Clinical Question

Do decongestants and/or antihistamines relieve symptoms of otitis media with effusion in children?

Evidence-Based Answer

Children with otitis media with effusion do not benefit from decongestants or antihistamines. Common adverse effects of these therapies are gastrointestinal upset, irritability, drowsiness, and dizziness (number needed to harm = 9).

Practice Pointers

Most acute otitis media episodes in children resolve spontaneously; however, the effusion persists in some children. Over-the-counter decongestants and antihistamines have been proposed as treatment options for children with persistent effusion.

This Cochrane review included 16 randomized controlled trials (1,737 total patients) of otherwise healthy patients younger than 18 years with otitis media with effusion (studies of patients with acute otitis media were not included). Oral or nasal decongestants, antihistamines, or a decongestant/antihistamine combination were compared with no medication or placebo. Outcomes were resolution of the effusion at less than one month, one to three months, and more than three months. Five of the 16 trials took place in community clinics. Although the meta-analysis had sufficient power to detect a benefit, no clinical benefit was found for any intervention or outcome.

Observation without antibiotics is an option for children with otitis media. The American Academy of Family Physicians and the American Academy of Pediatrics strongly recommend assessment and treatment of pain in patients with otitis media1; however, based on this Cochrane review, antihistamines and decongestants should be avoided.