Infants and proton pump inhibitors: tribulations, no trials.

In this issue of the Journal, Barron et al (1) report their retrospective analysis of data from 4 US health plans, in which they document an enormous rise in the use of proton pump inhibitors (PPIs) in infants for presumed gastroesophageal reflux disease (GERD): In the 4 years from 2000 through 2003 there was at least a 4-fold increase, and in the 6 years from 1999 through 2004, there was a >7-fold increase. One of the PPIs, available in a child-friendly liquid formulation, saw a 16-fold increase in use during that 6-year period. Overall, about 0.5% of the roughly 1 million infants in the study database received one of these drugs during their first year of life. Nearly 50% of the infants started taking a PPI before 4 months of age, and the median duration of treatment was 6 to 8 weeks with an isolated ‘‘gastroesophageal reflux’’ code, but about 3 months if comorbidities were also present. These are not clearly identified, but we presume from the tables Barron et al provide that they include other codes, such as those for respiratory conditions or ‘‘allergic diagnoses.’’ General pediatricians provided somewhat more than half of the prescriptions, with pediatric gastroenterologists writing most of the rest. Fewer than 10% of the infants had any diagnostic testing, and for one third of the infants the PPI was the first-line therapy. Barron et al point out that their study did not evaluate the clinical effectiveness of PPI treatment, and that it is possible that that PPI use did not improve symptoms in these infants. However, they also attempt to justify the high