3.1 Much of our evidence, including that given by the Consumers' Association and the Patients' Association, has suggested that patients' satisfaction with their CAM treatment is high and is likely to account in part for a significant proportion of the high level of CAM use. During the course of our Inquiry the Committee met several patients of CAM practitioners (at the Marylebone Health Centre and at the Southampton Centre for Complementary Health Studies - see Appendices 4 and 5), all of whom expressed high levels of satisfaction with the CAM treatment they had received. We also received many written letters of support for CAM by patients. We did not in fact hear directly from any patients who were unhappy with treatment they had received from a CAM practitioner. The high satisfaction shown by CAM patients suggests that the reasons given (in paras 1.24-1.28) for accessing CAM are largely justified in the event, and the conditions for which they seek help are indeed often relieved, as Zollman and Vickers stated in an article in the British Medical Journal last year[16].

3.2 During the our visit to Exeter University (see Appendix 3), Professor Edzard Ernst referred to a project his department had carried out, which compared satisfaction levels with CAM to satisfaction levels with conventional medicine, amongst arthritis sufferers who had experienced both types of treatment[17]. This work suggested that many CAM therapists were more friendly, spent more time with the patient and were more forthcoming with information on the treatment and the disease. Some patients also perceived CAM as giving slightly more efficacious treatments.

3.3 Evidence we heard from the Consumers' Association identified several reasons for high patient satisfaction with CAM. They concluded that patients appreciate CAM's emphasis on a person's overall well-being, and also suggested that the CAM consultation may be more satisfying to patients as it is longer, and CAM practitioners tend to have very good communication skills which put patients at ease. The Consumers' Association had conducted a survey in 1997 which showed that for therapies such as yoga, aromatherapy, massage and reflexology, people experience general life-style benefits just from the experience of taking part in the therapy (Q 829).

3.4 Submissions from the Royal College of Physicians (P 189) and the UK Cochrane Centre (P 223) both suggest that CAM consultations not only take more time, but are more thorough and more detailed than conventional medical consultations, especially in primary care. They also tend to include active listening techniques and demonstrate interest in the whole of the patient's life, not just in their physical health. Such factors may well contribute to higher levels of patient satisfaction with their treatment. Increasing pressures on conventional medical practitioners in an understaffed NHS are felt to be an important contributory factor.

3.5 Zollman and Vickers[18] gave several explanations for the popularity of CAM. It was suggested that the "…specific effects of particular therapies obviously account for a proportion of patient satisfaction, but many patients also value some of the general attributes of complementary medicine." These 'attributes' include those mentioned above but also add: the attention to personality and personal experience, the increased amount of patient involvement and choice, the increased levels of hope often provided by the holistic approach, the more human experience of healthcare (which comes from the increased amount of touch and 'low tech' equipment used in CAM), and the fact that CAM often specialises in dealing with ill-defined symptoms that conventional medicine sometimes is unable, or unwilling, to tackle. Finally they suggest that the holistic approach often provides a means of making sense of illness in a context that is more understandable and personally relevant to the patient.

3.6 HealthWatch (P 123) has suggested that one reason for patient satisfaction is that most CAM practitioners work in private practice and therefore have more time and greater resources with which to help their patients. Several CAM practitioners and HealthWatch (P 123) propose that CAM may function better in the private sector, as the experience of paying for healthcare increases patients' involvement in their own recovery and provides additional motivation. This may lead to greater treatment compliance and a greater degree of satisfaction.

3.7 Looked at altogether this evidence identifies several factors considered by many to contribute to patient satisfaction with CAM. The holistic approach of CAM, the individual emphasis, the greater time spent on patients by practitioners, were all very popular reasons given by witnesses for patient satisfaction. However, Dr George Lewith, head of the Centre for Complementary Health Studies in Southampton told us, during our visit, that no empirical evidence has shown that issues such as time account wholly for patient satisfaction. Therefore, no firm conclusions on the reasons behind patient satisfaction with CAM can be drawn until studies are conducted on this issue. We assume that time is an important factor but it is also likely that quality and not just quantity is important in relation to consultations. Although patient satisfaction may be a component of well-being and a marker of health itself, it is not necessarily a clear reflection of a treatment's clinical efficacy. The placebo effect can have a large role in patient satisfaction as can many of the factors discussed above. The role of patient satisfaction as a component of efficacy will be considered later in this report (see paras 4.24-4.27) as will the role of the placebo effect in CAM and conventional medicine (see paras 3.19 - 3.34).

3.10 Patients are also becoming increasingly aware of, and concerned about, the side-effects of conventional medical treatment, and particularly those of potent drugs. This is a problem the Faculty of Homeopathy, which represents medical practitioners who also practise homeopathy, told us they were very well aware of (P 81). The risk of iatrogenic[19] disease is therefore another reason why patients may try to find alternatives to conventional therapy.

3.11 It can be concluded that there are some factors in conventional medicine that lead patients to turn elsewhere to find the type of treatment to which they aspire. The Consumers' Association evidence points out that it is not invariably a matter of patients turning their back on one mode of treatment and replacing it with another. They suggest that the Government and the NHS are currently emphasising self-treatment of minor ailments, if only because of the inadequate numbers of doctors in all branches of medicine, and patients are increasingly taking on their rights and responsibilities and are choosing treatments that they feel are right for them. Therefore it is likely that the increased use of CAM is a result of patients using a 'pick and mix' combination of treatments rather than a sign of rejection of one school of medicine for another (Q 828). The Astin Survey, discussed above (see para 1.24) would appear to support this conclusion.

3.12 Whether this is true or not it is clear that conventional medicine as presently practised may lack something so that some patients are left feeling that not all their needs have been met. This factor, coupled with developments such as the Internet and the increased emphasis of consumer involvement in all service areas, has led to patients being increasingly aware of their options and responsibilities.

3.14 During the course of our Inquiry several witnesses drew our attention to Complementary Medicine: A Research Perspective[20]. This book includes a chapter on the consultation styles of conventional and complementary practitioners which reviews the few studies that there are in this area.

3.15 The work of one researcher in this area, Taylor, is reviewed in Vincent & Furnham's book. Taylor's work investigates the changing nature of the conventional medical encounter in the United Kingdom. Taylor suggests that in the last thirty years the consumer movement, the increased sense of entitlement and general demands for professional reform and accountability, have put pressure for democratisation and attention to customer service on the medical profession. However Taylor's work suggests the medical profession has resisted change and that there has in fact been a deterioration in the customer service side of the medical encounter. Several reasons are suggested for this:

• The increased threat of malpractice suits has made doctors more cautious and less relaxed with patients.

• There are fewer general practitioners and more specialists so a long-term doctor-patient relationship is less likely.

• Patients find changing doctors and getting second opinions a struggle and so feel they have no 'exit' option within the medical encounter.

• Patients feel doctors insist on clinical autonomy and they perceive a refusal to share information.

• Increased administration within the health service makes patients feel as if more attention is being paid to 'processing' them than appreciating their individual patterns and matching treatment to them.

• Increasing costs and rationing of services has led to feeling that services are being withdrawn.

3.16 These factors are coupled with the fact that, through high-profile medical advances, conventional medicine has acquired great power, prestige and influence, leading to even greater demand for services. This contributes to a vicious circle, whereby patients are demanding more, and feeling as though they are receiving less.

3.17 Vincent & Furnham's book goes on to review the characteristics of the CAM practitioner-patient relationship. They review the work of Kleinman[21] who suggests that although most CAM therapies do not share a common theoretical basis what they do share, which distinguishes them from conventional medicine, is an emphasis on the subjective experience of the patient and a focus on the whole patient, not just the disease. Kleinman suggests that there are several areas where CAM consultation styles may prove more attractive than those of conventional medicine. These are:

• Emphasis on overall experience of illness - CAM therapists often take into account social issues during their assessment of a patient, whereas some conventional medicine increasingly focuses on the individual patient and the specific complaint and bodily organ, or organs, involved. As patients will experience their problem in the context of their family and work etc. and may even see these things as the cause of their problems, they may prefer the CAM approach.

• Simple language - The language of conventional medicine has become increasingly technical and hard for patients to understand. CAM practitioners are more likely to use everyday language.

• Lay explanations - CAM explanations for disease are often easier for a patient to understand than the more technical conventional medical explanations. CAM explanatory models are also more likely to consider factors such as emotional and social factors in disease and so will be concerned with the patient's overall experience. This may lead to circumstances where there is a better fit between patient's view and the views of CAM practitioners.

• Illness without pathology - Patients sometimes feel that something is wrong but are told after a physical examination by a conventional medical practitioner that nothing can be found to support their claims of illness. However, in many cases they continue to feel unwell. Complementary practitioners are often more willing to diagnose and treat such symptoms and to provide an explanation which will be more satisfactory for the patient.

3.18 Another study is discussed in Vincent & Furnham's book, which shows that a doctor's consultative style can have considerable immediate, intermediate and long-term outcomes on patient health. Three communication variables have been found to have importance in the consultation: creating a good interpersonal (trusting, warm, open) relationship; the clear and comprehensible exchange of information; and skill in making treatment-related decisions. The study that identified these variables also identified four major medical outcomes that these variables affect: overall satisfaction; compliance and adherence to a treatment programme; the recall and understanding of exchanged information; final health status; and psychiatric morbidity[22]. This work suggests that the communication styles of CAM therapists, in comparison to conventional therapists, may play a significant role in determining patient satisfaction with CAM. There are two important implications that arise from this. Firstly, CAM research must take into account the potential effects of the patient-practitioner relationship and not side-line it as an incidental factor or a complication in research (see Chapter 7). Secondly, conventional medicine and the NHS may learn from CAM's strengths in this area. It is important to note that many practising medical practitioners possess and are taught exactly those communication skills and appreciation of the emotional and social factors which cause or influence disease, but may be prevented from deploying these skills fully because of pressures and constraints of time. It is widely accepted that some of the most intractable problems which patients present to doctors, often expressed as "illness without pathology" (see above), have a psychological or social basis of which the patient (and sometimes the doctor) may not be fully aware, or which they may be unable to acknowledge.

3.21 The placebo effect is nothing new, nor are attempts to enhance its effect unconventional. In fact the history of conventional medicine has largely been the history of the placebo effect. Vincent & Furnham's book also has a chapter on this subject, written by Phil Richardson who reviews some interesting studies. Most medicines used by doctors up until the 20th Century are now known to be inert, but they were often of exotic origin and thus were often perceived as having magical properties. Even today part of the conventional doctor's armoury may include inert capsules and sugar pills. In fact one study showed that 80 per cent of US hospital clinicians admitted to the occasional use of placebo medicines in routine clinical practice (Gray & Flynn, 1981)[23]. The reasons these doctors gave for this practice were concerned with deflecting the focus of the demanding patient and proving that the symptom thereby reduced was psychogenic and not of organic origin.

3.22 However, some would argue that these reasons demonstrate only a limited knowledge of relevant empirical findings. All treatments, physically active or otherwise, have a psychological impact when administered to a conscious patient. It is possible that this psychological effect should not be considered as a nuisance that hampers research or some kind of fraud, but an essential element of any holistic therapy. It could even be suggested that the placebo effect is a legitimate form of psychotherapy.

3.23 Many studies have been conducted where placebo treatments have been compared to no-treatment controls. Evidence from a wide range of studies indicates that placebo therapies in the context of conventional medicine can provide some relief from a huge range of conditions including allergies, angina, asthma, some forms of cancer, cerebral infarction, depression, diabetes, epilepsy, multiple sclerosis, ulcers and warts. Placebo responses have also been found to vary enormously —from 0 - 100 per cent — even for the same condition[24].

3.24 In the past the placebo effect has often had negative connotations as a worthless by-product of a treatment, notable only in that it complicates research design. As more evidence on this subject becomes available it may be considered that the term placebo effect is unhelpful because it embraces a number of disparate phenomena that are poorly understood. Evidence from placebo studies has provided ammunition to contradict the claim that the placebo effect can be attributed to the patient's wish to please the doctor by reporting symptom relief. Research shows the placebo effect has a measurable effect on objective measures such as blood pressure, post-operative swelling and gastric mobility (Richardson, 1989)[25]. In addition, there is increasing evidence of a neuro-effector mechanism ("mind over matter") which can influence significantly the immune system. In drug action trials there are sometimes even difficulties in differentiating placebos from the active agents that they are being compared with; several studies have shown parallel time-effect curves and dose-response relationships[26].

3.25 Studies in this area clearly show that the psychological impact of any treatment is potentially great. Comparing placebo groups to no-treatment groups does not rule out the possibility that the placebo effect is due to data distortion on the part of therapists, or even the possibility that results are affected by patients with high expectations or a desire to please the doctor. This is because it is very hard to blind patients to the simple fact that they are receiving treatment. However this does not explain changes in objectively measured physiological processes, and thus it seems there is a psychologically-mediated physical effect of most treatments.

3.26 Many studies in this area have looked into whether there are particular patient variables that increase the likelihood that an individual will exhibit the placebo effect. Although such studies have looked into a multitude of factors including sociological factors such as age, gender, ethnicity, educational level and intelligence, and personality factors such as extroversion and suggestibility, they have yielded weak and inconclusive results. It seems that placebo responders cannot be characterised by this type of variable. In fact evidence shows that people who are placebo responders on one occasion may not be on the next: thus it is not an enduring trait. Awareness of the fact that any patient may benefit from the placebo effect might do much to de-stigmatise it as a sign of patient neuroticism.

3.27 There has also been research on which therapies produce the strongest placebo effect. More serious or invasive procedures do seem to have greater placebo properties, with placebo surgery yielding very high positive response rates. Treatments that employ sophisticated technical equipment also enhance the placebo effect. Research on therapist variables has shown that those therapists who exhibit greater interest in their patients, greater confidence in their treatments and higher professional status, whatever their background of training, all appear to promote stronger placebo responses in their patients. This work does not entirely support the view that CAM's effects may be due to the placebo effect. CAM is not generally highly invasive, nor does it tend to involve highly sophisticated technical equipment. However, CAM therapists do seem to exhibit great interest in their patients and confidence in their treatments. It is also possible that the almost "magical" approach of some complicated and unusual therapies may have a similar effect to highly sophisticated technologies in inducing wonder in patients.

3.28 It is important to consider the possible modes of action through which the placebo effect may operate. Professor Patrick Bateson, Vice President of the Royal Society, explained how psychological factors might affect physical health: "...when somebody suffers chronic stress, bereavement or loses a job, under those conditions they are much more prone to disease and more likely to get cancer, and it is now believed that this is because of suppression of the immune system, which is constantly cleaning up bacteria and viruses and also cleaning up cells which are cancerous cells. So if you do the opposite of that and give a patient some reassurance, and if they are given a treatment which they believe in, then this will enhance the immune response - it will remove the stress which is causing the immune response to be suppressed - and so that may be one rather powerful mechanism by which the placebo effect works" (Q 155). However it is widely accepted that the exact mechanisms of action are as yet not well understood. Professor Timothy Shallice of the Academy of Medical Sciences was one of several witnesses who acknowledged this gap in our knowledge: "We would agree that the placebo effect is not fully understood, but this is because essentially the higher cognitive functions in general are not very well understood and the placebo effect operates through belief and a whole series of mechanisms on the body in general through the central nervous system" (P 1403).

3.29 Despite a lack of understanding of the exact mechanisms through which the placebo effect may operate, research clearly shows that the effect exists and can have a significant impact on health. This work has important implications for anyone who has identified a therapy which appears to be efficacious but which does not have a clearly identified mode of action and it is important that all research on such therapies takes account of the placebo effect.

3.30 Research in this area, and evidence we have heard, suggests that it may be over-simplistic, when evaluating physical treatment methods, to ask whether the treatment is a placebo or not. The more pertinent question will often be: "In what proportion may the effects of this treatment be accounted for by psychologically-mediated, as opposed to direct physically-mediated, changes?"[27] In the absence of direct evidence from placebo-controlled double-blind trials[28] it is proper to regard any new or unusual form of treatment as potentially a form of psychotherapy. This is the reason why the debate over the need for randomised controlled trials has become a central debate in the CAM world

3.31 We have also considered the implications of finding that any particular CAM therapy relies largely on the placebo effect and has little or no treatment-specific effect. Several of our witnesses have suggested this is a very important question. Professor Tom Meade of the Royal Society summed up this sentiment: "I think the important question is that if a CAM is claiming that it has a specific value for a particular condition, then it does have to be able to show that there is a treatment-specific effect over and above the placebo effect. I think that is important because, first of all, a lot of CAM is practised in private practice at the moment, and people…are entitled to know how they are spending their money. I think it is also important from the health service's point of view, as various trusts and general practitioners take CAMs up in increasing numbers (Q 155).

3.32 If a treatment makes people feel better, whether that be through treatment specific effects or the placebo effect, then it could be considered as being worthwhile. In fact, as the placebo effect is not just an imagined experience but can positively improve objective biological measures of health, then a treatment which enhanced such an effect could even be considered worth attaining in its own right. As well as stressing the need to prove treatment-specific effects Professor Patrick Bateson, giving evidence with Professor Tom Meade for the Royal Society, acknowledged that sometimes the placebo effect may be worth attaining in its own right.

3.33 However, the idea that the placebo effect might be something worth using as a treatment was not a majority opinion, and Professor Timothy Shallice of the Academy of Medical Sciences suggested that there is probably little justification for supporting the wider advocacy of any technique that relies on the placebo effect within the NHS "…since it depends so critically on the particular beliefs of that particular person at that particular time" (P 1403).

3.34 Professor Peter Lachmann of the Academy of Medical Sciences elaborated on why treatments which work through the placebo effect are not worth using as a treatment: "…it is not surprising that therapies which have no pharmacological basis but which affect mental state can stimulate the secretion of endogenous opioids and other mediators that affect lymphocytes because they also carry the relevant receptors. The fact remains that methods of doing just this (for example jogging) are not used for treating visceral diseases, nor are similar claims made for them. That immune cells can be affected by neurological mechanisms is neither unconventional nor terribly surprising" (Q 1413).

17   Resch, K., Hill, S. & Ernst, E. (1997) 'Use of Complementary Therapies by Individuals with Arthritis'. Clinical Rheumatology; 16:371.5. Back

18   Zollman, C. & Vickers, A. (1999) (Op.cit.). Back

19   The Oxford English Dictionary defines iatrogenic disease as "Med. (of an illness or symptoms) induced in a patient as a result of a physician's words or action".  Back

20   Vincent, C. & Furnham, A. Complementary Medicine: A Research Perspective (Chichester; Wiley & Sons; 1997) 119-121. Back

21   Kleinman, J. (1980) as cited in: Vincent, C. & Furnham, A. (1997) (Op.cit.). Back

22   Ong, de Haes and Lammes, (1995) as cited in: Vincent, C. & Furnham, A. (1997) (Op.cit.). Back

23   Gray & Flynn (1981) as cited in: Vincent, C. & Furnham, A. (1997) (Op.cit.). Back

24   Ross & Olson (1982) as cited in: Vincent, C. & Furnham, A. (1997) (Op.cit.). Back

25   Richardson (1989) as cited in: Vincent, C. & Furnham, A. (1997) (Op.cit.). Back

26   Ross & Olson (1982) as cited in: Vincent, C. & Furnham, A. (1997) (Op.cit.). Back

27   Richardson, P. (1997) as cited in Vincent, C. & Furnham, A. (Op. cit.). Back

28   Trials in which neither the practitioner nor the patient are aware of which treatment is being administered. In single-blind trials only the patient is unaware of which treatment is being administered. Back