Archief Roodbont

June 8, 2011 — The use of intranasal steroid sprays may not alleviate the manifestations of eustachian tube dysfunction (ETD), according to the results of a randomized, placebo-controlled, double-blind, prospective clinical trial reported in the May issue of Archives of Otolaryngology–Head & Neck Surgery.

"Although many interventions have been recommended to treat ETD, no single therapy has gained universal acceptance and been shown to be efficacious," write Michael B. Gluth, MD, formerly of the Mayo Clinic in Rochester, Minnesota (now with University of Arkansas for Medical Sciences in Little Rock), and colleagues. "Given the potential for inflammatory processes within the nasal cavity and nasopharynx to play a role in the acute development of ETD, it has been hypothesized that intranasal administration of topical corticosteroid medications may contribute to the management of this condition. Previous attempts to prospectively study the effectiveness of nasal steroids to treat ETD have been limited to the pediatric population."

Efficacy of Therapy

The goal of the study was to assess the efficacy of intranasal aqueous triamcinolone acetonide in reducing otitis media with effusion, negative middle ear pressure, and other tympanometric signs and symptoms of ETD. At a tertiary referral clinic, adults at least 18 years old and children 6 to 17 years old seen for otitis media with effusion and/or negative middle ear pressure were randomly assigned to receive aqueous triamcinolone or matching placebo administered once daily intranasally for 6 weeks.

Before and after treatment, all participants underwent tympanometry and otologic examination, and completed a symptom questionnaire. The main study endpoints consisted of resolution of abnormal tympanometry and change in severity and frequency of symptom scores. From September 1, 2005, through December 31, 2008, a total of 91 patients were enrolled.

Compared with the placebo group, the active treatment group had no statistically significant difference in normalization of abnormal tympanometric signs, either on a per-patient basis (19% vs 32%; P = .18) or a per-ear basis (22% vs 35%; P = .15). In an analysis of covariance model, the 2 groups did not differ significantly in the overall poststudy symptom score, after adjustment for the overall symptom score before the study (P = .27).

Do Not Overprescribe

"Readers should take away from these results that there is no evidence supporting the use of intranasal steroid spray just in case it may work or help normalize negative middle pressure or for relieving middle ear fluid," Julie L. Wei, MD, associate professor of pediatric otolaryngology, Department of Otolaryngology-Head Neck Surgery at the University of Kansas School of Medicine, told Medscape Medical News in an independent comment. "This is important so that we do not overprescribe a therapy that is not proven to be effective."

"While the treatment was not associated with adverse events, by not overprescribing we are saving unnecessary costs and medication use in adults and children," Dr. Wei said. "Also, since it would appear that not much improvement occurs after 6 weeks, physicians may want to reassess patients after a longer period of time than 6 weeks to see if fluid clears or middle ear negative pressure goes away."

Study Limitations, Strengths

Limitations of this study include slow rate of participant recruitment, resulting in enrollment of 91 rather than the targeted 146 participants; use of a nonvalidated eustachian tube symptom questionnaire; and lack of data on nasal septal deviation, turbinate hypertrophy, and adenoid hypertrophy. Patients with allergic rhinitis were not specifically included or excluded.

"Also, this study did not include children younger than age 6, and often physicians are treating this condition in preschool aged children," Dr. Wei said. "The strengths of this study include the fact that it is a well-designed clinical trial, described as prospective, randomized, placebo-controlled, double-blinded design. A second strength is the fact that this clinical trial included both adults and children (older than age 6), [reflecting] the general population with negative middle ear pressure and/or middle ear fluid that are seen and treated in the clinical setting by all physicians."

A third strength noted by Dr. Wei is use of both objective and subjective outcome measures, namely tympanometry to measure whether the pressure was normal or negative, and a questionnaire to assess subjective outcome self-reported by the patient or reported by the parents regarding symptoms of ETD.

"Finally, for the placebo group, this study showed that in general, even after waiting 6 weeks most patients did not get better," Dr. Wei said. In future research, she suggested use of a validated subjective ETD-related questionnaire, and studying this issue in children younger than 6 years, although a few such studies have already been done.

"[O]ur data portray a natural history of [otitis media with effusion and negative middle ear pressure] in this population that undergoes spontaneous resolution by 6 weeks in only approximately one-third of subjects," the study authors conclude. "The study medication was well tolerated without any unexpected adverse effects or serious adverse events reported."

This study was supported by sanofi-aventis US, LLC. The study authors and Dr. Wei have disclosed no relevant financial relationships.

Arch Otolaryngol Head Neck Surg. 2011;137:449-455. Abstract