Clinical Question

Which treatments for persistent otitis media with effusion are beneficial?

Evidence-Based Answer

Treatments such as antibiotics, steroids, antihistamines/decongestants, and mucolytics afford no long-term benefit in the treatment of patients with otitis media with effusion (OME). [Strength of recommendation: A] Surgical treatments such as ventilation tubes and adenoidectomy improve hearing. [Strength of recommendation: A] However, surgery has conflicting effects on improving language development and behavior. [Strength of recommendation: B] There is inconclusive evidence that autoinflation of the eustachian tube with a nasal balloon improves resolution of OME. [Strength of recommendation: B]

Evidence Summary

OME is defined as middle ear effusion without acute inflammation. Many treatments have been recommended, although data supporting them are limited.

The results of three meta-analyses^1–3 showed that antibiotics increased the resolution of OME in the short-term (less than one month). However, the results of a conflicting meta-analysis⁴ of only higher quality, placebo-controlled studies showed that antibiotic therapy resulted in no significant difference compared with placebo. One meta-analysis³ looked at outcomes beyond one month and showed no significant difference in resolution of OME.

The results of a well-designed systematic review⁵ of the use of steroids in patients with OME found that oral and nasal steroids do not have any significant benefit in the long-term (more than two weeks) when used alone or with antibiotics. A subsequent randomized controlled trial⁶ (RCT) of oral steroids given with antibiotics reached similar conclusions.

The results of meta-analyses on antihistamines/decongestants¹ and mucolytics⁷ showed no benefit in clearance of OME. Another meta-analysis⁸ looked at opening the eustachian tubes by autoinflation with a nasal balloon. The methods of this meta-analysis were unclear, and the studies were generally of low quality. However, within a homogenous subgroup of three RCTs, the odds ratio for improvement of OME with autoinflation was 3.5 (95 percent confidence interval, 2.0 to 6.1). The number needed to treat was three. Unblinded outcome assessments led the authors of the meta-analysis to not recommend autoinflation for clinical practice.

Surgical options include ventilation tubes, adenoidectomy, and tonsillectomy. The results of a systematic review⁹ of children with OME showed slight improvement (less than 12 dB) in hearing with the use of ventilation tubes or adenoidectomy alone. Combining the procedures offered little additional benefit. There were no data supporting tonsillectomy in the treatment of OME. A subsequent RCT¹⁰ of children with OME confirmed this conclusion, showing a 5 to 6 dB improvement in hearing with ventilation tubes at six and 12 months postprocedure. The results of two additional RCTs^11,12 using the same group of children showed that early insertion of ventilation tubes improves language development and decreases behavior problems at nine months postprocedure compared with watchful waiting. However, 85 percent of the children in the watchful-waiting group received ventilation tubes by 18 months, and there no longer were significant differences in outcomes.

It is important to note that the inclusion criteria for these RCTs were baseline disruptions to speech, language, learning, and behavior. The results of other RCTs without these inclusion criteria showed no difference in language development or quality of life with early insertion of ventilation tubes versus watchful waiting for periods of six to 12 months. Furthermore, the majority of children in the watchful-waiting groups in these latter studies avoided surgery by the end of the follow-up periods.^13–17

Recommendations from Others

A recent evidence-based practice guideline¹⁸ from the American Academy of Family Physicians, the American Academy of Pediatrics, and the American Academy of Otolaryngology–Head and Neck Surgery recommends against the use of antibiotics, steroids, antihistamine/decongestants, mucolytics, and autoinflation in the routine treatment of OME. Surgery for persistent OME should be reserved for use in children with significant hearing loss, persistent symptoms, risk factors for developmental difficulties, or structural damage to the tympanic membrane or middle ear. Antibiotics, with or without steroids, can be considered if the parents or caregivers are strongly opposed to surgery.

Clinical Commentary

Many patients and parents desire active treatment of OME, and treatment is still advocated by many physicians on the basis of habit, anecdote, or tradition. Therefore, it may be difficult for some physicians to not treat OME. Nevertheless, the evidence does not support most treatments. Instead of prescribing medicines, physicians must develop tracking and intervention systems to monitor children with OME over time and recognize complications such as significant hearing loss and developmental delays. Surgery should be considered for patients with these conditions. However, the optimal timing for surgery is unknown.