TY - JOUR
TI - Short-course therapy with amoxycillin-clarithromycin triple therapy for
10 days (ACT-10) eradicates Helicobacter pylori and heals duodenal ulcer
AU - Wurzer, H
AU - Rodrigo, L
AU - Stamler, D
AU - Archambault, A
AU - Rokkas, T
AU - and Skandalis, N
AU - Fedorak, R
AU - Bazzoli, F
AU - Hentschel, E and
AU - Mora, P
AU - Archimandritis, A
AU - Megraud, F
JO - Alimentary Pharmacology & Therapeutics
PY - 1997
VL - 11
TODO - 5
SP - 943-952
PB - Blackwell Science Ltd Oxford, UK
SN - 0269-2813, 1365-2036
TODO - 10.1046/j.1365-2036.1997.00223.x
TODO - null
TODO - 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 C-13-urea breath testing (C-13-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 C-13-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, Pretreatment 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,
Conclusion: 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.
ER -