1. The Research Question
Autoinflation as a treatment of Otitis Media with Effusion in primary care: a randomized controlled trial
Williamson I, Vennik J, Harnden A, Voysey M, Perera R, Kelly S, Yao G, Raftery J, Mant D, Little P
What is the clinical effectiveness of nasal balloon autoinflation in resolving effusions and improving symptoms and quality of life in children ?
Why is this important?
Otitis media with effusion (OME) is a very common problem that lacks an evidence-based non-surgical treatment option.
Health costs for this condition are estimated at $4 billion per annum.
Wider use of the balloon method may improve child health and development and reduce unnecessary antibiotics .
BP34 Adherence to Antibiotic Prescribing for LRTI and Association With Recovery (Oral Presentation On Completed Research) Nick Francis, MD, PhD, Cardiff University; David Gillespie; Jacqueline Nuttall; Paul Little; Theo Verheij; Samuel Coenen; Jochen Cals; Kerenza Hood; Herman Goossens; Christopher Butler

2. What the Researchers Did
Population/Subjects: 320 children aged 4-11 years (43 UK family practices), with a recent history of OME symptoms or concerns, and a confirmatory B tympanogram in one or both ears. Children were excluded if attending specialists.
Design: Pragmatic two arm randomised controlled trial
Methods:
Assessors were blinded to allocation
Main outcomes: The proportion of children with tympanometric resolution of effusion at 1 and 3 months.
Secondary outcomes: condition specific quality of life (OMQ-14) , weekly symptom diaries.
Intervention: Blowing a nasal balloon (Otovent) three times a day for 1-3 months plus standard care versus standard care only.
aged ≥18 years, consulting with an illness where an acute or worsened cough was the main or dominant symptom, or had a clinical presentation that suggested a lower respiratory tract infection that had been present for ≥28 days.

3. What the Researchers Found
Children showing normal (resolved) tympanograms:
1 MO - 47·3% (62/131) v 35·6% (47/132) for controls (adjusted RR 1·36, 95%CI 0·99-1·88).
3 MO - 49·6% (62/125) v 38·3% (46/120) (adjusted RR 1·37, 1·03 to 1·83; NNT 9).
Individual ears:
1 MO - Relative Risk of resolution of 1.38 ( ).
3 MO - RR 1.41 ( ).
Improved OMQ-14 at 3 months (adjusted score difference)
-0·42 95%CI to-0.22 p=<·001.
Effect-Size of 0.48 S.D favouring intervention.
Reported compliance was good: 89% in the first month and 80% in months 2-3.The ITT and per-protocol analyses were comparable.

4. What This Means for Clinical Practice
Evidence based reviews have previously failed to find an effective non-surgical treatment for OME that could be used in primary care where most children are initially seen (e.g. antibiotics have a NNT>20 and other disadvantages).
Our results show that autoinflation can be successfully applied to a large sample of children aged 4-11 years in primary care,
And indicate that autoinflation is likely to be more clinically beneficial (NNT~9) than standard care during an observation period of 1- 3 months.
We conclude that balloon autoinflation should be more widely used.