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

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.