Optimal duration of therapy combining ranitidine bismuth citrate with clarithromycin and metronidazole in the eradication of Helicobacter pylori infection.
BACKGROUND
Ranitidine bismuth citrate (RBC) co-prescribed with clarithromycin and metronidazole for 1 week has been shown to be an effective eradicating regimen for Helicobacter pylori.


OBJECTIVE
To determine the optimal duration of this regimen.


METHODS
A series of 165 dyspeptic patients were recruited for this randomized, open, parallel-group study. They were subdivided into three groups receiving RBC 400 mg b.d. plus clarithromycin 250 mg b.d. and metronidazole 500 mg b.d. for three different periods (4, 7 and 10 days). H. pylori infection was assessed by the concomitant positivity of CLO-test and histology performed at the pre-entry endoscopy. The bacterium was considered eradicated on the basis of a negative 13C-urea breath test performed at least 28 days after the completion of treatment.


RESULTS
The three subgroups were well matched and 16 patients dropped out of the study for many reasons (six in the 4-day, five in the 7-day and five in the 10-day treatment regimens). Intention-to-treat cure rates were 60%, 84% and 85%, and the per-protocol rates 67%, 92% and 94% in the 4-day, 7-day and 10-day treatment regimens, respectively. There was a significant difference, P = 0.003-0.006 on intention-to-treat and P = 0.001-0. 002 on per protocol analysis between the 4-day and the 7-day and the 4-day and the 10-day periods, respectively. The 7-day and 10-day periods did not differ from each other. Side-effects were reported in 9%, 14% and 20% of the 4-, 7- and 10-day regimens. They led to stopping treatment in four cases (one in the 7-day and three in the 10-day period). There was no statistical difference among them.


CONCLUSIONS
Reducing the duration of RBC-based triple therapy to 4 days provides a low and unacceptable rate of H. pylori eradication. As there is no difference between 7 and 10 days of treatment, 1 week represents the optimal time period for this kind of treatment, based on RBC plus two antibiotics.
Savarino
V
V
Dipartimento di Medicina Interna e Specialità Mediche, Cattedra di Gastroenterologia, Università di Genova, Italy. Vsavarin@unige.it
Zentilin
P
P
Bisso
G
G
Pivari
M
M
Bilardi
C
C
Biagini
R
R
Mele
M R
MR
Mansi
C
C
Termini
R
R
Vigneri
S
S
Celle
G
G
D000900:Anti-Bacterial Agents / Q000008:administration & dosage*; D000897:Anti-Ulcer Agents / Q000008:administration & dosage*; D001729:Bismuth / Q000008:administration & dosage*; D001944:Breath Tests / Q000379:methods; D017291:Clarithromycin / Q000008:administration & dosage*; D004359:Drug Therapy, Combination; D005260:Female; D016481:Helicobacter Infections / Q000188:drug therapy*; D016480:Helicobacter pylori; D006635:Histamine H2 Antagonists / Q000008:administration & dosage; D006801:Humans; D008297:Male; D008795:Metronidazole / Q000008:administration & dosage*; D008875:Middle Aged; D011899:Ranitidine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D016896:Treatment Outcome; D014508:Urea / Q000378:metabolism
D000900:Anti-Bacterial Agents; D000897:Anti-Ulcer Agents; D006635:Histamine H2 Antagonists; D008795:Metronidazole; C073340:ranitidine bismuth citrate; D011899:Ranitidine; D014508:Urea; D017291:Clarithromycin; D001729:Bismuth