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A Guide to Evidence-based Integrative and Complementary Medicine by Kotsirilos, Vitetta and Sali

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DESCRIPTION: A Guide to Integrative and Complementary Medicine for Health Practitioners is a comprehensive textbook on the non-pharmacological treatments for common medical practice problems, with the support of current scientific evidence. Non-pharmacological approaches include advice for lifestyle and behavioural factors, mind-body medicine, stress management, dietary changes, exercise and sleep advice, nutritional and herbal medicine, acupuncture, complementary medicines and the role of sunshine that may impact on the treatment of the disease(s). Only proven therapies from current research are included, particularly from Cochrane reviews and research from systematic reviews, randomized control trials and published cohort and case studies. KEY FEATURES: - Instant access to evidence-based clinical information on non-pharmacological treatments including complementary medicines, for common diseases/conditions. - Instant access to prevention, health promotion and lifestyle advice. - Each chapter of the textbook is summarised based on scientific evidence using the NHMRC guidelines grading system - One/two page, patient summary sheet at the end of each chapter. - Organised by common medical presentations ALSO available as an eBook!

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Clinicians have always performed the role of health care providers, where the family doctor has always been viewed as the logical interface with the community’s health needs. Integrative medicine (IM) is an established paradigm shift in medicine in areas such as the North American continent, India and China. Whereas in other areas of the world it is a developing movement, such as in continental Europe, especially Scandinavia, the Middle East and Australia. 1, 2

Integrative medicine is recognised as the practice of medicine in a way that relates to complete patient care. IM includes practices currently beyond the scope of conventional medical teachings. However, it neither rejects conventional therapies nor uncritically accepts alternative/complementary ones. It implicitly emphasises principles that may or may not be associated with complementary and alternative medicine (CAM) modalities such as:

• Whole person medicine . IM views patients beyond simply the physical picture of their symptoms. They are managed as mental/emotional beings who are members of communities and societies. These other dimensions of human life are relevant to health since antiquity and essential for the accurate diagnosis and effective treatment of disease. 3

• The natural healing power of the organism . IM assumes that the body has an innate capacity for healing. The primary goal of treatment should be to support, facilitate, and augment that innate capacity.

• The importance of lifestyle to improve the wellbeing of the sick patient, not necessarily a cure . Health or disease results from interactions between genes and all aspects of lifestyle and environment, including diet, physical activity, rest, sunshine exposure, freshair and sleep, life stressors (the balance between pleasure events and distressful events), 4 the quality of relationships and work. A plethora of studies demonstrate that positive lifestyle changes signifi cantly reduce the risk and progression of a number of major chronic diseases such as cardiovascular disease (e.g. myocardial infarction and stroke), diabetes, and cancer.

In a study of 23 153 German participants, aged 35 to 65 years, from the European Prospective Investigation Into Cancer and Nutrition – Potsdam study, found that adhering to just 4 lifestyle factors — namely, never smoking, having a body mass index less than 30, performing 3.5 hours/week or more of physical activity, and adhering to healthy dietary principles (high intake of fruits, vegetables, and whole-grain bread and low meat consumption) — signifi cantly reduces the risk of developing a chronic disease by up to 78%. 5

• The critical role of the doctor – patient relationship . Throughout history people have accorded the doctor – patient relationship special, even sacred, status. When a medically trained person sits with a patient and listens with full attention to his or her story, that alone can initiate healing before any treatment is offered. This latter pattern of care constitutes the basic essence of IM. 3

Western medicine and science has created some wonderfully useful ways of treating diseases and developing skills in surgery. Our goal should be not to replace conventional medicine, but to expand its boundaries and build a scientifi c foundation for integrating less well understood approaches to improve the functional status of patients and to provide a range of validated treatment options.

The medical profession is confronted by changing community attitudes, so a growing awareness of such therapies by the medical profession would seem to be in harmony with the growing public awareness for a more holistic form of health care.

Holistic health — caring for the whole person The holistic model is traced back to the Hippocratic school of medicine ( circa 400 BC) and the oath of Maimoides ( circa the 12th century AD) which have fashioned and defi ned the unique obligations that clinicians have toward their patients and their medical

Chapter 1

Introduction

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practices. Disease and illness was viewed as an ‘effect’ from imbalance and explored causes of disease from the environment and natural phenomena such as air, water, and food. Early health practitioners used the term vis medicatrix naturae , meaning the healing power of nature, to describe the body’s ability to heal itself. Furthermore, the Hippocratic oath states: ‘fi rst, do no harm’. It is important despite which style of medicine we use, whether it is a pharmaceutical agent, surgical approach or a natural therapy, that we do no harm to patients.

The World Health Organization (WHO) defi nition for optimal health suggests this should be inclusive of physical, social, psychological, emotional and spiritual wellbeing. The holistic or health model looks at maximising or supporting all aspects of a person’s health, which will then lead to the disease being healed by the body.

The health practitioner’s aim is to help empower patients to be active participants in their own healing process and to encourage personal responsibility for their health to improve quality of care and quality of life. The goal is not just to treat the illness, but to focus on promoting health and wellness.

Establishing and maintaining optimal health and balance is vital to prevention and treatment. Wellness is a state of being healthy characterised by positive emotions, thoughts and actions. Wellness is inherent in everyone, no matter what ‘disease’ is present. If wellness is truly recognised, focused upon and experienced, the individual will heal more quickly, not just through direct treatment of the ‘disease’ alone.

Holistic medicine also includes the integration of various safe, evidence-based complementary therapies and medicines that may provide a gentler, safer and, in some cases, more empowering approach to health care. Many medical and health practitioners worldwide are integrating various ethical non-pharmaceutical modalities into their clinical practice as part of the holistic approach. These forms of therapies aim to enhance a healthy lifestyle, work with the natural healing process, empower patients to be active participants in their own healing process and nurture the whole person. Where such therapies can be safely used, they include counselling, meditation and relaxation therapies, hypnosis, primary preventative medicine and lifestyle management, acupuncture, nutritional medicine, herbal medicine, environmental medicine, and physical and manipulative medicine. These therapies work in harmony with the natural healing

processes of the body. Natural medicines, when used properly, generally are well tolerated and rarely cause side-effects. They generally support the body’s healing mechanisms, rather than take over the body’s processes. 6

It is important to remain open-minded and fl exible, both philosophically and in research methodology, with such an approach to treating individuals. We must recognise that healing primarily comes from the individual and mostly depends on their motivation level.

Integrative medicine Integrative medicine (IM) refers to the blending of conventional and complementary medicines and therapies with the aim of using the most appropriate of either or both modalities to care for the patient as a whole. 7

This closely refl ects both the Hippocratic oath and the WHO defi nition discussed above. However, although some may view IM as synonymous with CAM, this was never so, nor was it ever the case. CAM comprises many therapeutic modalities that are not taught in a conventional medical syllabus, based on the ideas that range from those that are sensible and worth including in mainstream medicine to those that are extremely imprudent and a few that are very perilous. Neither the word alternative nor complementary captures the essence of IM. 8 The former suggests a replacement of conventional therapies by others whereas the latter suggests therapies of varying value that may be used as adjuncts.

IM embraces a holistic approach to clinical practice encouraging patient involvement in self-health care, prevention and interventions that focus on health maintenance by paying attention to all relative components of lifestyle, including diet, exercise, stress management, and the emotional wellbeing of the patient. IM also integrates evidence-based complementary medicines that are safe and may positively impact on the healing process and quality of life for the patient.

IM does not reject or compete with conventional health care but rather seeks to broaden conventional health care by providing the health practitioner, doctor and patient with options to improve health that can work alongside conventional health care.

IM emphasises a number of issues including: 9

• a focus on wellness and illness prevention

• being holistic in nature by focusing on physical, psychological, spiritual, social and lifestyle issues

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• incorporating evidence-based, safe and ethical complementary therapies and medicines

• individualising the approach to any particular patient or clinical situation using the best of all available modalities in conjunction with informed patient choice

• integrating all of the above into conventional medical care

• acknowledging that advances in health care will be dependent on scientifi c advances, improvements in health care delivery systems, and cultural change as well as practitioner and patient education.

When considering any therapy it is important to balance the risks, the benefi ts, the evidence, the costs, and the alternatives, such as other therapies or doing nothing.

Complementary and alternative medicine (CAM) Complementary and alternative medicine, as defi ned by the National Centre for Complementary and Alternative Medicine (NCCAM), is a group of diverse medical and health care systems, practices, and products that are not presently considered to be part of conventional medicine (see Table 1.1 ). 10

As the evidence-base for some CAM increases, medical practitioners have a legal obligation to inform patients of the effi cacy of relevant complementary therapies as treatment options, and to simultaneously be aware of the potential for adverse events and interactions that CAMs, such as nutritional and herbal supplements, may have when co-administered with pharmaceutical drugs or when a patient denier good orthodox core for any unproven CAM. 11 Knowledge in the effi cacy of a complementary medicine or therapy is essential when making clinical decisions for patient care to help weigh against potential risks, such as adverse reactions or delays in useful conventional treatment. This highlights the importance of medical practitioners having at least basic education in the area of CAM to enable them to communicate and inform patients about what therapies are appropriate to the individual. Education on potential risks such as nutrient toxicity, especially with single nutrient use, and any potential interactions with pharmaceuticals is also essential.

Popularity of IM and CAM Worldwide reports demonstrate that a large proportion of the public are using CAM and its popularity is increasing. For example, in

Table 1.1 NCCAM classifications 10

NCCAM classifies natural, complementary and alternative medicines into 5 categories, or domains

1 Alternative medical systems Alternative medical systems are built upon complete systems of theory and practice such as homeopathic and naturopathic medicine, Traditional Chinese medicine and Ayurveda.

2 Mind – body interventions These interventions include counselling, patient support groups, meditation, prayer, spiritual healing, and therapies that use creative outlets such as art, music, or dance.

3 Biologically based therapies These therapies include the use of herbs, foods, vitamins, minerals, dietary supplements.

4 Manipulative and body-based methods These methods include chiropractic or osteopathic manipulation, and massage.

5 Energy therapies Energy therapies involve the use of energy fields. They are of 2 types:

1 biofield therapies such as qigong, reiki, therapeutic touch 2 bioenergetic therapies involving the use of pulsed

electromagnetic fields, such as pulsed fields, magnetic fields, or alternating-current fields and/or alternating- and direct-current fields.

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Australia up to 70% of the population are using CAM. 12 In the United States, up to 62% of adults use CAM. 13 It is therefore vital that health and medical practitioners are well informed about the evidence in these areas.

In many respects, the enthusiasm to use CAM is largely driven by the public. The community has greater access to information and various complementary medicine practitioners and therapies. There are often various reasons why a patient will want to trial CAM. These include philosophical and cultural reasons — wanting a more holistic approach to health care, when there are no longer any other orthodox approaches to assist in their health care, especially if they have suffered any adverse events from orthodox treatments. Generally, patients who use CAM are not rejecting orthodox medicine but are looking for options to improve wellbeing. Unfortunately, medical practitioners underestimate the extent of use of CAM by patients. 14, 15 This is of great concern, considering the potential for adverse events such as herb – drug interactions and coordinating the overall management of the patient.

Cultural aspects in determining type of CAM use The WHO estimates that approximately 60% of medicine that is practiced worldwide is traditional medicine. 16 Traditional Chinese medicine (TCM) is practised in many Asian countries, Ayurveda medicine in India, Unani medicine in the Middle-East, Pakistan and India, while Kampo medicine is used in Japan. Biomedicine or conventional medicine is the predominant medicine practised in developed countries and its formation has also been infl uenced by cultural factors. 17

Many of these therapies have been used for centuries, and some for thousands of years, and have a long traditional use in some societies and cultures, being highly entrenched in their health care system. There may be little scientifi c evidence for these therapies, but some inherent safety considering long-term use, in some cases up to 2000 years.

Although it is correct to offer patients conventional medical treatment for acute illnesses, for a chronic illness though for which there is no ‘right’ answer it is likely that the best treatment is that which best matches the patient’s belief systems and cultural understanding. For example, a patient of Asian background may be very keen to use either herbal medicine or acupuncture. Under these circumstances it is mandatory that the practitioner is aware of possible toxicity, interactions with conventional medicines and the cost of such therapy.

IM strategies and healing A holistic approach to health care involves giving comprehensive lifestyle advice that is inclusive of physical, social, psychological, emotional and spiritual wellbeing. In this way, we are encouraging and promoting our patients to take personal responsibility and be active participants for their own health. The focus needs to be on wellness, and not specifi cally on the disease. Positive lifestyle changes and a typical integrative approach to assist healing that can work alongside conventional medicine to improve health outcome or quality of life are listed in Table 1.2 .

Health practitioner/doctor and patient satisfaction Holistic health care offers an enormous amount of satisfaction and joy to the health practitioner, working with patients to help restore good health. The patients are often satisfi ed with this style of medicine and this, in turn, equally satisfi es the doctors practising holistic health care. It empowers patients by providing them individually prescribed options for treating their health condition. Failure to treat or cure patients may occur due to a number of factors, such as lack of motivation, not changing lifestyle, choosing the wrong therapy, lack of commitment to the therapy for various reasons (e.g. fi nancial, lack of support, peer pressure, non-believers etc). It is important to be aware and sensitive to these factors by being intuitive and listening to patients’ needs carefully, and with clinical experience fi ne tune treatment modalities accordingly.

Furthermore, patients and doctors need to have access to quality information about complementary medicine to make well-informed decisions.

The health practitioner(HP)/doctor – patient relationship is precious, patient – centred and can result in a positive therapeutic outcome. It positively affects medical care and patient satisfaction. The HP/doctor – patient relationship is based on:

• kindness, compassion, and respect • genuine caring, honesty, and trust • the intention to heal • empowering the patient (and the HP/

doctor) • good communication • active listening and empathy.

Most studies actually indicate that over 80% of patients are satisfi ed with their general practitioner especially if they see the same doctor frequently. 18 A questionnaire

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Table 1.2 Summary of lifestyle and IM strategies

Lifestyle suggestions Diet/exercise/stress management Behavioural changes (avoidance of smoking, alcohol) Fun, laughter, joy; being in touch with nature; forgiveness Religion; spiritual belief Creative activities

Mind – body approaches Stress management, meditation, relaxation therapies; breathing techniques

Counselling — attitudinal healing, cognitive behavioural therapy

Social support and/or support groups Group therapy Hypnosis; self-hypnosis Imagery and creative visualising techniques; positive

thinking; mind training Communication; self-expression Personal development Biofeedback Spiritual healing; religion; prayer; exploring meaning and

purpose in life

Environmental advice Clean Air Fresh filtered water Organic foods Sun exposure (more or less) Soothing, relaxing sounds Chemical exposure (work and home) Avoiding household and work surroundings

Exercise Swimming, walking, cycling, yoga, tai chi, qigong

Dietary suggestions Low glycaemic index diet Mediterranean diet Asian diet Low-fat diet

Nutrient supplementation Vitamins Minerals Fish oils Amino acids

Herbal therapies Herbs Aromatherapy

Physical therapies Acupuncture Manipulation Massage TENS machine Hydrotherapy

Energetic Reiki Reflexology Homeopathy

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of 869 patients demonstrated that trust and commitment was positively associated with adherence to treatment. Positive relationships were also associated with adherence to treatment and commitment, and between trust and commitment, that led to positive lifestyle choices, such as healthy eating habits. 19 The researchers concluded:

Patients’ trust in their physician and commitment to the relationship offer a more complete understanding of the patient – physician relationship. In addition, trust and commitment favourably influence patients’ health behaviours. 18

It is also vital that patients are encouraged to take responsibility for their health and be well informed about all treatments (conventional or complementary) that are safe and suitable for their health care (see Tables 1.3 and 1.4 ).

Respect for the patient and their choice of treatment, compassion, trust and empathetic understanding all positively infl uence the HP/doctor – patient relationship, and help adherence to therapeutic regimens (see Table 1.5 ). 20, 21, 22

Other factors that infl uence the HP/doctor – patient relationship:

• the tone of the clinician’s voice • the clinician’s stress levels • the amount of talking by the clinician; is

it excessive or not enough? • clinician self-awareness of: voice, body

posture and any non-verbal cues • do clinicians hold on to patients when

care is limited … … ?

Respect and care of the patient Care of any patient needs to be fl exible and respectful of their individual needs and choices. It does require that the practitioner has a basic understanding of CAM and is willing to be honest with the patient and consider referral to a trusted, appropriately trained health practitioner (medically or non-medically

trained) if their knowledge is limited. Hence, there is a great need to further educate the medical profession on the effi cacy and safety of CAM.

The other area of concern is if the patient is led into particular CAM that is non-evidence based and leads to delay of potentially useful orthodox treatments. This situation is often seen in vulnerable groups, such as patients with cancer looking for cures.

HP/doctor – patient relationship and the ‘doctor’ as the teacher The doctor – patient relationship also refers here to the health practitioner – patient relationship as the basic principles of care are similar. Interestingly, the original meaning of the word ‘ doctore ’ is teacher. Thus as doctor’s we are also educator’s for lifestyle and health. Patient needs vary from one patient to another. Therefore, it is mandatory to remain fl exible and vary approaches using treatment according to an individual’s needs at the time. Many studies demonstrate that active listening, spending time with a patient, displaying a sympathetic, understanding, caring and warm attitude not only helps to develop patient trust, but also enhances the healing response (also known as placebo). To achieve all of this requires longer consultations.

The value of long clinical consultations Longer patient-centred consultations are of benefi t for those patients with chronic disease or mental health problems. The Australasian Integrative Medicine Association (AIMA) evaluated the evidence of long clinical consultations and

Table 1.3 Encourage patient responsibility

The holistic health care practitioner encourages patient responsibility by:

Empowering patients to be active participants in their health care

Promoting self-care

Helping patients to make informed decisions and choices

Respecting choices

Being honest about limitations

Table 1.4 The well-informed patient

The well-informed patient:

Chooses not to be passive

Actively sources material and information about their disease

Works together with their health care practitioner to achieve common goals based on mutual respect

Participates in their own health care

Is motivated to get better

Needs close monitoring and discussion if they refuse orthodox treatment — this requires careful documentation in clinical notes

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the impact on quality of health. The results demonstrated that long consultations: 23

• improved the therapeutic relationship, trust, rapport, and answers to questions

• enhanced health outcomes • enhanced handling of psychosocial

problems • decreased medication prescriptions • increased lifestyle advice • reduced litigation • enhanced both patient and doctor

satisfaction.

The thorough documentation of patient notes was essential with all medical notes but more so in particular with longer clinical consultations. Furthermore, it was reported that it is essential to write accurate notes to record informed choices made with patients, including refusal of treatment and why; known as informed refusal.

The IM consultation is extensive in order to allow the following essential components to be included by the clinician.

Mind – body medicine • Evaluation of lifestyle stressors . A key

aspect of the extended consultation is to ascertain the patient’s life stressors, which can be important cumulative risk factors for the pathogenesis of various chronic diseases.

• Providing advice on relaxation techniques and stress reduction/management . Numerous recent studies have demonstrated a signifi cant and effi cacious effect afforded to patients by relaxation and meditation techniques in managing lifestyle stressors. It should also be noted that there are many other stress-reduction modalities that can be employed, such as

exercise, massage therapy, music therapy, aromatherapy and art therapy, for stress reduction/management.

• Providing advice on lifestyle factors , such as sleep restoration. There are various studies that demonstrate that sleep deprivation can signifi cantly contribute to the pathogenesis of fatigue, depression, type II diabetes mellitus (T2DM) and cardiac disease.

• Providing advice on behavioural factors that may impact on disease outcomes e.g. drug, smoking and alcohol consumption.

• Exercise and appropriate sunshine exposure . There are numerous studies that have reported on the important value of exercise, not only in the prevention of illness but in the treatment of illness. Combined with prudent sunlight exposure, this assists to provide increased levels of serotonin, melatonin and vitamin D, all of which are essential for good health and enhanced immune function.

• Nutritional history . It is a well established fact that nutrition plays a critical role in the prevention of almost all illnesses.

• Nutritional and herbal supplements . Evidence-based medicine supports the use of nutrition and herbal supplements. Supplements such as folic acid during pregnancy have been demonstrated to prevent congenital abnormalities and reduce the risk of cognitive defi cits. Vitamin D defi ciency is common and widespread.

• Referral to other health professionals who can assist the patient with the necessary specifi c expertise can be essential in certain disease states (e.g. meditation, yoga, acupuncture). 24

Table 1.5 Hallmarks essential to the HP/doctor – patient relationship

Respect Compassion Trust Empathy Appropriate touch

Philosophical beliefs

Cultural background

Personal experiences

Choices

Deep awareness of the suffering of another coupled with the wish to relieve suffering

Integral to HP/doctor – patient relationship and influences healthy behaviour patterns

Empathy is the capacity to imagine what another person is feeling without feeling it yourself; the patient feels understood

Can convey • sympathy • empathy • reassurance Felt to be seen, heard,

understood Be sensitive to the

patient — use touch thoughtfully, not automatically

Varies person to person Varies consultation to

consultation

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The plant analogy If given the ‘right conditions’, the body has an innate capacity to heal. The body is equipped with natural healing mechanisms. A good analogy of this is the sick plant. Most gardeners know that plants can thrive well by providing the ‘right conditions’, such as: the right amount of sunlight; fresh air; nutrient-dense soil (occasionally supplementing with nutrients through fertilising); a stable, nurturing environment free of chemicals; and adequate water. Even if a plant appears unwell, changing any of these conditions can aid the recovery of the plant. If we apply this concept to the unwell person, their needs are very similar. Human needs for maintaining and restoring good health include: plenty of fresh air; exercise; adequate water; sunlight; good nutritious unprocessed foods; a peaceful environment free of chemicals, excessive noise and light; good quality sleep; contact with nature and people; meaning and joy in our lives; and minimising psychological stress.

Dis – ease The term dis – ease literally means the person is not at ease and illness is the body’s expression of imbalance that requires the necessary fundamental changes to bring about balance, ease and wellness. It is important for the patient to recognise that their current circumstances and lifestyle have contributed to their current health situation. Therefore, if patients are expected to gain maximum benefi t from treatment, they need to fully commit themselves to a number of positive lifestyle changes. The illness, therefore, should be viewed as positive, as it is the body’s expression that changes are necessary and this is the opportunity to change one’s life and adopt healthier behaviour patterns to allow this to occur.

Stress Most illnesses have a psychological component as a precipitator and/or as a consequence of the illness. Stress plays a major role in most diseases and stress management should be regularly prescribed to our patients. A common question one should ask patients is:

What was happening in your life at the onset of your illness?

This question often gives us a good clue as to what major stressors may have contributed to the onset or aggravation of the illness. Providing the time listen to patients and learing their stories can have profound lealing effects on them.

It is important to emphasise to patients to listen to their bodies, follow their own intuition

and learn to love oneself. If people are stressed and don’t care for themselves, they won’t follow our advice to exercise, eat right, to not smoke or drink alcohol. As health practitioners, we can play a vital role in helping to guide our patients towards better health, positive lifestyle changes and behaviour patterns through guidance, appropriate counselling and being suitable role models.

Communication with allied and CAM practitioners It is well established that patients are not communicating with medical practitioners about the use of CAM. 25, 26 What is not so well established is to what degree the CAM practitioners and regular doctors are communicating. Medical practitioners (MPs) have an established tradition of communicating with each other e.g. specialists (consultants) with general practitioners (GPs). A specialist knows that in general the GP will have some idea about the content of what they are communicating, as medical graduates would have had at least some exposure to do with the various medical specialties during their medical courses and postgraduate training. If a homeopath was to communicate with a GP there are major diffi culties as most GPs would either have no or little knowledge or understanding of homeopathy and the language behind it. Many patients do not communicate with their regular doctor about CAM use for fear of being misunderstood or jeopardising their doctor – patient relationship. However, studies indicate that patients prefer that GPs were more educated about the CAMs they use, so that they can then better communicate with their doctors about their use of CAMs. 12

There is a greater need to have more interaction between CAM and doctors when the patient chooses to see a CAM practitioner. An increasing number of medical practices include MPs plus various non-medical CAM practitioners and they are proving to be very popular with patients. Many of these medical practices have routine meetings to discuss the management of the patient. Other means of improving communication include letter writing, emails or phone discussions, especially with CAM practitioners at other clinics.

Referrals to regulated CAM practitioners such as osteopaths, chiropractors (in most states and territories of Australia) and TCM practitioners (Australia), reduces the risk of incompetent management. If the CAM practitioner is a member of a professional body this can provide evidence of at least some training, standards and guidelines for safe practise.

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It is also reassuring to the MP if it is known that the CAM practitioner has adequate experience and in particular is aware of their limitations and knows when to refer back to a MP. The MP should initially be involved if a diagnosis has to be made but this would not be necessary if a patient wanted, for example, dietary advice or wanted to learn relaxation techniques which could be obtained from a CAM practitioner. As a ground rule, MPs differentiate between medical and CAM practitioners and have expressed greater confi dence in medical colleagues who practice complementary medicine. 27, 28

There are unresolved issues to do with referrals by MPs to CAM practitioners and these include: 29

• Should a doctor refer a patient so the patient can be assessed regarding suitability for a complementary therapy?

• What information should the patient be given about the benefi ts and risks to do with the therapy?

• Should the doctor forward personal information to the therapist and vice versa?

• When should a CAM practitioner refer to a MP?

• What are the circumstances under which a patient is referred by one CAM practitioner to another?

Ethical and legal Issues A report on ethical and legal issues at the interface of CAM and conventional medicine suggests that when MPs are faced with patients wanting to trial CAM they should: 30

• be honest with patient’s direct questioning about CAM

• establish the patient’s understanding of CAM and why they use it

• take into account the burden of the patient’s illness and provide material of their expressed preferences

• discuss the risks and benefi ts of both CAM and orthodox treatment

• adequately inform the patient about available CAMs that have been shown to be safe and effective, and those that are shown to be ineffective

• become familiar with qualifi ed and competent CAM practitioners (both medical and non-medical) to whom referrals are made

• continue their relationship with the patient, and continue to monitor their health

• keep communication with the patient open and respectful.

The abovementioned points serve as useful guidelines for MPs in consultations involving CAM.

Evidence-based medicine (EBM) The defi nition of evidence-based medicine (EBM) is ‘the conscientious, explicit and judicious use of current best evidence in making decisions about the care of individual patients’. 31 EBM integrates the best external evidence with individual clinical expertise and patients’ choice. Furthermore it is noted that absence of evidence does not mean a therapy does not work. 32

EBM is a common term described as: the conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients. The practice of evidence-based medicine means integrating individual clinical expertise with the best available external clinical evidence from systematic research. By individual clinical expertise we mean the proficiency and judgment that individual clinicians acquire through clinical experience and clinical practice. 31

This defi nition emphasises that whilst scientifi c evidence is important in clinical judgment, clinical experience and expertise also play a major role in the care and choice of treatment for a patient.

EBM encourages doctors to look for well-structured, randomised placebo-controlled prospective studies (Level II evidence) and systematic reviews of such studies (Level I evidence) to support clinical practice, but as yet there are few of these for the majority of CAMs.

‘Outcome studies’ may be more appropriate for holistic models of health, such as TCM and traditional Ayurveda medicine, where a more individualised and holistic approach to treatment occurs. Randomised control trials (RCTs) may be suitable for the holistic approaches but need to be creative but still technically possible. Very little good quality research exists for these therapies. Lack of evidence is not necessarily associated with lack of patient benefi t.

Biomedical focus on evidence-based medicine and evidence-based research affecting IM and CAM Scientifi c evidence is the basis and is pivotal to biomedicine. Evidence on effi cacy and safety should be the basis of defi ning which CAMs are useful and which are not. To date, research in CAM has been limited due to a number of factors such as funding, the type of CAM used, the quality of the studies, the ability to patent a product and so forth, to make any fi rm conclusions about their potential role in health care. In saying this, there is also a large body of scientifi c evidence emerging for

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CAM worldwide. This evidence should be made accessible to the health profession and public, and also integrated into recommended national guidelines of treatment for specifi c health conditions. Once a therapy or medicine, be it orthodox or complementary, has scientifi c evidence to prove its effi cacy and safety, then the medical practitioner has a legal and ethical obligation to use the best treatment possible for the individual patient.

There are many CAMs that are not evidence-based to date. This may not mean that they are ineffective as funding may have not been allocated to research these therapies/medicines. However, until they are tested they need to be used cautiously.

National and Health Medical Research Council (NHMRC) guidelines to research Since 1999, the National and Health Medical Research Council (NHMRC) 33 has created useful guidelines to identify the varying levels of scientifi c evidence using a scale from I – IV. These guidelines help to identify which medicines or therapies carry greater weight in research, with Level I considered as superior research and Level IV considered the least superior. Refer to Table 1.6

To date, there is a growing body of clinical studies ranging from Level I – IV scientifi c evidence (NHMRC guidelines) for complementary medicines. Throughout this textbook reference is made using the NHMRC guidelines.

Cochrane collaboration A worldwide network of researchers called the Cochrane collaboration prepare, disseminate and continuously update systematic reviews of randomised clinical trials in all areas of health care. A CAM fi eld is set up and is bringing together evidence for CAM. This involves a conjoint effort of many scientifi c researchers and centres throughout the world.

A list of CAM Cochrane reviews and protocols can be accessed via:

http: // www . compmed . umm . edu / cochrane / Reviews2002 . pdf

Conclusion The use of CAM should have certain boundaries. Its use should not be to the exclusion of a clearly indicated, safe, effective and superior orthodox therapy. In making choices patients need to be informed about the range of reasonable options of orthodox and complementary therapies. Based on clear information patients should then

be allowed to make their choices as to what treatment they wish to pursue if they are low risk and have some proven effi cacy. It is easier to recommend CAMs when they have evidence for safety and effi cacy. There is now a growing body of scientifi c evidence to support CAMs such as some herbal medicines, acupuncture, nutritional medicine, and stress management techniques which work with the natural healing process of the body.

The basic principles of holistic health care include: • the patient must be motivated and have

an intention to heal, therefore the patient must be a willing participant in their own health care

• the health practitioner and/or doctor should have an intention to help the patient with compassion, understanding and kindness

• developing a good health practitioner/doctor – patient therapeutic relationship in a safe atmosphere is essential and listening carefully and intently to what they are saying

Table 1.6 NHMRC levels of evidence

Level I From a systematic review of all relevant randomised controlled trials, meta-analyses.

Level II From at least 1 properly designed randomised controlled clinical trial.

Level IIIa From well-designed pseudo-randomised controlled trials (alternate allocation or some other method).

Level IIIb From comparative studies (including systematic reviews of such studies) with concurrent controls and allocation not randomised, cohort studies, case-control studies, or interrupted time series with a parallel control group.

Level IIIc From comparative studies with historical control, 2 or more single-arm studies or interrupted time series without a parallel control group.

Level IV Opinions of respected authorities based on clinical experience, descriptive studies or reports of expert committees.

Level V Represents minimal evidence from testimonials.

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Chapter 1: Introduction — 13

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• all healing is self-healing; the CAM practitioner role is to empower patients to help heal themselves, to take charge and have personal responsibility of their health

• recognising that illness can be seen as positive and is an opportunity for positive change and growth, such as developing positive behaviour patterns

• the health practitioner and/or doctor should be a role model for good health and always endeavour to educate and encourage the patient to adopt healthy behaviour patterns and a healthy lifestyle.

This book summarises the key scientifi c and management strategies using an IM approach to treat common health problems faced by medical and health practitioners in everyday medical practices.

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