Rapid improvement of symptomatology with pantoprazole, amoxycillin and metronidazole in Helicobacter pylori-positive duodenal ulcer patients

BACKGROUND/AIMS: To evaluate the efficacy and tolerability of a new 1-week triple therapy regimen consisting of pantoprazole, amoxycillin and metronidazole. METHODOLOGY: The study involved 51 Helicobacter pylori (H. pylori) positive patients (M:30, F:21, mean age: 52.5 years, range: 24-75) affected with duodenal ulcer in active phase. At baseline and 6 weeks after the completion of treatment, clinical assessment, endoscopy with gastric biopsies, rapid urease test, C-13 urea breath test, and serum laboratory analyses were performed. All patients were treated with pantoprazole 40mg once daily, plus amoxycillin 1gram tid and metronidazole 250mg tid for 1 week, and pantoprazole 40mg once daily for a second week. A clinical diary for daily assessment of symptoms and side effects was completed by patients during the treatment period. RESULTS: Three patients were discontinued from the study. Six weeks after therapy, the ulcer was healed in 47 of 48 patients (97.9%, 95% CI=93.9-100). The cure rates of H. pylori infection, expressed using both the intention-to-treat and per protocol analyses, were 80.4% (95% CI=69.5-91.3) and 85.4% (95% CI=75.4-95.4), respectively. The therapy led to a significant, rapid disappearance or reduction in daytime epigastric pain, from 68.8% on day 1 to 82.2% on day 3 (p<0.001) and in nocturnal epigastric pain, from 80.6% on day 1 to 93.3% on day 3 (p<0.001). After 2 weeks of treatment, the percentage of patients completely free of pain was 82.2% for daytime pain and 90.3% for nocturnal pain. A rapid improvement in acid regurgitation, heartburn, nausea and vomiting was also observed with a median value of symptom disappearance of 2 days. The percentages of patients completely symptom-free were 37.5% after 1 day, 54.1% after 3 days, 75% after 2 weeks, and 83.3% after 2 months. H. pylori-cured patients showed a significant decrease in the histological activity of both antral (p=0.0001) and body (p<0.008) gastritis. Mild to moderate adverse events were reported by 15 patients. CONCLUSIONS: One week triple therapy with pantoprazole in combination with amoxycillin and metronidazole, followed by a second week of pantoprazole, was well tolerated and highly effective for the 1) rapid improvement or resolution of symptoms; 2) healing of the DU; 3) eradication of H. pylori infection; and, 4) reduction of histological signs of chronic gastritis activity.