PEDIATRICS Vol. 88 No. 2 August 1991, pp. 215-222
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Randomized, Controlled Trial Comparing Longterm Sulfonamide Therapy to Ventilation Tubes for Otitis Media With Effusion

Philippe A.M. Bernard MD, PhD, FRCS(C)1, Robert J. Stenstrom BSc, MSc2, William Feldman MD FRCP(C)3, and Andree Durieux-Smith PhD4

1 From the Department of Otolaryngology, Children's Hospital of Eastern Ontario, Ottawa, Canada
2 From the Departments of Otolaryngology and Pediatrics, Children's Hospital of Eastern Ontario, Ottawa, Canada
3 From the Department of Pediatrics, Children's Hospital of Eastern Ontario, Ottawa, Canada
4 From the Department of Audiology, Children's Hospital of Eastern Ontario, Ottawa, Canada

Several studies have indicated that either the surgical insertion of ventilation tubes (VTs) or long-term treatment with sulfonamide-based antibacterials is effective in the management of otitis media with effusion (OME; otherwise known as serous otitis media, secretory otitis media, and glue ear) when compared with a notreatment control or placebo. This controlled trial is the first to compare directly the effectiveness of these two treatments for long-standing OME. Outcome variables are treatment success rates, hearing thresholds, recurrent acute otitis media episodes, and side effects of medication or complications of VT placement. One hundred twenty-five children (aged 2.5 to 7 years) who met the usual indications for surgery (long-standing [>3 months] OME and conductive hearing loss) were randomly assigned to "medical" treatment (sulfisoxazole 75 mg/kg per day for 6 months) or "surgical" treatment (bilateral insertion of VTs). Subjects underwent pure-tone audiometry (500, 1000, 2000, 4000 Hz) and otomicroscopic examination at 2, 4, 6, 12, and 18 months. A significantly greater proportion of medical subjects (67%) than surgical subjects (48%) were treatment failures at 6, 12, or 18 months (P = .0208). Surgical subjects had significantly better hearing at 2 and 4 months (P values < .01) but not at 6, 12, and 18 months (P values > .2). A significantly greater proportion of surgical subjects (50%) experienced complications of treatment than did medical subjects (9%) (P < .001). Thirty-three percent of candidates for VT placement did not require surgery when treated with a 6-month course of sulfisoxazole. Given these findings, together with the low cost of sulfonamide, a 6-month trial of antimicrobial therapy is recommended for children with long-standing OME, before considering VT placement.

Key Words: otitis media with effusion • antimicrobial therapy • ventilation tubes • conductive hearing loss

Submitted on July 20, 1990
Accepted on December 12, 1990




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