than or equal to 20 or 25 decibels Hearing Level (db HL) depending on the type of measurement used.
- Similar non-significant results were seen at 12 months, with 69% (118/170) children who had taken steroids having acceptable hearing compared to 61% (99/162) who took a placebo.
- After 12 months, the mean otitis media symptom score measured by OM8-30 was −0.22 in children taking steroids and – 0.29 in children taking a placebo (adjusted difference 0.05, 95% CI −0.12 to 0.22). Lower scores mean a better quality of life related to otitis media according to infection-related physical health, general developmental impact and hearing difficulties.
What does current guidance say on this issue?
NICE’s 2008 guideline on otitis media with effusion in under 12s covers management of children who have glue ear in both ears and persistent hearing loss. It recommends against the use of topical or oral steroids for managing otitis media with effusion.
Surgical intervention with ventilation tubes, called grommets, is recommended for children who are affected for at least three months and have a hearing level of 25 to 30 dB HL in the better ear.
What are the implications?
The findings confirm the high rate of spontaneous resolution of glue ear at six months and one year. The small seven percentage point increase in acceptable hearing at five weeks was not statistically significant or clinically important and suggests that steroids do not have a worthwhile effect on hearing. Quality of life did not differ between groups, and this supports current guidance that oral steroids should not be prescribed for glue ear in children.
Grommets remain an option for those with bilateral effusion and persistent hearing loss.
There is a need to continue the search for effective non-invasive treatments for glue ear in children.
Citation and Funding
Francis NA, Cannings-John R, Waldron CA et al. Oral steroids for resolution of otitis media with effusion in children (OSTRICH): a double-blinded, placebo-controlled randomised trial. Lancet. 2018;392:557-68.
This project was funded by the National Institute for Health Research Health Technology Assessment programme (project number 11/01/26).
National Deaf Children’s Society. Glue ear. London: National Deaf Children’s Society; 2018.
NHS website. Glue ear. London: Department of Health and Social Care; last reviewed August 2017.
NICE. Otitis media with effusion. Clinical Knowledge Summary. London: National Institute for Health and Care Excellence; updated October 2016.
NICE. Otitis media with effusion in under 12s: surgery. CG60. London: National Institute for Health and Care Excellence; 2008.
Simpson SA, Lewis R, van der Voort J et al. Oral or topical nasal steroids for hearing loss associated with otitis media with effusion in children. Cochrane Database of Syst Rev. 2011; (5):CD001935.
Produced by the University of Southampton and Bazian on behalf of NIHR through the NIHR Dissemination Centre