Naturopathic Medicine for Endometriosis (NatME). Results of a pilot study

doi:10.21203/rs.3.rs-7396031/v1

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Research Article

Naturopathic Medicine for Endometriosis (NatME). Results of a pilot study

https://doi.org/10.21203/rs.3.rs-7396031/v1

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Background

Endometriosis is a chronic inflammatory condition characterised by pain and significant impacts on quality of life. Research shows women with endometriosis have unmet healthcare needs. Evidence also demonstrates naturopaths play an important role for women with endometriosis, and group visits are an effective model of care for chronic disease management. This study examines (a)the feasibility of a group visit model for delivering naturopathy to people with endometriosis, and (b)the preliminary effectiveness of the model.

Methods

a pilot feasibility study was delivered in four Australian locations. The intervention was a 12-week program comprising six visits, incorporating personalised naturopathic care and education within a supportive group environment. Outcomes were measured at baseline, end visit, and one-month follow-up. The study was registered February 2022 with Australian New Zealand Clinical Trials Registry (ACTRN12622000222741).

Results

Thirty-one participants were enrolled. High levels of satisfaction with the program structure, content, and facilitators were observed with high retention rates. Participants agreed (96.3%) or mostly agreed (3.7%) naturopathic group visits are a good way of receiving care for endometriosis. In clinical outcomes statistically significant improvements in pain-related items across all validated measures (Endometriosis Health Profile [EHP-5] pain baseline to follow-up p = 0.003; Health-related Quality of Life pain/work baseline to follow-up p = < 0.003), as well as in all five items of the EHP-5 and across all 13 items on the Pain Catastrophizing Scale.

Conclusion

A group naturopathic intervention program for endometriosis may result in clinical improvement of endometriosis, and has been seen to be feasible and well-accepted for women with endometriosis.

Naturopathy

complementary therapies

endometriosis

women’s health

group visits

shared medical appointments

Endometriosis is a complex, chronic inflammatory condition affecting women and persons assigned female at birth and characterized by endometrium-like tissue being present outside the endometrium(1). Over 14% of Australian females of reproductive-aged are diagnosed with endometriosis(2). The condition is often characterized by symptoms including chronic pain (pelvic and other pain), fatigue, painful urination and bowel movements, and painful sex along with other comorbidities including impacts on mental health, quality of life and financial wellbeing(3). Endometriosis can affect trans men and non-binary people, yet the available research on the condition is overwhelmingly focused on cis women. Women¹ with endometriosis have reported negative healthcare experiences, unfeasible costs of endometriosis-related healthcare, unmet healthcare needs and a desire for increased access to allied health and complementary therapies (non-pharmaceutical and non-surgical treatments)(4).

Naturopathy is a traditional medicine system originating from Europe(5) focused on supporting the body’s natural healing processes with key philosophical tenets including Tolle Causam (treat the cause) and Tolle Totum (treat the whole person)(6). Use of naturopathic medicine is high among Australian women(7) with women often consulting naturopaths for female-specific health concerns, such as menstrual disorders(8), menopause-related symptoms, pregnancy-related complaints(9) and polycystic ovary syndrome(10) amongst other chronic conditions(11). Evidence demonstrates naturopaths play a significant role in endometriosis with approximately 20% of Australian women with endometriosis reporting they consult with a naturopath(12). Naturopathy services in Australia are mostly delivered in private practice settings, generally using a one-on-one long consultation model (i.e. an individual patient consulting with an individual practitioner). This model proffers the benefit of person-centered care and individualization(13) but by its very nature, limits the number of patients any one clinician can reach, while adding a financial barrier for many patients. The cost burden of consultation fees and prescription are typically borne by the patient as an out-of-pocket expense(14). Both of these features represent financial and social barriers to community access to naturopathic care(15).

Group visits (also known as shared medical appointments [SMAs], group medical visits [GMVs], or - when they incorporate integrative therapies such as acupuncture, mind-body therapies or others - integrative medicine group visits [IMGVs]), are models of care that have been shown to increase access to health care for diverse populations in Australia(16), the United States (US)(17) and other countries(18, 19). A group visit is a patient-centered model where multiple patients (usually sharing a similar medical condition or risk factors) consult with a health professional or team of health professionals within a group setting; the appointment can include medical consultation including measurement of vitals, medication reviews, patient education and other integrative medicine disciplines(20). Group visits aim to improve patient outcomes by combining three important components – clinical care, patient education and peer support(21). Evidence shows group visits are effective in managing chronic conditions such as diabetes(22, 23) and chronic pain(24, 25) and they have been found to be feasible and well accepted for women’s health conditions(26). There is also a substantial body of evidence in support of group-delivered maternal and pregnancy care where group prenatal care has been found to be both feasible and more effective than individual care across a variety of settings and populations(27, 28). Although there is interest within the naturopathic profession to utilize the group visit model due to the model aligning well with naturopathic principles of practice(29), to date evidence is lacking for feasibility and efficacy of delivering naturopathic care using a group visit model. However, evidence for the benefits of group visits for chronic disease management and women’s health provides a good basis for more research examining the model for women with endometriosis through a naturopathic lens.

In summary, there is an issue of access to naturopathic medicine with the current mode of delivery using private consultations, and lack of access through health system pathways. Given that women with endometriosis are high users of naturopathy, have unmet healthcare needs and appear to demonstrate a desire for greater access to complementary therapies, research is needed into the feasibility and effectiveness of new models for delivering naturopathic care to women with endometriosis. Group visits have been seen to improve healthcare access, and be an effective healthcare model for chronic disease management. As such, this study – Naturopathic Medicine for Endometriosis (NatME) – used an uncontrolled pilot feasibility trial design to examine (a) the feasibility of a group visit model for delivering naturopathic care to people with endometriosis, and (b) the preliminary effectiveness of the group visit model in improving health outcomes of this population.

Study design and setting

NatME was an uncontrolled pilot feasibility study, that took place in four different locations in Australia between April 2022 and August 2022, with four cohorts of patients. The intervention comprised four cohorts of participants, across three urban locations within the region and one online cohort. The four separate study locations and settings included: i) Coolangatta, Queensland, Australia, in a seminar room within Southern Cross University Gold Coast campus; ii) within a private practice natural therapies clinic in Brisbane, Queensland iii) in Lismore, NSW, Australia in a teaching room within Southern Cross University Lismore campus; and iv) online via the zoom conferencing platform. Each location had space for group activity, as well as an adjoining space for private one-on-one consultations between patient and practitioner (and equivalent “breakout rooms” for the online cohort). The intervention was delivered to each cohort of patients by a qualified naturopath practitioner with expertise in women’s health and endometriosis, alongside a co-facilitator who was trained in shared medical appointment facilitation. The co-facilitator in the program was the lead researcher in this study. The study was approved by the Southern Cross University Human Research Ethics Committee (approval no. 2021/117) and registered with Australian New Zealand Clinical Trials Registry (ANZCTR) (registration no. ACTRN12622000222741) on 8th February 2022.

Participants

Patient participants were recruited using purposive sampling. For example, the study was advertised using a flyer through endometriosis support groups and key endometriosis advocacy groups (Endometriosis Australia and QENDO). Recruitment information was widely disseminated on social media and via emailed newsletters (via Southern Cross University, other stakeholder organizations and expert clinicians in endometriosis with well-established public profiles and online engagement).

Practitioner participants were recruited through professional naturopathic networks including the Naturopaths and Herbalists Association of Australia symposium and website, and naturopathic clinics identifying as having a clinical focus on women’s health and/or endometriosis. Practitioner participants were provided training in facilitating shared medical appointments through Australasian Society of Lifestyle Medicine and remuneration of $1000 at completion of the program, as well as counting their participation as continuing professional development (CPD). Snowball sampling was also used, where participants may have invited other prospective participants to the study.

Participants who fulfilled the following inclusion criteria were included in the study: aged ≥ 18 years, female sex, had a diagnosis of endometriosis made by a medical doctor, were intending to seek naturopathic care for the primary purpose of managing endometriosis-related symptoms, spoke fluent English and were willing to commit to attending group visits (i.e. could not foresee a reason for missing two or more sessions). Participants were excluded if they were seeking naturopathic services solely or primarily for fertility issues, preconception care or pregnancy, were pregnant, were currently under the care of a naturopath and/or taking herbal or naturopathic medicines, had a medical diagnosis of serious mental illness (a clinically diagnosed disorder that significantly interferes with an individual’s cognitive, emotional and social abilities, e.g. bipolar disorder or schizophrenia) or were had an active medically diagnosed substance abuse disorder (i.e. alcohol, prescribed or illicit drugs).

Four naturopath practitioners who fulfilled the following criteria were recruited to deliver the intervention: had a minimum of 5 years’ experience in naturopathic clinical practice, were currently working as a naturopath in part-time or full-time clinical practice (including casual or locum naturopaths who work at least one day per week), identified as experienced and having a clinical focus in the area of women’s health and/or endometriosis, were a member of an Australian professional association covering naturopaths, held a Bachelor degree or higher in naturopathy or an Advanced Diploma in Naturopathy completed prior to 2016, as their minimum qualification, held professional indemnity insurance that covered the practice of naturopathy, spoke fluent English and were female. All participants (including patients and practitioners) provided written, informed consent to participate in the study before any study procedures commenced.

Interventions

The NatME intervention was designed following an earlier suite of research comprising focus group studies involving people with endometriosis and naturopaths who specialize in endometriosis treatment. To inform the NatME intervention design, the previous qualitative research explored healthcare needs and experiences of people with endometriosis (4) and experiences and perspectives of patients and women’s health naturopaths on naturopathic treatment for endometriosis, alongside their views on prospective naturopathic group consultations.

Program structure

NatME used a group visit model to deliver six group naturopathic consultations consecutively to small groups of people with endometriosis over the course of three months which comprised of six fortnightly group visits lasting two hours per visit. Within the group naturopathic intervention, each patient received care in the presence of one another, that was reflective of general naturopathic practice including education on health topics relevant to the management of endometriosis (identified in prior research), self-care, and where appropriate, individualized prescription of herbal, nutritional or lifestyle medicine within the scope of naturopathic practice and according to individual patient needs. The intervention was administered by a qualified naturopath with clinical experience in the field of endometriosis and women’s health. The intervention reflected “usual naturopathic care” that would ordinarily be delivered in a one-on-one consultation but was delivered in the presence of other patients (i.e. as a group, where all patients had an opportunity to discuss the health topics collaboratively and to ask questions). Patients were permitted to speak from personal experience but were not permitted to provide advice to other participants. Only the naturopathic practitioner was permitted to provide expert advice. The naturopathic practitioner delivered the intervention collaboratively with the group facilitator.

The group facilitator managed the group, including managing group dynamics, encouraging participation, keeping to topic, keeping to time, recording clinical notes, and ensuring all participants have been reviewed by the naturopath at every visit. The group facilitator was also able to deliver specific group activities, such as group shares, mindfulness, sharing recipe ideas and discussing health topics if required, but only where the naturopathic practitioner was unavailable (i.e. was required to conduct a brief one-on-one consultation with patients or attending to urgent medical needs, the latter which did not occur). The group facilitator was also a qualified naturopathic practitioner.

Risk management

The facilitator and naturopathic practitioner were trained clinicians who were sensitive to any signs of distress, discomfort or adverse reactions related to the intervention or treatments prescribed within the intervention. At every group session, each patient had an individual (within the group setting) review of progress and prescriptions. As such, prescriptions were closely monitored (reflecting one-on-one real-world clinical practice) and were adjusted, ceased or continued according to patient progress, symptoms and preferences, with record keeping of adherence or modification via clinical note-taking. Patients were also required to complete an intake form on the day of the group visit, prior to the group commencing on which they indicated if they would like a brief (approx. five minutes) private check-in with the practitioner to discuss any concerns they did not wish to discuss within the group. The facilitator reviewed these forms prior to commencing the group and scheduled any private check-ins into the proceedings for the session (either at the beginning or end of the group). The naturopathic practitioner used their expert clinical judgement to assess the need for referral to another service such as a medical practitioner or counsellor, if required (reflecting one-on-one real-world clinical practice).

Outcomes measured

Primary outcome – feasibility

Feasibility was examined by measure the following six outcomes: i) acceptability, ii) demand, iii) compliance, iv) implementation, v) adaptation and vi) integration. A full description of the methods of measuring feasibility outcomes is presented in Table 1.

Table 1
Feasibility outcome measures
Outcome	Method of measurement
Acceptability The reaction of patients and practitioners to the intervention	(1) Patient questionnaire domains: experience of the intervention, satisfaction with the NatME curriculum, and perception of facilitator and practitioner performance (2) Practitioner questionnaire domain: experience and satisfaction with the intervention
Demand The reaction to and likelihood that patients and practitioners would utilize the intervention again	(1) Patient and practitioner questionnaire domains: likelihood of using the intervention again (2) Recruitment and retention rates
Compliance The extent to which participants complied with the treatments	(1) Observation and field notes documented by the facilitator
Implementation The extent to which the intervention could be fully implemented as planned and proposed	(1) Practitioner questionnaire domains: ease of implementation (2) Observation and field notes documented by the group facilitator
Adaptation The extent to which the intervention was modified to be appropriate for the situation, or could be modified to address populations with different health conditions	(1) Practitioner questionnaire domains: ease of adapting the intervention to other health conditions (2) Observation and field notes documented by the group facilitator
Integration The extent to which the new model can fit within existing naturopathic practice	(1) Patient questionnaire domains: Importance of the intervention, likelihood of recommending the program and using the program again or attending other naturopathic group visits (2) Practitioner questionnaire domains: satisfaction with the intervention, performance, and structure; likelihood of using the intervention again and recommending the intervention to other naturopaths (3) Observation and reflection on field notes documented by the group facilitator

>>Please insert Table 1 here>>

Secondary outcomes – clinical efficacy

Secondary outcomes were measured at baseline, post-intervention (week 12) and one-month follow-up (week 16). Five patient-reported outcome measures were self-administered by participants. Health-related quality of life was measured using the 12-item Short Form survey (SF-12) and Endometriosis Health Profile-5 (EHP-5). Individual patient outcomes were measured using the Measure Yourself Medical Outcome Profile (MYMOP). Sexual health was measured using the Sexual health outcomes in women questionnaire (SHOW-Q). Participants pain experience was measured using the Pain Catastrophizing Scale (PCS). Maintenance, or the extent to which effects in individuals are maintained over time was measured with a week 16 follow-up of all patient reported outcome measures.

Verification of primary and secondary outcome measures

Feasibility and clinical outcomes via program evaluation and validated clinical questionnaires were verified with verbal feedback during the final 15–30 minutes of the final session (visit 6) for each cohort. The group facilitator facilitated the feedback sessions. A sample run sheet with questions asked during these sessions is presented in Appendix 1, Table A1.

>Table A1. Session 6 week 12 NatME program verbal feedback run sheet>

Sample size

The study aimed to recruit four cohorts of 5–10 participants, which aligned with sample sizes reported in other pilot studies of group interventions(30–32) as well as recommended sample sizes for pilot studies(33).

Statistical methods

Data was either imported via Redcap, or entered manually (if derived from hard-copy documents). Data was then cleaned, coded and analyzed using SPSS v25. Due to the type of data collected, missing data were simply reported as missing.

Data was analyzed using descriptive analysis for numerical data. Frequency distributions and percentages were used to describe categorical data. Means and standard deviations (or medians and interquartile ranges) were used for continuous data, depending on data distribution. The Friedman test was used to determine p values for ordinal variables, alongside the Wilcoxon test with Bonferroni correction. The Cochran Q test was used to determine p values for nominal variables alongside the McNemar test with Bonferroni correction. Statistical significance was set at p < 0.05.

A total of 46 participants consented to participate of which 31 were enrolled into the study. Eleven of the 46 were placed on a waitlist because their requested location was already at capacity, and four participants withdrew consent prior to the baseline visit (enrolment). Of the 31 participants enrolled four participants were dropouts at visit two or earlier and their data was not included in analysis. A diagram of the flow of participants through the recruitment and enrolment processes is presented in Fig. 1.

Feasibility outcomes

Feasibility results of the patient program evaluation questionnaire are presented in Table 2. All participants agreed (96.3%) or mostly agreed (3.7%) that naturopathic group visits are a good way of receiving care for endometriosis. Demand and acceptability were high with an 87% (n = 27 of 31) retention rate and 96.3% reporting they would recommend NatME to other people with endometriosis while 100% of participants would participate in other naturopathic group visits. All participants were satisfied that their healthcare needs were met in the group visits and 100% were satisfied with the practitioner and facilitator. Over half of participants (51.9%) were satisfied with the program length (12 weeks), while 48.1% reported the program was too short. High levels of learning were also reported by majority of participants (74.1%). The extent to which participants were able to comply with the treatments were unable to be tracked due to the complexity of the intervention and heterogeneity of treatments prescribed. Compliance is discussed within the study limitations with recommendations for future studies of complex interventions. Verbal feedback was highly synonymous with questionnaire and clinical results. Verbal feedback reflected high levels of satisfaction with the overall program and with clinical results (e.g. reduced pain levels) as well as high levels of learning with increased knowledge leading to a sense of empowerment. One participant stated “Seeing how you can take your health into your own hands ..that really is empowering”; another stated “I'm more empowered, because I now have a lot of knowledge”. Verbal feedback also included satisfaction with the program structure, benefits of group support and feelings of safety within the group environment. For example, one participant stated “Just knowing that you're in an environment where people actually understand and it's okay to be in pain, I didn't have to pretend to be someone else, I could just sit there and just get lifted up by everyone else”; and others stated “It's a very safe space”. Some minor barriers and challenges to attending the program were reported verbally including motivation, traffic, and missing face-to-face sessions due to illness. A comprehensive list of participant quotes for each topic are included in Appendix 2, Table A2.

Table 2
Patient program evaluation questionnaire responses
Variable	Response	Frequency (%) n = 27
Expectations (How would you rate your experience of the NatME program?)	1 Exceeded expectations	21 (77.8%)
	2 Met expectations	5 (18.5%)
	3 Met most expectations	1 (3.7%)
	4 Fell slightly short of expectations	0 (0%)
	5 Fell extremely short of expectations	0 (0%)
Satisfaction (How satisfied were you with the NatME program overall?)	1 Very satisfied	23 (88.5%)
	2 Satisfied	2 (7.7%)
	3 Neither satisfied nor dissatisfied	1 (3.8%)
	4 Dissatisfied	0 (0%)
	5 Very dissatisfied	0 (0%)
Learning (How much did you learn in the NatME program?)	1 A great deal	20 (74.1%)
	2 Quite a bit	6 (22.2%)
	3 Adequate	1 (3.7%)
	4 A little	0 (0%)
	5 Nothing at all	0 (0%)
Session length (How would you describe the length of each group session (e.g. approx. 2hours)?)	1 About right	17 (63%)
	2 Slightly too long	5 (18.5%)
	3 Slightly too short	5 (18.5%)
	4 Much too short	0 (0%)
	5 Much too long	0 (0%)
Program length (How would you describe the length of the complete program (e.g. 3 months?)?)	1 About right	14 (51.9%)
	2 Slightly too long	0 (0%)
	3 Slightly too short	10 (37%)
	4 Much too short	3 (11.1%)
	5 Much too long	0 (0%)
Group size (How would you describe the size of the group?)	1 About right	26 (96.3%)
	2 Slightly too big	1 (3.7%)
	3 Slightly too small	0 (0%)
	4 Much too small	0 (0%)
	5 Much too big	0 (0%)
Facilitator satisfaction (How would you rate your satisfaction with the group facilitator?)	1 Very satisfied	25 (92.6%)
	2 Satisfied	2 (7.4%)
	3 Neither satisfied nor dissatisfied	0 (0%)
	4 Dissatisfied	0 (0%)
	5 Very dissatisfied	0 (0%)
Practitioner satisfaction (How would you rate your satisfaction with the naturopath?)	1 Very satisfied	26 (96.3%)
	2 Satisfied	1 (3.7%)
	3 Neither satisfied nor dissatisfied	0 (0%)
	4 Dissatisfied	0 (0%)
	5 Very dissatisfied	0 (0%)
Needs met (How satisfied were you that your individual healthcare needs were addressed in the group visits?	1 Very satisfied	20 (74.1%)
	2 Satisfied	7 (25.9%)
	3 Neither satisfied nor dissatisfied	0 (0%)
	4 Dissatisfied	0 (0%)
	5 Very dissatisfied	0 (0%)
Importance (How important do you think the NatME program is for people with endometriosis?	1 Extremely important	25 (92.6%)
	2 Very important	2 (7.4%)
	3 Moderately important	0 (0%)
	4 Slightly important	0 (0%)
	5 Not at all important	0 (0%)
Participation (Would you participate in other naturopathic group visits if available?)	1 Yes	27 (100%)
	2 No	0 (0%)
Recommendation (Would you recommend NatME to other people with endometriosis?)	1 Yes	26 ((96.3%)
	2 No	0 (0%)
	Did not answer	1 (3.7%)
Model (When considering your experience of the NatME program, please indicate your level of agreement with the following statement: Naturopathic group visits are a good way of receiving care for endometriosis)	1 Agree	26 (96.3%)
	2 Mostly agree	1 (3.7%)
	3 Undecided	0 (0%)
	4 Slightly disagree	0 (0%)
	5 Disagree	0 (0%)

>Table A2. NatME participant quotes from verbal feedback during end visit>

All practitioners (n = 4, 100%) reported high satisfaction with the program performance and ease of the potential for adapting the program for populations with other health conditions. 100% of practitioners would be likely to use the program again and recommend the program to other practitioners, while 75% found the program easy to implement. Results from the practitioner program evaluation questionnaire are presented in Table 3.

Table 3
Practitioner program evaluation questionnaire responses
Variable	Response	Frequency (%) n = 4
Satisfaction (How satisfied are you with the NatME program overall?)	1 Very satisfied	4 (100%)
	2 Satisfied	0 (0%)
	3 Neither satisfied nor dissatisfied	0 (0%)
	4 Slightly dissatisfied	0 (0%)
	5 Not satisfied at all	0 (0%)
Implementation (How easy was it to implement the program using the program manual?)	1 Very easy	2 (50%)
	2 Easy	1 (25%)
	3 So-so	1 (25%)
	4 A little difficult	0 (0%)
	5 Very difficult	0 (0%)
Topics (How satisfied were you with the health topics included in the program, for treating endometriosis?)	1 Very satisfied	3 (75%)
	2 Satisfied	1 (25%)
	3 Neither satisfied nor dissatisfied	0 (0%)
	4 Slightly dissatisfied	0 (0%)
	5 Not satisfied at all	0 (0%)
Performance (How satisfied were you with the performance of the program (thinking about the patient engagement, timing, compliance and behavior change)?	1 Very satisfied	4 (100%)
	2 Satisfied	0 (0%)
	3 Neither satisfied nor dissatisfied	0 (0%)
	4 Slightly dissatisfied	0 (0%)
	5 Not satisfied at all	0 (0%)
Structure (How satisfied were you with the structure of the program (e.g. 3 months, fortnightly, 2-hour sessions, structured content)?	1 Very satisfied	2 (50%)
	2 Satisfied	2 (50%)
	3 Neither satisfied nor dissatisfied	0 (0%)
	4 Slightly dissatisfied	0 (0%)
	5 Not satisfied at all	0 (0%)
Use (How likely would you be to use this program again if it was made available?)	1 Very likely	3 (75%)
	2 Likely	1 (25%)
	3 Unsure	0 (0%)
	4 Unlikely	0 (0%)
	5 Very unlikely	0 (0%)
Recommend (How likely would you be to recommend this program to other naturopaths?	1 Very likely	3 (75%)
	2 Likely	1 (25%)
	3 Unsure	0 (0%)
	4 Unlikely	0 (0%)
	5 Very unlikely	0 (0%)
Adaptation (To what degree do you think this program could be implemented in other populations (e.g. diabetes, PCOS, fibromyalgia, other health conditions) by altering the health topics?)	1 Very easily	3 (75%)
	2 Easily	1 (25%)
	3 So-so	0 (0%)
	4 A little difficult	0 (0%)
	5 Very difficult	0 (0%)

>>Please insert Tables 2–3 here>>

Clinical outcomes

Statistically significant improvements were observed in a number of items across each individual assessment tool used and are represented by a p-value of < 0.05. In the SF-12 ordinal variables, reduced mean scores indicate improvement in items 1, 8, 9 and 10, and increased mean scores indicated improvement in items 2, 3, 11 and 12. In the SHOW-Q, increased mean scores indicate improvement in items 3, 4, 5 and 8 and reduced mean scores indicate improvement for the remaining items. In all other tools, reduced mean scores indicate improvement.

EHP-5 scale scores are presented in Table 4. Statistically significant improvements were observed as reduced mean scores across four of five categories of the EHP-5 from baseline to end visit and in all five categories from baseline to follow-up. Pain scores improved from baseline(M:2.81; SD:1.11) to end visit(M:2.44;SD:0.89;p = 0.025) with a further improvement(M:2.19;SD:1.03;p = 0.003) at follow-up. Mean control and powerlessness scores improved from baseline(M:3.44;SD:1.12) to end visit(M:2.63;SD:0.92;p = < 0.003) with a further improvement(M:2.48;SD:1.05;p = < 0.003) at follow-up. In emotional wellbeing no significant improvement was observed from baseline to end visit, however statistically significant improvement was observed in mean scores from baseline(M:3.59;SD:0.93) to follow up(M:3.04;SD:0.94;p = 0.036). Social support scores improved from baseline(M:3.81;SD:0.87) to end visit(M:2.81;SD:0.92;p = < 0.003) with a further improvement(M:2.85;SD:1.13;p = < 0.003) at follow-up. Self-image scores improved from baseline(M:4.07;SD:0.78) to end visit(M:3.30;SD:0.99;p = 0.009) with a further improvement at follow-up(M:3.33;SD:0.92;p = 0.006).

SF-12 scale scores are presented in tables 5 and 6. Statistically significant improvements were observed across seven of the 12 items included in the SF-12 scale. Improvements in mean scores were observed from baseline(M:3.33;SD:0.92) to end visit(M:2.59;SD:1.08;p=0.015) in item eight (pain) with a further improvement(M:2.37;SD:1.04;p=<0.003) at follow-up. Improvements in mean scores were observed from baseline(M:4.26;SD:1.16) to end visit(M:3.44;SD:0.84;p=<0.003) in item nine (emotional wellbeing calm) with sustained improvement at follow up(M:3.63;SD:0.96;p=0.018). Improvement in mean scores were observed from baseline(M:4.74;SD:0.94) to end visit(M:3.96;SD:0.98;p=<0.003) in item ten (energy) with further improvement(M:3.70;SD:1.06;p=<0.003) at follow-up. In item 11 no significant improvement was observed from baseline to end visit, however significant improvement in mean scores were observed from baseline(M:3.81;SD:1.41) to follow-up(M:4.44;SD:1.12;p=0.021). In item 1 (general health) no significant improvement was observed from baseline to end visit, however significant improvement in mean scores was observed from baseline(M:3.52;SD:0.97) to follow-up(M:2.96;SD:0.64;p=0.024). In item 4 (physical health) no significant improvement was observed from baseline to end visit, however, significant improvement was observed from baseline to follow-up(p=0.024). In item 12 (social activities) significant improvement in mean scores was observed from baseline(M:3.30;SD:1.29) to end visit(M:4.15;SD:1.16;p=0.018) with improvement sustained at follow up(M4.11;SD:1.42;p=0.021). In the remaining items 2, 3, 5, 6, and 7 no significant improvements were observed at end visit or follow-up.

PCS scale scores are presented in table 7. Statistically significant improvements were observed across all items in the PCS. In item one improvement was observed in mean scores from baseline(M:1.93;SD:1.20) to end visit(M:1.15;SD:0.98;p=0.006) with further improvement observed in mean scores at follow-up (1.07 (1.03), p=0.006). In item two no significant improvement in mean scores was observed from baseline to end visit, however significant improvement was observed in mean scores from baseline(M:1.15SD:1.19) to follow-up(M0.67SD:0.96;p=0.015). Item three significant improvement was observed in mean scores from baseline(M1.81SD:1.11) to end visit(M:0.85;SD:0.81;p=<0.03) with improvement sustained at follow-up(M:1.00;SD1.00;p=0.021. In item four significant improvement in mean scores was observed from baseline(M:1.93;SD:1.10) to end visit(M:1.22;SD:1.01;p=0.015) with further improvement observed at follow up(M:1.19;SD:1.00;p=0.006. In item five significant improvement was observed in mean scores from baseline(M:1.78;SD:1.39) to end visit(M:0.96;SD:1.25;p=0.006) and improvement was sustained at follow-up(M:1.00;SD:1.17;p=0.006). In item six no significant improvement was observed in mean scores from baseline to end visit, however significant improvement was observed from baseline(M:1.93;SD:1.32) to follow-up(M:1.26;SD:1.13;p=0.033). In item seven significant improvement was observed in mean scores from baseline(M:1.44;SD:1.18) to end visit(M:0.67;SD:0.92;p=0.006) and improvement was sustained at follow-up(M:0.81;SD:1.00;p=0.024. In item eight no significant improvement was observed from baseline to end visit, however significant improvement was observed in mean scores from baseline(M:1.93;SD:1.20) to follow-up(M:1.00;SD:1.10;p=<0.003). In item nine significant improvement was observed in mean scores from baseline(M:1.70;SD:1.13) to end visit(M:1.15;SD:1.19;p=0.018) with further improvement observed at follow-up(M:1.04;SD:1.19;p=0.015). In item ten significant improvement was observed in mean scores from baseline(M:1.70;SD:1.13) to end visit(M:1.04;SD:1.28;p=0.003), and improvement was sustained at follow-up(M:1.04;SD:1.16;p=0.006). In item 11 significant improvement was observed in mean scores from baseline(M:1.85;SD:1.23) to end visit(M:1.26;SD:1.40;p=0.042), with further improvement observed at follow-up(M:1.15;SD:1.23;p=0.012). In item 12 significant improvement was observed in mean scores from baseline(M:1.63;SD:1.14) to end visit(M:1.04;SD:0.94;p=0.012), with further improvement observed at follow-up(M:0.85;SD:0.94;p=<0.003). In item 13 significant improvement was observed in mean scores from baseline(M:1.70;SD:1.17) to end visit(M:1.22;SD:1.12;p=0.045), with further improvement observed at follow-up(M:1.11;SD:1.05;p=0.015).

SHOW-Q results are presented in table 8. Statistically significant improvements were observed from baseline to end visit or follow-up in six of the 12 SHOW-Q items including satisfaction with frequency and enjoyment, satisfaction, and reduced interference of bleeding, pelvic pain and pelvic problems. In item one no significant improvement was observed from baseline to end visit, however significant improvement in mean scores from baseline(M:3.41;SD:1.36) to follow-up(M:2.70;SD:1.20;p=0.018). In item two, significant improvement was observed in mean scores from baseline(M:3.81;SD:1.27) to end visit(M:3.00;SD:1.33;p=0.003) with further improvement observed at follow-up(M:2.81;SD:1.41;p=0.006). In item four no significant improvement was observed from baseline to end visit, however significant improvement was observed in mean scores from baseline(M:3.56;SD:1.21) to follow-up(M:4.30;SD:1.17;p=0.030). In item 10 significant improvement was observed in mean scores from baseline(M:2.22;SD:1.28) to end visit(M:1.56;SD:0.97;p=0.042), however no significant improvement was observed from baseline to follow-up. In item 11 no significant improvement was observed from baseline to end visit, however significant improvement was observed in mean scores from baseline(M:3.41;SD:1.21) to follow-up(M:2.59;SD:1.15;p=<0.003). In item 12 no significant improvement was observed from baseline to end visit, however significant improvement was observed in mean scores from baseline(M:3.56;SD:1.18) to follow-up(M:2.56;SD:1.15;p=<0.003). In the remaining six items three, five, six, seven, eight and nine no significant improvement in mean scores was observed.

MYMOP results are presented in table 9. Statistically significant improvements were seen from baseline to end visit in severity of both the primary and secondary complaints reported by participants as well as in how those problems impacted regular activities. In symptom one significant improvements in mean scores were observed from baseline(M:3.85;SD:1.35) to end visit(M:2.52;SD:1.42;p=0.006) with further improvement observed at follow-up(M:2.41;SD:1.30;p=0.006). In symptom two significant improvement in mean scores was observed from baseline(M:4.04;SD:1.45) to end visit(M:2.20;SD:1.44;p=<0.003) with sustained results at follow-up(M:2.28;SD:1.27;p=<0.003). In how those symptoms impacted regular activities, significant improvement in mean scores were observed from baseline(M:3.74;SD1.34) to end visit(M:2.74;SD:1.43;p=0.012) with further improvement observed at follow-up(M:2.41;SD:1.42;p=<0.003). In wellbeing significant improvement in mean scores was observed from baseline(M:4.00;SD:1.14) to end visit(M:2.44;SD:1.25;p=<0.003) with sustained results at follow-up(M:2.22;SD:1.18;p=<0.003).

>>Please insert Tables 4-9 here (found in Additional file 1)>>

This pilot feasibility study is the first study to examine a group-delivered naturopathic medicine intervention for women with endometriosis. In this study, a 12-week naturopathic group visit intervention for endometriosis was tested, where results show the intervention was feasible, well accepted and resulted in clinical improvement for women with endometriosis. Similar to other studies examining IMGVs for chronic illnesses(26, 34), high levels of satisfaction were observed across all aspects of the NatME program including those aspects that differed between cohorts (i.e. satisfaction with practitioners and group size). With such diversity of program aspects having met satisfaction and expectations among participants, the reasons for these findings cannot be attributed to any one component of the intervention (e.g. positive clinical outcomes). Rather, it is likely that feasibility and acceptability outcomes were associated with the unique combination of components of the intervention including the benefit of personalized and person-centered care that characterizes naturopathic medicine(13), combined with the health enhancing effects of connection(35) and group support(36) with the addition of health education and in some cases natural medicines. However, it should also be noted that high levels of satisfaction often exist with complementary therapies due to their alignment with stated patient beliefs and values(37). As such, the reasons behind the acceptability of this program are likely to be multifarious, and to reflect the composite nature of both the group visit model, and of naturopathic care. Further research work examining what additive role group visits play in enhancing positive non-specific effects in health is warranted.

Further, in this study participants reported a sense of increased knowledge and empowerment resulting from the program. This knowledge and empowerment may also have contributed to their high satisfaction levels and experience of reduced pain, alongside efficacy of treatments prescribed. The group visit model proffers the opportunity to provide multifaceted healthcare, and lends itself well to pragmatic real-world interventions such as naturopathy that are rooted on principles of patient empowerment, education and person-centered care(29). As prior research has identified, women with endometriosis have significant unmet healthcare needs and suboptimal healthcare experiences often based on disempowerment(4, 38, 39). Patient empowerment has been identified as an important component in global chronic disease prevention, management and health promotion efforts(40, 41), and to date this does not appear to have translated to endometriosis-related healthcare(4, 38). Although specified tools measuring empowerment were not implemented in this study, the preliminary findings of patient empowerment reported here provide important insight to inform future endometriosis studies, which should use such tools measuring empowerment such as those used in other research(40, 42).

In addition to good feasibility outcomes and patient empowerment, the findings of this study showed promising clinical outcomes and notably, improved pain outcomes. Chronic pelvic pain and other types of pain are core issues for people with endometriosis(3). In this study, improvements were observed across all 13 items of the PCS. These findings have particular importance because pain catastrophizing has been shown to be associated with poor pain treatment outcomes in people with chronic pain(43). As such, improvements in pain catastrophizing can lead to better pain treatment outcomes. Further, although no significant changes were seen on some SF-12 and SHOW-Q items, the items where statistically significant improvements were observed included the items relating to pain across all four of the validated scales used. While assessed within the context of the study’s limitations as a pilot feasibility study, these results suggest the NatME program has potential as a clinically effective intervention for reducing pain associated with endometriosis, and larger, more controlled studies are warranted. Moreover, while improvements in pain were seen consistently across outcome measures, positive clinical results were not limited to pain outcomes. A diverse range of clinical improvements were observed across domains including quality of life and emotional and physical wellbeing. As discussed in the context of participant satisfaction the clinical outcomes observed cannot be solely attributed to the treatments prescribed in the intervention, because as was characteristic of the program design and is of naturopathic medicine itself – only some participants in the study were prescribed ingestible medicines, as was appropriate to their individual clinical and financial circumstances. Therefore, again the diverse range of positive clinical outcomes observed may also reflect the complexity and multifaceted form of the naturopathic group visit program.

As with all research, this study comes with limitations. Being a pilot feasibility study, the small sample size limits its generalizability and the study is also limited by a lack of control group. As such, while clinical outcomes were measured as secondary outcomes in this study, the study design limits its capacity to be used to interpret clinical efficacy. Despite this, the positive changes observed across clinical outcomes in this study were notable and exhibited in all four settings, however larger scale clinical trials are needed to further assess clinical efficacy. Results from this study may also inform the design of full-scale trials in future. Finally, measuring patient compliance in this study proved to be challenging due to the complex multifaceted form of intervention and as such compliance was unable to be reported among feasibility outcomes. For future studies on pragmatic real-world interventions, more specific data collection tools and strategies should be developed during the design phase to measure patient compliance. Overall the positive results of this study provide good rationale for future studies to provide a more thorough examination of clinical efficacy of the NatME intervention.

To date, endometriosis research has focused on medical and surgical treatments for endometriosis alongside some research examining the effects of dietary changes. However, recent research shows women with endometriosis do not believe they are getting the outcomes they need and want from standard medical approaches. Innovative new strategies for endometriosis management and treatment are needed, and a complex multi-systems condition with significant and diverse impacts on wellbeing and quality of life may warrant a complex multifaceted intervention to address those diverse impacts. The present study presents one such intervention and suggests the NatME program could benefit people with endometriosis by improving a wide range of symptoms while providing education, empowerment and connection, as well as making a treatment already actively sought out by women with endometriosis more accessible. The findings of this study indicate the NatME program is feasible and well-accepted. It has promising clinical outcomes and high levels of satisfaction across all elements of the program. Overall, these findings indicate a naturopathic group model of care may be an effective way to improve symptoms and healthcare experiences for people with endometriosis as well as address some of their unmet healthcare needs. Larger studies are needed to assess clinical efficacy of NatME, but this study indicates it may be an effective model of care for women with endometriosis, alongside available medical treatments.

Acknowledgements

The authors acknowledge the contribution from William Pinzon Perez for statistical support received through QCIF Biostatistics, QCIF Ltd, Brisbane, Queensland, Australia.

Data availability

Data will be made available upon request to the corresponding author.

Disclosure statement

The authors report there are no competing interests to declare.

Funding

This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.

Human ethics and consent to participate

This study was approved by the Human Research Ethics Committee (HREC) at Southern Cross University (approval no. 2021/117) and registered with Australian New Zealand Clinical Trials Registry (ANZCTR) (registration no. ACTRN12622000222741). Written informed consent was provided by all participants.

Authors contributions

Sophia Gerontakos: Conceptualization, methodology, data curation, investigation, formal analysis, writing – original draft. Amie Steel: Conceptualization, writing – review and editing, supervision. Jon Wardle: Conceptualization, methodology, validation, writing – review and editing, supervision. All authors approved the final version of the manuscript.

Biographical data

Professor Jon Wardle is Foundation Director of the National Centre for Naturopathic Medicine (NCNM) and Maurice Blackmore Chair of Naturopathic Medicine at Southern Cross University. In addition to clinical qualifications in nursing and naturopathic medicine, Jon has postgraduate qualifications in public health, law and health economics and holds visiting positions at Boston University, University of Washington and University of Oxford.

Amie Steel is an Associate Professor in the Australian Research Consortium in Complementary and Integrative Medicine (ARCCIM) at UTS. As an expert in women’s health - with a particular focus on pregnancy, fertility and preconception health – and complementary medicine, she is ranked as the #1 Traditional and Complementary Medicine Researcher in Australia (2021-present).

Sophia Gerontakos is a PhD candidate at the National Centre for Naturopathic Medicine at Southern Cross University. Sophia’s PhD research focuses on endometriosis and a group-delivered naturopathic medicine approach to meeting unmet healthcare needs for people with endometriosis and improving their healthcare experiences and access to complementary therapies. In addition to her PhD research Sophia is also a research assistant at the Sydney Adventist Hospital in Wahroonga, Sydney where she manages the Sydney branch of a longitudinal multiple sclerosis cohort study.

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The authors of this thesis recognise that not all people who experience menstruation and/or disorders of the menstrual cycle such as endometriosis identify as women. Trans men, intersex, non-binary and gender diverse people also experience menstruation and health conditions associated. They face both similar, and unique challenges to cis women. To date, the evidence on endometriosis overwhelmingly represents cis women’s experiences. Although trans men and gender diverse people were not excluded from this research, the participants who responded to recruitment notices identified as women. The word ‘women’ is used in this article to reflect the evidence drawn on throughout, and to reflect the women who participated in this research without misrepresenting the unique experiences and challenges of trans men, intersex, non-binary or gender diverse people. We note the gap in literature representing experiences of trans and gender diverse people, which should be built on in future.

No competing interests reported.

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Naturopathic Medicine for Endometriosis (NatME). Results of a pilot study

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Background

Methods

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Primary outcome – feasibility

Secondary outcomes – clinical efficacy

Verification of primary and secondary outcome measures

Results

Discussion

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Acknowledgements

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Human ethics and consent to participate

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