Proton-pump inhibiting drugs like lansoprazole may be doing more harm than good when given to kids with gastroesophageal reflux and asthma, according to a new study reently published in the Journal of the American Medical Association.
The notion of using the acid-suppressing drugs in the context of asthma comes from the combined beliefs that GERD is caused by excessive stomach acid production, and that reflux is a prime trigger of asthmatic episodes. The National Heart, Lung and Blood Institute recommends this treatment approach GER symptoms, especially in children with frequent episodes of nocturnal asthma (Allergy Clin Immunol. 2007 Nov;120(5 Suppl):S94).
Despite a lack of evidence, proton pump inhibitors (PPIs) are sometimes prescribed for children to improve asthma control, even in the absence of GER symptoms. The new data, from a study of 306 children with asthma poorly controlled by inhaled corticosteroids, pose a serious challenge to this approach.
Children (mean age 11 years) were randomized to lansoprazole vs. placebo for 24 weeks. All children were free of GER symptoms. Exclusion criteria included any reflux symptoms requiring treatment, any previous use of PPIs or other reflux medications, or history of antireflux surgery. The lansoprazole dose was 15 mg/day for children weighing < 30 kg (66 lbs) and 30 mg/day for children ≥ 30 kg.
The primary outcome was change in score on the Asthma Control Questionnaire (ACQ), which assesses wheezing, shortness of breath, nocturnal symptoms, activity level, use of bronchodilators, and pulmonary function. A change of 0.5 points on the 6-point scale is considered clinically important (reduction indicates improvement). At 24 weeks, there was no significant difference in ACQ scores (mean reduction 0.1 points for lansoprazole vs. 0.2 points for placebo) (level 1 [likely reliable] evidence). Lansoprazole was associated with higher rates of upper respiratory infection (63% vs. 49%, p = 0.02, NNH 7), sore throat (52% vs. 39%, p = 0.02, NNH 7), and bronchitis (7% vs.2% p=0.04, NNH 20). There were no significant differences in asthma-related quality of life, or rate of episodes of poor asthma control.
A group of 115 children had esophageal pH measurements prior to randomization, and 43% were found to have asymptomatic gastroesophageal reflux. There were no significant differences in any asthma outcomes comparing lansoprazole vs. placebo in this subgroup (JAMA 2012 Jan 25;307(4):373).
Thanks to our friends at DynaMed for calling attention to this study.