Chapter 20 Complementary/alternative medicine
Complementary/alternative medicine (CAM), originally referred to as ‘fringe’, ‘holistic’ or ‘natural’ medicine, was known as ‘alternative’ medicine in the 1970s and 1980s. Today it is increasingly called ‘integrated’ or ‘integrative’ medicine. Generally, it is referred to as complementary/alternative medicine, although the terms complementary medicine, alternative medicine and complementary therapies are used interchangeably. Zollman & Vickers’ (1999) definition of CAM, which has been adopted by the Cochrane Collaboration (see Ch. 17), is given in Box 20.1.
Box 20.1 Definition of complementary and alternative medicine (Zollman & Vickers 1999)
‘Complementary and alternative medicine (CAM) is a broad domain of healing resources that encompasses all health systems, modalities and practices and their accompanying theories and beliefs, other than those intrinsic to the politically dominant health system of a particular society or culture in a given historical period. CAM includes all such practices and ideas self-defined by their users as preventing or treating illness or promoting health and well-being. Boundaries within CAM and between the CAM domain and that of the dominant system are not always sharp or fixed.’
Historically, CAM was the main form of medicine available to the world’s populations, including those of Europe and the UK. In many parts of the world it still is today. What we now know as conventional or pharmaceutical medicine did not exist, hence the modern usage of the term. With the advent and expansion of discovery and production of mainly synthetic medicines by pharmaceutical companies, usage of mainly plant-based traditional medicines declined. These medicines are what we now refer to as CAM.
In essence, CAM is an umbrella term for a collection of different approaches to diagnosis and treatment. Over 50 diverse complementary therapies have been listed, some involving use of medicinal substances, while others use a range of therapeutic techniques. These range from homoeopathy (which involves the use of infinitely dilute preparations) to herbal medicine (the use of chemically rich plant material), and from acupuncture (the insertion of needles into specific points on the body) to therapeutic touch and spiritual healing (including ‘distant’ healing, which does not require the laying on of hands). Among the many forms of complementary therapies available, some use a variety of techniques but no medicinal products, some use only medicinal products, and there are also those which involve both medicines and techniques.
Some of the most well known complementary therapies, including those using medicinal products, are described in Box 20.2.
Box 20.2 Descriptions of complementary therapies common in the UK
Complementary medicines can be conveniently divided into three categories: those using only medicinal substances, those using a therapy without medicinal substances, and those using both.
The therapeutic use of aromatic substances, largely essential oils which typically contain numerous chemical constituents and are extracted from plants.
Aromatherapists believe that essential oils can be used not only for the prevention and treatment of disease, but also for their effects on mood, emotion and well-being. Aromatherapy is claimed to be a holistic therapy in that practitioners will select an essential oil or combination of essential oils to suit each client’s symptoms, personality and emotional state. The most common method used for application of essential oils is massage using a carrier oil; other methods include the addition of essential oils to baths and footbaths, inhalations, compresses and use in aromatherapy equipment, e.g. burners and vaporizers.
Developed in the UK by Dr Edward Bach, who believed that physical disease was the result of being at odds with one’s spiritual purpose, i.e. negative states of mind induce illness. His approach to health focused only on the mental state of the patient. He identified 38 negative psychological states of mind (e.g. jealousy, guilt, hopelessness) and developed a remedy designed to be used for each of these emotional states. The Bach collection comprises 39 remedies, 37 of which originate from flowers/trees, one from natural spring water, and ‘Rescue Remedy’, a combination of five of the other 38 remedies. Flower remedies are extremely dilute preparations, but are not homoeopathic remedies.
Many countries have their own collection of flower remedies/essences based on native plants/trees, e.g. Australian Bush Essences.
Traditional herbalism had a historical basis, partly based on the galenical model of the four ‘humours’ and the belief that an excess of any of the humours leads to disease. Today treatment is aimed at ‘restoring balance’ and ‘strengthening bodily systems’. Herbalists aim to treat patients in a holistic way by selecting a herb or combination of herbs to treat a particular person and his/her unique set of symptoms. One of the principal tenets is that the whole plant extract, and not an isolated constituent, is responsible for the clinical effect. It is claimed that herbal constituents, and even combinations of herbs, work synergistically to achieve benefit and reduce the possibility of adverse effects.
Rational phytotherapy/phytomedicine (science-based herbal medicine) has an entirely different approach to that of traditional herbalism. It involves the use of specific plant (or plant part) extracts standardized to specific constituents (where possible) with documented pharmacological activity for the treatment of specific clinical conditions. In this regard, phytotherapy has a similar approach to that of conventional medicine.
Herbalism involves preparations made from plants or plant parts. In some instances (e.g. use by herbalists), a crude drug (e.g. dried leaf) is used. Manufactured products use extracts of plants or plant parts, formulated as, for example, tablets, capsules, creams and tinctures. They may contain a single or multiple herbal ingredients, obviously including numerous single chemical entities.
The use of highly dilute, succussed substances to stimulate the body’s own healing activity (the ‘vital force’). One of the key principles is ‘like cures like’ – a substance which in large doses causes a set of symptoms in a healthy person can be used to treat such symptoms in an ill person, e.g. homoeopathic preparations of coffee (Coffea) are used to treat insomnia. Treatment is holistic – two patients with the same set of symptoms may be given different remedies depending on their personal characteristics, physical appearance, mental and emotional state, etc. Although there are several hypotheses, there is not yet a plausible explanation for the mechanism of action of homoeopathy. Furthermore, on balance, rigorous clinical trials do not show an effect for homoeopathy over that of placebo.
Homoeopathy uses highly dilute preparations which may be of plant, animal, mineral, insect, biological, drug/chemical or other origin. Formulations include tablets, pillules, creams/ointments, liquids and injections.
Nutraceuticals and food supplements are preparations of substances commonly found in the diet, e.g. fish oils, or occurring naturally in the body, e.g. co-enzyme Q10. In the UK, many herbal products, e.g. garlic tablets, are sold as dietary/food supplements.
An ancient Chinese method of health care which coexists alongside orthodox medicine today. TCM includes a range of therapies, such as Chinese massage, but is best known for the practices of traditional Chinese acupuncture (see Acupuncture) and traditional Chinese herbal medicine (CHM). The basic concepts of TCM (‘yin-yang’ and the ‘five elements’) apply to CHM. The fundamental principle of treatment is to restore ‘balance and harmony’. Medicinal substances are classified as having particular attributes, e.g. hot, cold, tonifying, moistening, and it is the consideration and combining of these attributes during therapy that is thought to bring about balance to patterns of clinical dysfunction. For example, ‘cooling’ herbs would be used to treat a patient whose pattern of illness is described as ‘hot’. Usually, herbal formulae comprising around 4–12 different medicinal substances are used to treat specific clinical patterns. Substances used as part of TCM may include animal as well as herbal material.
This involves insertion of needles into a specific point or set of points on the body for the treatment of specific conditions. Various forms exist, such as auriculoacupuncture (needling of specific points on the ear) and electroacupuncture (electrical stimulation of inserted needles). The two main types practised in the UK are described below.
Chiropractors believe that misaligned or maladjusted vertebrae (‘subluxations’), caused by accidents, strains, poor posture, innate skeletal distortions, etc. affect the spine and surrounding muscles, nerves and ligaments. This is believed to result in local or radiating pain, affecting joint movement, and causing swelling or weakening of muscle groups, thereby contributing to the disease process. There is, as yet, no clear explanation from current knowledge of spinal mechanics and neurophysiology as to how this might happen.
Chiropractic diagnosis includes physical examination, palpation of the vertebral column, assessment of posture, etc. and often the use of X-rays to examine bone alignment and to detect conditions such as osteoporosis which would contraindicate manipulative treatment. The principal technique used in chiropractic is a series of short sharp thrusts aimed at restoring normal joint motion, correcting subluxations, improving posture and/or removing painful stimulation to the nerves. Generally, chiropractors manipulate the neck and spine, but may also use techniques such as massage and even dietary and lifestyle advice as part of a holistic approach. McTimoney chiropractic uses lighter movements than does standard chiropractic.
A transmission of ‘therapeutic energy’ between healer and patient, which may or may not be associated with particular religious beliefs. It can be performed at a distance (‘distant healing’) or by laying on of hands (‘therapeutic touch’).
Osteopaths believe that a wide variety of disorders can be traced to disorders of the musculoskeletal system, particularly the spinal vertebrae, but also to dysfunction in certain muscle groups. Manipulative techniques are used to correct these joint and tissue disturbances to restore normal bodily function. Osteopaths use a detailed medical history, physical examination, assessment of posture, observation of patient movement, etc. and, occasionally, X-rays in diagnosis. Direct techniques (soft tissue and joint movement, and high-velocity thrusts) and indirect techniques (positioning-type techniques where the joints are moved without force) are used in treatment. Generally osteopaths use more rhythmical and gentler pressure on the whole body, including the spine, whereas chiropractors tend to use more sharp, short, thrusting pressure on the spine (see Chiropractic).
A form of treatment and diagnosis which involves massage of specific points on the feet (mainly on the soles but also on the tops and sides – maps of the areas of the feet corresponding to different areas/organs of the body have been drawn up). It is based on the belief that there are reflexes in the feet for all parts of the body. Reflexologists claim to be able to identify sites of tenderness and ‘lumps’ or granules of crystalline material, which, in reflexology, are taken to represent remote organ disease. Manual stimulation of the reflex points is believed to break down the deposits so that they can be eliminated, and to increase the flow of ‘healing energy’ through ‘channels’. At present, these theories are unsubstantiated.
A philosophical vision of health and disease based on the work of Rudolf Steiner who explored how man’s soul and spiritual nature relate to the health and function of the body. Steiner viewed each person as having four ‘bodies’ or ‘forces’: physical; etheric; astral; spiritual. Practitioners of anthroposophy aim to understand illness in terms of how these four elements interact; the aim of treatment is to stimulate the natural healing forces of the body. The anthroposophic approach is a holistic one; practitioners may use a range of therapies including diet, therapeutic movement (eurhythmy) and artistic therapies as well as anthroposophic medicines in an integrated therapeutic programme. The medicines are derived mainly from plant and mineral sources; many are combinations of herbal ingredients. Particular attention is paid to the source and methods of farming used in growing raw plant materials for preparing anthroposophic medicines (e.g. organic culture only).
The traditional system of medicine of India. Its essence is to achieve and maintain balance between the ‘elements’ and ‘energies’; illness is believed to result from imbalance. Ayurvedic diagnosis is based on physical observation and questioning. Treatment usually involves Ayurvedic herbal remedies as well as dietary modifications, meditation, exercise, massage. The medicines are herbal/mineral preparations; heavy metals (e.g. lead, arsenic) are sometimes used in the manufacturing process.
Several complementary therapies, such as herbalism, homoeopathy, aromatherapy and others, involve the administration of remedies, often in recognizable pharmaceutical formulations, e.g. herbal medicines, homoeopathic remedies and essential oils. These are collectively referred to as complementary (or ‘alternative’) medicines. As well as being used by some CAM practitioners in their practice, these types of products are widely available for purchase for self-treatment from pharmacies, health food stores, supermarkets, by mail order, via the Internet and from other outlets. Many of these are administered or recommended after consultation with therapists with varying range of abilities and qualifications, or simply bought by patients believing that they will be beneficial. In the UK, patients, the public, the media and many other groups consider the use of herbal medicines (whether prescribed by a herbalist or purchased over the counter) to be part of CAM. However, there is a view that herbal medicinal products with documented pharmacological activity and clinical efficacy lie alongside conventional medicines. Indeed, some herbal medicines, such as senna preparations, are conventional medicines.
This chapter discusses CAM, mainly from a UK perspective. In particular, the extent of use and regulatory aspects of CAM are considered, as well as issues of importance to pharmacy and pharmacists. There is a particular emphasis on complementary medicines, as these are widely available in pharmacies, and especially on ‘European’ herbal medicines, as these are among the most widely used ‘complementary medicines’ in the UK. Also, from a biomedical perspective, herbal medicines (rather than for example homoeopathic remedies) are likely to have the greatest potential in terms of both benefits and risks.
The use of CAM is a popular healthcare approach in developed countries, and there is evidence that use of complementary therapies and complementary medicines is increasing. For example, data from nationwide surveys involving US adults indicated that the use of CAM was increasing (Eisenberg et al 1998). Use of at least one of 16 complementary therapies in the previous year had risen significantly from 33.8% of the sample in 1990 to 42.1% in 1997. Self-treatment with herbal medicines was one of the therapies showing the greatest increase over this period (2.5% of sample in 1990 compared with 12.5% in 1997).
Reliable estimates of CAM use among adults in England come from a postal questionnaire survey involving 5010 adults (response rate = 59%) carried out in 1998 by Thomas et al (2001). The study found that within the previous 12 months, approximately 10% of the sample had used at least one of six complementary therapies (acupuncture, chiropractic, homoeopathy, medical herbalism, hypnotherapy or osteopathy), and that approximately 22% had purchased over the counter (OTC) homoeopathic or herbal medicines in the previous year.
Market research carried out by Mintel International (2005) estimated that retail sales of herbal medicines alone were worth £87 million in 2004, representing growth of 16% since 2002, whereas total sales of herbal medicines, homoeopathic remedies and essential oils have risen to £147 million by 2004. Around 50% of sales of herbal medicines and homoeopathic remedies are made in pharmacies. Mintel have estimated that 33% of the UK population have taken CAM during 2004, but only 4% have visited a CAM practitioner for their medicine. Self-treatment using CAM remedies raises the issue of the cause of any beneficial effects, as many of these are practiced as holistic therapies, which is not the case when simply purchasing medicinal products.
The use of CAM is not limited to the private sector – in some cases, the NHS funds access. For example, there are five NHS homoeopathic hospitals in the UK to which GPs can refer their patients. Also, GPs can prescribe homoeopathic preparations on NHS prescriptions. In 1998, over 150 000 homoeopathic items were dispensed against NHS prescriptions; data from the Prescription Pricing Authority show that the net ingredient cost for these was £927 600. Since that year there appears to have been an unexpected downward trend in NHS dispensing (Table 20.1). Furthermore, a survey reported by Thomas et al (2001) estimated that in 1998 there were over 2 million visits to complementary therapists funded by the NHS, and that the NHS expenditure on CAM was £50–£55 million per year. However, it has been claimed that many people who might like to take advantage of a wide range of CAM are prevented from doing so by lack of resources, as only 10% of CAM is currently provided by the NHS (Foundation for Integrated Health 2007).
Table 20.1 Trends in homoeopathic prescribing on the NHS
| Year | Number of items | Net cost (£) |
| 1998 | 150 000 | 927 000 |
| 2004 | 94 500 | 661 400 |
| 2005 | 83 000 | 593 000 |
| 2006 | 63 000 | 442 700 |
http://www.ic.nhs.uk/statistics-and-data-collections/primary-care/prescriptions
Complementary medicines are used by the general public and by patients both for general health maintenance and for the relief of minor, self-limiting conditions. For example, studies involving pharmacists and consumers have suggested that herbal products to help relieve stress and sleep problems are those most frequently requested by pharmacy customers and ‘recommended’ by pharmacists to consumers following consultations regarding symptoms.
Use of complementary medicines is not necessarily limited to symptoms or conditions suitable for OTC treatment. Indeed, many patients use complementary medicines and complementary therapies for symptom relief in, or treatment of, serious chronic illnesses, such as cancer, HIV/AIDS, multiple sclerosis, rheumatological conditions, asthma, depression, gastroenterological disorders, skin conditions and so on. Use of CAM is usually (but not always) to supplement conventional health care, rather than to replace it. Special patient groups also use CAM, including the elderly and women who are pregnant or breastfeeding. It is also used by some parents/guardians for children in their care.
A number of surveys of CAM users have been carried out; frequently females have been shown to have higher use than males, and usage tends to be greater between 35 and 64 years, and in higher social classes (Ernst & White 2000). A survey on the use of herbal products and nutraceuticals in over 60 000 elderly patients revealed extensive use for a range of medical conditions, a number of which would normally be expected to be treated by conventional medicines (Table 20.2).
Table 20.2 Levels of use of a number of herbal and nutraceutical products for treating a range of medical conditions
| Medical condition | Use among participants (%) | Herbal/nutraceutical product |
| Prostate cancer | 4.5 | Saw palmetto |
| 1.2 | Lycopene | |
| 0.7 | DHEA | |
| Enlarged prostate | 18.3 | Saw palmetto |
| 1.6 | Lycopene | |
| 1.4 | Cranberry | |
| Osteoarthritis | 28.7 | Glucosamine |
| 19.9 | Chondroitin | |
| 6.2 | MSM | |
| Bladder infections | 5.8 | Cranberry |
| Neck, back or joint pain | 16.6 | Glucosamine |
| 10.5 | Chondroitin | |
| 4.5 | MSM | |
| Depression | 5.8 | St John’s wort |
| Lactose intolerance | 0.9 | Lycopene |
| Degenerative eye conditions | 4.2 | Lutein |
| Perimenopause | 4.9 | Black cohosh |
| 1.7 | Dong quai* | |
| 6.7 | Soy products | |
| Stress | 3.2 | St John’s wort |
| Memory loss | 9.6 | Ginkgo biloba |
| 7.1 | Fish oil | |
| 6.0 | Coenzyme Q10 | |
| Insomnia | 3.6 | Melatonin |
| Diabetes | 0.2 | Dong quai* |
| 0.3 | Lycopene | |
| High blood pressure | 0.3 | Dong quai* |
Reprinted from Gunther S, Patterson RE, Kristal AR, Stratton KL, White E 2004 Demographic and health-related correlates of herbal and specialty supplement use. Journal of the American Dietetic Association 104(1):27–34, with permission from American Dietetic Association.
DHEA, dehydroepiandrosterone; MSM, methylsulfonylmethane
There are numerous reasons why people choose to use complementary medicines and therapies. They include dissatisfaction with conventional medicine in terms of effectiveness and/or safety, satisfaction with CAM and the perception that it is ‘safe’. There are also more complex reasons that are associated with cultural and personal beliefs, views on life and health and experiences with conventional healthcare professionals and CAM practitioners.
An individual’s choice to use CAM approaches is tied in with ‘healthcare pluralism’ – people may use any of several treatment options, such as taking advice from family and friends, consulting a CAM practitioner and consulting a pharmacist, GP or other healthcare professional. Related issues include whether individuals disclose CAM use to conventional healthcare professionals and whether there is better compliance with CAM treatment regimens than with conventional drug regimens.
There are around 40 000 complementary practitioners in the UK, according to a 1997 survey of CAM organizations commissioned by the Department of Health (Mills & Peacock 1997). These practitioners are using either medicinal products, alternative techniques, or both.
With the exception of osteopaths and chiropractors (the General Osteopathic Council and the General Chiropractic Council were established by acts of parliament to regulate their respective disciplines), CAM practitioners are not legally required to undertake any training before practising. While most CAM practitioners will have trained in their chosen therapy, others may not, or they may have trained in one complementary therapy but practise several. Furthermore, there is wide variation in the level of training and methods of assessment. For the major therapies – acupuncture, homoeopathy, herbal medicine, osteopathy and chiropractic – training is generally highly developed, with many institutions having university affiliation and offering courses at degree level. However, training for other complementary therapies is less intensive and more disparate.
The estimate of numbers of CAM practitioners given above is based on membership of CAM organizations, but cannot be precise as some practitioners are registered with more than one organization and some are not registered at all. Generally, practitioners are members of a registering or accrediting body, although criteria for membership vary widely. Also, many complementary therapies have several registering organizations, although some disciplines are taking steps to become unified under one regulatory body.
The practice of complementary therapies is not limited to CAM practitioners – some conventional healthcare professionals, including pharmacists, practise CAM. Some institutions offer specialized courses for conventional healthcare professionals, and there are registering organizations which represent state-registered healthcare professionals who have undertaken training in and practise certain complementary therapies. For example, the British Medical Acupuncture Society represents medically qualified individuals with training in acupuncture.
Against this background, the House of Lords (2000) report on CAM included several recommendations regarding training and regulation of CAM practitioners, including conventional healthcare professionals who practise CAM. In summary, these recommendations were:
The issue of training also relates to staff employed in retail outlets, e.g. health food stores which sell a vast range of complementary medicines, who sell or advise on complementary medicines. A small study has suggested that information and advice given by health food store staff may not always be appropriate.
The majority of complementary health products are not licensed as medicines. Therefore, the competent authority, which, in the UK, is the Medicines and Healthcare products Regulatory Agency (MHRA), has not assessed evidence of their quality, efficacy and safety.
Herbal products are available on the UK market as licensed herbal medicines, herbal medicines exempt from licensing and unlicensed herbal products sold as food supplements (Barnes et al 2007). In several cases, the same herb is available in all three categories. Potentially hazardous plants are controlled as prescription only medicines (POMs) and certain others are subject to dose (but not duration of treatment) and route of administration restrictions, or can only be supplied via a pharmacy and by, or under the supervision of, a pharmacist.
Most licensed herbal products were initially granted a product licence of right (PLR) because they were already on the market when the licensing system was introduced in the 1970s. When PLRs were reviewed, manufacturers of herbal products intended for use in minor self-limiting conditions were permitted to rely on bibliographic evidence to support efficacy and safety, rather than being required to carry out new controlled clinical trials, so many licensed herbal medicinal products have not necessarily undergone stringent testing.
Herbal products exempt from licensing are those:
This was initially intended to give herbalists the flexibility to prepare remedies for their patients. However, manufacturers can legally sell products under this exemption. Furthermore, at present, there is no statutory regulation of herbalists in the UK, although this is under review.
The majority of herbal products are sold as food supplements without making medical claims and are regulated under food, not pharmaceutical, legislation. In the UK, the MHRA has the statutory power to decide whether a specific product satisfies the definition of a relevant ‘medicinal product’ and, therefore, is subject to the provisions of regulations relating to Medicines for Human Use Regulations (1994, 2000, 2005). If a product is determined to be a relevant medicinal product, and if it does not meet criteria for exemption, then the manufacturer is required to submit an application for a full product licence and/or remove the product from the market. The procedure allows for the company to request a review of the decision. In this case, the views of an independent panel, the Independent Review Panel on Borderline Products, are taken into consideration.
Manufacturers of licensed medicines, including licensed herbal products, are required to satisfy the MHRA that their products are made according to the principles of good manufacturing practice (GMP). While some established manufacturers of unlicensed herbal products also manufacture their products to GMP standards, others do not. There is no guarantee that such products are of suitable pharmaceutical quality. The quality of plant raw materials can be affected by several factors and, therefore, it is important that finished (marketed) herbal products are of suitable quality. The European Pharmacopoeia (5th edition, 5.1–5.8, 2005–2007) contains over 100 monographs on herbal drugs, and further examples are in preparation.
‘Ethnic’ medicines available in the UK include traditional Chinese medicines (TCMs) and Ayurvedic medicines (see Box 20.2). Such products are subject to the same legislation as ‘western’ complementary medicines. In the UK, there are further restrictions on certain toxic herbal ingredients, namely Aristolochia species, found in some TCM products, and on other herbal ingredients that may be confused with toxic herbal ingredients. In addition to containing non-herbal ingredients such as animal parts and/or minerals, some manufactured (‘patent’) TCM products have been found to contain conventional drugs as listed ingredients, some of which (e.g. glibenclamide) may have POM status in the UK. Non-herbal active ingredients of any type cannot legally be included in unlicensed herbal remedies, and inclusion of drugs with POM status represents an additional infringement of UK medicines legislation. For some ingredients, such as certain animal parts, restrictions under the Convention on International Trade in Endangered Species (CITES) of Wild Fauna and Flora also apply.
Prior to 2004 it was widely considered that the system of licensing for herbal medicines did not give consumers adequate protection against poor-quality and unsafe unlicensed products. Nor did it allow manufacturers to provide appropriate information to inform consumers’ choice of products. Against this background, a new European Union (EU) directive (2004/24/EC) was proposed which aims to establish a harmonized legislative framework for authorizing the marketing of traditional herbal medicinal products. The directive requires EU member states to set up a specified simplified registration procedure for traditional herbal medicinal products which could not fulfil full medicines licensing criteria. Under this EU directive, all manufactured traditional medicinal herbal products are required to be registered under the Traditional Herbal Medicines Registration Scheme (THMRS). This directive has been in force from October 2005, but there is a transition period of 5 years from that date for manufacturers to meet the requirements. Some of the main features of this scheme are that manufacturers will be required to provide:
Under this directive, it is not possible to make claims about the product’s efficacy, but only regarding its traditional use. The new directive is not a route to licensing for herbal POMs or for traditional herbal medicines that can be licensed by the conventional route. As it stands, the proposed directive would accommodate ethnic medicines that have been used in the UK (or any other EU member state) for at least 15 years. This directive also lists problematic consequences of imported US products and restricted herbs.
EU Directive 2004/24/EC also gives guidance on permitted medicinal indications. Labelling may also be covered by the Joint Health Claims Initiative (JHCI), which restricts excessive claims.
In the UK, homoeopathic remedies are subject to medicines legislation. A simplified registration scheme (Simplified Scheme) exists in the UK (and the rest of the EU) for homoeopathic medicinal products which:
Since 1 September 2006, new homoeopathic products may be registered under the National Rules Scheme. For such products, manufacturers are required to demonstrate quality and safety, and efficacy, together with appropriate product labelling and literature. Manufacturers of homoeopathic medicinal products which are administered parenterally, are below the minimum dilution, or make efficacy claims are required to substantiate this in the same manner as is required for conventional drugs.
Products marketed as food or dietary supplements include non-herbal substances, such as glucosamine, vitamins, minerals and fish oils. These products are sold under food legislation and are marketed without medical claims. Such products may be deemed by the MHRA to be a relevant medicinal product (see ‘Herbal medicines’ above). Some ‘supplements’ are subject to stringent restrictions on their use. Melatonin is a POM, available on a ‘named patient’ basis only as there are no licensed melatonin products in the UK. However, in the USA, melatonin is sold as a food supplement. A new draft EU directive is aimed at harmonizing the marketing of food supplements in member states.
Gamma linolenic acid (GLA), widely available as unfractionated evening primrose oil, was widely used as a supplement, principally for premenstrual syndrome, but later obtained a full product licence for the two conditions of psoriasis and mastalgia, although these were withdrawn in 1995.
Essential oils used by aromatherapists in their practice for medicinal purposes are considered to be medicinal products, but are exempt from licensing provided they meet certain criteria (see ‘Herbal medicines’ above). Aromatherapy products sold through retail outlets are not subject to licensing regulations unless they are marketed as medicinal products. Some essential oils are available as licensed medicinal products, e.g. peppermint oil capsules, although such products are conventional medicines, not aromatherapy products. These examples highlight the possible confusion for both pharmacists and patients.
Pharmacies and pharmacists have several roles in the provision of CAM. Community pharmacies are a major source of complementary medicines for people who purchase and self-treat with these products. Pharmacists may also be asked for information and advice on self-treatment with complementary medicines. In addition, community pharmacists may be presented with NHS (FP10) prescriptions for homoeopathic medicines. Some independent pharmacies provide consulting rooms that are available for use on a sessional basis by CAM practitioners, and a similar initiative was recently adopted by some branches of a large multiple, which offered consultations with practitioners of several CAM therapies, including homoeopathy, herbalism and osteopathy. Also, there are several community pharmacies which specialize in CAM, e.g. homoeopathic pharmacies which offer professional homoeopathic pharmaceutical services.
Pharmacists’ involvement with CAM is not limited to the community. Pharmacists employed in NHS homoeopathic hospitals provide pharmaceutical services in the pharmacy and on the wards. Pharmacists employed in conventional NHS hospitals may be involved with the supply of certain complementary medicines.
In September 1999, the Science Committee of the Royal Pharmaceutical Society of Great Britain (RPSGB) set up a working group on complementary and alternative medicine to examine issues in this area of importance to pharmacy and pharmacists.
Pharmacists’ involvement in the provision of CAM at any level raises several issues, particularly with regard to pharmacists’ knowledge of and training in CAM, their professional accountability and the quality, safety and efficacy of complementary medicines sold or supplied. The RPSGB Code of Ethics states that pharmacists providing homoeopathic or herbal medicines or other complementary therapies have a professional responsibility:
Almost all pharmacies sell complementary medicines, particularly herbal medicines and homoeopathic remedies. The majority of pharmacists are asked for and ‘recommend’ specific complementary medicines. However, the extent of teaching on pharmacognosy (the scientific discipline which covers the chemistry, biological and clinical effects of natural products, particularly plants) and herbal and complementary medicines in the MPharm programme is limited and varies between schools of pharmacy. Furthermore, the majority of practising pharmacists have not undertaken or received training in areas of CAM, although Centre for Pharmacy Postgraduate Education (CPPE) training manuals are freely available in England.
Pharmacists’ training in CAM should not be limited to complementary medicines. It should include an awareness of the background to, evidence for and safety concerns with regard to complementary therapies such as acupuncture. This is because patients’ use of such treatments may have implications for pharmaceutical care. For example, research involving community pharmacists in the USA has suggested that some patients with chronic conditions temporarily or permanently use complementary therapies instead of their prescribed medicines. This has also been shown to have an effect during surgical operations (Ang-Lee et al 2001).
At present, pharmacists’ professional practice with regard to complementary medicines is not optimal. Many pharmacists do not routinely ask customers and patients specifically about their use of complementary medicines, nor record such use on patient medication records. Pharmacists are encouraged to apply principles of good professional practice with regard to complementary medicines, and to be aware that patients’ use of complementary medicines may have implications for pharmaceutical care. For example, it is possible that patients may use complementary medicines in addition to, or instead of, conventional medicines, without telling their doctor or pharmacist. The concurrent use of complementary medicines, particularly herbal medicines, and conventional drugs is of concern as there is a potential for interactions to occur. For example, important interactions have been documented between St John’s wort and certain prescribed medicines, including warfarin, digoxin, theophylline, ciclosporin, HIV protease inhibitors, anticonvulsants and oral contraceptives. Many other examples have been reported.
The role of the pharmacist in reporting suspected adverse drug reactions (ADRs) associated with herbal medicines has been recognized by the MHRA. In November 1999, the MHRA Yellow Card scheme for ADR reporting was extended to include reporting by all community pharmacists (hospital pharmacists were granted reporter status in April 1997) (see Ch. 47). Community pharmacists are asked by the MHRA to concentrate on areas of limited reporting by doctors, namely conventional OTC medicines and herbal products. The Yellow Card scheme also applies to unlicensed herbal products. While the MHRA does not formally request reports of suspected ADRs associated with other types of unlicensed products, it is unlikely that the MHRA would ignore a genuine report of a serious suspected ADR associated with a non-herbal unlicensed product.
It is beyond the scope of this chapter to consider evidence for the efficacy and safety of individual complementary medicines and complementary therapies. Evidence from randomized controlled trials for the efficacy of complementary therapies for specific conditions is rare, but a search of the Cochrane Library database reveals varying evidence of efficacy for a range of CAM products.
This is not to say that such approaches are not efficacious, rather that for many, rigorous research has not been carried out. There are several reasons for this, including a lack of research funding for and research infrastructure in CAM.
Similarly, CAM is often assumed to be ‘safe’, but this assumption is not based on appropriate studies. In fact, some complementary therapies have been associated with serious adverse effects. In addition, formal spontaneous reporting schemes (i.e. similar to the MHRA Yellow Card scheme for ADR reporting) do not exist for ‘manual’ complementary therapies, such as acupuncture, chiropractic and osteopathy.
The relative lack of research in CAM means that there is also a lack of evidence-based information on which to base treatment decisions for specific patients. Nevertheless, there are several sources of information in CAM, including specialist databases and specialist fields within established databases. Several reference texts written by pharmacists have summarized and critiqued the available evidence in areas of CAM (see Appendix 5 for further reading suggestions). An MHRA document, ‘Safety of herbal medicinal products’, lists intrinsically toxic constituents of herbal ingredients, a number of quality related issues, herb–drug interactions and precautions in specific patient groups.
On the basis of current trends in market research data, it has been predicted that sales of complementary medicines will continue to increase (Mintel International 2005). Longitudinal data on the utilization of complementary therapists are not available for the UK, although increasing numbers of such practitioners may suggest increasing public demand for holistic treatment with these therapies. In addition, the increasingly widespread marketing and sale of these products demonstrates the interest of large sections of the public to control their health by using these products.
With the EU directive on traditional herbal medicinal products, the future is set to bring improved quality standards for these preparations – manufacturers will need to meet standards for GMP, or remove their products from the market. Initiatives involving ethnic medicines are also aimed at improving quality standards for these preparations. However, as this sector is less developed in the UK, it is likely that improvements in the quality of ethnic medicines will be seen over a longer time period.
Improvements in quality standards, together with other requirements in the traditional herbal medicinal products directive, will put an increased emphasis on manufacturers to provide evidence supporting the safety of their products. At the same time, the increasing use of herbal medicines, particularly by patients using conventional drugs and those with serious chronic illness, may result in the emergence of new safety concerns, such as indications of uncommon ADRs, those occurring with long-term use and interactions with conventional medicines.
Against a background of widespread and increasing use of CAM, it is recognized that CAM practitioners need to be regulated, and that conventional healthcare professionals need to be knowledgeable about complementary medicines and therapies. The House of Lords Select Committee on Science and Technology’s (2000) report on CAM made several recommendations with regard to statutory regulation of those who practise CAM (see above), and these recommendations were accepted by the government (Department of Health 2001). Thus, in the future, conventional healthcare professionals should have a basic knowledge of complementary medicines and therapies, and doctors, pharmacists and others may interact with state-registered CAM practitioners.
In its response to the House of Lords’ report, the government stated that if a therapy gains a critical mass of evidence, the NHS and the medical profession should ensure that the public has access to that therapy. Thus, in addition to homoeopathic treatment, which is already available through the NHS, certain complementary therapies and licensed complementary medicines with a sound evidence base may also be available on NHS prescriptions.
In the long term, the future for ‘complementary medicines’, particularly herbal medicines and nutraceuticals, may lie with pharmacogenetics and pharmacogenomics. These relatively new fields of research are widely held to be central to the discovery of new drugs and to the future of therapeutics. Yet the pharmacogenetics of ADRs, and optimizing treatment on the basis of a patient’s genotype, has not been discussed in the context of herbal medicines. It is reasonable to assume that individuals with a different genetic profile will have different responses to complementary medicines as well as to conventional drugs.
The distrust of traditional CAM in the 1970s and 1980s has of course been followed not only by increased public awareness of their possible benefits, but also by major investigation by pharmaceutical companies, and by government and institutional researchers. This has led to recent (in terms of the historical development of conventional medicine) development of single product plant medicines, such as galantamine (Narcissus cultivars), atracurium (intermediate from Leontice leontopetalum), artesunate and artemether (Artemesia spp.), and taxol (Taxus spp.), with the prospect of more chemical entities being derived from CAM.