Randomized comparison of ranitidine bismuth citrate-based triple therapies for Helicobacter pylori.
OBJECTIVE
In an attempt to increase the efficacy and simplicity of FDA-approved regimens for Helicobacter pylori, we studied (1) addition of an inexpensive antibiotic (amoxicillin) to twice-daily ranitidine bismuth citrate (RBC)-clarithromycin dual therapy, and (2) substitution of RBC for bismuth subsalicylate + H2-receptor antagonist in bismuth-based triple therapy.


METHODS
Subjects with previously untreated Helicobacter pylori infection documented by 13C-urea breath test plus either endoscopic biopsy or serology were randomly assigned to a 2-wk course of (1) RBC 400 mg b.i.d., amoxicillin 1 g b.i.d., and clarithromycin 500 mg b.i.d. (RAC), or (2) RBC 400 mg b.i.d., metronidazole 250 mg t.i.d., and tetracycline 500 mg t.i.d. (RMT). Repeat breath test was performed 4 wk after the completion of therapy.


RESULTS
Intent-to-treat and per-protocol cure rates for RAC were 46 of 50 patients (92%) and 45 of 47 patients (96%); for RMT they were 40 of 50 patients (80%) and 37 of 42 patients (88%). Study drugs were stopped due to side effects in three patients (6%) taking RAC and six patients (12%) taking RMT.


CONCLUSIONS
Twice-daily RBC-based triple therapy with clarithromycin and amoxicillin produces Helicobacter pylori eradication rates over 90%, which is comparable to rates seen with proton pump inhibitor-based triple therapies. RBC also may be substituted for bismuth subsalicylate and an + H2-receptor antagonist in standard bismuth-based triple therapy.
Laine
L
L
University of Southern California School of Medicine, Los Angeles, USA.
Estrada
R
R
Trujillo
M
M
Emami
S
S
D000328:Adult; D000658:Amoxicillin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D000863:Antacids / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D000897:Anti-Ulcer Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001706:Biopsy; D001729:Bismuth / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D001944:Breath Tests; D002247:Carbon Isotopes; D017291:Clarithromycin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D004338:Drug Combinations; D005260:Female; D005500:Follow-Up Studies; D005773:Gastroscopy; D016481:Helicobacter Infections / Q000188:drug therapy* / Q000473:pathology; D016480:Helicobacter pylori; D006635:Histamine H2 Antagonists / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008795:Metronidazole / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D009942:Organometallic Compounds / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D010406:Penicillins / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D010437:Peptic Ulcer / Q000188:drug therapy / Q000382:microbiology / Q000473:pathology; D054328:Proton Pump Inhibitors; D011899:Ranitidine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D012459:Salicylates / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D013752:Tetracycline / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D014508:Urea
D000863:Antacids; D000900:Anti-Bacterial Agents; D000897:Anti-Ulcer Agents; D002247:Carbon Isotopes; D004338:Drug Combinations; D006635:Histamine H2 Antagonists; D009942:Organometallic Compounds; D010406:Penicillins; D054328:Proton Pump Inhibitors; D012459:Salicylates; D008795:Metronidazole; C015715:bismuth subsalicylate; D000658:Amoxicillin; D011899:Ranitidine; D014508:Urea; D013752:Tetracycline; D017291:Clarithromycin; C002791:bismuth tripotassium dicitrate; D001729:Bismuth