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Ranitidine bismuth citrate with clarithromycin alone or with metronidazole for the eradication of Helicobacter pylori.
Aliment Pharmacol Ther 2001; 15(8):1199-204AP

Abstract

BACKGROUND

Both triple therapy with ranitidine bismuth citrate (RBC) plus two antibiotics for 7 days and dual therapy of RBC with clarithromycin for 14 days have been extensively studied; both regimens effectively eradicate Helicobacter pylori. However, few studies have assessed the efficacy of dual therapy given for 7 days.

AIM

To compare the efficacy and safety of RBC 400 mg with clarithromycin 500 mg, alone or with metronidazole 400 mg, given twice daily for 7 days for the eradication of H. pylori.

METHODS

This single centre, randomized, double-blind study involved 118 patients with dyspepsia or a history of peptic ulcer disease. H. pylori infection was detected initially by CLO test, and confirmed in 109 patients by urea breath test and/or microbiology culture. H. pylori eradication was assessed 4 and 12 weeks after the end of treatment by urea breath test. H. pylori antibiotic susceptibility was assessed pre-study in all patients, and post-treatment in patients with a positive post-treatment urea breath test. Adverse events were recorded throughout the study.

RESULTS

H. pylori was eradicated in 93% of patients who received RBC with clarithromycin and metronidazole and in 84% of patients who received RBC with clarithromycin (intention-to-treat rates). Per protocol eradication rates were 98% and 90% for triple therapy and dual therapy, respectively. The eradication of metronidazole-resistant H. pylori was achieved in 100% and 88% of patients following dual therapy and triple therapy, respectively, and acquired resistance to clarithromycin occurred in only one patient following treatment failure. Both treatments were well-tolerated; only one patient (2%) was withdrawn from each treatment group due to adverse events.

CONCLUSIONS

RBC with clarithromycin and metronidazole is a highly effective and well-tolerated triple therapy regimen for the eradication of H. pylori. RBC with clarithromycin dual therapy has a similar efficacy, and offers an alternative to triple therapy when there are concerns about treatment with metronidazole or the use of multiple antibiotics. Both regimens are effective against antibiotic-resistant strains of H. pylori.

Authors+Show Affiliations

Rotherham District General Hospitals NHS Trust, UK. pmr3795@gsk.comNo 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
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

11472323

Citation

Bardhan, K D., et al. "Ranitidine Bismuth Citrate With Clarithromycin Alone or With Metronidazole for the Eradication of Helicobacter Pylori." Alimentary Pharmacology & Therapeutics, vol. 15, no. 8, 2001, pp. 1199-204.
Bardhan KD, Morton D, Perry MJ, et al. Ranitidine bismuth citrate with clarithromycin alone or with metronidazole for the eradication of Helicobacter pylori. Aliment Pharmacol Ther. 2001;15(8):1199-204.
Bardhan, K. D., Morton, D., Perry, M. J., Sanders, D. S., Morris, P., Rowland, A., ... Roberts, P. M. (2001). Ranitidine bismuth citrate with clarithromycin alone or with metronidazole for the eradication of Helicobacter pylori. Alimentary Pharmacology & Therapeutics, 15(8), pp. 1199-204.
Bardhan KD, et al. Ranitidine Bismuth Citrate With Clarithromycin Alone or With Metronidazole for the Eradication of Helicobacter Pylori. Aliment Pharmacol Ther. 2001;15(8):1199-204. PubMed PMID: 11472323.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Ranitidine bismuth citrate with clarithromycin alone or with metronidazole for the eradication of Helicobacter pylori. AU - Bardhan,K D, AU - Morton,D, AU - Perry,M J, AU - Sanders,D S, AU - Morris,P, AU - Rowland,A, AU - Thompson,M, AU - Mitchell,T R, AU - Roberts,P M, PY - 2001/7/27/pubmed PY - 2002/1/5/medline PY - 2001/7/27/entrez SP - 1199 EP - 204 JF - Alimentary pharmacology & therapeutics JO - Aliment. Pharmacol. Ther. VL - 15 IS - 8 N2 - BACKGROUND: Both triple therapy with ranitidine bismuth citrate (RBC) plus two antibiotics for 7 days and dual therapy of RBC with clarithromycin for 14 days have been extensively studied; both regimens effectively eradicate Helicobacter pylori. However, few studies have assessed the efficacy of dual therapy given for 7 days. AIM: To compare the efficacy and safety of RBC 400 mg with clarithromycin 500 mg, alone or with metronidazole 400 mg, given twice daily for 7 days for the eradication of H. pylori. METHODS: This single centre, randomized, double-blind study involved 118 patients with dyspepsia or a history of peptic ulcer disease. H. pylori infection was detected initially by CLO test, and confirmed in 109 patients by urea breath test and/or microbiology culture. H. pylori eradication was assessed 4 and 12 weeks after the end of treatment by urea breath test. H. pylori antibiotic susceptibility was assessed pre-study in all patients, and post-treatment in patients with a positive post-treatment urea breath test. Adverse events were recorded throughout the study. RESULTS: H. pylori was eradicated in 93% of patients who received RBC with clarithromycin and metronidazole and in 84% of patients who received RBC with clarithromycin (intention-to-treat rates). Per protocol eradication rates were 98% and 90% for triple therapy and dual therapy, respectively. The eradication of metronidazole-resistant H. pylori was achieved in 100% and 88% of patients following dual therapy and triple therapy, respectively, and acquired resistance to clarithromycin occurred in only one patient following treatment failure. Both treatments were well-tolerated; only one patient (2%) was withdrawn from each treatment group due to adverse events. CONCLUSIONS: RBC with clarithromycin and metronidazole is a highly effective and well-tolerated triple therapy regimen for the eradication of H. pylori. RBC with clarithromycin dual therapy has a similar efficacy, and offers an alternative to triple therapy when there are concerns about treatment with metronidazole or the use of multiple antibiotics. Both regimens are effective against antibiotic-resistant strains of H. pylori. SN - 0269-2813 UR - https://www.unboundmedicine.com/medline/citation/11472323/Ranitidine_bismuth_citrate_with_clarithromycin_alone_or_with_metronidazole_for_the_eradication_of_Helicobacter_pylori_ L2 - https://onlinelibrary.wiley.com/resolve/openurl?genre=article&sid=nlm:pubmed&issn=0269-2813&date=2001&volume=15&issue=8&spage=1199 DB - PRIME DP - Unbound Medicine ER -