Study: don’t universally treat OME with steroids

February 2003

PITTSBURGH — Treatment with prednisolone should not be universally recommended for treatment of chronic otitis media with effusion (OME), while treatment with amoxicillin, if used, should not continue beyond 14 days, according to results from a recent study.

Led by Ellen M. Mandel, MD, of Children’s Hospital of Pittsburgh, researchers set out to determine the efficacy of a short course of prednisolone given with amoxicillin vs. amoxicillin alone for the treatment of chronic middle ear effusion. The researchers also assessed the efficacy of two weeks versus four weeks of amoxicillin with and without steroids.

In an interview, Mandel said corticosteroids had been used in many trials before and seemed very promising, but steroids have adverse events and unless the benefits outweighed the risks, they would not be suitable as recommended treatment for so many children.

“Previous trials left some questions as to what the magnitude of steroid effect was and so we decided to pursue this,” said Mandel. “We did find that more children cleared their effusion if they were treated with steroid [and amoxicillin], but that this lasted for a short time, and even the children whose effusion did not clear with steroid treatment had better hearing than those with effusion who did not receive steroid.”

Study methods

In the researchers’ double-blind, randomized trial, 144 children who were 1 to 9 years of age and had middle ear effusion for at least two months were assigned to one of four treatment arms. The first arm was steroid and amoxicillin for 14 days, then amoxicillin for 14 more days; the second was steroid and amoxicillin for 14 days, then placebo for amoxicillin for 14 more days; the third was placebo (for steroid) and amoxicillin for 14 days, then amoxicillin for 14 more days; and the fourth arm was placebo (for steroid) and amoxicillin for 14 days, then placebo for amoxicillin for 14 more days.

Researchers examined children by tympanometry, otoscopy and audiometry at entry and at two and four weeks after entry; those without middle ear effusion at the four-week visit returned monthly for up to three more visits or until recurrence of effusion.

Of the 144 children entered; 135 children returned for the two-week visit, and 132 were seen for the four-week visit.

At the initial two-week follow-up, one-third of the children in the steroid and amoxicillin group had no middle ear effusion compared with 16.7% in the placebo and amoxicillin group (95% confidence interval for the difference in proportions: 2.4%–31.0%).

At the four-week visit, the percentage of children with no middle ear effusion in the steroid-treated group was 32.8%, whereas in the placebo group it was 20.0% (95% confidence interval for the difference in proportions in the two groups: -2.0%–27.7%). Comparing change in middle ear status from the two- to the four-week visit, there were no significant differences in recurrence of middle ear effusion or additional clearance of middle ear effusion between those who were treated with amoxicillin for two weeks and those who were treated for four weeks.

Finally, by the four-month visit, 68.4% of children who were in the steroid group had recurrence of middle ear effusion, as did 69.2% of such children in the placebo group.

Researchers said there was a significant difference in the proportion of children who were effusion-free immediately after 14 days of treatment with steroid and amoxicillin, compared with those who were treated only with amoxicillin for 14 days. Within two weeks of finishing treatment, there was no longer any significant difference between the two groups regardless of whether amoxicillin was continued or not. Hence, researchers concluded a longer course of therapy was not needed.

For more information:

• Mandel EM, Casselbrant ML, Rockette HE, Fireman P, et al. Systemic steroid for chronic otitis media with effusion in children. Pediatrics. 2002;110(6):1071.