Efficacy
and tolerability of St John's wort in moderate
to severe depression
Hypericum
extract (St John's
wort)is
as effective in the acute treatment of patients
with mild to moderate depression as treatment
with certain tricyclic antidepressants or
fluoxetine, moreover it is better tolerated than
synthetic compounds. The efficacy of St John's
wort in more severe depression has not, however,
been clearly demonstrated. Therefore the
efficacy of hypericum extract WS 5570 has been
recently compared with paroxetine in patients
with moderate to severe major depression.
A sample of 251 male and female outpatients in
21 psychiatric primary care centres was enrolled
in a randomised double blind, double dummy,
reference controlled, multicentre
non-inferiority trial. All participants were
18-70 years old and had single or recurrent
moderate or severe episodes of unipolar major
depression with a total score
³
22 points on the 17-item Hamilton depression
scale. A group of 125 patients were assigned to
hypericum extract 300 mg three times a day and
126 to paroxetine 20 mg once a day for six
weeks. Doses were doubled after two weeks of
treatment in patients whose total depression
score had not decreased by at least 20%. The
primary outcome measure was change in score on
Hamilton depression scale from baseline to day
42. Change in scores on Montgomery-Åsberg
depression rating scale, clinical global
impressions, and Beck depression inventory were
secondary measures.
After 42 days, the Hamilton depression scores
decreasd by 14.4 points in the hypericum group
and 11.4 points in the paroxetine group, which
corresponded to 57% and 45% of the baseline
value, respectively. Response rates were 71% and
60% in the hypericum group and in the paroxetine
group, respectively. Remission rates were 50%
and 35% in patients treated with hypericum and
paroxetine, respectively. Both the intention to
treat analysis and the per protocol analyses
showed non-inferiority of hypericum and
statistical superiority over paroxetine. All
secondary measures showed differences between
treatment groups in favour of hypericum.
Patients treated with hypericum (55%) reported
172 adverse events while those receiving
paroxetine (76%) reported 269.
These results show that hypericum extract, WS
5570, is at least as effective as paroxetine in
ameliorating the symptoms of moderately or
severely depressed patients and, since it is
well tolerated, this support its use as an
interesting alternative option in some fragile
depressed populations. Szegedi
A, Kohnen R, Dienel A, Kieser M. 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. BMJ Feb 2005, Online First,
10.1136/bmj.38356.655266.82.