Findings of Russian literature on the clinical application of Eleutherococcus senticosus (Rupr. & Maxim.): A narrative review.

ETHNOPHARMACOLOGICAL RELEVANCE: Eleutherococcus senticosus (Rupr. et Maxim.) Maxim (ES) (syn. Acanthopanax senticosus (Rupr. & Maxim.) Harms) is a medicinal plant used in traditional medicine of Russian Far East and East Asia and known as an adaptogen - a category of herbal medicinal products which have non-specific inter-system anti-stress effects throughout the human body. ES was first established as a medicinal plant officially in the pharmacopeia of the Union of Soviet Socialist Republics (USSR) in 1962, and is currently recommended by the European Medicines Agency (EMA) to be prescribed to treat symptoms of asthenia such as fatigue and weakness. AIM OF THE REVIEW: During the time of the USSR, a distinct research directive was undertaken on ES to examine substances which improve stamina and endurance, with over 1000 studies published. Due to security measures within the former USSR these papers were not accessible to the public and were never translated into English. This is the first study to make findings of the USSR studies on ES available to the international research and scientific community. METHODS: This study was an archival retrieval. References for studies were sought from printed journal and conference preceding's publications, then located within library catalogues of three libraries in St Petersburg Russia. Eligibility criteria included human clinical trials examining the efficacy of ES in any condition, published in the Russian language in the Soviet Union. RESULTS: A total of 46 studies published between 1962 and 1986 in the USSR were sourced. Of the retrieved articles, 29 were reported as placebo-controlled trials, 11 were reported as controlled trials and six studies did not report the study design. Trends in studies were those reporting on healthy volunteers (n=21) at a dose of 2 ml extract/day (n=14) examining outcomes such as physical and mental stamina under varying conditions, normal work conditions, high temperatures and high altitudes, incidence or prophylaxis of colds and influenza (n=5), effects on color perception and vision (n=2), work capacity (n=1), cognitive effects (n=1), prophylaxis of hearing loss (n=3), effects on blood cell counts (n=2) and sensitivity to UV radiation (n=1). CONCLUSIONS: ES appears to exhibit benefits for cognitive function and physical and mental endurance and its effect as a respiratory system infection prophylaxis treatment are promising. This study is the first to publish the findings of clinical trials on ES from the USSR, which supports the traditional use and offers a valuable contribution to the body of evidence on medicinal uses of ES when the data is applied within the context of its limitations.

Clinician perspectives and understanding of the adaptogenic concept: A focus group study with Naturopaths and Western Herbalists.

BACKGROUND: Herbal adaptogens are plant medicines which have traditional associations with herbal 'tonics' and promote homeostasis and non-specifically increase resistance to stress. Current definitions of adaptogens have been derived from extensive laboratory research, however there has not been sufficient clinical data for the concept to be standardised by regulatory bodies in Europe or Australia, nor is there clarity around how adaptogens are used and understood by herbalist clinicians themselves. This study aimed to identify how Australian Naturopaths measure adaptogenic activity relative to the clinical outcomes they aim to achieve. METHODS: A qualitative methodology was implemented using focus groups and thematic analysis. RESULTS: Three focus groups were conducted with a total of 17 Naturopaths with a Bachelor degree or higher qualification and over five years clinical experience. Three core themes were identified: ambiguous cultural origins with divergent perceptions on sources of knowledge about adaptogens; raising vitality and having a restorative effect, and intersystem activity. Within these three central themes, a number of sub-themes were identified. CONCLUSIONS: Naturopathic clinicians utilise both subjective and objective measures of vitalistic signs across multiple body systems; however, the current available research may not accurately reflect expert clinician understanding and use of adaptogens. The study opens pathways to developing novel approaches to measuring adaptogenic activity which may facilitate the process of international standardisation of the adaptogenic concept for the development of well-designed clinical studies.

A Critical Review to Identify the Domains Used to Measure the Effect and Outcome of Adaptogenic Herbal Medicines.

Background: Phytoadaptogens are considered to be herbal medicines with a multi-target effect that strengthen organ systems compromised by stress. Although animal and laboratory studies have identified numerous molecular targets associated with adaptogenic activity, the non-specific characteristic of these herbal medicines has meant there is no known methods to accurately determine efficacy of adaptogens in humans. This critical review of the evidence aims to identify domains which have been used to measure the effect of adaptogens in humans, in order to create pathways for translating laboratory, animal, and clinical studies on adaptogens into practical applications in the future. Methods: EMBASE, AMED, PubMed, Cochrane Library, and WHO ICTRP databases were searched for randomized trials which examined known physiological actions of adaptogens. Results: Twenty-four studies were identified and critically appraised using the Jadad scale. The findings identified three broad categories of outcome measures, including cognitive, mood and biological measures. Conclusions: There was a great heterogeneity in data making it difficult to draw conclusions as to the most effective measurement tools to capture the holistic activity in humans. Cognitive measures hold promise as a reliable measurement tool when used in conjunction with other relevant tools. Further investigation is necessary to determine the most appropriate and diverse tools to measure the complex multi-target action of adaptogens.

A naturalistic study of herbal medicine for self-reported depression and/or anxiety a protocol.

BACKGROUND: Mental health conditions including anxiety and depression account for around 8% of the global disease burden. Anxiety and depression often coexist and impose a high individual and social burden. Patients with mental and behavioural conditions may be at increased risk of co-morbidities and are often high health-care utilisers. Herbal medicine is estimated to be used by up to 80% of the worlds population, and by 22% of Australian women seeking care for depression. The holistic and tailored treatment approach offered by practitioners of herbal medicine is difficult to capture in randomised controlled trials and as such there is a paucity of research demonstrating the outcomes of real-life practice. This project aims to address this gap with a whole practice, observational model. METHODS/DESIGN: The study will employ a naturalistic observational design. Two-hundred patient participants will be recruited to be treated by 15 clinician participants from different naturopathic clinics. The observed changes in anxiety and depression symptoms of patients will be documented across three consultations using validated patient-reported outcome measures (SF-36, DASS-21, GHQ-28 and POMS-2). CONCLUSION: Clinical studies investigating the efficacy of individualised herbal medicine treatment as prescribed by a naturopath are rare. Our study attempts to fill this gap with a longitudinal observation of individualised care as practiced by naturopaths in Australia; to offer valuable insights into the effectiveness of individualised herbal medicine practice and provide contextualisation of data currently focused on individual herbal medicines in specific conditions.Trial Registration: Australian and New Zealand Clinical Trials Registry: ACTRN12616000010493.