Focus on Alternative and Complementary Therapies
www.pharmpress.com/fact
Focus Alternat Complement Ther©2005 Pharmaceutical Press
Focus Altern Complement Ther 2003; 8: 19–20
E Jane Maher
Since the early 1990s, evidence-based medicine (EBM) has been promoted as a means of moving a medical culture based on tradition and opinion towards one built on a secure scientific and objective base. There is now more robust information about the effectiveness of many medical interventions, and patients have increased access to treatments that work, rather than those that are ineffective. The case for resources to develop a secure evidence base for complementary medicine is undeniable but what are the priorities? Is the priority to develop safe medicines and interventions using the tried and tested methodologies and reject all others? In the USA, billions of dollars are spent on dietary supplements and herbal remedies with inadequate testing or quality control. This needs to be addressed. As Angell and Kassirer put it, ‘there is only medicine which has been adequately tested and medicine which has not’.1 Is this then our priority?
In 1986, when I started as a consultant oncologist, I became interested in complementary therapies reluctantly, not because of published evidence, but because my patients valued them, were already using them and wanted them to form part of a package of supportive care.2,3 Researchers have traditionally assumed that professionals and people with cancer prioritise the same issues and outcomes. Both value treatments that cure cancer but when it comes to interventions for the management of chronic illness and, in particular, care and support, this assumption is challenged. People who use complementary therapies value the ‘therapeutic relationship’ with the therapists, the acknowledgement of a link between mind, body and spirit and the emphasis on supporting health rather than treating pathology. These areas are difficult to research and studies do not result in a profitable product. It is still difficult to get the best researchers and funding to address the questions that are important to patients, clarify the outcomes that they value and develop the tools to measure these in ways that are meaningful to them. There is a case, perhaps even a priority, for ‘orthodox’ practitioners to work with complementary practitioners to learn why patients find them so valuable before decisions are made about the tools needed to measure and evaluate them. As Davidoff states, ‘the real issue for conventional medicine… is to learn from alternative practices… to regain the knowledge we have lost in information’.4
Three themes emerged for me in 15 years of working alongside complementary therapists: the value of the ‘people skills’ of therapists; the challenges of developing a language that is shared by orthodox practitioners, complementary practitioners and patients; and the lack of well-developed tools to measure some of the most important elements contributing to people’s perception of well-being. Common sense is also helpful. In the UK, most cancer centres provide non-evidence-based charitably funded ‘touch, talk and time’ therapies, for example aromatherapy massage. A systematic review of published evidence in 2000 concluded that ‘the effects of aromatherapy are probably not strong enough to be useful’.5 Should aromatherapy massage therefore cease? To demonstrate a significant difference between massage with and without aromatherapy using a randomised trial would need a sample size of over 1000, which would probably cost over £250 000.6 As a volunteer at our support and information centre commented: ‘Some cancer centres have a hairdresser who comes round the wards – it makes people feel better – have we got to have a randomised trial now to prove it’s a good idea?’
Much time and effort will be devoted to refining research questions and conducting rigorous expensive studies that produce valid results, but which ask the wrong questions about the wrong patient populations using irrelevant outcome measures unless more investment is made into explicitly involving patients in prioritising and designing research studies and investigating the areas that they prioritise. Surely, this is the real priority?
Edzard Ernst
In palliative care, research is difficult yet important. For example, it can be unethical to use placebo, sham or no treatment controls. Yet, rigorous clinical trials in this setting are feasible. Randomised equivalence trials, for example, could test the effectiveness of CAM versus another therapeutic approach. Such a study might compare CAM with the standard palliative care used in that particular setting before CAM was introduced.
Often, whole packages or combinations of treatments are used in palliative care. Some would argue that these cannot be submitted to testing in reductionist randomised controlled trials (RCTs). Yet, there is no good reason why a package of, say, half a dozen individualised CAM modalities cannot be tested in an RCT versus (a package of) conventional care. What is true, however, is that such studies are rarely undertaken; they are certainly (even) more arduous than conventional trials.
Medicine tends to quantify what is quantifiable rather than evaluate what matters (i.e. what cancer patients feel to be important). Some outcome measures used in clinical trials may be too insensitive to do justice to CAM (which can have very subtle effects) or to cancer patients (who have different priorities from researchers). Measures of well-being, quality of life or global clinical impressions exist, and even straightforward patients’ preference is quantifiable (i.e. usable as an outcome measure in RCTs). One might also point out that, if these or other parameters are not sensitive enough, the onus to produce an outcome measure that responds adequately to CAM lies with those that claim an effect.
Clinical trials can be immensely costly. The usually small effect size of a CAM therapy demands a large sample size, which obviously inflates cost. This, in my view, is unfortunate but not a good reason to abandon rigorous testing of CAM. If 1000 patients are needed in a trial of aromatherapy to generate a statistically significant effect, common sense tells me that the effect may not be all that clinically relevant. Thus, such an expensive trial would, in my view, not be a priority.
What about the proverbial hairdresser? Do we require RCTs of hairdressers to be certain they are of benefit to cancer patients? I don’t think so. In contrast to the aromatherapist, the hairdresser does not assume to be a healthcare professional. Neither do they expect to be paid by the NHS; nor do they claim to induce health effects. The proof of a pudding is in the eating. The proof of a hairdresser is in the satisfaction they give to their client. The proof of a medical treatment is in some sort of health effect beyond that of a hairdresser. This is not to deny the importance of human relationships – quite the contrary,1 their relevance to clinical practice should be acutely clear to the entire healthcare team. To delegate empathy, touch and tender loving care to either the aromatherapists or the hairdresser is wrong and would be a significant step in the wrong direction for palliative medicine.
All of us (researchers, clinicians and hairdressers) are in favour of doing everything possible for cancer patients. This obviously involves much more than healthcare. One important difference between the healthcare aspects and the non-healthcare aspects is that the former require adequate evaluation and the latter usually do not. This is not a question of science but a practical matter of optimising future patient care: without adequate evaluation there will be no (or only little) progress. Thus, rigorous trials are for the benefit of future patients.
