Children with otitis media with effusion were effectively treated with nasal balloons, a simple, nonsurgical treatment option for the millions of people diagnosed with the ailment annually in the United States, according to a pragmatic trial.
Ian Williamson, MD, from Primary Care and Population Sciences, Faculty of Medicine, University of Southampton, United Kingdom, and coauthors report the findings of their open randomized trial online July 27 in CMAJ.
Otitis media, or glue ear, affects up to 80% of children. Some 2.2 million children sought treatment for it in 2004 in the United States, racking up $4.0 billion in healthcare costs. Although nonsurgical remedies, such as antibiotics and antihistamines, are often prescribed, Dr Williamson and coauthors say they are ineffective. A minority of patients can benefit from surgery to clear the fluid that has accumulated in the middle ear, but surgery is expensive.
To test the clinical effectiveness of nasal balloon autoinflation, the study authors recruited children aged 4 to 11 years from 43 general practices in the United Kingdom from January 2012 to February 2013. The children had confirmed otitis media in at least one ear and a history of ear-related problems in the 3 months before.
Either a nurse or a parent showed the child how to properly stretch the balloon, insert it into a nostril, and inflate it by blowing through the nostril. The 160 children in the treatment group received standard care and inflated the balloon three times daily for up to 3 months. Another 160 children received standard care.
"Compared with standard care, children receiving autoinflation achieved tympanometric resolution more often at 1 month (adjusted relative risk [RR] 1.36, 95% confidence interval [CI] 0.99 to 1.88) and at 3 months (adjusted RR 1.37, 95% CI 1.03 to 1.83, number needed to treat [NNT] = 9)," Dr Williamson and colleagues write.
"At last, there is something effective to offer children with glue ear other than surgery," Chris Del Mar, MD, and Tammy Hoffmann, PhD, both from the Centre for Research in Evidence Based Practice, Bond University, Gold Coast, Queensland, Australia, write in a companion editorial. "Surgical insertion of grommet ventilation tubes through the tympanic membrane is immediately effective, as shown by a Cochrane review involving 1728 participants in 10 trials. However, it has no benefit beyond six months, at which time the deafness of most children in the control groups resolves naturally, and no effect has been shown on the important outcomes of speech and language development."
Because autoinflation may not be suitable for very young children, the study authors call for additional research.
"We have found use of autoinflation in young, school-aged children with otitis media with effusion to be feasible, safe and effective in clearing effusions, and in improving important ear symptoms, concerns and related quality of life over a 3-month watch-and-wait period," Dr Williamson and colleagues conclude.
Financial support for the research was provided by the National Institute for Health Research. The authors have disclosed no relevant financial relationships. One commentator disclosed receiving consultancy fees from Key Pharmaceuticals and GlaxoSmithKline Pharmaceuticals for products related to otitis media, and grants from the National Health and Medical Research Council and the National Institute for Health Research. The second commentator disclosed receiving fees from the Royal Australian College of General Practitioners.
CMAJ. Published online July 27, 2015. Article full text
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Cite this: Inflating Nasal Balloons Eases Children's Glue Ear Symptoms - Medscape - Jul 27, 2015.