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Michael Philipp a Bezirkskrankenhaus Landshut, D-84034 Landshut,
Germany, b Imerem Institute for Medical Research Management and
Biometrics, D-90478 Nuremberg, Germany, c Steiner Arzneimittel,
D-12207 Berlin, Germany
Correspondence to: K-O Hiller
kohiller.steiner{at}t-online.de
Objectives:
To assess the efficacy and safety of
hypericum extract (STEI 300, Steiner Arzneimittel, Berlin) compared
with imipramine and placebo in patients in primary care with a current episode of moderate depression.
Design:
Randomised, double blind, multicentre,
parallel group trial for 8 weeks.
Setting:
Trained panel of 18 general practitioners from four German states: Bavaria, Berlin, Rhineland Palatinate, and Saxony.
Participants:
263 patients (66 men, 197 women) with
moderate depression according to ICD-10 (international classification
of diseases, 10th revision) codes F32.1 and F33.1.
Interventions:
1050 mg hypericum extract (350 mg three
times daily), 100 mg imipramine (50 mg, 25 mg, and 25 mg daily), or placebo three times daily.
Main outcome measures:
Change from baseline score on
the 17 item version of the Hamilton depression scale, the Hamilton
anxiety scale, the clinical global impressions scale, Zung's self
rating depression scale, and SF-36, and adverse events profile.
Results:
Hypericum extract was more effective at
reducing Hamilton depression scores than placebo and as effective as
imipramine (mean
15.4 (SD 8.1),
12.1 (7.4), and -14.2 (7.3)
respectively). Comparable results were found for Hamilton anxiety and
clinical global impressions scales and were most pronounced for the
Zung self rating depression scale. Quality of life was more improved in
the standardised mental component scale of the SF-36 with both active
treatments than with placebo but in the physical component scale was
improved only by hypericum extract compared with placebo. The rate of
adverse events with hypericum extract was in the range of the placebo
group but lower than that of the imipramine group (0.5, 0.6, and 1.2 events per patient respectively).
Conclusions:
At an average dose of 350 mg three times
daily hypericum extract was more effective than placebo and at least as
effective as 100 mg imipramine daily in the treatment of moderate depression. Treatment with hypericum extract is safe and improves quality of life.
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