Long-term effects of eradication of Helicobacter pylori on relapse and histology in gastric ulcer patients: a two-year follow-up study.
BACKGROUND
The main purpose of this study was to compare omeprazole (ome) plus two antibiotics (OMC) with omeprazole plus placebo (OP) with regard to gastric ulcer relapse for a period of 2 years in patients who were Helicobacter pylori-positive at inclusion.


METHODS
Using double-blind randomization 125 patients with gastric ulcer were treated with either OMC (ome 20 mg b.i.d., metronidazole 400 mg b.i.d., clarithromycin 250 mg b.i.d.) (n = 64) or OP (ome 20 mg and placebo) (n = 61) for 1 week, followed by ome 20-40 mg o.d. until healing was confirmed endoscopically after 4, 8 or 12 weeks. Endoscopy and H. pylori diagnostics using culture, histology and serology were performed 6, 12 and 24 months after treatment or at symptomatic relapse. At inclusion, 35% of the OMC group and 38% of the OP group were taking non-steroidal anti-inflammatory drugs (NSAIDs). Nine percent (11/125) of the ulcers were malignant.


RESULTS
The prevalence of H. pylori was 82% and the eradication rate 88% in the OMC group and 3% in the OP group. More than 90% of the ulcers were healed after 12 weeks. After 2 years, 76% of patients in the OMC group were in remission compared with 28% in the OP group (ITT) (P < 0.001). Sixty percent of patients in the OMC group that continued to take NSAIDs were in remission after 2 years compared with none in the OP group. Atrophy but not intestinal metaplasia decreased after treatment.


CONCLUSIONS
Gastric ulcers are mainly caused by H. pylori, and relapse is effectively prevented by H. pylori eradication, even in patients on NSAIDs.
Befrits
R
R
Karolinska Institutet, Department of Medicine, Karolinska Hospital, SE-17176 Stockholm, Sweden. ragnar.befrits@ks.se
Sjöstedt
S
S
Tour
R
R
Leijonmarck
C-E
CE
Hedenborg
L
L
Backman
M
M
D000900:Anti-Bacterial Agents; D000897:Anti-Ulcer Agents / Q000627:therapeutic use; D004311:Double-Blind Method; D004359:Drug Therapy, Combination / Q000627:therapeutic use; D016099:Endoscopy, Gastrointestinal; D005260:Female; D005500:Follow-Up Studies; D016481:Helicobacter Infections / Q000150:complications / Q000188:drug therapy* / Q000473:pathology; D016480:Helicobacter pylori; D006801:Humans; D008297:Male; D008875:Middle Aged; D009853:Omeprazole / Q000627:therapeutic use; D012008:Recurrence; D013276:Stomach Ulcer / Q000188:drug therapy / Q000382:microbiology* / Q000473:pathology
D000900:Anti-Bacterial Agents; D000897:Anti-Ulcer Agents; D009853:Omeprazole