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.
Abbreviations
CCCPT II:Conners’ computerised continuous performance test II
HPA:hypothalamic-pituitary-adrenal
ICD:International Classification of Diseases
MADRS:Montgomery-Asberg depression rating scale
Qol:quality of life
Key words
Rhodiola rosea L. - Crassulaceae
- stress - fatigue - clinical trial
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Erik M. G. Olsson
Department of Psychology
Uppsala University
Box 1225
751 42 Uppsala
Sweden
Telefon: +46 70 359 27 59
eMail: erik.olsson@psyk.uu.se