Comparison of the effects of esomeprazole and fundoplication on airway responsiveness in patients with gastro-oesophageal reflux disease
Authorship and contributorship
Toni Kiljander and Tuomo Rantanen designed the study, interpreted the data, wrote the paper; Tuija Poussa analysed and interpreted the data, wrote the paper; Markku Nieminen designed the study, critically reviewed the paper; Ilmo Kellokumpu, Tiit Kööbi, Lauri Lammi, Arto Ranta, Seppo Saarelainen and Paulina Salminen collected data and critically reviewed the paper.
The study was accepted by local ethics committees and has been conducted in accordance with the ethical standards laid down in the Declaration of Helsinki. All patients gave a written informed consent prior to their inclusion in the study.
Conflict of interests
Dr Kiljander has received reimbursement for attending a symposium and fees for speaking or consulting from Novartis and Boehringer Ingelheim. Dr Saarelainen has received reimbursement for attending a symposium and fees for speaking or consulting from GSK and Boehringer Ingelheim. Other authors declare no conflict of interests.
Toni Kiljander, MD, PhD, Department of Respiratory Diseases, Terveystalo Hospital, Aninkaistenkatu 13, 20100
Tel: +358 40527 4472
Fax: +358 30633 3302
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.
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.
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).
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.
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.