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No improvement of poorly controlled asthma symptoms seen with addition of proton pump inhibitor
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Adding the proton pump inhibitor lansoprazole failed to improve symptoms of poorly controlled asthma in children without gastroesophageal reflux and may actually increase adverse events, according to study results published online.
Janet T. Holbrook, MPH, PhD, of the Johns Hopkins Bloomberg School of Public Health, and colleagues looked at a group of children enrolled in the Study of Acid Reflux in Children with Asthma, which is a randomized, placebo-controlled trial conducted from April 2007 to September 2010; 149 children were given lansoprazole and 157 received a placebo.
Researchers found no statistically significant difference between the two study groups in any of the criteria evaluated.
However, the researchers noted an increase in upper respiratory infections, pharyngitis and bronchitis in the treatment group (RR=1.3; 95% CI, 1.1-1.6).
“Untreated [gastroesophageal reflux] has been postulated to be a cause of inadequate asthma control in children, despite inhaled corticosteroid treatment,” they said, adding that proton pump inhibitor treatment of children with poorly controlled asthma without symptomatic gastroesophageal reflux was not an effective therapy for asthma and had significant safety concerns with long-term use of proton pump inhibitors in children.
An editorial by Fernando Martinez, MD, cited the overuse of proton pump inhibitors in children as an example of therapeutic creep, in which the use of a treatment with real or suggestive therapeutic effects observed in certain age group or in patients with a certain disease phenotype is given to other patients in whom the efficacy has not been demonstrated.
“Therapeutic creep increases the risk of adverse effects without any added advantage for patients,” Martinez said, adding that “this phenomenon has substantially contributed to the marked increase in asthma drug costs.”
Disclosure: The researchers report no relevant financial disclosures.
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With hard-to-control asthma, we often are forced to think “outside the box” to other factors that may be influencing the symptoms, in order to help obtain control. One such popular approach is to optimize reflux control, assuming that unrecognized GERD can induce cough, and that this may be the “difficult to control” component, thus sparing additional steroids. However, there has never been great evidence that this works, and this latest trial seems to suggest that in children with severe asthma and no underlying history or evidence of reflux, they in fact add no benefit in terms of improving scores on the Asthma Control Questionnaire (a validated asthma control measure) at 24 weeks of therapy.
Strengths of this trial included the fact that it was a randomized, placebo controlled trial with fairly rigorous entry criteria, and the authors did the appropriate intention to treat analysis. However, one needs to consider what the study really failed to show — a statistically significant improvement in the ACQ in the population randomized to take lansoprazole. This as a primary outcome may or may not have clinical significance for all settings, though this is a widely used, standardized measure.
It’s also important to keep in mind that there could have been other factors that were not accounted for that may explain the lack of difference between the groups — there is no mention of allergen control or how this was addressed in the study design, nor how any variable inspiratory obstruction (eg, “vocal cord dysfunction”) was addressed in the symptom scoring (not all that coughs is necessarily asthma). The authors themselves comment that this does not mean that GERD is not a potential cause of cough, and note that they did not check to make sure that acid production was suppressed, which may be a major confounder to their findings. However, I agree with the author’s conclusion that this data suggests that if a patient has no clinical suspicion of GERD, use of a proton pump inhibitor has no role in symptom management.
Matthew J. Greenhawt, MD
Infectious Diseases in Children Editorial Board
Disclosure: Dr. Greenhawt reports no relevant financial disclosures.
For more information:
Martinez FD. JAMA. 2012;307:406-407.
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