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Bismuth-based quadruple therapy using a single capsule of bismuth biskalcitrate, metronidazole, and tetracycline given with omeprazole versus omeprazole, amoxicillin, and clarithromycin for eradication of Helicobacter pylori in duodenal ulcer patients: a prospective, randomized, multicenter, North American trial.
Am J Gastroenterol 2003; 98(3):562-7AJ

Abstract

OBJECTIVES

This multicenter, randomized, active-controlled trial assessed efficacy of bismuth-based quadruple therapy with omeprazole, bismuth biskalcitrate, metronidazole, and tetracycline (OBMT) using a single-triple capsule of BMT compared with triple therapy with omeprazole, amoxicillin, and clarithromycin (OAC) in treatment of patients with Helicobacter pylori infection and duodenal ulcers.

METHODS

Patients with active duodenal ulcer or diagnosed within the past 5 yr and with infection documented by (13)C-urea breath test plus histology or culture were randomly assigned to 10-day course of OBMT using a single-triple capsule containing bismuth biskalcitrate 140 mg, metronidazole 125 mg, and tetracycline 125 mg given as three capsules q.i.d. with omeprazole 20 mg b.i.d., or a 10-day course of OAC, omeprazole 20 mg plus amoxicillin 1 g plus clarithromycin 500 mg, all b.i.d. Eradication was confirmed by two negative urea breath tests at >1 month and >2 months after therapy.

RESULTS

One hundred thirty-eight patients received OBMT and 137 OAC. Modified intent-to-treat eradication rates were 87.7% for OBMT and 83.2% for OAC (95% CI = -3.9%-12.8%; p = 0.29). OBMT eradicated 91.7% metronidazole-sensitive and 80.4% metronidazole-resistant strains (p = 0.06). OAC eradicated 92.1% clarithromycin sensitive and 21.4% clarithromycin-resistant strains (p < 0.001). Adverse events occurred in 58.5% of OBMT patients and 59.0% of OAC patients.

CONCLUSIONS

OBMT regimen using the single-triple capsule is as efficacious and well-tolerated as the widely used OAC regimen for H. pylori eradication. This OBMT therapy largely overcomes H. pylori metronidazole resistance, present in 40% of patients in this study.

Authors+Show Affiliations

University of Southern California School of Medicine, Los Angeles, CA 90033, USA.No 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

12650788

Citation

Laine, Loren, et al. "Bismuth-based Quadruple Therapy Using a Single Capsule of Bismuth Biskalcitrate, Metronidazole, and Tetracycline Given With Omeprazole Versus Omeprazole, Amoxicillin, and Clarithromycin for Eradication of Helicobacter Pylori in Duodenal Ulcer Patients: a Prospective, Randomized, Multicenter, North American Trial." The American Journal of Gastroenterology, vol. 98, no. 3, 2003, pp. 562-7.
Laine L, Hunt R, El-Zimaity H, et al. Bismuth-based quadruple therapy using a single capsule of bismuth biskalcitrate, metronidazole, and tetracycline given with omeprazole versus omeprazole, amoxicillin, and clarithromycin for eradication of Helicobacter pylori in duodenal ulcer patients: a prospective, randomized, multicenter, North American trial. Am J Gastroenterol. 2003;98(3):562-7.
Laine, L., Hunt, R., El-Zimaity, H., Nguyen, B., Osato, M., & Spénard, J. (2003). Bismuth-based quadruple therapy using a single capsule of bismuth biskalcitrate, metronidazole, and tetracycline given with omeprazole versus omeprazole, amoxicillin, and clarithromycin for eradication of Helicobacter pylori in duodenal ulcer patients: a prospective, randomized, multicenter, North American trial. The American Journal of Gastroenterology, 98(3), pp. 562-7.
Laine L, et al. Bismuth-based Quadruple Therapy Using a Single Capsule of Bismuth Biskalcitrate, Metronidazole, and Tetracycline Given With Omeprazole Versus Omeprazole, Amoxicillin, and Clarithromycin for Eradication of Helicobacter Pylori in Duodenal Ulcer Patients: a Prospective, Randomized, Multicenter, North American Trial. Am J Gastroenterol. 2003;98(3):562-7. PubMed PMID: 12650788.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Bismuth-based quadruple therapy using a single capsule of bismuth biskalcitrate, metronidazole, and tetracycline given with omeprazole versus omeprazole, amoxicillin, and clarithromycin for eradication of Helicobacter pylori in duodenal ulcer patients: a prospective, randomized, multicenter, North American trial. AU - Laine,Loren, AU - Hunt,Richard, AU - El-Zimaity,Hala, AU - Nguyen,Bich, AU - Osato,Michael, AU - Spénard,Jean, PY - 2003/3/26/pubmed PY - 2003/4/11/medline PY - 2003/3/26/entrez SP - 562 EP - 7 JF - The American journal of gastroenterology JO - Am. J. Gastroenterol. VL - 98 IS - 3 N2 - OBJECTIVES: This multicenter, randomized, active-controlled trial assessed efficacy of bismuth-based quadruple therapy with omeprazole, bismuth biskalcitrate, metronidazole, and tetracycline (OBMT) using a single-triple capsule of BMT compared with triple therapy with omeprazole, amoxicillin, and clarithromycin (OAC) in treatment of patients with Helicobacter pylori infection and duodenal ulcers. METHODS: Patients with active duodenal ulcer or diagnosed within the past 5 yr and with infection documented by (13)C-urea breath test plus histology or culture were randomly assigned to 10-day course of OBMT using a single-triple capsule containing bismuth biskalcitrate 140 mg, metronidazole 125 mg, and tetracycline 125 mg given as three capsules q.i.d. with omeprazole 20 mg b.i.d., or a 10-day course of OAC, omeprazole 20 mg plus amoxicillin 1 g plus clarithromycin 500 mg, all b.i.d. Eradication was confirmed by two negative urea breath tests at >1 month and >2 months after therapy. RESULTS: One hundred thirty-eight patients received OBMT and 137 OAC. Modified intent-to-treat eradication rates were 87.7% for OBMT and 83.2% for OAC (95% CI = -3.9%-12.8%; p = 0.29). OBMT eradicated 91.7% metronidazole-sensitive and 80.4% metronidazole-resistant strains (p = 0.06). OAC eradicated 92.1% clarithromycin sensitive and 21.4% clarithromycin-resistant strains (p < 0.001). Adverse events occurred in 58.5% of OBMT patients and 59.0% of OAC patients. CONCLUSIONS: OBMT regimen using the single-triple capsule is as efficacious and well-tolerated as the widely used OAC regimen for H. pylori eradication. This OBMT therapy largely overcomes H. pylori metronidazole resistance, present in 40% of patients in this study. SN - 0002-9270 UR - https://www.unboundmedicine.com/medline/citation/12650788/Bismuth_based_quadruple_therapy_using_a_single_capsule_of_bismuth_biskalcitrate_metronidazole_and_tetracycline_given_with_omeprazole_versus_omeprazole_amoxicillin_and_clarithromycin_for_eradication_of_Helicobacter_pylori_in_duodenal_ulcer_patients:_a_prospective_randomized_multicenter_North_American_trial_ L2 - https://onlinelibrary.wiley.com/resolve/openurl?genre=article&amp;sid=nlm:pubmed&amp;issn=0002-9270&amp;date=2003&amp;volume=98&amp;issue=3&amp;spage=562 DB - PRIME DP - Unbound Medicine ER -