Thursday, September 22nd, 2016
With a concerning number of individuals with serious health conditions favouring homeopathic medicines over conventional treatment, Australia’s National Health and Medical Research Council (NHMRC) recently declared that homeopathy was not efficacious for treating any health condition. Given homeopathy has existed since the 18th century as an alternative medical approach to treatment, the declaration naturally sparked tension with leading homeopathic authoritative bodies and practicing homeopaths. This article aims to review the laws and regulations underpinning homeopathy and its preparations in Australia, and critically appraises the opinions of major organisations for and against the use of homeopathic medicines in treating serious health conditions. It provides a brief overview of how clinicians can address the issue of using homeopathic remedies as an alternative to mainstream medicine with patients. Despite the positions of two leading homeopathic authoritative bodies, the Australian Homeopathy Association and Complementary Medicines Australia, against the NHMRC declaration; there is strong evidence to suggest the need for stricter industry regulations of homeopathic practice and preparations in Australia so as to maximise the health and safety of consumers. There is also strong scientific evidence to suggest that homeopathic remedies are unlikely to have clinical effects beyond placebo. Given this, it is up to clinicians to educate their patients and provide them with all the relevant information to not only maximise their health outcomes but also facilitate well-informed decision making regarding homeopathy.
Homeopathy, a branch of complementary and alternative medicine founded in the 18th century, is commonly used in Australia and worldwide on a regular basis as a form of treatment for a number of health conditions. It is based on two principles: 1) minute doses of substances that mimic illness or symptoms in healthy individuals can be used to treat the same illnesses or symptoms in those who are unwell; and 2) highly diluted preparations retain “memory” of original substances. In March 2015, the National Health and Medical Research Council (NHMRC), Australia’s peak medical research organisation, declared that homeopathy was not efficacious for treating any health condition [1], sparking tension with practicing homeopaths. The investigation was prompted after a concerning number of individuals with serious health conditions put their health at risk or delayed evidence-based treatment by favouring homeopathic medicines [2]. The NHMRC undertook a systematic review, overseen by their Homeopathy Working Committee (HWC) in which only controlled studies were considered i.e. those that compared a group of people who received homeopathic treatment with a similar group of people who did not receive homeopathic treatment [2]. Following this major systematic review, the latest NHMRC Strategic Plan 2013-15 has responded by broadening its aim to facilitate informed decision-making by Australians regarding their healthcare and the use of non-evidence based treatment [3]. The declaration by the NHMRC has sparked tension with leading homeopathic authoritative bodies. This article aims to review the laws and regulations underpinning homeopathy and its preparations in Australia. It critically appraises the opinions of major organisations for and against the use of homeopathic medicines for treating serious health conditions through evidence and case studies. Lastly, a brief overview of how clinicians can address the issue of using homeopathic remedies as an alternative to mainstream medicine with patients is provided.
Homeopathy, first articulated by a German physician in the 18th century, Dr Samuel Hahnemann (1755-1843), refers to a unique scientific system of medicine based on the principle of similarity (“like cures like”) [4,5]. Hahnemann describes this principle as a reactive process whereby giving minute doses of a substance thought capable of inducing a series of symptoms in healthy individuals can be used to cure the same symptoms in those suffering (“similia similibus curantur”) [4,5]. Derived from the Greek words hόmoios meaning similar and pathos meaning suffering, disease; the aim of this “simile-based” therapy is to restore health using a “holistic” approach by individually tailoring homeopathic remedies to enhance the individual’s natural healing processes and strengthen their body’s ability to fight against susceptibility of disease [6,7].
The phenomenon underpinning homeopathy as described by Hahnemann was that for homeopathic substances, the higher the dilution, the higher the potency [8]. In Britain, for example, two common preparations are sold over-the-counter: 6C and 30C dilutions. The 30C dilutions are significantly more dilute than the 6C (1 in 10030 vs. 1 in 1006 respectively), with the former considered to be more potent [4]. To explain this phenomenon, Hahnemann described that when the preparation is vigorously shaken between each dilution, the energy or essence of a substance is transferred to a solvent, a process called “potentiation” and “succession”, whereby a “memory” of the initial substance is retained in the solution [2,5]. This process is how the purported therapeutic effect is achieved [8]. The most common dilution factor is 1060, which can vary depending on the constituents and strengths [5]. Homeopathy is thus a form of therapy based on similarity and dilutions that considers the person as a whole so as to enhance the body’s natural healing processes against various health conditions. However, it is important to highlight here that due to the extensive dilution, standard scientific theory would attest that the final homeopathic preparation is statistically unlikely to contain a single molecule of the original active ingredient [9,10].
Originally, homeopathy was a self-regulated industry in Australia controlled by individual-state based organisations [11]. In 1997, these organisations merged to form what is known today as the Australian Homeopathy Association (AHA), which is the only national association of professional homeopaths in Australia that maintains the Australian Register of Homeopaths (AROH) [11,12].
Currently, to acquire a private health fund rebate for their services, homeopathic practitioners must be registered with AROH [13]. The AROH guidelines for registration necessitate that all registered practitioners have either passed a competency test for those who have not studied a homeopathic course accredited by AROH or have attained a three-year Advanced Diploma Course at a recognised institution; hold a current first aid certificate; maintain annual professional indemnity insurance; and undergo regular continuing professional development requirements [14]. Furthermore, homeopaths must abide by the AHA Code of Conduct as endorsed by the National Council, which requires them to refer patients with serious illnesses back to medical practitioners for evidence-based treatment [15].
The Australian national regulatory framework for homeopathic practice and its preparations is not as strict as some may anticipate. Homeopathic preparations are seldom registered with the Therapeutic Goods Administration (TGA), the national regulatory organisation that ensures the safety and quality of various therapeutic goods [16]. Those that qualify for registration are homeopathic preparations of no more than 1000-fold dilution, or contain apparent quantities of animal or human ingredients [17]. Most, however, either have undetectable amounts of the “active” ingredient or are too diluted. Such preparations are thus deemed exempt from the TGA good manufacturing practice requirements, circumventing the rigorous testing for safety and efficacy by TGA that other drugs must undergo [17]. This, in turn, raises the question regarding the safety and efficacy of homeopathic treatment.
On the Australian Register of Therapeutic Goods, complementary medicines including homeopathic preparations can either be “registered” or “listed” depending on the level of risk that the medicines carry [17]. As “registered” medicines carry a high level of risk, they must undergo rigorous and detailed assessment and regulation of all relevant randomised controlled trials so as to provide comprehensive quality, safety, and efficacious data [17]. In contrast, “listed” medicines are not evaluated by TGA as they are of low risk, however, the products must have proven safety, quality, and efficacy as per legislative requirements [17]. Currently, no homeopathic preparations are registered and those listed and claiming to be efficacious must be labelled with the disclaimer “contains homeopathic ingredients without approved therapeutic indications” [17].
The AHA website provides a list of homeopathic medicine suppliers, which is publicly available, with most being sold through health food shops and pharmacies [18]. Such preparations are commercially manufactured and made available to homeopathic practitioners by three Australian suppliers: Pharmaceutical Plant Company, Martin & Pleasance homeopathy lab, and Brauer [18]. In addition, the AHA stress that each homeopathic practitioner has their own unique approach to making custom prescriptions [6], however, no centralised body exists to regulate such practice in Australia [5].
Since the NHMRC declared homeopathy to be ineffective in treating any health condition, a number of disputes have been made by major organisations in favour of homeopathy. Australia’s two peak industry organisations, Complementary Medicines Australia (CMA) and the AHA, both argue in their letters to the NHRMC that the position was prejudiced based on a draft position statement leaked in 2012 stating “it is unethical for health practitioners to treat patients using homeopathy, for the reason that homeopathy (as a medicine or procedure) has been shown not to be efficacious [19,20].” Furthermore, both the CMA and AHA highlight serious concerns regarding the prelude to and instigation of the work of the NHMRC’s HWC as well as the conduct of the review itself to finalise their conclusion on the use of homeopathy. Several grave issues were raised in both letters with five common key flaws cited: (1) no explanation was provided as to why level 1 evidence including randomised control trials were excluded from the review; (2) the database search used was not broad enough to capture complementary medicine and homeopathic specific content, and excluded non-human and non-English studies; (3) no homeopathic expert was appointed in the NHMRC Review Panel; (4) prior to publication, the concerns raised over the methodology and selective use of data by research contractor(s) engaged for the HWC review were abandoned for unknown reasons; and (5) no justification was provided as to why only systematic reviews were used [19,20]. Other serious accusations made by the AHA in their response letter to the NHMRC involved the blatant bias of the NHMRC evident by: the leakage of their draft position statement in April 2011 and early release of the HWC Draft Review regarding homeopathy to the media; no discussion of prophylactic homeopathy i.e. preventative healthcare; and no reference to the cost-effectiveness, safety, and quality of homeopathic medicines [19].
Despite the NHMRC findings being strongly disputed, they are further supported by positions taken by a number of large and respected organisations. For example, in 2009, the World Health Organization (WHO) advised against the use of homeopathic medicines for various serious diseases following significant concerns being raised by major health authorities, pharmaceutical industries, and consumers regarding its safety and quality [21]. They reported the clinical effects were compatible with placebo effects [21]. Similarly, in Australia, the Australian Medical Association (AMA) further supports the NHMRC findings by stating in their position statement released in 2012 that there is “limited efficacy evidence” regarding most complementary medicines, thereby posing a risk to patient health [22]. More recently, in May 2015, the Royal College of General Practitioner’s (RACGPs) strongly advocated in their position statement against general practitioner’s prescribing homeopathic medicines, and pharmacists against supporting or recommending it, given the lack of evidence regarding its efficacy [23]. This is particularly pertinent to conventional vaccines given the recent case between the Australian Competition and Consumer Commission (ACCC) vs. Homeopathy Plus! Australia Pty Ltd. The Federal Court found Homeopathy Plus! Australia Pty Ltd guilty of contravening the Australian Consumer Law by engaging in misleading and deceptive conduct through claiming that homeopathic remedies were a proven, safe, and effective alternative to the conventional vaccine against whooping cough [24].
The positions of the NHMRC, WHO, AMA, and the RACGPs regarding homeopathy is further supported by Cochrane reviews, which provide high-quality evidence with minimal bias [25]. Of the twelve homeopathy Cochrane reviews available in the database, only seven address homeopathic remedies directly and were related to the following conditions: irritable bowel syndrome [26], attention deficit/hyperactivity disorder or hyperkinetic disorder [27], chronic asthma [28], dementia [29], induction of labour [30], cancer [31], and influenza [32]. Given most of these reviews were authored by homeopaths, bias against homeopathy is unlikely [26-32]. The overarching conclusions from these reviews fail to reveal compelling evidence regarding the efficacy of homeopathic remedies [26-32]. For example, Mathie, Frye and Fisher show that there is “no significant difference between the effects of homeopathic Oscillococcinum® and placebo in prevention of influenza-like illness: risk ratio (RR) = 0.48, 95% confidence interval (CI) 0.17-1.34, p-value = 0.16 [31].” The key reasons given for this failure to provide compelling evidence relate to low quality or unclear data, and lack of replicability, suggesting homeopathic remedies are unlikely to have clinical effects beyond placebo [26-32].
Sadly, the ACCC vs. Homeopathy Plus! Australia Pty Ltd is not the only case that has made headlines in Australia in recent years. An article in the Journal of Law and Medicine coincided with the NHMRC report regarding the number of deaths attributable to favouring homeopathy over conventional medical treatment in recent years [33]. One such case was that of Jessica Ainscough, who passed away earlier this year after losing her battle with a rare form of cancer – epithelioid sarcoma – after rejecting conventional treatment in favour of alternative therapies [34]. Although doctors recognise Ms. Ainscough’s right to choose her own cancer treatments and understand why she refused the disfiguring surgery to save her life, they fear her message may influence others to reject conventional treatments that could ultimately save their lives [35]. Another near death case was that of an eight-month-old boy whose mother was charged with “reckless grievous bodily harm and failure to provide for a child causing danger to death” after ceasing conventional medical and dermatological treatment for her son’s eczema as advised by her naturopath (an umbrella term that includes homeopathy) [36]. The “all-liquid treatment plan” left the boy severely malnourished and consequently, he now suffers from developmental issues [37]. This case is rather similar to that of R vs. Sam in 2009, where the parents of a nine-month-old girl were convicted of manslaughter by criminal negligence after favouring homeopathic treatment over conventional medical treatment for their daughter’s eczema. The girl died from septicaemia after her eczema became infected [36,37].
As the aim of the latest NHMRC Strategic Plain 2013-15 is to assist Australians in making informed decisions regarding their healthcare, the NHMRC published a resource in April 2014 “Talking with patients about Complementary Medicine – a Resource for Clinicians” [38]. This was developed to facilitate discussion between clinicians and their patients regarding their use of complementary medicines so patients can make well-informed decisions about their healthcare options [38]. Available through the NHMRC website, this resource provides background information on complementary medicines and its regulation in Australia as well as suggestions on how clinicians can initiate discussion with patients regarding its evidence, reliability, effectiveness, and potential risks [38]. For example, to initiate discussion, clinicians can ask their patients if “they have tried anything else to help with their problem” [38]. Such discussion is imperative as many patients fail to disclose they are taking complementary medicines, which in itself may lead to adverse outcomes. The resource also provides further additional information, resources, and links to help clinicians in providing patients with all relevant information so he/she can make a truly autonomous well-informed decision as per the AMA Code of Ethics [38,39].
Significant repercussions have followed the major review and final position statement by the NHMRC HWC regarding the efficacy of homeopathic remedies in treating health conditions. Despite the defensive position of the AHA and CMA, there is strong evidence to suggest that there is a need for stricter industry regulations for homeopathic practice and preparations. Furthermore, given that the efficacy of homeopathic remedies for treating any health condition is unlikely, it is now up to clinicians to provide and ensure that their patients have all the relevant information so they can make a well-informed decisions regarding their health. With a concerning number of individuals with serious health conditions favouring homeopathic medicines over conventional treatment, collaboration between leading regulatory bodies, clinicians and patients is vital in maximising patient safety and health outcomes.
Acknowledgements
None.
Conflicts of interest
None declared.
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