Acid Reflux without Symptoms Does Not Worsen Asthma
Study Suggests that Millions of Asthma Patients Could Consider Dropping Reflux Medication
A commonly used treatment for acid reflux does not improve asthma symptoms or
control in patients who do not have symptoms of gastroesophageal
reflux (GER), according to a new study supported by the National
Heart, Lung, and Blood Institute (NHLBI) of the National Institutes
of Health and by the American Lung Association (ALA). This suggests
that silent GER (acid reflux that causes only minimal or no reflux
symptoms) does not play a role in asthma, as has previously been
thought.
The multi-center, randomized clinical trial is the first to evaluate whether
adding esomeprazole (Nexium), to asthma therapy might improve asthma
control and quality of life in asthma patients who could have silent
GER. Esomeprazole is a type of medication called a proton pump
inhibitor (PPI), which is used to treat heartburn, GER, and ulcers
by reducing stomach acid. Researchers found no differences between
patients treated with the reflux medication and those who were
not. The results are published in the April 9, 2009, issue of the
New England Journal of Medicine.
"This study helps us rule out silent GER as one possible contributor to poorly
controlled asthma, and is important news for many patients," said NHLBI Director
Elizabeth G. Nabel, M.D. "Asthma patients who take medication for acid reflux
but who do not have reflux symptoms should talk with their doctors about whether
they should continue the medication."
Asthma is a common and complex condition that affects more than 22 million Americans.
Between 32 percent and 84 percent of people who have asthma also have GER, with
nearly half of them having no or minimal reflux symptoms. During GER, food or
fluid rises from the stomach into the esophagus (the tube that carries substances
from the mouth to the stomach) because the muscles linking the esophagus to the
stomach fail to close properly or they open spontaneously. Because GER is more
common in asthma patients than in the general population, it has been commonly
believed that acid reflux might contribute to worsening of asthma symptoms such
as coughing, wheezing, and shortness of breath, in part because GER might cause
the airways to narrow. The relationship between asthma and GER is complex and
not well understood, however. Nonetheless, medication for acid reflux is often
prescribed to patients whose asthma is poorly controlled, even when reflux symptoms
are lacking.
The new study followed 402 adults (average age 42) with poorly controlled asthma
despite taking moderate or higher doses of inhaled corticosteroids. Participants
reported that they did not have GER symptoms or that they had a history of GER
but their symptoms were minimal and they were not taking anti-reflux medication.
Researchers tested for GER with a probe to measure acidity (pH) levels in the
esophagus and found that about 40 percent of participants had silent GER.
Participants were randomly selected to either use esomeprazole (40 milligrams)
twice daily or a similar looking placebo (inactive ingredient) for six months
while continuing to take their asthma medications. They tracked their symptoms
and asthma control through asthma diaries, and visited the research clinic monthly
for lung function testing. They also completed standard quality-of-life questionnaires.
Overall, the numbers and severity of asthma symptoms, and quality-of-life scores
were similar between participants taking esomeprazole and participants who did
not take the anti-reflux medication. In addition, the outcomes were similar
among subgroups of participants, such as those with silent GER, those who were
overweight or obese, and those who had frequent night awakenings due to asthma.
"This study demonstrates that silent GER does not play a role in worsening asthma
symptoms and control," said Robert A. Wise, M.D., a coauthor of the paper and
a professor at Johns Hopkins University School of Medicine, where he is also
director of the coordinating center for the ALA Asthma Clinical Research Centers. "Based
on these results, we also believe that doctors do not need to test for GER in
asthma patients unless the patient is reporting symptoms of acid reflux."
Asthma patients with GER symptoms, however, may find relief from acid reflux
with esomeprazole or other PPIs.
The current asthma guidelines (Expert Panel Report 3 (EPR-3): Guidelines for
the Diagnosis and Management of Asthma - Full Report, 2007) recommend anti-reflux
treatment for patients who have reflux symptoms and a diagnosis of GER. The guidelines
also suggest that physicians consider testing for GER in patients whose asthma
is poorly controlled — especially those who have nighttime asthma symptoms —
and treating silent GER. The recommendations on treating silent GER in asthma
patients were based on extrapolating findings from studies on patients who have
GER symptoms, however, because evidence from randomized controlled clinical trials
in patients without GER symptoms was not available.
"This study fills a gap in our knowledge about the use of anti-reflux therapy
in patients with poorly controlled asthma and it will help inform the next update
of the asthma clinical guidelines, " noted Virginia Taggart, M.P.H., program director
in the NHLBI Division of Lung Diseases, and the study's project officer.
The guidelines are developed by the National Asthma Education and Prevention
Program (NAEPP), which is coordinated by NHLBI. NAEPP periodically convenes an
expert panel to conduct a systematic review of the published medical literature
to ensure that the asthma guidelines reflect the latest scientific advances.
The clinical trial was conducted at 19 sites: Baylor College of Medicine, Houston;
Columbia University-New York University Consortium, New York City; Duke University
Medical Center, Durham, N.C.; Emory University School of Medicine, Atlanta; Illinois
Consortium, Chicago; Indiana University, Asthma Clinical Research Center, Indianapolis;
Louisiana State University Health Sciences Center, Ernest N. Morial Asthma, Allergy,
and Respiratory Disease Center, New Orleans; National Jewish Medical and Research
Center, Denver; Nemours Children’s Clinic-University of Florida Consortium, Jacksonville,
Fla.; North Shore-Long Island Jewish Health System, New Hyde Park, N.Y.; The
Ohio State University Medical Center/Columbus Children’s Hospital, Columbus,
Ohio; St. Louis Asthma Clinical Research Center: Washington University, St. Louis;
University of Alabama at Birmingham; University of California, San Diego; University
of Miami-University of South Florida, Tampa; University of Minnesota, Minneapolis;
University of Missouri, Kansas City School of Medicine; University of Pennsylvania,
Philadelphia; University of Vermont, Burlington.
Esomeprazole and placebo used in the study was provided by its manufacturer,
AstraZeneca, based in Wilmington, Del.
Further information about this trial (NCT00069823 http://clinicaltrials.gov/ct2/show/NCT00069823) can be found at www.clinicaltrials.gov.
To interview an NHLBI asthma expert, contact the NHLBI Communications Office
at (301) 496-4236 or NHLBI_News@nhlbi.nih.gov. To interview Dr. Wise, contact
David March, Johns Hopkins Medicine Media Relations and Public Affairs, at
410-955-1534 or dmarch1@jhmi.edu.
For more information:
Part of the National Institutes of Health, the National Heart, Lung, and Blood Institute (NHLBI) plans, conducts, and supports research related to the causes, prevention, diagnosis, and treatment of heart, blood vessel, lung, and blood diseases; and sleep disorders. The Institute also administers national health education campaigns on women and heart disease, healthy weight for children, and other topics. NHLBI press releases and other materials are available online at www.nhlbi.nih.gov
.
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