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Competing Interests: Conflicts of interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: B Sebben, J Stone, K Mallie and S Barnett are cofounders of IPAT (Indigenous Psychedelic Assisted Therapies), a private company that has developed a model of psychedelic-assisted therapy based on Indigenous ways of knowing, being and doing and offers cultural consultation services. J Sarris and D Perkins helped fund IPAT and are also co-CEOs of Psychae Therapeutics, a commercial company developing psychedelic therapies. SGD Ruffell works for the not-for-profit arm of the aforementioned company. He is also the co-founder of a not-for-profit organisation conducting research into traditional plant medicines. VL Beesley has received unrelated funding from Woke Pharmaceuticals for a psilocybin-assisted therapy trial.

Purpose: Evidence suggests that yoga may help improve cancer-related symptoms though knowledge of the experiences, barriers and preferences of people diagnosed with cancer is limited. This study sought to examine the use of yoga in an Australian sample and identify the experiences and preferences associated with undertaking yoga practice as formative research to help inform a future yoga intervention., Methods: Adults diagnosed with any type of cancer completed a cross-sectional survey including questions regarding their demographics, experiences and preferences for yoga practice., Results: Sixty-eight people who had been diagnosed with cancer completed the survey. Most of the participants (70.8%) had practiced yoga since their diagnosis. A variety of reasons for practice were endorsed, and benefits experienced included physical and psychological factors. The most common barrier to practice was related to the physical ability to undertake yoga. Participants indicated a preference for group classes (44.1%), with a frequency of practice of 2-3 times per week (60.3%), 60 min in length (75%). The preferred time of practice was 9am-12pm (51.5%) and travel distance 5-10 km (44.1%). Online yoga delivery was endorsed, with participants preferring pre-recorded sessions., Conclusions: Results from this study provide insights into the experiences, barriers and preferences for yoga practice in people with cancer which will assist in developing yoga programs in this cohort to investigate the effects on cancer and treatment-related symptoms., (Copyright © 2022. Published by Elsevier Inc.)

Background: Recent shifting attitudes towards the medical use of cannabis has seen legal access pathways established in many jurisdictions in North America, Europe and Australasia. However, the positioning of cannabis as a legitimate medical product produces some tensions with other regulatory frameworks. A notable example of this is the so-called 'zero tolerance' drug driving legal frameworks, which criminalise the presence of THC (tetrahydrocannabinol) in a driver's bodily fluids irrespective of impairment. Here we undertake an analysis of this policy issue based on a case study of the introduction of medicinal cannabis in Australia., Methods: We examine the regulatory approaches used for managing road safety risks associated with potentially impairing prescription medicines and illicit drugs in Australian jurisdictions, as well as providing an overview of evidence relating to cannabis and road safety risk, unintended impacts of the 'zero-tolerance' approach on patients, and the regulation of medicinal cannabis and driving in comparable jurisdictions., Results: Road safety risks associated with medicinal cannabis appear similar or lower than numerous other potentially impairing prescription medications. The application of presence-based offences to medicinal cannabis patients appears to derive from the historical status of cannabis as a prohibited drug with no legitimate medical application. This approach is resulting in patient harms including criminal sanctions when not impaired and using the drug as directed by their doctor, or the forfeiting of car use and related mobility. Others who need to drive are excluded from accessing a needed medication and associated therapeutic benefit. 'Medical exemptions' for medicinal cannabis in comparable jurisdictions and other drugs included in presence offences in Australia (e.g. methadone) demonstrate a feasible alternative approach., Conclusion: We conclude that in medical-only access models there is little evidence to justify the differential treatment of medicinal cannabis patients, compared with those taking other prescription medications with potentially impairing effects., Competing Interests: Declarations of Interest IM has acted as a consultant to Kinoxis Therapeutics, has sat on the Medical Advisory Board of BOD Australia, and has received honoraria from Janssen. He is an inventor on several patents relating to novel cannabinoid therapeutics. J Sarris has received consultancy payment from Australian Natural Therapeutics Group (as an independent scientific advisor to a manufacturer of cannabis products). Other authors report no competing interests. J Sinclair has pro bono appointments on the scientific advisory boards of United in Compassion and the Australian Medicinal Cannabis Association., (Copyright © 2021. Published by Elsevier B.V.)

There has been increasing interest in nutraceutical augmentation strategies to boost the efficacy of antidepressants. This study assessed whether S-adenosylmethionine (SAMe), a methyl donor that occurs naturally in the body, may be of such benefit. We conducted an 8-week, double-blind RCT in which 107 treatment non-remittent outpatients with DSM-5 diagnosed Major Depressive Disorder (MDD) were randomized to either SAMe or placebo adjunctively to antidepressants. One-carbon cycle nutrients, pertinent single nucleotide polymorphisms (SNPs), and BDNF were also analysed as potential moderators of response. A linear mixed-effects model revealed a significant overall reduction in Montgomery-Asberg Depression Rating Scale (MADRS) score across time, however there was no significant between-group difference observed (p = 0.51). Response rates at Week 8 were 54.3% in the SAMe group and 50.0% in the placebo group, with remission rates 43.5% for SAMe and 38.3% for placebo (all results NS). No effect of SAMe was found on any secondary outcome. Differential response to SAMe was not modified by a range of key genotypes (e.g. COMT), nor reflected in a change of homocysteine, red cell folate, or BDNF. Use of SAMe elicited no significant adverse effects beyond placebo, however it was implicated in one case of serotonin syndrome-like symptoms. This study concludes that 800 mg/day of SAMe is not an effective adjunctive treatment in MDD, and no obvious biomarker reflected any differential response to treatment. Due to such a distinctly high placebo-response (despite rigorous screening), future studies should employ a placebo run-in period and other strategies to minimize placebo response., (Copyright © 2018. Published by Elsevier B.V.)

Whilst a number of previous studies have been conducted in order to investigate functional brain changes associated with eyes-closed meditation techniques, there is a relative scarcity in the literature with regards to changes occurring during eyes-open meditation. The current project used magnetoencephalography (MEG) to investigate differences in spectral power and functional connectivity between 11 long-term mindfulness meditators (LTMMs) with >5 years of experience and 12 meditation-naïve control participants both during baseline eyes-open rest and eyes-open open-monitoring (OM) mindfulness meditation. During resting with eyes-open, prior to meditating, greater mean alpha power was observed for LTMMs in comparison to controls. However, during the course of OM meditation, a significantly greater increase in theta power was observed over a broad fronto-centro-parietal region for control participants in comparison to LTMMs. In contrast, whole-head mean connectivity was found to be significantly greater for long-term meditators in comparison to controls in the theta band both during rest as well as during meditation. Additionally, mean connectivity was significantly lower for long-term meditators in the low gamma band during rest and significantly lower in both low and high gamma bands during meditation; and the variance of low-gamma connectivity scores for long-term meditators was significantly decreased compared to the control group. The current study provides important new information as to the trait functional changes in brain activity associated with long-term mindfulness meditation, as well as the state changes specifically associated with eyes-open open monitoring meditation techniques., (Copyright © 2015 Elsevier B.V. All rights reserved.)

Psychiatry is at an important juncture, with the current pharmacologically focused model having achieved modest benefits in addressing the burden of poor mental health worldwide. Although the determinants of mental health are complex, the emerging and compelling evidence for nutrition as a crucial factor in the high prevalence and incidence of mental disorders suggests that diet is as important to psychiatry as it is to cardiology, endocrinology, and gastroenterology. Evidence is steadily growing for the relation between dietary quality (and potential nutritional deficiencies) and mental health, and for the select use of nutrient-based supplements to address deficiencies, or as monotherapies or augmentation therapies. We present a viewpoint from an international collaboration of academics (members of the International Society for Nutritional Psychiatry Research), in which we provide a context and overview of the current evidence in this emerging field of research, and discuss the future direction. We advocate recognition of diet and nutrition as central determinants of both physical and mental health., (Copyright © 2015 Elsevier Ltd. All rights reserved.)

This paper provides an overview of the rapidly evolving paradigm of "Integrative Mental Health (IMH)." The paradigm of contemporary biomedical psychiatry and its contrast to non-allopathic systems of medicine is initially reviewed, followed by an exploration of the emerging paradigm of IMH, which aims to reconcile the bio-psycho-socio-spiritual model with evidence-based methods from traditional healing practices. IMH is rapidly transforming conventional understandings of mental illness and has significant positive implications for the day-to-day practice of mental health care. IMH incorporates mainstream interventions such as pharmacologic treatments, psychotherapy, and psychosocial interventions, as well as alternative therapies such as acupuncture, herbal and nutritional medicine, dietary modification, meditation, etc. Two recent international conferences in Europe and the United States show that interest in integrative mental health care is growing rapidly. In response, the International Network of Integrative Mental Health (INIMH: www.INIMH.org) was established in 2010 with the objective of creating an international network of clinicians, researchers, and public health advocates to advance a global agenda for research, education, and clinical practice of evidence-based integrative mental health care. The paper concludes with a discussion of emerging opportunities for research in IMH, and an exploration of potential clinical applications of integrative mental health care., (Copyright © 2012 Elsevier Inc. All rights reserved.)

Research in the area of herbal psychopharmacology has increased markedly over the past decades. To date however, a comprehensive review of herbal antidepressant, anxiolytic and hypnotic psychopharmacology and applications in depression, anxiety and insomnia has been absent. A search of MEDLINE (PubMed), CINAHL, PsycINFO, and the Cochrane Library databases was conducted (up to February 21st 2011) on commonly used psychotropic herbal medicines. A review of the literature was conducted to ascertain mechanisms of action of these botanicals, in addition to a systematic review of controlled clinical trials for treatment of mood, anxiety and sleep disorders, which are common comorbid psychiatric disorders. Specific emphasis was given to emerging phytomedicines. Analysis of evidence levels was conducted, as were effect sizes (Cohen's d) where data were available. Results provided evidence of a range of neurochemical, endocrinological, and epigenetic effects for 21 individual phytomedicines, which are detailed in this paper. Sixty six controlled studies were located involving eleven phytomedicines. Several of these provide a high level of evidence, such as Hypericum perforatum for major depression, and Piper methysticum for anxiety disorders. Several human clinical trials provide preliminary positive evidence of antidepressant effects (Echium amoenum, Crocus sativus, and Rhodiola rosea) and anxiolytic activity (Matricaria recutita, Ginkgo biloba, Passiflora incanata, E. amoenum, and Scutellaria lateriflora). Caution should however be taken when interpreting the results as many studies have not been replicated. Several herbal medicines with in vitro and in vivo evidence are currently unexplored in human studies, and along with use of emerging genetic technologies "herbomics", are areas of potential future research., (Copyright © 2011 Elsevier B.V. All rights reserved.)

Overview: Complementary and Alternative Medicines (CAMs) are frequently given to children and adolescents for reputed benefits in the treatment of hyperkinetic and concentration disorders such as Attention Deficit Hyperactivity Disorder (ADHD). In such vulnerable populations high quality evidence is required to support such claims., Aims: The aim of the paper is to assess the current evidence of herbal and nutritional interventions for ADHD using a systematic search of clinical trials meeting an acceptable standard of evidence., Methods: PubMed, PsycINFO, Cochrane Library and CINAHL were searched up to May 26th, 2011 for randomised, controlled clinical trials using CAM products as interventions to treat ADHD. A quality analysis using a purpose-designed scale, and an estimation of effect sizes (Cohen's d) where data were available, were also calculated., Results: The review revealed that 16 studies met inclusion criteria, with predominant evidentiary support found for zinc, iron, Pinus marinus (French maritime pine bark), and a Chinese herbal formula (Ningdong); and mixed (mainly inconclusive) evidence for omega-3, and l-acetyl carnitine. Current data suggest that Ginkgo biloba (ginkgo), and Hypercium perforatum (St. John's wort) are ineffective in treating ADHD., Conclusion: The research suggests only some CAMs may be beneficial in ADHD, thus clinicians need to be aware of the current evidence. Promising candidates for future research include Bacopa monniera (brahmi) and Piper methysticum (kava), providing potential efficacy in improving attentional and hyperkinetic disorders via a combination of cognitive enhancing and sedative effects., (Copyright © 2011 Elsevier Ltd. All rights reserved.)

Background: Although dietary and nutrient interventions have been extensively studied as a means of improving arterial stiffness, to our knowledge no systematic analysis of the data has been conducted., Objective: The aim of the current study was to systematically review the human clinical trial data and qualitatively examine the efficacy of dietary and nutrient interventions in the treatment of arterial stiffness., Design: We systematically searched multiple databases until July 2010 for relevant randomized controlled human clinical trials of common dietary and nutrient interventions in the treatment of arterial stiffness. Located studies were subject to strict inclusion criteria and objectively assessed for scientific quality., Results: Of the 75 relevant studies located, we considered 38 studies to be appropriate for review. Results revealed support for intakes of omega-3 (n-3) fish oils (Cohen's d = 0.21-0.81) and soy isoflavones (Cohen's d = 0.35-0.39) in the treatment of arterial stiffness. There was limited but consistent evidence to suggest that salt restriction (Cohen's d = 0.28-0.37) as well as consumption of fermented-milk products (Cohen's d = 0.15-0.33) that contain bioactive peptides improved arterial stiffness. The evidentiary support for intakes of vitamins, micronutrients, and herbal medicines was insufficient. Limited but consistent evidence suggested that caffeine intake acutely increased arterial stiffness (Cohen's d = 0.34-0.51)., Conclusions: Current evidence from several small studies suggests that omega-3 and soy isoflavone supplementation provides an effective means of reducing arterial stiffness. There was little research that explored intakes of herbal medicines or micronutrients in the treatment of arterial stiffness, and this remains an area of potential research.

Objectives: To report on the design, significance and potential impacts of the first documented human clinical trial assessing the anxiolytic and thymoleptic efficacy of an aqueous mono-extract of Piper methysticum (kava). The significance of the qualitative element of our clinical trial is also explored. The Kava Anxiety Depression Spectrum Study (KADSS) is a 3-week placebo-controlled, double-blind, cross-over trial involving 60 adult participants (18-65) with elevated stable anxiety and varying levels of depressive symptoms., Aims: The aims of KADSS are: (1) to determine whether an aqueous standardised extract of kava is effective for the treatment of anxiety; (2) to assess the effects of kava on differing levels of depression; and (3) to explore participants' experience of taking kava via qualitative research. The study also provides preliminary assessment of the safety of an aqueous extract of kava in humans., Conclusion: If results reveal that the aqueous kava preparation exerts significant anxiolytic effects and appears safe, potentially beneficial impacts may occur. Data supporting a safe and effective kava extract may encourage a re-introduction of kava to Europe, UK and Canada. This may provide a major socioeconomic benefit to Pacific Island nations, and to sufferers of anxiety disorders.