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Naproxen in otitis media with effusion
Insights
Prostaglandin E2 (PGE2) levels were measured in children with secretory otitis media. Naproxen did not significantly improve otalgia or hearing loss, suggesting non-steroidal anti-inflammatory drugs are unlikely to benefit this condition.
Area of Science:
- Otolaryngology
- Pediatrics
- Pharmacology
Background:
- Secretory otitis media is a common pediatric condition.
- Prostaglandin E2 (PGE2) is implicated in inflammatory processes.
- The therapeutic efficacy of non-steroidal anti-inflammatory drugs (NSAIDs) in secretory otitis media is not well-established.
Purpose of the Study:
- To measure PGE2 levels in middle ear effusions of children with secretory otitis media.
- To evaluate the therapeutic effect of naproxen on otalgia and hearing loss in this condition.
Main Methods:
- A placebo-controlled, double-blind trial was conducted.
- Middle ear aspirates were analyzed for PGE2 levels.
- Patients received either naproxen or placebo for eight weeks.
Main Results:
- Detectable PGE2 levels were found in 7 out of 19 middle ear aspirates.
- PGE2 levels ranged from 1.0 to 14.4 ng/mL.
- Naproxen showed no significant improvement in otalgia or hearing loss compared to placebo.
Conclusions:
- PGE2 may be present in middle ear effusions of children with secretory otitis media.
- Naproxen did not provide significant therapeutic benefit.
- NSAIDs are unlikely to be effective treatments for secretory otitis media.
Abstract:
The levels of prostaglandin E2 (PGE2) were measured in aspirates of the effusion fluid from children suffering from secretory otitis media. The effects of naproxen 5 mg./kg. twice daily for eight weeks on the condition were studied in a placebo-controlled double-blind trial. Nineteen middle-ear aspirates from 13 children, six of whom had bilateral aspirations were examined. Detectable levels of PGE2 (greater than 1.0 ng. per ml.) were present in seven aspirates from seven children and ranged from PGE2 1.0 to 14.4 ng. per ml. In four of the six patients who had bilateral aspirations, PGE2 was detectable in the aspirate from one ear but not the other. However, the severity of otalgia and hearing loss was almost identical in the ears with detectable levels of PGE2 and those without. In a separate trial of naproxen, 11 patients received active drug and 13 received placebo. Naproxen had no significant effect on otalgia or hearing loss compared to placebo. These findings suggest that it is unlikely that non-steroidal anti-inflammatory drugs will be of therapeutic benefit in secretory otitis media.