Comparison of lansoprazole-based triple and dual therapy for treatment of Helicobacter pylori-related duodenal ulcer: an Asian multicentre double-blind randomized placebo controlled study.
BACKGROUND
[corrected] In Asian countries with limited resources, clarithromycin-based triple therapy may not be readily available. There are also few direct comparisons of different regimens in Asia.


OBJECTIVE
To compare two lansoprazole-based non-clarithromycin triple therapies and one dual therapy in a prospective double-blind placebo-controlled study of Helicobacter pylori eradication and duodenal ulcer healing.


METHODS
Fourteen centres in Asia participated in this study. Patients with acute duodenal ulcer who were H. pylori-positive were recruited. They were randomized to receive: (a) lansoprazole 30 mg b.d., amoxycillin 1 g b.d. and metronidazole 500 mg b.d. for 2 weeks (LAM-2 W), or (b) LAM for 1 week and placebo (LAM-1 W), or (c) lansoprazole 30 mg b.d., amoxycillin 1 g b.d. and placebo for 2 weeks (LA-2 W). Upper endoscopy was repeated at week 6 to check for duodenal ulcer healing. Symptoms and side-effects were recorded.


RESULTS
A total of 228 patients were recruited, and two patients took less than 50% of the drugs. H. pylori eradication rates (intention-to-treat) were 68 out of 82 (83%) with LAM-2 W, 55 out of 71 (78%) with LAM-1 W and 43 out of 75 (57%) with LA-2 W. There were significant differences (P=0. 001) in eradication rates when comparing either LAM-2 W or LAM-1 W with LA-2 W. The eradication rate in patients with metronidazole resistant H. pylori strains were significantly lower than those with metronidazole sensitive strains (P=0.0001). The duodenal ulcer healing rates at week 6 were 85%, 85% and 72% in LAM-2 W, LAM-1 W and LA-2 W, respectively (P=0.065). Side-effects occurred in 13%, 11% and 9% in LAM-2 W, LAM-1 W and LA-2 W, respectively. H. pylori eradication and initial ulcer size were factors affecting duodenal ulcer healing.


CONCLUSIONS
This Asian multicentre study showed that 1-week lansoprazole-based triple therapy without clarithromycin has similar efficacy in H. pylori eradication and ulcer healing compared with a 2-week regimen. Both triple therapies were significantly better than dual therapy in H. pylori eradication. Therefore, 1-week lansoprazole-based triple therapy is as safe and effective as 2-week therapy in eradication of H. pylori infection and healing of duodenal ulcer in these Asian centres.
Wong
B C
BC
Department of Medicine, University of Hong Kong, Hong Kong, China.
Xiao
S D
SD
Hu
F L
FL
Qian
S C
SC
Huang
N X
NX
Li
Y Y
YY
Hu
P J
PJ
Daldiyono
Manan
C
C
Lesmana
L
L
Carpio
R E
RE
Perez
J Y
JY
Fock
K M
KM
Kachintorn
U
U
Phornphutkul
K
K
Kullavanijaya
P
P
Ho
J
J
Lam
S K
SK
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000658:Amoxicillin / Q000009:adverse effects / Q000627:therapeutic use; D000897:Anti-Ulcer Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001208:Asia; D001944:Breath Tests; D017291:Clarithromycin / Q000009:adverse effects / Q000627:therapeutic use; D004311:Double-Blind Method; D004352:Drug Resistance, Microbial / Q000502:physiology; D004359:Drug Therapy, Combination; D004381:Duodenal Ulcer / Q000188:drug therapy*; D004724:Endoscopy; D005260:Female; D016481:Helicobacter Infections / Q000188:drug therapy*; D016480:Helicobacter pylori / Q000187:drug effects; D006801:Humans; D064747:Lansoprazole; D008297:Male; D008795:Metronidazole / Q000009:adverse effects / Q000627:therapeutic use; D008875:Middle Aged; D009853:Omeprazole / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D012307:Risk Factors; D014508:Urea / Q000032:analysis
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000897:Anti-Ulcer Agents; D064747:Lansoprazole; D008795:Metronidazole; D000658:Amoxicillin; D014508:Urea; D017291:Clarithromycin; D009853:Omeprazole