Prospective evaluation of ranitidine bismuth citrate-based triple therapy for the treatment of Helicobacter pylori infection.
BACKGROUND
There is a need for effective and inexpensive therapy for Helicobacter pylori with good patient compliance.


OBJECTIVE
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 Five patients were prematurely withdrawn (side-effects 2, took additional antibiotics 2 and surgery 1) and one patient was lost to follow-up; therefore, 44 (88%) patients completed the H. pylori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%.
Mönkemüller
K E
KE
Department of Medicine, Division of Gastroenterology, University of Alabama, Birmingham, Alabama 35294, USA.
Hirschowitz
B I
BI
D000328:Adult; D000368:Aged; D000897:Anti-Ulcer Agents / Q000008:administration & dosage*; D001729:Bismuth / Q000008:administration & dosage* / Q000009:adverse effects; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D016481:Helicobacter Infections / Q000188:drug therapy*; D016480:Helicobacter pylori / Q000187:drug effects*; D006801:Humans; D008297:Male; D008795:Metronidazole / Q000008:administration & dosage / Q000009:adverse effects; D008875:Middle Aged; D011446:Prospective Studies; D011899:Ranitidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D013752:Tetracycline / Q000008:administration & dosage / Q000009:adverse effects
D000897:Anti-Ulcer Agents; D008795:Metronidazole; C073340:ranitidine bismuth citrate; D011899:Ranitidine; D013752:Tetracycline; D001729:Bismuth