Resolution of otitis media with effusion with the use of a stepped treatment regimen of trimethoprim–sulfamethoxazole and prednisone

This double blind, placebo-controlled trial was designed to determine whether intervention with a stepped regimen of trimethoprim-sulfa-methoxazole (TMP-SMX) and prednisone would prevent high risk children from developing chronic otitis media with effusion (OME)and recurrent acute otitis media. Forty-two children were enrolled, assigned to treatment with active drug or placebo and then examined at 2-week intervals. They received TMP-SMX (or placebo) during the first 2 weeks, TMP-SMX and prednisone (or placebo) during Weeks 3 and 4 for persistent OME and TMP-SMX (or placebo) for Weeks 5 and 6 if OME was still unresolved. After treatment 48% of active drug and 14% placebo subjects resolved OME bilaterally (P < 0.05). Active drug subjects also had fewer acute otitis media episodes than placebo subjects while receiving study treatment (P < 0.01). Although this treatment regimen produced short term OME resolution, long term benefits were not demonstrated.