‘A glimmer of hope’: perceptions, barriers, and drivers for medicinal cannabis use amongst Australian and New Zealand people with endometriosis – a qualitative study

Abstract

Introduction

Endometriosis is an oestrogen-dependent, chronic inflammatory condition characterised by the presence of endometrial-like tissue outside of the uterine cavity (Hickey et al. 2014, Johnson et al. 2017) and is fairly common, with prevalence rates ranging between 5 and 11% of women and those assigned female at birth (Zondervan et al. 2020, Rowlands et al. 2021). Common symptoms include chronic pelvic pain, fatigue, period pain, painful urination, back pain and painful sex (Ramin-Wright et al. 2018, Armour et al. 2021). The severe and unrelenting nature of symptoms can have a deleterious effect across numerous life domains, negatively affecting academic, social, work, and sexual/romantic relationships, which consequently impinge upon mental/emotional well-being (De Graaff et al. 2013, Armour et al. 2020). Moreover, the disease contributes to a significant cost of illness burden to both individuals and society (Nnoaham et al. 2011, Armour et al. 2019a, O’Hara et al. 2020, Malik et al. 2022), with lost productivity being the most significant modifiable factor (Nnoaham et al. 2011, Armour et al. 2019a).

The updated European Society of Human Reproduction and Embryology (ESHRE) guidelines released in 2022 (Becker et al. 2022) strongly recommend hormone treatments utilising combined hormonal contraceptives, progestogens, or gonadotrophin releasing hormone (GnRH) agonists or antagonists, and surgical removal of lesions, to address endometriosis-associated pain. Surgical studies report short- to medium-term reduction in pain (Leonardi et al. 2020), but these invasive procedures are associated with considerable cost and risk, and require access to skilled surgeons. Opioid, non-steroidal anti-inflammatory (NSAID) and anti-neuropathic medications have also been used for pain management, but variously, a lack of effectiveness, their side effects or the risk of addiction limit their long-term use (Australian Institute of Health and Welfare 2018, Roxburgh 2018, Bolshakova et al. 2019). Most endometriosis patients report ongoing challenges with pain and symptom management (Moradi et al. 2014, Hawkey et al. 2022). A modest reduction in pain of just 20% would save approximately AU$9,000 per person per year (Armour et al. 2019a), in addition to improvements in health-related quality of life. Therefore, effective pain management strategies are vital to reduce these burdens.

The chemical constituents of Cannabis spp. (mainly phytocannabinoids) such as delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) have well-described analgesic, anti-inflammatory, anxiolytic, antidepressant, and anti-emetic actions (Rahn & Hohmann 2009, Bolognini et al. 2010, Zanelati et al. 2010, Aggarwal 2013, 2017, Burstein 2015). Previous research has demonstrated that both legal and illicit cannabis is being utilised by endometriosis patients to not only manage pain, but also ameliorate other challenging co-morbid symptoms such as nausea, fatigue, poor sleep, mood disorders, and gastrointestinal issues (Armour et al. 2019b, 2021, 2022, Sinclair et al. 2019, 2021). Australia legalised medicinal cannabis in 2016, with Special Access Scheme (Category B) prescription numbers reaching 375,466 as of 15 June 2023. New Zealand adopted the Medicinal Cannabis Scheme in July of 2020, with both countries opting for strict regulatory controls and high-quality standards for dispensing medicinal cannabis products. The majority of those with endometriosis report the use of illicit cannabis, even in countries with legal access (Sinclair et al. 2021, Armour et al. 2022). Therefore, whilst patient uptake of legal cannabis is growing across both countries, what is currently unclear is why those with endometriosis are still commonly choosing to use illicit sources of cannabis.

Despite its relative popularity as a self-management strategy (Armour et al. 2019b), the evidence base for use of medicinal cannabis to manage endometriosis is scarce, and randomised controlled trials or similar prospective designs are urgently needed to determine the effectiveness of medicinal cannabis on endometriosis. Co-design is a crucial aspect of clinical trials, and given that concerns around medicinal cannabis usage have been raised for primary dysmenorrhoea (i.e. period pain) (Sinclair et al. 2022a), it is crucial that the acceptability and feasibility of using medicinal cannabis is explored, with possible barriers considered, when designing future trials for those with endometriosis.

The aims for this study were first to explore the drivers and barriers for use of medicinal cannabis in endometriosis with both cannabis consumers and non-consumers and, second, to investigate concerns about acceptability and feasibility of medicinal cannabis as a potential treatment option for endometriosis pain and symptoms.

Materials and methods

Results

In total, 39 subjects participated in the online focus groups. No data on gender identity were collected. Two of the participants did not use the same username in the focus group as they had provided in the survey, so their quantitative data sets were eliminated, leaving a balance of 37 total participants (Australia n = 24/New Zealand n = 13). Table 1 outlines the demographics of participants.

Table 2 outlines the endometriosis related demographics, symptoms and self-management options. The majority of participants had been diagnosed by laparoscopy (91%), and were less than 5 years from diagnosis. Both opioids and non-opioids were commonly used pharmaceuticals, whilst heat and dietary choices were the most popular self-management options.

PPIQ and EHP-30 scores are provided in Tables 3 and​and4,4, respectively. Both tools demonstrated a noticeable impact, with the EHP-30 demonstrating a substantive impact to participants in both countries across domains such as self-image, control and powerlessness, and social support.

Discussion

Focus-group participants in this study frequently highlighted that their current medical management of endometriosis-associated pain and related symptoms was sub-optimal. This was their main driver for cannabis use, with the majority using illicitly procured cannabis despite barriers associated with criminal risks, lack of quality assurance and the experience of inconsistent clinical outcomes. Apparently greater barriers associated with prescribed cannabis included the high cost of the quality-assured product; the stigma still surrounding even legal medicinal cannabis; an inability for participants to obtain a legal prescription from their doctor due to what their doctor described as a paucity of evidence; and a lack of medical practitioner knowledge for the prescription of cannabis. Incorrect information conveyed to patients by doctors about current drug-driving laws was also a concern for some who had been told that a THC dose 8 h before driving would not appear in a roadside (oral swab) drug test. On the contrary, whilst patients would possibly be unimpaired 8 h post administration, the highly lipophilic nature of phytocannabinoids (Huestis 2007) means positive oral swab results for THC would be highly probable (Anizan et al. 2013, Swortwood et al. 2017) (dependent on dose and frequency) and could result in criminal charges. Additional barriers to medicinal cannabis utilisation included concern over current workplace drug testing policies and roadside drug driving laws, and that even though cannabis was now legally available as a management option, participant real-world experience deemed that others in their life, whether personal or professional, viewed it through a lens of being less legitimate than classically prescribed pharmaceuticals. This weighed heavily on participant considerations for initiating or continuing cannabis use.

The cost of legally prescribed medicinal cannabis products was raised as a barrier to access. This has been reported in previous qualitative research on primary dysmenorrhoea (Sinclair et al. 2022b), and in an Australian Senate inquiry report by the Community Affairs References Committee (2020). Media articles have also identified cost as a major barrier to patient access across New Zealand (NZ Herald 2020, 1 News NZ 2022). Product costs, depending on dosage form and phytocannabinoid concentration, can vary widely. The Victorian Government reports that medicinal cannabis products may cost between AU$200 and $4000 per month (Department of Health 2022) depending on the clinical indication. Cannabis industry reports suggest the average monthly cost is declining over time, with 2020 (Fresh Leaf Analytics 2020) and 2021 (Fresh Leaf Analytics 2021) reports placing the average monthly cost to patients at AU$384 and AU$278, respectively. Whilst the exact mechanisms for these declining prices are unknown, they are likely the result of growing competition and increased product availability, as the Australian medicinal cannabis cultivation/manufacturing industry matures. However, even these declining costs still represent a significant barrier to more widespread utilisation when compared to products available via prescription (e.g. codeine) or over-the-counter (e.g. ibuprofen) access. Medicinal cannabis products are not currently subsidised by Medicare or via the Pharmaceutical Benefits Scheme for endometriosis. Additional out-of-pocket costs for prescribed cannabis products include consultation and prescription costs, with initial medical consultations costing between AU$300-500 (2020c) which may exceed the cost of a specialist gynaecological consultation.

Current driving regulations across all states and territories in Australia do not exempt medicinal cannabis use (i.e. provide a medical defence (Perkins et al. 2021). The presence of THC constitutes a strict liability offence (i.e. criminal record, fines, and driving licence disqualification) if detected via a mobile drug testing (MDT) event, despite that test not being able to prove impairment. Participants complained (particularly those in Australia) that it is unfair that the bodily presence of medications such as opioids and benzodiazepines, which have been shown to cause impairment (Lader 2011, Strand et al. 2017), were not of concern for roadside drug testing, and that current laws negatively impacted their decision to explore or continue medicinal cannabis as a potential management option. Patients face the risk of losing their driving licence, which represents a threat often too difficult to ignore, considering familial, social and career responsibilities. In addition, for participants living in rural and remote locations, the problem is compounded because of distance, and they struggle to even locate a cannabis prescribing doctor/clinic. In contrast, current New Zealand regulations require both evidence of impairment (i.e. field impairment assessment at roadside by police) and THC presence in blood to constitute an offence. A recently introduced bill pending in the New Zealand parliament proposed changes to their drug-driving laws, with the inclusion of offences for the presence of THC in oral fluid. However, a medical defence will be available to those prescribed medicinal cannabis (Perkins et al. 2021, Ministry of Transport 2020d). Similarly, workplace drug testing policies in both countries were also mentioned as a significant barrier, being described as lagging behind the laws regulating cannabis use as a medicine. Employees in government roles, including teaching, defense, transport, police, maritime, and mining activities, all potentially face the prospect of random drug testing, which is deemed as mandatory within their employment contracts, constituting a further barrier to patient utilisation.

Although legal access policies for medicinal cannabis have been adopted across many international jurisdictions over the previous 20 years, it is not yet normalised as a treatment, with a stigma often associated with its use (Reid 2020). Disapproval, marginalisation, discrimination, or loss of social status from the wider population are commonly described by users of medicinal cannabis products (Bottorff et al. 2013). They are also highly vulnerable to the effects of stigma, with individuals’ fear of discrimination leading to self-perceptions of guilt and shame (Bottorff et al. 2013). Given the low levels of understanding, funding, education, and support for female reproductive conditions, including endometriosis, the additional stigma associated with cannabis use may exacerbate the self-imposed protective isolation that such patients already experience. Participants in this study highlighted substantial concerns around reputational damage, or others perceiving them as irresponsible regarding their legal medicinal cannabis use, particularly in the workplace. This worry demonstrates that despite medicinal cannabis being a legal medicine, much more needs to be done to educate the general public, law enforcement personnel and healthcare providers.

Access to medicinal cannabis was raised as a substantive barrier, with many of the participants’ doctors refusing to prescribe it, often citing a lack of evidence as their predominant rationale. Clinical trial results are not currently available to directly support the use of medicinal cannabis for endometriosis, per se. However, indirect evidence resides within data from the Australian Therapeutic Goods Administration (2022). They report that as of the 15 June 2023, over 199,000 approvals have been granted for chronic pain conditions (of which endometriosis qualifies) through the Special Access Scheme Category B pathway (Therapeutic Goods Administration 2022a). Moreover, co-morbid clinical indications commonly experienced by endometriosis patients have also seen consistent approvals, including for anxiety (n = 90,000 approvals), insomnia (n = 7600), sleep disorders (n = 17,450), migraines (n = 2180), and depression (n = 5040) (Therapeutic Goods Administration 2022b). In New Zealand, cannabidiol based medicines that meet minimum quality standards are prescription medicines, whereas all other cannabinoid-type medicines (with the exception of Sativex™) are classified as unapproved medicines or controlled drugs, with prescription pathways being more onerous. Official figures for medicinal cannabis approval numbers in New Zealand do not appear to exist in the public domain, although a media source reported that approximately 17,000 New Zealanders had accessed cannabis legally in 2020 (NZ Drug Foundation 2022). Whilst more significant clinical trial evidence for medicinal cannabis efficacy in endometriosis is required, medical practitioners need to be aware of the role that their behaviours or actions may have in contributing to the stigma of cannabis use as a medicine when communicating with patients. Clearly, as has been demonstrated by this small sample of participants, cannabis use may be a useful management option when all else has failed.

Conclusion

People with moderate-to-severe symptoms of medically diagnosed endometriosis reported inadequacies with their current medical and self-management strategies, and were optimistically disposed to try medicinal cannabis. A substantial proportion of this cohort already utilise cannabis for this reason and report significant symptomatic relief and substitution of cannabis with current pharmaceuticals, mainly due to reduced side effects and self-perceived effectiveness. Barriers against the adoption of cannabis use in this cohort included high costs of legal medicinal cannabis products, lack of clarity and fairness in current roadside drug testing laws and workplace drug testing policies, concern over the impact of stigma affecting familial, social, and workplace life domains, and subsequent judgement and lack of education/engagement from their medical providers. Given the common nature of endometriosis, and its significant burden on quality of life, with consequent economic hardships, formal trials of cannabis therapies and other types of evidence-based alternatives for symptom management are urgently needed.

Declaration of interest

As a medical research institute, NICM Health Research Institute receives research grants and donations from foundations, universities, government agencies, and industry. Sponsors and donors provide united and tied funding for work to advance the vision and mission of the institute. JS1 formerly sat on the scientific advisory board for BioCeuticals and is a current member of the scientific advisory board for United in Compassion (pro bono) and a board member of the Australian Medicinal Cannabis Association (pro bono). JA reports funding in the form of grants and honoraria from MRFF for multiple endometriosis-related research; is a member on advisory boards with Hologic Australia and CSL Vifor (formerly Vifor Pharma Pty. Ltd.); is a member of the Endometriosis Advisory Group to the Australian Government; chairs the Expert Endometriosis Working Group for the Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG); was the chair for the publication of the Diagnosis and Management of Endometriosis Clinical Guideline in 2021. CN manages research grant funding from the MRFF and was a previous employee with CSL Vifor (formerly Vifor Pharma Pty. Ltd.). MA is an advisory board member for Evolv Health. All other authors declare that there is no conflict of interest that could be perceived as prejudicing the impartiality of the research reported.

Funding

Funding was provided to JS1 in the form of a Western Sydney University Post-Graduate Research Scholarship.

Author contribution statement

JS1 and MA wrote the manuscript. JS1 performed focus-group content analysis and data analysis from the quantitative survey, which was supervised by MA. JA, AM-W, SE, CN, and JS2 provided feedback on the manuscript and tables. All authors reviewed the manuscript prior to submission.

Supplementary Materials

Acknowledgements

References