Two new treatment regimens for Helicobacter pylori eradication: a randomised study.
BACKGROUND
Several studies have found a fairly low Helicobacter pylori eradication rate using a standard 7-day triple therapy in Italy. Recently, two new therapeutic schedules have been proposed with an eradication rate higher than 90%. This study compared the efficacy of these two treatment regimens.


METHODS
A total of 131 patients with Helicobacter pylori infection and either non-ulcer dyspepsia (73 patients] or peptic ulcer (58 patients) were enrolled. Helicobacter pylori infection was assessed by rapid urease test and histology on gastric biopsies. Patients were randomised to receive either a 5-day course of ranitidine bismuth citrate 400 mg bid, clarithromycin 500 bid, and tinidazole 500 bid, or a 10-day course of omeprazole 20 mg bid plus amoxycillin 1 g bid for the first 5 days, and omeprazole 20 mg bid, clarithromycin 500 mg bid and tinidazole 500 mg bid for the remaining 5 days. Eradication was assessed by endoscopy 4-6 weeks after therapy.


RESULTS
Overall, 4 patients (2 for each treatment group) were lost to follow-up. Helicobacter pylori eradication rates were 67.2% (95% confidence interval: 55.7-78.7) and 65.2% (95% confidence interval: 53.7-76.6) at per protocol and intention-to-treat analyses, respectively, after the 5-day regimen, and 96.8% (95% confidence interval: 92.5-100) and 93.8% (95% confidence interval: 88-99.7) after the 10-day regimen (p<0.05). Both treatments were well tolerated, and no major side-effects were reported.


CONCLUSIONS
The 5-day regimen gave disappointing results, while the eradication rate after the 10-day regimen was very high.
De Francesco
V
V
Division of Gastroenterology and Digestive Endoscopy, Riuniti Hospital, Foggia, Italy.
Zullo
A
A
Hassan
C
C
Faleo
D
D
Ierardi
E
E
Panella
C
C
Morini
S
S
D000328:Adult; D000368:Aged; D000658:Amoxicillin / Q000008:administration & dosage; D000900:Anti-Bacterial Agents / Q000627:therapeutic use; D000897:Anti-Ulcer Agents / Q000008:administration & dosage*; D000994:Antitrichomonal Agents / Q000627:therapeutic use; D001729:Bismuth / Q000008:administration & dosage*; D017291:Clarithromycin / Q000008:administration & dosage; D004359:Drug Therapy, Combination; D005260:Female; D016481:Helicobacter Infections / Q000188:drug therapy*; D016480:Helicobacter pylori; D006801:Humans; D008297:Male; D008875:Middle Aged; D009853:Omeprazole / Q000008:administration & dosage*; D011446:Prospective Studies; D011899:Ranitidine / Q000008:administration & dosage* / Q000031:analogs & derivatives*; D014011:Tinidazole / Q000008:administration & dosage; D016896:Treatment Outcome
D000900:Anti-Bacterial Agents; D000897:Anti-Ulcer Agents; D000994:Antitrichomonal Agents; D014011:Tinidazole; C073340:ranitidine bismuth citrate; D000658:Amoxicillin; D011899:Ranitidine; D017291:Clarithromycin; D009853:Omeprazole; D001729:Bismuth