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Study 3
Effectiveness and tolerance of hypericum extract LI 160 compared
to Maprotiline: A multicenter double-blind study
Au:Harrer-G, Huebner-D, Podzuweit-H
So: J Geriatr Psychiatry Neurol 1994: 7(suppl 1): S24-28
Description
- 102 patients, aged 24-65 years, 29 males and 73 females, were
given indistinguishable tablets of either hypericum extract LI
160 0.9 mg (standardized hypericin content) x 3 or Maprotiline
25 mg x 3 for 4 weeks in a randomized double-blind trial.
- Inclusion criteria were depression according to ICD-10 (F32.1)
with a single moderately severe depressive episode for at least
2 weeks. The sum of the HAMD with 17 items had to be at least
16.
Results
HAMD score
- The mean HAMD fell from 20.5 to 12.2 in the hypericum group
and from 21.5 to 10.5 in the Maprotiline group.
- There were no statistically significant differences between
the groups.
- There was a slight difference in favor of Maprotiline after
two weeks of treatment (39% decrease compared to 29% with hypericum)
treatment, indicating faster effect. The difference diminished
after 6 weeks and was no longer significant.
- 61% of the patients fulfilled the response criteria (50% HAMD
reduction or HAMD<10) on hypericum and 67% on Maprotiline.
D-S score
- The mean D-S score fell from 26 to 16 on hypericum and from
25 to 14 on Maprotiline.
CGI score
- The CGI score for change in status and severity of illness
showed a tendency towards better recovery in the hypericum group.
Results are summarized figure 3.
Figure 3 CGI-score change in status
ADRs
Adverse drug effects (ADRs) occurred in 13 patients on hypericum
(25%) and on 18 patients on Maprotiline (35%) (see Table 6).
There were no changes in laboratory parameters or clinical status,
except for a slight rise in serum creatinine in one patient on
Maprotiline (1.1 to 1.8 mg/dl).
Researchers' comments
This study agrees with previous studies comparing Maprotiline,
known for its fast effect, and hypericum, known for its benign
side-effect profile.
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