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Randomized clinical trial comparing two one-week triple-therapy regimens for the eradication of Helicobacter pylori infection and duodenal ulcer healing.
Am J Gastroenterol. 1998 Jan; 93(1):35-8.AJ

Abstract

OBJECTIVE

One-week triple therapy has been shown to be effective in Helicobacter pylori eradication and duodenal ulcer healing. However, the optimal therapeutic combination has not yet been identified. Bismuth-containing regimens have the advantage of requiring only one antibiotic. It has been suggested that high doses of omeprazole improve the bactericidal efficacy of antimicrobial regimens against H. pylori. We evaluated the efficacy of two 1-wk triple-therapy regimens for H. pylori eradication and duodenal ulcer healing.

METHODS

On an intention-to-treat basis, 182 patients with H. pylori-associated duodenal ulcer were randomized. Group OCB patients (n = 91) were given omeprazole 40 mg b.i.d., clarithromycin 500 mg b.i.d., and colloidal bismuth subcitrate 120 mg q.i.d. for 7 days. Group OCA patients (n = 91) were treated with omeprazole and clarithromycin at the same doses plus amoxicillin 1 g b.i.d., also for 7 days. Endoscopies were performed at entry and at 4 wk after the end of treatment. The presence of H. pylori was assessed by urease test, histology, Gram stain, and culture. No patient received follow-up treatment.

RESULTS

H. pylori eradication rates achieved in the OCB and OCA groups were similar whether by intention-to-treat (82.4% vs 88.9% ;p = 0.21) or per protocol analysis (83.3% vs 89.9%; p = 0.19). Duodenal ulcer healing rates also were the same for OCB and OCA in intention-to treat (91.2% vs 91.1%) and per protocol analysis (92.2% vs 92.1%), respectively (p = 0.98).

CONCLUSIONS

High rates of H. pylori eradication and duodenal ulcer healing were obtained with both short-treatment regimens, which were safe and well-tolerated. Colloidal bismuth subcitrate seems to be a good alternative to amoxicillin in the triple-therapy combination with omeprazole and clarithromycin. The omeprazole dose does not seem to play a major role in H. pylori eradication in these therapeutic combinations.

Authors+Show Affiliations

Department of Gastroenterology, Hospital Mútua de Terrassa, University of Barcelona, Spain.No 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
Comparative Study
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

9448170

Citation

Forné, M, et al. "Randomized Clinical Trial Comparing Two One-week Triple-therapy Regimens for the Eradication of Helicobacter Pylori Infection and Duodenal Ulcer Healing." The American Journal of Gastroenterology, vol. 93, no. 1, 1998, pp. 35-8.
Forné M, Viver JM, Esteve M, et al. Randomized clinical trial comparing two one-week triple-therapy regimens for the eradication of Helicobacter pylori infection and duodenal ulcer healing. Am J Gastroenterol. 1998;93(1):35-8.
Forné, M., Viver, J. M., Esteve, M., Fernández-Bañares, F., Lite, J., Espinós, J. C., Quintana, S., Salas, A., & Garau, J. (1998). Randomized clinical trial comparing two one-week triple-therapy regimens for the eradication of Helicobacter pylori infection and duodenal ulcer healing. The American Journal of Gastroenterology, 93(1), 35-8.
Forné M, et al. Randomized Clinical Trial Comparing Two One-week Triple-therapy Regimens for the Eradication of Helicobacter Pylori Infection and Duodenal Ulcer Healing. Am J Gastroenterol. 1998;93(1):35-8. PubMed PMID: 9448170.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Randomized clinical trial comparing two one-week triple-therapy regimens for the eradication of Helicobacter pylori infection and duodenal ulcer healing. AU - Forné,M, AU - Viver,J M, AU - Esteve,M, AU - Fernández-Bañares,F, AU - Lite,J, AU - Espinós,J C, AU - Quintana,S, AU - Salas,A, AU - Garau,J, PY - 1998/2/3/pubmed PY - 1998/2/3/medline PY - 1998/2/3/entrez SP - 35 EP - 8 JF - The American journal of gastroenterology JO - Am J Gastroenterol VL - 93 IS - 1 N2 - OBJECTIVE: One-week triple therapy has been shown to be effective in Helicobacter pylori eradication and duodenal ulcer healing. However, the optimal therapeutic combination has not yet been identified. Bismuth-containing regimens have the advantage of requiring only one antibiotic. It has been suggested that high doses of omeprazole improve the bactericidal efficacy of antimicrobial regimens against H. pylori. We evaluated the efficacy of two 1-wk triple-therapy regimens for H. pylori eradication and duodenal ulcer healing. METHODS: On an intention-to-treat basis, 182 patients with H. pylori-associated duodenal ulcer were randomized. Group OCB patients (n = 91) were given omeprazole 40 mg b.i.d., clarithromycin 500 mg b.i.d., and colloidal bismuth subcitrate 120 mg q.i.d. for 7 days. Group OCA patients (n = 91) were treated with omeprazole and clarithromycin at the same doses plus amoxicillin 1 g b.i.d., also for 7 days. Endoscopies were performed at entry and at 4 wk after the end of treatment. The presence of H. pylori was assessed by urease test, histology, Gram stain, and culture. No patient received follow-up treatment. RESULTS: H. pylori eradication rates achieved in the OCB and OCA groups were similar whether by intention-to-treat (82.4% vs 88.9% ;p = 0.21) or per protocol analysis (83.3% vs 89.9%; p = 0.19). Duodenal ulcer healing rates also were the same for OCB and OCA in intention-to treat (91.2% vs 91.1%) and per protocol analysis (92.2% vs 92.1%), respectively (p = 0.98). CONCLUSIONS: High rates of H. pylori eradication and duodenal ulcer healing were obtained with both short-treatment regimens, which were safe and well-tolerated. Colloidal bismuth subcitrate seems to be a good alternative to amoxicillin in the triple-therapy combination with omeprazole and clarithromycin. The omeprazole dose does not seem to play a major role in H. pylori eradication in these therapeutic combinations. SN - 0002-9270 UR - https://www.unboundmedicine.com/medline/citation/9448170/Randomized_clinical_trial_comparing_two_one_week_triple_therapy_regimens_for_the_eradication_of_Helicobacter_pylori_infection_and_duodenal_ulcer_healing_ L2 - https://Insights.ovid.com/pubmed?pmid=9448170 DB - PRIME DP - Unbound Medicine ER -