Complementary therapies

Consumer engagement is invaluable for informing, and thus supporting, improvements in the quality of health care delivery by services. Indeed, consumer engagement in health care has become an essential paradigm for Australian policy over the past 20 years, with one of the eight National Safety and Quality Health Service Standards focusing entirely on partnering with consumers.1 For Aboriginal and Torres Strait Islander peoples living with kidney disease, several consumer engagement activities were enabled by support from the National Indigenous Kidney Transplantation Taskforce (NIKTT) and other partners in recent years.2,3,4,5 These consultations allowed communities around the country to provide feedback, opinions, and solutions to kidney care challenges. Partnering with patients to overcome complex transplantation challenges is crucial and must be done with recognition and acknowledgement of the ways of knowing, being and doing that exist for Aboriginal and Torres Strait Islander peoples.6 For Aboriginal and Torres Strait Islander peoples living with kidney disease and after transplantation, the health system must embed true partnership, engagement and, most importantly, real change from existing verbal feedback that is backed by evidence. Our health systems need to be empowered to embrace, accept and work with (and not against) Indigenous knowledges.7,8,9 The barriers that Aboriginal and Torres Strait Islander peoples face when contending with renal services are numerous, as discussed elsewhere in this supplement. The kidney transplant pathway has aptly been described by one Aboriginal patient as “fragmented, confusing, isolating, and burdensome”.10 In order to address some of these barriers, through authentic engagement with consumers, the NIKTT catalysed the establishment of Indigenous Reference Groups (IRGs) within transplantation units around Australia. Five transplantation units were initially selected to host these IRGs — these represented the hospitals that serve the largest proportion of Aboriginal and Torres Strait Islander peoples on kidney replacement therapy: the Royal Adelaide Hospital (RAH) in South Australia, Princess Alexandra Hospital in Queensland, Westmead Hospital and the Royal Prince Alfred Hospital in New South Wales, and Sir Charles Gairdner Hospital in Western Australia. In this Perspective article, we describe the establishment of the RAH IRG to demonstrate how consumer engagement can deliver effective, culturally safe change. Doing it right: establishing an effective Indigenous Reference Group in Adelaide At the RAH, Aboriginal and Torres Strait Islander patients come from South Australia, the Northern Territory and western New South Wales to receive kidney transplantation care. This unit therefore provides care to people from many different Nations, each with their own languages, practices and ceremonies, and each with a distinct history of colonisation and health care experiences. These patients and their families travel enormous distances to receive care in a system that was created by, and predominantly for, an English‐speaking, Western‐orientated population. Although located on Kaurna Country, an out‐of‐the‐way wall is the only welcome in Language that consumers coming to the RAH experience. Due to the complexity of care for patients on kidney replacement therapies, especially those undertaking or having received a transplantation, a specific IRG was established to help patients’ voices systematically report on barriers to care from within the hospital system. To best achieve this, the NIKTT first established a Consumer and Community Engagement (CCE) working group and a dedicated CCE officer role to guarantee consumers were not only consulted but, more importantly, were leading the process of improving access to transplantation. The RAH IRG originally consisted of 20 patients, but as members unfortunately died, membership was subsequently opened to carers and family members. Seven key design elements (Box 1) for the IRG were developed throughout the establishment of the RAH group. Reflective practices11 were used so that what worked, and what did not work, was continuously discussed and allowed to guide future meetings and partnership growth. From the experience of establishing this reference group at the RAH, the CCE working group found that specific enablers paved the way for the IRG's successful engagement, integration and activism. Creating a Blak space Aboriginal and Torres Strait Islander voices were privileged by the creation of a safe, decolonised space through which the IRG could communicate with the clinical world. As no non‐Aboriginal people attended the IRG meetings, the space was seen as a wholly “Blak space”,12 where only Aboriginal and/or Torres Strait Islander people were invited to participate, lead and govern meetings. The IRG was positioned as a catalyst to forming trusting relationships between the patients and the hospital staff, as two‐way communication and Aboriginal and Torres Strait Islander‐led change were actively embraced at a local level. Reflective practices were employed to ensure meetings were examined and improved upon, a practice that reflects Aboriginal ways of knowing, being and doing by valuing the acts of deep listening and reflection.12 Questions such as “have the communities’ needs been heard and met?”, “what worked for us and what did not?”, and “how can we do it better next time?” were asked after each IRG meeting. This reflection and real‐time feedback allowed for each meeting to advance and develop based on feedback from within the Blak space. Engaging clinicians Clinical support and renal unit “buy‐in” were instrumental in helping to gain traction within the hospital system, specifically formalised first through a letter of support from the head of unit and then through another letter committing to undertake change based on the IRG recommendations. The CCE officer and another member of the IRG formally presented these recommendations to the transplant management meeting in the form of a message stick and a written letter. Without the support of doctors, nurses, coordinators and administrators, the success of the IRG would have been limited: non‐Aboriginal allies throughout the hospital system allowed for doors to be metaphorically opened and lines of communication begun. Box 2 illustrates this process for change and integration. Leading from within Aboriginal leads, and strong community connections, allowed for a resilient network to be built and maintained. Having Aboriginal kidney patients drive meeting times, agendas and outputs allowed for powerful momentum within the group to carry its message forward. In addition, having an Aboriginal person lead from within the renal unit was seen as vital to drive the project and maintain momentum. Early outcomes from the Adelaide Indigenous Reference Group Real practice change has occurred within the first year of the RAH IRG's existence, due to the strong relationships and trust built between IRG members and clinical staff. These changes include: Smoking (organ cleansing) Ceremonies are available on hospital grounds. In June 2022, the first kidney transplant Smoking Ceremony was held to pay respect to the organ donor and their family, while connecting the recipient and organ to the present. By facilitating such ceremonies, the RAH has enabled a holistic view of healing, delivering a more culturally sensitive system of care.13 A new cultural safety training course is being developed by Aboriginal kidney patients. More Aboriginal health practitioners are being employed in the renal unit. Non‐Aboriginal staff have expressed gratitude for the opportunity to better understand cultural protocols to facilitate culturally sensitive, and therefore safer, care. A formal evaluation of this group, and the impact and outcomes it has on the transplantation and renal unit, has been recommended by the CCE and IRG members. What could hold us back Although the establishment of the RAH IRG has been successful and provided learnings for NIKTT, there are general challenges for establishing and sustaining IRGs. Funding IRGs need financial support for both establishment and continued engagement. Costs are as low as $500 per meeting to cover sitting fees, catering and venue. Secured funding for the sustained support of IRGs is an easy obstacle to overcome once the benefits are considered. As units create new Aboriginal and/or Torres Strait Islander staff positions within kidney teams, more facilitators become available to ensure the cultural safety and continuity of each group. Powerful partnerships Although fundamentally enablers, trusting partnerships can also be obstacles if not continuously considered and acted upon. Aboriginal and Torres Strait Islander peoples have experienced innumerable broken promises over the hundreds of years of colonial subjugation. It therefore comes as no surprise that further broken promises or commitments unhonoured lead to frustration, mistrust and, ultimately, lack of engagement from Aboriginal patients. Taking time Finally, an important consideration for both the creation of and continued engagement with patient reference groups is time. It takes time to develop the trust and relationships that must occur for IRGs to be effective, and it takes time to implement the cultural considerations of deep listening and reflection. Follow‐up is crucial to this process: anything raised in a meeting, reflected upon after a meeting, or brought up outside of a meeting by members or hospital staff must be recorded and revisited until everyone feels the issue has been managed. These ways of working take up dedicated physical and mental time — a notion that may be antithetical to some hospital processes. Talking to take action The benefits of establishing IRGs, from ensuring voices are heard to creating trusting relationships, far outweigh the challenges to implementation. Transplantation units around Australia must prioritise and ensure the sustainable funding of IRGs for them to become embedded within the system. While we continue to grapple with an inequitable health system, new models of care are needed that best serve disparate consumers. Establishing IRGs within hospitals is one important way to enact positive, meaningful and active consumer‐led change. Box 1 – Essential design elements for the creation of a successful Indigenous Reference Group (IRG) Transplantation unit directors and heads of units were consulted before the establishment of the IRG and asked to clearly commit, in writing, to engaging with IRG suggestions on an ongoing basis. This was essential for engaging patients so they could trust that their voices would lead to meaningful change, rather than be sought, collated, and then ignored. The Consumer and Community Engagement (CCE) officer identified local clinical leaders and staff in the transplant unit that would be involved with the delivery of care and system change suggested by the IRG, to distinguish advocates and allies. The CCE officer used relational networks, clinical patient contacts, and community connections to identify potential IRG members. A “Blak space” was created wherein IRG meetings were only led by, and involved only, Aboriginal and Torres Strait Islander peoples. This space was deliberately set up to exist both physically and strategically within the transplantation hospital. Crucially, a terms of reference document was created that outlined the way in which the IRG worked together and in partnership with the hospital. The IRG then created a list of priorities that provided a positive framework for the unit specifically, and the hospital generally, to improve the cultural safety. These priorities were presented to the head of unit and the transplantation team in the form of a report and a specially commissioned message stick. Meeting minutes were made available to the transplantation team after each meeting. All IRG members were compensated for their time and the expertise that they shared. Finally, the IRG was brought together every three months using the considerations of time, deep listening, and reflection. Box 2 – The design and process of the Royal Adelaide Hospital's Indigenous Reference Group (IRG)* NIKTT = National Indigenous Kidney Transplantation Taskforce. * This workflow illustrates the ongoing flow of consultation and knowledge exchange allowed both for patients to feel more heard and for clinicians to gain a better understanding of cultural practices and protocols.

Kelli J Owen · Katie Cundale · Jaquelyne T Hughes · Stephen P McDonald · Matilda D'Antoine · Shilpanjali Jesudason

To the Editor: In August 2020, the South Eastern Sydney Public Health Unit, located in New South Wales, Australia, received a statutory laboratory notification of an elevated blood lead level of 0.34 µmol/L in a preschool‐aged child recently diagnosed with autism. This was above the 0.24 µmol/L level requiring notification under the Public Health Act 2010 (NSW). The test had been requested by the child's paediatrician due to concern about the child’s recent consumption of an oral Ayurvedic medicine prescribed by a naturopath. Our environmental health officers undertook a home lead assessment, during which a soil sample and the Ayurvedic medication sample were taken for heavy metals analysis. The soil lead concentration was 160 mg/kg. The medication was labelled Manasmithra Vatika (MV), manufactured in India (Box). Analysis revealed that it comprised 0.96% lead by weight. The naturopath indicated that they had prescribed the medication to other child and adult patients, some of whom were seeking treatment for autism. Most consultations were conducted online and the prescriptions were purchased online. We were concerned about the risk of lead toxicity in the naturopath’s other patients who had been prescribed MV, and mounted a public health investigation in order to inform patients of their risk, to advise them to cease use of the medication, and to identify the extent of the problem. The naturopath provided a list of 28 patients (13 children) to whom they had prescribed the medication. We directly followed up the 12 NSW patients (other than the index case), asking whether they had taken MV, and, if so, in what dosage and over what period. We advised those who were taking MV to immediately cease its use, and to seek blood lead level testing through their own doctors. We asked patients to provide us with any remaining MV for lead analysis. Five patients provided MV samples; analysis showed lead content of 0.74–0.96% (mean, 0.81%) by weight. Four patients had an elevated blood lead level ranging from 0.30 to 0.68 µmol/L (reference interval, < 0.24 µmol/L). A fifth patient, whose blood lead level was undetectable (< 0.1 µmol/L) had ceased taking the MV at least 3 months before measurement. Based on these findings, we initiated a multi‐agency investigation involving NSW and Australian government regulatory bodies. Action taken against the naturopath by the Australian Health Practitioner Regulation Agency and NSW Health Care Complaints Commission prohibited them from treating medical conditions, such as autism. The naturopath voluntarily ceased prescribing MV and immediately contacted their patients to inform them of the lead adulteration of the preparation. The NSW distributor of the MV medication was investigated by the NSW Health Pharmaceutical Regulatory Unit and the Therapeutic Goods Administration, leading to the distributor ceasing to import the adulterated MV. The Therapeutic Goods Administration issued a public warning regarding the presence of lead in MV preparations generally, without naming an implicated brand or source.1 Lead exposure in children can be linked to reduced intelligence, and behavioural and developmental impacts.2,3 Ayurvedic medicines are formulated and prescribed based on ancient Indian texts. Although they are herbally based, Ayurevedic texts also provide for formulation with heavy metals including lead.4 Their use has been associated with elevated blood lead levels in patients.5 The public health investigation and subsequent multi‐agency intervention we have described prevented ongoing exposure of patients to a lead‐contaminated herbal product. As a result of this investigation, we suggest: ▪ health practitioner awareness be raised regarding the risks of recommending or prescribing unregistered, imported medications; ▪ clinicians consider testing for blood lead in patients who have consumed unregistered, imported Ayurvedic medications; ▪ public health professionals be engaged in the investigation of patients with elevated blood lead levels in the absence of an occupational source; ▪ community awareness be raised regarding the risk of consuming unregistered, imported Ayurvedic medications; and ▪ a multi‐agency response is required to effectively address prescribing of unsafe complementary medications by unregistered health professionals. Box – Manismithra Vatika tablets provided by a patient with an elevated blood lead level

Mark J Ferson · Sinead Flanigan · Toni Cains

To the Editor: We commend Cohen and colleagues1 on their recently published study, which is the largest randomised controlled trial (RCT) of acupuncture in the emergency department (ED). We recently completed a systematic review and meta-analysis on the role of acupuncture for analgesia in the emergency setting.2 Our meta-analysis incorporated 19 RCTs and included non-English language publications. The trial by Cohen and colleagues1 was not published at the time of our review; however, it strengthens our main conclusion that acupuncture was non-inferior to standard analgesia in the emergency setting. We also found similar evidence of improved patient satisfaction. It was interesting that the authors reported an adverse effects rate of 51% for acupuncture, whereas our study found an overall rate of 5%, with significant adverse effects being 1%. Our figures are consistent with other reviews3 and almost certainly highlight the difficulties in developing agreed definitions on adverse effects in acupuncture. Our review found that acupuncture in two out of four RCTs decreased pain medication requirements, whereas Cohen and colleagues’ study had the potential to inform this outcome, but did not report such data. The study by Cohen and colleagues1 illustrates many of the challenges in acupuncture trials, including having no sham comparator group. Some acutely painful conditions might resolve simply because of time or careful patient attention. Sham acupuncture is difficult to deliver as a control4 and needs to be plausible, realistic and, if possible, blinded. Our meta-analysis showed acupuncture to be superior, with clinically significant reductions in acute pain scores compared with sham. This latest significant RCT gives further impetus to carefully designed research on acupuncture in the emergency setting, which will require acupuncture techniques applicable to the time-constrained ED environment (eg, ear acupuncture), provision of a suitable sham acupuncture technique, and minimisation of assessment bias. We suggest that the specific outcomes to be assessed should include the impact of acupuncture as an adjunct to standard analgesia, side effects recorded using standard definitions, and reductions in medication use. Most importantly, the analgesic effect of acupuncture is unlikely to be equal for all pain presentations in the emergency setting and, therefore, the conditions for which its role is most beneficial need to be delineated.

Andrew L Jan · Ian Rogers · Eric J Visser

To the Editor: The conclusions made by Cohen and colleagues1 can be challenged on the basis of study design and results. A significant flaw in the design is that of all patients not excluded due to additional medical problems, 38% of potential study participants declined to be included, possibly because they were not prepared to be assigned to the acupuncture-only arm. This flaw introduces a critical bias when analysing the 62% who did participate, as it is reasonable to assume that they are statistically more inclined to experience a placebo benefit from acupuncture and more likely to be positive at 48 hours about repeating this therapy. Even with this bias, however, the results of the study do not support a broad interpretation of non-inferiority, given that 39% of acupuncture-only patients required rescue therapy at or after one hour, compared with 22.5% of pharmacotherapy-only patients. In the context of an emergency department (ED) and patients with mean verbal numerical rating scale score of 8.5 at presentation, this difference in pain reduction and satisfaction with the initial therapy during the first hour of treatment should render the acupuncture-only option unacceptable. The authors have selectively and speculatively interpreted their data to support their enthusiasm for acupuncture. Results for patients with migraine are given minimum discussion or reference in the conclusions. The inferior performance of acupuncture-only patients’ willingness to repeat the therapy at one hour is dismissed as being influenced by patients’ concerns about length of stay and transport arrangements, whereas they indicate that the same parameter at 48 hours is more meaningful. I suggest that the results at one hour more accurately reflect a patient’s experience of their pain and desire for abatement, whereas the improved satisfaction at 48 hours is the result of shifted perspective following self-resolution — in a selected patient population with an existing positive bias for acupuncture. The authors’ suggestion that acupuncture use in EDs would reduce opioid addiction is an opportunistic grab at exploiting popular sentiment among people who do not understand the causes and parameters of this serious problem. This article does not support diversion of resources towards acupuncture use in EDs or a change in evidence-based treatment protocols in emergency medicine.

Anitra J Wenden

In reply

Marc M Cohen · Michael Ben-Meir · Nick Andrianopoulos

To the Editor:I thank Byard and colleagues1 for their review of risks of herbal products to the Australian community, which highlighted the high rates of use in younger women with a tertiary education and in patients with chronic diseases or comorbidities. Refugee and migrant women represent a group with potentially high rates of use of herbal products as well as other traditional practices, particularly during pregnancy. Ethnobotany surveys found that 90% of women in eastern Ivory Coast and 80% of women in Mali used medicinal plants during pregnancy.2 A prospective cohort study found that 45% of women in China consumed Chinese herbal medicine during pregnancy and the postpartum period.3 The ingestion of soil, clay or chalk has been observed in up to 84% of pregnant women in African countries, and may be complicated by hypokalaemic paralysis, iron and zinc deficiency, lead poisoning, intestinal obstruction and parasitic infestation.4,5 It is commonly reported that migrant women transfer cultural practices to their new country. In the United Kingdom, geophagia is associated with immigrants from South Asia and West Africa.6 Likewise, Congolese and Zimbabwean women commonly consume clay during pregnancy after migrating to Cape Town.7 In addition, the use of skin lightening creams has been reported in 69% of pregnant women on their third-trimester attending a standard maternal centre in Dakar, which may result in maternal Cushing’s syndrome and adrenal insufficiency and in fetal intrauterine growth restriction. Most case reports in the literature describing Cushing’s syndrome due to skin lightening creams have been on African women who had migrated to Australia, the United States or Europe.8 Skin lightening creams may also contain mercury, with the risk of birth defects and irreversible neurological damage to the child. These products are usually obtained over the counter in African shops, and thus are not subject to any form of safety regulation. A further difficulty is that migrant women may not disclose their use of herbal medicines or other traditional products, even when questioned specifically. Therefore, health professionals in Australia should be aware of the risk of use of herbal and other natural products and practices by migrant women, particularly during pregnancy. Engagement with matriarchal figures, nurses and doulas within migrant communities may be valuable in identifying the extent of these practices.

Adam Morton

To the Editor:The recent review by Byard and colleagues1 highlighted the need for tighter regulation and monitoring of traditional herbal products sold in Australia to minimise the risk of exposure to preparations containing toxic substances, including heavy metals. Use of imported Ayurvedic medicines containing high levels of lead is a concerning exposure source among Victorians and elsewhere in Australia.2 Between 2010 and 2015, 1530 incident cases with blood lead levels above 10 μg/dL were notified to the Department of Health and Human Services under the Public Health and Wellbeing Act 2008 (Vic). Eight patients, aged 26–41 years, reported Ayurvedic medicine use, including one case of occult lead poisoning described previously.3 The median blood lead levels were higher in patients using Ayurvedic medicines (median, 79.5 μg/dL [range, 26.1–102.9]) compared with other non-occupational lead exposures (n = 184; median, 16.4 μg/dL [range, 10.0–63.6]). For patients reporting Ayurvedic medicine use, testing was often prompted by clinical symptoms, including abdominal pain and vomiting. All patients obtained different products directly from India (n = 7) or Pakistan (n = 1). Analysis at an independent laboratory revealed that these products had 2000–15 000 times the maximum amount of lead allowed in complementary medicines by the Therapeutic Goods Administration under the Poisons Standard (ie, 10 mg/kg or 0.001%).4 The ease by which these Ayurvedic products were obtained via the internet or by travellers to non-regulated countries means that they remain a difficult product to monitor. It is also concerning that all female patients (n = 3) reported using these products as fertility therapies or for the treatment of morning sickness, as high blood lead levels may be passed onto babies during pregnancy and while breastfeeding.5 We support the assertion that clinical vigilance is necessary in monitoring lead and other heavy metal levels in patients reporting traditional medicine use.2,3 Difficulties may arise if the health-seeking behaviours of people using Ayurvedic therapies result in fewer contacts with health services, reducing opportunities to test individuals at greatest risk. Public health messages about the potential risks of traditional and Ayurvedic medicines were distributed using targeted media for at-risk communities, Chief Health Officer alerts and the Victorian Government’s Better Health Channel.

Tanyth de Gooyer · Rohani Savage · Nicola Stephens

In reply

Roger W Byard · Garth Maker · Michael Bunce