Triple therapy with clarithromycin, omeprazole, and amoxicillin for eradication of Helicobacter pylori in duodenal ulcer patients in Asia and Africa.
BACKGROUND
Studies assessing the efficacy of triple therapy containing clarithromycin and amoxicillin for the eradication of Helicobacter pylori infection and healing of duodenal ulcers in Asian and African countries are limited.


OBJECTIVE
To determine the efficacy and safety of 1-week triple therapy with omeprazole, amoxicillin and clarithromycin for eradicating H. pylori infection in patients with active duodenal ulcer living in Asian and African regions.


METHODS
This was an open-label, multicentre study in 11 centres in Asia and Africa. Patients with endoscopy-proven duodenal ulcer and who were H. pylori-positive were treated with clarithromycin 500 mg, omeprazole 20 mg, and amoxicillin 1000 mg, all given twice daily for 7 days. Upper endoscopy was repeated at week 6 to check for ulcer healing and H. pylori status.


RESULTS
A total of 117 patients were recruited. H. pylori eradication rates were 85% by per protocol analysis and 80% by intention-to-treat analysis. Ulcer healing was found in 94% of subjects (per protocol analysis). Clinical success, measured by change of pre-treatment ulcer symptoms, was strongly supported by complete resolution or improvement in 100% of the evaluable patients (per protocol analysis). Since treatment-related adverse events, when present, were largely mild or moderate, the triple therapy regimen was considered safe.


CONCLUSIONS
Seven-day triple therapy with omeprazole, amoxicillin, and clarithromycin was efficacious for treating Asian and African patients with duodenal ulcer disease associated with H. pylori infection, and the treatment regimen was well-tolerated.
Wong
B C
BC
Department of Medicine, University of Hong Kong, Queen Mary Hospital, Hong Kong. bcywong@hku.hk
Chang
F Y
FY
Abid
S
S
Abbas
Z
Z
Lin
B R
BR
Van Rensburg
C
C
Chen
P C
PC
Schneider
H
H
Simjee
A E
AE
Hamid
S S
SS
Seebaran
A
A
Zhang
J
J
Destefano
M
M
Lam
S K
SK
D000658:Amoxicillin / Q000009:adverse effects / Q000627:therapeutic use*; D000900:Anti-Bacterial Agents / Q000009:adverse effects / Q000627:therapeutic use*; D000897:Anti-Ulcer Agents / Q000009:adverse effects / Q000627:therapeutic use*; D017291:Clarithromycin / Q000009:adverse effects / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D004381:Duodenal Ulcer / Q000150:complications / Q000188:drug therapy*; D016481:Helicobacter Infections / Q000150:complications / Q000188:drug therapy*; D006723:Hong Kong; D006801:Humans; D009853:Omeprazole / Q000009:adverse effects / Q000627:therapeutic use*; D010154:Pakistan; D010406:Penicillins / Q000009:adverse effects / Q000627:therapeutic use*; D013019:South Africa; D013624:Taiwan; D016896:Treatment Outcome
D000900:Anti-Bacterial Agents; D000897:Anti-Ulcer Agents; D010406:Penicillins; D000658:Amoxicillin; D017291:Clarithromycin; D009853:Omeprazole