Efficacy of Conservative Therapy as Taught in the Primary Care Setting for Symptoms Suggesting Infant Gastroesophageal Reflux

doi:10.1016/j.jpeds.2007.09.009

The Journal of Pediatrics

Volume 152, Issue 3, March 2008, Pages 310-314.e1

Presented in part at the American Gastroenterology Association annual meeting, Washington, DC, May 21, 2007, and published in part as: Orenstein SR, McGowan JD, Duke AL, Taghadosi M, Harris-Ford LA, Harvey BM, Lauzon JD. Efficacy of conservative therapy as taught in the primary care setting for infant reflux symptoms: prospective validated assessment by the I-GERQ-R during the run-in for a placebo-controlled clinical trial of nizatidine oral solution. Gastroenterology 2007;132(4, Suppl 2):A442.

https://doi.org/10.1016/j.jpeds.2007.09.009 Get rights and content

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.

Section snippets

Subjects

Between August 31 and October 2, 2006, 5 outpatient general pediatric sites in the United States recruited the first 50 patients to a prospective, double-blind, placebo-controlled, randomized clinical trial of an oral solution of an H₂RA. Of those 50 patients, 40 met all the inclusion/exclusion criteria for the study (Table I; available at www.jpeds.com) including abnormal (>16/42) screening scores on the Infant Gastroesophageal Reflux Questionnaire Revised (I-GERQ-R),² and their parents were

I-GERQ-R Total Scores (Figure)

Of the 37 infants who completed 2 weeks of conservative therapy, 78% (29/37) improved their scores, 68% (25/37) improved more than the minimally important difference of 3 points, and 59% (22/37) experienced the clinically meaningful drop of at least 5 points.

Scores of 24% of the total (9 infants) actually became normal (ie, lower than the threshold score of 16). Of that 24% of infants whose scores normalized, the median change was −11 (range, −2-−16), and only 1 of the infants with scores that

Discussion

Two weeks of conservative therapy measures can improve symptoms in 78% of infants with GERD who are seen and treated in the primary care setting, normalizing symptoms in 24%. These findings replicate those found in infants referred by pediatricians to pediatric gastroenterologists,¹ but with more rigor: symptom severity at initiation of conservative therapy was confirmed to be diagnostic for GERD via a previously validated questionnaire, improvements in symptoms were substantiated by an

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: Financial support of the parent clinical trial from which these data were obtained was provided by Braintree Laboratories, Inc. The sponsor did not, however, provide financial support for the current manuscript’s data analysis and preparation. Dr Susan Orenstein drafted the manuscript and was not paid to do so.

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Original articleEfficacy of Conservative Therapy as Taught in the Primary Care Setting for Symptoms Suggesting Infant Gastroesophageal Reflux

Objective

Study design

Results

Conclusions

Section snippets

Subjects

I-GERQ-R Total Scores (Figure)

Discussion

J Pediatr

Clin Gastro Hep

J Pediatr

Ann Allergy Asthma Immunol

J Pediatr

Curr Ther Res

Gastroenterology

Natural history of infant reflux esophagitis: symptoms and morphometric histology during one year without pharmacotherapy

Am J Gastroenterol

When does the maturation process really occur?

Behaviors associated with onset of gastroesophageal reflux episodes in infants: prospective study using split-screen video and pH probe

Clin Pediatr

Infant apnea and gastroesophageal reflux: a critical review and framework for further investigation

Curr Gastro Reports

Controversies and cases: issues in diagnosis and management of pediatric GERD

Contemp Pediatr

Vomiting and gastric motility in infants with cow’s milk allergy

J Pediatr Gastroenterol Nutr

Gastroesophageal reflux associated with cow’s milk allergy in infants: which diagnostic examinations are useful?

Am J Gastroenterol

Gastroesophageal reflux and cow’s milk allergy in infants: a prospective study

J Allergy Clin Immunol

Mucosal mast cells distinguish allergic from gastroesophageal reflux-induced esophagitis (abstract)

J Pediatr Gastroenterol Nutr

Original article
Efficacy of Conservative Therapy as Taught in the Primary Care Setting for Symptoms Suggesting Infant Gastroesophageal Reflux