Abstract | BACKGROUND/AIMS: 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, 13C urea breath test, and serum laboratory analyses were performed. All patients were treated with pantoprazole 40 mg once daily, plus amoxycillin 1 gram tid and metronidazole 250 mg tid for 1 week, and pantoprazole 40 mg 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:
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Authors | A Pilotto, G Leandro, M Franceschi, L Bierti, R Di Battista, A Notarbartolo, G Pisciotta, A Grassi, B Crestani, G Tafner, S Michelagnoli, F Garotta |
Journal | Hepato-gastroenterology
(Hepatogastroenterology)
1999 Jan-Feb
Vol. 46
Issue 25
Pg. 245-51
ISSN: 0172-6390 [Print] Greece |
PMID | 10228801
(Publication Type: Clinical Trial, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
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Chemical References |
- 2-Pyridinylmethylsulfinylbenzimidazoles
- Anti-Bacterial Agents
- Anti-Ulcer Agents
- Benzimidazoles
- Penicillins
- Sulfoxides
- Metronidazole
- Amoxicillin
- Pantoprazole
- Omeprazole
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Topics |
- 2-Pyridinylmethylsulfinylbenzimidazoles
- Adult
- Aged
- Amoxicillin
(therapeutic use)
- Anti-Bacterial Agents
(therapeutic use)
- Anti-Ulcer Agents
(therapeutic use)
- Benzimidazoles
(therapeutic use)
- Drug Therapy, Combination
- Duodenal Ulcer
(drug therapy, microbiology)
- Female
- Helicobacter Infections
(drug therapy)
- Helicobacter pylori
- Humans
- Male
- Metronidazole
(therapeutic use)
- Middle Aged
- Omeprazole
(analogs & derivatives)
- Pantoprazole
- Penicillins
(therapeutic use)
- Prospective Studies
- Sulfoxides
(therapeutic use)
- Treatment Outcome
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