Original article—alimentary tract
Comparison of Outcomes Twelve Years After Antireflux Surgery or Omeprazole Maintenance Therapy for Reflux Esophagitis

https://doi.org/10.1016/j.cgh.2009.05.021Get rights and content

Background & Aims

It is important to evaluate the long-term effects of therapies for gastroesophageal reflux disease (GERD). In a 12-year study, we compared the effects of therapy with omeprazole with those of antireflux surgery.

Methods

This open, parallel group study included 310 patients with esophagitis enrolled from outpatient clinics in Nordic countries. Of the 155 patients randomly assigned to each arm of the study, 154 received omeprazole (1 withdrew before therapy began), and 144 received surgery (11 withdrew before surgery). In patients who remained in remission after treatment, post-fundoplication complaints, other symptoms, and safety variables were assessed.

Results

Of the patients enrolled in the study, 71 who were given omeprazole (46%) and 53 treated with surgery (37%) were followed for a 12-year follow-up period. At this time point, 53% of patients who underwent surgery remained in continuous remission, compared with 45% of patients given omeprazole with a dose adjustment (P = .022) and 40% without dose adjustment (P = .002). In addition, 38% of surgical patients required a change in therapeutic strategy (eg, to medical therapy or another operation), compared with 15% of those on omeprazole. Heartburn and regurgitation were significantly more common in patients given omeprazole, whereas dysphagia, rectal flatulence, and the inability to belch or vomit were significantly more common in surgical patients. The therapies were otherwise well-tolerated.

Conclusions

As long-term therapeutic strategies for chronic GERD, surgery and omeprazole are effective and well-tolerated. Antireflux surgery is superior to omeprazole in controlling overall disease manifestations, but post-fundoplication complaints continue after surgery.

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)

  • R. Carlsson et al.

    Prognostic factors influencing relapse of oesophagitis during maintenance therapy with antisecretory drugs: a meta-analysis of long term omeprazole trials

    Aliment Pharmacol Ther

    (1997)
  • J. Labenz et al.

    Prospective follow-up data from the ProGERD study suggests that GERD is not a categorical disease

    Am J Gastroenterol

    (2006)
  • L. Lundell et al.

    Continued (5-year) follow-up of a randomised clinical study comparing antireflux surgery and omeprazole in gastro-oesophageal reflux disease

    J Am Coll Surg

    (2001)
  • P.J. Kahrilas et al.

    Hiatus hernia in the esophagus

  • L. Lundell et al.

    Seven-year follow-up of randomized clinical trial comparing proton-pump inhibition with surgical therapy for reflux oesophagitis

    Br J Surg

    (2007)
  • Cited by (0)

    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.

    View full text