US double-blind, controlled trials of omeprazole and amoxycillin for treatment of Helicobacter pylori.
BACKGROUND
Widely variable Helicobacter pylori eradication rates have been reported with omeprazole/amoxycillin dual therapy. We present the first US double-blind, controlled trials of this dual therapy.


METHODS
Three separate studies were performed: Studies 1 and 2 included patients with an active duodenal ulcer and Study 3 included patients with a documented history of duodenal ulcer. H. pylori eradication regimens in all studies were omeprazole plus amoxycillin vs. omeprazole vs. amoxycillin for 2 weeks. Doses in Study 1 were omeprazole 40 mg b.d. and amoxycillin 500 mg t.d.s., and in Studies 2 and 3 they were omeprazole 20 mg b.d. and amoxycillin 1 g t.d.s. Endoscopic biopsy tests were used for H. pylori diagnosis, and testing for H. pylori eradication was done at least 4 weeks after the completion of therapy. Amoxycillin sensitivities were performed in Study 2.


RESULTS
Intention-to-treat (ITT) and per protocol (PP) analyses showed that eradication rates with omeprazole/amoxycillin [ITT: 39%, 40%, 46% (n = 72, 62, 48); PP: 50%, 46%, 54% (n = 54, 52, 37)] were significantly greater than monotherapy with either omeprazole (ITT: 0-4%); PP: 0-5%) or amoxycillin (ITT: 2-5%; PP: 0-11%). No patients taking the dual therapy discontinued therapy due to adverse events. Amoxycillin resistance was not seen at baseline (n = 76) or after amoxycillin therapy (n = 56).


CONCLUSIONS
Omeprazole/amoxycillin dual therapy is well tolerated but the eradication rate which can be expected in the USA is at best about 50%.
U.S.C. School of Medicine, Los Angeles, California 90033, USA.
L
L
Laine
E
E
Johnson
L
L
Suchower
P
P
Ronca
C
C
Hwang
G
G
Neil
D000284:Administration, Oral; D000328:Adult; D000658:Amoxicillin / Q000627:therapeutic use*; D000897:Anti-Ulcer Agents / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D004381:Duodenal Ulcer / Q000382:microbiology; D005260:Female; D016481:Helicobacter Infections / Q000188:drug therapy*; D016480:Helicobacter pylori / Q000187:drug effects*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009853:Omeprazole / Q000627:therapeutic use*; D010406:Penicillins / Q000627:therapeutic use*; D016896:Treatment Outcome
D000897:Anti-Ulcer Agents; D010406:Penicillins; D000658:Amoxicillin; D009853:Omeprazole