Antihistamines and/or decongestants serve 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 that practitioners not use antihistamines, decongestants, or antihistamine/decongestant combinations to treat otitis media with effusion in children,” wrote the researchers, who were 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).
For the review, which appears in the Oct. 18 issue of the Cochrane Database of Systematic Reviews (2006, Issue 4), 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 (Epub doi:10.1002/14651858.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 of the 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 only 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.
The investigators acknowledged that a key limitation of the review was the small number of studies found, but “the studies were so consistent in their findings that even if we missed a study, the summary results are unlikely to be overturned.”