Abstract |
With the objective of evaluating the efficacy of cefixime and the combination of cefixime and betamethasone in the treatment of secretory otitis media (SOM), we enrolled 142 children 2 to 12 years old in a randomized, double-blind, placebo-controlled study. All children suffered from SOM, verified by otomicroscopy and tympanometry, of at least 3 months' duration. Active treatment was a 10-day course of cefixime with and without a single dose of 6 mg betamethasone. On hundred forty children were available for efficacy evaluation 14 to 23 days after the start of treatment. A statistically significant treatment effect was found in the group treated with cefixime plus betamethasone (n = 59), with a 44.1% cure rate as compared to 19.7% in the cefixime-treated group (n = 61; p < .005) and 5% in the placebo group (n = 20; p < .005). Relapse rates were high and no statistically differences between groups remained at last valid visit. Adverse events possibly or probably associated with active treatment were reported in 11 cases (9.2%). One patient reported a severe adverse event. No serious events occurred. The study did not show any significant long-term effect of cefixime treatment or any long-term treatment benefit with the addition of betamethasone to the antibiotic.
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Authors | C Hemlin, C Carenfelt, G Papatziamos |
Journal | The Annals of otology, rhinology, and laryngology
(Ann Otol Rhinol Laryngol)
Vol. 106
Issue 5
Pg. 359-63
(May 1997)
ISSN: 0003-4894 [Print] United States |
PMID | 9153098
(Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial)
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Chemical References |
- Anti-Bacterial Agents
- Anti-Inflammatory Agents
- Placebos
- Cefixime
- Betamethasone
- Cefotaxime
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Topics |
- Anti-Bacterial Agents
(administration & dosage, therapeutic use)
- Anti-Inflammatory Agents
(administration & dosage, therapeutic use)
- Betamethasone
(administration & dosage, therapeutic use)
- Cefixime
- Cefotaxime
(administration & dosage, analogs & derivatives, therapeutic use)
- Child
- Child, Preschool
- Dose-Response Relationship, Drug
- Double-Blind Method
- Drug Therapy, Combination
- Female
- Haemophilus influenzae
(isolation & purification)
- Humans
- Male
- Moraxella catarrhalis
(isolation & purification)
- Otitis Media with Effusion
(drug therapy, microbiology)
- Placebos
- Recurrence
- Streptococcus pneumoniae
(isolation & purification)
- Treatment Outcome
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