NEW YORK (Reuters Health) – Steroid nasal spray does not have a beneficial effect on the tympanometric signs and symptoms of eustachian tube dysfunction in school-aged children and adults, according to results of a randomized controlled study.
“Our findings, which do not include preschool-aged children, do not demonstrate a statistically significant benefit in normalizing tympanometry when comparing the use of nasal steroid spray with placebo spray at 6 weeks,” the researchers note.
Acute eustachian tube dysfunction is common in children and adults, and may contribute to otitis media with effusion and negative middle ear pressure. No single therapy has been widely accepted or found effective for treatment of the manifestations of acute eustachian tube dysfunction, although intranasal steroid treatment has been proposed as a treatment.
Dr. Laura J. Orvidas from the Mayo Clinic in Rochester, Minnesota and colleagues tested the effects of intranasal aqueous triamcinolone acetonide (Nasacort AQ Nasal Spray; Sanofi-Aventis US, LLC) versus placebo in 91 children and adults (aged 6 and older) with eustachian tube dysfunction and either otitis media or negative middle ear pressure at baseline.
Once daily for 6 weeks, 45 subjects used the steroid nasal spray and 46 used a matching placebo spray. Resolution of abnormal tympanometry and change in symptom severity and frequency were the main outcome measures.
The researchers failed to see any statistically significant between-group differences in normalization of abnormal tympanometric signs.
On a per-patient basis, 18.9% of those receiving the steroid spray and 32.4% of those receiving the placebo spray experienced complete normalization (P = 0.18). On a per-ear basis, the corresponding figures were 22% and 35% (P = 0.15).
“On the basis of responses to pre- and post-treatment questionnaire, it also appears unlikely that nasal steroid spray improves eustachian tube dysfunction-related symptom complaints,” Dr. Orvidas and colleagues report.
A subgroup analysis looking only at the pediatric patients also failed to yield evidence of a benefit to the nasal steroid spray over placebo.
Dr. Orvidas and colleagues point out that some clinicians take a “wait and see” approach to eustachian tube dysfunction, due to a lack of a single accepted intervention and the “ostensibly benign nature of this condition.”
While this may be “reasonable,” an analysis of the placebo arm of this study shows that only about one-third of cases will resolve spontaneously. Still, there didn’t seem to be any severe adverse consequences of watchful waiting, they say.
This information on the natural history of eustachian tube dysfunction may be helpful in counseling patients, they add.
The study was funded by a grant from Sanofi-Aventis US, LLC.
Arch Otolaryngol Head Neck Surg