Objective: The objective of this double-blind, randomised, placebo-controlled, multicentre clinical
study was to demonstrate the non-inferiority and safety of the hypericum extract STW3-VI
in a once-daily dosage regime in the treatment of moderate depression. During the
6-week treatment phase, the course of depression was documented by use of HAMD (items
1-17), the von Zerssen’s Adjective Mood Scale (BfS) and the CGI scales. The primary
objective of this 3-arm design study was to demonstrate the non-inferiority of hypericum
extract STW3-VI (900 mg) to the SSRI citalopram (20 mg) and superiority of hypericum
over placebo. Methods: Outpatients (N = 388) suffering from moderate depression were enrolled. The safety
and tolerability of hypericum extract in comparison to citalopram and placebo was
investigated on the basis of CGI, the occurrence of adverse events and the investigation
of laboratory parameters and vital signs. Results: From almost identical baseline values of 21.9 ± 1.2 points (hypericum extract), 21.8
± 1.2 points (citalopram) and 22.0 ± 1.2 points (placebo), the HAMD score was reduced
to 10.3 ± 6.4 (hypericum extract), 10.3 ± 6.4 (citalopram) and 13.0 ± 6.9 (placebo),
respectively. Based on this data, the statistical significant therapeutic equivalence
of hypericum extract STW3-VI to citalopram (p < 0.0001) and the superiority of this
hypericum extract over placebo (p < 0.0001) was demonstrated. At the end of treatment
54.2 % (hypericum extract), 55.9 % (citalopram) and 39.2 % (placebo) of the patients
were assessed as therapy responders. The secondary efficacy parameters, change in
BfS, CGI and amount of therapy responders showed that the hypericum group was not
statistically different from the citalopram group, and significantly superior to the
placebo group. Significantly more adverse events with ”certain”, ”probable” or ”possible”
relation to study medication were documented in the citalopram group (hypericum: 17.2
%, citalopram: 53.2 %, placebo: 30 %). In most cases, the investigators assessed the
tolerability of hypericum extract, citalopram and placebo as ”good” or ”very good”.
Conclusion: The non-inferiority of hypericum extract as compared to citalopram and the superiority
of both active compounds to placebo were demonstrated, as well as a better safety
and tolerability of hypericum extract in comparison to citalopram. These results revealed
that hypericum extract STW3-VI is a good alternative to chemically defined antidepressants
in the treatment of outpatients with moderate depression.
References
Hypericum perforatum - a review of clinical studies.
Pharmacopsychiatry.
2001;
34 (Suppl. 1)
51-55
m.gastpar@uni-essen.de
