While the study may have answered questions about acid reflux, attempts to compare costs of the two approaches were more problematic because of cost variations between the countries involved and surgical advances since the study.
In presenting results on behalf of the Nordic GERD Study Group on Gerd Wedge, Dr. Lars Lundell from Sahlgrenska University Hospital at the University of Gothenburg in Sweden said it was “an undisputable fact” antireflux surgery is effective in the control of reflux disease. In addition, he said, there is an accumulation of data showing omeprazole is also highly effective for Barrett’s esophagus. “The question of today and for years to come,” he said, is which of the two approaches is the best strategy for treating GERD patients.
To address the issue, 310 patients with documented reflux in a number of hospitals in Sweden, Norway, Denmark and Finland were first treated with omeprazole to heal esophagitis and relieve symptoms. They were then randomized to surgery or long-term omeprazole therapy.
Dr. Lundell said an attempt was made to standardize the technique used by surgeons in the various countries so that all did open fundoplication surgery, but this did not occur in all cases.
Patients were followed for three years with symptoms being measured on a regular basis. GERD was also assessed using pH manometry. Quality of life was assessed using the Psychological General Well-being Index.
Treatment failure criteria were “very strict,” Dr. Lundell said, and consisted of moderate to severe GERD symptoms after treatment, esophagitis, or a change in therapy after allowing for a change in dose of omeprazole.
Overall, 139 patients in the omeprazole group and 131 in the surgery group completed the full three years of followup. Initial evaluation showed significantly more patients in remission after surgery than after treatment with omeprazole, he said.
But a further analysis showed when dosing changes for omeprazole were taken into account the outcomes were “absolutely identical” between the two groups. In both groups 30% of patients had developed GERD symptoms after three years followup. These patients were being managed successfully with intermittent omeprazole therapy, Dr. Lundell said. He noted a substantial percentage of patients in the medical group required 40 mg/day omeprazole to maintain remission rather than the 20 mg dose.
The total quality of life score was also the same between the two groups, he said. “The race so far is very even,” Dr. Lundell concluded in his presentation.
