Published in Pediatrics, the review of 12 studies of almost 900 children aged 0-17 noted the paucity of evidence to support the current widespread prescribing of PPIs in infants, as well as in older children.
Although some guidelines recommend considering antisecretory treatments for distressed infants or for children and adolescents with heartburn, the authors noted the evidence to support this had been “extrapolated from adult studies”.
Furthermore, clinical recovery with PPIs “may be ascribed to a placebo reaction or physiologic symptom resolution over time”, the authors wrote.
The review found that for reduction of GORD symptoms in infants, PPIs were not effective in two studies, equally effective in two studies compared with placebo, and more effective in just one study compared with hydrolysed formula.
Meanwhile, placebo-controlled trials in older children were lacking.
For gastric acidity in infants and children, PPIs were more effective compared with placebo, alginates or ranitidine in four studies. And for reducing histologic aberrations, the studies showed no difference between PPIs compared with ranitidine and alginates.
Although PPIs were generally well-tolerated, the authors noted they “may increase susceptibility to acute gastroenteritis and community acquired pneumonia, respiratory infections, gastric polyps, and bacterial overgrowth”.
Speaking with Gastroenterology Update, study co-author, Dr Taher Omari from the Women and Children’s Hospital in Adelaide said that “on balance you have to accept that the weight of evidence suggests that these drugs are not very effective in treating infants with gastroesophageal reflux disease”.
He added that diagnosing GORD in infants was “extremely problematic” and a process of elimination. “PPIs have been the mainstay of treatment in babies with GORD symptoms…and anecdotally the paediatricians and the parents all believe that these drugs are effective in reducing vomiting and irritability,” he said.
However, he said there had now been a number of RCTs, including in Australia, showing that half the babies on placebo improved significantly. Meanwhile no trials had demonstrated significant improvement in infants given PPIs “no matter what drug you’re looking at”.