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Antibiotic treatment of children with secretory otitis media. A randomized, double-blind, placebo-controlled study
J Thomsen1, J Sederberg-Olsen, V Balle
1Ear-Nose-Throat Department, Gentofte University Hospital, Hellerup, Denmark.
Insights
Amoxicillin-clavulanate potassium effectively treated secretory otitis media in children, improving tympanometry results significantly compared to placebo. This suggests antibiotics are a viable treatment before considering ventilating tubes.
Area of Science:
- Pediatrics
- Otolaryngology
- Pharmacology
Background:
- Secretory otitis media (SOM) is a common pediatric condition.
- Current treatment guidelines for SOM often involve watchful waiting or tympanostomy tube insertion.
- The efficacy of antibiotic treatment for SOM requires further investigation.
Purpose of the Study:
- To evaluate the efficacy of amoxicillin-clavulanate potassium in treating children with secretory otitis media.
- To compare the outcomes of antibiotic treatment versus placebo in children with SOM.
Main Methods:
- A double-blind, randomized, placebo-controlled trial involving 264 children aged 1-10 years.
- Participants received either amoxicillin-clavulanate potassium or placebo for one month.
- Tympanometry was used to assess middle ear status at baseline, monthly during treatment, and for 12 months post-treatment.
Main Results:
- 61% of children in the antibiotic group showed disease reversal compared to 30% in the placebo group (P < .0001).
- The significant improvement in favor of antibiotics persisted for eight months post-treatment.
- Middle ear status at the end of treatment predicted long-term outcomes, irrespective of initial treatment group.
Conclusions:
- Amoxicillin-clavulanate potassium is effective in treating secretory otitis media in children.
- Antibiotic therapy can improve tympanometric conditions, supporting its use before ventilating tube insertion.
- The study highlights the potential of antibiotics as a first-line treatment for SOM.
Abstract:
A double-blind, randomized, placebo-controlled clinical trial was conducted to evaluate one month of amoxicillin-clavulanate potassium treatment of children with secretory otitis media. In total, 264 children, aged 1 to 10 years, were randomly assigned to either antibiotic or placebo treatment; 43 patients were excluded during treatment, equally distributed in both groups, leaving 221 patients completing the trial. The inclusion criterion was a type C2 and type B tympanometry result of at least three months' duration. Tympanometry was performed every month for 12 additional months. At the end of the treatment period, the disease was reversed in 61% in the antibiotic-treated group compared with 30% in the placebo-treated group (P less than .0001), and the improvement was persistently significant in favor of antibiotic for eight months. The effect was present in all age groups and independent of laterality of disease. The middle-ear status at the end of treatment was the determining factor for the outcome of tympanometry the year following treatment. From the end of treatment, there was no difference between tympanometry in a patient having been treated with the antibiotic and a patient having been treated with placebo. Antibiotic treatment shifts the individual patient from poor to better tympanometric conditions, so antibiotics can be recommended in the treatment of secretory otitis media before inserting ventilating tubes.