"Using the nose to inflate a balloon helps heal glue ear," BBC News reports. The technique, known as autoinflation, was found to be effective in around half of cases of this common childhood ear condition.
Glue ear is when the middle ear becomes filled with fluid. It is common among young children and can cause hearing problems. Most cases get better without treatment, but sometimes hearing aids or grommets (small tubes inserted into the eardrum to drain fluid) may be used.
Autoinflation is where a child blows into a special balloon with their nose. It is not a new concept, but research into its effectiveness compared with other treatments for glue ear – which usually boils down to "watch and wait" – has been lacking.
More than 300 children were included in the study and received autoinflation (three times daily for one to three months) in addition to usual care or usual care alone (control). After one month, 47.3% of the autoinflation group were diagnosed as having normal hearing, compared with 35.6% in the control group.
Autoinflation will only provide a solution for children who are able to inflate the nasal balloon and can do so on a regular, daily basis. This means it may not be suitable for everyone. The technique should not be used without medical supervision and training.
Where did the story come from?
The study was carried out by researchers from the University of Southampton and the University of Oxford.
Funding was provided by the Health Technology Assessment of the National Institute for Health Research.
This study has been reported accurately by BBC News and the Daily Mirror, although the reporting gives the impression autoinflation is a new technique. In fact the technique has been used for decades, but there has been persistent controversy about whether it is effective or not.
What kind of research was this?
This was a randomised controlled trial (RCT) to assess the effectiveness of autoinflation in the treatment of children with glue ear.
Glue ear is when the middle ear becomes filled with fluid. It is quite common among young children – the study reports that up to half of children have been affected by the age of four to five – and can cause problems with hearing and sometimes speech and language development.
The exact cause isn't always clear, but it may be the result of previous ear infection or irritation from environmental allergic substances or smoke.
Most cases get better without treatment, but sometimes hearing aids or grommets may be used. Autoinflation, where the child blows into a special balloon with their nose, is another treatment option.
A randomised controlled study design is the best way to assess the effect of a treatment.
What did the research involve?
This study included 320 children aged 4 to 11 with glue ear and a recent (past three months) history of hearing loss or other relevant ear-related problems. The children were recruited from 43 general practices in the UK between January 2012 and February 2013.
They were randomly assigned to autoinflation three times daily for between one and three months in addition to usual care, or usual care only (control).
Assessment of middle ear fluid was made at between one and three months by an expert who was unaware of which treatment the children received.
Ear-related quality of life was compared with the baseline values – essentially, the impact any hearing loss had on day-to-day living for each child. Data from weekly symptom diaries related to glue ear was summarised according to the number of days with symptoms.
What were the basic results?
Baseline characteristics were similar in the two groups. The children who received autoinflation had better outcomes – 47% had no symptoms at one month, compared with 35% in the control group. At three months, the condition had cleared up in 50% in the autoinflation group, compared with 38% in the control group.
It was calculated that nine children would need to be treated with autoinflation for one additional child to benefit from the treatment, compared with what would be expected for usual care. In other words, autoinflation had a number needed to treat (NNT) of nine.
Further analyses found age (above or below 6.5 years), the severity of the symptoms, quality of life or gender had no effect on treatment outcome. Autoinflation increased ear-related quality of life, with children having fewer days with symptoms at one and three months than the usual care group.
Adverse effects were generally similar in both groups, with nosebleeds occurring most frequently (15% and 14% in each group). Mild respiratory tract infections (such as a runny nose) were more common in the autoinflation group, with 15% of children affected, compared with 10% in the control group.
How did the researchers interpret the results?
The researchers concluded that, "Autoinflation in children aged 4 to 11 years with otitis media with effusion [glue ear] is feasible in [general practice] and effective both in clearing effusions and improving symptoms and ear-related child and parent quality of life."
This RCT aimed to assess the use of autoinflation as a treatment for glue ear. More than 300 children were included in the study and were randomly assigned to receive autoinflation, in addition to usual care for up to three months, or usual care alone.
The use of autoinflation does appear to show some promise at one and three months, and the side effects were generally mild. However, this will only provide a solution for children who are able to perform the technique and do this regularly. This means it may not be a suitable treatment for everyone.
This study's main strength is that it included a representative sample of the UK population. The researchers conducted a power calculation to ensure they had enrolled a sufficient number of participants to increase the certainty of their findings.
Group assignment was also random, which reduces the risk of bias, and the analysis was by assigned group, with fairly low drop-out (8% at one month and 12% at three months).
Participants were not blinded to the treatment they were receiving, but this is not really possible with this type of intervention. However, the investigators assessing the outcome of the treatment were blinded, which is a strength.
However, the study only assessed school-age children, who were more likely to be able to perform autoinflation, and does not address very young children with glue ear.
This study also cannot inform us how autoinflation may compare with other treatments, such as the use of hearing aids or grommets, particularly in the longer term.
Overall, this study has provided some positive results, which should be confirmed by a larger study over a longer period of time that also involves younger children.
The treatment does have the advantage of being relatively cheap and non-invasive. It could be a useful first-line treatment as part of a step-wise approach to treat glue ear. If it proves ineffective in individual cases, other treatments such as grommets could then be used.