Dual therapy with high or low doses of omeprazole does not achieve an acceptable rate of Helicobacter pylori eradication in duodenal ulcer patients. A multicentre randomized long-term detailed study.
BACKGROUND
It has been reported that dual therapy with high doses of omeprazole and amoxycillin proves efficient for Helicobacter pylori eradication.


OBJECTIVE
To compare the efficacy, safety and tolerability of eradicating regimens with omeprazole/amoxycillin.


METHODS
In this randomized multicentre study, 267 duodenal ulcer patients were treated for 2 weeks with omeprazole 40 bid (Group A) or 20 mg bid (Group B), respectively, and with amoxycillin 0.5 g. qid followed by 4 weeks of 20 mg omeprazole om. Helicobacter pylori status was assessed by both histology and urease test in the antrum and the corpus. The patients were then followed-up for 9 months.


RESULTS
Helicobacter pylori infection was cured in 62.9% of group A (95% CI: 53.8-71.4) and in 44.8% of group B (95% CI: 35.6-54.3; p = 0.007). Healing was achieved in 91.9% of patients in group A (95% CI:85.7-96.1), and in 87.9% of patients in group B (95% CI:80.6-93.2). The estimated probability of being in ulcer remission for cured patients was 0.95 (95% CI: 0.90-0.99) and for the not cured was 0.41 (95% CI: 0.24-0.59; p = 0.0001). However, between the two treatment groups no significant differences in symptom relief or ulcer recurrence were observed. Both regimens were well tolerated with minor side-effects occurring likewise within the two groups. At two months in cured patients antral histology revealed a total (group A + B) prevalence of 13.7% of active chronic gastritis.


CONCLUSIONS
This long-term, large-size study clearly indicates that dual therapy does not represent a truly effective eradication therapy and this regime cannot be recommended.
Maconi
G
G
Gastrointestinal Unit, L. Sacco University Hospital, Milan, Italy.
Bordi
C
C
Cesana
B
B
Pilato
F P
FP
Damilano
I
I
Franceschi
M
M
Annibale
B
B
D000293:Adolescent; D000328:Adult; D000368:Aged; D000658:Amoxicillin / Q000008:administration & dosage*; D000897:Anti-Ulcer Agents / Q000008:administration & dosage*; D002908:Chronic Disease; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D004381:Duodenal Ulcer / Q000188:drug therapy* / Q000382:microbiology; D005260:Female; D005756:Gastritis / Q000473:pathology; D016481:Helicobacter Infections / Q000175:diagnosis / Q000188:drug therapy*; D016480:Helicobacter pylori / Q000187:drug effects* / Q000302:isolation & purification; D006801:Humans; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D009853:Omeprazole / Q000008:administration & dosage*; D010406:Penicillins / Q000008:administration & dosage*; D011379:Prognosis; D011706:Pyloric Antrum / Q000473:pathology; D012008:Recurrence; D012044:Regression Analysis; D016896:Treatment Outcome
D000897:Anti-Ulcer Agents; D010406:Penicillins; D000658:Amoxicillin; D009853:Omeprazole