A new 1-week therapy for Helicobacter pylori eradication: ranitidine bismuth citrate plus two antibiotics.
BACKGROUND
One-week triple regimens are currently the most recommended therapy for the eradication of Helicobacter pylori. No previous study has evaluated the efficacy of a short-term regimen combining ranitidine bismuth citrate with two antibiotics.


METHODS
Seventy-two consecutive H. pylori-positive dyspeptic patients were recruited for this randomized, three-centre, open, parallel-group study. They were subdivided into two groups receiving either ranitidine bismuth citrate 400 mg b.d. + clarithromycin 250 mg b.d. and metronidazole 500 mg b.d. (group A) or ranitidine bismuth citrate 400 mg b.d. + clarithromycin 250 mg b.d. and metronidazole 250 mg q.d.s (group B) for 1 week. H. pylori infection was assessed by CLO-test and histology on both antral and corpus biopsies before and at least 4 weeks after the end of therapy. The bacterium was considered eradicated when both tests were negative. Eradication rates and the number of side-effects were evaluated in each group. The Chi-squared test was used for statistical analysis.


RESULTS
One patient with only CLO-test positivity was erroneously randomized to group B and four patients dropped out of the study (two in group A and two in group B), mainly because they refused the second endoscopy. In group A, H. pylori was eradicated in 31 of 36 patients (intention-to-treat = 86%; 95% CI = 71-95% and per protocol 31/34 = 91%; 95% CI = 76-98%). Side-effects occurred in 10 patients (27%) and they were generally mild. In group B, H. pylori was eradicated in 29 of 35 patients (intention-to-treat = 83%; 95% CI = 66-93%; and per protocol 29/33 = 88%; 95% CI = 72-97%). Seven patients (20%) complained of modest side-effects. There was no significant difference between the two treatment arms (P = N.S.): no severe adverse events occurred and none of the patients was withdrawn from the study because of them.


CONCLUSIONS
The co-administration of ranitidine bismuth citrate plus clarithromycin at low dosage and metronidazole in twice daily doses for 1 week is a short, effective and well-tolerated regimen for the eradication of H. pylori. These findings should provide the impetus for large-scale investigations.
Savarino
V
V
Dipartimento di Medicina Interna, Cattedra di Gastroenterologia, Università di Genova, Italy.
Mansi
C
C
Mele
M R
MR
Bisso
G
G
Mela
G S
GS
Saggioro
A
A
Caroli
M
M
Vigneri
S
S
Termini
R
R
Olivieri
A
A
Tosatto
R
R
Celle
G
G
D000900:Anti-Bacterial Agents / Q000008:administration & dosage* / Q000627:therapeutic use*; D001729:Bismuth / Q000627:therapeutic use*; D017291:Clarithromycin / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D016481:Helicobacter Infections / Q000188:drug therapy* / Q000382:microbiology; D016480:Helicobacter pylori / Q000302:isolation & purification; D006635:Histamine H2 Antagonists / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008795:Metronidazole / Q000008:administration & dosage*; D011706:Pyloric Antrum / Q000382:microbiology; D011899:Ranitidine / Q000031:analogs & derivatives* / Q000627:therapeutic use
D000900:Anti-Bacterial Agents; D006635:Histamine H2 Antagonists; D008795:Metronidazole; C073340:ranitidine bismuth citrate; D011899:Ranitidine; D017291:Clarithromycin; D001729:Bismuth