A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Standardized Extract SHR-5 of the Roots of Rhodiola rosea in the Treatment of Subjects with Stress-Related Fatigue – Source: Planta Medica, Nov 18, 2008

[Note: Stress-related fatigue (“burnout”) is associated with disturbances in the stress regulatory endocrine system (hypothalamic-pituitary-adrenocortical axis) including levels of cortisol, the “fight or flight” hormone.]

The aim of the study was to assess the efficacy of the standardized 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 randomized, 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 randomized 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’ computerized 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 analyzed 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’ computerized continuous performance test II; HPA: hypothalamic-pituitary-adrenal; ICD: International Classification of Diseases; MADRS: Montgomery-Asberg depression rating scale; Qol: quality of life.

Source: Planta Medica, Nov 18, 2008 [E-pub ahead of print]. PMID: 19016404, by Olsson EM, von Schéele B, Panossian AG. Department of Psychology, Uppsala University, Uppsala, Sweden.

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