Effectiveness of naturopathy for pregnancy in women with diminished ovarian reserve: feasibility randomized controlled trial.

RESEARCH QUESTION: Is conducting a randomized control trial (RCT) to assess the effectiveness of whole-system naturopathy in improving pregnancy rates among women with diminished ovarian reserve (DOR) feasible? DESIGN: A two-arm, parallel group, assessor-blinded feasibility RCT was conducted. Women with DOR, trying to conceive naturally or by ART, were randomly assigned to naturopathy plus usual care, or usual care alone for 16 weeks. Primary outcomes were feasibility (recruitment, adherence, retention rates), acceptability and safety. Secondary outcomes included ongoing pregnancy rates, live birth rates and health-related outcomes (mental health, quality of life, diet, exercise, sleep and weight). Statistical significance of the differences between the two groups (P-values) were exploratory. RESULTS: One hundred and fifteen women completed the screening survey between March and November 2022. Of these, 66 women were assessed for eligibility and 41 (62%) consented. Recruitment resulted in seven enrolments each month. All 41 participants (100%) adhered to the intervention, 38 (93%) completed end-point questionnaires, 32 (78%) found study participation to be acceptable and 18 out of 21 (86%) from the intervention group would recommend a naturopathic intervention to other women with DOR. The naturopathic treatment was associated with only mild and temporary adverse events. No between-group differences were observed for pregnancy and live birth rates. CONCLUSION: The evaluation of whole-system naturopathy through a RCT was feasible and the treatment was acceptable and well tolerated according to women with DOR. Outcomes from this study will help inform sample size calculations powered for fertility outcomes for future RCTs on this topic.

The effectiveness and safety of lifestyle medicine and integrative therapies in inflammatory arthritis: an umbrella review using a hierarchical evidence gathering approach.

Objective: An umbrella review was conducted to provide a comprehensive evaluation of the evidence on lifestyle medicine and integrative therapies for inflammatory arthritis. Methods: Five electronic databases were searched for umbrella reviews, meta-analyses, and systematic reviews of randomised controlled trials on acupuncture, diet, exercise, herbal medicine, nutrient supplements, and mind-body therapies for rheumatoid arthritis, spondyloarthritis, and gout published from January 2012 to December 2022. The primary outcomes were functional status and quality of life. Quality assessment was performed using the A MeaSurement Tool to Assess systematic Reviews (AMSTAR-2) tool, and the certainty of evidence for our primary outcomes was assessed using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach where possible. Results: We included 52 reviews. Exercise was beneficial for functional status in both rheumatoid arthritis and spondyloarthritis, with moderate certainty of evidence. Chinese herbal medicine in combination with disease-modifying anti-rheumatic drugs may improve functional status in rheumatoid arthritis (very low certainty evidence). Acupuncture may improve functional status in rheumatoid arthritis and pain in both rheumatoid arthritis and gout; however, the evidence is of very low certainty. Evidence for other therapies was not clinically significant; however, it suggests possible benefits from quercetin and polyunsaturated fatty acids. Yoga may result in a moderate improvement in functional status when used as an adjunct to medication; however, the certainty of evidence is very low. Diet interventions offered inconsistent improvements to functional status in rheumatoid arthritis, spondyloarthritis, and gout with low to very low certainty. Conclusion: Exercise should be prescribed for people with rheumatoid arthritis and spondyloarthritis. More research is needed to confirm or refute evidence for Chinese herbal medicine, acupuncture, yoga, and anti-inflammatory diets.

Health needs, treatment decisions and experience of traditional complementary and integrative medicine use by women with diminished ovarian reserve: A cross-sectional survey.

BACKGROUND: Women with diminished ovarian reserve (DOR) have fewer eggs than would be expected at their age. It is estimated that 10% of women seeking fertility treatment are diagnosed with DOR. However, the success rate of medically assisted reproduction (MAR) is significantly lower in women with DOR, thus many seek additional approaches. AIM: To explore the health needs of women with DOR, treatment options and experience of treatment including traditional complementary integrative medicine (TCIM). METHODS: Anyone with a diagnosis of DOR, living in Australia or New Zealand, aged over 18 were invited to complete an online survey distributed via fertility support networks and social media platforms from April to December 2021. RESULTS: Data from 67 respondents were included. The main aspects of health that were impacted by DOR were fertility (91.0%) and mental health (52.2%). The main treatment recommended was MAR with most women either currently using MAR (38.8%) or having previously used MAR (37.3%). TCIM was widely used with 88.1% of women utilising supplements, 74.6% consulting with TCIM practitioners, and 65.7% adopting self-care practices. The main reasons for using TCIM were to improve fertility or support pregnancy, and to support general health and well-being. CONCLUSIONS: Women with DOR have additional health needs apart from infertility, most notably mental health support. The main form of treatment utilised is MAR, despite DOR being challenging for fertility clinicians. TCIM was widely used, and respondents perceived benefits related to improving fertility, supporting pregnancy, or improving well-being through use of acupuncture, meditation, naturopathy, massage, yoga.

Phytonutrients and outcomes following breast cancer: a systematic review and meta-analysis of observational studies.

BACKGROUND: Phytonutrient intakes may improve outcomes following breast cancer, but the impact of postdiagnosis introduction vs established prediagnostic exposure as well as optimum doses has not been established. Evidence from observational studies for key exposures was evaluated, including dosage and intake time frames. METHODS: MEDLINE, EMBASE, CINAHL, Cochrane Library, ClinicalTrials.gov, and the ISRCTN registry were searched for prospective and retrospective observational studies investigating the impact of soybean, lignans, cruciferous (cabbage-family) vegetables, green tea, or their phytonutrients on breast cancer survival outcomes. A random-effects model was used to calculate summary hazard ratios (HRs) and 95% confidence intervals (CIs). Nonlinear dose-response analyses were conducted using restricted cubic splines. RESULTS: Thirty-two articles were included. Soy isoflavones were associated with a 26% reduced risk of recurrence (HR = 0.74, 95% CI = 0.60 to 0.92), particularly among postmenopausal (HR = 0.72, 95% CI = 0.55 to 0.94) and estrogen receptor-positive survivors (HR = 0.82, 95% CI = 0.70 to 0.97), with the greatest risk reduction at 60 mg/day. In mortality outcomes, the reduction was mostly at 20 to 40 mg/day. Soy protein and products were inversely associated with cancer-specific mortality for estrogen receptor-positive disease (HR = 0.75, 95% CI = 0.60 to 0.92). An inverse association was observed for serum or plasma enterolactone, measured prediagnosis and early postdiagnosis, with cancer-specific mortality (HR = 0.72, 95% CI = 0.58 to 0.90) and all-cause mortality (HR = 0.69, 95% CI = 0.57 to 0.83). No effects were observed for cruciferous vegetables. There was a 44% reduced risk of recurrence with prediagnostic green tea for stage I and II breast cancer (HR = 0.56, 95% CI = 0.38 to 0.83). CONCLUSIONS: Soy, enterolactone, and green tea demonstrated significant risk reductions in outcomes following breast cancer. Evidence is needed regarding the impact of postdiagnostic introduction or substantial increase of these exposures.

Type and Frequency in Use of Nutraceutical and Micronutrient Supplementation for the Management of Polycystic Ovary Syndrome: A Systematic Scoping Review.

Lifestyle strategies are considered first-line treatment for the management of polycystic ovary syndrome (PCOS). However, complementary therapies, including nutrient supplementation, have been identified as a potential adjunct therapy. Therefore, we systematically mapped the available literature to identify the type and frequency of the use of nutraceutical and micronutrient supplementation for the management of PCOS features. A systematic search of the literature was conducted using CINAHL, Cochrane reviews, Medline, PsycINFO, Scopus and LILACS. All types of study designs were included if they reported on the use of nutraceuticals and/or micronutrient supplementation on features of PCOS in women aged ≥18 years. A total of 344 articles were included. Forty-one supplements were identified, with the most frequently investigated being inositols (n = 86), vitamin D (n = 53), N-acetylcysteine (n = 27) and omega-3 fatty acids (n = 25). Reproductive outcomes were the most commonly reported (n = 285; 83%), followed by metabolic (n = 229; 67%), anthropometric (n = 197; 57%) and psychological (n = 8; 2%). Our results identified that nutraceutical and micronutrient supplementation require further investigation of psychological outcomes in women with PCOS. Moreover, adequately powered primary studies are warranted to investigate therapeutic doses needed for clinical benefits.

Use of traditional and complementary medicine by ethnic Indian women living with polycystic ovary syndrome: a global survey.

BACKGROUND: Traditional, complementary, and integrative medicine (TCIM) is commonly used by those living with Polycystic Ovary Syndrome (PCOS) but little is known about the use of TCIM such as yoga and Ayurveda in ethnic Indian women with PCOS living worldwide. This survey aimed to explore the prevalence and types of TCIM used and in particular the pattern of use of yoga and Ayurveda including reasons for not using and future interest in using them among non-users. METHOD: An online, international cross-sectional survey was conducted using a pre-designed survey tool. Participants were ethnic Indian women of reproductive age who reported that they were medically diagnosed with PCOS. Descriptive analysis was used to identify the proportion of TCIM users, while a multivariable binary logistic regression was used to analyze their characteristics. RESULTS: Data from 3130 respondents were analysed. The prevalence of TCIM use was 80% (2515/3130). Yoga and Ayurveda were the most frequently practised TCIM modalities with a prevalence of 57% and 37% respectively. We found a high future interest in using yoga (81%) and Ayurveda (70%) among the non-users. The motivation for most Ayurveda use was a recommendation from family/friends (66%), rather than personal choice (38%) or the internet (19%). Most women used Ayurveda because it has natural ingredients (64%) and it is safe (60%) and cited its use to be safe and somewhat helpful. The majority of women were currently practising yoga (73%) up to four times a week (54%) at home (93%). Yoga was primarily used to improve overall health (67%), manage weight (64%), stress (54%) hormonal imbalance (49%) and emotional well-being (48%). Barriers to practising yoga were common among the current users and non-users and included lack of motivation (59% and 59%), time constraints (48% and 39%), and non-availability of yoga teachers specialised in PCOS (31% and 23%). Most women found yoga to be helpful and preferred individual one-on-one (52%) yoga sessions specifically tailored for PCOS (58%). CONCLUSION: This is the first international study that discovered the prevalence and pattern of TCIM use among ethnic Indian women with PCOS living worldwide. We support the urgent need for more research, education, and regulation of different TCIM modalities to promote safe and effective practices globally.

A Scoping Review of Ayurveda Studies in Women with Polycystic Ovary Syndrome.

Introduction: Polycystic Ovary Syndrome (PCOS) is a complex disorder with diverse clinical presentations. Women with PCOS use traditional, complementary, and integrative medicines, including Ayurveda (traditional Indian medicine) to manage their symptoms. Therefore, it is important to understand the current evidence base and the potential areas that require further research. Objective: This novel study aimed at providing a description of the Ayurveda studies conducted on women with PCOS and identifying gaps for future research. Methods: This scoping review was undertaken using the Joanna Briggs Institute scoping review guidelines. Relevant electronic databases were searched for any peer-reviewed original research that examined the role of Ayurveda (interventions using single/compound formula of herbs or minerals or metals, Panchakarma procedures and other therapies, and Ayurveda-based diet and lifestyle) for managing symptoms of PCOS in women of reproductive age. Two reviewers independently screened the records, extracted the data on population, intervention, comparator, and outcome characteristics and descriptively summarized the data. Results: Of the 1820 records identified, 57 articles met the inclusion criteria; 32 case studies, 13 randomized controlled trials, 9 pre-post trials, 2 case series, and 1 non-randomized trial. Most studies were conducted in India and used either a compound formula or a complex intervention (e.g., panchakarma therapies and lifestyle modifications). The majority of the case studies/series used an Ayurvedic diagnostic approach that influenced the choice of Ayurveda intervention. Among the interventions, shatapushpa (dill seeds) and krishnatila (black sesame seeds) were the most used single herbs whereas kanchanara guggulu and rajapravartini vati were the most used compound formulas. Basti karma (therapeutic enema) was the most used complex intervention. Reproductive outcomes were the most studied; menstruation, PCOS-related infertility, and polycystic ovary morphology. Conclusions: There are a number of clinical studies on Ayurveda interventions for PCOS with a promising role in managing symptoms of PCOS. However, a few gaps were identified. Future research should aim at: (1) exploring a wider range of interventions, including Ayurvedic diet and lifestyle in different settings/locations; (2) exploring the effectiveness of Ayurveda treatments as an adjunct to biomedical treatments (3) a greater range of outcome measures such as obesity, type 2 diabetes, anxiety, depression, and quality of life needs to be further explored in women with PCOS; and (4) finally, safety and adverse event reporting needs to be undertaken rigorously and systematically.

Lifestyle management in polycystic ovary syndrome - beyond diet and physical activity.

Polycystic ovary syndrome (PCOS) is a common condition affecting reproductive-aged women with reproductive, metabolic and psychological consequences. Weight and lifestyle (diet, physical activity and behavioural) management are first-line therapy in international evidence-based guidelines for PCOS. While these recommend following population-level diet and physical activity guidelines, there is ongoing interest and research in the potential benefit of including psychological and sleep interventions, as well as a range of traditional, complimentary and integrative medicine (TCIM) approaches, for optimal management of PCOS. There is limited evidence to recommend a specific diet composition for PCOS with approaches including modifying protein, carbohydrate or fat quality or quantity generally having similar effects on the presentations of PCOS. With regards to physical activity, promising evidence supports the provision of vigorous aerobic exercise, which has been shown to improve body composition, cardiorespiratory fitness and insulin resistance. Psychological and sleep interventions are also important considerations, with women displaying poor emotional wellbeing and higher rates of clinical and subclinical sleep disturbance, potentially limiting their ability to make positive lifestyle change. While optimising sleep and emotional wellbeing may aid symptom management in PCOS, research exploring the efficacy of clinical interventions is lacking. Uptake of TCIM approaches, in particular supplement and herbal medicine use, by women with PCOS is growing. However, there is currently insufficient evidence to support integration into routine clinical practice. Research investigating inositol supplementation have produced the most promising findings, showing improved metabolic profiles and reduced hyperandrogenism. Findings for other supplements, herbal medicines, acupuncture and yoga is so far inconsistent, and to reduce heterogeneity more research in specific PCOS populations, (e.g. defined age and BMI ranges) and consistent approaches to intervention delivery, duration and comparators are needed. While there are a range of lifestyle components in addition to population-recommendations for diet and physical activity of potential benefit in PCOS, robust clinical trials are warranted to expand the relatively limited evidence-base regarding holistic lifestyle management. With consumer interest in holistic healthcare rising, healthcare providers will be required to broaden their knowledge pertaining to how these therapies can be safely and appropriately utilised as adjuncts to conventional medical management.

Mindfulness-based Interventions and Yoga for Managing Obesity/Overweight After Breast Cancer: A Scoping Review.

INTRODUCTION: Weight gain after breast cancer is common, and obesity after breast cancer increases breast cancer recurrence and mortality. Mindfulness-based interventions (MBIs) and yoga have been shown to be effective in managing obesity/overweight in people without breast cancer. There is a need to systematically map the extent and range of evidence on yoga and MBIs for managing obesity/overweight after breast cancer in order to aid planning and commissioning of future research. METHODS: We conducted a scoping review informed by methods described by Levac et al. Five electronic databases were searched for any peer-reviewed original research (including systematic reviews) that examined the role of yoga and/or MBIs for managing overweight/obesity after breast cancer. Data were extracted on study, population, intervention, comparator and outcome characteristics, and described narratively. RESULTS: We found 18 publications representing 15 unique studies (11 clinical trials, 2 systematic reviews, and 2 observational studies). There were 10 studies on yoga, and 5 on MBIs. Of the clinical trials, only 4/11 examined a weight-related outcome as the primary outcome. The remaining trials examined lifestyle or metabolic outcomes (5/11) or unrelated outcomes such as psychological health (2/11). Gaps in the literature included small sample sizes, lack of cultural diversity amongst participants, inadequate reporting of the intervention, few lifestyle co-interventions offered, lack of active comparator groups, and inadequate safety reporting. CONCLUSIONS: There is a need for adequately-powered RCTs that adhere to reporting guidelines. The use of gold-standard methods for measuring outcomes, and active comparator groups, is also recommended.

Efficacy and Safety of Nutrient Supplements for Glycaemic Control and Insulin Resistance in Type 2 Diabetes: An Umbrella Review and Hierarchical Evidence Synthesis.

Background: Nutrient supplements are widely used for type 2 diabetes (T2D), yet evidence-based guidance for clinicians is lacking. Methods: We searched the four electronic databases from November 2015−December 2021. The most recent, most comprehensive, high-ranked systematic reviews, meta-analyses, and/or umbrella reviews of randomised controlled trials in adults with T2D were included. Data were extracted on study characteristics, aggregate outcome measures per group (glycaemic control, measures of insulin sensitivity and secretion), adverse events, and Grading of Recommendations Assessment, Development, and Evaluation (GRADE) assessments. Quality was assessed using A Measurement Tool to Assess Systematic Reviews Version 2.0 (AMSTAR 2). Results: Twelve meta-analyses and one umbrella review were included. There was very low certainty evidence that chromium, Vitamin C, and omega-3 polyunsaturated fatty acids (Ω-3 PUFAs) were superior to placebo for the primary outcome of glycated hemoglobin (HbA1c) (Mean Difference/MD −0.54, −0.54 and ES −0.27, respectively). Probiotics were superior to placebo for HbA1c (Weighted Mean Difference/WMD −0.43%). There was very low certainty evidence that Vitamin D was superior to placebo for lowering HbA1c in trials of <6 months (MD −0.17%). Magnesium, zinc, Vitamin C, probiotics, and polyphenols were superior to placebo for FBG. Vitamin D was superior to placebo for insulin resistance. Data on safety was limited. Conclusions: Future research should identify who may benefit from nutrient supplementation, safety, and optimal regimens and formulations.

A Qualitative Study Exploring Feasibility and Acceptability of Acupuncture, Yoga, and Mindfulness Meditation for Managing Weight After Breast Cancer.

INTRODUCTION: Weight gain is common after breast cancer. Yoga, mindfulness meditation, and acupuncture may assist with managing weight. However, evidence on effectiveness is limited. This study assessed the feasibility and acceptability of recruiting for and implementing a randomized controlled trial (RCT) evaluating these interventions as adjuncts to lifestyle interventions (diet and exercise) for weight management in women with breast cancer. METHODS: Qualitative study involving virtual focus groups or semi-structured interviews. Participants were recruited via email invitation from a breast cancer consumer organization and breast cancer center in Australia. Eligible participants had received treatment for breast cancer, and were fluent in English. A purposive sample of culturally and linguistically diverse (CALD) participants was also recruited. Focus groups and interviews were audio-recorded, transcribed verbatim and analyzed using thematic analysis with the constant comparison method. RESULTS: Emails were sent to 1415 women of which 37 provided data in 5 focus groups and 1 semi-structured interview, including 1 focus group (n = 6) with only women from CALD backgrounds. Yoga and mindfulness meditation were perceived as feasible and acceptable for weight management, but acupuncture was seen to be too invasive to be acceptable. A focus on wellness rather than weight reduction, flexible program delivery, trusted advice, consideration of participant burden and benefit, and peer-support were key factors perceived to increase feasibility and acceptability. CONCLUSIONS: Yoga and mindfulness meditation are acceptable and useful adjuncts to lifestyle interventions for weight management after breast cancer. This research places end-users at the forefront of trial design, and will inform future trials using these interventions for weight management and improving health and wellbeing after breast cancer.

Nutritional Supplements and Complementary Therapies in Polycystic Ovary Syndrome.

Polycystic ovary syndrome (PCOS) affects 1 in 5 women of reproductive age, and is characterized by menstrual irregularities, clinical or biochemical hyperandrogenism, and the presence of polycystic ovary morphology. One of the recommended treatment strategies in the international evidence-based guidelines is lifestyle modification, which includes diet and exercise, with the aim of improving a range of health outcomes. The incurable nature of PCOS reinforces the importance of developing novel and innovative symptomatic relief strategies, which are currently the only available approaches for improving quality of life for these women. Women with PCOS tend to be nutrient deficient in many common vitamins and minerals, thought to be associated with the psychological (depression, anxiety, etc.) and physiological (insulin resistance, diabetes, infertility, etc.) sequelae of the condition. Nutrient supplementation and the integration of complementary medicine as adjuncts to traditional lifestyle-based therapies in PCOS could therefore provide additional benefits to these women. In this review, we synthesize the evidence regarding nutrient supplementation and complementary therapies in PCOS, predominantly from randomized controlled trials, systematic reviews, and meta-analyses, to provide an overview of the state of knowledge in this field. The evidence to date suggests that specific vitamins (B-12, inositols, folate, vitamins D, E, and K), vitamin-like nutrients (bioflavonoids and α-lipoic acid), minerals (calcium, zinc, selenium, and chromium picolinate), and other formulations (melatonin, ω-3 fatty acids, probiotics, and cinnamon), as well as some complementary approaches such as acupuncture and yoga may be beneficial in PCOS. However, there remain areas of uncertainty and key limitations in the literature that must be overcome before these therapies can be integrated into routine clinical practice.

Treatment of refractory obsessive-compulsive disorder with nutraceuticals (TRON): a 20-week, open label pilot study.

BACKGROUND: Obsessive-compulsive disorder (OCD) is often challenging to treat and resistant to psychological interventions and prescribed medications. The adjunctive use of nutraceuticals with potential neuromodulatory effects on underpinning pathways such as the glutamatergic and serotonergic systems is one novel approach. OBJECTIVE: To assess the effectiveness and safety of a purpose-formulated combination of nutraceuticals in treating OCD: N-acetyl cysteine, L-theanine, zinc, magnesium, pyridoxal-5' phosphate, and selenium. METHODS: A 20-week open label proof-of-concept study was undertaken involving 28 participants with treatment-resistant DSM-5-diagnosed OCD, during 2017 to 2020. The primary outcome measure was the Yale-Brown Obsessive-Compulsive Scale (YBOCS), administered every 4 weeks. RESULTS: An intention-to-treat analysis revealed an estimated mean reduction across time (baseline to week-20) on the YBOCS total score of -7.13 (95% confidence interval = -9.24, -5.01), with a mean reduction of -1.21 points per post-baseline visit (P ≤ .001). At 20-weeks, 23% of the participants were considered "responders" (YBOCS ≥35% reduction and "very much" or "much improved" on the Clinical Global Impression-Improvement scale). Statistically significant improvements were also revealed on all secondary outcomes (eg, mood, anxiety, and quality of life). Notably, treatment response on OCD outcome scales (eg, YBOCS) was greatest in those with lower baseline symptom levels, while response was limited in those with relatively more severe OCD. CONCLUSIONS: While this pilot study lacks placebo-control, the significant time effect in this treatment-resistant OCD population is encouraging and suggests potential utility especially for those with lower symptom levels. Our findings need to be confirmed or refuted via a follow-up placebo-controlled study.

Complementary medicines and therapies in clinical guidelines on pregnancy care: A systematic review.

BACKGROUND: There is a need for evidence-based guidance on complementary medicines and therapies (CMT) use during pregnancy due to high prevalence of use and lack of guidance on the balance of benefit and harms. AIM: Evaluate the extent to which current clinical practice guidelines relevant to Australian healthcare professionals make clear and unambiguous recommendations about CMT use in pregnancy, and synthesise these recommendations. METHODS: The search included EMBASE, PubMed, the National Health and Medical Research Council's Clinical Practice Guidelines Portal, and websites of Australian maternity hospitals and professional/not-for-profit organisations for published guidelines on pregnancy care. Data were synthesised narratively. Guidelines were appraised by two independent reviewers using the Appraisal of Guidelines for Research and Evaluation (AGREE II) instrument. FINDINGS: A total of 48 guidelines were found, of which 41% provided recommendations that were not limited to routine vitamin and mineral supplementation. There were wide variations in recommendations, particularly for vitamin D and calcium. There was some consensus on recommending ginger and vitamin B6 for nausea and vomiting, and additional supplementation for women with obesity. Guidelines generally scored poorly in the domains of editorial independence and rigour of development. DISCUSSION: There is a lack of guidance with regard to appropriate CMT use during pregnancy, which may result in less-than-optimal care. Inconsistency between guidelines may lead to variations in care. CONCLUSION: Guidelines should include clear and unambiguous guidance on appropriate CMT use during pregnancy, be based on a structured search of the evidence and informed by stakeholder engagement.

Integrative Medicine in General Practice in Australia: A Mixed-Methods Study Exploring Education Pathways and Training Needs.

BACKGROUND: Globally, a substantial proportion of general practitioners (GPs) incorporate integrative medicine (IM) into their clinical practice. OBJECTIVE: This study aimed to map the IM education and training pathways and needs of a cohort of Australian GPs who are members of the Royal Australian College of General Practitioners' IM Specific Interest Network, which is a group of GPs with interest in IM. METHODS: We conducted a mixed-methods study comprising of an online, cross-sectional survey supplemented with in-depth semi-structured interviews. Data from the survey and interviews were initially analysed separately and then combined. RESULTS: Eighty-three (83) of 505 eligible GPs/GPs in training (16.4%) participated in the survey, and 15 GPs were interviewed. Results from the two datasets either converged or were complementary. Almost half (47%) of survey respondents had undertaken formal undergraduate or postgraduate IM education, a short course (63%), informal education (71%) or self-education (54%), in at least one of 20 IM modalities listed. Interviewees affirmed there was no single education pathway in IM. Survey respondents who identified as practicing IM were significantly more likely to have IM education, positive attitudes towards IM, particularly natural products, and higher self-rated IM knowledge and competencies. However, knowledge gaps were identified in professional skills domains of population health and context, and organisational and legal dimensions of applied IM practice. Interviewees also highlighted a range of professional and systemic barriers to the practice of IM, education, and training. There was broad support for recognition of IM as a sub-specialty through formalised post-graduate training and accreditation. Most survey respondents (62%) expressed interest in post-fellowship recognition of GPs with advanced skills in IM. CONCLUSION: Our findings demonstrate that it is important to define best practice in IM for GPs in Australia and provide a standardised pathway towards recognition of advanced skills in IM.

Tai Chi for health and well-being: A bibliometric analysis of published clinical studies between 2010 and 2020.

The objective of this bibliometric review was to identify the volume, breadth, and characteristics of clinical studies evaluating Tai Chi published between January 2010 and January 2020. Five English and four Chinese language databases were searched. Following independent screening, 1018 eligible publications representing 987 studies were identified, which was a three-fold increase from the previous decade. Most common were randomized controlled trials (548/987, 55.5 %), followed by systematic reviews (157/987, 15.9 %), non-randomized controlled clinical studies (152/987, 15.4 %), case series (127/987, 12.9 %) and case reports (3/987, 0.3 %) that were conducted in China (730/987, 74.0 %), followed by the United States of America (123/987, 12.5 %) and South Korea (20/987, 2.0 %). Study participants were mostly in the adult (55.2 %) and/or older adult (72.0 %) age groups. The top ten diseases/conditions were hypertension, chronic obstructive pulmonary disease, diabetes, knee osteoarthritis, heart failure, depression, osteoporosis/osteopenia, breast cancer, coronary heart disease and insomnia. A quarter of the studies enrolled healthy participants to evaluate the effects of Tai Chi on health promotion/preservation, balance/falls, and physiological/biomechanical outcomes. Yang style Tai Chi was the most popular, followed by Chen and Sun style. Tai Chi was mostly commonly delivered face-to-face by a Tai Chi instructor in group settings for 60 min, three times a week, for 12 weeks. Most studies (93.8 %) reported at least one outcome in favor of Tai Chi. Adverse events were underreported (7.2 %). Over half fell short of expected intervention reporting standards, signalling the need for Tai Chi extensions to existing guidelines.

The effectiveness of a modified Gui Zhi Fu Ling Wan formulation (Gynoclear™) for the treatment of endometriosis: a study protocol for a placebo-controlled, double-blind, randomised controlled trial.

BACKGROUND: Endometriosis is the presence of tissue similar to that of the endometrium outside the uterine cavity and is the most common cause of chronic pelvic pain. Current non-surgical treatments such as non-steroidal anti-inflammatories, oral contraceptive pills and hormonal treatments have limited effectiveness, and the side effect profile is bothersome. This study will evaluate the efficacy of Gynoclear™ by change in endometriosis-related pain based on the Endometriosis Pain Daily Diary (EPPD) scores. METHODS: This randomised, double-blind, placebo-controlled trial will recruit a minimum of 90 adult participants across Australia who have a laparoscopic visualisation/confirmation of endometriosis in the last 5 years and have current moderate or greater pelvic pain. Participants will be randomly allocated in a 1:1 ratio to receive either Gynoclear™ (active) or placebo. Gyncolear's active ingredients are Carthamus tinctorius (Safflower), Cinnamomum cassia (Chinese cinnamon), Poria cocos (Hoelen), Paeonia suffriticosa (Tree peony), Paeonia lactiflora (Peony) and Salvia miltiorrhiza (Red sage). Participants are asked to complete a total of 5 months' worth of pain diary entries via the EPDD v3, including 1-month screening, 2-month treatment period and 1-month post-treatment follow-up. The primary outcome variable is change in endometriosis-related pain based on the EPDD v3 scores. Secondary outcomes include change in health-related quality of life via the Endometriosis Health Profile (EHP-30), SF-12 and EQ-5D scores as well as changes in rescue analgesic usage, dyspareunia and fatigue via the EPDD. DISCUSSION: This study will determine the safety and efficacy of Gynoclear™ to reduce the severity and duration of non-cyclical pelvic pain, dysmenorrhoea, dyspareunia and other symptoms of endometriosis. Study outcomes will be of interest to health professionals and members of the public who suffer from endometriosis. TRIAL REGISTRATION: Australia and New Zealand Clinical Trials Registry ACTRN12619000807156 . Registered on 3 June 2019.

Can We All Speak the Same 'Language' for Our Patients' Sake? Feedback on Interprofessional Communication and Related Resources.

Background: The Australasian Integrative Medicine Association (AIMA) established a working group to develop the AIMA Guiding Principles for Letter Writing and Letter Writing Templates. The guiding principles were developed to promote effective communication between the diverse range of healthcare practitioners (HCPs) that patients choose to consult. Following the development of the Interprofessional Communication (IPC) resources, AIMA undertook a public consultation as part of a quality assurance process to evaluate the relevance and utility of the resource. Aim: This study reports stakeholder feedback on AIMA's draft guiding principles document. It explores stakeholder attitudes towards IPC and HCPs letter-writing, and interest in ongoing continuing professional development (CPD). Methods: A cross-sectional survey involving 1) an online public consultation survey and 2) a paper survey collected following IPC CPD activities. Quantitative data were analysed using Chi square and Fisher-Freeman-Halton Test. Responses to open ended questions were coded and subject to a thematic analysis. Results: The 64 survey participants and 55 CPD participants represented the Australian healthcare sectors and lay community. Most thought IPC is important (n = 112/117; 96%) and the resources were informative (n = 112/119; 94%), understandable (n = 111/119; 93%), and clinically relevant (n = 105/117; 90%). HCP reported wide variations in their frequency of correspondence with other practitioner types, with rates often concerningly low. Key IPC themes identified were the importance of continuity of care, clarity of communication, and professional practice. CPD participants were most interested in further IPC training (p = 0.001). Conclusions: The IPC resources affirm the role of formal communication pathways, such as letters of correspondence to support coordinated, patient-centred and multidisciplinary care. Challenges with letter writing and IPC signal the need for more student and professional education on the subject to promote continuity of patient care and the delivery of high quality, integrative medicine and health care services.

What do medical specialists think about a proposed academic, integrative health centre in Australia? A qualitative study.

OBJECTIVES: This qualitative study aimed to explore medical specialists' perspectives on a proposed academic integrative healthcare (IHC) centre to be established in their local district. METHODS: A convenience sample of medical specialists were recruited via direct email invitations that was augmented with snowball sampling until data saturation was reached. The in-depth, semi-structured interviews were conducted via telephone, audio recorded and transcribed verbatim, followed by a thematic analysis. RESULTS: Eight participants took part in the study. Three main themes emerged: 1) the benefits of an academic setting, 2) sound clinical governance, and 3) specialists in the field of traditional, complementary and integrative medicine (TCIM). Underpinning the three themes was the belief that patients were at risk of harm due to haphazard, unsupervised use of unproven TCIM. It was anticipated that an academic centre would address these issues with appropriate risk management protocols, effective interprofessional communication, and by upholding the principles of evidence- based practice to ensure safe and coordinated patient-centred care. Opportunities from collaborations within secondary care included centre being recognized as specialists in the field of TCIM, conducting research, and bidirectional learning. CONCLUSIONS: The findings demonstrated that medical specialists acknowledged the need for a TCIM model of care that interfaces with the local secondary care landscape through the implementation of sound safeguards, credentialed practitioners, and evidence-based practice to adequately protect patients and clinicians. The findings will be amalgamated with the input from other stakeholder groups via a community-based participatory research framework to refine the model of care.