Double-blind placebo-controlled trial of omeprazole in irritable infants with gastroesophageal reflux☆

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.

Abbreviations:  GER, Gastroesophageal reflux, RI, Reflux index, Group OP, Treatment sequence omeprazole, then placebo, VA, Visual analog, Group PO, Treatment sequence placebo, then omeprazole