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

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.