Article
Short course acid suppressive treatment for patients with
functional dyspepsia: results depend on
Helicobacter pylori
status
A L Bluma, R Arnoldb, M Stoltec, M Fischerd, H R Koelze, and the Frosch Study Group
a Division of
Gastroenterology, Department of Medicine, University Hospital,
Lausanne, Switzerland, b Centre of
Internal Medicine, Philipps-University, Marburg, Germany, c Institute of Pathology, Bayreuth, Germany, d Institut
für numerische Statistik, Köln, Germany, e Department of Medicine, Triemli Hospital,
Zurich, Switzerland
Correspondence to: Professor A L Blum, Gastroenterology, CHUV, 1011 Lausanne, Switzerland. Email: andre.blum{at}chuv.hospvd.ch
Accepted for publication 28 April 2000
BACKGROUND AND
AIMS
Treatment of functional dyspepsia with acid
inhibitors is controversial and it is not known if the presence of
Helicobacter pylori infection influences the response.
METHODSAfter a
complete diagnostic workup, 792 patients with functional dyspepsia
unresponsive to one week of low dose antacid treatment were randomised
to two weeks of treatment with placebo, ranitidine 150 mg, omeprazole
10 mg, or omeprazole 20 mg daily. Individual dyspeptic and other
abdominal symptoms were evaluated before and after treatment according
to H pylori status.
RESULTSThe
proportions of patients considered to be in remission (intention to
treat) at the end of treatment with placebo, ranitidine 150 mg,
omeprazole 10 mg, and omeprazole 20 mg were, respectively, 42%, 50%,
48%, and 59% in the H pylori positive
group and 66%, 73%, 64%, and 71% in the H
pylori negative group. In H pylori positive patients, the therapeutic gain over placebo was significant for omeprazole 20 mg (17.6%, 95% confidence intervals (CI) 4.2-31.0; p<0.014 using the Bonferroni-adjusted p level of 0.017) but not for
omeprazole 10 mg (6.8%, 95% CI 
6.7-20.4) or ranitidine 150 mg
(8.9%, 95% CI 4.2-21.9). There was no significant therapeutic gain from active treatment over placebo in H
pylori negative patients. Complete disappearance of symptoms and
improvement in quality of life also occurred most frequently with
omeprazole 20 mg and was significant in both H
pylori positive and H pylori negative groups. The six month relapse rate of symptoms requiring treatment was
low (<20%) in all groups.
CONCLUSIONSOmeprazole
20 mg per day had a small but significant favourable effect on outcome
in H pylori positive patients. The
differential response in these patients may be explained by an enhanced
antisecretory response in the presence of H
pylori. The effect of weaker acid inhibition was unsatisfactory.
Keywords: functional dyspepsia; omeprazole; ranitidine; Helicobacter pylori; randomised controlled trial; quality of life
Details of
the Frosch Study Group are given in the appendix.
© 2000 by Gut
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