Seven-day 'rescue' therapy after Helicobacter pylori treatment failure: omeprazole, bismuth, tetracycline and metronidazole vs. ranitidine bismuth citrate, tetracycline and metronidazole.

Abstract

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.

AIM:

: 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.

CONCLUSION:

Therapy with RbcTM is a promising option after H. pylori eradication failure with OCA, achieving a higher efficacy than quadruple therapy with OBTM.

• Authors: J P Gisbert, J L Gisbert, S Marcos, R G Grávalos, D Carpio, J M Pajares
• Journal: Alimentary pharmacology & therapeutics (Aliment Pharmacol Ther) Vol. 13 Issue 10 Pg. 1311-6 (Oct 1999) ISSN: 0269-2813 [Print] England
• PMID: 10540045 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Randomized Controlled Trial)

Chemical References

• Anti-Bacterial Agents
• Anti-Ulcer Agents
• Penicillins
• Metronidazole
• ranitidine bismuth citrate
• Amoxicillin
• Ranitidine
• Tetracycline
• Clarithromycin
• Omeprazole
• Bismuth

Topics

• Adult
• Amoxicillin (therapeutic use)
• Anti-Bacterial Agents (adverse effects, therapeutic use)
• Anti-Ulcer Agents (adverse effects, therapeutic use)
• Bismuth (adverse effects, therapeutic use)
• Clarithromycin (therapeutic use)
• Drug Administration Schedule
• Drug Therapy, Combination
• Female
• Follow-Up Studies
• Helicobacter Infections (drug therapy)
• Helicobacter pylori
• Humans
• Male
• Metronidazole (adverse effects, therapeutic use)
• Middle Aged
• Omeprazole (adverse effects, therapeutic use)
• Penicillins (therapeutic use)
• Prospective Studies
• Ranitidine (adverse effects, analogs & derivatives, therapeutic use)
• Tetracycline (adverse effects, therapeutic use)
• Treatment Failure