Proton Pump Inhibitors Ineffective in Infants With GERD

Laurie Barclay, MD

April 06, 2011

April 6, 2011 — Proton pump inhibitors (PPIs) are ineffective in reducing gastroesophageal reflux disease (GERD) symptoms in infants, and placebo-controlled trials in older children are lacking, according to the results of a systematic review reported online April 4 and will appear in the May print issue of Pediatrics.

"Use of ...PPIs for the treatment of ...GERD in children has increased enormously," write Rachel J. van der Pol, MD, from the Department of Pediatric Gastroenterology and Nutrition at Emma Children's Hospital AMC in Amsterdam, the Netherlands, and colleagues. "However, effectiveness and safety of PPIs for pediatric GERD are under debate."

The investigators searched PubMed, EMBASE, and the Cochrane Database of Systematic Reviews for studies of PPIs in children aged 0 to 18 years with GERD. Inclusion criteria were randomized controlled trials and crossover studies investigating the efficacy and safety of PPIs, with reported outcomes including reduction in GERD symptoms, gastric pH, histologic abnormalities, and adverse events.

Data from children aged 0 to 17 years were included from 12 identified studies. For reduction of GERD symptoms among infants, PPIs were more effective in 1 study (vs hydrolyzed formula), ineffective in 2 studies, and equally effective in 2 studies (vs placebo). Compared with alginates, ranitidine, or a different PPI dosage, PPIs were equally effective for children and adolescents.

In 4 studies reporting on gastric acidity, PPIs were more effective in infants and children than placebo, alginates, or ranitidine. Three studies showed that PPIs were comparable to ranitidine or alginates for reducing histologic abnormalities. Six studies showed no differences in treatment-related adverse events for PPIs vs placebo or a different PPI dosage.

"PPIs are not effective in reducing GERD symptoms in infants," the review authors write. "Placebo-controlled trials in older children are lacking. Although PPIs seem to be well tolerated during short-term use, evidence supporting the safety of PPIs is lacking."

Limitations of this review include statistical and clinical heterogeneity of the included studies, precluding a pooled analysis with a fixed- or random-effect model. Also, there were few well-designed randomized, placebo-controlled trials with high methodologic quality, and sample sizes were often small.

"[P]hysicians should be careful when prescribing PPIs, medications that are not approved for infants and have potential adverse effects, unless there is documented disease or with careful monitoring," the review authors write.

"Large, well-designed, placebo-controlled, randomized trials with well-chosen end points are necessary to evaluate the effect and safety of PPIs in the entire pediatric age range. Furthermore, we recommend more pathophysiological research on symptom genesis to be able to clearly define homogeneous patient groups and to enable the development of a therapy to tackle this growing health care problem."

Two of the study authors have disclosed various financial relationships with AstraZeneca. The other study authors have disclosed no relevant financial relationships.

Pediatrics. Published onine April 4, 2011. Abstract

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