NEW YORK (Reuters Health) – Untreated gastroesophageal reflux does not appear to be a factor in poorly controlled asthma in children, as adding a proton pump inhibitor to treatment in such cases does not improve symptoms or lung function.
In fact, “There may be significant safety concerns for long-term PPI use in children that warrant further study,” note the authors of the report in the Journal of the American Medical Association for January 25.
Dr. Janet T. Holbrook, with the Johns Hopkins Center for Clinical Trials in Baltimore, Maryland, and colleagues explain that asymptomatic gastroesophageal reflux (GER) commonly occurs in children with asthma and has been thought to be a possible reason for inadequate asthma control. To see if gastric acid suppression might be helpful, the team conducted a trial involving 306 asthmatic children without overt GER.
The participants were randomly assigned to receive either lansoprazole or placebo for 24 weeks. Their mean age was 11 years. Children in the lansoprazole group weighing less than 30 kg were given 15 mg/d, those weighing more were given 30 mg/d.
The main outcome was the change in score on the Asthma Control Questionnaire (ACQ). The instrument has a scale of 0 – 6 units, and a change of 0.5 units or more is considered clinically relevant. In the trial, the mean difference in change in the ACQ score between the lansoprazole and placebo groups was 0.2 units, the investigators report.
Furthermore, differences between the two arms in changes of secondary measures were not significant, the report indicates. Specifically, the between-group difference in mean FEV1 change was 0.0L, and the relative risk of episodes of poor asthma control was 1.2.
A subset of 115 children had esophageal pH measured before randomization, and 43% were found to have GER, the authors report. In the GER group, lansoprazole compared to placebo had no effect on any asthma outcome.
“The results of this clinical trial are uniformly negative regarding the benefit of acid suppression therapy on symptom relief, lung function, airways reactivity, or quality of life,” Dr. Holbrook and colleagues conclude.
They also report that lansoprazole compared with placebo was associated with more upper respiratory infections (93 vs 74), and episodes of sore throat (77 vs 59) and bronchitis (10 vs 3). In addition, while it did not reach statistical significance, there were more activity-related bone fractures in the lansoprazole group (6) than the placebo group (1). “Our study raises important questions about adverse effects of lansoprazole treatment of children with asthma,” the authors state.
In an editorial, Dr. Fernando D. Martinez of the University of Arizona, Tucson, says the results indicate that the generalized use of PPIs for treatment of asthma should be strongly discouraged, especially in children.
He adds, “The tentative recommendation by the current National Heart, Lung, and Blood Institute guidelines of an empirical trial of GERD therapy in patients with poorly controlled asthma (which was based on the few data available at the time the guidelines were written) is unjustified and should be promptly revised.”
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