Omeprazole coupled with two antibiotics for Helicobacter pylori eradication and prevention of ulcer recurrence.
BACKGROUND
Numerous therapeutic trials aimed at eradicating Helicobacter pylori (HP) from the gastric mucosa and preventing ulcer recurrence have been carried out; however, an optimal treatment has not yet been established with carefully controlled randomized studies.


OBJECTIVE
The aim of our study was to evaluate the efficacy of an association of omeprazole (OM) coupled with two antibiotics in the eradication of HP and prevention of duodenal ulcer (DU) recurrence.


METHODS
One hundred and eighty three patients with active DU were randomized under double-blind conditions to receive either OM 20 mg for 4 wk plus amoxycillin 3 g daily and metronidazole 1 g daily during the 2nd and 3rd wk (91 patients, group A) or OM 20 mg for 4 wk plus matching placebo (92 patients, group B). Endoscopy was performed before and at the end of the 4-wk treatment as well as 2, 6, and 12 months later. Biopsies were taken from the duodenum, antrum, and gastric body at each endoscopic examination for HP histological detection and for evaluation of inflammatory changes according to the Sydney system.


RESULTS
After 4 wk, 84/86 patients (98%) of group A and 80/86 (93%) of group B were healed of their ulcers. The percentage of eradication was 90% in group A and 1% in group B. During a 12-month follow-up, DU relapsed in 4/63 (6%, including two of three reinfected cases) HP-eradicated group A patients, 4/8 (50%) HP-noneradicated group A patients, and 52/65 (80%) persistently HP-positive group B patients. Rapid, complete, and persistent suppression of gastroduodenitis activity and gastric surface epithelium lesions was observed in most HP-eradicated group A patients, whereas a transient decrease of bacterial colonization and inflammatory scores in the antrum and a transient worsening of corpus gastritis were found in group B patients.


CONCLUSIONS
The combined therapy with amoxycillin, metronidazole, and omeprazole is highly effective in both HP eradication and prevention of duodenal ulcer recurrence.
Bianchi Porro
G
G
Gastrointestinal Unit, L. Sacco University Hospital, Milan, Italy.
Lazzaroni
M
M
Bargiggia
S
S
Maconi
G
G
Trespi
E
E
Perego
M
M
Alvisi
C
C
Villani
L
L
Luinetti
O
O
Fiocca
R
R
Franceschi
M
M
Cesana
B
B
Solcia
E
E
D000328:Adult; D000658:Amoxicillin / Q000008:administration & dosage*; D000900:Anti-Bacterial Agents / Q000008:administration & dosage*; D000897:Anti-Ulcer Agents / Q000008:administration & dosage*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D004381:Duodenal Ulcer / Q000453:epidemiology / Q000382:microbiology* / Q000517:prevention & control*; D005260:Female; D005500:Follow-Up Studies; D005756:Gastritis / Q000188:drug therapy* / Q000453:epidemiology / Q000382:microbiology*; D016481:Helicobacter Infections / Q000188:drug therapy* / Q000453:epidemiology; D016480:Helicobacter pylori / Q000302:isolation & purification*; D006801:Humans; D008297:Male; D008795:Metronidazole / Q000008:administration & dosage*; D009853:Omeprazole / Q000008:administration & dosage*; D012008:Recurrence; D013997:Time Factors
D000900:Anti-Bacterial Agents; D000897:Anti-Ulcer Agents; D008795:Metronidazole; D000658:Amoxicillin; D009853:Omeprazole