Antihistamines and/or decongestants have no benefit for children who have otitis media with effusion, a Cochrane review of medical literature has concluded.
In fact, children who used them experienced an 11% spike in side effects such as gastrointestinal upset and drowsiness, compared with those who did not use them.
“Because we found no benefit for any of the studied interventions for any of the outcomes measured, and we found harm from the side effects of the interventions, we recommend practitioners not use antihistamines, decongestants, or antihistamine/decongestant combinations to treat otitis media with effusion in children,” wrote the researchers, led by Dr. Glenn Griffin of Quinte West Medical Center in Trenton, Ont. They noted that the findings mirror the current joint guidelines on the management of otitis media with effusion (OME) from the American Academy of Family Physicians, the American Academy of Otolaryngology-Head and Neck Surgery, and the American Academy of Pediatrics (Pediatrics 2004;113:1412–29).
Dr. Griffin and his associates studied 15 randomized, controlled trials of 1,516 children with OME that compared antihistamines, decongestants, or a combination of the two and that appeared in the medical literature through March 2006. Studies that randomized children based on acute otitis media were not included in the analysis (Cochrane Database Syst Rev. 2006;[4]:CD003423). The researchers found no benefit of taking decongestants alone or in combination with antihistamines in terms of being cured within 1 month, lessening hearing loss, risk of OME recurrence, development of otitis media, and the need for tympanostomy.
Six studies in the analysis measured side effects of medications. In these, 17% of children who received decongestants alone or in combination with antihistamines suffered side effects such as gastrointestinal upset and drowsiness, compared with 6% of children who took placebo, a difference of 11%. The researchers estimated that for every nine children treated with the drugs, one would be harmed.
Dr. Griffin and his associates acknowledged that a key limitation of the review was the small number of studies found. “However, we were unlikely to miss studies given our comprehensive search, and we found many more than the previous systematic review on this topic,” they wrote.