Per G Farup1. 1. Enhet for anvendt klinisk forskning, Det medisinske fakultet, Norges teknisk-naturvitenskapelige universitet, Trondheim. per.farup@medisin.ntnu.no
Abstract
BACKGROUND: Indications for H. pylori treatment as well as treatment regimens vary. MATERIAL AND METHODS: This trial compares three regimens with ranitidine bismuth citrate (RBC) or omeprazole as first line therapy, evaluates the effect of one regimen for retreatment, compares practice at Norwegian centres, and evaluates the utility of internet-based collaboration. Consecutive H. pylori positive outpatients at 14 centres were randomised to open treatment with one of the regimens. Patients in whom the first treatment was unsuccessful were offered an "enhanced" regimen with RBC. All participating centres submitted their data to a shared database via the internet. RESULTS: The RBC 400 mg, clarithromycin 250 mg and metronidazole 500 mg regimen, all drugs given twice daily for 7 days, was significantly more effective than the other regimens; infections in 141 out of 146 patients (97%) were successfully eradicated. An enhanced regimen with RBC, clarithromycin and metronidazole was less suitable for retreatment after failure. There were significant differences in patient age and indication for treatment between the centres. The data were of high quality. INTERPRETATION: The regimen RBC, clarithromycin and metronidazole was the most effective and seems suitable as first-line treatment. The internet collaboration yielded data of high quality that disclosed that patients were not uniformly managed. Our collaborative approach seems to be a suitable method for quality assurance and the organisation of simple clinical multicentre trials.
RCT Entities:
BACKGROUND: Indications for H. pylori treatment as well as treatment regimens vary. MATERIAL AND METHODS: This trial compares three regimens with ranitidine bismuth citrate (RBC) or omeprazole as first line therapy, evaluates the effect of one regimen for retreatment, compares practice at Norwegian centres, and evaluates the utility of internet-based collaboration. Consecutive H. pylori positive outpatients at 14 centres were randomised to open treatment with one of the regimens. Patients in whom the first treatment was unsuccessful were offered an "enhanced" regimen with RBC. All participating centres submitted their data to a shared database via the internet. RESULTS: The RBC 400 mg, clarithromycin 250 mg and metronidazole 500 mg regimen, all drugs given twice daily for 7 days, was significantly more effective than the other regimens; infections in 141 out of 146 patients (97%) were successfully eradicated. An enhanced regimen with RBC, clarithromycin and metronidazole was less suitable for retreatment after failure. There were significant differences in patient age and indication for treatment between the centres. The data were of high quality. INTERPRETATION: The regimen RBC, clarithromycin and metronidazole was the most effective and seems suitable as first-line treatment. The internet collaboration yielded data of high quality that disclosed that patients were not uniformly managed. Our collaborative approach seems to be a suitable method for quality assurance and the organisation of simple clinical multicentre trials.