title: 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.
abstract: OBJECTIVE
  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.
  
  
  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.
  
  
  CONCLUSIONS
  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.affiliation: Acıbadem University School of Medicine, Department of Gastroenterology, Istanbul, Turkey.
authors.forename: Erol
authors.initials: E
authors.lastname: Avşar
authors.forename: Arzu
authors.initials: A
authors.lastname: Tiftikçi
authors.forename: Sule
authors.initials: S
authors.lastname: Poturoğlu
authors.forename: Yusuf
authors.initials: Y
authors.lastname: Erzin
authors.forename: Ozan
authors.initials: O
authors.lastname: Kocakaya
authors.forename: Dinç
authors.initials: D
authors.lastname: Dinçer
authors.forename: Bulut
authors.initials: B
authors.lastname: Yıldırım
authors.forename: Sefa
authors.initials: S
authors.lastname: Güliter
authors.forename: Cansel
authors.initials: C
authors.lastname: Türkay
authors.forename: Uğur
authors.initials: U
authors.lastname: Yılmaz
authors.forename: Mehmet Derya
authors.initials: MD
authors.lastname: Onuk
authors.forename: Cengiz
authors.initials: C
authors.lastname: Bölükbaş
authors.forename: Ender
authors.initials: E
authors.lastname: Ellidokuz
authors.forename: Ahmet
authors.initials: A
authors.lastname: Bektaş
authors.forename: Güralp
authors.initials: G
authors.lastname: Taşan
authors.forename: Necip
authors.initials: N
authors.lastname: Aytuğ
authors.forename: Yüksel
authors.initials: Y
authors.lastname: Ateş
authors.forename: Sabahattin
authors.initials: S
authors.lastname: Kaymakoğlu
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000658:Amoxicillin / Q000008:administration & dosage* / Q000009:adverse effects; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000009:adverse effects; D001729:Bismuth / Q000008:administration & dosage* / Q000009:adverse effects; D017291:Clarithromycin / Q000008:administration & dosage / Q000009:adverse effects; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D004415:Dyspepsia / Q000188:drug therapy* / Q000382:microbiology; D016145:Endoscopy, Digestive System; D005260:Female; D016481:Helicobacter Infections / Q000175:diagnosis / Q000188:drug therapy*; D016480:Helicobacter pylori / Q000187:drug effects*; D006635:Histamine H2 Antagonists / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D064747:Lansoprazole / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D054328:Proton Pump Inhibitors / Q000008:administration & dosage / Q000009:adverse effects; D011899:Ranitidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000900:Anti-Bacterial Agents; D006635:Histamine H2 Antagonists; D054328:Proton Pump Inhibitors; D064747:Lansoprazole; C073340:ranitidine bismuth citrate; D000658:Amoxicillin; D011899:Ranitidine; D017291:Clarithromycin; D001729:Bismuth