NIHR Signal Blowing up a balloon with the nose helps restore hearing in children with glue ear

Published on 7 September 2015

The use of a simple nasal balloon can help restore hearing in children aged 4 to 11 with glue ear. After 3 months, this non-surgical treatment restored normal hearing to 49.6% of children with glue ear compared with 38.3% receiving usual care. Children inflate the balloon by blowing it up with their noses rather than their mouths. The activity which is done three times a day can be taught by nurses in a GP surgery. Few non-surgical treatments exist for children with glue ear. Some, such as antibiotics, are used despite evidence they don’t work. It is hoped using the nasal balloon may help reduce this unnecessary use of antibiotics and reduce the number of children requiring surgery, the last choice for symptoms persisting past three months.

Very young children find the balloon technique harder to learn, so it is not appropriate for them.

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Why was this study needed?

Glue ear is a common condition in childhood where the middle ear is filled with fluid, without infection. About one in five children around the age of two will be affected by glue ear at any given time, and in the UK, GPs see about 200,000 children each year because of it.

Over half of children with glue ear get better without treatment within three months but sometimes it can last longer and cause prolonged deafness. So for the first three months after diagnosis the GP monitors it through “active observation” but does not usually treat it. After three months drugs such as antibiotics or nasal decongestants are considered, but a number of systematic reviews have found they are not effective. Ventilation tube surgery (grommets) can be effective however this is a more costly treatment that may not be suitable for all children.

Several small hospital based studies have found that a simple, non-surgical procedure using a nasal balloon device can be effective in resolving hearing loss caused by glue ear. This trial was funded by the NIHR to assess the effectiveness of this procedure in primary care. It is the largest trial to date and one of a few to measure response at three months.

What did this study do?

This large, pragmatic randomised controlled trial included 320 children aged 4 to 11 recruited from 43 general practices in the UK, representing a reliable source of evidence. The children were randomly allocated to one of two groups: usual care only, or usual care plus autoinflation using a nasal balloon three times a day for one to three months. It was not possible to hide treatment allocation from the children or nurses delivering the treatment, but the researchers assessing the results were kept unaware of treatment allocations to avoid bias.

After randomisation 29 children in the nasal balloon group and 28 in the usual care group were excluded mainly because data was missing or uninterpretable. The analysis at one month included data from the remaining 131 and 132 children respectively.

What did it find?

  • After one month of treatment a higher proportion of children treated with the nasal balloon (47.3%) were diagnosed as having normal hearing, compared with children in the usual care group (35.6%), but this was not statistically significant, (adjusted relative risk [RR] 1.36, 95% confidence interval [CI] 0.99 to 1.88).
  • At three months the difference was similar: 49.6% of children treated with the nasal balloon had improved compared with 38.3% in the usual care group (adjusted RR 1.37, 95% CI 1.03 to 1.83), but this time it was statistically significant.
  • This meant that about nine children need to be treated with the nasal balloon, for one extra child to recover normal hearing by three months (number needed to treat 9). This is a clinically important result.
  • Adverse effects were similar in both groups, with nosebleeds reported most frequently (15% and 14% in each group). Respiratory tract infections were more during nasal balloon treatment (15%) compared with usual care (10%).

What does current guidance say on this issue?

The 2008 NICE guideline on surgical management of otitis media with effusion (glue ear) in children recommends the insertion of ventilation tubes for children with persistent problems over three months and a certain level of hearing loss in both ears. Non-surgical treatments including drugs are not recommended due to lack of evidence on effectiveness.

The NICE guideline recommends the use of autoinflation during the observation period for children who are likely to be able to use the procedure.

What are the implications?

The nasal balloon device – a simple, low cost non-surgical treatment that can be taught by nurses in general practice – restored normal hearing in up to half of children with glue ear by three months so should be considered a treatment option during this time. While 38% of children got better on their own, in those using the nasal balloon, this was boosted to almost 50%. If you have a prescription for a child less than 16 years of age the treatment is free on the NHS. Over the counter it costs about £7.84. As there is evidence that drugs are not effective for glue ear the introduction of this treatment will reduce the unnecessary use of antibiotics in primary care.

The results are consistent with a 2013 Cochrane systematic review which included eight trials involving 702 patients.

This treatment could potentially reduce the number of surgical interventions required as a higher proportion of children will have restored hearing within three months.

However it may not be suitable for very young children as they might not be able to use the nasal balloon device.

Citation

Williamson I, Vennik J, Harnden A, et al. Effect of nasal balloon autoinflation in children with otitis media with effusion in primary care: an open randomized controlled trial. CMAJ. 2015 Jul 27. pii: cmaj.141608.

This project was funded by the National Institute for Health Research Health Technology Assessment Programme (project number 09/01/27).

Bibliography

NHS Choices. Glue ear. London: Department of Health; 2015.

NICE. Surgical management of otitis media with effusion in children. [CG60]. London: National Institute for Health and Care Excellence; 2008.

Perera R, Glasziou PP, Heneghan CJ et al. Autoinflation for hearing loss associated with otitis media with effusion. Cochrane Database Syst Rev. 2013;(5):CD006285.

van Zon A, van der Heijden GJ, van Dongen TMA et al. Antibiotics for otitis media with effusion in children. Cochrane Database Syst Rev. 2012;(9):CD009163.

Why was this study needed?

Glue ear is a common condition in childhood where the middle ear is filled with fluid, without infection. About one in five children around the age of two will be affected by glue ear at any given time, and in the UK, GPs see about 200,000 children each year because of it.

Over half of children with glue ear get better without treatment within three months but sometimes it can last longer and cause prolonged deafness. So for the first three months after diagnosis the GP monitors it through “active observation” but does not usually treat it. After three months drugs such as antibiotics or nasal decongestants are considered, but a number of systematic reviews have found they are not effective. Ventilation tube surgery (grommets) can be effective however this is a more costly treatment that may not be suitable for all children.

Several small hospital based studies have found that a simple, non-surgical procedure using a nasal balloon device can be effective in resolving hearing loss caused by glue ear. This trial was funded by the NIHR to assess the effectiveness of this procedure in primary care. It is the largest trial to date and one of a few to measure response at three months.

What did this study do?

This large, pragmatic randomised controlled trial included 320 children aged 4 to 11 recruited from 43 general practices in the UK, representing a reliable source of evidence. The children were randomly allocated to one of two groups: usual care only, or usual care plus autoinflation using a nasal balloon three times a day for one to three months. It was not possible to hide treatment allocation from the children or nurses delivering the treatment, but the researchers assessing the results were kept unaware of treatment allocations to avoid bias.

After randomisation 29 children in the nasal balloon group and 28 in the usual care group were excluded mainly because data was missing or uninterpretable. The analysis at one month included data from the remaining 131 and 132 children respectively.

What did it find?

  • After one month of treatment a higher proportion of children treated with the nasal balloon (47.3%) were diagnosed as having normal hearing, compared with children in the usual care group (35.6%), but this was not statistically significant, (adjusted relative risk [RR] 1.36, 95% confidence interval [CI] 0.99 to 1.88).
  • At three months the difference was similar: 49.6% of children treated with the nasal balloon had improved compared with 38.3% in the usual care group (adjusted RR 1.37, 95% CI 1.03 to 1.83), but this time it was statistically significant.
  • This meant that about nine children need to be treated with the nasal balloon, for one extra child to recover normal hearing by three months (number needed to treat 9). This is a clinically important result.
  • Adverse effects were similar in both groups, with nosebleeds reported most frequently (15% and 14% in each group). Respiratory tract infections were more during nasal balloon treatment (15%) compared with usual care (10%).

What does current guidance say on this issue?

The 2008 NICE guideline on surgical management of otitis media with effusion (glue ear) in children recommends the insertion of ventilation tubes for children with persistent problems over three months and a certain level of hearing loss in both ears. Non-surgical treatments including drugs are not recommended due to lack of evidence on effectiveness.

The NICE guideline recommends the use of autoinflation during the observation period for children who are likely to be able to use the procedure.

What are the implications?

The nasal balloon device – a simple, low cost non-surgical treatment that can be taught by nurses in general practice – restored normal hearing in up to half of children with glue ear by three months so should be considered a treatment option during this time. While 38% of children got better on their own, in those using the nasal balloon, this was boosted to almost 50%. If you have a prescription for a child less than 16 years of age the treatment is free on the NHS. Over the counter it costs about £7.84. As there is evidence that drugs are not effective for glue ear the introduction of this treatment will reduce the unnecessary use of antibiotics in primary care.

The results are consistent with a 2013 Cochrane systematic review which included eight trials involving 702 patients.

This treatment could potentially reduce the number of surgical interventions required as a higher proportion of children will have restored hearing within three months.

However it may not be suitable for very young children as they might not be able to use the nasal balloon device.

Citation

Williamson I, Vennik J, Harnden A, et al. Effect of nasal balloon autoinflation in children with otitis media with effusion in primary care: an open randomized controlled trial. CMAJ. 2015 Jul 27. pii: cmaj.141608.

This project was funded by the National Institute for Health Research Health Technology Assessment Programme (project number 09/01/27).

Bibliography

NHS Choices. Glue ear. London: Department of Health; 2015.

NICE. Surgical management of otitis media with effusion in children. [CG60]. London: National Institute for Health and Care Excellence; 2008.

Perera R, Glasziou PP, Heneghan CJ et al. Autoinflation for hearing loss associated with otitis media with effusion. Cochrane Database Syst Rev. 2013;(5):CD006285.

van Zon A, van der Heijden GJ, van Dongen TMA et al. Antibiotics for otitis media with effusion in children. Cochrane Database Syst Rev. 2012;(9):CD009163.

Effect of nasal balloon autoinflation in children with otitis media with effusion in primary care: an open randomized controlled trial

Published on 29 July 2015

Williamson, I.,Vennik, J.,Harnden, A.,Voysey, M.,Perera, R.,Kelly, S.,Yao, G.,Raftery, J.,Mant, D.,Little, P.

CMAJ , 2015

BACKGROUND: Otitis media with effusion is a common problem that lacks an evidence-based nonsurgical treatment option. We assessed the clinical effectiveness of treatment with a nasal balloon device in a primary care setting. METHODS: We conducted an open, pragmatic randomized controlled trial set in 43 family practices in the United Kingdom. Children aged 4-11 years with a recent history of ear symptoms and otitis media with effusion in 1 or both ears, confirmed by tympanometry, were allocated to receive either autoinflation 3 times daily for 1-3 months plus usual care or usual care alone. Clearance of middle-ear fluid at 1 and 3 months was assessed by experts masked to allocation. RESULTS: Of 320 children enrolled, those receiving autoinflation were more likely than controls to have normal tympanograms at 1 month (47.3% [62/131] v. 35.6% [47/132]; adjusted relative risk [RR] 1.36, 95% confidence interval [CI] 0.99 to 1.88) and at 3 months (49.6% [62/125] v. 38.3% [46/120]; adjusted RR 1.37, 95% CI 1.03 to 1.83; number needed to treat = 9). Autoinflation produced greater improvements in earrelated quality of life (adjusted between-group difference in change from baseline in OMQ-14 [an ear-related measure of quality of life] score -0.42, 95% CI -0.63 to -0.22). Compliance was 89% at 1 month and 80% at 3 months. Adverse events were mild, infrequent and comparable between groups. INTERPRETATION: Autoinflation in children aged 4-11 years with otitis media with effusion is feasible in primary care and effective both in clearing effusions and improving symptoms and ear-related child and parent quality of life. TRIAL REGISTRATION: ISRCTN, No. 55208702.

Otitis media with effusion also known as “glue ear” is an accumulation of fluid in the middle ear. It is estimated that one in five children around the age of two will be affected by glue ear at any given time, and about four in every five children will have had glue ear at least once by the time they are 10 years old. Hearing loss is the main symptom of glue ear. If this condition persists it can lead to ear infections or speech and language development problems especially in younger children.

Author commentary

Regular nasal balloon autoinflation can augment the natural resolution process of glue-ear in a beneficial, inexpensive, safe and timely fashion for many children with typical symptoms of hearing loss or related health concerns. It is a worthwhile initial management option, considering the generally unsatisfactory nature of other approaches that often includes advice only, or giving an ineffective and harmful treatment such as antibiotics or decongestants, or referring the child prematurely for surgery for lack of treatment. The evidence of effectiveness appears sufficiently strong to justify far wider use in the NHS. It is however mostly limited to use in children aged 4 or over, and those willing to use the method regularly for 1-3 months.

A very brief instruction video on the method is available on the CMAJ website.

Dr Ian Williamson, Associate Professor of Primary Care, University of Southampton