Treatment of secretory otitis media with local instillation of hydroxyzine.

The study is a preliminary single-blind, placebo- and prednisolone-controlled investigation of the treatment of 156 children with otitis media with effusion (secretory otitis media, SOM), ranging from 2 to 12 years. The protocol involved tympanotomy and placement of a ventilation tube (grommet), through which control or drug solutions were introduced. Other parameters and coexisting symptoms which could contribute to SOM were also examined. Patients were divided into 3 groups as follows: group A: control (normal saline, 2 ml); group B: prednisolone (25 mg in 2 ml); group C: hydroxyzine pamoate (10(-5) M in 2 ml). The results indicate that in those children treated with hydroxyzine, the rate of relapse was significantly reduced and so was the amount of histamine present in middle ear effusions. The effectiveness of hydroxyzine is discussed in the context of the pathophysiology of SOM, especially with respect to mast cells and their activation by allergic and nonallergic means.

RCT Entities:   Population Interventions Outcomes