Effects of omeprazole or anti-reflux surgery on lower oesophageal sphincter characteristics and oesophageal acid exposure over 10 years

Abstract

Objective: To compare the effect of anti-reflux surgery (ARS) versus proton pump inhibitor therapy on lower oesophageal sphincter (LOS) function and oesophageal acid exposure in patients with chronic gastro-oesophageal reflux disease (GORD) over a decade of follow-up.

Material and methods: In this randomised, prospective, multicentre study we compared LOS pressure profiles, as well as oesophageal exposure to acid, at baseline and at 1 and 10 years after randomisation to either open ARS (n = 137) or long-term treatment with omeprazole (OME) 20–60 mg daily (n = 108).

Results: Median LOS resting pressure and abdominal length increased significantly and remained elevated in patients operated on with ARS, as opposed to those on OME. The proportion of total time (%) with oesophageal pH <4.0 decreased significantly in both the surgical and medical groups, and was significantly lower after 1 year in patients treated with ARS versus OME. After 10 years, oesophageal acid exposure was normalised in both groups, with no significant differences, and bilirubin exposure was within normal limits. After 10 years, patients with or without Barrett’s oesophagus did not differ in acid reflux control between the two treatment options.

Conclusions: Open ARS and OME were both effective in normalising acid reflux into the oesophagus even when studied over a period of 10 years. Anatomically and functionally the LOS was repaired durably by surgery, with increased resting pressure and abdominal length.

Keywords:

• Barrett's oesophagus
• bilirubin
• oesophageal sphincter
• lower
• fundoplication
• gastric acidity determination
• gastroesophageal reflux
• manometry
• omeprazole
• proton pump inhibitors

Acknowledgements

Madeline Frame, BSc, PhD, a medical scientist who was affiliated to AstraZeneca Gothenburg, provided medical writing support to the principal author in terms of draughting the methods and results. All writing was carried out in close collaboration with the first author and the steering committee, and they gave major input into the introduction, interpretation and discussion sections. Editorial assistance was provided by Richard Claes, PhD, of PharmaGenesis London, London, UK, funded by AstraZeneca Gothenburg, Mölndal, Sweden.

Disclosure statement

The remaining authors have no conflicts of interest to declare.

Funding

The study was funded through a grant from AstraZeneca. ARM and TL are former employees of AstraZeneca.