title: Pilot study: miscellaneous therapy is highly successful for Helicobacter pylori eradication.
abstract: BACKGROUND
  Success in H. pylori eradication with conventional therapies has decreased to unacceptable levels (≤80%). New schemes of combined treatment are currently needed.
  
  
  OBJECTIVE
  To test a miscellaneous therapy for H. pylori eradication.
  
  
  METHODS
  Open-label, pilot, single-centre and prospective study. Patients received a 15-day treatment scheme that consisted of 5 initial days of lansoprazole 30 mg b.d., amoxicillin 1 g b.d., and metronidazole 500 mg t.d.s.; days 6 to 10: lansoprazole 30 mg q.d.s. and metronidazole 500 mg t.d.s.; days 11 to 15: lansoprazole 30 mg b.d., clarithromycin 500 mg b.d. and metronidazole 500 mg t.d.s. Each patient underwent an upper endoscopy before treatment and a second follow-up endoscopy at least 4 weeks after therapy. Success was defined on the basis of an eradication rate following a per-protocol analysis ≥95%. Biopsies before and after therapy were obtained for histological evaluation and rapid urease test.
  
  
  RESULTS
  One hundred and twenty-two patients were enrolled and 118 patients completed the study. The eradication rate for H. pylori with miscellaneous therapy was 94% (confidence Interval (CI) 95%, 90-98.3%) in the per-protocol analysis (PP) and 91% (95% CI, 86-96%) in the intention-to-treat (ITT) analysis. Adherence to treatment was 96% (113 patients). Among patients who completed treatment, 55% presented adverse events, mainly nausea and abdominal pain.
  
  
  CONCLUSIONS
  A miscellaneous therapy, based on the combination of multiple medications in high doses for 2 weeks, and with gastric pH elevation, is a highly effective treatment as a first-line therapy for the eradication of H. pylori.
authors: Department of Gastroenterology and Hepatology, Fundación Santa Fe de Bogotá y Universidad de los Andes, Facultad de Medicina, Bogotá, Colombia. fersi17@yahoo.com
authors: F
authors: F
authors: Sierra
authors: J D
authors: JD
authors: Forero
authors: M
authors: M
authors: Rey
authors: M L
authors: ML
authors: Botero
authors: A
authors: A
authors: Cárdenas
mesh_terms: D000328:Adult; D000658:Amoxicillin / Q000627:therapeutic use; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D017291:Clarithromycin / Q000627:therapeutic use; D004359:Drug Therapy, Combination / Q000379:methods; D005260:Female; D005745:Gastric Acidity Determination; D005756:Gastritis / Q000188:drug therapy* / Q000382:microbiology; D005773:Gastroscopy; D016481:Helicobacter Infections / Q000188:drug therapy* / Q000382:microbiology; D016480:Helicobacter pylori / Q000187:drug effects* / Q000302:isolation & purification; D006801:Humans; D006863:Hydrogen-Ion Concentration; D064747:Lansoprazole / Q000627:therapeutic use; D008297:Male; D008795:Metronidazole / Q000627:therapeutic use; D008875:Middle Aged; D010437:Peptic Ulcer / Q000188:drug therapy* / Q000382:microbiology; D010865:Pilot Projects; D011446:Prospective Studies; D054328:Proton Pump Inhibitors / Q000627:therapeutic use*; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
chemical_list: D000900:Anti-Bacterial Agents; D054328:Proton Pump Inhibitors; D064747:Lansoprazole; D008795:Metronidazole; D000658:Amoxicillin; D017291:Clarithromycin