Focus on Alternative and Complementary Therapies
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Focus Alternat Complement Ther©2005 Pharmaceutical Press
Focus Altern Complement Ther 2005; 10: 171–6
CAM is an umbrella term for a range of diagnostic and therapeutic methods not normally employed in orthodox medicine. However CAM is defined, it is important to point out that essentially CAM is medicine. As such, it has much in common with conventional health care:
Some of the most tangible differences between CAM and conventional medicine include:5
This article addresses the research ethics in CAM – first by considering the fundamental overriding principles of autonomy, beneficence/maleficence and justice, and subsequently by applying these principles to the practicalities of conducting CAM research.
A set of prima facie principles has evolved in medical ethics, providing a common moral commitment, a common moral language and a common set of moral issues.7 These principles are also applicable to CAM.3–5,8
Autonomy puts people in a position to make informed decisions. Respect for autonomy is the moral obligation of honouring the deliberated self-rule of others.7 In CAM research, this requires investigators to consult and sufficiently inform research subjects or patients before commencing a project. Informed consent, including adequate communication in obtaining it, is as essential for CAM research as it is for other areas of medical research. Yet there are situations in CAM research where informed consent may not be feasible or practical, e.g. if informed consent from study participants would significantly distort the result of a research project (see below).
The need for confidentiality is another direct consequence of respect for autonomy. Medical researchers implicitly or explicitly promise to keep secret the information confided to them. Keeping this promise is an expression of respect for autonomy.7 Confidentiality applies to the subject of CAM as much as it applies to any other medical research.6
Respect for autonomy also requires the absence of deception. In clinical research, this can pose problems, for instance when conducting surveys of CAM practitioners in which information about the research question is likely to distort the results.9 Thus a degree of pretence may, on occasion, be unavoidable. In such cases, all measures have to be taken to minimise deception.
Empowerment, i.e. putting patients in a position to be in control, follows from the two moral obligations of beneficence and respect for autonomy.7 Patients tend to try CAM because they feel empowered by this choice.1 In CAM research, patient empowerment may mean that patients influence the type of research, outcome measures, etc. Considering that CAM is much more patient-driven than other areas of medicine, empowerment in CAM research may be particularly important.
CAM may well be less risky than conventional medicine. In fact, several CAM modalities, such as homoeopathy, reflexology and aromatherapy, are not associated with significant direct risks at all.1 Contrary to what many patients and therapists believe, CAM is, however, not free of risks. The potential for harm ranges from herb–drug interactions to vertebral artery dissection after upper spinal manipulation (Table 1).10 With any type of medicine, the aim must always be to do more good than harm. In the words of Miller et al.3 ‘research must have a favourable risk:benefit ratio, minimizing the risks to subjects and justifying the risks by the potential benefits to subjects and the value of the knowledge to be gained from the research’. For many CAM research projects, this can pose myriad problems.
Table 1. Examples of risks related to same CAM treatments
| Treatment | Risk |
|---|---|
| Acupuncture | Minor risks (e.g. pain, bleeding) occur in 7–10% of patients; major risks (e.g. pneumothorax, infections) are rare |
| Aromatherapy | Allergy to essential oils |
| Chelation therapy | Hypocalcaemia, kidney malfunction |
| Chiropractic | Mild, transient adverse effects (e.g. pain) occur in ~50% of all patients; major risks (e.g. vascular accidents) are probably rare |
| Herbalism | Toxicity of some plants, contamination or adulteration of some preparations, herb–drug interactions |
| Homoeopathy | Aggravation of symptoms is expected in ~20% of patients |
| Osteopathy | Similar to chiropractic |
| Yoga | Injuries with extreme postures |
Harm is conceivable not merely as a result of the adverse effects of a therapeutic or diagnostic intervention. Harm can also occur through the lack of training and education of people involved in research (lack of professional competence), through meaningless or flawed research or through fraud.
The potential for harm must be weighed against the potential for benefit, and the benefit of research obviously goes beyond the well-being of research subjects. Potential benefits for society or patient groups need to be considered as well. Vis-à-vis the remarkably high prevalence of CAM usage within the population,11 the benefits of CAM research can be high: ‘the widespread use of CAM underscores the social value of rigorous research to verify whether the assumptions of its safety and efficacy are valid.’11
Defining who will benefit and who might be harmed as a result of a CAM research project can be difficult. We need empirical information about the probabilities of various benefits and risks. This information has to come from effective research, which means that (CAM) research is a ‘prima facie moral obligation.’7
In medical ethics, justice can be defined as the ‘moral obligation to act on the basis of fair adjudication between competing claims.’7 In relation to research ethics, justice may refer to fair distribution of funds, to respect for patients’ rights and to observing the legal framework that covers CAM. The principle of justice applied to CAM research raises a number of questions. Should public research funds be distributed in proportion to the usage of CAM by the public? Currently, this is clearly not the case (Table 2).12 How much say should the public have in deciding which research themes will be investigated (i.e. receive research funds) and which will not?
Table 2. NIH funding for CAM as a proportion of NIH total research budget
| Year | 2000 | 2001 | 2002 | 2003 | 2004 |
|---|---|---|---|---|---|
| CAM funding | |||||
| Absolutea | 68 390 | 89 138 | 104 407 | 113 407 | 116 978 |
| Relativeb | 0.38 | 0.44 | 0.45c | 0.42 | 0.42 |
aIn thousand US$.
bPercentage of total NIH research budget.
cIn 2002, a NIH survey showed that 62% of the US general population use at least one form of CAM.
The following section is intended to take us through some of the practicalities of conducting CAM research. It points out some of the ethical problems that can arise. The natural sequence from planning, conducting, evaluating, publishing and implementing research will be followed. It is not possible to address all the ethical issues that may arise. This section will therefore focus on those which, in the personal experience of the author, are characteristic for CAM research.
Even before planning a CAM research project, it is advisable to be open about any conflicts of interest. In conventional medicine, such conflicts often centre on financial issues. In CAM, where powerful financial interests are usually secondary or non-existent, they frequently relate to a strong belief in the value of CAM. Such belief can be a significant hindrance to objectivity and may thus distort research findings. ‘Personal convictions may be valuable to the individual clinician and their patients, it is of little help in contributing to collective, dependable knowledge.’13 Many published CAM articles contain statements about their aim that make such conflicts obvious. Instead of conducting research to test hypotheses, CAM researchers often state that they want to ‘prove’ or ‘demonstrate’ the effectiveness of their therapies.5 In doing so, these investigators inadvertently show their own biases and conflicts of interest.
In order to avoid bias and the flaws in research they create, it is mandatory that any research project is an honest (i.e. unbiased) attempt to find the truth. Studies that are aimed at confirming the beliefs of the CAM researcher are likely to mislead – in the final analysis, such an approach would be unethical.
Research funding is scarce in all areas of medical research but in CAM it is particularly limited, both in the USA and the UK, and elsewhere.12 The NIH, for instance, is often quoted as generously supporting CAM research. In absolute terms, US funding for CAM research is indeed larger than anywhere else in the world. In 2004 the NIH dedicated US$ 116 978 000 to the work of its National Centre for Complementary and Alternative Medicine. In percentage terms, this sum is, however, minute; it amounts to 0.42% of the total NIH research budget (Table 2).
Vis-à-vis the immense popularity of CAM in the population, this raises the question of fairness. Since research funds usually originate directly or indirectly from the consumer, one could argue that the level of CAM research funding should reflect the current popularity of CAM, particularly since even the most essential questions about efficacy and safety remain largely unanswered.1 In view of the ethical principle of justice, this should be seen as an ethical issue and requires proper debate and transparent decision processes. Our aim must be to avoid double standards.
If financial support for a CAM research project is obtained, this obviously has to be handled in the same transparent and ethical way as any sponsorship of medical research. It is noteworthy that, according to a recent analysis, funding sources of CAM research are frequently not mentioned in published CAM articles.14
CAM research can be methodologically complex (Table 3) and often extends beyond the areas of competence of institutional review boards (IRBs). Thus IRBs may face problems when trying to assess CAM protocols.15 In addition, many CAM researchers are concerned about the attitude of IRBs towards CAM. Some committee members may regard CAM as marginal or flawed in principle.15 There is concern that CAM protocols may not always be treated fairly by IRBs. Again, double standards are not acceptable in any area of health care.
Table 3. Examples of methodological complexities in CAM research
| Problem | Explanation |
|---|---|
| No placebo exists | With some CAM interventions (e.g. massage, hypnotherapy), no credible placebo or sham intervention is conceivable; clinical studies have to use other comparator interventions |
| Patients/therapists cannot be blinded | For interventions that have no conceivable placebo, patient/therapist blinding may be impossible; clinical studies have to be conducted without blinding |
| Clinical effects of intervention may be subtle or small or only apparent after prolonged treatment | Outcome measures for quantifying subtle effects may not be available; small effect sizes usually require large sample sizes (which may not be available or too expensive); long-term effects require long follow-up |
| Intervention may be holistic and complex | Some CAM treatments (e.g. traditional Chinese medicine) are more than single modalities; this can cause problems in clinical trials testing their efficacy |
| Treatments may be individualised | Some CAM treatments (e.g. homoeopathy) require highly individualised therapeutic approaches; thus standardisation requirements in clinical trials might be difficult to meet |
It has been repeatedly pointed out that our current system of ethical review is unnecessarily bureaucratic, wasteful of time, money, energy and paper, as well as slow and inconsistent.16 This situation tends to disadvantage CAM researchers, who often do not have the resources or experience to cope with such adversity.
Many published CAM articles fail to mention any ethical review at all.14 In some countries, e.g. China, ethical review may not be obligatory or available. Thus research emerges from China, with some regularity, which elsewhere would be deemed as overtly unethical.17,18 Countries like China are of obvious importance to CAM research, and it seems important that ethical standards are the same everywhere.
‘CAM research requires the highest standards of rigor including meeting the quality criteria of model validity.’19 Seven requirements have been proposed that need to be fulfilled for any clinical trial to be deemed ethical:20
There is no good reason why this set of criteria should not be applicable to CAM research. Some CAM therapies may, for instance, be too implausible to merit research (Table 4).21 Investigating such topics might therefore be unethical. Many authors have pointed out that much of CAM research is methodologically flawed.6,22 Strictly speaking, flawed research must be regarded as unethical.23 Because there is little research culture and expertise in CAM,6 many would-be researchers will be ill-equipped to cope with the high demands of the above criteria.24
Table 4. Examples of implausible claims in CAM
| Modality | Claim |
|---|---|
| Acupuncture | Health is governed by two opposing forces: ‘yin and yang’; life energy ‘qi’ flows in meridians |
| Bach Flower Remedies | All diseases are rooted in emotional imbalances that can be rebalanced with highly dilute flower remedies |
| Chelation therapy | Atherosclerosis is caused by calcium deposition in the arterial wall |
| Chiropractic | Malalignment of the spine is a main cause for most diseases |
| Homoeopathy | Like cures like |
| Reflexology | Specific zones on the soles of the feet relate to inner organs, which can be influenced by massaging these zones |
CAM seems to generate more surveys than any other field of medical research.25 Surveys are often considered to be ethically unproblematic. On closer inspection, however, they can raise several ethical issues.26
Patient surveys could, for instance, create unnecessary anxieties for the patient, particularly in relation to life-threatening illnesses such as cancer. Other CAM surveys may raise positive expectations, which can lead to disappointment when they are not or cannot be met. Much more important is the harm that can be done by CAM surveys being flawed or wasteful research projects without value or relevance for society or science. At present, CAM surveys with debatable social or scientific value are being conducted in abundance. For example, each year dozens of surveys are published aimed at assessing the prevalence of CAM usage. Many of these articles are not representative, e.g. because of small sample size or low response rate, and therefore are of very limited value. Arguably such projects are not ethical.
The publication of a research project is a complex, often tedious process. It is governed by a set of guidelines27 that are often disregarded in CAM. This can create many problems. For instance, ‘failure to disclose that an analysis was post hoc is unacceptable.’27 Yet, in CAM articles, such disclosure seems more the exception rather than the rule. Conflicts of interest often remain undeclared.14 Dual publication of results without declaration is not acceptable,27 yet this practice is rife in CAM.
Dishonesty, misconduct and fraud are serious problems in medical research.28 They are certainly not specific to CAM but it does not seem to exclude them either. Misrepresentation of data, for instance, might be construed as a forgivable error of minor importance in CAM,29 while in other areas of medical research it would be considered fraudulent. The lack of experience in research could be a risk factor for misconduct in CAM research.
Of all Medline-listed CAM journals, only two require acknowledgement of sponsorship and conflicts of interest, and none insists on statements about informed consent.14 Conflicts of interest ‘can be personal, professional or financial; and they can be actual (do influence judgement) or potential (could affect judgement).’30 In published CAM research this principle is far from being implemented.14 For instance, hundreds of acupuncture studies have been published, yet none carries a declaration of whether the authors are proponents or opponents of this therapy.
Ignoring CAM is not an option.8 The ethical problems of CAM research are numerous and complex. In principle, they are not different from those in other areas of medical research. Because CAM differs in several respects from conventional medicine, the problems are, however, likely to vary in practice. The reluctance of many CAM practitioners to participate in research is ‘ethically unsustainable.’6 The onus is on CAM researchers to overcome their apathy towards research, to confront and solve the many difficulties posed by CAM research, and to provide us with convincing evidence solidly founded on rigorous and ethical research.
