The Journal of Pediatrics
Volume 152, Issue 3 , Pages 310-314.e1, March 2008

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

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.

  • Susan R. Orenstein, MD

      Affiliations

    • University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania
    • Corresponding Author InformationReprint requests: Susan R. Orenstein, MD, Professor, Pediatric Gastroenterology, University of Pittsburgh School of Medicine, 303 Church Ln, Pittsburgh, PA 15238-1006.
    • ,
  • John D. McGowan, BS

      Affiliations

    • Braintree Laboratories, Braintree, Masschusetts.

Received 4 May 2007; received in revised form 7 August 2007; accepted 5 September 2007. published online 09 November 2007.

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.

Abbreviations: GERD, Gastroesophageal reflux disease, H2RA, Histamine-2 receptor antagonist, I-GERQ-R, Infant Gastroesophageal Reflux Questionnaire-Revised

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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.

PII: S0022-3476(07)00854-2

doi:10.1016/j.jpeds.2007.09.009

Refers to article:

  • Talk is Cheap, Often Effective: Symptoms in Infants Often Respond to Non-Pharmacologic Measures

    Eric Hassall
    The Journal of Pediatrics March 2008 (Vol. 152, Issue 3, Pages 301-303)

The Journal of Pediatrics
Volume 152, Issue 3 , Pages 310-314.e1, March 2008

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