Effect of omeprazole on symptoms of gastroesophageal reflux disease in children with cystic fibrosis. A randomized, double-blind, placebo-controlled trial

M. Dziekiewicz, M. Mielus, A. Lisowska, J. Walkowiak, D. Sands, A. Radzikowski, A. Banaszkiewicz

Department of Pediatric Gastroenterology and Nutrition, Medical University of Warsaw, Warsaw, Poland. marcin.dziekiewicz@wum.edu.pl

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• Pharmacology

OBJECTIVE: The incidence of gastroesophageal reflux disease (GERD) is higher in patients with cystic fibrosis (CF) than in the general population. While the relationship between GERD and its typical symptom, heartburn, is beyond doubt, its effect on cough or abdominal pain is unclear. In CF patients, in particular, it is often difficult to confirm the causal relationship between GERD and these symptoms. The aim of this trial was to evaluate the effect of omeprazole treatment of GERD on abdominal pain and cough, in children with CF.

PATIENTS AND METHODS: This was a multicentre, randomized, double-blind, placebo-controlled trial. All children aged 4-18 years underwent 24-hour multichannel intraluminal pH-impedance monitoring. The patients with diagnosed GERD were randomly assigned to receive omeprazole (20 mg twice daily for 12 weeks) or placebo. The severity of symptoms was assessed on visual analog scale.

RESULTS: 22 consecutive patients (median age 11.02± 3,67, range 6.4-17.0) were enrolled. A statistically significant reduction in abdominal pain and typical GERD symptoms, but not cough, was observed in both omeprazole (N=12) and placebo (N=10) groups. However, there were no statistically significant differences between the groups in the degree of reduction. We did not observe any differences between the groups in terms of adverse reactions.

CONCLUSIONS: Treatment of GERD in children with CF seems not to have a stronger effect than a placebo on the severity of cough and abdominal pain. Considering this, as well as the previously raised concerns about the impact of chronic proton pump inhibitor treatment on the course of CF, perhaps one should be more careful in intensively treating suspected atypical GERD symptoms in patients with CF.

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