title: Helicobacter pylori eradication therapy success regarding different treatment period based on clarithromycin or metronidazole triple-therapy regimens.
abstract: BACKGROUND
  The study compares the eradication success of standard first-line triple therapies of different durations (7, 10, and 14 days).
  
  
  METHODS
  A total of 592 naive Helicobacter pylori-positive patients were randomized to receive pantoprazole, amoxicillin, and clarithromycin or metronidazole for 14 days (PACl14 or PAM14), 10 days (PACl10 or PAM10), or 7 days (PACl7 or PAM7). H. pylori eradication was assessed by histological, microbiological, and rapid urease examination.
  
  
  RESULTS
  The intention-to-treat (ITT) and per-protocol (PP) analyses have shown no overall statistically significant differences between the eradication success of PACl and PAM treatment groups (ITT p = .308, PP p = .167). Longer treatment duration has yielded statistically significant increase in eradication success for clarithromycin (ITT p = .004; PP p = .004) and metronidazole (ITT p = .010; PP p = .034) based regimens. Namely, PACl10, PACl14, and PAM14 protocols resulted in eradication success exceeding 80% in ITT and 90% in PP analysis. Primary resistance to clarithromycin and metronidazole equals 8.2% and 32.9%, respectively. Prolonging the metronidazole-based treatment duration in patients with resistant strains resulted in statistically significant higher eradication success.
  
  
  CONCLUSIONS
  For all antimicrobial combinations, 14 days protocols have led to a significant increase of H. pylori eradication success when compared to 10 and 7 days, respectively. Prolonging the treatment duration can overcome the negative effect of metronidazole resistance. Only PAM14, PACl10 protocols achieved ITT success > 80% and should be recommended as the first line eradication treatment in Croatia.
authors.affiliation: University Hospital Merkur, Zagreb, Croatia. tajana_filipec@yahoo.com
authors.forename: Tajana
authors.initials: T
authors.lastname: Filipec Kanizaj
authors.forename: Miroslava
authors.initials: M
authors.lastname: Katicic
authors.forename: Bruno
authors.initials: B
authors.lastname: Skurla
authors.forename: Mirjana
authors.initials: M
authors.lastname: Ticak
authors.forename: Vanda
authors.initials: V
authors.lastname: Plecko
authors.forename: Smilja
authors.initials: S
authors.lastname: Kalenic
mesh_terms: D000328:Adult; D000368:Aged; D000658:Amoxicillin / Q000008:administration & dosage / Q000009:adverse effects; D000900:Anti-Bacterial Agents / Q000008:administration & dosage* / Q000009:adverse effects; D017291:Clarithromycin / Q000008:administration & dosage* / Q000009:adverse effects; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D016481:Helicobacter Infections / Q000188:drug therapy* / Q000382:microbiology; D016480:Helicobacter pylori / Q000187:drug effects; D006801:Humans; D008297:Male; D008795:Metronidazole / Q000008:administration & dosage* / Q000009:adverse effects; D008875:Middle Aged; D016896:Treatment Outcome
chemical_list: D000900:Anti-Bacterial Agents; D008795:Metronidazole; D000658:Amoxicillin; D017291:Clarithromycin