ABSTRACT
Objective:
To develop a North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition (NASPGHAN) and European Society for Pediatric Gastroenterology, Hepatology, and ...Nutrition (ESPGHAN) international consensus on the diagnosis and management of gastroesophageal reflux and gastroesophageal reflux disease in the pediatric population.
Methods:
An international panel of 9 pediatric gastroenterologists and 2 epidemiologists were selected by both societies, which developed these guidelines based on the Delphi principle. Statements were based on systematic literature searches using the best‐available evidence from PubMed, Cumulative Index to Nursing and Allied Health Literature, and bibliographies. The committee convened in face‐to‐face meetings 3 times. Consensus was achieved for all recommendations through nominal group technique, a structured, quantitative method. Articles were evaluated using the Oxford Centre for Evidence‐based Medicine Levels of Evidence. Using the Oxford Grades of Recommendation, the quality of evidence of each of the recommendations made by the committee was determined and is summarized in appendices.
Results:
More than 600 articles were reviewed for this work. The document provides evidence‐based guidelines for the diagnosis and management of gastroesophageal reflux and gastroesophageal reflux disease in the pediatric population.
Conclusions:
This document is intended to be used in daily practice for the development of future clinical practice guidelines and as a basis for clinical trials.
During the last decade, clinical practice saw a rapid increase of patients with esophageal eosinophilia who were thought to have gastroesophageal reflux disease (GERD) but who did not respond to ...medical and/or surgical GERD management. Subsequent studies demonstrated that these patients had a “new” disease termed eosinophilic esophagitis (EE). As recognition of EE grew, so did confusion surrounding diagnostic criteria and treatment. To address these issues, a multidisciplinary task force of 31 physicians assembled with the goal of determining diagnostic criteria and making recommendations for evaluation and treatment of children and adults with suspected EE. Consensus recommendations were based upon a systematic review of the literature and expert opinion. EE is a clinicopathological disease characterized by (1) Symptoms including but not restricted to food impaction and dysphagia in adults, and feeding intolerance and GERD symptoms in children; (2) ≥ 15 eosinophils/HPF; (3) Exclusion of other disorders associated with similar clinical, histological, or endoscopic features, especially GERD. (Use of high dose proton pump inhibitor treatment or normal pH monitoring). Appropriate treatments include dietary approaches based upon eliminating exposure to food allergens, or topical corticosteroids. Since EE is a relatively new disease, the intent of this report is to provide current recommendations for care of affected patients and defining gaps in knowledge for future research studies.
To develop an international consensus on the definition of gastroesophageal reflux disease (GERD) in the pediatric population.
Using the Delphi process, a set of statements was developed and voted on ...by an international panel of eight pediatric gastroenterologists. Statements were based on systematic literature searches using Medline, EMBASE, and CINAHL. Voting was conducted using a six-point scale, with consensus defined, a priori, as agreed by 75% of the group. The strength of each statement was assessed using the GRADE system.
There were four rounds of voting. In the final vote, consensus was reached on 98% of the 59 statements. In this vote, 95% of the statements were accepted by seven of eight voters. Consensus items of particular note were: (i) GERD is present when reflux of gastric contents causes troublesome symptoms and/or complications, but this definition is complicated by unreliable reporting of symptoms in children under the age of approximately 8 years; (ii) histology has limited use in establishing or excluding a diagnosis of GERD; its primary role is to exclude other conditions; (iii) Barrett's esophagus should be defined as esophageal metaplasia that is intestinal metaplasia positive or negative; and (iv) extraesophageal conditions may be associated with GERD, but for most of these conditions causality remains to be established.
The consensus statements that comprise the Definition of GERD in the Pediatric Population were developed through a rigorous process. These statements are intended to be used for the development of future clinical practice guidelines and as a basis for clinical trials.
Objective To assess the efficacy and safety of lansoprazole in treating infants with symptoms attributed to gastroesophageal reflux disease (GERD) that have persisted despite a ≥ 1-week course of ...nonpharmacologic management. Study design This multicenter, double-blind, parallel-group study randomized infants with persisting symptoms attributed to GERD to treatment with lansoprazole or placebo for 4 weeks. Symptoms were tracked through daily diaries and weekly visits. Efficacy was defined primarily by a ≥ 50% reduction in measures of feeding-related crying and secondarily by changes in other symptoms and global assessments. Safety was assessed based on the occurrence of adverse events (AEs) and clinical/laboratory data. Results Of the 216 infants screened, 162 met the inclusion/exclusion criteria and were randomized. Of those, 44/81 infants (54%) in each group were responders—identical for lansoprazole and placebo. No significant lansoprazole–placebo differences were detected in any secondary measures or analyses of efficacy. During double-blind treatment, 62% of lansoprazole-treated subjects experienced 1 or more treatment-emergent AEs, versus 46% of placebo recipients ( P = .058). Serious AEs (SAEs), particularly lower respiratory tract infections, occurred in 12 infants, significantly more frequently in the lansoprazole group compared with the placebo group (10 vs 2; P = .032). Conclusions This study detected no difference in efficacy between lansoprazole and placebo for symptoms attributed to GERD in infants age 1 to 12 months. SAEs, particularly lower respiratory tract infections, occurred more frequently with lansoprazole than with placebo.
Objective To characterize those pediatric patients who receive long-term proton pump inhibitors (PPIs) and to determine the safety of long-term use of PPIs in this population. Study design Patient ...databases were screened for long-term PPI use, defined as more than 9 months of continuous prescription, between 1989 and 2004. Results The median duration of PPI use in the 166 patients in the study group was 3 years (range, 0.75 to 11.25 years). A total of 80 patients used PPIs for 3 to 11 years duration; 35 of these for more than 5 years, and 15 for more than 8 years. Mean age at initial prescription was 7.8 years. At least 1 gastroesophageal reflux disease (GERD)-predisposing disorder was present in 79% of the patients; the major disorders were neuromotor (in 66%) and esophageal atresia (in 14.5%). No GERD-predisposing disorder was present in 35 patients (21%). Endoscopic findings included hiatal hernia in 39% and histologically proven Barrett’s esophagus in 4.8%. Omeprazole was used in 90% of the patients; lansoprazole, in 7%. Six adverse reactions seen in 4 patients were potentially related to PPI (nausea and diarrhea, skin rash, agitation, and irritability). Conclusions Children with underlying GERD-predisposing disorders compose the majority of long-term PPI users. Few adverse reactions to these drugs occur, and discontinuation of the drug is seldom indicated. These preliminary data suggest that PPIs may be efficacious and safe for continuous use for up to 11 years’ duration in children.
PDF
