Background. Conventional medical treatment for gastroesophageal reflux disease involves lifestyle modifications and combination drug therapy, but few studies have included these features in their protocols. Antireflux surgery has seldom been studied prospectively, and there have been no trials comparing modern medical and surgical treatments for reflux disease. Methods. We conducted a long-term, randomized trial of medical therapy (lifestyle modifications and up to four medications) and surgical therapy (Nissen fundoplication) in 247 patients (243 men and 4 women) with peptic esophageal ulcer, stricture, erosive esophagitis, or Barrett's esophagus. They received by random assignment either continuous medical therapy, medical therapy for symptoms only, or surgical therapy. Symptoms were assessed quarterly with a disease-activity index; esophagoscopy was performed at base line and each year for two years. The outcomes evaluated at one and two years included the activity index and the endoscopic grade of esophagitis. Results. Follow-up data were available for 176 patients at one year and for 106 patients at two years. The mean (±SE) activity-index score (possible range, 74 to 172) decreased in one year from 108±3 to 87±2 in the group receiving continuous medical therapy, from 107±3 to 88±2 in the group receiving medical therapy for symptoms only, and from 109±3 to 78±2 in the surgical-therapy group (P<0.0001 for the change from base line, for all comparisons). The mean (±SE) grade of esophagitis (possible range, 1 to 4) decreased in the respective groups from 2.9±0.1 to 2.0±0.1, from 2.9±0.1 to 2.3±0.1, and from 2.9±0.1 to 1.4±0.1 (P<0.005 vs. base line, for all comparisons). The mean activity-index score and the grade of esophagitis were significantly better in the surgical-therapy group than in either medical-therapy group during the two years of follow-up (P<0.003). Conclusions. In men with complicated gastroesophageal reflux disease, surgery is significantly more effective than medical therapy in improving the symptoms and endoscopic signs of esophagitis for up to two years, although medical treatment is also effective. (N Engl J Med 1992; 326:786–92.).
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