1: Effects on Mild to Moderate Depression
Nord J Psychiatry. 2007;61(6):503.
Clinical trial of Rhodiola rosea L. extract SHR-5 in the treatment of mild to moderate depression.
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.
2: Clinical Study Reviews
A 2002 review in HerbalGram, the journal of the American Botanical Council, reported that numerous studies of rhodiola in both humans and animals have indicated that it helps prevent fatigue, stress, and the damaging effects of oxygen deprivation. Evidence also suggests that it acts as an antioxidant, enhances immune system function, and can increase sexual energy. Rhodiola's efficacy was confirmed in a 2011 review of 11 placebo-controlled human studies. The reviewers considered studies that all had study designs rated as moderate to good quality, and the analysis of their combined data concluded that rhodiola might have beneficial effects on physical performance, mental performance, and certain mental health conditions. The reviewers noted that very few adverse events are reported, suggesting a good safety profile.
Many studies support what even the ancient Chinese emperors knew - that Rhodiola rosea gives a terrific lift to body and mind. In one study of people with stress-related fatigue conducted in Sweden, the Rhodiola exerted an anti-fatigue effect, increased mental performance, decreased the stress hormone cortisol in the blood, and reduced stress overall. In another study reported in The Journal of Alternative and Complementary Medicine, Rhodiola rosea caused improvement in patients with generalized anxiety disorder. Yet another study of depressed people in Armenia showed significant improvement in overall mood as a result of taking Rhodiola rosea extract. Over 300 human studies on Rhodiola rosea show that the plant has anti-stress, anti-anxiety, and anti-depressant properties, and that taking the extract of the root produces no significant negative effects. This is in sharp contrast to drugs for the same purposes, which typically cause sleep disorders, digestive upset, sexual dysfunction and a variety of mood disorders.
3. Rhodiola rosea Helps Mitigate Depression, Well-Tolerated
Rhodiola rosea versus sertraline for major depressive disorder: A randomized placebo-controlled trial
Background: We performed a proof of concept trial to evaluate relative safety and efficacy of Rhodiola rosea (R. rosea) versus sertraline for mild to moderate major depressive disorder.
Hypothesis: We hypothesize that R. rosea would have similar therapeutic effects as sertraline but with less adverse events.
Study design: Phase II randomized placebo controlled clinical trial.
Methods: 57 subjects were randomized to 12 weeks of standardized R. rosea extract, sertraline, or placebo. Changes over time in Hamilton Depression Rating (HAM-D), Beck Depression Inventory (BDI), and Clinical Global Impression Change (CGI/C) scores among groups were examined using mixed-effects models.
Results: Modest, albeit statistically non-significant, reductions were observed for HAM-D, BDI, and CGI/C scores for all treatment conditions with no significant difference between groups (p = 0.79, p = 0.28, and p = 0.17, respectively). The decline in HAM-D scores was greater for sertraline (−8.2, 95% confidence interval [CI], −12.7 to −3.6) versus R. rosea (−5.1, 95% CI: −8.8 to −1.3) and placebo (−4.6, 95% CI: −8.6 to −0.6). While the odds of improving (versus placebo) were greater for sertraline (1.90 [0.44–8.20]; odds ratio [95% CI]) than R. rosea (1.39 [0.38–5.04]), more subjects on sertraline reported adverse events (63.2%) than R. rosea (30.0%) or placebo (16.7%) (p = 0.012).
Conclusions: Although R. rosea produced less antidepressant effect versus sertraline, it also resulted in significantly fewer adverse events and was better tolerated. These findings suggest that R. rosea, although less effective than sertraline, may possess a more favorable risk to benefit ratio for individuals with mild to moderate depression.
Keywords: Rhodiola rosea; Sertraline; Depression; Complementary and alternative medicine; Botanical psychopharmacology