Download A pilot study of Rhodiola rosea (Rhodax) for generalized anxiety

A pilot study of Rhodiola rosea (Rhodax) for generalized
anxiety disorder (GAD).
Bystritsky A, Kerwin L, Feusner JD.
Source
Department of Psychiatry, University of California, Los Angeles, CA, USA. [email protected]
Abstract
BACKGROUND:
Rhodiola rosea is an herbal supplement that many in the general population in Russia and elsewhere in the
world have used for decades to alleviate everyday anxiety, depression, and insomnia. Whether R. rosea is
effective in reducing similar symptoms in clinical samples is unknown. The goal of this pilot study was to
evaluate whether R. rosea is effective in reducing symptoms of generalized anxiety disorder (GAD).
METHOD:
Ten (10) participants with a DSM-IV diagnosis of GAD, recruited from the UCLA Anxiety Disorders
Program and between the ages of 34 and 55, were enrolled in this study from November 2005 to May 2006.
Participants received a total daily dose of 340 mg of R. rosea extract for 10 weeks. Assessments included the
Hamilton Anxiety Rating Scale (HARS), the Four-Dimensional Anxiety and Depression Scale, and the
Clinical Global Impressions of Severity/Improvement Scale.
RESULTS:
Individuals treated with R. rosea showed significant decreases in mean HARS scores at endpoint (t=3.27,
p=0.01). Adverse events were generally mild or moderate in severity, the most common being dizziness and
dry mouth.
CONCLUSIONS:
Significant improvement in GAD symptoms was found with R. rosea, with a reduction in HARS scores
similar to that found in clinical trials. These preliminary findings warrant further exploration of treatment
with R. rosea in clinical samples.
2012 Aug;26(8):1220-5. doi: 10.1002/ptr.3712. Epub 2012 Jan 6.
Therapeutic effects and safety of Rhodiola rosea extract WS®
1375 in subjects with life-stress symptoms--results of an openlabel study.
Edwards D, Heufelder A, Zimmermann A.
Source
White House Surgery, Horsefair, Chipping Norton, UK.
Abstract
The trial was conducted to investigate the therapeutic effects and safety of a 4 week treatment with Rhodiola
rosea extract WS® 1375 in subjects with life-stress symptoms. This was a multicentre, non-randomized, openlabel, single-arm trial. One hundred and one subjects were enrolled in this clinical study and received the
study drug at a dose of 200 mg twice daily for 4 weeks. Assessments with seven questionnaires included
Numerical Analogue Scales of Subjective Stress Symptoms, Perceived Stress Questionnaire,
Multidimensional Fatigue Inventory 20, Numbers Connecting Test, Sheehan Disability Scale and Clinical
Global Impressions to cover various aspects of stress symptoms and adverse events. Invariably, all tests
showed clinically relevant improvements with regard to stress symptoms, disability, functional impairment
and overall therapeutic effect. Improvements were observed even after 3 days of treatment, as were continuing
improvements after 1 and 4 weeks. Rhodiola rosea extract WS® 1375 was safe and generally well tolerated.
Adverse events were mostly of mild intensity and no serious adverse events were reported. Rhodiola extract
at a dose of 200 mg twice daily for 4 weeks is safe and effective in improving life-stress symptoms to a
clinically relevant degree
2009 Feb;75(2):105-12. doi: 10.1055/s-0028-1088346. Epub 2008 Nov 18.
A randomised, double-blind, placebo-controlled, parallel-group
study of the standardised extract shr-5 of the roots of Rhodiola
rosea in the treatment of subjects with stress-related fatigue.
Olsson EM, von Schéele B, Panossian AG.
Source
Department of Psychology, Uppsala University, Uppsala, Sweden. [email protected]
Abstract
The aim of the study was to assess the efficacy of the standardised extract SHR-5 of roots of Rhodiola Rosea
L. in the treatment of individuals suffering from stress-related fatigue. The phase III clinical trial took the
form of a randomised, double-blind, placebo-controlled study with parallel groups. Participants, males and
females aged between 20 and 55 years, were selected according to the Swedish National Board of Health and
Welfare diagnostic criteria for fatigue syndrome. A total of 60 individuals were randomised into two groups,
one ( N = 30) of which received four tablets daily of SHR-5 extract (576 mg extract/day), while a second ( N
= 30) received four placebo tablets daily. The effects of the extract with respect to quality of life (SF-36
questionnaire), symptoms of fatigue (Pines' burnout scale), depression (Montgomery -Asberg depression
rating scale - MADRS), attention (Conners' computerised continuous performance test II - CCPT II), and
saliva cortisol response to awakening were assessed on day 1 and after 28 days of medication. Data were
analysed by between-within analyses of variance. No serious side effects that could be attributed to the extract
were reported. Significant post-treatment improvements were observed for both groups (placebo effect) in
Pines' burnout scale, mental health (SF-36), and MADRS and in several CCPT II indices of attention,
namely, omissions, commissions, and Hit RT SE. When the two groups were compared, however, significant
effects of the SHR-5 extract in comparison with the placebo were observed in Pines' burnout scale and the
CCPT II indices omissions, Hit RT SE, and variability. Pre- VERSUS post-treatment cortisol responses to
awakening stress were significantly different in the treatment group compared with the control group. It is
concluded that repeated administration of R. ROSEA extract SHR-5 exerts an anti-fatigue effect that
increases mental performance, particularly the ability to concentrate, and decreases cortisol response to
awakening stress in burnout patients with fatigue syndrome.
2007;61(5):343-8.
Clinical trial of Rhodiola rosea L. extract SHR-5 in the
treatment of mild to moderate depression.
Darbinyan V, Aslanyan G, Amroyan E, Gabrielyan E, Malmström C, Panossian A.
Source
Department of Neurology, Armenian State Medical University, Yerevan, Armenia.
Erratum in Nord J Psychiatry. 2007;61(6):503.
Abstract
The objective of this study was to assess the efficacy and safety of standardized extract SHR-5 of rhizomes of
Rhodiola rosea L. in patients suffering from a current episode of mild/moderate depression. The phase III
clinical trial was carried out as a randomized double-blind placebo-controlled study with parallel groups over
6 weeks. Participants, males and females aged 18-70 years, were selected according to DSM-IV diagnostic
criteria for depression, the severity of which was determined by scores gained in Beck Depression Inventory
and Hamilton Rating Scale for Depression (HAMD) questionnaires. Patients with initial HAMD scores
between 21 and 31 were randomized into three groups, one of which (group A: 31 patients) received two
tablets daily of SHR-5 (340 mg/day), a second (group B: 29 patients) received two tablets twice per day of
SHR-5 (680 mg/day), and a third (group C: 29 patients) received two placebo tablets daily. The efficacy of
SHR-5 extract with respect to depressive complaints was assessed on days 0 and 42 of the study period from
total and specific subgroup HAMD scores. For individuals in groups A and B, overall depression, together
with insomnia, emotional instability and somatization, but not self-esteem, improved significantly following
medication, whilst the placebo group did not show such improvements. No serious side-effects were reported
in any of the groups A-C. It is concluded that the standardized extract SHR-5 shows anti-depressive potency
in patients with mild to moderate depression when administered in dosages of either 340 or 680 mg/day over
a 6-week period
2007 Jul-Aug;24(4):929-39.
Efficacy and tolerability of a Rhodiola rosea extract in adults with physical and cognitive deficiencies.
Fintelmann V, Gruenwald J.
Source
Carl Gustav Carus Akademie Hamburg e. V., Hamburg, Germany.
Abstract
During a 12-wk drug monitoring study, the efficacy and safety of a Rhodiola rosea extract given in
combination with vitamins and minerals (vigodana(R)) were tested in 120 adults (83 women and 37 men,
ages 50-89 y) with physical and cognitive deficiencies. Two different dosage regimens were chosen. One
group of 60 patients (group 1) took 2 capsules orally in the morning after breakfast, and the other group
(group 2) took 1 capsule after breakfast and 1 after lunch. Three medical examinations were performed during
the course of the study (at baseline, after 6 wk, and after 12 wk). The evaluated symptoms were divided into
physical disturbances such as exhaustion, decreased motivation, daytime sleepiness, decreased libido, sleep
disturbances, and cognitive complaints (eg, concentration deficiencies, forgetfulness, decreased memory,
susceptibility to stress, irritability). A statistically highly significant improvement (P<.001) in physical and
cognitive deficiencies was observed in the overall group, as well as in the separately evaluated groups 1 and 2.
In addition, the time needed to complete a digit connection test decreased significantly in all groups (P<.001).
Improvements in group 1 were more pronounced than in group 2, however, indicating that the intake of 2
capsules after breakfast is more effective than the intake of 1 capsule after breakfast and 1 after lunch. Global
assessment of efficacy revealed that treatment was "very good" or "good" for 81% of patients, as reported by
physicians, and for 80%, as reported by patients. Ninety-nine percent of patients and physicians rated safety
as "good" or "very good." No adverse events occurred during the course of the study. The results of this drug
monitoring study are very promising, but they still need to be corroborated by future placebo-controlled
clinical trials.