A COMPARISON OF 5 MAINTENANCE THERAPIES FOR REFLUX ESOPHAGITIS

Background. Patients with reflux esophagitis have a high rate of relap se within one year after therapy is discontinued. Methods. We enrolled 175 adults with endoscopy-confirmed reflux esophagitis in a prospecti ve study comparing five maintenance therapies. All the patients were i nitially treated with omeprazole (40 mg orally once a day) for four to eight weeks, and healing was confirmed by endoscopy. Participants wer e then stratified according to their initial grade of esophagitis and randomly assigned to 12 months of treatment with one of the following: cisapride (10 mg three times a day), ranitidine (150 mg three times a day), omeprazole (20 mg per day), ranitidine plus cisapride, or omepr azole plus cisapride. Endoscopy was repeated after 6 and 12 months of treatment; the endoscopists were blinded to the treatment assignments. Remission was defined as the absence of esophageal lesions on schedul ed or unscheduled follow-up endoscopy. Results. In an intention-to-tre at analysis, the numbers of patients in continued remission at 12 mont hs were 19 of 35 (54 percent) in the cisapride group, 17 of 35 (49 per cent) in the ranitidine group, 28 of 35 (80 percent) in the omeprazole group, 23 of 35 (66 percent) in the ranitidine-plus-cisapride group, and 31 of 35 (89 percent) in the omeprazole-plus-cisapride group. Omep razole was significantly more effective than cisapride (P=0.02) or ran itidine (P=0.003), and combination therapy with omeprazole plus cisapr ide was significantly more effective than cisapride alone (P=0.003), r anitidine alone (P<0.001), or ranitidine plus cisapride (P=0.03). Rani tidine plus cisapride was significantly better than ranitidine alone ( P=0.05). Conclusions. For maintenance treatment of reflux esophagitis, omeprazole alone or in combination with cisapride is more effective t han ranitidine alone or cisapride alone, and the combination of omepra zole and cisapride is more effective than ranitidine plus cisapride.