Therapy with Gastric Acidity Inhibitors Increases the Risk of Acute Gastroenteritis and Community‐acquired Pneumonia in Children.

Therapy with Gastric Acidity Inhibitors Increases the Risk of Acute Gastroenteritis and Community-acquired Pneumonia in Children. Canani RB, Cirillo P, Roggero P, et al. Pediatrics 2006;117:e817-20. Summary: The authors performed a prospective, controlled trial involving 91 children, ages 4 to 36 months, who were diagnosed with gastroesophageal reflux disease (GERD) by endoscopic biopsy and pH probe. They received either high-dose ranitidine (dosage, 10 mg/kg/day) or omeprazole (dosage, 1 mg/kg/day) during a 4-month study period. The authors compiled the rates of gastroenteritis and pneumonia in these acid-suppressed patients and in a cohort of 95 healthy children matched for age, sex, growth, and number of infections in the 4 months before the treatment period. Excluded were children with conditions predisposing to recurrent infection, including diabetes, chronic lung or cardiac disease, and congenital gastrointestinal motility disorders. Data were also compiled for the 4 months before the introduction of acid-suppressive therapy. Gastroenteritis was defined as the presence of diarrhea of 2 to 7 days' duration, with or without other symptoms such as fever. Pneumonia was defined as clinical symptoms confirmed with a chest radiograph. The diagnosis of these infections was prompted by self-referral-parents were instructed to contact their primary physician or the study center if symptoms developed. The study period coincided with the time of year during which Italy experiences the highest rates of rotavirus and respiratory syncytial virus infections. The control group had 19 cases of gastroenteritis compared with 43 in the treated group (P = 0.001; OR = 3.58), and 2 control pneumonias compared with 11 in the treated group (P = 0.03; OR = 6.39). The baseline infection rates in the treatment and control cohorts during the 4 months before the start of the study were the same. The increased infection rate in the treated group lasted beyond the 4 months of the study. Comment: There are some methodological vulnerabilities in this study. Most important, the primary outcomes were self-reported and the trial was open label. In this setting, knowing that their children were receiving a newly prescribed medication, the parents may have been more vigilant and more likely to report new symptoms compared with the parents of healthy, untreated children. In addition, the children in the treated group were diagnosed with GERD after their parents sought medical care for symptoms suggestive of GERD. Again, such parents may have had a lower threshold for seeking medical attention than those of healthy controls. These selection biases could have confounded the results. The working definition of gastroenteritis in this study was quite liberal and could have captured cases of changes in stool pattern due to dietary changes or even introduction of the study medication itself. In addition, the groups were not controlled for daycare attendance as a risk factor for acquisition of infections-this is important, given the age of the study population. Aside from these factors, Dr Canani and his colleagues deserve high commendation for performing a prospective, controlled study of this important topic in children. The odds ratios of risk are impressive, even when given the potential for inflation by the biases already mentioned. On the other hand, the dose of proton pump inhibitor administered was relatively low, and this may have reduced the magnitude of the findings. This study adds to a growing literature on risks of infection in acid-suppressed individuals. For example, acid suppression has been linked to an increase in community-acquired pneumonias in adults 1, an increased pneumonia incidence in mechanically ventilated patients 2,3, an increased risk of Clostridium difficile infection 4, and an increase in necrotizing enterocolitis in very low birth weight infants 5. Although much more data are required, these emerging data should serve as reminder to all of us that although the use of acid suppressives has benefited patients enormously, the use of any treatment is a risk-benefit equation. Recent trends toward the widespread empirical use of acid suppressives are of concern, especially in young children 6. It is also important for the prescribing physician to remember that even when acid suppression is indicated, it is not necessary to make patients achlorhydric to achieve symptom response or healing. Joel R. Rosh, MD Associate Professor of Pediatrics, UMD-NJ Medical School Director, Pediatric Gastroenterology Atlantic Health, Morristown, NJ [email protected] Eric Hassall, MBChB, FRCPC Professor of Pediatrics Division of Gastroenterology BC Childrens Hospital/University of British Columbia Vancouver BC, Canada

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