A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Standardised Extract SHR-5 of the Roots ofRhodiola roseain the Treatment of Subjects with Stress-Related Fatigue

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.

<b><i>Rhodiola rosea</i></b> in Subjects with Prolonged or Chronic Fatigue Symptoms: Results of an Open-Label Clinical Trial

“…Still, the mean total score of the BDI-II significantly decreased at weeks 4 and 8, which suggests a beneficial effect of WS® 1375 on the symptoms of depression in patients suffering from prolonged or chronic fatigue. This finding supports the results obtained by Olsson et al [26], who reported a marked beneficial effect of R. rosea on both fatigue- and depression-related symptoms as measured by the Pines burnout scale and the Montgomery-Asberg depression rating scale (MADRS), respectively.…”

“…A controlled trial showed the superiority of R. rosea over placebo in improving mental fatigue as measured by the Pines burnout scale [26]. Furthermore, results from animal studies suggest a stimulating effect of R. rosea on the physical work capacity [27].…”

The Effects of Adaptogens on the Physical and Psychological Symptoms of Chronic Stress

“…A randomized, double-blind, placebo-controlled, parallel group study of 60 individuals examined the effects of a 3% rosavin standardized extract of SHR-5 Rhodiola at 576 mg. The posttreatment cortisol response to awakening stress was significantly reduced in the group that had received SHR-5 for 28 days than in the control group (Olsson et al, 2009).…”

“…Some of the symptoms of elevated cortisol levels include anxiety, depression, hypertension, osteoporosis, stress-related fatigue, insulin resistance, and obesity (Pawar & Shivakumar, 2012). Stress-related fatigue is a form of occupational stress, which can often induce long-term exhaustion and diminished interest, producing a condition known as burnout syndrome (Maslach, Schaufeli, & Leiter, 2001;Olsson, von Scheele, & Panossian, 2009;Weber & Jaekel-Reinhard, 2000). This syndrome is characterized by high levels of emotional exhaustion (EE) and depersonalization (DP) in relationships with a reduced level of personal accomplishment (PA) (Maslach et al, 2001).…”

ADAPTOGENIC POTENTIALS OF <i>CYPHOSTEMMA GLAUCOPHILLA</i> AQUEOUS LEAF EXTRACT

“…Panossian and Wikman (2009) showed that ingestion of certain plant extracts could improve stress markers in laboratory animals. However, between 1950 and1960, these plant remedies were termed adptogens and three criteria were set to describe their remedial action (Olsson et al, 2009). An adaptogen should be innocuous and cause minimal disturbance to the normal physiological function of an organism, its action should be non specific and it should have a normalizing action irrespective of the direction of the preceding pathological changes.…”