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Previous Volume 333:1106-1110 October 26, 1995 Number 17 Next

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ABSTRACT

Background Patients with reflux esophagitis have a high rate of relapse within one year after therapy is discontinued.

Methods We enrolled 175 adults with endoscopy-confirmed reflux esophagitis in a prospective study comparing five maintenance therapies. All the patients were initially treated with omeprazole (40 mg orally once a day) for four to eight weeks, and healing was confirmed by endoscopy. Participants were 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 omeprazole 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 scheduled or unscheduled follow-up endoscopy.

Results In an intention-to-treat analysis, the numbers of patients in continued remission at 12 months were 19 of 35 (54 percent) in the cisapride group, 17 of 35 (49 percent) 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. Omeprazole was significantly more effective than cisapride (P = 0.02) or ranitidine (P =0 .003), and combination therapy with omeprazole plus cisapride was significantly more effective than cisapride alone (P = 0.003), ranitidine alone (P<0.001), or ranitidine plus cisapride (P = 0.03). Ranitidine 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 than ranitidine alone or cisapride alone, and the combination of omeprazole and cisapride is more effective than ranitidine plus cisapride.

Source Information

From the Institute of Internal Medicine and Geriatrics, University of Palermo, Palermo (S.V., R.T., S.B., M.P.); Hospital S. De Bellis, Castellana Grotte, Bari (G.L.); the Department of Internal Medicine, University of Genoa, Genoa (V.S., G.S.M.); the Department of Gastroenterology, University of Padua, Padua (F.D.M., M.P.); the Gastroenterology and Endoscopy Unit, Hospital of Venice, Venice (G.B.); the Geriatrics Unit, Hospital of Schio, Vicenza (A.P.); and the Department of Medicine, University of Chieti, Chieti (G.D.) — all in Italy.

Address reprint requests to Dr. Vigneri at the Institute of Internal Medicine and Geriatrics, Via del Vespro 143, Palermo 90127, Italy.

Full Text of this Article

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Maintenance Therapies for Reflux Esophagitis
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