title: Greater than 95% success with 14-day bismuth quadruple anti- Helicobacter pylori therapy: a pilot study in US Hispanics.
abstract: BACKGROUND
  A combination capsule of bismuth, metronidazole, and tetracycline plus omeprazole given as 10-day therapy has an overall effectiveness of 92-93% in per-protocol analysis (Grade B) with eradication of 86-91% of metronidazole-resistant Helicobacter pylori. This study aimed to explore whether extending the duration to 14 days would improve overall effectiveness per protocol to ≥95% (Grade A) in a population in which metronidazole resistance was anticipated to exist.
  
  
  METHODS
  A one-arm, open-label pilot study of H. pylori-infected, asymptomatic/mildly dyspeptic adults, Hispanic residents of El Paso, Texas, received a 14-day course of omeprazole, plus the combination capsule. We cultured and Gram-stained specimens obtained using a minimally invasive orogastric brush. Helicobacter pylori status was determined by (13)C-urea breath test at 4 or more weeks post-therapy.
  
  
  RESULTS
  Forty-seven subjects (7 men and 40 women, average age 42 years) were entered. The per-protocol effectiveness was 97.1% (33/34) (95% mid-P CI: 86.3, 99.9); 100% of metronidazole-resistant strains were eradicated. Side effects were mild and self-limited but contributed to nonadherence. Therapy taken for <10 days was more likely to result in eradication failure (p < .001). Office-based orogastric brushing was well tolerated; positive cultures were obtained in 95%. Gram staining showed H. pylori-like forms in all specimens.
  
  
  CONCLUSIONS
  This pilot study supports the concept that 14-day OBMT therapy is likely to be more efficacious for H. pylori eradication (Grade A, PP basis) than a 10-day course where metronidazole resistance is suspected. If confirmed, 14 days should be recommended in populations where metronidazole resistance is common.
authors.affiliation: University of Texas-Houston School of Public Health, El Paso Regional Campus, El Paso, TX 79902, USA.
authors.forename: Cesar O
authors.initials: CO
authors.lastname: Salazar
authors.forename: Victor M
authors.initials: VM
authors.lastname: Cardenas
authors.forename: Rita K
authors.initials: RK
authors.lastname: Reddy
authors.forename: Delfina C
authors.initials: DC
authors.lastname: Dominguez
authors.forename: Lindsey K
authors.initials: LK
authors.lastname: Snyder
authors.forename: David Y
authors.initials: DY
authors.lastname: Graham
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000900:Anti-Bacterial Agents / Q000008:administration & dosage*; D001729:Bismuth / Q000008:administration & dosage*; D001944:Breath Tests; D004359:Drug Therapy, Combination / Q000379:methods; D005260:Female; D016481:Helicobacter Infections / Q000188:drug therapy*; D016480:Helicobacter pylori / Q000302:isolation & purification; D006630:Hispanic or Latino; D006801:Humans; D008297:Male; D008795:Metronidazole / Q000008:administration & dosage; D008875:Middle Aged; D009853:Omeprazole / Q000008:administration & dosage; D010865:Pilot Projects; D013752:Tetracycline / Q000008:administration & dosage; D013781:Texas; D013997:Time Factors; D016896:Treatment Outcome; D014508:Urea / Q000032:analysis
chemical_list: D000900:Anti-Bacterial Agents; D008795:Metronidazole; D014508:Urea; D013752:Tetracycline; D009853:Omeprazole; D001729:Bismuth