Comparison of 1-week vs. 2- or 4-week therapy regimens with ranitidine bismuth citrate plus two antibiotics for Helicobacter pylori eradication

Abstract

Background: Helicobacter pylori eradication therapies based on ranitidine bismuth citrate have recently been introduced in clinical practice.

Aim: To compare the efficacy of three regimens containing ranitidine bismuth citrate given for 1, 2 and 4 weeks, combined with two antibiotics for the first week, in the eradication of H. pylori.

Methods: Eighty-six consecutive patients (50 duodenal ulcer disease, 36 non-ulcer dyspepsia) with H. pylori infection were offered three eradication regimens: (a) 1-week group (n=28), ranitidine bismuth citrate 400 mg b.d. for 7 days; (b) 2-week group (n=29), ranitidine bismuth citrate 400 mg b.d. for 14 days; and (c) 4-week group (n=29), ranitidine bismuth citrate 400 mg b.d. for 28 days. In all patients, clarithromycin 500 mg b.d. and metronidazole 500 mg b.d. were given for the first week. Endoscopy was repeated 1 month after the end of treatment and eradication was considered to be successful if both rapid urease test and histology were negative.

Results: Overall, H. pylori was eradicated in 84% (72/86) patients on intention-to-treat analysis, whereas the per protocol cure rate was 89% (72/81). Eradication rates were 23/27 (85%) (95% confidence interval (CI): 66-96%), 25/27 (92%) (95% CI: 76-99%) and 24/27 (89%) (95% CI: 71-98%) in the 1-, 2- and 4-week groups, respectively, on per protocol analysis, and 25/28 (82%) (95% CI: 63-94%), 25/29 (86%) (95% CI: 68-96%) and 24/29 (83%) (95% CI: 64-94%), respectively, on intention-to-treat analysis (P > 0.05, N.S.). No significant differences were observed between groups concerning duodenal ulcer healing, resolution of symptoms and adverse effects.

Conclusions: The 1-week regimen with ranitidine bismuth citrate, clarithromycin and metronidazole is effective in H. pylori eradication. Prolongation of treatment with ranitidine bismuth citrate for 2 or 4 weeks does not achieve a statistically significant more favourable outcome.