Ranitidine bismuth citrate with either clarithromycin 1 g/day or 1.5 g/day is equally effective in the eradication of H. pylori and healing of duodenal ulcer.
BACKGROUND
No randomized double-blind studies have been performed to compare clarithromycin 1 g/day with higher doses of the macrolide (1.5 g/day) when combined with ranitidine bismuth citrate (RBC).


OBJECTIVE
To compare H. pylori eradication and ulcer healing rates of RBC 400 mg b.d. for 4 weeks combined for the first 2 weeks either with clarithromycin 500 mg b.d. (Group A) or clarithromycin 500 mg t.d.s. (Group B).


METHODS
Two hundred and seventy-three patients with H. pylori-positive active duodenal ulcer were included. H. pylori infection was detected by CLO-test and histology on antral and corpus biopsies before and at least 4 weeks after the end of therapy. Eradication was assumed if both CLO-test and histology results were negative for H. pylori.


RESULTS
Eradication/healing rates according to intention-to-treat and per protocol analysis were 76/82% and 87/92% for Group A and 78/85% and 88/95% for Group B, respectively (P = N.S.). Adverse events were reported by 7% and 12% of patients in Groups A and B, respectively, and they were generally mild.


CONCLUSIONS
RBC in co-prescription with clarithromycin 500 mg b.d. is as effective as RBC plus clarithromycin 500 t.d.s. in eradicating H. pylori and healing duodenal ulcers.
Regional Hospital of Bolzano, Italy.
G
G
Dobrilla
G
G
Di Matteo
M
M
Dodero
A
A
Fratton
G
G
Iaquinto
P
P
Loriga
S
S
Marchi
L
L
Marzio
R
R
Muratori
D
D
Pacini
A
A
Saggioro
V
V
Savarino
P
P
Spinelli
G
G
Zamboni
P
P
Fina
R
R
Tosatto
A
A
Olivieri
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D000897:Anti-Ulcer Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D001729:Bismuth / Q000008:administration & dosage / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D017291:Clarithromycin / Q000008:administration & dosage / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004359:Drug Therapy, Combination; D004381:Duodenal Ulcer / Q000188:drug therapy* / Q000382:microbiology; D005260:Female; D016480:Helicobacter pylori / Q000187:drug effects*; D006635:Histamine H2 Antagonists / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011899:Ranitidine / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use
D000900:Anti-Bacterial Agents; D000897:Anti-Ulcer Agents; D006635:Histamine H2 Antagonists; C073340:ranitidine bismuth citrate; D011899:Ranitidine; D017291:Clarithromycin; D001729:Bismuth