title: A randomized clinical trial to determine the efficacy of regimens containing clarithromycin, metronidazole, and amoxicillin among histologic subgroups for Helicobacter pylori eradication in a developing country.
abstract: BACKGROUND
  Most treatments deemed effective for Helicobacter pylori eradication in developed countries are less effective in developing countries. Regimens containing clarithromycin, metronidazole, and amoxicillin seem efficacious despite antibiotic resistance, and may be a viable option in developing countries.
  
  
  METHODS
  We evaluated the efficacy of a 14-day regimen with 500 mg clarithromycin b.i.d., 500 mg metronidazole t.i.d., and 500 mg amoxicillin t.i.d. (with and without a proton pump inhibitor), and a 10-day regimen containing 500 mg clarithromycin b.i.d., 1 g amoxicillin b.i.d., and 20 mg omeprazole b.i.d. in Pasto, Colombia, using a randomized, single-blind design stratified by presence of atrophic gastritis.
  
  
  RESULTS
  H. pylori was eradicated in 86.8% and 85.3% of the participants randomized to a clarithromycin-metronidazole-amoxicillin and clarithromycin-amoxicillin-omeprazole regimens, respectively (p = .79). Per-protocol analyses indicated greater efficacy for the clarithromycin-metronidazole-amoxicillin regimen (97%) versus the clarithromycin-amoxicillin-omeprazole regimen (86%) (p = .04), particularly for participants with atrophic gastritis (clarithromycin-metronidazole-amoxicillin = 100%, clarithromycin-amoxicillin-omeprazole = 81%; p = .02). Adverse events were mild, but adverse event-related non-compliance was reported more often for regimens containing clarithromycin, metronidazole, and amoxicillin.
  
  
  CONCLUSIONS
  Our results suggest that an eradication rate of > 85% can be achieved with 14-day clarithromycin, metronidazole, and amoxicillin and 10-day clarithromycin, amoxicillin, and omeprazole regimens in Pasto, Colombia. The regimens containing clarithromycin, metronidazole, and amoxicillin appear to be superior to the clarithromycin, amoxicillin, and omeprazole regimen for compliant participants and those with atrophic gastritis. Our findings provide treatment options for a population in a developing country with a high prevalence of H. pylori infections and antibiotic resistance.
authors.affiliation: Department of Epidemiology, University of North Texas Health Science Center, Fort Worth, TX, USA. lfischba@hsc.unt.edu
authors.forename: Lori Ann
authors.initials: LA
authors.lastname: Fischbach
authors.forename: Luis Eduardo
authors.initials: LE
authors.lastname: Bravo
authors.forename: Guillermo Rosero
authors.initials: GR
authors.lastname: Zarama
authors.forename: Juan Carlos
authors.initials: JC
authors.lastname: Bravo
authors.forename: Rohit Priyadarshi
authors.initials: RP
authors.lastname: Ojha
authors.forename: Priyadarshi Rohit
authors.initials: PR
authors.lastname: Ojha
authors.forename: Elisa Lynne
authors.initials: EL
authors.lastname: Priest
authors.forename: Tito
authors.initials: T
authors.lastname: Collazos
authors.forename: Alba Lucy
authors.initials: AL
authors.lastname: Casabon
authors.forename: Lucy Alba
authors.initials: LA
authors.lastname: Casabon
authors.forename: Lorena Zambrano
authors.initials: LZ
authors.lastname: Guerrero
authors.forename: Karan P
authors.initials: KP
authors.lastname: Singh
authors.forename: P Karan
authors.initials: PK
authors.lastname: Singh
authors.forename: Pelayo
authors.initials: P
authors.lastname: Correa
mesh_terms: D000328:Adult; D000368:Aged; D000658:Amoxicillin / Q000008:administration & dosage* / Q000009:adverse effects; D000900:Anti-Bacterial Agents / Q000008:administration & dosage; D017291:Clarithromycin / Q000008:administration & dosage* / Q000009:adverse effects; D015331:Cohort Studies; D003105:Colombia; D003906:Developing Countries; D004359:Drug Therapy, Combination; D005260:Female; D005757:Gastritis, Atrophic / Q000188:drug therapy / Q000473:pathology; D016481:Helicobacter Infections / Q000188:drug therapy* / Q000473:pathology; D016480:Helicobacter pylori / Q000187:drug effects; D006801:Humans; D008297:Male; D008795:Metronidazole / Q000008:administration & dosage* / Q000009:adverse effects; D008875:Middle Aged; D016037:Single-Blind Method; D016896:Treatment Outcome
chemical_list: D000900:Anti-Bacterial Agents; D008795:Metronidazole; D000658:Amoxicillin; D017291:Clarithromycin