A new 1-week therapy for Helicobacter pylori eradication: Ranitidine bismuth citrate plus two antibiotics

V. Savarino, C. Mansi, M. R. Mele, G. Bisso, G. S. Mela, A. Saggioro, M. Caroli, S. Vigneri, R. Termini, A. Olivieri, R. Tosatto, G. Celle

Research output: Contribution to journalArticlepeer-review

Abstract

Background: One-week triple regimens are currently the most recommended therapy for the eradication of Helicobacter pylori. No previous study has evaluated the efficacy of a short-term regimen combining ranitidine bismuth citrate with two antibiotics. Methods: Seventy-two consecutive H. pylori-positive dyspeptic patients were recruited for this randomized, three-centre, open, parallel-group study. They were subdivided into two groups receiving either ranitidine bismuth citrate 400 mg b.d. + clarithromycin 250 mg b.d. and metronidazole 500 mg b.d. (group A) or ranitidine bismuth citrate 400 mg b.d. + clarithromycin 250 mg b.d. and metronidazole 250 mg q.d.s (group B) for 1 week. H. pylori infection was assessed by CLO-test and histology on both antral and corpus biopsies before and at least 4 weeks after the end of therapy. The bacterium was considered eradicated when both tests were negative. Eradication rates and the number of side-effects were evaluated in each group. The Chi-squared test was used for statistical analysis. Results: One patient with only CLO-test positivity was erroneously randomized to group B and four patients dropped out of the study (two in group A and two in group B), mainly because they refused the second endoscopy. In group A, H. pylori was eradicated in 31 of 36 patients (intention-to-treat = 86%; 95% CI = 71-95% and per protocol 31/34 = 91%; 95% CI = 76-98%). Side-effects occurred in 10 patients (27%) and they were generally mild. In group B, H. pylori was eradicated in 29 of 35 patients (intention-to-treat = 83%; 95% CI = 66-93%; and per protocol 29/33 = 88%; 95% CI = 72-97%). Seven patients (20%) complained of modest side-effects. There was no significant difference between the two treatment arms (P = N.S.); no severe adverse events occurred and none of the patients was withdrawn from the study because of them. Conclusions: The co-administration of ranitidine bismuth citrate plus clarithromycin at low dosage and metronidazole in twice daily doses for 1 week is a short, effective and well-tolerated regimen for the eradication of H. pylori. These findings should provide the impetus for large-scale investigations.

Original languageEnglish
Pages (from-to)699-703
Number of pages5
JournalAlimentary Pharmacology and Therapeutics
Volume11
Issue number4
Publication statusPublished - 1997

ASJC Scopus subject areas

  • Pharmacology (medical)
  • Pharmacology, Toxicology and Pharmaceutics(all)

Fingerprint

Dive into the research topics of 'A new 1-week therapy for Helicobacter pylori eradication: Ranitidine bismuth citrate plus two antibiotics'. Together they form a unique fingerprint.

Cite this