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A randomized controlled comparison of three quadruple therapy regimens in a population with low Helicobacter pylori eradication rates
Author(s) -
Sotudehmanesh Rasool,
Malekzadeh Reza,
Fazel Ali,
Massarrat Sadegh,
ZiadAlizadeh Behrooz,
Eshraghian Mohammed Reza
Publication year - 2001
Publication title -
journal of gastroenterology and hepatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.214
H-Index - 130
eISSN - 1440-1746
pISSN - 0815-9319
DOI - 10.1046/j.1440-1746.2001.02416.x
Subject(s) - medicine , gastroenterology , metronidazole , helicobacter pylori , omeprazole , clarithromycin , rapid urease test , tolerability , population , tetracycline , ranitidine , antibiotics , gastritis , adverse effect , microbiology and biotechnology , environmental health , biology
Background and Aim: We sought to compare the efficacy and tolerability of an omeprazole/clarithromycin/bismuth/tetracycline‐based quadruple therapy to that of a ranitidine/metronidazole/bismuth/tetracycline‐based quadruple therapy of 2 or 3 weeks duration in a population with a high prevalence of metronidazole‐resistant Helicobacter pylori and low triple therapy eradication rates. Methods: Two hundred and twenty‐one patients who presented endoscopically proven duodenal ulcers and a positive rapid urease test were randomized to receive either: (i) omeprazole 20 mg b.i.d., clarithromycin 250 mg b.i.d., bismuth subcitrate 240 mg b.i.d. and tetracycline 500 mg b.i.d (OCBT) for 2 weeks; (ii) ranitidine 300 mg b.i.d., metronidazole 500 mg b.i.d, bismuth subcitrate 240 mg b.i.d. and tetracycline 500 mg b.i.d. (RMBT2) for 2 weeks; or (iii) ranitidine 300 mg b.i.d., metronidazole 500 mg b.i.d, bismuth subcitrate 240 mg b.i.d. and tetracycline 500 mg b.i.d. (RMBT3) for 3 weeks. Patients were interviewed 2 weeks after the completion of therapy to review compliance and side‐effects. Eradication of H. pylori was assessed 8 weeks after the completion of therapy with the use of a 14 C‐urea breath test. Results: The per‐protocol eradication rate was significantly higher with OCBT (88%) than RMBT2 (73%) or RMBT3 (71%) ( P < 0.05). The intent‐to‐treat eradication rate was numerically higher with OCBT (80%) than RMBT2 (68%) or RMBT3 (68%), although this difference did not reach statistical significance ( P = 0.09). Per‐protocol or intent‐to‐treat eradication rates were similar with RMBT2 and RMBT3. There were significantly greater side‐effects with the RMBT2 regimen. Conclusions: The omeprazole/clarithromycin/bismuth/tetracycline‐based quadruple therapy provides higher H. pylori eradication rates than the ranitidine/metronidazole/bismuth/tetracycline‐based quadruple therapy when administered per protocol. The prolongation of the latter regimen from 2 to 3 weeks did not increase eradication rates.