Research - Rhodiola rosea
Multicenter, open-label, exploratory clinical trial with Rhodiola rosea extract in patients suffering from burnout symptoms4
Abstract
Purpose: This study is the first clinical trial aiming to explore the clinical outcomes in burnout patients treated with Rhodiola rosea. The reported capacity of R. rosea to strengthen the organism against stress and its good tolerability offer a promising approach in the treatment of stress-related burnout. The aim of the treatment was to increase stress resistance, thus addressing the source rather than the symptoms of the syndrome and preventing subsequent diseases associated with a history of burnout. The objective of the trial was to provide the exploratory data required for planning future randomized trials in burnout patients in order to investigate the clinical outcomes of treatment with R. rosea dry extract in this target group.
Methods: The study was planned as an exploratory, open-label, multicenter, single-arm trial. A wide range of rating scales were assessed and evaluated in an exploratory data analysis to generate hypotheses regarding clinical courses and to provide a basis for the planning of subsequent studies. A total of 118 outpatients were enrolled. A daily dose of 400 mg R. rosea extract (WS® 1375, Rosalin) was administered over 12 weeks. Clinical outcomes were assessed by the German version of the Maslach Burnout Inventory, Burnout Screening Scales I and II, Sheehan Disability Scale, Perceived Stress Questionnaire, Number Connection Test, Multidimensional Mood State Questionnaire, Numerical Analogue Scales for different stress symptoms and impairment of sexual life, Patient Sexual Function Questionnaire, and the Clinical Global Impression Scales.
Results: The majority of the outcome measures showed clear improvement over time. Several parameters had already improved after 1 week of treatment and continued to improve further up to the end of the study. The incidence of adverse events was low with 0.015 events per observation day. Discussion: The trial reported here was the first to investigate clinical outcomes in patients suffering from burnout symptoms when treated with R. rosea. During administration of the study drug over the course of 12 weeks, a wide range of outcome measures associated with the syndrome clearly improved.
Conclusion: The results presented provide an encouraging basis for clinical trials further investigating the clinical outcomes of R. rosea extract in patients with the burnout syndrome.
Source : Neuropsychiatric Disease and Treatment
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Rhodiola rosea L. as a putative botanical antidepressant
Abstract
Background
Rhodiola rosea (R. rosea) is a botanical adaptogen with putative anti-stress and antidepressant properties. Evidence-based data supporting the effectiveness of R. roseafor depression in adults is limited, and therefore a comprehensive review of available animal and human studies suggesting a putative antidepressant action is warranted.
Purpose
A review of the literature was undertaken to ascertain studies of possible antidepressant mechanisms of action and studies of the safety and effectiveness of R. rosea extracts in animals and adult humans.
Methods
A search of MEDLINE and the Russian state library database was conducted (up to October 2015) on R. rosea.
Results
Mechanism of action: R. rosea extracts and its purified constituent, salidroside, has been shown to produce a variety of mediator interactions with several molecular networks of neuroendocrine-immune and neurotransmitter receptor systems likely to be involved in the pathophysiology of depression. A wide variety of preclinical in vivo and ex vivostudies with laboratory animals suggests the presence of several biochemical and pharmacological antidepressant-like actions.
Effectiveness
Clinical assessment of R. rosea L. rhizome extracts in humans with various depressive syndromes is based upon results from two randomized, double-blind, placebo-controlled trials of 146 subjects with major depressive disorder and seven open-label studies totaling 714 individuals with stress-induced mild depression (diagnosed as asthenic syndrome or psychoneurosis). Overall, results of these studies suggests a possible antidepressant action for R. rosea extract in adult humans.
Safety
In contrast to most conventional antidepressants, R. rosea extract appears to be well-tolerated in short-term studies with a favorable safety profile.
Conclusions
R. rosea demonstrates multi-target effects on various levels of the regulation of cell response to stress, affecting various components of the neuroendocrine, neurotransmitter receptor and molecular networks associated with possible beneficial effects on mood.
Source : Journal Phytomedicine
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Rhodiola rosea versus sertraline for major depressive disorder: A randomized placebo-controlled trial
- Jun J. Maoa, b, , ,
- Sharon X. Xieb,
- Jarcy Zeeb,
- Irene Soellera, c,
- Qing S. Lia, c,
- Kenneth Rockwelld,
- Jay D. Amsterdamc
Abstract
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, andp = 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.
Source : Phytotherapy Journal
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