Helicobacter pylori eradication in the healing and recurrence of benign gastric ulcer: A two-year, double-blind, placebo controlled study

M. Lazzaroni, M. Perego, S. Bargiggia, G. Maconi, R. Fiocca, E. Solcia, M. Franceschi, B. Cesana, G. Bianchi Porro

Research output: Contribution to journalArticle

18 Citations (Scopus)

Abstract

Background. Helicobacter pylori infection is associated with idiopathic gastric ulcer in about 90% of the cases, but only a few controlled studies aimed at evaluating gastric ulcer healing and the natural history after Helicobacter pylori-eradication have been carried out. Objective. The aim of the present study was to evaluate the efficacy of omeprazole coupled with amoxicillin in the eradication of Helicobacter pylori and healing and prevention of gastric ulcer recurrence. Patients. Fifty-nine patients with active gastric ulcer were randomized under double-blind conditions to receive either omeprazole 20 mg twice daily for four weeks plus amoxicillin 3 g daily during the first and second week (29 patients, Group A) or omeprazole 20 mg twice daily for 4 weeks plus placebo for two weeks (30 patients, Group B). Methods. Endoscopic studies were carried out at the end of the 4 weeks treatment (or after 8 weeks in non-healed patients) as well as 2, 6 and 12 months later. A total of 3 biopsies in the antrum, 3 in the gastric body and at least seven at the edge of the crater were taken at each endoscopic control for exclusion, of malignancy, histological detection of Helicobacter pylori and for evaluation of gastric histology according to the Sydney system. Results. With intention to treat analysis, the percentage of healing after 4 and 8 weeks was 86% and 100% in Group A patients and 86% and 93% in Group B, respectively. Two patients dropped out in Group B for non medical reasons. The percentage of eradication was 63% in Group A and 7% in Group B. During a 12-month follow-up gastric ulcer relapsed in 20/32 (63%) of the persistently Helicobacter pylori positive patients. Only two out 20 (10%) Helicobacter pylori cured patients showed a gastric ulcer relapse and Helicobacter pylori reinfection. Twenty out of 30 patients, still healed after 12 months, underwent endoscopic control after two years. A gastric ulcer relapse was observed in three out of nine (33%) patients with persisting infection after treatment. No gastric lesions, but one case of erosive oesophagitis were observed in the 11 Helicobacter pylori-eradicated patients. Conclusions. In our experience, Helicobacter pylori eradication does not favour gastric ulcer healing but does positively influence the subsequent natural history.

Original languageEnglish
Pages (from-to)220-227
Number of pages8
JournalItalian Journal of Gastroenterology and Hepatology
Volume29
Issue number3
Publication statusPublished - 1997

Fingerprint

Stomach Ulcer
Helicobacter pylori
Placebos
Recurrence
Omeprazole
Stomach
Amoxicillin
Natural History
Intention to Treat Analysis
Esophagitis
Helicobacter Infections
Histology
Biopsy

Keywords

  • Amoxicillin
  • Eradicating therapy
  • Gastric ulcer
  • Helicobacter pylori
  • Omeprazole

ASJC Scopus subject areas

  • Gastroenterology

Cite this

Helicobacter pylori eradication in the healing and recurrence of benign gastric ulcer : A two-year, double-blind, placebo controlled study. / Lazzaroni, M.; Perego, M.; Bargiggia, S.; Maconi, G.; Fiocca, R.; Solcia, E.; Franceschi, M.; Cesana, B.; Bianchi Porro, G.

In: Italian Journal of Gastroenterology and Hepatology, Vol. 29, No. 3, 1997, p. 220-227.

Research output: Contribution to journalArticle

Lazzaroni, M. ; Perego, M. ; Bargiggia, S. ; Maconi, G. ; Fiocca, R. ; Solcia, E. ; Franceschi, M. ; Cesana, B. ; Bianchi Porro, G. / Helicobacter pylori eradication in the healing and recurrence of benign gastric ulcer : A two-year, double-blind, placebo controlled study. In: Italian Journal of Gastroenterology and Hepatology. 1997 ; Vol. 29, No. 3. pp. 220-227.
@article{a9127bd331b0426b8e7eb32273187e59,
title = "Helicobacter pylori eradication in the healing and recurrence of benign gastric ulcer: A two-year, double-blind, placebo controlled study",
abstract = "Background. Helicobacter pylori infection is associated with idiopathic gastric ulcer in about 90{\%} of the cases, but only a few controlled studies aimed at evaluating gastric ulcer healing and the natural history after Helicobacter pylori-eradication have been carried out. Objective. The aim of the present study was to evaluate the efficacy of omeprazole coupled with amoxicillin in the eradication of Helicobacter pylori and healing and prevention of gastric ulcer recurrence. Patients. Fifty-nine patients with active gastric ulcer were randomized under double-blind conditions to receive either omeprazole 20 mg twice daily for four weeks plus amoxicillin 3 g daily during the first and second week (29 patients, Group A) or omeprazole 20 mg twice daily for 4 weeks plus placebo for two weeks (30 patients, Group B). Methods. Endoscopic studies were carried out at the end of the 4 weeks treatment (or after 8 weeks in non-healed patients) as well as 2, 6 and 12 months later. A total of 3 biopsies in the antrum, 3 in the gastric body and at least seven at the edge of the crater were taken at each endoscopic control for exclusion, of malignancy, histological detection of Helicobacter pylori and for evaluation of gastric histology according to the Sydney system. Results. With intention to treat analysis, the percentage of healing after 4 and 8 weeks was 86{\%} and 100{\%} in Group A patients and 86{\%} and 93{\%} in Group B, respectively. Two patients dropped out in Group B for non medical reasons. The percentage of eradication was 63{\%} in Group A and 7{\%} in Group B. During a 12-month follow-up gastric ulcer relapsed in 20/32 (63{\%}) of the persistently Helicobacter pylori positive patients. Only two out 20 (10{\%}) Helicobacter pylori cured patients showed a gastric ulcer relapse and Helicobacter pylori reinfection. Twenty out of 30 patients, still healed after 12 months, underwent endoscopic control after two years. A gastric ulcer relapse was observed in three out of nine (33{\%}) patients with persisting infection after treatment. No gastric lesions, but one case of erosive oesophagitis were observed in the 11 Helicobacter pylori-eradicated patients. Conclusions. In our experience, Helicobacter pylori eradication does not favour gastric ulcer healing but does positively influence the subsequent natural history.",
keywords = "Amoxicillin, Eradicating therapy, Gastric ulcer, Helicobacter pylori, Omeprazole",
author = "M. Lazzaroni and M. Perego and S. Bargiggia and G. Maconi and R. Fiocca and E. Solcia and M. Franceschi and B. Cesana and {Bianchi Porro}, G.",
year = "1997",
language = "English",
volume = "29",
pages = "220--227",
journal = "Digestive and Liver Disease",
issn = "1590-8658",
publisher = "Elsevier B.V.",
number = "3",

}

TY - JOUR

T1 - Helicobacter pylori eradication in the healing and recurrence of benign gastric ulcer

T2 - A two-year, double-blind, placebo controlled study

AU - Lazzaroni, M.

AU - Perego, M.

AU - Bargiggia, S.

AU - Maconi, G.

AU - Fiocca, R.

AU - Solcia, E.

AU - Franceschi, M.

AU - Cesana, B.

AU - Bianchi Porro, G.

PY - 1997

Y1 - 1997

N2 - Background. Helicobacter pylori infection is associated with idiopathic gastric ulcer in about 90% of the cases, but only a few controlled studies aimed at evaluating gastric ulcer healing and the natural history after Helicobacter pylori-eradication have been carried out. Objective. The aim of the present study was to evaluate the efficacy of omeprazole coupled with amoxicillin in the eradication of Helicobacter pylori and healing and prevention of gastric ulcer recurrence. Patients. Fifty-nine patients with active gastric ulcer were randomized under double-blind conditions to receive either omeprazole 20 mg twice daily for four weeks plus amoxicillin 3 g daily during the first and second week (29 patients, Group A) or omeprazole 20 mg twice daily for 4 weeks plus placebo for two weeks (30 patients, Group B). Methods. Endoscopic studies were carried out at the end of the 4 weeks treatment (or after 8 weeks in non-healed patients) as well as 2, 6 and 12 months later. A total of 3 biopsies in the antrum, 3 in the gastric body and at least seven at the edge of the crater were taken at each endoscopic control for exclusion, of malignancy, histological detection of Helicobacter pylori and for evaluation of gastric histology according to the Sydney system. Results. With intention to treat analysis, the percentage of healing after 4 and 8 weeks was 86% and 100% in Group A patients and 86% and 93% in Group B, respectively. Two patients dropped out in Group B for non medical reasons. The percentage of eradication was 63% in Group A and 7% in Group B. During a 12-month follow-up gastric ulcer relapsed in 20/32 (63%) of the persistently Helicobacter pylori positive patients. Only two out 20 (10%) Helicobacter pylori cured patients showed a gastric ulcer relapse and Helicobacter pylori reinfection. Twenty out of 30 patients, still healed after 12 months, underwent endoscopic control after two years. A gastric ulcer relapse was observed in three out of nine (33%) patients with persisting infection after treatment. No gastric lesions, but one case of erosive oesophagitis were observed in the 11 Helicobacter pylori-eradicated patients. Conclusions. In our experience, Helicobacter pylori eradication does not favour gastric ulcer healing but does positively influence the subsequent natural history.

AB - Background. Helicobacter pylori infection is associated with idiopathic gastric ulcer in about 90% of the cases, but only a few controlled studies aimed at evaluating gastric ulcer healing and the natural history after Helicobacter pylori-eradication have been carried out. Objective. The aim of the present study was to evaluate the efficacy of omeprazole coupled with amoxicillin in the eradication of Helicobacter pylori and healing and prevention of gastric ulcer recurrence. Patients. Fifty-nine patients with active gastric ulcer were randomized under double-blind conditions to receive either omeprazole 20 mg twice daily for four weeks plus amoxicillin 3 g daily during the first and second week (29 patients, Group A) or omeprazole 20 mg twice daily for 4 weeks plus placebo for two weeks (30 patients, Group B). Methods. Endoscopic studies were carried out at the end of the 4 weeks treatment (or after 8 weeks in non-healed patients) as well as 2, 6 and 12 months later. A total of 3 biopsies in the antrum, 3 in the gastric body and at least seven at the edge of the crater were taken at each endoscopic control for exclusion, of malignancy, histological detection of Helicobacter pylori and for evaluation of gastric histology according to the Sydney system. Results. With intention to treat analysis, the percentage of healing after 4 and 8 weeks was 86% and 100% in Group A patients and 86% and 93% in Group B, respectively. Two patients dropped out in Group B for non medical reasons. The percentage of eradication was 63% in Group A and 7% in Group B. During a 12-month follow-up gastric ulcer relapsed in 20/32 (63%) of the persistently Helicobacter pylori positive patients. Only two out 20 (10%) Helicobacter pylori cured patients showed a gastric ulcer relapse and Helicobacter pylori reinfection. Twenty out of 30 patients, still healed after 12 months, underwent endoscopic control after two years. A gastric ulcer relapse was observed in three out of nine (33%) patients with persisting infection after treatment. No gastric lesions, but one case of erosive oesophagitis were observed in the 11 Helicobacter pylori-eradicated patients. Conclusions. In our experience, Helicobacter pylori eradication does not favour gastric ulcer healing but does positively influence the subsequent natural history.

KW - Amoxicillin

KW - Eradicating therapy

KW - Gastric ulcer

KW - Helicobacter pylori

KW - Omeprazole

UR - http://www.scopus.com/inward/record.url?scp=0031446523&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0031446523&partnerID=8YFLogxK

M3 - Article

C2 - 9646213

AN - SCOPUS:0031446523

VL - 29

SP - 220

EP - 227

JO - Digestive and Liver Disease

JF - Digestive and Liver Disease

SN - 1590-8658

IS - 3

ER -