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Q Are antihistamines, decongestants, or both effective in treating children with otitis media with effusion (OME)?
Cochrane Ear, Nose, and Throat Disorders Group Trials Register, Cochrane Central Register of Controlled Trials, Medline (1951–2006), EMBASE/Excerpta Medica (1974–2006), grey literature database, references of included trials and relevant reviews, manufacturers of decongestants and antihistamines, and authors in the field.
Study selection and assessment:
randomised controlled trials (RCTs) comparing oral or nasal decongestants or antihistamines with no medication or placebo in children ⩽18 years of age with OME. Trials in which the data of patients with acute otitis media, anatomical deformity, or other chronic immunocompromised states could not be separated from those of patients meeting criteria were excluded. 16 RCTs (n = 1737) met the selection criteria. The quality of included studies was assessed using the method of Mohar and included randomisation procedure, follow up, blinding, and allocation concealment.
lack of resolution of effusion at ⩽1 month. Secondary outcomes included lack of resolution at 1–3 months and ⩾3 months, hearing loss, school performance, and adverse effects.
Among the 6 RCTs that could be combined in a meta-analysis, antihistamines or decongestants did not differ from placebo or no treatment in resolving effusion at ⩽1 month, 1–3 months, or >3 months (table). Trials that evaluated the interventions separately also showed no difference. Results of individual trials that were not pooled were consistent with the meta-analysis. No intervention reduced hearing loss at ⩽1 month (4 RCTs, relative risk [RR] 1.08, 95% CI 0.93 to 1.27) or at >3 months (1 RCT, RR 1.50, CI 0.63 to 3.56). 1 RCT showed no effect of antihistamines plus decongestants on school performance (RR 0.81, CI 0.35 to 1.86). More patients had side effects with antihistamines or decongestants than with placebo or no treatment (table).
Antihistamines, decongestants, or both are not effective in treating children with otitis media with effusion and cause adverse effects.
OME is a common childhood condition and is a potential cause of hearing loss. This is a concern because hearing loss, especially over the long term, can affect language development and learning. OME frequently resolves spontaneously. For those children requiring treatment, various pharmaceutical and surgical treatment options are available. The meta-analysis by Griffin et al evaluated the evidence for the use of antihistamines or decongestants, alone, or in combination.
The primary outcome was persistence of OME. Secondary outcomes included complications of OME, hearing loss, school performance, and surgery. The review found that neither antihistamines nor decongestants, alone or combined, improved any of the measured outcomes. Therefore, consistent with several best practice guidelines,1 the authors recommend that these drugs should not be used in the treatment of OME. An additional important finding of the review is that not only are these drugs not helpful, they have harmful adverse effects. The quality and results of the review confirm that antihistamines and decongestants are ineffective and have potentially detrimental side effects in the treatment of OME.
Clinicians should inform parents about the unequivocal evidence against the use of antihistamines and decongestants for OME. Otherwise healthy children benefit from a 3 month period of “watchful waiting,” during which most OME resolves.1 Parents should be warned to expect that their child will exhibit some signs of hearing loss that are most likely temporary and should be instructed on how to accommodate for this. Children with coexisting speech, language, and learning problems require more aggressive follow up.1
For correspondence: Dr G Griffin, Quinte West Medical Centre, Trenton, Ontario, Canada.
Source of funding: no external funding.
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