Omeprazole once or twice daily with clarithromycin and metronidazole: PATIENTS AND METHODS
Patients were recruited from a single gastroenterology practice in Guelph, Ontario. Guelph has 94,000 inhabitants and is located near several large academic medical centres. In this community, it is not possible to culture H pylori and perform antibiotic susceptibility testing. The nearest centre performing C urea breath tests is a large teaching centre in Hamilton, Ontario, 45 km from Guelph. The C-urea breath test was not readily available when this study was performed. The study was approved by the ethics review committee of the Guelph General Hospital.
Patients referred to the practice and subjected to endos- copy for evaluation had two antral and two body biopsies to confirm H pylori infection. Patients were invited to participate in this open cohort study if they were positive for H pylori by histology using the Geimsa stain. All patients gave written informed consent.
Patient diagnosis of inactive duodenal or gastric ulcer disease (considered collectively as peptic ulcer disease), gastro- esophageal reflux disease and nonulcer dyspepsia were recorded. Inclusion criteria were 18 to 80 years of age and histologically proven H pylori infection. Patients who had taken antibiotics in the previous month, females who were pregnant or lactating, sexually active females in reproductive years who did not have adequate contraception and any patient currently involved in another clinical trial were excluded. Eligible patients were randomly assigned in this un- blinded, cohort study to one of two regimens – seven days of treatment with clarithromycin 250 mg and metronidazole 500 mg bid in combination with omeprazole 20 mg, either once or twice daily.
All patients were warned to avoid alcohol and to expect potential side effects such as taste disturbance, nausea or loose stools. Patients were encouraged to complete all their medications and were informed that successful completion of treatment would offer a greater chance of eradication success. Patients were reassessed at the end of drug treatment after one week to check compliance to medication by pill count and record spontaneously reported side effects to medications.
At least four weeks after the end of drug treatment, repeat endoscopy with four gastric biopsies (two antral and two body, Giemsa stain) was done to assess H pylori eradication. H pylori had to be negative in all four specimens to be considered negative, and the pathologist was not aware of the drug treatment given. Save on your pharmacy bills. Buy generic canadian pharmacies online
All patients who took at least one dose of medication were included in a conservative intent-to-treat (ITT) analysis, where all patients without final H pylori determination were considered treatment failures. A more realistic, all-patients-treated (APT) analysis was also performed. In this group, patients who may have been noncompliant with medications were included as long as a final H pylori evaluation was performed. In the per-protocol (PP) analysis, patients who took less than 80% of any of the medications or had taken confounding medications such as other antibiotics were excluded. It was recognized a priori that to show statistical equivalence between regimens, a sample size far larger than is practically feasible would be required. All statistical evaluations were done using Statistix for Windows 95 (Analytical software, Tallahassee, Florida).
