Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
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Efficacy of conservative therapy as taught in the primary care setting for symptoms suggesting infant gastroesophageal reflux.

OBJECTIVE: To determine the efficacy of non-pharmacologic conservative therapy for infant gastroesophageal reflux disease (GERD).

STUDY DESIGN: Consenting parents of the first 50 screened infants who met inclusion/exclusion criteria including abnormal (>16/42) scores on the Infant Gastroesophageal Reflux Questionnaire-Revised (I-GERQ-R; n = 40) were taught conservative therapy measures by each site's study nurse: feeding modifications, positioning, and tobacco smoke avoidance. We compared I-GERQ-R scores and symptom response details before and 2 weeks after institution of these measures with 2-tail Wilcoxon signed ranks test in the 37 infants (age range, 4-43 weeks; median age, 13 weeks) who completed the run-in.

RESULTS: The median initial and final scores were 23 (16-36) and 18 (7-34; P < .000001). The median score change was -5 (+6--16). Scores of 78% improved at all; 59% improved at least the threshold of 5 points; 24% became normal. Scores for individual symptoms related to regurgitation, crying, and arching improved significantly.

CONCLUSIONS: Two weeks of conservative therapy measures taught in primary care improved 59% beyond the 5-point threshold and normalized 24% of infants with symptom severity diagnostic for GERD, as substantiated with a responsiveness-validated instrument.

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