19th March 2012
A Cochrane review concluded that there was no clinical benefit and some harms (number needed to harm [NNH] 9) from the use of antihistamines and/or decongestants for the management of otitis media with effusion (OME) in children (age 18 or under).
Level of evidence:
Level 1 (good quality patient-oriented evidence) according to the SORT criteria.
Health professionals should follow NICE guidance on the surgical management of OME in children. The guidance states that topical or systemic antihistamines and/or decongestants are not recommended for the management of OME. Most cases of OME will resolve without active treatment. Before any clinical interventions are offered, the NICE guidance suggests that the persistence of bilateral OME should be confirmed over a period of three months before intervention is considered. The child’s hearing should be retested at the end of this time. During the active observation period, advice on educational and behavioural strategies to minimise the effects of hearing loss should be offered. If there is no improvement in hearing loss, then surgical intervention (insertion of ventilation tubes) should be considered.
What is the background to this?
A previous Cochrane review considered by NICE in developing its OME guidance was unable to find any benefit for the use of antihistamines or decongestants in the treatment of OME, but showed an increased risk of harms. This review (search date February 2011) was carried out to update the earlier review.
What does this study claim?
This systematic review of 16 RCTs (n=1880 participants aged 18 years or younger) found no benefit and some harm from the use of antihistamines or decongestants alone or in combination in the management of OME. Therefore the reviewers recommend against their use. Pooling data for any medication combination (antihistamine, decongestants or antihistamine/decongestant in combination) resulted in a risk ratio (RR) of 0.99 with a 95% confidence interval (CI) from 0.92 to 1.05. Separating out the various interventions had little effect. For decongestant alone the RR for the primary outcome was 1.06 (95% CI 0.92 to 1.22) and for antihistamine/decongestant combinations the RR was 0.97 (95% CI 0.89 to 1.04) both non-significant, statistically and clinically. In terms of harms, there was a statistically significant and clinically meaningful increase in the risk of medication side effects in the intervention group (17% versus 6%; RR 2.7; 95% CI 1.9 to 3.9; NNH=9).
This review adds little to what is already known about the benefits and harms of antihistamines/decongestants that was considered by NICE when developing its guidance on the surgical management of OME in children. The findings of the review support NICE guidance, which states that topical or systemic antihistamines and/or decongestants are not recommended for the management of OME in children.
Although this was a well-conducted systematic review, it has many limitations. These include the relatively small number of trials and total participant volume, and methodological flaws within some of the trials. The included studies varied in duration and thoroughness of follow up, and most studies had poor allocation concealment , unclear randomisation and blinding processes and no intention-to-treat analysis. It should also be noted, however, that this review defined ‘children’ as anyone under 18 years for the purposes of study selection, whereas NICE guidance on management of OME in children covers children under the age of 12.
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.
Total of 1880 participants, nearly all of whom were under the age of 18 year, who had a diagnosis of OME.
Intervention and comparison
The intervention of interest was the use of oral or nasal decongestant and/or antihistamine as compared to no medication or placebo.
Outcomes and results
OME persistence (lack of cure at or before one month) was the primary efficacy outcome. After combining all the medications into a common treatment group (antihistamine, decongestants or antihistamine/decongestant in combination), no significant difference was found between the intervention and the control group for the various outcomes measured RR of 0.99 with a 95% CI from 0.92 to 1.05. No significant difference with placebo was also seen when individual comparisons were made between antihistamines and decongestants versus placebo respectively. Other secondary outcomes were also explored, e.g. OME persistence at 1–3 months and after 3 months, and other efficacy measures (e.g. hearing loss, effusion). However, no statistically significant benefit from any treatment or combination of treatment was found for any of the measured patient oriented outcomes. Pooling of the studies that evaluated medication side effects identified an increased risk of harm in the intervention group compared with placebo (17% versus 6%; RR 2.7; 95% CI 1.9 to 3.9; NNH=9).
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