A PROSPECTIVE RANDOMIZED STUDY OF AMOXICILLIN AND OMEPRAZOLE WITH ANDWITHOUT METRONIDAZOLE IN THE ERADICATION TREATMENT OF HELICOBACTER-PYLORI

A combination of amoxycillin and omeprazole is often used to treat Hel icobacter pylori infection. A three-drug regimen comprising metronidaz ole, amoxycillin and omeprazole has been proposed as an alternative th erapy. In a prospective, randomized, comparative study, we evaluated t hese two regimens with respect to safety and efficacy in patients with H. pylori infection. Sixty patients with peptic ulcer (gastric, 32 pa tients; duodenal, 28 patients) who had a history of ulcer recurrence w ere randomly assigned to dual therapy with amoxycillin (500 mg three t imes daily for 2 weeks) and omeprazole (20 mg once daily for 8 weeks) or to triple therapy with metronidazole (500 mg twice daily for 2 week s) plus amoxycillin and omeprazole, given in the same dosages as dual therapy. Forty-eight patients completed the protocol; treatment was di scontinued because of side effects in nine patients, and three patient s dropped out of the study. On the basis of all patients treated, the rate of H. pylori eradication was significantly higher for triple ther apy 20/23 cases, 87.0%; 95% confidence interval (CI), 0.664-0.972) tha n for dual therapy 13/25, 52.0%; 0.313-0.722; P < 0.05). On an intenti on-to-treat basis, the difference between the groups in the rate of H. pylori eradication was marginally significant (P = 0.06 [0.028-0.512] ), Side effects were reported by five patients receiving triple therap y (skin rash, one; nausea, two; headache, one; abdominal pain, one), a nd four patients receiving dual therapy (skin rash, two; abdominal pai n, one; diarrhoea, one). All side effects resolved spontaneously after termination of treatment. There was no significant difference in safe ty between the two regimens. Triple therapy with metronidazole, amoxyc illin, and omeprazole was significantly more effective for the eradica tion of H. pylori than dual therapy with amoxycillin and omeprazole al one. The safety of these regimens was similar, and triple therapy was found to be clinically acceptable.