Objective: To determine whether eradication of
Helicobacter pylori infection reduces recurrence of
benign gastric ulceration.
Design: Randomised, double blind, controlled study.
Patients were randomised in a 1:2 ratio to either omeprazole 40 mg once
daily for eight weeks or the same treatment plus amoxycillin 750 mg
twice daily for weeks 7 and 8. A 12 month untreated follow up ensued.
Setting: Teaching and district general hospitals
between 1991 and 1994.
Subjects: 107 patients with benign gastric ulcer
associated with H pylori.
Main outcome measures: Endoscopically confirmed
relapse with gastric ulcer (analysed with life table methods), H
pylori eradication, and healing of gastric ulcers
(Mantel-Haenszel test).
Results: 172 patients were enrolled. Malignancy was
diagnosed in 19; 24 were not infected with H pylori;
four withdrew because of adverse events; and 18 failed to attend for
start of treatment, leaving 107 patients eligible for analysis (35
omeprazole alone; 72 omeprazole plus amoxycillin). In the
omeprazole/amoxycillin group 93% (67/72; 95% confidence interval 84%
to 98%) of gastric ulcers healed and 83% (29/35; 66% to 94%) in the
omeprazole group (P=0.103). Eradication of H pylori was
58% (42/72; 46% to 70%) and 6% (2/35; 1% to 19%) (P>0.001) and
relapse after treatment was 22% (16/72) and 49% (17/35) (life table
analysis, P>0.001), in the two groups, respectively. The recurrence
rates were 7% (3/44) after successful H pylori
eradication and 48% (30/63) in those who continued to be infected
(P>0.001).
Conclusions: Eradication of H pylori
reduces relapse with gastric ulcer over one year. Eradication rates
achieved with this regimen, however, are too low for it to be
recommended for routine use.
Leeds General Infirmary,
Leeds LS1 3EX
A T
R Axon, professor of gastroenterology
M
F Dixon, reader in gastrointestinal
pathology
Meath and Adelaide Hospitals,
Dublin 8,
Republic of
Ireland
C A Ó'Moráin, consultant
gastroenterologist
Rotherham District General
Hospital,
Rotherham S60 2UD
K D
Bardhan, consultant physician
Mater
Misericordiae Hospital,
Dublin 7,
Republic of Ireland
J P
Crowe, consultant gastroenterologist
Southern
General Hospital,
Glasgow G51 4TF
A D
Beattie, consultant physician
St Thomas'
Hospital,
London SE1 7EH
R P H
Thompson, consultant physician
Llandough
Hospital, South Glamorgan
CF64 2XX
P M
Smith, consultant
physician
Oldchurch Hospital,
Romford,
Essex RM7 0BE
F D
Hollanders, consultant physician and
gastroenterologist
St Mary's Hospital,
London W2 1NY
J
H Baron, consultant physician and
gastroenterologist
Leeds Public Health Laboratory,
Leeds LS15
7PR
D S Tompkins, director
Blackburn,
Hyndburn and Ribble Valley Health Care NHS Trust,
Blackburn,
Lancashire
BB2 3LR
D A F Lynch, consultant
physician
Astra Clinical Research Unit,
Edinburgh EH7 4HG
H Birrell, clinical research
scientist
K R W Gillon, head of
projects
Correspondence to: Professor Axon.