Duodenal ulcer healing rates in a one-year follow-up study with ranitidine bismuth citrate and antibiotics.
OBJECTIVE
The aim of this study was to determine the one-year outcome of an eradication therapy with ranitidine bismuth citrate and antibiotics in Helicobacter pylori-positive duodenal ulcer patients in respect to ulcer and Helicobacter pylori relapse rates.


METHODS
This multicenter, randomized, double-blind study involved 648 duodenal ulcer patients and had been carried out to compare the following regimens: ranitidine bismuth citrate b.i.d. co-prescribed with either clarithromycin 250 mg q.i.d. or clarithromycin 500 mg b.i.d. or clarithromycin 500 mg b.i.d. plus metronidazole 400 mg b.i.d. for 2 weeks, followed by a further 14 days of treatment with ranitidine bismuth citrate 400 mg b.i.d. to facilitate ulcer healing. H. pylori eradication was assessed by 13C-urea breath test and histology at least 4 weeks, 26 weeks and 52 weeks after the end of treatment. Ulcer relapse and H. pylori status were assessed 4 weeks, 26 weeks and 52 weeks post-treatment or if ulcer symptoms recurred. For the remainder of the follow-up period only serious adverse events were collected.


RESULTS
At 12 months data of 438 (69%) patients were evaluable. The observed H. pylori eradication rates were 88-91%. H. pylori relapse rates were 2.1% after 26 weeks and 3.9% after 52 weeks. At the week 26 visit 26 patients (5.6%) and at the week 52 visit 25 patients (5.7%) had documented gastroesophageal reflux disease.


CONCLUSIONS
Our data confirm the reduction of duodenal ulcer relapses after the cure of Helicobacter pylori infection.
Wurzer
H
H
2nd Medical Department, General Hospital, Graz, Austria. Herbert.Wurzer@klinikum-graz.at
Bardhan
K D
KD
Marcelino
M
M
Jahnsen
J
J
Allmaier
M
M
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D001729:Bismuth / Q000627:therapeutic use*; D017291:Clarithromycin / Q000008:administration & dosage / Q000627:therapeutic use*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D004381:Duodenal Ulcer / Q000188:drug therapy* / Q000382:microbiology; D016481:Helicobacter Infections / Q000188:drug therapy*; D016480:Helicobacter pylori; D006801:Humans; D008795:Metronidazole / Q000008:administration & dosage / Q000627:therapeutic use; D008875:Middle Aged; D011899:Ranitidine / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D055502:Secondary Prevention; D016896:Treatment Outcome
D000900:Anti-Bacterial Agents; D008795:Metronidazole; C073340:ranitidine bismuth citrate; D011899:Ranitidine; D017291:Clarithromycin; D001729:Bismuth