What role for complementary medicine in treating cancer?
Leading British cancer specialist Michael Baum caused a storm with his letter criticising the NHS for spending money on alternative therapies. Here, he answers his critics.
At the end of May, Michael Baum, emeritus professor of surgery at University College London, and other leading medical practitioners caused a storm of controversy with a letter criticising the National Health Service’s support for complementary and alternative medicine (CAM).
The letter was written to the chief executives of all 476 acute and primary care trusts in the UK, demanding that only evidence-based therapies should be provided free to patients. It was then published in The Times (London) around the same time that Prince Charles gave a speech in which he expressed his interest in and support for CAM. Later, a spokesman for the prince’s Foundation for Integrated Health accused Baum and the other signatories to the letter of being ‘clinical barons’ and much of the media also attacked them. This is the letter in full:
‘We are a group of physicians and scientists who are concerned about ways in which unproven or disproved treatments are being encouraged for general use in the NHS. We would ask you to review practices in your own trust, and to join us in representing our concerns to the Department of Health because we want patients to benefit from the best treatments available.
‘There are two particular developments to which we would like to draw your attention. First, there is now overt promotion of homeopathy in parts of the NHS (including the NHS Direct website). It is an implausible treatment for which over a dozen systematic reviews have failed to produce convincing evidence of effectiveness. Despite this, a recently published patient guide, promoting use of homeopathy without making the lack of proven efficacy clear to patients, is being made available through government funding. Further suggestions about benefits of homeopathy in the treatment of asthma have been made in the “Smallwood Report” and in another publication by the Department of Health designed to give primary care groups “a basic source of reference on complementary and alternative therapies.” A Cochrane review of all relevant studies, however, failed to confirm any benefits for asthma treatment.
‘Secondly, as you may know, there has been a concerted campaign to promote complementary and alternative medicine as a component of healthcare provision. Treatments covered by this definition include some which have not been tested as pharmaceutical products, but which are known to cause adverse effects, and others that have no demonstrable benefits. While medical practice must remain open to new discoveries for which there is convincing evidence, including any branded as “alternative”, it would be highly irresponsible to embrace any medicine as though it were a matter of principle.
‘At a time when the NHS is under intense pressure, patients, the public and the NHS are best served by using the available funds for treatments that are based on solid evidence. Furthermore, as someone in a position of accountability for resource distribution, you will be familiar with just how publicly emotive the decisions concerning which therapies to provide under the NHS can be; our ability to explain and justify to patients the selection of treatments, and to account for expenditure on them more widely, is compromised if we abandon our reference to evidence. We are sensitive to the needs of patients for complementary care to enhance wellbeing and for spiritual support to deal with the fear of death at a time of critical illness, all of which can be supported through services already available within the NHS without resorting to false claims.
‘These are not trivial matters. We urge you to take an early opportunity to review practice in your own trust with a view to ensuring that patients do not receive misleading information about the effectiveness of alternative medicines. We would also ask you to write to the Department of Health requesting evidence-based information for trusts and for patients with respect to alternative medicine.’
Here, Professor Baum takes issue with those who slammed him as an arrogant ‘clinical baron’, asking: why do some cancer patients seek out complementary and alternative medicines, and is there any role for CAM in the treatment of a terminal illness such as cancer?
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Patients diagnosed with cancer have many needs. The news comes as a shock, and maybe for the first time the individual must face his or her mortality. So before health service providers even think about the role of medicine, they must consider patients’ needs for moral and spiritual support. At times like this, a close supportive family and membership of a faith community are invaluable. Sadly, there are many cancer sufferers who lack family support and have no spiritual mentor. So perhaps one explanation for the growth in the interest in complementary and alternative medicine even among cancer patients is the unmet need of the patient when conventional medical practice fails to fill this aching void.
The next need for cancer subjects is to be free of whatever symptoms plague their life as a result of the disease. Of course, in the early stages the patients may be symptom-free, but in the later stages suffering is common from pain, nausea and weakness. The science of pain control is well established and palliative care for those close to the end is a well-developed specialty thanks to the British hospice movement. In addition, there may well be a role for interventions such as therapeutic massage, acupuncture and counselling to help the patient feel better.
Relatively new is the discipline of ‘psycho-social oncology’, which aims to identify and manage the more subtle subjective symptoms of cancer, such as anxiety and depression. This field of activity emerged about 20 years ago with the development of psychometric instruments, and it addresses the psychological, social, spiritual and behavioural dimensions thrown up by the diagnosis of cancer from both perspectives: those of the patient and those of his or her friends and family members. Furthermore, there exists a mind-body nexus that, in theory, could be modulated to influence the natural course of the disease so that if the patient ‘feels better’ it might indirectly help them ‘get better’.
The history of cancer treatment
The third need of cancer victims is to be cured, or at least to have their lives prolonged.
From the years 200 to 1800 CE, following the teachings of Aristotle and Galen, cancer was believed to be a consequence of the coagulation of ‘black bile’ (melancholia) in the target organ. Black bile was one of the four metaphysical humours (black bile, yellow bile, phlegm and blood) that needed to be in balance for perfect health. The therapeutic responses to this belief were purgation (enemas), leaching, cupping, bloodletting and extreme diets. There was never any evidence that the treatments worked, but undoubtedly the patient’s suffering was increased. Such ‘ancient wisdom’ is best confined to the rubbish bin of history. In the past 200 years, we have learnt much about the exquisite mechanisms of the body at molecular, cellular, whole-organ and whole-person levels. These realities are more beautiful, awesome and mysterious than ever dreamt of in Galen’s philosophy.
In the late nineteenth century, with the development of anaesthesia and antisepsis, surgery began to replace irrational nostrums. Not long after this, radiotherapy was introduced, which increased the chances of local control of cancer. These early successes in functional and symptomatic relief led to a period of complacency in the medical profession, which only began to be shaken with the development of effective (albeit toxic) medical regimens for treating cancer about 30 years ago.
At the same time, the randomised controlled trial (RCT) was introduced to evaluate, critically, combinations of these three modalities, measuring both efficacy (improvement in survival) and tolerability (side effects and quality of life). Using this approach, we have made slow incremental improvements and can now negotiate with our patients ‘trade offs’ between increasing length of life and the toxicity/side effects of the treatments with a degree of precision and individualisation that increases with each trial completed.
We have still a long way to go and once again there is no room for complacency. The challenge for the oncologists of today is to get the correct balance between the curiosity (scientific interest in helping patients of the future) and the compassion (helping patients of the present) in order to reach the optimal-efficiency level of care both in routine clinical practice and for the patient treated in the context of clinical research. Against this background, let us consider the meaning of needs for complementary and alternative medicine (CAM).
Semantics and the definitions of CAM
The English language has a rich and beautiful vocabulary. All these wonderful words have precise meaning and we tamper with them at our peril. George Orwell’s terrifying book Nineteen Eighty-Four illustrates the ultimate triumph of the evil of a totalitarian state. By the simple device of distorting the language to make it impossible even to harbour subversive thoughts, ‘Big Brother’ ruled absolutely. It saddens me to witness, today, how the language is being debased by a pseudo-culture that encourages transient values and transient meanings to our vocabulary. I have the same worry in relation to the use of those three words, alternative, complementary and holistic, when applied to the practice of medicine.
The first question you have to ask about ‘alternative’ is: alternative to what? Proponents of alternative medicine will describe the practice of doctors in the National Health Service, both in primary and tertiary care, as ‘orthodox’, ‘mainstream’, ‘Western’, ‘reductionist’, and so on. In return, the practitioners of conventional medicine view ‘alternative/unconventional’ medicine as a series of comprehensive health belief systems, superficially with little in common, yet sharing beliefs in metaphysical concepts of balance and similarities which date back to Galenic doctrine from the second century CE, or oriental mysticism 2,000 years older.
So in this parallel universe of alternative medicine, treatments are based on metaphysical concepts, rather than orthodox physiology and biochemistry. Yet it has to be accepted that each view of the other is to some extent pejorative, and if we are to establish a dialogue between the champions on either side of this conceptual divide we must show mutual trust and mutual respect. Perhaps for the time being we might blur these distinctions by using the word ‘unproven’, which can apply equally well to therapeutic interventions on each side. Of course, the issue of the definition of ‘proof’ then raises problems that I will address in a moment.
Next we must consider the definition of ‘complementary’. The Oxford English Dictionary defines the word as ‘that which completes or makes perfect, or that which when added completes a whole’. In other words, while modern medical science struggles to cure patients, complementary medicine helps patients to feel better, and who knows, by feeling better the act of healing itself may be complemented. Some complementary approaches may be placebos, and the touch of the ‘healer’ or the hand of the massage therapist could be guided by strange belief systems that are alien to modern science. Yet providing that the intention is to support the clinician in his endeavours rather than compete in the relativistic marketplace of ideas, one might set aside these concerns.
Finally ‘holism’, a slippery word whose ownership is competed for by both sides of the therapeutic divide. The word holism was coined by General Jan Smuts in 1926. He used it to describe the tendency in nature to produce wholes from the ordered grouping of units (holons). Chambers’ Twentieth-Century Dictionary describes holism in a precise and economic way: ‘Complete and self-contained systems from the atom and the cell by evolution to the most complex forms of life and mind.’ It can be perceived, then, that the concept of holism is complex and exquisite, and as an open system lends itself to study and experimentation. As such it should be a concept that unites us rather than a continuing source of dispute.
To do justice to General Jan Smuts’ definition of the word holism, we have to start at the molecular level, and then from these basic building blocks attempt to reconstruct the complex organism that is the human subject living in harmony within the complex structure of a modern democratic nation state.
The basic building block of life has to be a sequence of DNA that codes for a specific protein. These DNA sequences or genes are organised within chromosomes forming the human genome. The chromosomes are packed within the nucleus with a degree of miniaturisation, which is awe-inspiring. The nucleus is a holon looking inwards at the genome and outwards at the cytoplasm of the cell. The cell is a holon that looks inwards at the proteins, which guarantee its structure and function contained within its plasma membrane, and at the energy transduction pathways contained within the mitochondria, which produce the fuel for life. As a holon, the cell looks outwards at neighbouring cells of a self-similar type which may group together as glandular elements, but the cellular holon also enjoys cross talk with cells of a different developmental origin.
These glandular elements group together as a functioning organ which is holistic in looking inwards at the exquisite functional integrity of itself, and outwards to act in concert with the other organs of the body. This concert is orchestrated at the next level in the holistic hierarchy through the neuro-endocrine and immunological control mediated via the hypothalamic pituitary axis, the thyroid gland, the adrenal gland, the endocrine glands of sexual identity, and the lympho-reticular system that can distinguish self from non-self. Even this notion of selfness is primitive compared with the next level up the hierarchy, where the person exists in a conscious state somewhere within the cerebral cortex, with the mind, the great-unexplored frontier, which will be the scientific challenge for doctors in this new millennium.
It could even be argued that complementary medicine is practised at the highest level in the hierarchy that governs the human organism. Providing the ‘complementary’ practitioner concentrates on making the patient feel better and spiritually at ease, then his or her position is secure in the modern world. We would also urge proponents of alternative and complementary medicine to appreciate that the holistic system is an open system that lends itself to the experimental method. There is much research that is urgently required to investigate the psychosomatic aspects of disease, and the spiritual dimension to healing.
CAM and the unmet needs of the cancer patient
The prevalence of CAM usage in the world can no longer be ignored by the practitioners of evidence-based medicine. This is relevant to medical practice in a number of ways. First of all it must reflect the unmet needs of cancer patients. Secondly we have a duty of care to protect our patients from the dangers of remedies that might be toxic, interact unfavourably with our own medications, or be promoted as alternatives to evidence-based treatment.
The massive emotional impact after the disclosure of diagnosis of cancer can result in fear, confusion and isolation. The fear can be countered by reassurance and the offer of hope by the responsible clinician. Hope is not a promise but a state of mind. Confusion can be countered by improvement in the communication skills of the practitioner. I welcome the developments in the undergraduate and postgraduate curricula designed to teach professional development and communication skills.
At the same time, the negative judgement on the medical profession made by some CAM practitioners and representatives of the media regarding the concern about the subjective outcomes of medical care must be challenged. It should be remembered that surgical and medical oncologists were the first to invent, critically evaluate and implement quality-of-life measurement tools. In addition, counselling is well accepted by the nursing and the medical profession. Here, for a start, is a non-controversial way of building bridges among all professionals involved.
Beyond that, the popularity of CAM might reflect the time constraints of medical practitioners in understaffed and under-funded government health services; unrealistic expectations of the patient of the best that modern medicine can offer; a desperation of the patient or his or her family in facing up to the terminal stages of the disease; or even a cultural/philosophical objection to modern medicine which is one component of the postmodern relativistic philosophy popular in parts of Europe today.
Religious and spiritual support
All ‘believers’ and ‘non-believers’ accept that there is a transcendental component to life that can offer comfort, support and an explanation for the ‘human condition’. Atheists might gain this through fine art, music, literature, poetry and theatre. ‘Believers’, in addition to their access to the arts, may achieve the transcendental via membership of a faith community or by seeking their spiritual salvation through any number of ‘new-age’ belief systems.
However spiritual comfort is achieved, focusing on the transcendental enhances a sense of personal control, builds self-esteem, offers a meaning to both life and death, provides comfort and hope, and if ‘believers’ are members of an organised faith community they will have access to community support too. Of course, belief in God and belief in modern medicine are not mutually exclusive. However, there can be a downside to all this, if religiosity is confused with magic or subverted to be in conflict with a doctor’s duty of care.
Even the word ‘healing’ is open to semantic abuse, where it can be used in a loose way to imply ‘healing of the spirit’ rather than the common usage where ‘to heal’ is meant ‘to cure’. Some charlatans appear content to allow this misconception to stand uncorrected, yet deny ever claiming that their interventions contributed to a cure. Others, who truly believe in their healing powers as a cure, often invoke a view of a lost ‘Golden Age’ when nature offered a cure for all human ailments. In this respect, medical practitioners must take a robust position. There never was such a Golden Age – nature is neutral and ‘left to nature’ would mean observing the natural history of cancer. At the same time, Golden Age beliefs imply a denial of progress. Most sinister of all are the faith systems that look upon disease as ‘God’s will’ and cancer as some kind of punishment, in which case ‘healing’ can only follow prayer. This is an evil doctrine equivalent to those who claimed that the victims of the tsunami disaster in Asia reflected God’s anger at mankind’s corruption.
The rules of evidence and the nature of ‘proof’
In order to promote a dialogue, and for the sake of our patients, it would be helpful to lay to rest the myth that doctors working in the conventional healthcare systems are knowingly denying patients the proven benefits of therapeutic strategies developed by proponents of CAM. If there is evidence for the claims linked to an intervention, then it doesn’t matter what their point of origin or provenance might be. In return, if approached by professionals engaged in CAM for help in testing whether their favoured intervention is of value, then it should be the responsibility of the medical establishment to assist the best it can. What has to be agreed, however, is there cannot be a double standard. In the broadest terms, there are three categories of research design involving cancer patients.
Firstly there is ‘qualitative research’, which usually has the intention of capturing the individual patient’s experience and defining their needs. This in itself does not provide evidence of efficacy of an individual treatment but should be used to set the agenda for other research models.
Next there is observational research that is the tool of epidemiologists. They might provide clues to suggest therapies – for example, dietary intervention – or more importantly ideas for the prevention of disease.
Finally, there is the clinical trial. It is at this point that we have to consider the randomised controlled trial (RCT). This study design is sufficiently robust to cope with the extraordinary variability and to some extent unpredictability of cancer. The properly designed and conducted RCT therefore can control for case mix, selection bias, observer bias and placebo effect, and is sufficiently malleable to accommodate the needs of CAM.
For example if the CAM intervention is aimed at improving quality of life or patients’ satisfaction, then these can be defined as primary endpoints and measured by one or more of the many psychometric instruments that have already been validated. If the primary endpoint is not already covered by one of the instruments, for example in the spiritual domain, then the onus should be on its proponent to develop a new instrument, remembering Lord Kalvin’s aphorism, ‘if it exists then you can measure it’. Another problem that has to be accommodated concerns the individualisation of treatment often used as an excuse to avoid RCTs. Here, again, a robust design would allow randomisation of the ‘individualised’ intervention against a non-individualised ‘one-size-fits-all’ treatment, and let the best man win.
Clinical trials often generate results that are not entirely in agreement with each other. Thus, it is misleading to rely on the finding one prefers and to omit the ones one doesn’t like. In other words, we have to consider the totality of the available data. Systematic reviews are attempts to summarise and evaluate the totality of the available evidence of a pre-defined nature on a certain subject. All the components of the approach and assessment are made explicit so that the result is entirely reproducible. If statistical pooling is used, this is called a meta-analysis. The strength of systematic reviews is that they minimise selection (that is, the emphasis on the trials that reinforce a prejudice) and random biases (that is, the play of chance). Thus, they can provide the most objective evidence on a given subject and are a sound basis for clinical decisions. The same standards of quality must be used for CAM and for mainstream medicine. A double standard situation is not acceptable.
I believe that, should a promising treatment one day emerge from ‘alternative’ therapy, it should be investigated without delay by oncologists and adopted into routine care as soon as the data supporting its use are sufficiently strong. For example, plant-based cancer medications such as Vincristin and Vinblastin (both extract from the plant Vinca rosea) or Taxol (Taxus baccata) are already in routine use.
Although I have often been outspoken in my criticism of proponents of CAM, one thing we must all accept is that practitioners of conventional medicine and practitioners of CAM are working in good faith to improve the length and quality of life for patients with cancer.
The way forward is to build bridges, but I predict these bridges will never be completed because of the subversion by the increasingly vocal anti-science lobby in the UK.
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