Williamson, Ian, Vennik, Jane, Harnden, Anthony, Voysey, Merryn, Perera, Rafael, Breen, Maria, Bradley, Brendan, Kelly, Sadie, Yao, Guiqing, Raftery, James, Mant, David and Little, Paul (2015) An open randomised study of autoinflation in 4- to 11-year-old school children with otitis media with effusion in primary care. Health Technology Assessment, 19 (72), 1-150. (doi:10.3310/hta19720).
Abstract
Background: otitis media with effusion (OME) is a very common problem in primary care, but one that lacks an evidence-based non-surgical treatment.
Objective: to determine the clinical effectiveness of nasal balloon autoinflation for the treatment of OME in children.
Design: a pragmatic, two-arm, open randomised controlled trial.
Setting: forty-three general practices from 17 UK primary care trusts recruited between January 2012 and February 2013.
Participants: school children aged 4-11 years with a history of OME symptoms or related concerns in the previous 3 months, and a type B tympanogram, diagnostic of a middle ear effusion, in one or both ears.
Intervention: three hundred and twenty children were randomised, 160 to each group, using independent web-based computer-generated randomisation (with minimisation based on age, sex and baseline severity of OME) to either nasal balloon autoinflation performed three times per day for 1-3 months plus usual care, or usual care alone.
Main outcome measures: the proportion of children demonstrating clearance of middle ear fluid in at least one ear (with normal tympanograms) at 1 and 3 months, assessed blind to treatment. An ear-related measure of quality of life (QoL) [a 14-point questionnaire on the impact of OME (OMQ-14)], weekly diary recorded symptoms, compliance and adverse events were all secondary outcomes.
Results: at 1 month, the proportion of children with normal tympanograms was 47.3% (62/131) in those allocated to autoinflation and 35.6% (47/132) in those receiving usual care [adjusted relative risk (RR) 1.36, 95% confidence interval (CI) 0.99 to 1.88]. At 3 months, the proportions were 49.6% (62/125) and 38.3% (46/120), respectively (adjusted RR 1.37, 95% CI 1.03 to 1.83; number needed to treat = 9). The change in OMQ-14 also favoured the intervention arm (adjusted global score difference -0.42; p = 0.001). Reported compliance was good: 89% in the first month and 80% in months 2 and 3. Adverse events included otalgia in 4% of treated children compared with 1% in the control group. Minor nosebleeds (14% vs. 15%) and respiratory tract infections (18% vs. 13%) were noted.
Conclusion: we found the use of autoinflation in young children with OME to be feasible in primary care and effective in both clearing effusions and improving child and parent ear-related QoL and symptoms. This method has scope to be used more widely. Further research is needed for very young children, and to inform prudent use in different health settings.
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