Læknablaðið : fylgirit - 01.06.1992, Page 63

LÆKNABLAÐIÐ/FYLGIRIT 21
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EFFICACY OF SUCRALFATE 1N THE TREATMENT OF
NON-ULCER DYSPEPSIA. A DOUBLE-BLIND PLACEBO
CONTROLLED STUDY.
Hallgrimur Guðjónsson, Einar Oddsson,Siguróur
Björnsson,ólafur Gunnlaugsson, Ásgeir Theodórs,
Tómas A.JÓnasson, Olaf Bonnevie, Bjarni Þjóó-
leifsson. Dept.of Medicine, Landspítalinn.
The object of the study was to assess the effi-
cacy of sucralfate in the treatment of non-
ulcer dyspepsia (NUD).
MATERIAL AND METHODS: The diagnosis of NUD was
made by exclusion. All patients underwent
upper GI endoscopy for exclusion of malignancy
or ulcer and abdominal ultrasound and blood
tests were done as clinically indicated.
Patients with a history of peptic ulcer were
not included. Symptomatic assessment was done
at the beginning and end of the study. The
patients registered on a diary card their most
prominent dyspeptic symptoms, whether they im-
proved, were unchanged or worse. The study
was double-blind. Placebo or sucralfate
(antepsin) 1 gr was given half an hour betwæn
meals (x3) and before sleep for 3 weeks.
RESULTS: Over a 2 year period 104 patients
were included in the study, 56 received sucral-
fate and 48 placebo. Nine patients were ex-
cluded because of poor compliance or side
effects, 6 from the sucralfate group and 3
from the placebo group. The sucralfate (34 pt)
and placebo (32 pt) groups were comparable in
symptom and clinical parameters.
Global assessment of symptoms showed that in
the sucralfate group 34 improved (68%), 11
were unchanged and 5 were worse. In the
placebo group 31 improved (69%), 11 were un-
changed and 3 were worse. There was no stat-
istical difference between the groups.
Further analysis according to sex or initial
severity of symptoms showed no significant
difference.
CONCLUSIONS: A three week course of sucral-
fate 1 gr x 4 in patients with non-ulcer
dyspepsia did not show symptomatic improve-
ment over placebo.
OMEPRAZOLE 20 OR 40 MG DAILY FOR
HEALING OF DUODENAL ULCER?
K. Lauritsen, K. Rutgersson, H. Gudjonsson,
S. Björnsson, O. Gunnlaugsson, T. A.Jonasson
E. Oddsson, A. Theodors. B. Thjodleifsson
International Multicentre Study þ.m.t. á
Landspítala, Borgarspítala, Landakotsspítala
og St. Jósefsspítala Hf.
A total of 1004 patients with duodenal ulcer
from 70 centres in 16 countries were allo-
cated at random to double-blind treatment
with 20 or 40 mg of omeprazole daily for 2,
4, or 8 weeks until healing was confirmed
endoscopically. Patients with an unhealed
ulcer after 8 weeks' treatment were treated
with omeprazole 40 mg daily for another 4
-8 weeks. The cumulative healing rates in
the 20 mg group at 2, 4, and 8 weeks
were 66.0%, 93,3%, and 96,7%, respectively.
In the 40 mg group these figures were
71,6%, 97,1%, and 99,8%. The comparison
of the cumulative healing curves (life
table technique: Mantel-Haenszel test)
showed a significant difference, P=0.003.
The treatment differences (95% confidence
interval) at 2, 4, and 8 weeks were 5,6%
(-0,3% to 11,5%), 3,8% (1,0-6,6%) and 3,1%
(1,3-4,8%). Although statistically significant,
these differences may be considered of
minor clinical importance. After 8 weeks'
treatment only 1,5% (13 patients in the 20
mg group and one in the 40 mg group)had
an unhealed ulcer, and in all cases ulcers
healed on continued omeprazole 40 mg dai-
ly for a further 4-8 weeks. Ulcer size, but
not age, sex, duration of disease, smoking
or use of NSAIDs was predictive of ulcer
healing at 2 weeks. A rapid relief of symp-
toms occured in both groups, and both
doses were well tolerated. We conclude
that 20 mg of omeprazole daily is an
appropriate dosage for most patients with
duodenal ulcer. In the few patients with an
unhealed ulcer after 8 weeks' treatment, a
dose increase to 40 mg of omeprazole may
be considered.