Antihistamines with or without decongestants for otitis media with effusion (OME) ('glue ear') in children

Griffin G, Flynn CA

Published Online:

September 7, 2011

Otitis media with effusion (OME), also known as glue ear or serous otitis media, is a condition in which there is fluid persisting in the middle ear. Many treatments have been suggested. This review summarizes the studies using antihistamines, decongestants or a combination of antihistamines and decongestants and finds no benefit for any of the short or long-term outcomes including resolution of the fluid, hearing problems or the necessity of additional referral to specialists. Further, using these medications causes significant side effects, such as gastrointestinal upset, irritability, drowsiness or dizziness, in approximately 10% of patients. Therefore antihistamines, decongestants or antihistamine/decongestant combinations are not recommended treatments for OME. Watchful waiting is the best approach with consideration of referral for evaluation by an ENT consultant if symptoms persist beyond 12 weeks.

Abstract (click to read)

Background:

This is an update of a Cochrane Review first published in The Cochrane Library in Issue 4, 2006.

Otitis media with effusion (OME) is common and may cause hearing loss with associated developmental delay. Treatment remains controversial. The effectiveness of antihistamines, decongestants and antihistamine/decongestant combinations in promoting the resolution of effusions has been assessed by randomized controlled trials.

Objectives:

The objective of this review was to determine whether antihistamine, decongestant or combination therapy is effective in treating children who present with OME.

Search strategy:

We searched the Cochrane Ear, Nose and Throat Disorders Group Trials Register; the Cochrane Central Register of Controlled Trials (CENTRAL); PubMed; EMBASE; CINAHL; Web of Science; BIOSIS Previews; Cambridge Scientific Abstracts; ISRCTN and additional sources for published and unpublished trials. The date of the most recent search was 1 February 2011, following a previous search in 2006.

Selection criteria:

Randomized controlled trials (RCTs) using antihistamines, decongestants or antihistamine/decongestant combinations as treatment for OME in children. We excluded trials that randomized on the basis of acute otitis media (AOM) even though OME was also studied in follow up.

Data collection and analysis:

Two authors independently extracted data from the published reports using standardized data extraction forms and methods. The two authors assessed the methodological quality of the included studies independently. We expressed dichotomous results as a risk ratio with 95% confidence intervals using a fixed-effect model when homogeneous and a random-effects model when heterogeneous. Nearly all outcomes analyzed were homogeneous. We discussed continuous results qualitatively. We conducted statistical analysis using RevMan 5.1 software.

Main results:

Sixteen studies (1880 participants) were included in the review. No statistical or clinical benefit was found for any of the interventions or outcomes studied. However, treated study subjects experienced 11% more side effects than untreated subjects (number needed to treat to harm = 9).

Authors' conclusions:

The pooled data demonstrate no benefit and some harm from the use of antihistamines or decongestants alone or in combination in the management of OME, therefore we recommend against their use.

This record should be cited as:

Griffin G, Flynn CA. Antihistamines and/or decongestants for otitis media with effusion (OME) in children. Cochrane Database of Systematic Reviews 2011, Issue 9. Art. No.: CD003423. DOI: 10.1002/14651858.CD003423.pub3

Assessed as up to date:

February 1, 2011

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Primary Review Group:

Ear, Nose and Throat Disorders Group

PEARLS - Practical Evidence About Real Life Situations (click to read)

Clinical question:

Are antihistamines, decongestants or combination therapy effective in children with otitis media with effusion (OME)?

Bottom line:

Antihistamines and/or decongestants do not help and may harm when used for symptoms of OME (‘glue ear”). There was no benefit for any of the short or long-term outcomes including resolution of the fluid, hearing problems or the necessity of additional referral to specialists.

Caveat:

These medications caused significant side-effects, such as gastro-intestinal upset, irritability, drowsiness or dizziness in approximately 10% of the patients.

Context:

OME is a common condition in which there is fluid persisting in the middle ear. Many treatments have been suggested. Watchful waiting is the best approach with consideration of referral for evaluation by an ENT consultant if symptoms persist beyond 12 weeks.

Cochrane Systematic Review:

Griffin GH, Flynn C, Bailey RE, Schultz JK. Antihistamines and/or decongestants for otitis media with effusion (OME) in children. Cochrane Database of Systematic Reviews 2006, Issue 4. Art. No.: CD003423. DOI: 10.1002/14651858.CD003423.pub2. This review contains 16 trials involving 1,737 participants.

Authored by:

Brian R McAvoy

Cochrane Primary Health Care Field

Health topics:

Ear, nose, & throat > Ear > Chronic otitis media

Cochrane Summaries^beta

Independent high-quality evidence for health care decision making

Antihistamines with or without decongestants for otitis media with effusion (OME) ('glue ear') in children

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