Fran Lowry

November 22, 2011

November 22, 2011 (Boston, Massachusetts) — The nasal corticosteroid spray ciclesonide is more effective than a broad-spectrum oral antibiotic for the treatment of children with otitis media with effusion, according to a small study presented in an oral session here at the American College of Allergy, Asthma & Immunology 2011 Annual Scientific Meeting.

A resolution of otitis media with effusion occurred after 8 days of treatment with the aqueous nasal spray, but it took 14 days for a resolution in children treated with amoxicillin and clavulanate, Safa Nsouli, MD, director of the Danville Asthma and Allergy Clinic in California, reported.

In an open-label study, Dr. Nsouli and colleagues randomized 40 atopic children, 6 to 11 years of age, with otitis media with effusion to 1 of 2 groups: 2 sprays of ciclesonide 50 µg per nostril daily (n = 20); or amoxicillin and clavulanate potassium 90 mg/kg per day in 2 divided doses every 12 hours (n = 20). Both treatments were given for a 2-week period.

The effectiveness of the 2 treatments was assessed objectively using pneumatic otoscopy, impedance tympanometry, and audiometry.

"There is a nasal obstruction that occurs with otitis media. If we eliminate the nasal obstruction with ciclesonide, we decrease the aspiration reflex of the nasopharyngeal secretions into the middle ear that occur via the eustacian tube," Dr. Nsouli told Medscape Medical News.

"We also reduce the allergic inflammatory obstruction of the eustacian tube. Ciclesonide decreases those mechanisms, which helps clear the otitis media much faster than a plain antibiotic treatment that works only on the bacteria," he said. "It's like having a clogged sink. You can try to clean the sink but it is impossible unless the sink is unplugged and drained."

In addition to resolving otitis media symptoms more rapidly, ciclesonide is a safer option, Dr. Nsouli said.

"I am sure many doctors and parents have noticed that their pediatric patients with otitis media can be on several antibiotic courses, sometimes for 6 to 8 months, with no results. They have even inserted an ear tube for drainage of the secretions. Our study shows that we can eliminate the long-term course of antibiotics," Dr. Nsouli said.

Heartening Results

Medscape Medical News invited Chitra Dinakar, MD, professor of pediatrics at the University of Missouri at Kansas City, for her views on this study.

"Studies have shown that only about 1 in 3 children with middle-ear effusion who undergo myringotomy and placement of ventilation tubes have a bacterial pathogen identified; in general, qualitative studies suggest low bacterial densities in such effusions," Dr. Dinakar noted. "Additionally, inflammatory exudates or infiltration of neutrophils in the fluid is typically not found.

Despite this, pediatricians encounter patients with "fluid in the ear" who are given multiple course of antibiotics, raising concerns about "the development of multidrug-resistant pathogens and the effects of antibiotics on a young child's natural flora and immune system," she said.

"It is heartening to note that this small open-label study showed more rapid resolution of symptoms with a nasal steroid, compared to a course of an appropriate antibiotic, at least in the short-term assessment period of 2 weeks," Dr. Dinakar said.

Dr. Nsouli has disclosed no relevant financial relationships. Dr. Dinakar reports financial relationships with AstraZeneca and GlaxoSmithKline.

American College of Allergy, Asthma & Immunology (ACAAI) 2011 Annual Scientific Meeting: Abstract 62. Presented November 6, 2011.


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