The "therapeutic footprint" of medical, complementary and alternative therapies and a doctor's duty of care

The increasingly high profile of complementary and alternative therapies is undeniable.1,2 By spending billions on therapies that rarely have strong evidence of efficacy,3 or have been disproven,4 patients clearly are seeking something different to standard medical care, without demanding the kind of information about efficacy and risk now routinely requested of doctors.

There are complex societal factors influencing the use of complementary and alternative therapies.5 Reasons for their popularity include a pragmatic pursuit of better outcomes for chronic health problems,6 which may relate to “effectiveness gaps” in medical care;7 a preference for self-care, and “holistic” or “natural” approaches to health;8,9 and beliefs about disease causation that differ from the medical paradigm.10

The use of complementary and alternative therapies mostly occurs in parallel with medical care.2,11 It can be viewed as a form of health consumerism.12 Health consumerism has interlinked facets, which include a market-based approach promoting individual choice; advocacy for the inclusion of consumer perspectives within health care;13 and formal mechanisms for protecting consumers’ rights.

Increasingly, health consumerism may not just challenge the doctor–patient relationship, but sidestep it altogether. This occurs when medications are sold directly via the Internet, or “natural” health products and do-it-yourself diagnostic kits are bought over the counter or in supermarkets. Many consumers have misplaced expectations about consumer protection mechanisms and assume (wrongly) that these products are independently tested for efficacy before being marketed.2 These developments create new challenges — how is a doctor’s duty of care for his or her patients affected when patients “treat” their health problems outside the medical setting?14

Here, we explore the doctor’s role in the dichotomy between the doctor–patient relationship within standard medical care, and consumers taking non-prescribed complementary or alternative treatments outside the medical setting. We propose the concept of the “therapeutic footprint” in which the balance between potential risks and the evidence supporting a treatment allows standard medical care to be compared with complementary and alternative therapies — approaches that are otherwise “incommensurable”.5

Complementary and alternative therapies include a diversity of practices.15 However, we should not lose sight of the distinction between the concepts “complementary” and “alternative”. The often-used acronym “CAM” (complementary and alternative medicine) obscures important differences between therapies that are complementary to medicine (eg, aromatherapy to lessen discomfort after surgery) and therapies that are used as alternatives or substitutes for medical treatments (eg, a diet recommended as a treatment for cancer instead of undergoing chemotherapy for a chemoresponsive cancer). Ultimately, however, the intention of the provider and/or user of a therapy may determine whether a treatment is complementary or alternative. Alternative therapies that replace conventional medical care, and are promoted as such, present specific risks and problems, which vary according to the health context of the user.

The therapeutic footprint is a conceptual model that “plots” medical therapies and complementary and alternative therapies in relationship to one another and to their levels of risk and supporting evidence. The balance between evidence and risk (Box 1) distinguishes standard medical practice from complementary therapies and even more so from alternative therapies. While risks associated with complementary and alternative therapies may be minimal,16 even a low risk of a severe adverse event is less acceptable if related to a treatment whose benefits are small or unproven.17 The model acknowledges that any discussion of risks of complementary and alternative therapies would be disingenuous without including the hazards associated with standard medical care.

In evidence-based medicine, the skills involved in weighing risks against benefits, and assisting patients to make individual choices, are central to clinical practice. The professional relationship between doctor and patient defines the parameters for decision making according to ethical principles. The duty of care to patients is further defined by professional standards and legal sanctions. In Australia’s largely publicly funded health care system, doctors act as gatekeepers to health resources, and management decisions must be clinically justifiable and socially responsible.

Complementary and alternative therapies respond to consumer demand. When people choose to use these therapies outside a medical setting, their rights and responsibilities are not defined by the doctor–patient relationship, but by protections and safeguards for consumers. They are buying a product, and the only limitation is their capacity to pay. Some health-specific protections exist — for instance, regulation by the Office of Complementary Medicines within the Therapeutic Goods Administration22 — but these barely keep pace with the growth in complementary and alternative therapies. Consumerist mechanisms protect choice, but result in greater risk being borne directly by the consumer. Consumers are protected by a safety net, which mainly comes into effect after a problem has occurred, eg, via complaint mechanisms and product recalls. In contrast, informed consent is proactive — identifying and deciding about the degree of risk or burden patients are likely to encounter or willing to accept if they elect to have a particular treatment. One reason for the success of complementary and alternative therapies is that, because a culture of informed consent is lacking, consumers believe they are inherently safe,18 compared with medicine where risk is appropriately brought to the foreground.

Doctors practising as alternative therapists may have stepped outside their professional boundaries, as their medical status may gain credibility for alternative therapies. Doctors who provide or endorse unproven or unorthodox treatments have the same duties and responsibilities as those in standard medical care,23 and thus consumers harmed by these treatments have more avenues for redress than those treated by non-medical therapists.

However, the push to professionalise specific complementary therapies is likely to redefine practitioners’ responsibilities, creating an ethical context closer to that of medicine in terms of informed consent, provider accountability, and potential for redress if harm results from a treatment.24

The integrative medicine movement argues for complementary therapies to be blended with standard medical care where sufficient evidence exists to support particular practices. Integration further implies that these practices can be incorporated within a professional model of health care, and that usual professional responsibilities would then apply. Boundaries between medicine and complementary therapies are being continually redefined, and the process by which therapies are accepted as part of standard care is subject to debate, particularly regarding what kinds and levels of evidence are acceptable.25

Recognition that there is considerable overlap between the therapeutic footprint of standard medical care and that of complementary therapies suggests that the gap is not always as large as might be thought. Research that contributes to establishing the place of those complementary therapies already in common use is valuable. However, research into patterns of marketing and use of alternative therapies and their associated risks is also needed.

The prevalence of complementary and alternative therapy use presents doctors with significant professional challenges (Box 3). Problems often relate to boundaries between complementary therapies and standard medical care. Discussing these issues with patients can be challenging. However, these conversations provide opportunities to explore patients’ concerns, and discuss and review goals of treatment. This in itself is a valuable outcome with the potential to improve the therapeutic relationship.

In an age of consumerism, doctors’ professional roles are evolving. In responding to patients’ wishes and to competition from other providers, doctors should not lose sight of their responsibility to guide patients’ decision making, applying medical knowledge in the patient’s best interests, using standards for which they are professionally accountable. This is not paternalism: we need to recognise that being a patient is not the same as being a customer.

1 The “therapeutic footprint”: a theoretical model of standard medical care compared with complementary and alternative therapies