SAN FRANCISCO — Antibiotic therapy for acute otitis media may be more effective than some physicians think, a study has shown.
Some new data add to controversy that has been stirring since 2004 clinical practice guidelines from the American Academy of Pediatrics and the American Academy of Family Physicians included the option of watchful waiting in some children with uncomplicated acute otitis media (Pediatrics 2004;113:1451-65).
Support for management by observation came primarily from the desire to avoid escalation of antibiotic resistance and from the results of several meta-analyses suggesting that antibiotics are only modestly beneficial in treating acute otitis media, compared with placebo.
“Many of the meta-analyses had substantial flaws,” and included studies that used weak definitions of acute otitis media and so classified some children who had otitis media with effusion as having acute otitis media, Dr. Ellen R. Wald said at the meeting.
Because antibiotic therapy does not help otitis media with effusion, it's no wonder that antibiotics barely outperformed placebo in these studies, said Dr. Wald, professor and chair of pediatrics at the University of Wisconsin, Madison.
She described a new study led Dr. Alejandro Hoberman, chief of pediatrics at Children's Hospital, Philadelphia, that found significantly lower rates of treatment failure in children treated with amoxicillin-clavulanate, compared with placebo, she added. The results have been submitted for publication.
The study randomized 291 children who were aged 6-23 months and had confirmed acute otitis media to treatment with the antibiotics or placebo for 10 days, with follow-up on days 4/5, days 10/12, and days 21/25. Patients with clinical failure to first-round therapy received amoxicillin and cefixime.
The amoxicillin-clavulanate treatment failed at or before days 4/5 in 4% of patients, compared with a 23% clinical failure rate in the placebo group (P less than .001). Clinical failure rates at or before days 10-12 were 16% in the amoxicillin-clavulanate group and 51% in the placebo group (P less than .001).
These differences are “more dramatic than in previously reported trials,” Dr. Wald said. For children aged 6-23 months who have acute otitis media, treatment with amoxicillin-clavulanate for 10 days provides measurable short-term benefit, she said.
In a separate study by other investigators, surveys completed by 1,114 physicians found no significant increase in the proportion who managed acute otitis media without antibiotics after the guidelines (16%), compared with before the guidelines (11%), she added (Pediatrics 2010 [doi:10.1542/peds.2009-1115]).
Dr. Wald said that she had no relevant conflicts of interest.
'Many of the meta-analyses [supporting management by observation] had substantial flaws.'
Source DR. WALD