Double-blind placebo-controlled trial of omeprazole in irritable infants with gastroesophageal reflux☆
Received 25 July 2002; received in revised form 12 December 2002 and 10 March 2003; accepted 3 April 2003.
Abstract
Objective To assess the efficacy of omeprazole in treating irritable infants with gastroesophageal reflux and/or esophagitis.
Study design Irritable infants (n=30) 3 to 12 months of age met the entry criteria of esophageal acid exposure >5% (n=22) and/or abnormal esophageal histology (n=15). They completed a 4-week, randomized, double-blind, placebo-controlled crossover trial of omeprazole. Cry/fuss diary (minutes/24 hours) and a visual analogue scale of infant irritability as judged by parental impression were obtained at baseline and the end of each 2-week treatment period.
Results The reflux index fell significantly during omeprazole treatment compared with placebo (−8.9%±5.6%, −1.9%±2.0%, P<.001). Cry/fuss time decreased from baseline (267±119), regardless of treatment sequence (period 1, 203±99, P<.04; period 2, 188±121, P<.008). Visual analogue score decreased from baseline to period 2 (6.8±1.6, 4.8±2.9, P=.008). There was no significant difference for both outcome measures while taking either omeprazole or placebo.
Conclusions Compared with placebo, omeprazole significantly reduced esophageal acid exposure but not irritability. Irritability improved with time, regardless of treatment.
From the Centre for Paediatric and Adolesent Gastroenterology, Women's and Children's Hospital, the Department of Paediatrics, University of Adelaide, the Department of Paediatrics, Flinders Medical Centre, and the Public Health Unit, Women's and Children's Hospital, Adelaide, Australia
Reprint requests: David Moore, MBBS, FRACP, Gastroenterology Unit, Women's and Children's Hospital, North Adelaide SA 5006, Australia.
☆ This study was jointly funded by the J.H. and J.D. Gunn Medical Research Foundation and the Channel 7 Children's Research Foundation. The omeprazole and placebo capsules were supplied free of charge by AstraZeneca Pty Ltd (Australia)
ABSTRACT