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Treatment with the proton pump inhibitor (omeprazole) and single antibiotic (amoxycillin), two synergistic compounds, can cure Helicobacter pylori (H. pylori) infection, but this therapy is not as effective as had been expected. However, some studies show promising results. The aim of our study was to evaluate the effect of two weeks dual-therapy with omeprazole (O) and amoxycillin (A) on gastric (GU) and duodenal ulcer (DU) patients: ulcer healing, eradication of the H. pylori and recurrence rate of the ulcer. We studied 216 patients (aged 18-70) endoscopically proven GU (58 patients) and DU (158 patients). Rapid urease test from the two antrum biopses and two antral and two corporeal biopses using Giemsa stain method for confirmation of the H. pylori infection were used. The patients were treated with omeprazole 20 mg BID and amoxycillin 1.0 g BID for 2 weeks and investigated every 4 months during 2 years. Clearance effect of Hp infection was achieved in 65.1% GU and 66.4% DU patients. Eradication ("check point" after 4 months) in 43% DU and 56.6% GU patients was confirmed. Reinfection rate was found in 16% during 2 years. We conclude--dual-therapy (O and A) is not sufficiently effective to be recommended as an anti-H. pylori treatment. H. pylori eradication prevents recurrence of peptic ulcer and is an important issue in attempts to achieve permanent ulcer healing.

Ebrotidine (N-[(E)-[[2-[[[2-[(diaminomethylene)amino]-4 -thiazoly]methyl]thio]ethyl]amino]methylene]-4-bromo-benzenesulfon amide, CAS 100981-43-9, FI-3542) is a new H2-receptor antagonist characterized by its high receptor affinity and gastroprotective effect. This Phase II study has been undertaken to establish the efficacy and safety of ebrotidine, administered in four dosages as a single evening dose versus placebo in the treatment of duodenal ulcer. A total of 110 duodenal ulcer patients were studied in a randomized, double-blind, placebo-controlled, multicentre clinical trial. The patients were assigned to 5 groups: placebo, 200 mg, 400 mg, 600 mg and 800 mg of ebrotidine once daily. Controls were performed at baseline and every two weeks at four follow-up visits unless ulcer healed before. Endoscopic examination was the main parameter for the assessment of treatment efficacy and ulcer healing rate. Vital signs and blood/ urine analysis were used to establish safety. The three groups treated with higher dosages (400 to 800 mg of ebrotidine daily) showed an endoscopic ulcer healing rate of 90-95%, significantly higher than 55% achieved with placebo (p < 0.05), whilst the differences between these three dosages of ebrotidine were not statistically significant. Healing rate in the group treated with 200 mg of ebrotidine daily was not significantly different from that in the placebo group. The development of symptoms, number of episodes of ulcer-related pain, total ulcerated surface area or subjective ratings by the patients and investigators also differed significantly between ebrotidine (400, 600 and 800 mg daily) and placebo, and again, no marked differences were found between these three doses of ebrotidine. As far as tolerance is concerned, no clinically or statistically significant changes were observed in vital signs and analytical parameters. The incidence of side effects was less than that presented by the placebo group, possibly due to a greater consumption of antacids in this group. Results showed that a daily dose of 400 mg ebrotidine is effective and safe in the treatment of duodenal ulcers.

Objective: To compare the efficacy and safety of ebrotidine and ranitidine administered once daily in equimolar doses of 800 and 300 mg, respectively., Patients: A total of 298 duodenal ulcer patients were studied., Design: A multicentre, parallel, randomized clinical trial., Methods: Of the 298 patients studied, 150 were randomly assigned to ebrotidine and 148 to ranitidine treatment. Digestive endoscopy was performed at enrolment and at weeks 4, 6 and 8 unless the ulcer had healed before. Endoscopic findings were the main parameter for the assessment of treatment efficacy. Plasma gastrin and pancreatic polypeptide concentrations were also measured before and after termination of the therapy., Results: Ebrotidine achieved a duodenal ulcer healing rate comparable to that of ranitidine, and no statistically significant difference was found between the two drugs. The drugs were equally effective in improving ulcerous dyspeptic symptoms and in relieving gastric pain. Both tobacco and ethanol consumption influenced ulcer healing adversely, but healing in smokers was more pronounced in patients treated with ebrotidine, possibly because of its cytoprotective activity., Conclusions: Ebrotidine 800 mg is as effective and safe as ranitidine 300 mg in healing duodenal ulcer, but ebrotidine appears to be superior in promoting the healing of duodenal ulceration in smokers.

The purpose of the work was an evaluation of duodenal ulcer recurrence rate in patients with a history of at least two years of ulcer treated during one year with the preparation Ulfamid (famotidine) Krka in a maintenance dose of 20 mg before sleep. The study involved 30 patients of either sex in whom complete healing of the ulcer niche was obtained in the first phase. Control endoscopy was carried out after 3, 6, 9, and 12 months. In the first phase of the study, complete healing of the ulcer niche after the treatment with Ulfamid in a therapeutic dose of 40 mg for six weeks was obtained in 94.9%. In the second phase of the study, after three months on Ulfamid in a maintenance dose, the recurrence rate was 13.3%, after six months 26.6%, after nine months another 6.1%. After 12 months the recurrence rate of duodenal ulcer reached jointly 46.7%. Of interest is the observation of a large number of the so called asymptomatic ulcers which accounted for 50% of the observed recurrencies.