No evidence to support PPI efficacy in infants, children

Evidence does not support the use of proton pump inhibitors (PPIs) to treat symptoms of gastroesophageal reflux disease (GERD) in infants, and placebo-controlled evidence is lacking in children and adolescents, according to researchers of a systematic review. Their findings appear online in Pediatrics.

“If the primary aim is to treat GERD symptoms in infants, PPIs should not be prescribed,” they advise.

North American and European guidelines allow for consideration of antisecretory treatment, including PPIs, for infants with GERD accompanied by crying and distressed behavior and recommend acid-suppressing drugs for children and adolescents with GERD symptoms, the researchers note. The recommendation in the latter groups is based on extrapolation from adult studies.

Ten randomized controlled trials and 2 crossover studies were reviewed to assess the evidence for the efficacy and safety of PPIs for the treatment of symptoms of GERD in children up to 17 years old. The studies included 895 participants.

In 5 placebo-controlled studies conducted in infants up to 12 months, omeprazole was not effective in reducing GERD symptoms in 2 studies, lansoprazole and pantoprazole were no more effective than placebo in 2 studies, and lansoprazole was more effective than hydrolyzed formula in 1 study. There were no differences found between groups in the rate of treatment-related adverse events.

In 5 studies conducted in children aged 6 months to 13.4 years, none of which were placebo-controlled, GERD symptoms were reduced equally in groups receiving PPIs and the control groups. In all groups, GERD symptoms were reduced significantly compared with baseline symptoms. Two of the 5 studies reported mild to moderate adverse events, with the most common treatment-related adverse events being headache and diarrhea.

In 2 dose-finding studies (esomeprazole and pantoprazole in adolescents aged 12 to 17 years), GERD symptoms were reduced similarly in the PPI and control groups, which received different-dosage PPIs, and were significantly reduced from baseline in all groups. Headache, infection, and pharyngitis were the most common treatment-related adverse events reported.

In all age groups, PPIs reduced gastric acidity. Short-term use of PPIs was well tolerated, but long-term safety data are lacking, the researchers write.

van der Pol RJ, Smits MJ, van Wijk MP, Omari TI, Tabbers MM, Benninga MA. Efficacy of proton-pump inhibitors in children with gastroesophageal reflux disease: a systematic review. Pediatrics. 2011. Epub ahead of print.