Seven-day triple therapy with ranitidine bismuth citrate or omeprazole and two antibiotics for eradication of Helicobacter pylori in duodenal ulcer: a multicentre, randomized, single-blind study.
OBJECTIVE
To investigate the efficacy of a 1-week triple therapy with amoxycillin, clarithromycin, and omeprazole or ranitidine bismuth citrate (RBC) in curing Helicobacter pylori infection and healing duodenal ulcers.


METHODS
One hundred and ninety-two consecutive out-patients with duodenal ulcer, in whom H. pylori infection was confirmed by histology and a urease biopsy test, were randomly assigned to a 1-week treatment with either 400 mg b.d. ranitidine bismuth citrate (RAC group) or 20 mg omeprazole b.d. (OAC group) in combination with 1 g amoxycillin b.d. and 500 mg clarithromycin b.d.


RESULTS
Eradication of H. pylori was successful in 77% (per protocol) and 61% (intention-to-treat) of the patients in the RAC group and in 79% (per protocol) and 70% (intention-to-treat) of those in the OAC group. The difference was not significant. Per protocol analysis showed ulcers were healed in 97% of patients in the RAC group and 96% in the OAC group. Adverse effects were seen in four patients in each group: they caused discontinuation of the therapy in one patient of the OAC group.


CONCLUSIONS
Eradication rates obtained in this study were lower than those expected on the basis of previously reported studies. The two 1-week treatment regimens were equally effective in healing H. pylori associated duodenal ulcer disease.
Spinzi
G C
GC
Department of Internal Medicine, Valduce Hospital Como, Italy. medicina2@valduce.it
Boni
F
F
Bortoli
A
A
Colombo
E
E
Ballardini
G
G
Venturelli
R
R
Minoli
G
G
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000658:Amoxicillin / Q000627:therapeutic use; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D000897:Anti-Ulcer Agents / Q000627:therapeutic use*; D001729:Bismuth / Q000627:therapeutic use*; D017291:Clarithromycin / Q000627:therapeutic use; D004381:Duodenal Ulcer / Q000188:drug therapy* / Q000382:microbiology; D005260:Female; D016481:Helicobacter Infections / Q000188:drug therapy* / Q000382:microbiology; D016480:Helicobacter pylori; D006801:Humans; D008297:Male; D008875:Middle Aged; D009853:Omeprazole / Q000627:therapeutic use; D010349:Patient Compliance; D010406:Penicillins / Q000627:therapeutic use; D011446:Prospective Studies; D011899:Ranitidine / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D016037:Single-Blind Method
D000900:Anti-Bacterial Agents; D000897:Anti-Ulcer Agents; D010406:Penicillins; C073340:ranitidine bismuth citrate; D000658:Amoxicillin; D011899:Ranitidine; D017291:Clarithromycin; D009853:Omeprazole; D001729:Bismuth