Sequential Therapy Versus Triple Therapy for Helicobacter Pylori Eradication: a Placebo-Controlled Trial
|Helicobacter Pylori Infection||Drug: Placebo amoxicillin pantoprazole clarithromycin tinidazole||Phase 2 Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Sequential Therapy Versus Triple Therapy for Helicobacter Pylori Eradication: a Placebo-Controlled Trial|
- 13C urea breath test, upper endoscopy, histology, rapid urease test assessment
- bacterial culture, and antibiotic resistance assessment
|Study Start Date:||July 2003|
|Estimated Study Completion Date:||February 2006|
Background: Antimicrobial resistance has decreased eradication rates for H. pylori worldwide.
Objective: To assess if a sequential treatment regimen better eradicates H. pylori than does a triple drug regimen in adults with dyspepsia or peptic ulcer disease.
Design: Placebo-controlled trial. Setting: Two Italian Hospitals between September 2003 and April 2006. Patients: 300 dyspeptic or peptic ulcer patients Measurements: 13C urea breath test, upper endoscopy, histology, rapid urease test, bacterial culture, and antibiotic resistance assessment.
Intervention: 10-day sequential regimen (pantoprazole 40 mg, amoxicillin 1 g plus placebo for the first 5 days, followed by pantoprazole 40 mg, clarithromycin 500 mg and tinidazole 500 mg for the remaining 5 days) in 150 patients or standard 10-day therapy (pantoprazole 40 mg, clarithromycin 500 mg, and amoxicillin 1 g) in 150 patients. All drugs were given twice daily.
Results: There were 295 patients (Intent to treat) of whom 91% (95% CI: 86.5–95.7) had successful eradication with sequential therapy compared to 78% (95% CI: 71.2–84.5) for standard therapy (difference: 13.3%; 95%). The sequential therapy was significantly more effective in patients with clarithromycin resistant strains (88.9% patients vs. 28.6%; P = 0.0034). The incidence of major and minor side effects did not differ between therapy groups (17% vs. 17%).
Limitations: Follow-up was incomplete in 4.6% and 2.7% patients in sequential and standard therapy, respectively. The higher efficacy of sequential regimen should be confirmed outside Italy.
Conclusions: Sequential therapy is superior to conventional therapy for the eradication of H. pylori and it is significantly more effective in patients harbouring clarithromycin resistant strains.
The incidence side effects did not differ between therapy groups.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00403364
|S.Orsola/Malpighi Teaching Hospital, University|
|Bologna, Italy, 40138|
|Principal Investigator:||Dino Vaira, M.D.||S.Orsola/Malpighi Teaching Hospital, University of Bologna, Italy|