Five-day regimens containing ranitidine bismuth citrate plus high-dose clarithromycin and either amoxycillin or tinidazole for Helicobacter pylori infection.
BACKGROUND
Ranitidine bismuth citrate (RBC)-based triple therapies for a period of 7 days have proved to be an effective treatment for Helicobacter pylori.


OBJECTIVE
To investigate the eradication efficacy, safety profile and patient compliance of two RBC-based triple therapies given for 5 days.


METHODS
Eighty H. pylori-positive patients with dyspeptic symptoms, referred to us for gastroscopy, were consecutively enrolled in this prospective, randomized, open-label study. These patients were randomly assigned to receive a 5-day course of RBC 400 mg b.d. plus clarithromycin 500 mg b.d. and either tinidazole 500 mg b.d. (RBCCT group) or amoxycillin 1 g b.d. (RBCCA group). The H. pylori status was assessed by means of histology and rapid urease test at entry, and by 13C-urea breath test 8 weeks after the completion of treatment.


RESULTS
All enrolled patients completed the study. Thirty-seven of 40 patients treated with RBCCT (both PP and ITT analysis: 93%; 95% CI: 80-98%) and 35 of 40 in the RBCCA group (both PP and ITT analysis: 88%; 95% CI: 73-96%) returned H. pylori-negative. Slight or mild side-effects occurred in 4/40 patients (10%) in the RBCCT group and in 5/40 (12%) in the RBCCA group.


CONCLUSIONS
This is the first study demonstrating the efficacy of RBC-based triple therapies given for only 5 days. RBC regimens containing high-dose clarithromycin and either amoxycillin or tinidazole prove to be well tolerated, safe and preserve good eradication rates even when administered for a shorter than conventional duration.
Cammarota
G
G
Department of Internal Medicine and Gastroenterology, Catholic University of Rome, Italy. dora.erasmo@tiscalinet.it
Cannizzaro
O
O
Ojetti
V
V
Cianci
R
R
Pastorelli
A
A
Armuzzi
A
A
Gentiloni
N
N
Gasbarrini
A
A
Pirozzi
G
G
Gasbarrini
G
G
D000658:Amoxicillin / 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*; D001729:Bismuth / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001944:Breath Tests; D017291:Clarithromycin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D004415:Dyspepsia / Q000188:drug therapy / Q000209:etiology; D016481:Helicobacter Infections / Q000188:drug therapy* / Q000382:microbiology; D016480:Helicobacter pylori; D006801:Humans; D010406:Penicillins / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D011899:Ranitidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D014011:Tinidazole / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D014508:Urea / Q000032:analysis
D000900:Anti-Bacterial Agents; D000897:Anti-Ulcer Agents; D010406:Penicillins; D014011:Tinidazole; C073340:ranitidine bismuth citrate; D000658:Amoxicillin; D011899:Ranitidine; D014508:Urea; D017291:Clarithromycin; D001729:Bismuth