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.


METHODS
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.
Moore
David John
DJ
Centre for Paediatric and Adolesent Gastroenterology, Women's and Children's Hospital, North Adelaide, SA 5006, Australia. moored@wch.sa.gov.au
Tao
Billy Siang-Kuo
BS
Lines
David Robin
DR
Hirte
Craig
C
Heddle
Margaret Lila
ML
Davidson
Geoffrey Paul
GP
D000897:Anti-Ulcer Agents / Q000627:therapeutic use*; D018592:Cross-Over Studies; D004311:Double-Blind Method; D004942:Esophagitis, Peptic; D005260:Female; D005764:Gastroesophageal Reflux / Q000188:drug therapy*; D006801:Humans; D007223:Infant; D018730:Infant Behavior / Q000187:drug effects*; D008297:Male; D009853:Omeprazole / Q000627:therapeutic use*
D000897:Anti-Ulcer Agents; D009853:Omeprazole