A one-week course of oral steroid tablets does not provide any significant benefits for most 2-8 year old children who have had glue ear with hearing loss for at least three months, finds a study published in the The Lancet from researchers at the Universities of Cardiff and Oxford.
Glue ear, otherwise known as otitis media with effusion, is the most common cause of hearing loss in children and one of the most common reasons for children to have surgery (insertion of grommets). Most cases get better within a few weeks or months, but some children can experience prolonged hearing loss that can affect their learning, language development, confidence and mental health.
The OSTRICH study is the largest ever trial of using oral steroids for children with glue ear. 389 children with glue ear and hearing loss in both ears for at least three months were randomly allocated to take steroid tablets once a day for one week or a matched dummy tablet (placebo) for the same amount of time. They completed a symptom diary for five weeks and had their hearing assessed five weeks, six months and 12 months after being entered into the study.
The National Institute for Health Research-funded study found that children who took the steroid tablets were more likely to have satisfactory hearing by five weeks, but the difference was small and may have just been a chance finding.
Oxford University's Professor Chris Butler, a South Wales GP and Professor of Primary Care in the Nuffield Department of Primary Care Health Sciences, co-led the study with Professor Nick Francis from Cardiff University. Commenting on the results, Professor Butler said:
"Doing a study of the effectiveness of a medication in children for this important condition to such a high standard is a great achievement: we have obtained a clear answer to a critical clincial question, thanks to the contribution of the clinicians, and the children and their carers. In addition, the data on the natural history of otitis media with effusion from this piece of research will also help shared clinical decisions making.
"The National Institute of Health Research made this study possible, and we are grateful for the way they support the generation of evidence to support better care.”
Cardiff University's Professor Frances said: “Our study shows that a glue ear often gets better by itself – one in three of these children with prolonged glue ear, and who took placebo tablets, had satisfactory hearing by five weeks.
“We found limited evidence of a benefit from steroid tablets for most children, but it is possible that around one in 14 will get better more quickly following a one-week course of tablets. We didn’t include younger children (under two) in our study, so can’t say whether steroids would be more or less effective in these children.”
A short summary of the trial can be found here: https://youtu.be/VVw5SYZ1r3U
Or visit the study website: www.ostrich-study.co.uk
The full paper can be read here: Oral steroids for resolution of otitis media with effusion in children (OSTRICH): a double-blind, placebo-controlled randomised trial. Francis et al, The Lancet 2018.