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Addition of Metronidazole to Rabeprazole‐Amoxicillin‐Clarithromycin Regimen for Helicobacter pylori Infection Provides an Excellent Cure Rate with Five‐Day Therapy
Author(s) -
Nagahara Akihito,
Miwa Hiroto,
Ogawa Kaoru,
Kurosawa Akihiko,
Ohkura Ryuichi,
Iida Noboru,
Sato Nobuhiro
Publication year - 2000
Publication title -
helicobacter
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.206
H-Index - 79
eISSN - 1523-5378
pISSN - 1083-4389
DOI - 10.1046/j.1523-5378.2000.00013.x
Subject(s) - clarithromycin , metronidazole , amoxicillin , regimen , rabeprazole , helicobacter pylori , medicine , gastroenterology , proton pump inhibitor , adverse effect , antibiotics , microbiology and biotechnology , biology
Background. New triple therapy for eradication of Helicobacter pylori based on a proton pump inhibitor (PPI) provides a cure rate of approximately 90% with few adverse effects. Recently, a PPI‐based quadruple therapy, which consists of a PPI plus bismuth‐based triple therapy for 7 days, has been studied, and a sufficient eradication rate has been achieved. However, a shorter duration results in improved compliance. In this study, newly developed short‐term, simple twice‐daily quadruple therapy consisting of rabeprazole, amoxicillin, clarithromycin, and metronidazole (RACM) was compared with a PPI‐based triple‐therapy regimen for eradication of H. pylori. Patients and Methods. This study was designed as a randomized open, prospective single‐center study. Of a total of 105 H. pylori –positive patients, 55 received the RACM regimen for 5 days (rabeprazole, 10 mg bid; amoxicillin, 750 mg bid; clarithromycin, 200 mg bid; and metronidazole, 250 mg bid), and 50 received the RAC regimen for 5 days (rabeprazole, 10 mg bid; amoxicillin, 750 mg bid; and clarithromycin, 200 mg bid). Cure of the infection was assessed by HpSA ( H. pylori stool antigen immunoassay) 1 month after completion of therapy. Results. The rates of eradication of H. pylori by RACM versus RAC were 94.5% (95% CI, 85–99) versus 80.0% (95% CI, 66–90) by intention‐to‐treat analysis; 98.1% (95% CI, 90–100) versus 87.0% (95% CI, 74–95) by all‐patients‐treated analysis; and 98.1% (95% CI, 90–100) versus 86.7% (95% CI, 73–95) by per‐protocol analysis. No major adverse effects were reported, and 98.0% of patients reported complete compliance. Conclusions. The simple twice‐daily and short‐term quadruple regimen for only 5 days provided an excellent eradication rate. Compliance with the regimen was high, and serious adverse effects were few. Therefore, the RACM regimen can be considered as safe and effective.