RESUMO
OBJECTIVE: To compare the efficacy and safety of ranitidine 300 mg twice daily plus amoxycillin 1000 mg twice daily for 2 weeks (RA2) with ranitidine 300 mg twice daily, amoxycillin 1000 mg twice daily, plus tinidazole 500 mg twice daily for 2 weeks (RAT2) for the eradication of Helicobacter pylori. DESIGN: Prospective, randomized, double-blind, parallel-group study in patients who were H. pylori positive on 13C urea breath test (13C UBT). SETTING: Twenty-four UK consultant gastroenterologists entered mostly hospital out-patients. PATIENTS: A total of 232 patients with gastric or duodenal ulceration or endoscopic appearances suggestive of gastritis (160 male, 72 female, mean age 51) were entered following routine endoscopy; 223 were H. pylori positive on 13C UBT. Patients with medical conditions or medications which could interfere with study response or measurements and those at risk of pregnancy were excluded. Two hundred and three patients completed the study. INTERVENTIONS: Patients underwent endoscopy with biopsy for rapid urease (CLO) test. Those who were positive had a 13C UBT. Patients were randomized to receive RA2 or RAT2. Eradication of H. pylori was assessed by 13C UBT 4 weeks after completion of therapy. Blood was taken for haematological and biochemical screening at the beginning and end of treatment. MAIN OUTCOME MEASURE: H. pylori eradication at least 28 days after end of treatment. RESULTS: In the intention-to-treat sample analysis, H. pylori was eradicated in 78/115 patients (68%) taking RAT2 and 42/108 patients (39%) taking RA2. In the per-protocol sample analysis H. pylori eradication was successful in 68/79 patients (86%) taking RAT2 and 36/71 patients (51%) taking RA2. One hundred and seventeen patients experienced 242 adverse events. CONCLUSION: Twice daily ranitidine triple therapy is a useful H. pylori eradication regimen.
