Gastroesophageal reflux disease (GERD) is a common chronic condition ranging from mild heartburn to erosive damage of the esophageal lining. Symptoms can be severe, causing a marked reduction in overall quality of life. Medical treatment has improved with the use of proton pump inhibitor (PPI) therapy, which results in rapid relief of symptoms and esophageal healing in most patients. With prolonged therapy, these patients can remain in clinical remission for longer periods. Antireflux surgery, another efficacious therapy, has previously been demonstrated to be superior to non–PPI-based medical therapies in the long-term management of GERD.
Lundell and associates performed a randomized clinical trial comparing omeprazole PPI therapy and antireflux surgery. Patients with chronic GERD symptoms and documented esophagitis were treated with 20 mg of omeprazole, usually for four to eight weeks, with dosages increased to 40 mg in patients with incomplete response. This therapy to control symptoms and heal esophagitis lasted no longer than four months.A total of 310 patients who were taking omeprazole to control their symptoms were randomized to receive omeprazole treatment or antireflux surgery. The type of antireflux surgery performed was determined by the operating surgeon, but conventional total or partial fundoplication was recommended. Patients underwent endoscopic evaluation before randomization and during follow-up at 12, 36 and 60 months. Symptoms were also assessed regularly. Treatment failures were defined as (1) moderate or severe heartburn during the seven days before the respective visit, (2) isolated esophageal erosions on endoscopy, (3) moderate or severe dysphagia occurring beyond the first three postoperative months,(4) randomization to surgery and subsequently requiring a re-operation or more than eight weeks of omeprazole to control symptoms, (5) randomization to omeprazole and requiring antireflux surgery to control symptoms as determined by the treating physician and (6) randomization to omeprazole with the patient preferring antireflux surgery during the course of the study.
The treatment failure rate was significantly higher in the omeprazole group during the five years of follow-up. When, in cases of symptom relapse, the omeprazole dosage was adjusted up to 60 mg daily, the relapse curves more closely approached each other. Over the same period, no differences were found between the two groups in preventing Barrett's esophagus, strictures requiring dilation or quality of life assessment.
The authors conclude that antireflux surgery seems to be more effective than omeprazole therapy in controlling relapse symptoms and in maintaining patients in clinical remission. Surgical therapy was associated with increased flatus, inability to belch and dysphagias, but these symptoms did not affect the quality-of-life assessments.