Objective: Proton-pump inhibitors (PPIs) reduce acid gastroesophageal reflux (GER) and esophageal acid exposure in infants; however, they do not reduce total GER or symptoms attributed to GER. Reflux is reduced in the left lateral position (LLP). We hypothesize that the effect of LLP in combination with acid suppression is most effective in reducing GER symptoms in infants.
Methods: In this prospective sham-controlled trial, infants (0–6 months) with symptoms suggestive of gastroesophageal reflux disease were studied using 8-hour pH-impedance, cardiorespiratory and video monitoring, direct nurse observation, and a validated questionnaire. Infants demonstrating a positive GER symptom association were randomized to 1 of 4 groups; PPI + LLP, PPI + head of cot elevation (HE), antacid (AA) + LLP, or AA + HE. HE and AA were considered “sham” therapies. After 2 weeks the 8-hour studies were repeated on-therapy.
Results: Fifty-one patients were included (aged 13.6 [2–26] weeks). PPI + LLP was most effective in reducing GER episodes (69  to 46 , P < 0.001) and esophageal acid exposure (median [interquartile range] 8.9% [3.1%–18.1%] to 1.1% [0%–4.4%], P = 0.02). No treatment group showed improvement in crying/irritability, although vomiting was reduced in AA + LLP (from 7  to 2  episodes P = 0.042). LLP compared with HE produced greater reduction in total GER (−21  vs −10 , P = 0.056), regardless of acid-suppressive therapy. Acid exposure was reduced on PPI compared with AA (−6.8 [2.1] vs −0.9 [1.4]%, pH < 4, P = 0.043) regardless of positional intervention. A post-hoc analysis using automated analysis software revealed a significant reduction in crying symptoms in the PPI + LLP group (99 [65–103] to 62 [32–96] episodes, P = 0.018).
Conclusions: “Symptomatic gastroesophageal reflux disease” implies disease causation for distressing infant symptoms. In infants with symptoms attributed to GER, LLP produced a significant reduction in total GER, but did not result in a significant improvement in symptoms other than vomiting; however, automated analysis appeared to identify infants with GER-associated crying symptoms who responded to positioning therapy. This is an important new insight for future research.
*Pediatric Gastroenterology and Nutrition, Emma Children's Hospital, AMC, Amsterdam, The Netherlands
†School of Medicine, Flinders University, Adelaide
‡Pediatric Gastroenterology, Royal Children's Hospital, Brisbane
§Neonatal Intensive Care Unit, Women's and Children's Health Network, Adelaide
||North Western Academic Centre University of Melbourne, Melbourne, Australia.
Address correspondence and reprint requests to Taher Omari, PhD, Flinders Medical Science and Technology, School of Medicine, Flinders University, South Australia, Adelaide, Australia (e-mail: firstname.lastname@example.org).
Received 24 October, 2013
Accepted 1 April, 2014
This study was supported by grants from the National Health and Medical Research Council (ID: 508053), the Financial Markets Foundation for Children (grant no. 2009-112), the Dutch Digestive Disease Foundation (grant no. WO 07-07), the Channel 7 Children's Research Foundation, and the Women's & Children's Hospital Foundation. Part of the equipment was kindly provided by AstraZeneca. None of these bodies had a role in the study design; the collection, analysis, and interpretation of data; the writing of the report; and the decision to submit the article for publication.
The authors report no conflicts of interest.