Sint-janskruid
heilzaam bij depressie*
Sint-janskruid
is werkzaam bij zware depressie. Dat schrijven Duitse onderzoekers in het
British Medical Journal.
In een onderzoek waaraan 250 patiënten met een matige tot zware depressie deelnamen, blijkt dat sint-janskruid ten minste even effectief is als reguliere antidepressiva.
Acute treatment of
moderate to severe depression with hypericum extract WS 5570 (St John's wort):
randomised controlled double blind non-inferiority trial versus paroxetine
A
Szegedi, managing
senior physician1, R
Kohnen, head of scientific affairs2, A
Dienel, head of clinical trials department3, M
Kieser, head of biometry department3
1 Charité-Universitätsmedizin Berlin,
Campus Benjamin Franklin, Department of Psychiatry and Psychotherapy,
Eschenallee 3, 14050 Berlin, Germany, 2 Institute for Medical
Research Management and Biometrics GmbH, Scheurlstraße 21, 90478 Nürnberg,
Germany, 3 Dr Willmar Schwabe Pharmaceuticals, PO Box 410925, 76209
Karlsruhe, Germany
Correspondence to:
M Kieser meinhard.kieser@schwabe.de
Objective
To investigate the efficacy of hypericum extract WS 5570 (St John's
wort) compared with paroxetine in patients with moderate to severe
major depression.
Design Randomised
double blind, double dummy, reference controlled, multicentre
non-inferiority trial.
Setting 21
psychiatric primary care practices in Germany.
Participants 251
adult outpatients with acute major depression with total score
more
than 22 on the 17 item Hamilton depression scale.
Interventions 900
mg/day hypericum extract WS 5570 three times a day or 20 mg
paroxetine once a day for six weeks. In initial non-responders doses
were increased to 1800 mg/day hypericum or 40 mg/day paroxetine after
two weeks.
Main outcome
measures Change in score on Hamilton depression scale from baseline
to day 42 (primary outcome). Secondary measures were change in scores
on Montgomery-Åsberg depression rating scale, clinical global
impressions, and Beck depression inventory.
Results The
Hamilton depression total score decreased by mean 14.4 (SD 8.8)
points, corresponding to 56.6% (SD 34.3%) of the baseline value, in
the hypericum group and by 11.4 (SD 8.6) points (44.8% (SD 33.5%) of
baseline value) in the paroxetine group (intention to treat analysis;
similar results were observed in the per protocol analysis). The
intention to treat analysis (lower one sided 97.5% confidence limit
1.5 points for the difference hypericum minus paroxetine) and the per
protocol analysis (lower confidence limit 0.7 points) showed
non-inferiority of hypericum and statistical superiority over
paroxetine. The lower limits in both cases exceeded the pre-specified
non-inferiority margin of -2.5 points and the superiority margin of
0. The incidence of adverse events was 0.035 and 0.060 events per day
of exposure for hypericum and paroxetine, respectively.
Conclusions In the
treatment of moderate to severe major depression, hypericum extract WS 5570 is at least as effective as
paroxetine and is better tolerated.
(Maart 2005)