Antibiotic Treatment of Persistent Otitis Media With Effusion
ABSTRACT & COMMENTARY
Synopsis: Children with otitis media with effusion (OME) that had persisted for at least six months were randomized to receive two weeks of therapy with amoxicillin-clavulanate or placebo. There was a significantly greater rate of clearing of OME in the antibiotic group.
Source: vanBalen FAM, et al. Double-blind randomized trial of co-amoxiclav versus placebo for persistent otitis media with effusion in general practice. Lancet 1996;348:713-716.
The treatment of persistent otitis media with effusion (OME) is controversial but is the most common reason for children to be referred to ENT specialists. Previous reports of trials with antibiotics have been inconclusive. vanBalen and coworkers, generalists at the University of Utrect in the Netherlands, started with a group of 443 children, 6 months to 6 years of age, who had been diagnosed with OME in 57 general practices. After three months of watchful waiting, 223 (52%) had persistent OME. Of these, 152 were randomized, in double-blind fashion, to receive co-amoxiclav (20 mg/kg amoxicillin; 5 mg/kg clavulanate) or matching placebo for two weeks. Seventy-nine children who received antibiotics and 70 who received placebo had interpretable tympanograms after the two weeks of therapy. There was significantly greater clearing of both bilateral and unilateral OME in the antibiotic compared to the placebo group (84% vs 53%, bilateral OME; and 93% vs 77%, unilateral OME). The authors conclude that their study in a general practice setting confirmed the benefits of short-term antibiotic therapy for OME and suggest that such therapy be considered by the practitioner before referral to an ENT surgeon for tympanotomy.
COMMENT BY DAVID E. KARAS, MD
This article attempts to provide another piece to the puzzle concerning the appropriate time for referral of the child with persistent middle ear effusion to the otolaryngologist. Specifically, the authors treated children with persistent effusions with a two-week course of amoxicillin/clavulanate and 0.25% xylometazoline (decongestant) nose drops in the treatment group. The placebo group was only given the xylometazoline drops.
The study is valuable in that it supports other studies which have indicated that there is a clinically significant treatment effect of antibiotics on the resolution of OME. Several investigators have come to this conclusion independently. Additionally, two meta-analyses have come to the same conclusion despite including different studies.1,2 The general consensus of these studies is that there is a small but significantly positive treatment effect with the use of antibiotics on the resolution of OME. This point is well-articulated in the clinical practice guideline published by the Agency for Health Care Policy and Research.3 Although this guideline is targeted for children age 1-3 years, the panel reviewed many studies that included children of different ages.
This study, although well-thought-out and methodologically sound, has some features that should be noted. The authors state that all patients are given topical nasal decongestants because this is the standard of care in the Netherlands. This is not the standard of care in the United States, and there are no studies to support the use of topical decongestants for OME. Additionally, the Clinical Practice Guidelines specifically made a strong recommendation not to use oral decongestants since there are no studies supporting their use.4 The use of decongestants may or may not affect the final results of this study.
In the study group, there is a significantly higher percentage of boys in the placebo group than in the treatment group. Since boys are known to have a worse prognosis for development and persistence of middle ear effusions, not controlling for this discrepancy could potentially bias the results of the study. The antibiotic course given is not the usual dosage and duration given for otitis media. In this study, the antibiotic dosage is 20 mg/kg amoxicillin, 5 mg/kg clavulanate given three times a day for 14 days. This is a 50% increase in the usual daily dosage of 40 mg/kg amoxicillin, 10 mg/kg clavulanate divided in three daily dosages. Additionally, the antibiotic in this study was given for 14 days instead of the standard 10-day therapy.
Finally, since most children are given at least one course of antibiotics (usually multiple course) in the United States before being referred to the otolaryngologist, the likelihood of this study changing current U.S. practices is low. One additional point should be made. Currently, antibiotic treatment for otitis media is uncommon in the Netherlands. This is in contrast to current therapy in this country, where antibiotics are prescribed more freely. This fact may make effusions more difficult to eradicate in a population that has already been treated with antibiotics for acute otitis media.
Despite these points, the study does indicate that, at least for their population, antibiotic treatment was somewhat effective in clearing middle ear effusions. (Dr. Karas is Assistant Professor of Surgery, Pediatric Otolaryngology, Yale University School of Medicine.)
References
1. Rosenfeld RM, Post JC. Meta-analysis of antibiotics for the treatment of otitis media with effusion. Otalaryngol Head Neck Surg 1992;106:378-386.
2. Williams RL, et al. Use of antibiotics in preventing recurrent acute otitis media and in treating otitis media with effusion: A meta-analytic attempt to resolve the brouhaha. JAMA 1993;270:1344-1351.
3. The Otitis Media Guidelines PanelClinical Practice GuidelinesOtitis media with effusion in young children. Rockville, MD. Agenda for Health Care Policy and Research, 1994 (AHCRR Pub No 94-0622).
4. Sasaki C. Adrenergic nosedrops and middle ear pressure in infants with colds. Pediatr Adolesc Med Rep 1996;1:68.
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