Evidence Profile: Watchful Waiting

Aggregate evidence quality: B, systematic review of cohort studies.

Benefit: avoid unnecessary interventions, take advantage of favorable natural history, and avoid unnecessary referrals and evaluations.

Harm: delays in therapy for OME that will not resolve with observation; prolongation of hearing loss.

Benefits-harms assessment: preponderance of benefit over harm.

Policy level: recommendation.

MEDICATION: ANTIHISTAMINES AND DECONGESTANTS ARE INEFFECTIVE FOR OME AND ARE NOT RECOMMENDED FOR TREATMENT; ANTIMICROBIALS AND CORTICOSTEROIDS DO NOT HAVE LONG-TERM EFFICACY AND ARE NOT RECOMMENDED FOR ROUTINE MANAGEMENT

This recommendation is based on systematic review of randomized, controlled trials and the preponderance of harm over benefit.

Therapy for OME is appropriate only if persistent and clinically significant benefits can be achieved beyond spontaneous resolution. Although statistically significant benefits have been demonstrated for some medications, they are short-term and relatively small in magnitude. Moreover, significant adverse events may occur with all medical therapies.

The prior OME guideline found no data supporting antihistamine-decongestant combinations in treating OME. Meta-analysis of 4 randomized trials showed no significant benefit for antihistamines or decongestants versus placebo. No additional studies have been published since 1994 to change this recommendation. Adverse effects of antihistamines and decongestants include insomnia, hyperactivity, drowsiness, behavioral change, and blood-pressure variability.

Long-term benefits of antimicrobial therapy for OME are unproved despite a modest short-term benefit for 2 to 8 weeks in randomized trials. Initial benefits, however, can become nonsignificant within 2 weeks of stopping the medication. Moreover, ~7 children would need to be treated with antimicrobials to achieve one short-term response. Adverse effects of antimicrobials are significant and may include rashes, vomiting, diarrhea, allergic reactions, alteration of the child's nasopharyngeal flora, development of bacterial resistance, and cost. Societal consequences include direct transmission of resistant bacterial pathogens in homes and child care centers.

The prior OME guideline1 did not recommend oral steroids for treating OME in children. A later meta-analysis showed no benefit for oral steroid versus placebo within 2 weeks but did show a short-term benefit for oral steroid plus antimicrobial versus antimicrobial alone in 1 of 3 children treated. This benefit became nonsignificant after several weeks in a prior meta-analysis and in a large, randomized trial. Oral steroids can produce behavioral changes, increased appetite, and weight gain. Additional adverse effects may include adrenal suppression, fatal varicella infection, and avascular necrosis of the femoral head. Although intranasal steroids have fewer adverse effects, one randomized trial showed statistically equivalent outcomes at 12 weeks for intranasal beclomethasone plus antimicrobials versus antimicrobials alone for OME.

Antimicrobial therapy with or without steroids has not been demonstrated to be effective in long-term resolution of OME, but in some cases this therapy can be considered an option because of short-term benefit in randomized trials, when the parent or caregiver expresses a strong aversion to impending surgery. In this circumstance, a single course of therapy for 10 to 14 days may be used. The likelihood that the OME will resolve long-term with these regimens is small, and prolonged or repetitive courses of antimicrobials or steroids are strongly not recommended.

Other nonsurgical therapies that are discussed in the OME literature include autoinflation of the eustachian tube, oral or intratympanic use of mucolytics, and systemic use of pharmacologic agents other than antimicrobials, steroids, and antihistamine-decongestants. Insufficient data exist for any of these therapies to be recommended in treating OME.