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.

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.

Manuka oil based ECMT-154 versus vehicle control for the topical treatment of eczema: study protocol for a randomised controlled trial in community pharmacies in Aotearoa New Zealand.

BACKGROUND: Eczema is a chronic, relapsing skin condition commonly managed by emollients and topical corticosteroids. Prevalence of use and demand for effective botanical therapies for eczema is high worldwide, however, clinical evidence of benefit is limited for many currently available botanical treatment options. Robustly-designed and adequately powered randomised controlled trials (RCTs) are essential to determine evidence of clinical benefit. This protocol describes an RCT that aims to investigate whether a manuka oil based emollient cream, containing 2% ECMT-154, is a safe and effective topical treatment for moderate to severe eczema. METHODS: This multicentre, single-blind, parallel-group, randomised controlled trial aims to recruit 118 participants from community pharmacies in Aotearoa New Zealand. Participants will be randomised 1:1 to receive topical cream with 2% ECMT-154 or vehicle control, and will apply assigned treatment twice daily to affected areas for six weeks. The primary outcome is improvement in subjective symptoms, assessed by change in POEM score. Secondary outcomes include change in objective symptoms assessed by SCORAD (part B), PO-SCORAD, DLQI, and treatment acceptability assessed by TSQM II and NRS. DISCUSSION: Recruitment through community pharmacies commenced in January 2022 and follow up will be completed by mid-2023. This study aims to collect acceptability and efficacy data of manuka oil based ECMT-154 for the treatment of eczema. If efficacy is demonstrated, this topical may provide an option for a novel emollient treatment. The community-based design of the trial is anticipated to provide a generalisable result. ETHICS AND DISSEMINATION: Ethics approval was obtained from Central Health and Disability Ethics Committee (reference: 2021 EXP 11490). Findings of the study will be disseminated to study participants, published in peer-reviewed journal and presented at scientific conferences. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12621001096842. Registered on August 18, 2021 ( https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=382412&isReview=true ). PROTOCOL VERSION: 2.1 (Dated 18/05/2022).

Mapping the clinical practice of traditional, complementary and integrative medicine in oncology in Western countries: A multinational cross-sectional survey.

BACKGROUND: Many cancer patients seek adjunctive therapies to biomedical cancer treatments at some point of their disease trajectory. While acupuncture is increasingly recommended by leading oncological associations, limited evidence exists concerning the evidence-informed practice and adherence to current guidelines of traditional complementary and integrative medicine (TCIM) practitioners treating cancer patients. METHODS: An international online-survey assessed the demographical data, clinical practice, and sources of information used by TCIM practitioners in Austria, Germany, United States of America, Australia, and New Zealand. RESULTS: In total, 404 respondents completed the survey, of which 254 (62.9%) treated cancer patients. Most practitioners were acupuncturists and herbalists (57.1%), had (16.8 ± 9.9) years of clinical experience and see a median of 2 (1, 4) cancer patients per week. Breast cancer (61.8%) is the most common cancer type seen in TCIM clinics. Adjunctive TCIM treatments are frequently concurrent with the patient's cancer specific treatment (39.9%), which is also reflected by the main goal of a TCIM treatment to alleviate side effects (52.4%). However, only 28.0% of the respondents are in contact with the treating oncologist. According to the respondents, pain is most effectively treated using acupuncture, while herbal medicine is best for cancer-related fatigue. TCIM practitioners mostly use certified courses (33.1%) or online databases (28.3%) but often believe that experts are more reliable to inform their practice (37.0%) than research publications (32.7%). CONCLUSION: Acupuncturists and herbalists commonly treat cancer patients. Most practitioners use TCIM as an adjunct to biomedicine as supportive care and use it largely in accordance with current oncological guidelines. PLEASE CITE THIS ARTICLE AS: Huemer M, Graca S, Bitsche S, Hofmann G, Armour M, Pichler M. Mapping the clinical practice of traditional, complementary and integrative medicine in oncology in Western countries: A multinational cross-sectional survey. J Integr Med. 2024; 22(1): 64-71.

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.

Acupuncture for endometriosis: A systematic review and meta-analysis.

Background: Current endometriosis treatments do not always provide symptom relief, with many using complementary approaches. This study examined the effectiveness of acupuncture on pain and quality of life in people with endometriosis. Methods: Searches were conducted on Cochrane Central Register of Controlled Trials (CENTRAL), PubMed, Allied and Complementary Medicine Database (AMED) and Embase (Ovid), Epistemonikos, and Cumulative Index to Nursing and Allied Health Literature (CINAHL; EBSCOhost) on 20 March 2023. Trials were included if they used penetrating acupuncture. Risk of bias was assessed with Cochrane RoB2 and GRADE for overall evidence certainty. Random-effects meta-analyses were undertaken, using Hedges' g or mean difference (MD) both with 95 % confidence intervals (CI). Results: Six studies involving a total of 331 participants were included. Evidence for benefit was found for acupuncture compared to non-specific acupuncture on overall pelvic pain (g = 1.54, 95 % CI 0.92 to 2.16, 3 RCTs, n = 231, low certainty evidence, p<0.001), menstrual pain (g = 1.67, 95 % CI 1.23 to 2.12, 1 RCT, n = 106, moderate certainty evidence, p<0.001), and non-specified pelvic pain (MD -2.77, 95 % CI 2.15 to 3.38, 2 RCTs, n = 125, low certainty evidence, p<0.001), and compared to usual care on menstrual pain (g = 0.9, 95 % CI 0.15 to 1.64, 1 RCT, n = 19, very low certainty evidence, p = 0.02). Most studies reported low rates of adverse events. Conclusion: Acupuncture treatment for endometriosis demonstrated clinically relevant improvements in pelvic pain and should be considered as a potential treatment intervention. Study registration: PROSPERO ID: CRD42023408700.

The Place of Cannabinoids in the Treatment of Gynecological Pain.

Cannabis sativa (L), a plant with an extensive history of medicinal usage across numerous cultures, has received increased attention over recent years for its therapeutic potential for gynecological disorders such as endometriosis, chronic pelvic pain, and primary dysmenorrhea, due at least in part to shortcomings with current management options. Despite this growing interest, cannabis inhabits an unusual position in the modern medical pharmacopoeia, being a legal medicine, legal recreational drug, and an illicit drug, depending on jurisdiction. To date, the majority of studies investigating cannabis use have found that most people are using illicit cannabis, with numerous obstacles to medical cannabis adoption having been identified, including outdated drug-driving laws, workplace drug testing policies, the cost of quality-assured medical cannabis products, a lack of cannabis education for healthcare professionals, and significant and persistent stigma. Although currently lacking robust clinical trial data, a growing evidence base of retrospective data, cohort studies, and surveys does support potential use in gynecological pain conditions, with most evidence focusing on endometriosis. Cannabis consumers report substantial reductions in pelvic pain, as well as common comorbid symptoms such as gastrointestinal disturbances, mood disorders such as anxiety and depression, and poor sleep. Substitution effects were reported, with >50% reduction or cessation in opioid and/or non-opioid analgesics being the most common. However, a substantial minority report not disclosing cannabis consumption to their health professional. Therefore, while such deprescribing trends are potentially beneficial, the importance of medical supervision during this process is paramount given the possibility for withdrawal symptoms.

Cannabis, whether purchased illicitly, or obtained through legal means, is commonly used by those with chronic pelvic pain, especially people with endometriosis. People report several benefits from using cannabis, including being able to reduce their normal medications including opioid based painkillers, but often don't tell their health professional about this. This could lead to issues with withdrawal symptoms, so clinicians should be aware of the high prevalence of use of cannabis in this population.

Unmet Needs of Australians in Endometriosis Research: A Qualitative Study of Research Priorities, Drivers, and Barriers to Participation in People with Endometriosis.

Background and Objectives: Endometriosis causes significant personal and societal burden. Despite this, research funding lags behind other chronic conditions. Determining where to prioritise these limited funds is therefore vital. Research priorities may also differ between individuals with endometriosis and clinicians/researchers. The aim of this research project is to explore research priorities and factors shaping participation in endometriosis research from the perspective of people with endometriosis in Australia. Materials and Methods: Four focus groups involving 30 people with endometriosis were conducted and analysed using qualitative inductive content analysis. Results: Two categories were developed from the data: unmet research needs and motivators and barriers to participation in endometriosis research. Participants expressed interest in developing non-invasive diagnostic tools and a more multidisciplinary or holistic approach to treatment. Participants urgently desired research on treatment options for symptom management, with many prioritising non-hormonal treatments, including medicinal cannabis and complementary medicine. Others prioritised research on the causes of endometriosis over research on treatments to assist with prevention and eventual cure of the disease. The main drivers for participating in endometriosis research were hope for symptom improvement and a reduction in time to diagnosis. Research design features that were important in supporting participation included ease of access to testing centres (e.g., for blood tests) and sharing test results and automated data collection reminders, with simple stra-tegies to record data measurements. Research incentives for younger people with endometriosis and a broad dissemination of information about research projects was considered likely to increase participant numbers. Barriers included time commitments, a lack of flexibility around research appointments for data collection, travel or work commitments, concerns about the safety of some products, and trying to conceive a child. Conclusions: People with endometriosis were open to participating in research they felt aligned with their needs, with a significant focus on diagnostic tools and symptom relief. However, researchers must co-design approaches to ensure convenience and flexibility for research participation.

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.

The changing clinical landscape in acupuncture for women's health: a cross-sectional online survey in New Zealand and Australia.

BACKGROUND: Acupuncture is a popular treatment for women's health. Several trials and meta-analysis have been published in recent years on key women's health conditions but it is unclear if this has led to any changes in clinical practice or referrals from other health professionals. The aim of this survey was to explore if, how, and why, aspects of acupuncture practice have changed since our survey in 2013. METHOD: An online cross-sectional survey of registered acupuncturists and Chinese Medicine practitioners in Australia and New Zealand. Questions covered the practitioner demographics and training, women's health conditions commonly treated, modalities used, sources of information and continuing education (CE) (e.g. webinars), changes in clinical practice, and referral networks. RESULTS: One hundred and seventy registered practitioners responded to this survey, with 93% reporting treating women's health in the last 12 months. The majority of respondents were from Australia (60%), held a bachelors level qualification (60%), and used a traditional Chinese medicine framework (86%). Most practitioners incorporated other modalities in addition to acupuncture. Most practitioners' referral networks were predominantly based on word of mouth for menstrual, fertility and pregnancy related conditions, with referrals from medical practitioners being much less common. More than half (57%) reported having changed their women's health practice in the past 12 months; just over a quarter of those who changed treatment (27%) reported it was due to research findings. The most commonly used sources of information/CE used to inform treatment were webinars and conferences, while peer-reviewed journal articles were the least commonly used source. CONCLUSION: Acupuncture practitioners in Australia and New Zealand commonly treat women's health conditions, but this is usually the result of women seeking them out, rather than being referred from a medical practitioner. The majority of practitioners did report changing their women's health practice, but peer reviewed academic articles alone are not an ideal medium to convey this information since practitioners favour knowledge obtained from webinars and conferences. Academics and other clinician researchers should consider alternative means of disseminating knowledge beyond traditional academic publications and conferences, special interest groups may assist in this and also help improve research literacy.

Allied health and complementary therapy usage in Australian women with chronic pelvic pain: a cross-sectional study.

BACKGROUND: Chronic pelvic pain (CPP) causes non-cyclical pelvic pain, period pain, fatigue and other painful symptoms. Current medical and surgical management strategies are often not sufficient to manage these symptoms and may lead to uptake of other therapies. AIMS: To determine the prevalence of allied health (AH) and complementary therapy (CM) use, the cost burden of these therapies and explore predictive factors for using allied health or complementary medicines. MATERIALS AND METHODS: An online cross-sectional questionnaire using the WERF EndoCost tool was undertaken between February to April 2017. People were eligible to participate in the survey if they were aged 18-45, living in Australia and had chronic pelvic pain. RESULTS: From 409 responses, 340/409 (83%) of respondents reported a diagnosis of endometriosis. One hundred and five (30%) women with self-reported endometriosis, and thirteen (18%) women with other forms of CPP saw at least one AH or CM practitioner in the previous two months, with physiotherapists and acupuncturists the most common. Women who accessed CM or AH services spent an average of $480.32 AUD in the previous two months. A positive correlation was found between education and number of AH or CM therapies accessed in the past two months (p < 0.001) and between income level and number of therapists (p = 0.028). CONCLUSIONS: Women with CPP commonly access AH and CM therapies, with a high out of pocket cost. The high cost and associations with income and education levels may warrant a change to policy to improve equitable access to these services.

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.

Effects of cannabis ingestion on endometriosis-associated pelvic pain and related symptoms.

BACKGROUND: The use of cannabis for symptoms of endometriosis was investigated utilising retrospective archival data from Strainprint Technologies Ltd., a Canadian data technology company with a mobile phone application that tracks a range of data including dose, mode of administration, chemovar and their effects on various self-reported outcomes, including pelvic pain. METHODS: A retrospective, electronic record-based cohort study of StrainprintTM users with self-reported endometriosis was conducted. Self-rated cannabis efficacy, defined as a function of initial and final symptom ratings, was investigated across the included symptom clusters of cramps, pelvic pain, gastrointestinal pain, nausea, depression, and low libido. Cannabis dosage form, dose and cannabinoid ratio information was also recorded. RESULTS: A total number of 252 participants identifying as suffering endometriosis recorded 16193 sessions using cannabis between April 2017 and February 2020. The most common method of ingestion was inhalation (n = 10914, 67.4%), with pain as the most common reported symptom being treated by cannabis (n = 9281, 57.3%). Gastrointestinal symptoms, though a less common reason for cannabis usage (15.2%), had the greatest self-reported improvement after use. Inhaled forms had higher efficacy for pain, while oral forms were superior for mood and gastrointestinal symptoms. Dosage varied across ingestion methods, with a median dose of 9 inhalations (IQR 5 to 11) for inhaled dosage forms and 1 mg/mL (IQR 0.5 to 2) for other ingested dosage forms. The ratio of THC to CBD had a statistically significant, yet clinically small, differential effect on efficacy, depending on method of ingestion. CONCLUSIONS: Cannabis appears to be effective for pelvic pain, gastrointestinal issues and mood, with effectiveness differing based on method of ingestion. The greater propensity for use of an inhaled dosage delivery may be due to the rapid onset of pain-relieving effects versus the slower onset of oral products. Oral forms appeared to be superior compared to inhaled forms in the less commonly reported mood or gastrointestinal categories. Clinical trials investigating the tolerability and effectiveness of cannabis for endometriosis pain and associated symptoms are urgently required.

Manual Acupuncture Plus Usual Care Versus Usual Care Alone in the Treatment of Endometriosis-Related Chronic Pelvic Pain: A Randomized Controlled Feasibility Study.

Objective: To determine the acceptability and feasibility of acupuncture for the treatment of endometriosis-related chronic pelvic pain. Design: A prospective, randomized controlled feasibility study. Setting: Outpatient setting in Sydney, Australia. Subjects: Participants who were aged 18-45 years, had a confirmed laparoscopic diagnosis of endometriosis in the past 5 years, and had regular menstrual periods and mean pelvic pain scores ≥4/10. Interventions: Sixteen acupuncture treatments delivered by registered acupuncturists using a standardized point protocol over 8 weeks, twice per week plus usual care compared with usual care alone. Outcome measures: Primary outcome measures were feasibility, safety, and acceptability of the acupuncture intervention. Secondary outcomes were changes in self-reported pelvic pain scores, changes in quality of life as measured by the Endometriosis Health Profile (EHP-30), changes in descending pain modulation, and changes in systemic inflammation (plasma interleukin [IL-6] concentrations). Results: Twenty-nine participants were eligible to participate, with 19 participants completing the trial. There was unequal withdrawals between groups; the acupuncture group had a withdrawal rate of 14% compared with 53% in usual care. Adverse events were uncommon (6.7%) and generally mild. A 1.9 point decrease in median nonmenstrual pain scores and a 2.0 decrease in median menstrual pain scores between baseline and end of trial were observed in the acupuncture group only. Improvements in all domains of the EHP-30 were seen in the acupuncture group, with no changes seen in usual care. There was no difference between baseline and end of treatment in IL-6 concentrations for either group. Conclusions: Acupuncture was an acceptable, well-tolerated treatment and it may reduce pelvic pain and improve quality of life; however, usual care was not an acceptable control group. Trial Registration: anzctr.org.au: ACTRN12617000053325. Prospectively registered January 11, 2017.

Dietary Practices of Women with Endometriosis: A Cross-Sectional Survey.

Background: Endometriosis causes deleterious effects on the lives of sufferers across multiple domains impacting quality of life. Commonly utilized pharmaceutical interventions offer suboptimal efficacy in addition to potentially intolerable side effects for many women. There is some evidence for dietary therapies reducing endometriosis symptoms, but little data on dietary preferences/strategies used, and their impact, in a community setting. Methods: A cross-sectional online survey was conducted between October and December 2017 to investigate the self-management strategies employed by women with endometriosis. Participants were aged 18-45 years, living in Australia, and had a surgically confirmed diagnosis of endometriosis. Results: Four hundred eighty-four responses were included for analysis, with 76% of women reporting the use of general self-management strategies within the last 6 months. Of these, 44% of respondents reported using dietary strategies for symptom management. Reducing or eliminating gluten, reducing or eliminating dairy, and the low-fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAP) diet were the most commonly reported dietary strategies utilized. Respondents reported a 6.4/10 effectiveness score for reduction in pelvic pain with dietary changes, with no difference in pain reduction between the various diets used. Furthermore, women self-reported significant improvements in comorbidities such as gastrointestinal (GI) disturbance (39%), nausea and vomiting (15%), and fatigue (15%). Conclusions: Dietary modifications are a very common self-management strategy employed by people with endometriosis, with the greatest benefit reported on GI symptoms. Reducing or eliminating gluten, dairy, or FODMAPs or a combination of these was the most common strategy. No single diet appeared to provide greater self-reported benefits than others.

A cross-sectional study of traditional Chinese medicine practitioner's knowledge, treatment strategies and integration of practice of chronic pelvic pain in women.

BACKGROUND: Chronic pelvic pain (CPP) in women is persistent, intermittent cyclical and non-cyclical lower abdominal pain, lasting for more than 6 months. Traditional Chinese Medicine (TCM) is a popular treatment option for women's health conditions, but little is known about how treatment for CPP is delivered by TCM practitioners. The aim of this survey was to explore practitioners understanding and treatment of women with CPP, and how they integrate their management and care into the health care system. METHOD: An online cross-sectional survey of registered TCM practitioners in Australia and New Zealand between May and October 2018. Survey domains included treatment characteristics (e.g. frequency), evaluation of treatment efficacy, referral networks, and sources of information that informed clinical decision making. RESULTS: One hundred and twenty-two registered TCM practitioners responded to this survey, 91.7% reported regular treatment of women with CPP. Treatment decisions were most-often guided by a combination of biomedical and TCM diagnosis (77.6%), and once per week was the most common treatment frequency (66.7%) for acupuncture. Meditation (63.7%) and dietary changes (57.8%) were other commonly used approaches to management. The effectiveness of treatment was assessed using multiple approaches, most commonly pain scales, (such as the numeric rating scale) and any change in use of analgesic medications. Limitations to TCM treatment were reported by over three quarters (83.7%) of practitioners, most commonly due to cost (56.5%) and inconvenience (40.2%) rather than safety or lack of efficacy. Sources informing practice were most often Integration within the wider healthcare system was common with over two thirds (67.9%) receiving referrals from health care providers. CONCLUSION: TCM practitioners seeing women with various CPP symptoms, commonly incorporate both traditional and modern diagnostic methods to inform their treatment plan, monitor treatment progress using commonly accepted approaches and measures and often as a part of multidisciplinary healthcare for women with CPP.

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.

The Role of Research in Guiding Treatment for Women's Health: A Qualitative Study of Traditional Chinese Medicine Acupuncturists.

BACKGROUND: Surveys of acupuncture practitioners worldwide have shown an increase in the use of acupuncture to treat women's health conditions over the last ten years. Published studies have explored the effectiveness of acupuncture for various conditions such as period pain, fertility, and labor induction. However, it is unclear what role, if any, peer-reviewed research plays in guiding practice. METHODS: Acupuncturists with a significant women's health caseload were interviewed online in three small groups to explore factors that contribute to acupuncturists' clinical decision made around treatment approaches and research. RESULTS: Eleven practitioners participated in the focus groups. The overarching theme that emerged was one of 'Not mainstream but a stream.' This captured two themes relating to acupuncture as a distinct practice: 'working with what you've got' as well as 'finding the right lens', illustrating practitioners' perception of research needing to be more relevant to clinical practice. CONCLUSIONS: Acupuncture practitioners treating women's health conditions reported a disconnect between their clinical practice and the design of clinical trials, predominantly due to what they perceived as a lack of individualization of treatment. Case histories were popular as a learning tool and could be used to support increasing research literacy.