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Ranitidine bismuth citrate plus clarithromycin 7-day regimen is effective in eradicating Helicobacter pylori in patients with duodenal ulcer.
Aliment Pharmacol Ther 1998; 12(5):447-51AP

Abstract

BACKGROUND

No clinical study has been performed to-date to evaluate the efficacy of the dual therapy of ranitidine bismuth citrate (RBC) plus clarithromycin (C) 500 mg b.d. given for 7 days for the eradication of H. pylori.

AIM

To assess the eradication rates achieved by treatment with RBC 400 mg b.d. for 28 days combined with clarithromycin 500 mg b.d. for 7 days in H. pylori-positive duodenal ulcer patients.

METHODS

One hundred and twelve H. pylori-positive patients with endoscopically proven active duodenal ulcer were included in a multicentre, open, randomized trial. H. pylori infection was initially detected by CLO-test and histology on antral and corpus biopsies, and by 13C-urea breath test (UBT). Patients were included if at least two of the tests were positive for H. pylori infection. Patients were randomized to receive RBC 400 mg b.d. for 4 weeks combined with clarithromycin 500 mg b.d. for the first 7 days (Group A) or 14 days (Group B). A second endoscopy was performed at least 28 days after the end of therapy for the assessment of ulcer healing and H. pylori infection. Eradication was assumed if all the tests (CLO-test, histology and UBT) were negative for H. pylori.

RESULTS

Fifty patients in Group A and 55 in Group B were assessed for H. pylori eradication and ulcer healing. The eradication rates according to intention-to-treat analysis were 75% in Group A and 80% in Group B. Considering only those patients with evaluable data at least 28 days after the end of therapy, H. pylori eradication was achieved in 84% and 82% in Group A and B, respectively. No statistically significant difference in eradication was found between the two groups by Mantel-Haenszel test. Only one patient, in Group A, was withdrawn because of adverse events (epigastric pain and pruritus).

Authors+Show Affiliations

Gastroenterology Unit, Policlinico S. Orsola, Bologna, Italy.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

9663724

Citation

Pozzato, P, et al. "Ranitidine Bismuth Citrate Plus Clarithromycin 7-day Regimen Is Effective in Eradicating Helicobacter Pylori in Patients With Duodenal Ulcer." Alimentary Pharmacology & Therapeutics, vol. 12, no. 5, 1998, pp. 447-51.
Pozzato P, Zagari M, Cardelli A, et al. Ranitidine bismuth citrate plus clarithromycin 7-day regimen is effective in eradicating Helicobacter pylori in patients with duodenal ulcer. Aliment Pharmacol Ther. 1998;12(5):447-51.
Pozzato, P., Zagari, M., Cardelli, A., Catalano, F. A., Giglio, A., Lami, F., ... Roda, E. (1998). Ranitidine bismuth citrate plus clarithromycin 7-day regimen is effective in eradicating Helicobacter pylori in patients with duodenal ulcer. Alimentary Pharmacology & Therapeutics, 12(5), pp. 447-51.
Pozzato P, et al. Ranitidine Bismuth Citrate Plus Clarithromycin 7-day Regimen Is Effective in Eradicating Helicobacter Pylori in Patients With Duodenal Ulcer. Aliment Pharmacol Ther. 1998;12(5):447-51. PubMed PMID: 9663724.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Ranitidine bismuth citrate plus clarithromycin 7-day regimen is effective in eradicating Helicobacter pylori in patients with duodenal ulcer. AU - Pozzato,P, AU - Zagari,M, AU - Cardelli,A, AU - Catalano,F A, AU - Giglio,A, AU - Lami,F, AU - Pilotto,A, AU - Scarpulla,G, AU - Spadaccini,A, AU - Susi,D, AU - Tosatto,R, AU - Olivieri,A, AU - Bazzoli,F, AU - Roda,E, PY - 1998/7/15/pubmed PY - 1998/7/15/medline PY - 1998/7/15/entrez SP - 447 EP - 51 JF - Alimentary pharmacology & therapeutics JO - Aliment. Pharmacol. Ther. VL - 12 IS - 5 N2 - BACKGROUND: No clinical study has been performed to-date to evaluate the efficacy of the dual therapy of ranitidine bismuth citrate (RBC) plus clarithromycin (C) 500 mg b.d. given for 7 days for the eradication of H. pylori. AIM: To assess the eradication rates achieved by treatment with RBC 400 mg b.d. for 28 days combined with clarithromycin 500 mg b.d. for 7 days in H. pylori-positive duodenal ulcer patients. METHODS: One hundred and twelve H. pylori-positive patients with endoscopically proven active duodenal ulcer were included in a multicentre, open, randomized trial. H. pylori infection was initially detected by CLO-test and histology on antral and corpus biopsies, and by 13C-urea breath test (UBT). Patients were included if at least two of the tests were positive for H. pylori infection. Patients were randomized to receive RBC 400 mg b.d. for 4 weeks combined with clarithromycin 500 mg b.d. for the first 7 days (Group A) or 14 days (Group B). A second endoscopy was performed at least 28 days after the end of therapy for the assessment of ulcer healing and H. pylori infection. Eradication was assumed if all the tests (CLO-test, histology and UBT) were negative for H. pylori. RESULTS: Fifty patients in Group A and 55 in Group B were assessed for H. pylori eradication and ulcer healing. The eradication rates according to intention-to-treat analysis were 75% in Group A and 80% in Group B. Considering only those patients with evaluable data at least 28 days after the end of therapy, H. pylori eradication was achieved in 84% and 82% in Group A and B, respectively. No statistically significant difference in eradication was found between the two groups by Mantel-Haenszel test. Only one patient, in Group A, was withdrawn because of adverse events (epigastric pain and pruritus). SN - 0269-2813 UR - https://www.unboundmedicine.com/medline/citation/9663724/Ranitidine_bismuth_citrate_plus_clarithromycin_7_day_regimen_is_effective_in_eradicating_Helicobacter_pylori_in_patients_with_duodenal_ulcer_ L2 - https://onlinelibrary.wiley.com/resolve/openurl?genre=article&sid=nlm:pubmed&issn=0269-2813&date=1998&volume=12&issue=5&spage=447 DB - PRIME DP - Unbound Medicine ER -