Objective: the aim of this study was to determine ulcer healing and H. pylo
ri eradication rates obtained with triple therapy (omeprazole, amoxicillin
and clarithromycin). Ulcer relapsing rate one year after eradication was al
so assessed. Maintenance therapy with placebo was compared with ranitidine
therapy and the effect of eradication on histological variables of the gast
ric mucosa was studied.
Methods: a prospective, double-blind parallel study was performed in 85 pat
ients endoscopically diagnosed of duodenal ulcer H. pylori positive. Patien
ts were randomized to a 7-days triple therapy (group A) or omeprazole plus
antibiotic placebo (group B). All patients were treated only with omeprazol
e for the next three weeks. Patients with ulcer healing after treatment wer
e entered in a one-year follow up phase with ranitidine placebo (group A) o
r ranitidine (group B). Endoscopy and biopsies were performed at baseline,
after treatment (5 weeks) and after 12 months of follow-up or when relapsin
g symptoms appeared.
Results: healing rate was 90.2% in group A and 85.7% in group B. Eradicatio
n rate was 78% in group A and 0% in group B, Out of 37 healed patients in g
roup A, eradication was achieved in 29 and only one relapse was found (3.4%
). Three out of eight patients with healing but without eradication relapse
d at 12 months (35%) (p<0.05). Histopathological results showed statistical
ly significant differences (p<0.05) between eradicated and non eradicated p
atients in terms of severity of inflammation and intestinal metaplasia, but
not in terms of atrophy.
Conclusions: H. pylori eradication is useful to prevent ulcer relapse and t
o improve gastric mucosa status.