Trimethoprim-sulfamethoxazole in children with chronic otitis media: a randomized comparison of costs and effects.

OBJECTIVE

To study the cost-effectiveness of a 6- to 12-week course of high-dose oral trimethoprim-sulfamethoxazole in children with chronic active otitis media (COM).

STUDY DESIGN

Cost-effectiveness study including both direct and indirect costs alongside a randomized placebo-controlled trial.

SETTING

Tertiary care university hospital in the Netherlands.

PATIENTS

One hundred one children aged 1 to 12 years with a documented history of COM for at least 3 months.

INTERVENTION

Six to 12 weeks of oral trimethoprim-sulfamethoxazole 18 mg/kg twice daily versus placebo.

MAIN OUTCOME MEASURES

Incremental cost-effectiveness in terms of costs per number needed to treat (NNT) to cure 1 patient (incremental cost-effectiveness ratio [ICER]). Curation was defined as no otomicroscopic signs of otorrhea in either ear.

RESULTS

After 6 weeks of follow-up, the difference in mean cost per patient between the trimethoprim-sulfamethoxazole and placebo groups was Euro100 (US $126). The NNT was 4 (clinical effect), and the corresponding ICER was Euro400 (US $504), that is, the average extra costs to cure 1 child from otorrhea is Euro400 (US $504). After 12 weeks of follow-up, the difference in mean costs between both groups was Euro159 (US $201), the NNT was 7, and the corresponding ICER was Euro1,113 (US $1,407).The mean costs after 1 year of follow-up were Euro1,601 (US $2,021) in the trimethoprim-sulfamethoxazole group and Euro1,164 (US $1,469) in the placebo group. Because the clinical effect of trimethoprim-sulfamethoxazole disappeared after its discontinuation, we did not calculate an ICER at 1 year of follow-up.

CONCLUSION

In children with active COM, direct and indirect costs of a 6- to 12-week course of high-dose oral trimethoprim-sulfamethoxazole are modest in the light of its short-term clinical benefit.