Proton pump inhibitors (PPIs) are the most potent acid suppressing medications currently available. These acid-suppressing drugs have revolutionized the treatment of GE reflux disease, and we and others have shown the enormous value of their use in children over last 15 years.1-3

However, there is no question but that PPIs are frequently prescribed inappropriately in infants.4, 5 This practice is not without potential harm. These are facts on which experts agree. In discussing this issue, it's important first to clarify the terminology.

Definitions: Newborns and infants are those of ages 0-12 months (hereinafter ‘infants').6, 7

Gastroesophageal reflux or GER or GE reflux refers to the passage of gastric contents into the esophagus with or without regurgitation and vomiting.6, 7 GER is a normal physiologic process occurring several times per day in healthy infants, children, and adults. Most episodes of GER in healthy individuals last <3 minutes, occur during or immediately following meals, and cause few or no symptoms. Up to 70% of otherwise happy, healthy, thriving infants spit up at least once daily; they have reflux, not reflux disease. By the age of 12-15 months, less than 5% are spitting up. GE reflux does not warrant pharmacologic treatment.

In contrast:

Gastroesophageal reflux disease or GERD is present when the reflux of gastric contents causes troublesome symptoms and/or complications.6, 7 Complications include esophagitis, esophageal stricture (narrowing), Barrett's esophagus (not under the age of 5 years), sometimes chronic cough or pneumonias, occasionally failure to gain weight and grow, and other conditions. ‘Troublesome' is a subjective term that can be reported reliably only by older children, adolescents or adults - not by infants. We as parents are often ‘troubled' when our child is crying or unhappy; but the fact that we are troubled does not make the diagnosis of reflux disease. In making the diagnosis of reflux disease, we are looking for a condition that requires treatment, which can alleviate the symptoms.

The problem:

a) Many (the majority) of otherwise healthy infants spit up - this is true;
b) Many infants are unhappy/irritable/have unexplained crying - this is also true.

This does not mean that the ‘spitting up' or ‘reflux' is the cause of the unexplained crying. It's more often than not a case of ‘true-true-unrelated'.

The evidence for overprescription. Recently, 162 infants with symptoms said to be those of GERD (eg spitting up, arching, unexplained crying) were randomized, in double-blind fashion, to a PPI vs a placebo.8 After 2 weeks, an identical number - 54% - of infants in each group, responded. In other words, active drug - in this case PPI - was no better than placebo. This is the largest such study in the literature. The likeliest explanation is that the great majority of these infants did not have GERD. GE reflux disease (esophagitis and the like) does not respond to placebo. Other studies have shown this.