SAN FRANCISCO — Although it may seem logical that corticosteroids, antihistamines, and/or decongestants may be good adjunctive treatments of acute otitis media, the evidence does not bear this out, Dr. Tasnee Chonmaitree said at the annual meeting of the Pediatric Academic Societies.
The rationale for using corticosteroids and antihistamines is clear: Drugs that can inhibit the synthesis or counteract the actions of inflammatory mediators should help improve the outcome—or at least provide some symptom relief—in acute otitis media (AOM), said Dr. Chonmaitree of the University of Texas, Galveston.
Corticosteroids, for example, inhibit the recruitment of leukocytes and monocytes to the affected area, reduce vascular permeability, and inhibit the synthesis or release of numerous inflammatory mediators and cytokines. Moreover, there is evidence that corticosteroids improve outcomes in otorrhea in children and AOM in animal models.
But two randomized controlled trials conducted by Dr. Chonmaitree and her colleagues demonstrated no clear benefit for corticosteroids and antihistamines alone or in combination in patients taking antibiotics. Both studies had four arms. Some patients received two placebos, some received one placebo plus corticosteroid, some received one placebo plus antihistamine, and some received corticosteroid plus antihistamine.
The first study involved 80 patients, aged 3 months to 6 years, who were followed for 3 months. There were no differences in laboratory values, including levels of histamine and leukotriene B4 that could be attributed to either of the drugs. However, corticosteroid treatment was associated with a lower rate of treatment failure within the first 2 weeks and a shorter duration of middle ear effusion.
A second trial followed 180 high-risk children with at least two previous episodes of AOM for 6 months. There were no statistically significant differences in the percentage of patients experiencing treatment failure in the first 2 weeks. But there was a significant difference in the duration of middle ear effusion. This difference favored placebo.
Patients receiving placebo alone experienced a median of 25 days of middle ear effusion. Patients receiving antihistamine alone experienced middle ear effusion for a median of 73 days, almost three times longer. Patients taking corticosteroid alone had about the same duration of effusion as did the placebo patients, and patients taking antihistamine and corticosteroid experienced a median of 36 days of effusion. The conclusion was that antihistamines actually prolong middle air effusion in patients with AOM and thus should not be used. The Cochrane Collaboration conducted a detailed metaanalysis on the use of antihistamines and/or decongestants in AOM and came to similar conclusions (Cochrane Database Syst. Rev. 2004;[3]:CD001727).