Antibiotics of short-term benefit for children with chronic active otitis media

Article Outline

• Van der Veen EL, Rovers MM, Albers FW, Sanders EA, Schilder AG. Effectiveness of trimethoprim/sulfamethoxazole for children with chronic active otitis media: a randomized, placebo-controlled trial. Pediatrics 2007;119:897-904
  • Question
  • Design
  • Setting
  • Participants
  • Intervention
  • Outcomes
  • Results
  • Conclusions
  • Commentary
• Copyright

Back to Article Outline

Van der Veen EL, Rovers MM, Albers FW, Sanders EA, Schilder AG. Effectiveness of trimethoprim/sulfamethoxazole for children with chronic active otitis media: a randomized, placebo-controlled trial. Pediatrics 2007;119:897-904 

Question 

In children with chronic active otitis media (COM), does prolonged outpatient treatment with trimethoprim/sulfamethoxazole result in less otorrhea?

Design 

Randomized, placebo-controlled trial.

Setting 

Pediatric otorhinolaryngology department of the University Medical Center, Utrecht, The Netherlands.

Participants 

101 children (1-12 years of age) with COM (defined as otorrhea for ≥12 weeks).

Intervention 

All children were given a short course of steroid and antibiotic eardrops. They were then assigned randomly to 6 to 12 weeks of orally administered trimethoprim/sulfamethoxazole (18 mg/kg, 2 times per day) or placebo.

Outcomes 

The primary end point was otomicroscopic signs of otorrhea in the presence of a tympanostomy tube or tympanic membrane perforation. Secondary outcome measures included use of medication other than the study medication for ear disease, adverse effects of the study medication, health-related quality of life, pure-tone hearing levels, and bacteriologic findings for the otorrhea samples.

Results 

At 6 weeks, 28% of children in the trimethoprim/sulfamethoxazole group and 53% of children in the placebo group had otomicroscopic signs of otorrhea (number needed to treat [NNT] = 4). At 12 weeks, these values were 32% and 47%, respectively, which were not significantly different. At 1 year, the numbers of children with otorrhea were similar in the 2 groups (25% and 20%, respectively). In 1 child in the trimethoprim/sulfamethoxazole group, a skin rash developed. Vomiting or diarrhea was reported for 9% of the trimethoprim/sulfamethoxazole group and 2% of the placebo group. Pure-tone hearing levels and health-related quality of life improved during the study, but did not differ between the trimethoprim/sulfamethoxazole group and the placebo group. Pseudomonas aeruginosa was the most frequently isolated bacteria in the otorrhea samples from both groups.

Conclusions 

A 6- to 12-week course of high-dose, orally administered trimethoprim/sulfamethoxazole therapy is beneficial for children with COM. The treatment effect is most pronounced with the shorter course and disappears when the medication is discontinued.

Commentary 

COM is frequently difficult to treat. P aeruginosa and Staphylococcus aureus are the most commonly isolated species. Aggressive medical management with topical antibiotic/steroid preparations, aural toilet, and oral or intravenous antibiotics can fail to provide long-term disease control. Surgical intervention may ultimately be required. The role of biofilms, fungal entities and resistant bacteria have also been described, especially in the context of tympanostomy tubes and prolonged antimicrobial usage. van der Veen et al document better disease control in the treatment group after 6 weeks (72% resolution versus 47% resolution in control subjects). This study provides encouraging evidence that in the short-term, an inexpensive, well-tolerated oral antibiotic may provide relief from COM in some patients. Several factors should be considered in interpreting the study results. The use of antimicrobial mnedications is carefully regulated in the Netherlands, raising the possibility that these results may not be generalizable to settings with less restricted use of broad spectrum antibiotics. Moreover, at the 1-year follow-up evaluation, there were no significant differences seen between the treatment and control groups in the rate of persistent COM, quality of life, or hearing. The similarity in long-term outcomes between the treatment and control groups questions the usefulness of long-term administration of even a relatively well-tolerated antibiotic, unless the goal is short-term disease management before surgical intervention. Finally, after a year, nearly one-fourth of the patients in both groups had persistent otorrhea despite continued treatment by their physicians after study participation. That high rate of persistent disease underscores the recalcitrant nature of COM and further reinforces the need for continued investigation into optimal treatments for long-term disease resolution.