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Current American asthma guidelines recommend assessing patients with poorly controlled asthma for gastro-oesophageal reflux disease (GORD) and treating silent GORD. However, these recommendations were based on studies on patients with GORD symptoms. This study is the first of its kind to evaluate whether the addition of proton pump inhibitors (PPIs) in silent GORD may improve the symptoms of asthma.
Four hundred and twelve patients with poorly controlled asthma receiving inhaled corticosteroids with no GORD symptoms or a history of GORD with minimal symptoms and not on antireflux medication were randomised to receive either 40 mg esomeprazole twice daily or placebo for 24 weeks while continuing their asthma medications. Similar proportions of patients in each group had silent GORD. The primary outcome measure was the rate of episodes of poor asthma control. Secondary outcome measures included spirometry, bronchodilator response, nocturnal awakening, quality of life and asthma symptoms (assessed through questionnaires). Ambulatory pH monitoring was used to assess oesophageal reflux.
Forty percent of participants had silent GORD. Both primary and secondary outcome measures were similar between the two groups. No significant differences in asthma-related symptoms were found between patients with documented reflux and those without. Subgroup analyses did not identify any patients whose asthma symptoms benefited from PPIs.
It is concluded that silent GORD does not play a role in worsening asthma symptoms and may be more important in other diseases. The addition of esomeprazole to traditional asthma treatment therefore does not appear to be of benefit.
▸ The American Lung Association Asthma Clinical Research Centers. Efficacy of esomeprazole for treatment of poorly controlled asthma. N Engl J Med 2009;360:1487–99.
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