A Scandinavian team compared the efficacy of antireflux surgery (ARS) and proton pump therapy in the control of gastroesophageal reflux disease (GERD).
310 patients with erosive esophagitis were enrolled in the trial and were randomized to continuous omeprazole therapy (n=155) or to open antireflux surgery (n=155).
|Failure rates were higher in patients randomized to omeprazole treatment.
|Journal of the American College of Surgeons
122 patients who had originally had an antireflux operation and 133 in the omeprazole group completed the 5-year follow-up.
Symptoms, endoscopy, and quality-of-life questionnaires were used to document clinical outcomes.
Treatment failure was defined to occur if at least one of the following criteria were fulfilled:
- moderate or severe heartburn or acid regurgitation during the last 7 days before the respective visit
- esophagitis of at least grade 2
- moderate or severe dysphagia or odynophagia symptoms reported in combination with mild heartburn or regurgitation
- if randomized to surgery and subsequently required omeprazole for more than 8 weeks to control symptoms, or having a re-operation
- if randomized to omeprazole and considered to require antireflux surgery to control symptoms
- if randomized to omeprazole and the patient, for any reason, preferred antireflux surgery during the course of the study
The researchers found there were significantly more treatment failures in patients who were originally randomized to omeprazole treatment.
In case of symptom recurrence, dose adjustment in patients allocated to omeprazole therapy to either 40 or 60 mg daily was allowed. The curves subsequently describing the failure rates still remained separated in favor of surgery, although the difference did not reach statistical significance.
Quality of life assessment revealed values within normal ranges in both therapy arms during the 5 years.
Dr Lars Lundell, of the Sahlgrenska University Hospital, Göteborg, Sweden concluded on behalf of the team, "In this randomized multi-center trial with a 5-year follow-up, we found antireflux surgery to be more effective than omeprazole in controlling gastroesophageal reflux disease as measured by the treatment failure rates.
"However, if the dose of omeprazole was adjusted in case of relapse, the two therapeutic strategies reached levels of efficacy that were not statistically different."