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Prevention and therapy of serous otitis media by oral decongestant: a double-blind study in pediatric practice
Insights
Oral decongestants like pseudoephedrine do not prevent or treat serous otitis media (SOM) in children. This study found no significant benefits, with some allergic patients worsening when using decongestants.
Area of Science:
- Pediatrics
- Otolaryngology
- Pharmacology
Background:
- Serous otitis media (SOM) is a common condition in children.
- The efficacy of oral decongestants for preventing or treating SOM remains unclear.
Purpose of the Study:
- To evaluate the effectiveness of oral pseudoephedrine in preventing SOM development in children with acute otitis media.
- To assess the efficacy of oral pseudoephedrine in treating existing SOM.
Main Methods:
- A randomized, double-blind, placebo-controlled study involving 190 children.
- Participants received antibiotics with either pseudoephedrine or placebo.
- Evaluations included tympanometry, clinical assessment, and pneumotoscopy at two weeks and four weeks for persistent SOM.
Main Results:
- No significant difference in SOM development or resolution between pseudoephedrine and placebo groups.
- Males developed SOM more frequently than females.
- Children with an allergy history showed worse outcomes with pseudoephedrine treatment.
Conclusions:
- Pseudoephedrine offers no benefit in preventing or treating serous otitis media in children.
- Gender and allergic history may influence SOM development and treatment response.
Abstract:
We studied the efficacy of (1) preventing the development of serous otitis media (SOM) by using an oral decongestant in children with acute otitis media and (2) treating SOM with an oral decongestant. In a randomized double-blind study, 190 children were treated for acute otitis media with antibiotics and either pseudoephedrine hydrochloride (Sudafed) or placebo. They were evaluated two weeks later by tympanometry and (independently) by clinical evaluation and pneumotoscopy. There were no significant differences between the two groups, except that males developed SOM significantly more often than did females. Use of decongestant and placebo was continued in 78 patients with SOM for up to four more weeks. Again, there were no siginificant differences between the treatment groups except that patients with an allergic history did significantly worse using a decongestant. Overall there was no benefit from pseudoephedrine in either the prevention or treatment of SOM.