New support for nonsurgical OME intervention

August 18, 2015

Antibiotics and other medications don’t do any good and surgery is sometimes an extreme fix for otitis media with effusion (OME). Now, a United Kingdom researcher is giving new credence to a nonsurgical treatment that children can do on their own at home.

Antibiotics and other medications don’t do any good and surgery is sometimes an extreme fix for otitis media with effusion (OME). Now, a United Kingdom researcher is giving new credence to a nonsurgical treatment that children can do on their own at home.

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Pediatricians and primary care physicians should not rely on antibiotics or similar medications to treat otitis media with effusion (OME), according to a new study, and surgery should be reserved for only particular cases.

Instead of traditional medications and surgery, Ian Williamson, MB, ChB, MD, FRCS(Ed), FRCGP, a primary care lecturer at the University of Southampton, UK, says autoinflation offers children and parents a new, effective remedy that can be used at home.

“There is now more evidence to support several earlier small surgical (hospital)-based trials of nasal balloon autoinflation,” says Williamson. “The method works in clearing effusions, improving symptoms, and reduces the overall impact of OME on the life of the child and family over a 3-month waiting period.”

The balloon autoinflation treatment complements natural resolution effects, Williamson says, and should improve patient satisfaction with management of the problem. “We think balloon autoinflation should be more widely used,” Williamson says.

Autoinflation employs a specially manufactured balloon (Otovent). The balloon is placed inside the child’s nose, and the child exhales through the nose to blow it up. The act of blowing up the balloon is believed to help open the eustachian tube, allowing fluid to drain away from the middle ear. The balloon therefore helps to equalize pressure and relieve OME symptoms. Children are shown how to use the device by watching a nurse or parent demonstrate first. The balloon is inflated 3 times daily for the first month, and children with a type-B tympanogram after that first month were instructed to continue the treatment for another 2 months.

“Autoinflation would be a good substitute for antibiotics which don’t work in (OME), and have well-known harms and side effects,” Williamson says, adding that using autoinflation as an alternative to surgery would have to be judged on a case-by-case basis.

“If the doctor thinks the condition is severe and meets the criteria for surgery, then using nasal balloon autoinflation may cause unnecessary and unwanted delay. However the majority of children affected by OME do not meet these criteria but still have symptoms and concerns worthy of a nonsurgical treatment,” Williamson says. “In these instances we would suggest nasal balloon autoinflation is a good first-line therapy. It’s possible to speculate some children may avoid surgery altogether.”

Otitis media with effusion, also known as “glue ear,” is the accumulation of fluid in the middle ear without the usual signs and symptoms of an ear infection. Often associated with viral infections, the prevalence of OME is highest (46%) in children aged 4 to 5 years, and about a third of children experience a recurrence after initial treatment.

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There were 2.2 million cases of OME diagnosed in the United States in 2004, according to the study, and treatment costs reached an estimated $4 billion.

Otitis media with effusion can occur in the aftermath of a normal ear infection or when the eustachian tube is partially blocked. Allergies, irritants, respiratory infections, drinking while lying on one’s back, and sudden increases in air pressure can all cause additional swelling or blockage of the eustachian tube leading to increased fluid accumulation. Children are more prone to OME because of the shorter length, softer structure, and straighter shape of their eustachian tubes, according to the National Library of Medicine.

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Available treatments for OME include antibiotics, antihistamines, decongestants, and intranasal steroids, but Williamson says those treatments are all ineffective and deliver unwanted adverse effects. Surgical intervention is an option for some OME patients, but Williamson says the autoinflation technique offers a simpler, lower cost, and nonsurgical treatment option.

Study outcomes were measured by testing tympanometric resolution-illustrated by a type-A or type-C1 tympanogram indicating normal middle ear pressure. Quality of life was measured in participants at 3 months posttreatment using parent diaries of symptoms, adverse events, compliance, lost school days, complaints from the child, and more.

More than 250 participants were studied from December 2011 to February 2013, with about half receiving standard OME care and the other half receiving standard care plus autoinflation.

Williamson’s report notes that compared with those children who received standard care, more children in the autoinflation arm of the study achieved tympanometric resolution after 1 and 3 months of treatment. Additionally, children in the autoinflation treatment group reported fewer days with symptoms after 1 month than their counterparts receiving standard OME care.

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Eighty-nine percent of parents say they used the device “most” or “all of the time” during the first month of autoinflation treatment, and the report notes that compliance was reinforced through daily sticker charts. In the group that completed autoinflation treatment for 3 months, compliance rates were around 80%, according to the report.

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As far as adverse effects go, there were no more nosebleeds in the treatment group receiving the autoinflation therapy versus the standard care control group (15% vs 14%, respectively), but researchers did note there were 5% more respiratory infections in the treatment group. Overall, 15% of the treatment group reported respiratory infections, mainly mild afebrile rhinorrhea. Eight children in the treatment group reported ear pain compared with 2 in the control group, and 5 children in the treatment group experienced acute otitis media compared with 4 in the control group. Two children were withdrawn from the treatment group, Williamson says-1 who was admitted to the hospital with mild/early mastoiditis, and another who was withdrawn because of ear pain.

However, Williamson notes that because fluid in the ear does not always clear completely, even after 3 months, physicians must be vigilant against recurrences and keep the option for surgical treatment available.

“Best evidence suggests there are currently no proven nonsurgical interventions for glue ear. Parents often see temporizing strategies as caus­ing unreasonable delay, and this can also lead to use of ineffective treatments, such as antibiotics,” Williamson continues. “For the child, parent, and professional, the main issue is the impact caused by otitis media with effusion.”

Moderate improvement in ear-related quality of life with autoinflation treatment were promising, the study notes.

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Although the study group consisted of children aged 4 to 11 years, Williamson says the treatment could likely be used in younger children depending on their abilities and level of compliance.

“Families of the very youngest children might have more to gain by considering surgery where autoinflation will be likely less effective or sometimes impossible to do,” Williamson says. “However in the UK, most surgery is done in children aged over 3 years, with generally greater benefit observed for those with more protracted and frequent episodes (ie, older children).”

Williams says autoinflation in school-aged children is both feasible in the primary care setting and effective in resolving OME infections and symptoms.

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“Autoinflation is a simple, low-cost procedure that can be taught to young children in a primary care setting with a reason­able expectation of compliance,” Williamson says. “It is a relatively noninvasive option that can add benefit by helping to fill the current gap between either doing nothing effective or refer­ring for surgery. Wider use of this device has considerable potential to address the present lack of treatment options for most symptomatic chil­dren, and the frequency with which inappropri­ate antibiotics continue to be used to fill this gap.”

More research is needed on the benefits of autoinflation, and not all children are candidates, but Williamson says the treatment still offers an alternative treatment option for some.

“Autoinflation may not be suitable for all children, especially those under 4 years of age, and does require ongoing commitment to treatment,” Williamson says. “Further research is needed for very young children, and to inform prudent use across different health set­tings . . .  [but] wider use of nasal balloon autoinflation could address the present lack of treatment options for children with symptomatic otitis media with effusion.”