Comparison of the effects of esomeprazole and fundoplication on airway responsiveness in patients with gastro-oesophageal reflux disease

Clin Respir J. 2013 Jul;7(3):281-7. doi: 10.1111/crj.12005. Epub 2012 Oct 24.

Abstract

Introduction: Gastro-oesophageal reflux disease (GORD) is suggested to cause or aggravate several respiratory conditions. Studies with proton pump inhibitors have resulted in only minor improvements in pulmonary outcomes in patients with GORD. It has been speculated that operative treatment of GORD might be more efficient as it also diminishes non-acidic reflux.

Objectives: To compare the effects of esomeprazole 40 mg bid and fundoplication on airway responsiveness, forced expiratory volume in 1 s (FEV1), exhaled nitric oxide (NO) and respiratory symptoms in patients with moderate-to-severe GORD.

Methods: Sixty-nine GORD patients had methacholine inhalation challenge performed on them, and FEV1, exhaled NO and respiratory symptoms were measured at baseline, after a 3-month treatment with esomeprazole and 3 months after fundoplication. Primary outcome variable was dose-response slope (DRS), i.e. decline in FEV1 during methacholine challenge divided with the amount of methacholine administered (%/μmol). Pre-defined subgroup analysis was performed among those with concomitant asthma (n = 12).

Results: There was no improvement in DRS, FEV1 or exhaled NO after esomeprazole treatment or fundoplication. Cough and dyspnoea measured with visual analog scale improved with esomeprazole treatment (P < 0.001), and further after fundoplication (P < 0.001). Among those with concomitant asthma, significant improvements in St George Respiratory Questionnaire (SGRQ) scores could be seen after fundoplication.

Conclusions: Neither esomeprazole treatment nor fundoplication diminishes airway responsiveness or exhaled NO, or improves FEV1 in patients with GORD. Improvements in respiratory symptoms and SGRQ scores after GORD treatments could be detected. However, as this was not a placebo-controlled study, the findings in these secondary endpoints should not be emphasised. ClinicalTrials.cov: NCT00994708.

Keywords: asthma; esomeprazole; fundoplication; gastro-oesophageal reflux; hyperresponsiveness; nitric oxide.

Publication types

  • Clinical Trial
  • Comparative Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Anti-Ulcer Agents / therapeutic use*
  • Asthma / etiology
  • Breath Tests
  • Bronchial Hyperreactivity / etiology*
  • Esomeprazole / therapeutic use*
  • Female
  • Forced Expiratory Volume
  • Fundoplication*
  • Gastroesophageal Reflux* / complications
  • Gastroesophageal Reflux* / drug therapy
  • Gastroesophageal Reflux* / surgery
  • Humans
  • Male
  • Middle Aged
  • Nitric Oxide / metabolism
  • Treatment Outcome

Substances

  • Anti-Ulcer Agents
  • Nitric Oxide
  • Esomeprazole

Associated data

  • ClinicalTrials.gov/NCT00994708