BACKGROUND: AOM is a frequent complication of viral URIs. Theoretically, intranasal steroids may reduce eustachian tube dysfunction and thus reduce AOM secondary to viral URIs. The authors designed a study to test this hypothesis.
POPULATION STUDIED: A total of 210 Finnish children 6 months to 4 years old (average=2.1 years) with less than 48 hours of symptoms of a URI were studied. Children were excluded from the study protocol for current AOM, antibiotic or steroid use within 2 weeks, history of adenoidectomy, or typanostomy tubes. Patients were recruited from outpatient clinics and through media advertisements and thus did not make up a tertiary referral population.
STUDY DESIGN AND VALIDITY: Children were randomly assigned in double-blind fashion to intranasal fluticasone (100 mg twice daily) for 7 days or matching placebo. Nasopharyngeal aspirates for viral cultures were also obtained. Children were reexamined at 7 days or earlier if desired by parents because of symptoms of AOM. Authors defined AOM as a middle ear effusion with signs or symptoms of acute infection. Treatment allocation assignment appears to have been concealed, although this was not explicitly stated. Follow-up was excellent, with 208 of 210 children (99%) being analyzed. Two children were not included in the analysis, because one did not use the medication and the other used it incorrectly. These 2 were not included in the final analysis (intention-to-treat analysis was not performed), but adding them to the results would not have affected the outcome. The control and treatment groups differed only by parental smoking status (47% in treatment group vs 30% in the control group). Since this was a negative trial (showing no difference between the treatment and control groups), it is important that the study was adequately powered to not miss a true difference. The study recruited enough patients to have an 80% power to detect a 60% reduction in AOM.
OUTCOMES MEASURED: Incidence of AOM was the primary outcome measured. Resolution of URI symptoms and viral pathogens identified were also measured.
RESULTS: There was a nonsignificant trend toward increased AOM in the steroid-treated group versus the control group (38% vs 28%; P=.13). There were significantly more cases of AOM identified in the treatment subgroup of children with URIs documented to be caused by rhinovirus infection (46.7% vs 14.7; P=.005; number needed to harm=3.2). There was no difference in symptom resolution between the 2 groups.
Intranasal steroids given to children with URIs do not provide symptomatic relief or decrease episodes of AOM and may in fact increase this undesired outcome. They should not be used for presumed viral URIs in children younger than 4 years. It is important to remember that 80% to 90% of patients with the common cold also develop purulent rhinitis (Sinusitis and the common cold. EBP 1999; 2[1]:5.).