title: Nonbismuth quadruple "concomitant" therapy versus standard triple therapy, both of the duration of 10 days, for first-line H. pylori eradication: a randomized trial.
abstract: OBJECTIVE
  To compare the efficacy, compliance, and tolerability of a quadruple, nonbismuth-containing concomitant therapy with standard triple therapy, both of the duration of 10 days, for Helicobacter pylori eradication.
  
  
  BACKGROUND
  Eradication rates obtained with standard therapies are declining as antibiotic resistance becomes more prevalent worldwide. New first-line treatment strategies are needed.
  
  
  METHODS
  Two hundred fifty-seven patients with H. pylori infection were included in the study. Patients were randomized to receive 10-day concomitant therapy comprising esomeprazole 40 mg, amoxicillin 1000 mg, clarithromycin 500 mg, and metronidazole 500 mg, all bid, or 10-day standard triple therapy comprising of esomeprazole 40 mg, amoxicillin 1000 mg, and clarithromycin 500 mg, all bid. Cure rates were defined as a negative 13C urea breath test 8 weeks after the start of treatment.
  
  
  RESULTS
  Two hundred forty-six patients completed the study. The intention-to-treat cure rates were 90.5% [95% confidence interval (CI): 84.1%-95%] and 73.8% (95%CI, 65.6%-80.7%), whereas the per protocol cure rates were 93.3% (95%CI, 87.2% -97.1%) and 78.5% (95%CI, 70.3%-84.9%), respectively. The eradication rate was significantly higher in the concomitant group compared with the triple therapy group in both the intention-to-treat (P=0.0006) and per protocol (P=0.0014) populations. Adverse events were generally of mild/moderate intensity and did not interfere significantly with compliance, which was excellent for both treatment groups (96.6% and 98.5%, respectively, P=0.44).
  
  
  CONCLUSIONS
  Performance of a 10-day conventional triple regimen is suboptimal. A 10-day concomitant regimen achieved a significantly higher eradication rate and seems to be an effective, safe, and well-tolerated treatment option for H. pylori eradication.
authors.affiliation: Gastroenterology Department, Athens Medical, P. Faliron Hospital, Athens, Greece.
authors.forename: Sotirios
authors.initials: S
authors.lastname: Georgopoulos
authors.forename: Vasilios
authors.initials: V
authors.lastname: Papastergiou
authors.forename: Elias
authors.initials: E
authors.lastname: Xirouchakis
authors.forename: Foteini
authors.initials: F
authors.lastname: Laoudi
authors.forename: Philipos
authors.initials: P
authors.lastname: Lisgos
authors.forename: Charikleia
authors.initials: C
authors.lastname: Spiliadi
authors.forename: Nikitas
authors.initials: N
authors.lastname: Papantoniou
authors.forename: Stylianos
authors.initials: S
authors.lastname: Karatapanis
mesh_terms: D000328:Adult; D000658:Amoxicillin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001944:Breath Tests; D017291:Clarithromycin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D004359:Drug Therapy, Combination; D064098:Esomeprazole / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D005260:Female; D005500:Follow-Up Studies; D016481:Helicobacter Infections / Q000188:drug therapy*; D016480:Helicobacter pylori / Q000302:isolation & purification*; D006801:Humans; D008297:Male; D055118:Medication Adherence; D008795:Metronidazole / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D008875:Middle Aged; D011446:Prospective Studies; D016896:Treatment Outcome; D014508:Urea / Q000032:analysis
chemical_list: D000900:Anti-Bacterial Agents; D008795:Metronidazole; D000658:Amoxicillin; D014508:Urea; D017291:Clarithromycin; D064098:Esomeprazole