Omeprazole plus clarithromycin and either tinidazole or tetracycline for Helicobacter pylori infection: a randomized prospective study.
OBJECTIVE
Helicobacter pylori has begun to show resistance to imidazoles and could result in the low efficacy of short-term triple therapy. The aim of this study was to assess whether administration of tetracycline instead of tinidazole in short-term low-dose triple therapy could increase the H. pylori eradication rate.


METHODS
In a prospective study, 113 patients with peptic ulcer (n = 36) or non-ulcer dyspepsia (n = 77) were randomized to receive 1-wk treatment, composed of omeprazole 20 mg b.i.d., clarithromycin 250 mg b.i.d., and either tinidazole 500 mg b.i.d. (n = 57) or tetracycline 500 mg b.i.d. (n = 56), upon detection of H. pylori infection at endoscopy.


RESULTS
H. pylori eradication, defined as a negative bacterial finding in a rapid urease test and upon histologic assessment at least 4 wk after cessation of therapy, was achieved in 86% (49 of 57; 95% confidence interval = 76.9-95) of patients in the first group and in 71.4% (40 of 56; 95% confidence interval = 59.6-83.3) in the second group (p = not significant). Side effects occurred in 28% of patients from the tinidazole-based group and in 12.5% from the tetracycline group (p = not significant). Two patients in the tinidazole group discontinued therapy at 5 and 6 days because of side effects.


CONCLUSIONS
The administration of tetracycline instead of tinidazole in short-term triple therapy yielded disappointing results in H. pylori eradication.
Zullo
A
A
Department of Clinical Medicine, Gastroenterology II, La Sapienza University, Rome, Italy.
Rinaldi
V
V
Pugliano
F
F
Diana
F
F
Attili
A F
AF
D000293:Adolescent; D000328:Adult; D000368:Aged; D000900:Anti-Bacterial Agents / Q000009:adverse effects / Q000627:therapeutic use*; D000897:Anti-Ulcer Agents / Q000627:therapeutic use*; D017291:Clarithromycin / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D004415:Dyspepsia / Q000188:drug therapy*; D005260:Female; D016481:Helicobacter Infections / Q000188:drug therapy*; D016480:Helicobacter pylori; D006801:Humans; D008297:Male; D008875:Middle Aged; D009853:Omeprazole / Q000627:therapeutic use*; D010437:Peptic Ulcer / Q000188:drug therapy*; D011446:Prospective Studies; D013752:Tetracycline / Q000009:adverse effects / Q000627:therapeutic use*; D014011:Tinidazole / Q000009:adverse effects / Q000627:therapeutic use*
D000900:Anti-Bacterial Agents; D000897:Anti-Ulcer Agents; D014011:Tinidazole; D013752:Tetracycline; D017291:Clarithromycin; D009853:Omeprazole