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The impact of primary antibiotic resistance on the efficacy of ranitidine bismuth citrate- vs. omeprazole-based one-week triple therapies in H. pylori eradication--a randomised controlled trial.
Wien Klin Wochenschr. 2002 Jun 28; 114(12):448-53.WK

Abstract

AIMS

To compare ranitidine bismuth citrate with omeprazole as to their efficacy to eradicate H. pylori in two different treatment schedules both consisting of a combination of either of above with two antibiotics for 1 week, and to relate these treatment results to primary antibiotic resistance.

METHODS

256 H. pylori positive patients with non-ulcer dyspepsia were randomised to one of the following four treatment groups: omeprazole 20 mg + clarithromycin 500 mg + amoxycillin 1000 mg (OCA); ranitidine bismuth citrate 400 mg + clarithromycin 500 mg + amoxycillin 1000 mg (RBCCA); omeprazole 20 mg + clarithromycin 500 mg + metronidazole 500 mg (OCM); ranitidine bismuth citrate 400 mg + clarithromycin 500 mg + metronidazole 500 mg (RBCCM). All drugs were given twice daily for one week. The patients were assessed for prevalence of H. pylori by CLO test, histology and culture on gastric biopsy samples obtained during upper gastrointestinal endoscopy before randomisation and 4-6 weeks after completion of therapy. Bacterial sensitivity to clarithromycin, metronidazole and amoxycillin was determined by E-test.

RESULTS

On per-protocol analysis, overall eradication rates were 96% for RBCCA vs. 85% for OCA (p = 0.03), and 95% for RBCCM vs. 79% for OCM (p = 0.01). Amongst the 196 patients (77% of the entire study group) in whom antibiotic sensitivity testing was technically feasible, primary resistance was found in 8% for clarithromycin, in 33% for metronidazole, and in 0% for amoxycillin. Eradication of clarithromycin sensitive/resistant strains was 89%/40% for OCA (p = 0.0042) and 98%/80% for RBCCA (p = 0.0428). When strains were sensitive to both antibiotics, cure rates with OCM/RBCCM were 87%/96% respectively (p = 0.39), for strains resistant to clarithromycin only, eradication was achieved in 82% with OCM vs. 94% with RBCCM (p = 0.2), and in the case of metronidazole resistance in 85% with OCM vs. 94% with RBCCM (p = 0.09).

CONCLUSIONS

Ranitidine bismuth citrate in combination with clarithromycin and either metronidazole or amoxycillin produced higher eradication rates than omeprazole co-administered with the same antibiotics. This appeared especially prominent in the subgroups with clarithromycin resistance without, however, reaching statistical significance. Efficacy of neither eradication regimen was influenced by metronidazole sensitivity to a significant degree.

Authors+Show Affiliations

Department of Hepatogastroenterology, Internal Medicine, General Hospital Sveti Duh, Zagreb, Croatia.No 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
Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

12422579

Citation

Bago, Josip, et al. "The Impact of Primary Antibiotic Resistance On the Efficacy of Ranitidine Bismuth Citrate- Vs. Omeprazole-based One-week Triple Therapies in H. Pylori Eradication--a Randomised Controlled Trial." Wiener Klinische Wochenschrift, vol. 114, no. 12, 2002, pp. 448-53.
Bago J, Halle ZB, Strinić D, et al. The impact of primary antibiotic resistance on the efficacy of ranitidine bismuth citrate- vs. omeprazole-based one-week triple therapies in H. pylori eradication--a randomised controlled trial. Wien Klin Wochenschr. 2002;114(12):448-53.
Bago, J., Halle, Z. B., Strinić, D., Kućisec, N., Jandrić, D., Bevanda, M., Tomić, M., & Bilić, A. (2002). The impact of primary antibiotic resistance on the efficacy of ranitidine bismuth citrate- vs. omeprazole-based one-week triple therapies in H. pylori eradication--a randomised controlled trial. Wiener Klinische Wochenschrift, 114(12), 448-53.
Bago J, et al. The Impact of Primary Antibiotic Resistance On the Efficacy of Ranitidine Bismuth Citrate- Vs. Omeprazole-based One-week Triple Therapies in H. Pylori Eradication--a Randomised Controlled Trial. Wien Klin Wochenschr. 2002 Jun 28;114(12):448-53. PubMed PMID: 12422579.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The impact of primary antibiotic resistance on the efficacy of ranitidine bismuth citrate- vs. omeprazole-based one-week triple therapies in H. pylori eradication--a randomised controlled trial. AU - Bago,Josip, AU - Halle,Zeljka Belosić, AU - Strinić,Dean, AU - Kućisec,Nastja, AU - Jandrić,Dubravka, AU - Bevanda,Milenko, AU - Tomić,Monika, AU - Bilić,Ante, PY - 2002/11/9/pubmed PY - 2003/1/22/medline PY - 2002/11/9/entrez SP - 448 EP - 53 JF - Wiener klinische Wochenschrift JO - Wien. Klin. Wochenschr. VL - 114 IS - 12 N2 - AIMS: To compare ranitidine bismuth citrate with omeprazole as to their efficacy to eradicate H. pylori in two different treatment schedules both consisting of a combination of either of above with two antibiotics for 1 week, and to relate these treatment results to primary antibiotic resistance. METHODS: 256 H. pylori positive patients with non-ulcer dyspepsia were randomised to one of the following four treatment groups: omeprazole 20 mg + clarithromycin 500 mg + amoxycillin 1000 mg (OCA); ranitidine bismuth citrate 400 mg + clarithromycin 500 mg + amoxycillin 1000 mg (RBCCA); omeprazole 20 mg + clarithromycin 500 mg + metronidazole 500 mg (OCM); ranitidine bismuth citrate 400 mg + clarithromycin 500 mg + metronidazole 500 mg (RBCCM). All drugs were given twice daily for one week. The patients were assessed for prevalence of H. pylori by CLO test, histology and culture on gastric biopsy samples obtained during upper gastrointestinal endoscopy before randomisation and 4-6 weeks after completion of therapy. Bacterial sensitivity to clarithromycin, metronidazole and amoxycillin was determined by E-test. RESULTS: On per-protocol analysis, overall eradication rates were 96% for RBCCA vs. 85% for OCA (p = 0.03), and 95% for RBCCM vs. 79% for OCM (p = 0.01). Amongst the 196 patients (77% of the entire study group) in whom antibiotic sensitivity testing was technically feasible, primary resistance was found in 8% for clarithromycin, in 33% for metronidazole, and in 0% for amoxycillin. Eradication of clarithromycin sensitive/resistant strains was 89%/40% for OCA (p = 0.0042) and 98%/80% for RBCCA (p = 0.0428). When strains were sensitive to both antibiotics, cure rates with OCM/RBCCM were 87%/96% respectively (p = 0.39), for strains resistant to clarithromycin only, eradication was achieved in 82% with OCM vs. 94% with RBCCM (p = 0.2), and in the case of metronidazole resistance in 85% with OCM vs. 94% with RBCCM (p = 0.09). CONCLUSIONS: Ranitidine bismuth citrate in combination with clarithromycin and either metronidazole or amoxycillin produced higher eradication rates than omeprazole co-administered with the same antibiotics. This appeared especially prominent in the subgroups with clarithromycin resistance without, however, reaching statistical significance. Efficacy of neither eradication regimen was influenced by metronidazole sensitivity to a significant degree. SN - 0043-5325 UR - https://www.unboundmedicine.com/medline/citation/12422579/The_impact_of_primary_antibiotic_resistance_on_the_efficacy_of_ranitidine_bismuth_citrate__vs__omeprazole_based_one_week_triple_therapies_in_H__pylori_eradication__a_randomised_controlled_trial_ L2 - https://medlineplus.gov/helicobacterpyloriinfections.html DB - PRIME DP - Unbound Medicine ER -