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Rhodiola (Rhodiola rosea)
is a medicinal plant
with adaptogenic,
antioxidant, endocrine,
reproductive, and
central nervous system
effects.1 Rhodiola root
preparations have been
extensively studied and
used in Scandinavia and
Russia as an herbal
medicine.1
In this double-blind,
placebo-controlled,
randomized phase III
clinical trial, the
authors
examine the effect of
the proprietary
standardized rhodiola
rhizome extract SHR-5 on
mild
to moderate depression.
Both SHR-5 and the
placebo were
manufactured by the
Swedish
Herbal Institute
(Gothenburg, Sweden)
following Good
Manufacturing Practices.
(SHR-5 is
used in the special
extract Arctic Root® and
is available in the
United States from
ProActive
BioProducts, Inc.,
Phoenix, AZ). Each 400
mg tablet of SHR-5
contained 170 mg of
rhodiola extract. SHR-5
is a standardized
extract of rhodiola root
that provides 4.5 mg of
salidroside in 185 mg of
extract. The placebo
contained 170 mg
lactose. The study
medication and the
placebo were virtually
identical in appearance.
Male and female patients
aged 18-70 years (n=89)
and diagnosed with mild
to moderate
depression according to
the DSM-IV2 were
recruited from the
clinics of Erebouni
Medical
Center (Armenian State
Medical University,
Yerevan, Armenia). There
is no indication if
these patients were
inpatients or
outpatients. During a
2-week run-in period,
the patients
received no medication.
Then, patients were
randomized to receive 2
tablets once daily of
SHR-5 (340 mg/day)
(n=31), 2 tablets twice
daily of SHR-5 (680
mg/day) (n=29), or 2
placebo tablets once
daily (n=29). The
randomization method
used followed the
"principles
of total randomization,
whereby each patient was
randomly assigned an
integer 1-90." The Beck
Depression Inventory (BDI)
and the Hamilton Rating
Scale for Depression
(HAMD) were applied to
the patients on Day 0
and Day 42 of the 6 week
study period. Two
patients dropped out of
the trial "for
non-medical reasons." No
adverse effects were
reported. After 6 weeks,
the HAMD scores showed
that symptoms were
significantly
improved for the 2
groups receiving SHR-5
(P<0.0001). For the
low-dose SHR-5 group
(340 mg/day), the
average total HAMD score
decreased from 24.52 to
15.97 (P<0.0001).
The average total HAMD
score decreased from
23.79 to 16.72
(P<0.0001) for the
high-dose
SHR-5 group (680
mg/day). The average
total HAMD scores of the
2 SHR-5 groups were
significantly different
from the placebo group
at the end of the study
(P<0.001). The placebo
group did not show a
significant improvement
in HAMD scores. In
addition, the HAMD
ratings for self-esteem
were significantly
improved in the
high-dose SHR-5 group
(P=0.0002).
This clinical trial
shows that the special
rhodiola rhizome extract
SHR-5 "possesses a clear
and significant
anti-depressive activity
in patients suffering
from mild to moderate
depression." In
addition, the extract
appears to be safe for
short-term use, with no
adverse
effects reported. The
authors expect that
future clinical trials
including a 12-week
follow-up
period and a larger
multi-center study
design will show how the
efficacy of SHR-5
compares with
conventional
pharmaceutical
antidepressants. In
addition, more research
is
needed to confirm the
mechanism of action for
this observed
antidepressant activity.
Dr. Richard P. Brown,
MD, Associate Professor
of Clinical Psychiatry
at the Columbia
University College of
Physicians and Surgeons,
states "In addition to
mood elevation,
evidence indicates that
R. rosea has numerous
other benefits,
including enhancement of
cognitive function,
sexual function, and
both mental and physical
performance under
stress.
Additional studies are
needed to explore and
establish the potential
applications of this
herbal extract. In the
meantime, phytomedicinal
researchers and
consumers can be
encouraged by these
findings." (personal
communication to Mark
Blumenthal, November
19, 2007)
—Marissa Oppel, MS
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