Cure rates obtained with five different Helicobacter pylori eradication protocols in patients with duodenal ulcer: A prospective, open-label, randomized study in a primary care setting in Turkey
M. Ungan et al., Cure rates obtained with five different Helicobacter pylori eradication protocols in patients with duodenal ulcer: A prospective, open-label, randomized study in a primary care setting in Turkey, CURR THER R, 62(6), 2001, pp. 462-472
Citations number
21
Categorie Soggetti
Pharmacology,"Pharmacology & Toxicology
Journal title
CURRENT THERAPEUTIC RESEARCH-CLINICAL AND EXPERIMENTAL
Background: Helicobacter py[ori is the main causative agent in peptic ulcer
disease. Duodenal ulcer disease is a chronic, recurring condition, and the
risk of recurrence and complications does not diminish over time unless H
pylori is eradicated. Several treatment protocols exist to eradicate H pylo
ri, but their efficacy and costs vary. Because of regional variations in ba
cterial resistance and in treatment costs, primary care physicians must use
the most appropriate protocol for their own region and population.
Objective: The primary aim of this study was to compare the cure rates obta
ined with 5 different H pylori eradication protocols in H pylori-positive d
uodenal ulcer patients in Turkey. A secondary objective was to determine th
e accuracy of the duodenal ulcer diagnoses made by primary care physicians
relying on information from physical examination and medical history alone.
Methods: In a primary care setting, 2 family physicians, 5 general physicia
ns (medical school graduates), 1 general surgeon, and 1 internal medicine s
pecialist identified 265 symptomatic duodenal ulcer patients using medical
history and physical examination results. These patients were referred to a
n open-access endoscopy unit for upper gastrointestinal endoscopy. Patients
who had an endoscopically confirmed duodenal ulcer and who tested positive
for H pylori were randomly assigned to receive 1 of 5 H pylori eradication
treatments: (1) omeprazole/amoxicillin/clarithromycin; (2) lansoprazole/am
oxicillin/clarithromycin; (3) omeprazole/ornidazole/amoxicillin; (ll) lanso
prazole/amoxicillin/clarithromycin/ornidazole or (5) ranitidine bismuth cit
rate/amoxicillin/metronidazole. Follow-up endoscopies and biopsies were per
formed 6 weeks and 6 months after the end of treatment.
Results: Of the 265 patients suspected to have duodenal ulcers based on med
ical history and physical examination findings, 181 (68.3%) had endoscopica
lly confirmed duodenal ulcers. At both 6 weeks and 6 months after treatment
, eradication rates were not significantly different between treatment grou
ps in the intent-to-treat or per-protocol analyses. There was no significan
t difference in tolerability between the 5 regimens.
Conclusions: Our results confirm the high accuracy of the duodenal ulcer di
agnoses and endoscopy referrals made by primary care physicians based on ph
ysical examination and medical history of the patient. Primary care physici
ans should play an Important role in treatment decisions regarding H pylori
eradication. The 5 treatments studied are similar with respect to H pylori
eradication rates. If the cost of treatment is an important consideration,
the less expensive omeprazole/ornidazole/amoxicillin triple regimen may be
a good choice for eradicating H pylori. In cases of resistant H pylori inf
ection, the lansoprazole/amoxicillin/clarithromycin/ornidazole quadruple th
erapy appears to be the best choice for a second-line treatment if reliable
culture and resistance testing are not available. Depending on regional va
riables, each nation needs to develop its own guidelines for the eradicatio
n of H pylori.