Allergy drugs for glue ear do more harm than good

17 October 2006

Children who have persistent glue ear are more likely to be harmed than helped by antihistamines and decongestants, a new review of studies has found.

The drugs are no better than placebo in alleviating symptoms or avoiding complications of glue ear, and expose children to a significant risk of drug-related side effects.

"This review finds no benefit for any of the short- or long-term outcomes, including resolution of the fluid, hearing problems or the necessity of additional referral to specialists," concluded review authors led by Glenn Griffin MD, of Quinte West Medical Centre in Ontario, Canada. "However, treated study subjects experienced 11 percent more side effects than untreated subjects."

The review appears in the current issue of The Cochrane Library, a publication of The Cochrane Collaboration, an international organization that evaluates research in all aspects of health care. Systematic reviews draw evidence-based conclusions about medical practice after considering both the content and quality of existing trials on a topic.

Antihistamines and decongestants, commonly used to treat symptoms of allergies and colds, are sometimes prescribed for glue ear. According to the review authors, these drugs theoretically could alleviate congestion and decrease obstruction of the Eustachian tube, allowing drainage of fluid.

The reviewers pooled the results of 15 randomized controlled trials involving 1,516 children that compared antihistamines, decongestants or the combination to a placebo for glue ear.

The findings were consistently negative. Children who received decongestants alone or in combination with antihistamines were no more likely to be cured within one month than children who received a placebo. The same results were seen when children were evaluated at one to three months or after more than three months.

Likewise, for each of the other major outcomes the reviewers examined — hearing loss, risk of recurrent glue ear, development of acute otitis media and the need for surgery to drain fluid from the middle ear — the drugs performed no better than placebo. In fact, for hearing loss, there was a trend toward worse outcomes among the children who received medication.

In parallel with the consistent lack of benefit, the reviewers also found a significant risk of harm. In the six studies that evaluated side effects, 17 percent of children who received medication suffered side effects, compared with 6 percent of children who received a placebo.

The 11 percent difference in side effects means that for every nine children treated with these drugs, one would be harmed while none would benefit.

Source: Newswise
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