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Combined therapy with egualen sodium and cimetidine for patients with gastric ulcer. Second article of a report: Clinical evaluation for the prevention of gastric ulcer relapse: A maintenance study in comparison with cimetidine alone



Combined therapy with egualen sodium and cimetidine for patients with gastric ulcer. Second article of a report: Clinical evaluation for the prevention of gastric ulcer relapse: A maintenance study in comparison with cimetidine alone



Japanese Archives of Internal Medicine 42(8): 125-134



A multicenter controlled study on post-healing maintenance therapy was carried out to clarify the preventive efficacy on gastric ulcer relapse and safety of combination therapy with egualen sodium and cimetidine in comparison with cimetidine alone therapy. This maintenance study was performed on the cases healed in the initial treatment study which we previously reported. According to the randomized allocation in the initial treatment, the object cases were given egualen (30mg/day) +cimetidine (400mg/day, half of dosage for initial treatment) or placebo+cimetidine (400mg/day) for 12 weeks immediately after confirmation of gastric ulcer scar. One hundred and fourteen patients whose ulcer healed in the initial treatment agreed to participate in the maintenance study, of which 59 cases in combination therapy group and 47 cases in cimetidine alone group were suitable for analysis. The results are following 1. The cumulative relapse rate of the combination group based on Kaplan-Meier method was significantly lower than that of the cimetidine alone group (Generalized Wilcoxon test, p lt 0.05) through 12 weeks observation period. 2. As for the safety, only one patient who received cimetidine alone showed the elevation of gamma-GTP and LDH which were not serious. No adverse effect was noted in both groups. These results indicated that combination therapy with egualen sodium and cimetidine would be effective and safe for the prevention of gastric ulcer relapse.

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