Original article—alimentary tractComparison of Outcomes Twelve Years After Antireflux Surgery or Omeprazole Maintenance Therapy for Reflux Esophagitis
Section snippets
Study Design
This Nordic multicenter study (the SOPRAN study) was an extended follow-up (from year 5 up to 12 years) of patients previously studied for 5 years in Study I-635. The original study was started in 1991, with the objective of determining the recurrence rate of reflux symptoms (with or without erosive disease) during a 5-year period after initial healing in patients randomized to either continuous medical therapy with omeprazole (OME), 20 mg or 40 mg each morning, or open ARS.10, 12 At the end of
Patients
The demographic and baseline characteristics for all patients who entered the original study and the SOPRAN study are summarized in Table 1, for comparison of the total and diminishing patient groups that continued for the whole study. The characteristics for each of the groups were recorded at the beginning of the first study period. Of the 155 patients randomized to OME, no further information was available for 1 patient, leaving 154 patients on OME. Among the 155 patients randomized to ARS,
Discussion
When our reflux esophagitis patients were followed for 12 years after randomization to either an open ARS or continuous OME therapy, significantly more patients were kept in continuous clinical remission (ie, not classified as treatment failure) after ARS than if treated long-term with OME. However, the surgical therapeutic strategy was burdened by postoperative complaints that counterbalanced the improved reflux control, leading to similar scores for quality of life in the 2 treatment groups
Acknowledgments
The authors would like to acknowledge medical writing assistance from Dr Madeline Frame, an employee of AstraZeneca R&D.
References (30)
- et al.
Heartburn underestimates erosive oesophagitis in elderly patients with GERD
Gastroenterology
(2004) - et al.
Omeprazole versus H2-receptor antagonists in treating patients with peptic stricture and esophagitis
Gastroenterology
(1994) - et al.
Prospective trial of laparoscopic Nissen fundoplication versus proton pump inhibitor therapy for gastroesophageal reflux disease: seven-year follow-up
J Gastrointest Surg
(2006) - et al.
Complications and antireflux medications use after antireflux surgery
Clin Gastroenterol Hepatol
(2006) - et al.
Clinical effectiveness of laparoscopic fundoplication in a US community
Am J Med
(2003) Epidemiology and natural history of gastroesophageal reflux disease
Digestion
(1992)- et al.
Epidemiology of reflux disease and reflux esophagitis
Scand J Gastroenterol
(1989) - et al.
Measurement of the impact of heartburn and dyspepsia on quality of life
Aliment Pharmacol Ther
(1997) - et al.
Clinical symptoms in endoscopic reflux esophagitis: evaluation in 8031 adult subjects
Dig Dis Sci
(2003) - et al.
Direct comparative trials of the efficacy of proton pump inhibitors in the management of gastro-oesophageal reflux disease and peptic ulcer disease
Aliment Pharmacol Ther
(2003)
Prognostic factors influencing relapse of oesophagitis during maintenance therapy with antisecretory drugs: a meta-analysis of long term omeprazole trials
Aliment Pharmacol Ther
Prospective follow-up data from the ProGERD study suggests that GERD is not a categorical disease
Am J Gastroenterol
Continued (5-year) follow-up of a randomised clinical study comparing antireflux surgery and omeprazole in gastro-oesophageal reflux disease
J Am Coll Surg
Hiatus hernia in the esophagus
Seven-year follow-up of randomized clinical trial comparing proton-pump inhibition with surgical therapy for reflux oesophagitis
Br J Surg
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This article has an accompanying continuing medical education activity on page 1260. Learning Objectives—At the end of this activity, the learner should be able to understand the effectiveness of long-term medical and surgical therapies for gastroesophageal reflux disease and the long-term side effects of each therapy.
Conflicts of interest The authors disclose the following: Anders Malm, Tore Lind, and Anders Walan are employed by AstraZeneca. The remaining authors disclose no conflicts.
Funding This study was funded by AstraZeneca.