Randomized, controlled trial comparing long-term sulfonamide therapy to ventilation tubes for otitis media with...

Area of Science:

• Pediatric Otolaryngology
• Evidence-Based Medicine
• Clinical Trials

Background:

• Otitis media with effusion (OME), also known as glue ear, affects many children.
• Current management options include ventilation tubes (VTs) or medical treatment.
• Direct comparisons of these treatments for long-standing OME are limited.

Purpose of the Study:

• To directly compare the effectiveness of surgical VTs versus long-term sulfonamide antibacterial treatment for persistent OME in children.
• To evaluate outcomes including treatment success, hearing improvement, OME recurrence, and treatment-related complications.

Main Methods:

• A randomized controlled trial involving 125 children (2.5-7 years) with long-standing OME and conductive hearing loss.
• Children were assigned to either medical treatment (sulfisoxazole for 6 months) or surgical treatment (bilateral VTs).
• Outcomes were assessed via audiometry and otomicroscopy at multiple time points up to 18 months.

Main Results:

• Medical treatment resulted in a significantly higher proportion of treatment failures (67%) compared to surgical treatment (48%) at 6, 12, or 18 months (P = .0208).
• Surgical treatment led to significantly better hearing at 2 and 4 months, but this difference was not sustained at later time points.
• Complications were significantly more frequent in the surgical group (50%) than the medical group (9%) (P < .001).

Conclusions:

• While surgical VTs offer initial hearing benefits, long-term treatment with sulfisoxazole is a viable alternative for OME management.
• A significant percentage of children considered for VT placement may avoid surgery with a 6-month course of sulfisoxazole.
• Medical management presents a lower risk of treatment-related complications compared to surgical intervention.