title: Short-course therapy with amoxycillin-clarithromycin triple therapy for 10 days (ACT-10) eradicates Helicobacter pylori and heals duodenal ulcer. ACT-10 Study Group.
abstract: BACKGROUND
  Whilst the role of Helicobacter pylori eradication in managing duodenal ulcers has been established, consensus regarding the ideal regimen has not been achieved.
  
  
  METHODS
  Patients with H. pylori-positive active duodenal ulcer were randomly assigned to receive triple therapy with amoxycillin 1000 mg b.d. + clarithromycin 500 mg b.d. + omeprazole 20 mg daily for 10 days (ACT-10) or dual therapy with clarithromycin 500 mg t.d.s. + omeprazole 40 mg daily for 14 days (Dual). No additional acid suppression was provided following eradication therapy. Endoscopy, with biopsy for culture and histology, as well as 13C-urea breath testing (13C-UBT) were performed pre-treatment to assess H. pylori infection. H. pylori eradication was established at 4-6 weeks follow-up with culture (2 antral, 1 corpus biopsies), histology (2 antral biopsies), and 13C-UBT. Ulcer healing by endoscopy and change in clinical symptoms were also assessed at 4-6 weeks.
  
  
  RESULTS
  Two hundred and sixty-seven (267) patients were randomized to ACT-10 (n = 137) or Dual therapy (n = 130). By per-protocol and intention-to-treat analyses, H. pylori eradication at 4-6 weeks follow-up was 91% (115/127) and 88% (120/136), respectively, for ACT-10 patients and 59% (68/115) and 55% (72/130), respectively, for Dual therapy patients (P < 0.001 for both analyses). Ulcer healing was high in both treatment groups: ACT-10, 93% (118/127) and 90% (122/136), respectively; and Dual therapy, 91% (104/114) and 85% (111/130), respectively. Pre-treatment resistance to clarithromycin was low (4%, 8/214) as compared to metronidazole resistance which was over 40%. Emergence of resistance to clarithromycin was observed in 2% of patients receiving ACT-10 and in 25% of those receiving Dual therapy. ACT-10 and Dual therapy patients experienced similar rates of drug-related adverse events (33% vs. 32%, respectively) and discontinuation from therapy due to an adverse event (1.5% vs. 5%, respectively). More than 90% of patients were compliant with each prescribed medication.
  
  
  CONCLUSIONS
  In patients with active duodenal ulcer, a 10-day course of amoxycillin-clarithromycin-based triple therapy without additional acid suppression is highly effective in eradicating H. pylori and healing duodenal ulcer.
authors.affiliation: Department of Gastroenterology, Landeskrankenhaus-Universitaetskliniken, Graz, Austria.
authors.forename: H
authors.initials: H
authors.lastname: Wurzer
authors.forename: L
authors.initials: L
authors.lastname: Rodrigo
authors.forename: D
authors.initials: D
authors.lastname: Stamler
authors.forename: A
authors.initials: A
authors.lastname: Archambault
authors.forename: T
authors.initials: T
authors.lastname: Rokkas
authors.forename: N
authors.initials: N
authors.lastname: Skandalis
authors.forename: R
authors.initials: R
authors.lastname: Fedorak
authors.forename: F
authors.initials: F
authors.lastname: Bazzoli
authors.forename: E
authors.initials: E
authors.lastname: Hentschel
authors.forename: P
authors.initials: P
authors.lastname: Mora
authors.forename: A
authors.initials: A
authors.lastname: Archimandritis
authors.forename: F
authors.initials: F
authors.lastname: Megraud
mesh_terms: D000328:Adult; D000658:Amoxicillin / Q000627:therapeutic use*; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D002170:Canada; D017291:Clarithromycin / Q000627:therapeutic use*; D004311:Double-Blind Method; D004352:Drug Resistance, Microbial; D004359:Drug Therapy, Combination / Q000627:therapeutic use*; D004381:Duodenal Ulcer / Q000188:drug therapy* / Q000473:pathology; D004791:Enzyme Inhibitors / Q000627:therapeutic use; D005060:Europe; D005260:Female; D016481:Helicobacter Infections / Q000188:drug therapy*; D016480:Helicobacter pylori / Q000187:drug effects; D006801:Humans; D008297:Male; D008795:Metronidazole / Q000494:pharmacology; D008875:Middle Aged; D009853:Omeprazole / Q000627:therapeutic use; D010406:Penicillins / Q000627:therapeutic use*; D054328:Proton Pump Inhibitors
chemical_list: D000900:Anti-Bacterial Agents; D004791:Enzyme Inhibitors; D010406:Penicillins; D054328:Proton Pump Inhibitors; D008795:Metronidazole; D000658:Amoxicillin; D017291:Clarithromycin; D009853:Omeprazole