Low-dose erythromycin in the treatment of gastro-oesophageal reflux disease in infants. Apilot, randomised, double-blind, placebo-controlled trial
Abstract number: P1944
Banaszkiewicz A., Gawroñska A., Albrecht P., Radzikowski A.
Objectives: Gastro-oesophageal reflux disease (GERD) is defined as symptoms or complications of reflux of gastric content into the oesophageus. Commonly used medications for the treatment of GERD include acid-suppressant and prokinetic drugs. Based on systematic review, the literature supports the use of erythromycin as a prokinetic agent, however most reviewed trials were conducted in preterm infants.
The aim of this study was to assess the effectiveness of low-dose erythromycin in the treatment of gastro-oesophageal reflux (GERD) in full-term infants.
Methods: This was a double-blind, randomised, placebo-controlled clinical trial. Subjects aged 111 months with symptoms of GERD confirmed both by 24-hours pH-monitoring and the Infant Gastroesophageal Reflux Questionnaire Revised (I-GERQ-R) were randomly assigned to receive either erythromycin at dose 13 mg/kg/dose or a comparable placebo. Both the active treatment and placebo were taken orally three times daily (20 minutes before meals) for 2 weeks. Parents were asked to fill out the I-GERQ-R at the study entry and at 2 and 4 weeks after enrollment.
Results: 24 infants were enrolled in the study, 12 in erythromycin group and 12 in placebo group; no significant difference was found between two groups. Difference in the I-GERQ-R score in erythromycin group compared with placebo group was statistically significant reduced (p = 0.000003) between beginning therapy and 4 weeks but was not between beginning therapy and 2 weeks (p = 0.07).
Conclusions: Erythromycin at dose 13 mg/kg/dose given three times daily was effective in treating GERD in full-term infants. Its effect seemed to be time-dependent.
|Session name:||19th European Congress of Clinical Microbiology and Infectious Diseases|
|Location:||Helsinki, Finland, 16 - 19 May 2009|
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