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A multicenter, randomized, prospective study of 14-day ranitidine bismuth citrate- vs. lansoprazole-based triple therapy for the eradication of Helicobacter pylori in dyspeptic patients.
Turk J Gastroenterol. 2013; 24(4):316-21.TJ

Abstract

BACKGROUND/AIMS

Proton-pump inhibitor and ranitidine bismuth citrate-based triple regimens are the two recommended first line treatments for the eradication of Helicobacter pylori. We aimed to compare the effectiveness and tolerability of these two treatments in a prospective, multicentric, randomized study.

MATERIALS AND METHODS

Patients with dyspeptic complaints were recruited from 15 study centers. Presence of Helicobacter pylori was investigated by both histology and rapid urease test. The patients were randomized to either ranitidine bismuth citrate 400 mg bid plus amoxicillin 1 g bid plus clarithromycin 500 mg bid (n=149) or lansoprazole 30 mg bid plus amoxicillin 1 g bid plus clarithromycin 500 mg bid (n=130) treatment arm for 14 days. Adverse events have been recorded during the treatment phase. A 13 C urea breath test was performed 6 weeks after termination of treatment to assess the efficacy of the therapy. Eradication rate was calculated by intention-to-treat and per-protocol analysis.

RESULTS

Two hundred seventy-nine patients (123 male, 156 female) were eligible for randomization. In per-protocol analysis (n=247), Helicobacter pylori was eradicated with ranitidine bismuth citrate- and lansoprazole-based regimens in 74,6% and 69,2% of cases, respectively (p>0,05). Intention-to-treat analysis (n=279) revealed that eradication rates were 65,1% and 63,6% in ranitidine bismuth citrate and in lansoprazole-based regimens, respectively (p>0,05). Both regimes were well-tolerated, and no serious adverse event was observed during the study.

CONCLUSION

Ranitidine bismuth citrate-based regimen is at least as effective and tolerable as the classical proton-pump inhibitor-based regimen, but none of the therapies could achieve the recommendable eradication rate.

Authors+Show Affiliations

Acıbadem University School of Medicine, Department of Gastroenterology, Istanbul, Turkey.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 availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

24254262

Citation

Avşar, Erol, et al. "A Multicenter, Randomized, Prospective Study of 14-day Ranitidine Bismuth Citrate- Vs. Lansoprazole-based Triple Therapy for the Eradication of Helicobacter Pylori in Dyspeptic Patients." The Turkish Journal of Gastroenterology : the Official Journal of Turkish Society of Gastroenterology, vol. 24, no. 4, 2013, pp. 316-21.
Avşar E, Tiftikçi A, Poturoğlu S, et al. A multicenter, randomized, prospective study of 14-day ranitidine bismuth citrate- vs. lansoprazole-based triple therapy for the eradication of Helicobacter pylori in dyspeptic patients. Turk J Gastroenterol. 2013;24(4):316-21.
Avşar, E., Tiftikçi, A., Poturoğlu, S., Erzin, Y., Kocakaya, O., Dinçer, D., Yıldırım, B., Güliter, S., Türkay, C., Yılmaz, U., Onuk, M. D., Bölükbaş, C., Ellidokuz, E., Bektaş, A., Taşan, G., Aytuğ, N., Ateş, Y., & Kaymakoğlu, S. (2013). A multicenter, randomized, prospective study of 14-day ranitidine bismuth citrate- vs. lansoprazole-based triple therapy for the eradication of Helicobacter pylori in dyspeptic patients. The Turkish Journal of Gastroenterology : the Official Journal of Turkish Society of Gastroenterology, 24(4), 316-21.
Avşar E, et al. A Multicenter, Randomized, Prospective Study of 14-day Ranitidine Bismuth Citrate- Vs. Lansoprazole-based Triple Therapy for the Eradication of Helicobacter Pylori in Dyspeptic Patients. Turk J Gastroenterol. 2013;24(4):316-21. PubMed PMID: 24254262.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A multicenter, randomized, prospective study of 14-day ranitidine bismuth citrate- vs. lansoprazole-based triple therapy for the eradication of Helicobacter pylori in dyspeptic patients. AU - Avşar,Erol, AU - Tiftikçi,Arzu, AU - Poturoğlu,Sule, AU - Erzin,Yusuf, AU - Kocakaya,Ozan, AU - Dinçer,Dinç, AU - Yıldırım,Bulut, AU - Güliter,Sefa, AU - Türkay,Cansel, AU - Yılmaz,Uğur, AU - Onuk,Mehmet Derya, AU - Bölükbaş,Cengiz, AU - Ellidokuz,Ender, AU - Bektaş,Ahmet, AU - Taşan,Güralp, AU - Aytuğ,Necip, AU - Ateş,Yüksel, AU - Kaymakoğlu,Sabahattin, PY - 2013/11/21/entrez PY - 2013/11/21/pubmed PY - 2014/8/16/medline SP - 316 EP - 21 JF - The Turkish journal of gastroenterology : the official journal of Turkish Society of Gastroenterology JO - Turk J Gastroenterol VL - 24 IS - 4 N2 - BACKGROUND/AIMS: Proton-pump inhibitor and ranitidine bismuth citrate-based triple regimens are the two recommended first line treatments for the eradication of Helicobacter pylori. We aimed to compare the effectiveness and tolerability of these two treatments in a prospective, multicentric, randomized study. MATERIALS AND METHODS: Patients with dyspeptic complaints were recruited from 15 study centers. Presence of Helicobacter pylori was investigated by both histology and rapid urease test. The patients were randomized to either ranitidine bismuth citrate 400 mg bid plus amoxicillin 1 g bid plus clarithromycin 500 mg bid (n=149) or lansoprazole 30 mg bid plus amoxicillin 1 g bid plus clarithromycin 500 mg bid (n=130) treatment arm for 14 days. Adverse events have been recorded during the treatment phase. A 13 C urea breath test was performed 6 weeks after termination of treatment to assess the efficacy of the therapy. Eradication rate was calculated by intention-to-treat and per-protocol analysis. RESULTS: Two hundred seventy-nine patients (123 male, 156 female) were eligible for randomization. In per-protocol analysis (n=247), Helicobacter pylori was eradicated with ranitidine bismuth citrate- and lansoprazole-based regimens in 74,6% and 69,2% of cases, respectively (p>0,05). Intention-to-treat analysis (n=279) revealed that eradication rates were 65,1% and 63,6% in ranitidine bismuth citrate and in lansoprazole-based regimens, respectively (p>0,05). Both regimes were well-tolerated, and no serious adverse event was observed during the study. CONCLUSION: Ranitidine bismuth citrate-based regimen is at least as effective and tolerable as the classical proton-pump inhibitor-based regimen, but none of the therapies could achieve the recommendable eradication rate. SN - 2148-5607 UR - https://www.unboundmedicine.com/medline/citation/24254262/A_multicenter_randomized_prospective_study_of_14_day_ranitidine_bismuth_citrate__vs__lansoprazole_based_triple_therapy_for_the_eradication_of_Helicobacter_pylori_in_dyspeptic_patients_ L2 - http://www.turkjgastroenterol.org/eng/makale/2769/201/Full-Text DB - PRIME DP - Unbound Medicine ER -