Prospective evaluation of ranitidine bismuth citrate-based triple therapy for the treatment of Helicobacter pylori infection.

Abstract

BACKGROUND:

There is a need for effective and inexpensive therapy for Helicobacter pylori with good patient compliance.

AIM:

To evaluate a simplified twice daily schedule for treating H. pylori.

METHODS:

Patients infected with H. pylori (positive by CLO- and 13C-urea breath tests [UBT]) and not previously treated with anti-H. pylori therapy were treated with ranitidine bismuth citrate (RBC) and two inexpensive antibiotics (metronidazole, tetracycline) twice daily for 14 days in an open-label study. Eradication was established by a negative UBT 4 weeks after ending therapy.

RESULTS:

Twenty men and 30 women (age 54+/-14 years, range 26-74) were included in the study. Five patients were prematurely withdrawn (side-effects 2, took additional antibiotics 2 and surgery 1) and one patient was lost to follow-up; therefore, 44 (88%) patients completed the H. pylori eradication protocol. Per protocol (PP) cure rate was 82% (36/44 patients, 95% CI: 68-95%), and intention-to-treat cure rate was 72% (36/50 patients, 95% CI: 58-82%). Five patients (10%) developed side-effects during therapy, most commonly nausea (3 patients). Four weeks after the end of treatment, 78% (PP) of patients were symptomatically improved.

CONCLUSIONS:

A 2-week course of twice-daily RBC-based triple therapy was well tolerated, eradicated H. pylori in 72% (ITT) and 82% (PP) of patients, respectively, and relieved symptoms in 78%.

• Authors: K E Mönkemüller, B I Hirschowitz
• Journal: Alimentary pharmacology & therapeutics (Aliment Pharmacol Ther) Vol. 13 Issue 5 Pg. 661-5 (May 1999) ISSN: 0269-2813 [Print] England
• PMID: 10233190 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Anti-Ulcer Agents
• Metronidazole
• ranitidine bismuth citrate
• Ranitidine
• Tetracycline
• Bismuth

Topics

• Adult
• Aged
• Anti-Ulcer Agents (administration & dosage)
• Bismuth (administration & dosage, adverse effects)
• Drug Administration Schedule
• Drug Therapy, Combination
• Female
• Helicobacter Infections (drug therapy)
• Helicobacter pylori (drug effects)
• Humans
• Male
• Metronidazole (administration & dosage, adverse effects)
• Middle Aged
• Prospective Studies
• Ranitidine (administration & dosage, adverse effects, analogs & derivatives)
• Tetracycline (administration & dosage, adverse effects)