Ranitidine bismuth citrate with clarithromycin alone or with metronidazole for the eradication of Helicobacter pylori
Authors: Bardhan, K. D.1; Morton, D.1; Perry, M. J.1; Sanders, D. S.1; Morris, P.1; Rowland, A.1; Thompson, M.1; Mitchell, T. R.2; Roberts, P. M.2
Source: Alimentary Pharmacology & Therapeutics, Volume 15, Number 8, August 2001 , pp. 1199-1204(6)
Publisher: Blackwell Publishing
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Abstract:
Background : Both triple therapy with ranitidine bismuth citrate (RBC) plus two antibiotics for 7 days and dual therapy of RBC with clarithromycin for 14 days have been extensively studied; both regimens effectively eradicate Helicobacter pylori. However, few studies have assessed the efficacy of dual therapy given for 7 days. Aim : To compare the efficacy and safety of RBC 400 mg with clarithromycin 500 mg, alone or with metronidazole 400 mg, given twice daily for 7 days for the eradication of H. pylori. Methods : This single centre, randomized, double-blind study involved 118 patients with dyspepsia or a history of peptic ulcer disease. H. pylori infection was detected initially by CLO test, and confirmed in 109 patients by urea breath test and/or microbiology culture. H. pylori eradication was assessed 4 and 12 weeks after the end of treatment by urea breath test. H. pylori antibiotic susceptibility was assessed pre-study in all patients, and post-treatment in patients with a positive post-treatment urea breath test. Adverse events were recorded throughout the study. Results : H. pylori was eradicated in 93% of patients who received RBC with clarithromycin and metronidazole and in 84% of patients who received RBC with clarithromycin (intention-to-treat rates). Per protocol eradication rates were 98% and 90% for triple therapy and dual therapy, respectively. The eradication of metronidazole-resistant H. pylori was achieved in 100% and 88% of patients following dual therapy and triple therapy, respectively, and acquired resistance to clarithromycin occurred in only one patient following treatment failure. Both treatments were well-tolerated; only one patient (2%) was withdrawn from each treatment group due to adverse events. Conclusions : RBC with clarithromycin and metronidazole is a highly effective and well-tolerated triple therapy regimen for the eradication of H. pylori. RBC with clarithromycin dual therapy has a similar efficacy, and offers an alternative to triple therapy when there are concerns about treatment with metronidazole or the use of multiple antibiotics. Both regimens are effective against antibiotic-resistant strains of H. pylori.Document Type: Research article
DOI: 10.1046/j.1365-2036.2001.01040.x
Affiliations: 1: Rotherham District General Hospitals NHS Trust, UK 2: Glaxo Wellcome R & D, UK
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