Systematic review: proton pump inhibitors for the treatment of gastroesophageal reflux in infants

Introduction: Currently, proton pump inhibitors (PPI) are increasingly being used to treat infants with gastroesophageal reflux disease (GERD). However, evidence of the role of PPI as a primary treatment for GERD remains unclear. Aim of study: We aimed to systematically evaluate the published randomized controlled trials (RCTs) evaluating the efficacy and safety of PPI for the treatment of GERD in infants. Material and methods: Using medical subject headings and free-language terms, we searched the Cochrane Central Register of Control-led Trials (CENTRAL), MEDLINE, EMBASE, CINAHL databases, and proceedings of the European and North American pediatric gastro-enterology conferences (from 2000) in October 2007; additional references were obtained from reviewed articles. Results: 2 studies were eligible for inclusion. Study quality was reasonable. Moore 2003 enrolled 30 irritable infants with GER diagnosis thatwas basedon esophageal biopsy and pH criteria. Omari 2007 enrolled 10 premature infants with reflux symptoms and pathological acid reflux on 24-h pH probe. Meta-analysis of 2 RCTs found significant difference in reflux index (weighted mean difference -4.8%, 95% CI -7 to -2) in infants treated with omeprazole. 1 RCT reported a significant reduction in number of acid GER episodes (mean dif-ference, MD -60, 95% CI -127 to -7), number of reflux episodes of pH<4 lasting>5 minutes, and duration of longest episode of pH<4 (MD -32 min, 95% CI -58 to -7). No significant difference in clinical symptoms of GER was found. Two trials reported no adverse events. Conclusions: There is insufficientevidencetodeterminethe roleof PPI for treatment of GERD in infants. Further trials are needed addres-sing both safety and efficacy of PPI in infants.