PPI Ineffective for Asthma Control in Children With No GERD Symptoms

An acid reflux drug frequently prescribed for children with poorly controlled asthma does not improve asthma control if the child has no symptoms of acid reflux, according to a recent study published in JAMA: the Journal of the American Medical Association. In such cases, the treatment actually increases the risk of sore throat, bronchitis and other respiratory problems.

"The study demonstrates that this recently advocated treatment is not effective and reminds us to focus on evidence-based practice in real-world settings," said family physician Kurt Elward, M.D., of Charlottesville, Va., the Academy's liaison to the National Asthma Education and Prevention Program.

Untreated gastroesophageal reflux has been proposed as a cause of inadequate asthma control in children despite inhaled corticosteroid treatment. Previous research has suggested that proton pump inhibitors (PPIs), which often are prescribed for children with asthma who have symptoms of gastroesophageal reflux disease (GERD), improves asthma control in these children.

In the JAMA study, which was conducted by investigators with the American Lung Association Asthma Clinical Research Centers and supported by the National Heart, Lung and Blood Institute, 306 children ages 6 years through 17 years who had poorly controlled asthma were randomly assigned to receive the PPI lansoprazole or a placebo in addition to their inhaled steroid therapy. During a 24-week period, the children kept a daily log of asthma-related issues and their oral corticosteroid use and visited a clinical center once every four weeks for an assessment.

About 40 percent of participants in the study tested positive for GERD, as determined by pH probe testing, but did not show symptoms. These participants did not see any improvement in asthma control with lansoprazole use.

In fact, treating asymptomatic acid reflux in children with asthma can carry risks. The JAMA study reported increased adverse side effects in those who took lansoprazole, such as a higher frequency of upper respiratory infections and a slight increase in activity-related bone fractures, compared with the placebo group.

The outcome of this study mirrors the findings of a similar study in 2009 (13-page PDF; About PDFs), that tested the use of esomeprazole, another PPI, in adults with asymptomatic gastroesophageal reflux.

According to Elward, the JAMA study shows that there needs to be a good research base for the treatments doctors provide.

"It reminds us that simply extending therapy that works in one group to another subset of patients without proper evidence should be done with caution," he told AAFP News Now.

A better approach, said Elward, might be for physicians to investigate factors that trigger asthma attacks in patients and focus on appropriate controller medications and asthma action plans. Good patient-oriented evidence shows these options are central to asthma management.

In an editorial that accompanied the JAMA study, Fernando Martinez, M.D., of the University of Arizona, Tucson, calls such inappropriate expansions of treatment "therapeutic creep." He describes therapeutic creep as when "clinicians extend the use of a treatment with real or suggestive therapeutic effects observed in a certain age group or in patients with a certain disease phenotype to other patients in whom the efficacy has never been demonstrated."

Elward noted that this study reminds doctors of the unintended consequences of therapeutic creep.

"This is the type of area where more studies, including those within practice-based primary care networks, could answer such questions effectively and in a way that directly relates to frontline clinical care," he said.