Seven-day 'rescue' therapy after Helicobacter pylori treatment failure: omeprazole, bismuth, tetracycline and metronidazole vs. ranitidine bismuth citrate, tetracycline and metronidazole.
BACKGROUND
Eradication therapy with omeprazole (O), amoxycillin (A) and clarithromycin (C) is used extensively, although it often fails. A 'rescue' therapy with a quadruple combination of O, bismuth (B), tetracycline (T) and metronidazole (M) has been recommended.


OBJECTIVE
: To assess ranitidine bismuth citrate (Rbc) instead of O and B for treatment failure.


METHODS
Sixty consecutive patients (13 duodenal ulcer, 47 non-ulcer dyspepsia) in whom a previous eradication trial with O, A and C had failed were randomized to receive one of two regimens for 7 days: O (20 mg b.d.), B (120 mg q. d.s.), T (500 mg q.d.s.) and M (250 mg q.d.s.) (group OBTM, n=30); or Rbc (400 mg b.d.), T (500 mg q.d.s.) and M (250 mg q.d.s.) (group RbcTM, n=30). Eradication was defined as a negative 13C-urea breath test 1 month after completing therapy.


RESULTS
Mean age +/- s.d. was 45 +/- 12 years, 47% were males. Distribution of studied variables (age, sex, smoking, duodenal ulcer/non-ulcer dyspepsia) was similar in both therapeutic groups. Per protocol eradication was achieved in 17 out of 29 patients (59%) in group OBTM and in 25 out of 29 patients (86%) in group RbcTM (P < 0.05). Intention-to-treat eradication was achieved, respectively, in 17 out of 30 (57%) and in 25 out of 30 (83%) (P < 0.05). In the multivariate analysis the variables which influenced on H. pylori eradication were the type of therapy (odds ratio, OR=3.9; 95%CI: 1.02-15; P < 0.05) and diagnosis (duodenal ulcer/non-ulcer dyspepsia) (OR=0.1; CI: 0.02-0.4). Adverse effects were infrequent and mild with both regimens.


CONCLUSIONS
Therapy with RbcTM is a promising option after H. pylori eradication failure with OCA, achieving a higher efficacy than quadruple therapy with OBTM.
Gisbert
J P
JP
Department of Gastroenterology, University Hospital of 'La Princesa', Madrid, Spain. gisbert@meditex.es
Gisbert
J L
JL
Marcos
S
S
Grávalos
R G
RG
Carpio
D
D
Pajares
J M
JM
D000328:Adult; D000658:Amoxicillin / Q000627:therapeutic use; D000900:Anti-Bacterial Agents / Q000009:adverse effects / Q000627:therapeutic use; D000897:Anti-Ulcer Agents / Q000009:adverse effects / Q000627:therapeutic use; D001729:Bismuth / Q000009:adverse effects / Q000627:therapeutic use*; D017291:Clarithromycin / Q000627:therapeutic use; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D016481:Helicobacter Infections / Q000188:drug therapy*; D016480:Helicobacter pylori; D006801:Humans; D008297:Male; D008795:Metronidazole / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D009853:Omeprazole / Q000009:adverse effects / Q000627:therapeutic use*; D010406:Penicillins / Q000627:therapeutic use; D011446:Prospective Studies; D011899:Ranitidine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D013752:Tetracycline / Q000009:adverse effects / Q000627:therapeutic use*; D017211:Treatment Failure
D000900:Anti-Bacterial Agents; D000897:Anti-Ulcer Agents; D010406:Penicillins; D008795:Metronidazole; C073340:ranitidine bismuth citrate; D000658:Amoxicillin; D011899:Ranitidine; D013752:Tetracycline; D017291:Clarithromycin; D009853:Omeprazole; D001729:Bismuth