[Ofloxacin in the therapy of Campylobacter pylori-positive duodenal ulcer. A prospective controlled randomized study].

50 patients with duodenal ulcer and Campylobacter pylori cultured from the antral mucosa were randomly divided into two groups of 25. They received either ranitidine 300 mg at night or the same dose of ranitidine combined with twice daily 200 mg ofloxacin. Endoscopic check and biopsy for histological and microbiological tests were performed every two weeks until demonstrable cure of the ulcer. After two weeks the cure rates were 44 and 80%, respectively, after four weeks 68 and 92%, and after six weeks 88 and 100%. The difference in healing time between ranitidine alone and ranitidine plus ofloxacin was statistically significant (P less than 0.025). Campylobacter pylori was no longer demonstrable in two of 25 patients after ranitidine alone and in 24 of 25 after ranitidine-ofloxacin. The minimal inhibitory concentration of ofloxacin against tested Campylobacter pylori strains was 0.5-1.0 micrograms/ml. Both groups were comparable as to age and sex distribution; duration of history of ulcer, and number of previous ulcers; nicotine and alcohol consumption; intake of nonsteroidal antirheumatic drugs; other previous treatment; size and complications of the ulcers; and number of accompanying diseases. The results speak for Campylobacter pylori playing a role in the pathogenesis of duodenal ulcer.

RCT Entities:   Population Interventions Outcomes