Six regimens for the eradication of Helicobacter pylori (Hp) in duodenal ulcer patients: three consecutive trials (1995-1999).

AIM: to present our experience in eradicating Hp in three consecutive trials performed between 1995 and 1999. METHODS: 320 duodenal ulcer outpatients have been enrolled in three open, prospective controlled trials. Hp infection was confirmed by Giemsa stain and Rut. In Trial I, 52 cases received 20 mg omeprazole + 2 x 250 mg clarithromycin + 2 x 500 mg tinidazole (OCT), 48 patients were given 20 mg omeprazole, 2 x 1000 mg amoxicillin + 2 x 500 mg metronidazole (OAM) for 7 days; in Trial II, 48 cases received 40 mg pantoprazole + 2 x 1000 mg amoxicillin + 2 x 500 mg clarithromycin (PAC) for 7 days and 5l cases 2 x 400 mg ranitidin bismuth citrate + 2 x 500 mg clarithromycin for 14 days (RBC-C); in Trial III, 60 cases were treated with 2 x 30 mg lansoprazole + 2 x 250 mg clarithromycin + 2 x 500 mg metronidazole and 6l patients received 2 x 400 mg ranitidin bismuth citrate+2 x 250 mg clarithromycin + 2 x 500 mg metronidazole (RBC-CM). The patients were controlled within 4-6 weeks by endoscopy in trials I-II and 13C-urea breath test in trial III. RESULTS: Eradication rates on ITT/PP basis were: OCT: 72.3/80.2% vs OAM 51.2/63.5% (P = 0.02/P = 0.03); PAC: 80.8/88.3% vs RBC-C 80.3/85.4% (P = 0.65/0.67) and LCM 78.3/92.1% vs RBC-CM 78.7/90.5% (P = 0.86/P = 0.93). Side effects occurred in 5.2, 8.6, 9.5, 14.5, 13.5 and 18.3% of the cases. CONCLUSION: Regimens using 2 x l PPI or RBC + 2 antibiotics for l week proved to be the most effective for Hp eradication in duodenal ulcer patients.

[Lansoprazole versus ranitidine bismuth citrate containing triple regimens for Helicobacter pylori eradication in patients with duodenal ulcer]. / Lanzoprazol- vagy ranitidin bizmut citrát-tartalmú hármas kezelés a Helicobacter pylori-fertózés eradikációjában nyombélfekélyes betegekben.

The aim of this study was to compare in an open, controlled and prospective trial the efficacy of one-week regimen using either lansoprazole (2 x 30 mg) + 2 x 500 mg metronidazole + 2 x 250 mg clarithromycin (group I, 60 cases) or ranitidine bismuth citrate (2 x 400 mg) + 2 x 500 mg metronidazole + 2 x 250 mg clarithromycin (group II, 61 cases) on the eradication of Hp infection in duodenal ulcer patients. The diagnosis was stated endoscopically. Hp infection was confirmed from 2 antral + 2 corporeal biopsies by the modified Giemsa stain and rapid urease test. After eradication the patients were given on-demand treatment with 30 mg lansoprazole (group I) or 2 x 150 mg ranitidine (group II). Control 13C-urea breath test was performed 4-6 weeks after eradication. On intention to treat basis, Hp was eradicated in 78.3% (confidence interval, CI: 67.6-89.1%) in group I and 78.7% (CI: 68.1-89.2%) in group II (p > 0.05). Per protocol eradication rates were 92.1% (CI: 84.5-99.7%) in group I and 90.5 (CI: 82.4-98.6%) in group II (p > 0.05). Side effects were recorded in 13.5% in group I and 18.3% of cases in group II. Short term triple therapies using either lansoprazole or ranitidine bismuth citrate + 2 antimicrobials were effective and safe in the eradication of Hp in duodenal ulcer patients.